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Week Ending: June 30th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
June 24th, 2007
Iron in foods may affect hepatitis C prognosis
http://www.yomiuri.co.jp
The Yomiuri Shimbun
Some health food products containing turmeric, chlorella and other substances can hinder the prognosis of patients with chronic hepatitis C liver disease, because the additives include iron levels that exceed the recommended daily average without indicating that on the label, according to a group of researchers.
About 2 million people suffer from hepatitis C. Healthy people do not need to worry about excessive iron intake, but it can accumulate in the liver of patients with the disease.
Excessive iron can create oxidized cells, which destroy liver cells or contribute to the development of liver cancer.
Masahiko Kaito, an associate professor of liver internal medicine at Mie University, and other researchers examined the amount of iron in 67 health food products taken by patients being treated at a university-affiliated hospital.
They found that chlorella tablets include 138.3 milligrams of iron per 100 grams, equivalent to 11.1 milligrams on a daily basis, exceeding the recommended daily average intake of 8.1 milligrams for male adults.
Among other products, kale tablets included 127.2 milligrams of iron per 100 grams, while multivitamin tablets contained 118.7 milligrams of iron per 100 grams. Another product containing turmeric contained 22.4 milligrams of iron per 100 grams.
Kaito has been recommending patients take less than 6 milligrams of iron per day. The liver function of a patient who had ingested a daily total of 8.5 milligrams of iron from 11 health food products reportedly improved after the patient discontinued them.
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BreathID completes clinical trial
http://www.globes.co.il
Gali Weinreb
The company tested its system in the diagnosis of liver disease.
BreathID Ltd. (TASE:BRTI), which was floated a month ago, announced today that it successfully completed a trial on 15 patients with Acute Liver Disease.
The trial, which was conducted at the Hadassah Medical Center assessed the patients using BreatheID's non-invasive device, which diagnoses diseases of the liver and other symptoms by analyzing the composition of the air exhaled from the patients' lungs. The results were then compared with those obtained from the existing procedures for monitoring these patients. It was found that BreathID's device produced similar results to those of the existing testing procedures, without having to wait a day or more for the results.
BreatheID's system is a diagnostic device so the company will be able to begin marketing it to for use in trials at leading medical centers, although its commercial success will depend on the completion of trials on a larger scale. BreathID has already successfully completed trials of its device on patients with Hepatitis C and Non Alcoholic Fatty Liver Disease.
Published by Globes [online], Israel business news - www.globes.co.il - on June 24, 2007
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Doctor sued in spread of hepatitis C
http://www.sciencedaily.com
NEW YORK, June 24 (UPI) -- Two more people have contracted hepatitis C after receiving intravenous anesthesia from a doctor in New York who is under investigation.
Dr. Brian Goldweber, 64, is accused of spreading the disease by failing to follow proper infection control protocols, The New York Post reported Sunday.
A 45-year-old woman with a prominent corporate post filed a lawsuit last week against Goldweber and three other doctors at the Manhattan practice, where she underwent a colonoscopy in 2004.
She filed her suit as "Jane Doe" due to what she called the "stigma, discrimination and embarrassment" of a hepatitis C infection, which typically affects drug addicts and the sexually promiscuous (sic).
Another woman has notified the city Health Department after contracting hepatitis C after an outpatient procedure. That notification brings the number of possible victims to at least five, the Post said.
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June 25th, 2007
Giaconda Announces Commencement of Clinical Trial for Hepaconda® in Hepatitis C
http://www.aspecthuntley.com.au
Sydney, Australia 25 June 2007. Giaconda Ltd (ASX: GIA) announced that a Phase IIa clinical trial of Hepaconda® for the treatment of Hepatitis C virus (HCV) genotype 1 refractory to current therapy has commenced. The study is being carried out by the Centre for Digestive Diseases and the first patient has been enrolled in the trial and begun treatment.
The current standard treatment for chronic HCV has limited efficacy, especially in genotype 1 and poor tolerability with the result that many patients cease treatment. Genotype 1 Hepatitis C virus has the lowest response rate to standard treatment compared to other genotypes and carries a higher risk of post-treatment relapses and progression to liver cirrhosis and liver cancer.
Hepaconda® is a combination of bezafibrate and chenodeoxycholic acid, both of which have demonstrated activity against HCV as single compounds. Giaconda believes that the combination of bezafibrate, with chenodeoxycholic acid may offer a synergistic advantage over current treatment.
The clinical trial is a two centre, open label, prospective study of the efficacy and safety of the combination of chenodeoxycholic acid and bezafibrate in the treatment of subjects diagnosed with Hepatitis C Virus genotype 1, who have failed standard therapy (peg-interferon and Ribavirin combination therapy).
The primary endpoints of the trial are to obtain a virological response and a reduction in viral load at 3 months and 6 months. The secondary objectives are to obtain clinically significant improvements in elevated liver function tests at 3 and 6 months and to obtain an acceptable safety profile. Subject to recruitment, it is anticipated that the trial will finish by the end of 2007 and that results will be made available in 2008. (Further details in the Appendix 1)
“Hepatitis C is a significant health issue across the globe and a significant number of patients fail conventional treatment,” said Professor Tom Borody, Chief Medical Officer of Giaconda.
“We are committed to developing an alternative for these patients and we believe that Hepaconda® may offer such an alternative.”
About Giaconda Limited
Giaconda Limited is a biotechnology company involved in developing and licensing innovative and cost effective medical therapies in the field of gastroenterology. Giaconda’s products are targeted towards the treatment of serious conditions that are not adequately addressed by any existing therapy. In this way, Giaconda’s products are intended to satisfy these significant unmet medical needs of the gastrointestinal market. The Giaconda portfolio consists of five products, all of which are novel combinations of known compounds. Giaconda has two lead products, Myoconda® for the treatment of Crohn’s Disease and Heliconda® for the treatment of resistant Helicobacter pylori infection. Both of these products are ready for Phase III clinical trials, with a Phase IIIa already complete for Myoconda®.
For more information please visit www.giacondalimited.com
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Second Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
http://biz.yahoo.com
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced that Study 103, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread® (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint. The data show that Viread is non-inferior to the company's once-daily antiviral drug Hepsera® (adefovir dipivoxil) among patients with "e" antigen (HBeAg)-positive chronic hepatitis B. The primary efficacy endpoint, the proportion of patients with a complete response at week 48, was defined by serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two point reduction in the Knodell necroinflammatory score (a measure of necro-inflammation - an inflammatory process in the liver including or leading to death of liver cells) with no concurrent worsening of fibrosis (scarring of liver tissue).
At 48 weeks, 66.5 percent of patients in the Viread arm (n=176) had a complete response compared to 12.2 percent in the Hepsera arm (n=90; p less than 0.001). The most commonly observed treatment-emergent adverse events of moderate intensity or higher were abdominal pain, back pain, headache, respiratory infections and transaminase elevations. The incidence of these events was comparable between the Viread and Hepsera arms of the study. In addition, the most frequently observed grade 3 or 4 laboratory abnormalities were elevations in transaminase and serum amylase and were comparable between the two arms. Full study results will be submitted for presentation at an upcoming scientific meeting.
Study 103 is the second of two Phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B to have met its primary efficacy endpoint. Earlier this month, the company announced that the first study (Study 102) met its primary 48-week efficacy endpoint showing that Viread is non-inferior to Hepsera among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B.
"The preliminary data observed in both Phase III trials evaluating Viread as a potential treatment option for chronic hepatitis B are very encouraging," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. "We look forward to reviewing these data with regulatory authorities and are working quickly to file a New Drug Application in the United States and Marketing Authorisation Application in Europe in the fourth quarter of this year."
The active ingredient in Viread, tenofovir DF, is currently the most prescribed molecule in the United States for combination HIV therapy. Viread received approval as an anti-HIV medication from the U.S. Food and Drug Administration (FDA) in October 2001 and from the European Commission in February 2002. Viread is not approved as a treatment for chronic hepatitis B, and data from this analysis have not been reviewed by the FDA.
Study Design
Study 103 is a multi-center, randomized, double-blind Phase III clinical trial that compares the efficacy, safety and tolerability of Viread and Hepsera over 48 weeks among patients with HBeAg-positive chronic hepatitis B. Two hundred and sixty-six patients were randomized in a 2:1 ratio to receive either Viread (300 mg once daily; n=176) or Hepsera (10 mg once daily; n=90).
About Viread (tenofovir disoproxil fumarate)
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Viread should not be used in combination with the fixed-dose combination products Truvada® or Atripla(TM) because they already contain Viread.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Viread is not approved for the treatment of chronic hepatitis B and the safety and efficacy of Viread have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue Viread. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of Viread. It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy with Viread and as clinically appropriate during therapy. Coadministration of Viread and didanosine should be undertaken with caution. Patients should be monitored closely for didanosine-associated adverse events, and didanosine should be discontinued if these occur. Patients on atazanavir and lopinavir/ritonavir plus Viread should be monitored for Viread-associated adverse events, and Viread should be discontinued if these occur. When co-administered with Viread, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Viread.
Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Changes in body fat have been observed in patients taking anti-HIV medicines. The cause and long-term health effect of these changes are unknown. Immune Reconstitution Syndrome has been reported in patients treated with combination therapy, including Viread.
The most common adverse events among patients receiving Viread with other antiretroviral agents in a pivotal clinical study (Study 903) were mild to moderate gastrointestinal events and dizziness. Moderate to severe adverse events occurring in more than 5 percent of patients receiving Viread included rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash and pustular rash), headache, pain, diarrhea, depression, back pain, fever, nausea, abdominal pain, asthenia (weakness) and anxiety. In another pivotal study (Study 907), less than 1 percent of patients discontinued participation because of gastrointestinal events.
It is important for patients to be aware that anti-HIV medicines including Viread do not cure HIV infection or AIDS and do not reduce the risk of transmitting HIV to others. Full prescribing information is available at www.GileadHIV.com.
The parent compound of Viread was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium.
About Hepsera
Hepsera, a nucleotide analogue for the treatment of chronic hepatitis B, works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.
In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The adverse reactions considered at least possibly related to treatment reported in 3 percent or greater of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia, headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With extended treatment, mild to moderate increases in serum creatinine were observed uncommonly in patients with chronic hepatitis B and compensated liver disease treated with Hepsera for a median of 49 weeks up to a maximum of 240 weeks. Changes in serum creatinine were observed very commonly in patients pre- and post-transplantation with lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, and the occurrence of lactic acidosis and severe hepatomegaly with steatosis. Dosing instructions for patients with underlying renal impairment and for patients co-infected with HIV are also provided in the package insert, which is available for download online at www.hepsera.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead's ability to successfully commercialize tenofovir DF for chronic hepatitis B. For example, safety and efficacy data from additional clinical studies may not warrant further development of this compound for the treatment of chronic hepatitis B and completing our clinical studies may take longer or cost more than expected. In addition, feedback from regulatory authorities or results from clinical trials might require modifications or delays in later stage clinical trials or additional trials to be performed. Further, the FDA and other regulatory authorities may not approve tenofovir DF for the treatment of chronic hepatitis B, and marketing approval, if granted, may have significant limitations on its use and physicians and may not see advantages of tenofovir DF over other treatment options and may therefore be reluctant to prescribe tenofovir DF for chronic hepatitis B. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2006 and its Quarterly Report on Form 10-Q for the first quarter of 2007, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Hepsera and Viread are registered trademarks of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com .
Contact:
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
James Loduca, 650-522-5908 (Media)
www.gilead.com
Source: Gilead Sciences, Inc.
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PEGINTRON(TM) and REBETOL(R) Combination Therapy Approved in European Union for Treating Hepatitis C in Patients Coinfected With HIV
http://biz.yahoo.com/
KENILWORTH, N.J., June 25 /PRNewswire--FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today announced that the European Commission has approved combination therapy with PEGINTRON(TM) (peginterferon alfa-2b, 1.5 mcg/kg once weekly) and REBETOL® (ribavirin, 800 - 1,200 mg daily) for the treatment of previously untreated adult patients with chronic hepatitis C who are coinfected with clinically stable HIV. Approximately 40 percent of the estimated 2.5 million people living with HIV in Europe are coinfected with the hepatitis C virus (HCV), according to the World Health Organization (WHO).
The European Commission approval of this expanded indication for PEGINTRON and REBETOL results in Marketing Authorization with unified labeling that is valid in the current European Union (EU) 27 member states as well as in Iceland and Norway. PEGINTRON and REBETOL were previously approved in the EU for treating adult patients with chronic hepatitis C alone.
"Effective treatment of HCV is critically important for people coinfected with HIV, as liver disease caused by chronic HCV infection is now a leading cause of morbidity and mortality among these patients," said Josep Mallolas, M.D., Ph.D., Infectious Diseases Service, Hospital Clinic Universitari de Barcelona, Spain, and a lead author of one of the published studies supporting the approval. "For patients already facing the complex challenge of managing their HIV infection, the efficacy and predictability of response with PEGINTRON and REBETOL combination therapy provides an important new option for treating HCV."
In two clinical studies, HCV/HIV coinfected patients treated with PEGINTRON combination therapy achieved higher statistically significant sustained virological response (SVR) rates overall compared to conventional interferon alfa-2b and ribavirin.(1,2) SVR is defined as undetectable HCV-RNA six months following the end of treatment and is the standard measure of treatment success for hepatitis C.
Importantly, PEGINTRON combination therapy demonstrated a predictable response in HCV/HIV coinfected patients. Early virological response by treatment week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for SVR. The negative predictive value for SVR in HCV/HIV coinfected patients treated with PEGINTRON combination therapy was 99 percent.(1)
"This means patients with hepatitis C who fail to achieve an early virological response are highly unlikely to become sustained virological responders and can have their therapy stopped," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "This predictability of response provided by PEGINTRON combination therapy can be a very effective tool in the management of coinfected patients, who are at greater risk for treatment-related adverse events."
Clinical Studies
The European Commission approval of PEGINTRON and REBETOL combination therapy for HCV/HIV coinfection is based on the results of two published clinical studies in previously untreated adult patients with chronic hepatitis C who were coinfected with HIV. RIBAVIC(1) was a multicentre study that randomized 412 patients to receive either PEGINTRON or conventional interferon alfa-2b (3 MIU three times weekly) in combination with flat-dosed ribavirin (800 mg daily) for 48 weeks. The second study(2) was a randomized, single- centre study in which 95 patients were randomized to receive either PEGINTRON or conventional interferon alfa-2b in combination with weight-based REBETOL (800-1,200 mg daily) for 48 weeks, except for patients infected with HCV genotypes 2 or 3 and HCV viral load less than 800,000 IU/ml who were treated for 24 weeks.
Based on the results of these studies, the recommended duration of dosing with PEGINTRON and REBETOL combination therapy for HCV/HIV coinfected patients is 48 weeks, regardless of HCV genotype.
PEGINTRON in the European Union
PEGINTRON and REBETOL combination therapy for chronic hepatitis C was approved in the EU in March 2001. The recommended dose in the EU for combination therapy for all patients, whether HCV coinfected with HIV or HCV alone is PEGINTRON 1.5 mcg/kg once weekly plus REBETOL 800-1,200 mg daily, adjusted to body weight. The recommended duration of treatment is 24 weeks for patients with HCV genotype 1 and low viral load, or HCV genotype 2 or 3. For patients with HCV genotype 1 and high viral load, HCV genotype 4 or with HCV/HIV coinfection regardless of genotype, the recommended duration of treatment is 48 weeks. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.
PEGINTRON in the United States
In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
WARNING
Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEGINTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEGINTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEGINTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or
during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEGINTRON
There are no new adverse events specific to PEGINTRON as compared to INTRON® A (Interferon alfa-2b, recombinant) for Injection; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu- like" symptoms, occurring in approximately 50 percent of patients, which may decrease in severity as treatment continues. Application site disorders were common (47 percent), but all were mild (44 percent) or moderate (4 percent) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2 percent of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57 percent) with PEGINTRON but similar to INTRON A (58 percent). Depression was most common at 29 percent. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1 percent of patients during or shortly after completing treatment with PEGINTRON.
PEGINTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia). The following serious or clinically significant adverse events have been reported at a frequency less than 1 percent with PEGINTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL combination trial the incidence of serious adverse events was 17 percent in the PEGINTRON/REBETOL groups compared to 14 percent in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23 percent in the INTRON A/REBETOL group and 31-34 percent in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42 percent of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34 percent of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential of and the potential market for PEGINTRON and REBETOL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in the company's first quarter 2007 10-Q.
References:
1. Carrat F, Bani-Sadir F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
2. Laguno M, Murillas J, Blanco J et al. AIDS 2004; 18(13): F27-F36.
Source: Schering-Plough Corporation
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Association of Hepatitis C Seropositivity With Increased Risk for Developing End-stage Renal Disease
http://archinte.ama-assn.org
Judith I. Tsui, MD, MPH; Eric Vittinghoff, PhD; Michael G. Shlipak, MD, MPH; Daniel Bertenthal, MS; John Inadomi, MD; Rudolph A. Rodriguez, MD; Ann M. O’Hare, MD, MA
Arch Intern Med. 2007;167:1271-1276.
Background
Infection with chronic hepatitis C virus (HCV) has been linked to glomerulonephritis. We undertook this study to determine whether having a positive HCV test result was associated with an increased risk for developing treated end-stage renal disease (ESRD).
Methods
Using data from Medicare, the Department of Veterans Affairs, and the United States Renal Data System, we performed a retrospective cohort study of 474 369 adult veterans who had serum creatinine levels measured between October 1, 2000, and September 30, 2001, and HCV antibody testing within 1 year of creatinine testing. Patients were followed up until October 1, 2004, for the outcome of treated ESRD, defined as the onset of chronic dialysis or renal transplantation. Cox proportional hazards models were used to determine the relative hazard for ESRD associated with HCV, adjusted for other covariates (age, sex, race/ethnicity, and comorbidities).
Results
Of 474 369 patients in the cohort, 52 874 (11.1%) had a positive HCV antibody test result. Patients with HCV were more likely to develop ESRD: the rate per 1000 person-years was 4.26 (95% confidence interval, 3.97-4.57) for HCV-seropositive patients vs 3.05 (95% confidence interval, 2.96-3.14) for HCV-seronegative patients. For patients aged 18 to 70 years with an estimated glomerular filtration rate of at least 30 mL/min per 1.73 m2, HCV seropositivity was associated with a greater than 2-fold risk for developing ESRD (adjusted hazard rate, 2.80; 95% confidence interval, 2.43-3.23).
Conclusion
In this large national cohort of adult veterans, patients younger than 70 years with HCV seropositivity were at increased risk for developing ESRD treated with dialysis or transplantation.
Author Affiliations:
Departments of Medicine (Drs Tsui, Vittinghoff, Shlipak, Inadomi, Rodriguez, and O’Hare) and Epidemiology and Biostatistics (Drs Vittinghoff and Shlipak), University of California, San Francisco, Department of Medicine (Drs Tsui, Shlipak, and O’Hare) and Health Services Research and Development Research Enhancement Award Program (Mr Bertenthal), Veterans Affairs Medical Center, and Department of Medicine, San Francisco General Hospital (Drs Inadomi and O’Hare), San Francisco.
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June 26th, 2007
Vaccine May Ease Drug Addition Withdrawal
http://www.vaccinerx.com
Written by OJ Fagbire
Research results released by scientists at Baylor College of Medicine (BCM) revealed that a new vaccine pair might relieve addition to cocaine and methamphetamine while easing symptoms of withdrawal.
The vaccines work by targeting the drug while still in the bloodstream but before it reaches the brain, which prevents the feelings that lead to dependency.
"These are therapeutic, not preventative vaccines," stated Dr. Thomas Kosten, the lead investigator at BCM, "They are meant for those who are already suffering from drug addiction"
Dr. Kosten goes on the say that the vaccine may help overcome addition but does not guarantee against relapse. The patient needs to pair the use of the vaccine with counseling to deal with the reasons behind the drug use in the first place.
The vaccines aren't one-shot deals either; recipients can expect several injections over a three-month time span. FDA approval is expected after one-more large-scale test. "The vaccine slowly decreases the amount of cocaine that reaches the brain," said Kosten, "It's a slow process, and patients do not go through an significant withdrawal symptoms."
The vaccine against methamphetamine is still in its infant stage but has shown results much like the cocaine vaccine. It is the different protein composition that determines which drug the vaccines are effective against.
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Dynavax Starts HEPLISAV(TM) Phase 3 in Europe; U.S. Study; and Phase 2 in ESRD in Canada
http://biz.yahoo.com
Licensure-directed clinical trials in place for planned 2008 BLA
BERKELEY, Calif., June 26 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX - News) announced today the initiation of three clinical trials to support licensure of HEPLISAV(TM), its novel hepatitis B virus (HBV) vaccine:
- The ongoing multi-center pivotal Phase 3 trial in Canada has been expanded to include seven sites in Germany as planned;
- A U.S. study is enrolling subjects 11 through 55 years of age. The data from the U.S. study, plus the Phase 3 trials in Canada and Europe, and subsequent lot-to-lot consistency trials will contribute to a safety database of approximately 4,000 subjects for a planned BLA submission in 2008. The lot-to-lot consistency studies will compare three consecutive lots of HEPLISAV manufactured at Dynavax Europe and are planned to begin in the second half of the year in the U.S., Canada, and Germany.
- A Phase 2 trial in patients with end-stage renal disease (ESRD) has been approved by Health Canada and is expected to begin enrolling subjects shortly.
According to President and Chief Executive Officer Dino Dina, M.D., "These three trials are critical milestones on the regulatory path for the licensure of HEPLISAV and for commercialization of this novel vaccine. With the trials in place, we can efficiently build upon the already strong safety and immunogenicity database for HEPLISAV and begin preparing for our BLA submission planned for the second half of 2008."
Enrollment in the multi-center Phase 3 pivotal trial, known as PHAST (Phase 3 HeplisAv Short-regimen Trial) began in Germany on June 14. This comparative immunogenicity trial, initiated in late 2006 in Canada, is enrolling subjects 11 through 55 year of age. The trial compares a two-dose regimen of HEPLISAV administered at 0 and 1 month to the conventional three- dose regimen of Engerix-B marketed by GlaxoSmithKline. The total enrollment target for the Phase 3 pivotal study in Canada and in Germany is approximately 2,000 subjects.
An immunogenicity and safety study in the United States began enrolling subjects in early June. Consistent with the PHAST trial, subjects 11 through 55 years of age are receiving a two-dose regimen of HEPLISAV, at 0 and 1 month. The primary endpoint of this trial will be measured four weeks after the second dose.
A Phase 2 trial evaluating the safety and immunogenicity of two different doses of HEPLISAV was approved by Health Canada to begin enrolling ESRD patients in Canada. The trial will enroll adults 40 through 70 years of age who have progressive loss of renal function (GFR less than or equal to 45 mL/min) and are either pre-dialysis or hemodialysis patients. This is a difficult-to-immunize patient population for whom conventional hepatitis B vaccines have shown limited efficacy.
About HEPLISAV
Dynavax's HBV vaccine, HEPLISAV, is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. HEPLISAV combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection. Previously reported clinical trials results have shown 100% seroprotection after two doses in subjects 18 to 39 years of age and after three doses in difficult-to-immunize subjects 40 to 70 years of age.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapy; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinical hepatitis C therapeutic program. While the NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com .
This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about the initiation of clinical trials for HEPLISAV, the potential safety and efficacy of HEPLISAV and the potential for HEPLISAV to meet regulatory requirements and achieve clinical and commercial success. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; achieving our collaborative and licensing agreement objectives and obtaining regulatory approval; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Source: Dynavax Technologies Corporation
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Medical Marijuana
http://www.newschannel5.com
For more than 4,000 years it was used medicinally. Then in 1942 medical marijuana was banned in the United States, but that's not the end of the story. Today, patients with illnesses like cancer, AIDs and MS say it relieves pain and reduces nausea from their meds, and is the only thing that got them through.
Brian Klein takes three pills twice a day for HIV. He's also recovering from Hepatitis C.
"It was pretty devastating getting both at the same time," Klein said.
Hep-C meds are known for their severe side effects -- like nausea. Klein tried lots of treatments to relieve it, but only one worked - marijuana.
"Within a few minutes I could go eat, whereas before, before using it, I couldn't even keep down water. So it was amazing, dramatic difference," Klein said.
A study on Hep-C patients showed smoking pot made them three-times more likely to get rid of the virus, because it got them through treatment.
"If there's a patient for whom that medicine doesn't work, and they do get benefit from marijuana, then that could really be the difference between life and death."
Donald Abrams is a long-time HIV researcher and oncologist and has studied the use in patients.
"When we talk about the side effects, if you will, of marijuana compared to many, many prescription drugs that doctors prescribe on a daily basis, it's really quite safe," Abrams said.
But although medical marijuana is allowed in 12 states, the federal government has declared it "is not medicine" and "not safe." Opponents believe much more research is needed and that it's linked to a higher risk of cancer, heart attack and brain damage.
For Klein, it was a short term fix. He's free of the Hep-C virus and has the energy to do simple things like read and even exercise.
"This was relieving my nausea, and it worked. And I didn't need it for anything more or less," Klein said.
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June 27th, 2007
Update on Migenix Agreement with Schering-Plough for Hepatitis C Virus Treatment
http://pharmalive.com
VANCOUVER and SAN DIEGO, June 27, 2007 /PRNewswire-FirstCall/ - MIGENIX Inc. , a clinical-stage developer of drugs for infectious diseases, has received notice that Schering-Plough Corporation ("Schering") will not enter into a second period of exclusivity to negotiate terms of a license agreement for MIGENIX's Hepatitis C Virus ("HCV") product, celgosivir. MIGENIX is, therefore now free to advance discussions with other interested parties. Schering has expressed a willingness to consider providing MIGENIX with guidance on study design and drug supplies in support of celgosivir's further clinical development. The exclusivity with Schering arose in connection with the terms of a Material Transfer and License Option Agreement between MIGENIX and Schering related to a recently completed Phase II non-responder study of celgosivir.
Jim DeMesa, M.D., President and CEO of MIGENIX stated, "The results from the recent non-responder study demonstrated clinically significant benefits when celgosivir was added to the standard of care (pegylated interferon plus ribavirin). Those results have increased the interest of both the clinical community and of several pharma and biotech companies active in HCV product development. Because celgosivir offers a unique mechanism of action, once-daily oral dosing, a good safety profile, and has demonstrated synergy with other HCV treatments, we are optimistic about the potential of celgosivir to contribute to the treatment of HCV patients."
About Celgosivir (MX-3253)
Celgosivir, an oral inhibitor of alpha-glucosidase I, is currently the only anti-HCV drug in clinical development that acts on host-directed glycosylation. In preclinical studies, celgosivir has shown excellent in vitro synergy with various interferons in the clinic or in development including Pegasys, PEG-Intron, Infergen, Alferon and IFN-omega (with or without ribavirin) and other drugs in development for the treatment of HCV (e.g. polymerase inhibitors) and therefore has the potential to be included in many combination therapy approaches to improve efficacy in anti-HCV treatment.
The Phase II non-responder combination study reported April 11, 2007 was designed to determine, over 12 weeks of treatment, the efficacy, safety, and tolerability of celgosivir in combination with peginterferon alfa-2b, with or without ribavirin, in HCV-positive (genotype 1) patients who were non-responders or partial responders to prior therapy with optimized pegylated interferon and ribavirin. The following is a summary of the non-responder data:
- a 42% Early Virologic Response ("EVR") with the triple combination compared to a 10% EVR in the control treatment arm. (x) EVR = 2 log10 or greater HCV viral load reduction at 12 weeks.
- a mean HCV viral load reduction ("VLR") of 1.63 log10 (triple combination) compared to a 0.92 log10 reduction (control).
- 90% viral load reduction (1 log10) reduction, or greater, at 12 weeks in 66% (8/12) of the triple combination patients, compared to only 40% (4/10) in patients in the control treatment.
- EVR in 57% of null responders (4/7) in the triple therapy arm (null responders = patients who have not achieved greater than a 0.4 log10 viral load reduction on prior treatment with optimized peg-interferon plus ribavirin).
Celgosivir combination therapy was well tolerated and resulted in no significant adverse events. As expected from previous experience, the most frequent side effects related to celgosivir were gastrointestinal in nature and were generally mild. Other frequently observed side effects were fatigue and flu-like symptoms - which are side effects usually associated with pegylated interferon and ribavirin. Fifty of 57 patients entering the study completed all 12 weeks of treatment.
Material Transfer and License Option Agreement with Schering-Plough
Under the terms of the Agreement, Schering supplied PEGETRON(TM) (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) as well as certain technical and laboratory support and other services for MIGENIX's celgosivir Phase II combination study in chronic HCV patients and a related extension protocol. In addition, the Agreement granted Schering limited periods of exclusivity for data review of clinical trial results and for the negotiation of a license agreement.
About HCV
HCV, the most common chronic blood-borne infection in the United States, causes inflammation of the liver and may progress to more serious complications such as cirrhosis of the liver, liver cancer and death. Approximately 2.7 million people in the United States are chronically infected with HCV, and the Centers for Disease Control and Prevention (CDC) estimates that by the year 2010, the number of deaths attributed annually to HCV could surpass that due to HIV/AIDS in the US. Worldwide, the World Health Organization estimates that 170 million individuals have chronic HCV infection, with 3 to 4 million new infections each year.
Therapy for HCV currently employs a drug combination approach, which is anticipated to continue in the future. The current standard of care for treatment-naive chronic hepatitis C is pegylated interferon combined with ribavirin, which fails to provide a satisfactory outcome for approximately 50% of patients infected with HCV genotype 1 (the most prevalent genotype in North America). In addition, these drugs can cause significant side effects that limit tolerance to therapy, or a frequent lack of sustained treatment response.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs primarily in the area of infectious diseases. The Company's clinical programs include drug candidates for the treatment of chronic hepatitis C infections (Phase II and preclinical), the prevention of catheter-related infections (Phase III) and the treatment of dermatological diseases (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.
"Jim DeMesa"
James M. DeMesa, M.D.
President & CEO
FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, and forward looking information within the meaning of applicable securities laws in Canada, (collectively referred to as "forward-looking statements"). Statements, other than statements of historical fact, are forward-looking statements and include, without limitation, statements regarding our strategy, future operations, timing and completion of clinical trials, prospects, plans and objectives of management. The words "anticipates", "believes", "budgets", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "projects", "schedule", "should", "will", "would" and similar expressions are often intended to identify forward-looking statements, which include underlying assumptions, although not all forward-looking statements contain these identifying words. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other things contemplated by the forward-looking statements will not occur.
Although our management believes that the expectations represented by such forward-looking statements are reasonable, there is significant risk that the forward-looking statements may not be achieved, and the underlying assumptions thereto will not prove to be accurate. Forward-looking statements in this news release include, but are not limited to, statements concerning: our expectations for advancing discussions with parties interested in celgosivir; and celgosivir having the potential to be included as part of many combination therapy approaches to improve efficacy in anti-HCV therapy.
With respect to the forward-looking statements contained in this news release, we have made numerous assumptions regarding, among other things, our ability to successfully advance discussions with parties interested in celgosivir, our ability to manage licensing opportunities; the competitiveness of the celgosivir study results to date and future results supporting its potential in the treatment of HCV.
Actual results or events could differ materially from the plans, intentions and expectations expressed or implied in any forward-looking statements, including the underlying assumptions thereto, as a result of numerous risks, uncertainties and other factors including: uncertainties related to early stage of technology and product development; uncertainties as to the requirement that a drug be found to be safe and effective after extensive clinical trials and the possibility that the results of such trials, if completed, will not establish the safety or efficacy of our products; dependence on corporate collaborations; uncertainties as to future expense levels and the possibility of unanticipated costs or expenses or cost overruns; the possibility that opportunities will arise that require more cash than presently anticipated and other uncertainties related to predictions of future cash requirements; and other risks and uncertainties which may not be described herein. Certain of these factors and other factors are described in detail in the Company's Final Prospectus dated November 29, 2006, Annual Information Form and Annual Report on Form 20-F for the year ended April 30, 2006 and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission.
Forward-looking statements are based on our current expectations and MIGENIX assumes no obligations to update such information to reflect later events or developments.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
CONTACT: Art Ayres, MIGENIX Inc., Tel: (604) 221-9666 Ext. 233, Email: ; Dian Griesel, Ph.D., Investor Relations Group, Tel: (212) 825-3210, Email: aayres@migenix.com Theproteam@aol.com
Ticker Symbol: (Toronto:MGI.),(NASDAQ-OTCBB:MGIFF)
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SciClone Initiates Phase 2 Clinical Trial Using SCV-07 to Treat Hepatitis C Patients
http://www.marketwirecanada.com
SAN MATEO, CA--(Marketwire - June 27, 2007) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced it has initiated a proof-of-concept phase 2 clinical trial using its proprietary compound SCV-07 as a sole agent to treat patients infected with the hepatitis C virus (HCV). The trial is designed to evaluate the therapeutic effect of SCV-07 on patients with HCV.
"SCV-07 has shown broad applicability in viral diseases, and we are eager to determine the therapeutic benefit of this compound for patients with HCV," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "The objective of this trial is to demonstrate SCV-07's effect on hepatitis C viral load as well as on other measures of immune response, and we expect to report data in the first quarter of 2008. If we are able to determine that SCV-07 stimulates the immune system in a method similar to that of interferon alpha, but without side effects, this could be a significant treatment advance for patients suffering from HCV."
The randomized, placebo-controlled trial plans to enroll 30 patients infected with the difficult to treat genotype 1 strain of the HCV virus who previously responded to treatment with interferon alpha and ribavirin, but subsequently relapsed. Patients will be randomized into three cohorts of escalating doses, and will receive daily subcutaneous injections of SCV-07 or placebo. After completing seven days of therapy, all patients will be monitored for 14 days. The primary endpoint of the trial will be a single-log reduction in the hepatitis C viral load.
About SCV-07
SciClone's proprietary drug candidate SCV-07 (gamma-D-glutamyl-L-tryptophan) is a synthetic peptide with proven immune stimulating effects. SCV-07 has shown efficacy in treating various viral and bacterial infections. SCV-07 specifically stimulates the immune system through its effects on T-helper 1 cells, which are essential for clearance of viral infections. In June 2007, SciClone reported that SCV-07 also inhibits melanoma tumor growth, a cancer know to be sensitive to immune modulation, in an animal model study. Additional preclinical studies with SCV-07 are ongoing.
About Hepatitis C Virus
HCV is a viral disease which attacks the liver and can lead to cirrhosis of the liver, liver cancer and death. According to the Centers for Disease Control and Prevention, approximately 3.2 million individuals in the United States are chronically infected with HCV. Approximately 75% of these chronically infected carriers are infected with the difficult to treat genotype 1 strain of the virus. Unfortunately, currently approved therapy, including the immunotherapy interferon alpha with or without the antiviral drug ribavirin, has significant side effects and is ineffective in treating most patients infected with HCV genotype 1.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead™. For the U.S. market, SciClone's clinical-stage drug development candidates are SCV-07 for the treatment of hepatitis C virus and RP101 for the treatment of pancreatic cancer. For more information about SciClone, visit www.sciclone.com.
This press release contains forward-looking statements including our statement regarding timing and expectations for an SCV-07 Phase 2 clinical trial and because the experimental or clinical data described may imply certain actual results in larger patient populations. These statements are subject to risks and uncertainties and may. Actual outcomes may differ from our forward-looking statements because of the inherent uncertainties in the timing of clinical trial events including patient enrollment. Experimental data and clinical results derived from studies with animals or a limited group of patients may not be predictive of the results of larger studies and, therefore, such experimental or clinical data is not necessarily predictive of efficacy or safety or the results of larger studies and clinical trials.
Corporate Contact:
Richard Waldron
Executive Vice President and Chief Financial Officer
SciClone Pharmaceuticals, Inc.
650-358-3437
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ViroPharma's hepatitis C drug fast tracked
http://www.bizjournals.com
Philadelphia Business Journal
The Food and Drug Administration granted fast-track status Wednesday to ViroPharma's experimental hepatitis C drug HCV-796.
The designation allows for an expedited review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. It allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package.
ViroPharma Inc. (NASDAQ:VPHM) of Exton is developing HCV-796 in a partnership with Wyeth Pharmaceuticals of Collegeville, Pa., a division of Wyeth (NYSE: WYE) of Madison, N.J.
The FDA also granted priority review status Wednesday to Isentress, Merck & Co. Inc.'s experimental HIV medicine.
Merck (NYSE:MRK) is based in Whitehouse Station, N.J.
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A slew of appointees named to state agencies
http://www.freep.com
By JOE ROSSITER
FREE PRESS STAFF WRITER
Michigan -- Several area residents were appointed this week to state boards or agencies by Gov. Jennifer Granholm.
Those appointed to the State Child Abuse and Neglect Prevention Board include:
Shirley Mann Gray of West Bloomfield, director of clinical support services for the Children’s Hospital of Michigan, will represent professional providers of child abuse and neglect prevention services for a term expiring Dec. 19, 2010.
Renee T. Farhat-Loepp of Birmingham has been appointed to represent the general public for a term expiring Dec. 19, 2008. She succeeds Teressa V. Staten whose term has expired.
Sophie J. Womack of Detroit, vice president of medical affairs for Harper University and Hutzel Women’s Hospital, has been appointed to represent the religious community for a term expiring Dec. 19, 2007. She succeeds Bishop Nathaniel Wells who has resigned.
The State Child Abuse and Neglect Prevention Board, also known as Children’s Trust Fund, is responsible for developing a plan to distribute funds to statewide education programs that work to develop awareness of child abuse and neglect.
Warren C. Evans of Detroit, sheriff of Wayne County and a member of the Automobile Theft Prevention Authority Board of Directors, is appointed to represent electors of the metropolitan district for the Huron-Clinton Metropolitan Authority for a term expiring May 2, 2011. He succeeds Harry E. Lester whose term has expired.
The Huron-Clinton Metropolitan Authority facilitates the operation and maintenance of parks, connecting drives, and limited access highways within the metropolitan district that includes Livingston, Macomb, Oakland, Washtenaw and Wayne counties. The authority has the ability to collect fees and charges for the usage of facilities under its control.
The Hepatitis C Advisory Task Force has new members:
Rosalind V. Andrews-Worthy of Detroit, founder and executive director of Gospel Against AIDS/Global Research, Education and Training Networks, has been appointed to represent religious organizations for a term expiring June 25, 2008.
Carolyn W. Bird of Pontiac, chief of medical services of the health division for Oakland County, has been appointed to represent associations representing local public health for a term expiring June 25, 2010.
Charles P. Craig of Ann Arbor, owner of Charles P. Craig M.D., PC., has been appointed to represent health care providers for a term expiring June 25, 2010.
Edward B. Goldman of Ann Arbor, deputy legal counsel for University of Michigan, has been appointed to represent the legal community for a term expiring June 25, 2009.
Peter G. Gulick of Okemos, associate professor of medicine for the College of Osteopathic Medicine at Michigan State University, has been appointed to represent health care providers for a term expiring June 26, 2009.
James W. Lewis of Rochester Hills, hepatology market specialist for Roche Laboratories Inc., has been appointed to represent business and industry for a term expiring June 25, 2008.
Janet D. Olszewski of Williamston, director of Michigan Department of Community Health, has been appointed for a term expiring June 25, 2009.
Andrew C. Potter of Lake Odessa, state vice president of the Michigan Corrections Organization, has been named to represent labor for a term expiring June 25, 2008.
Harry L. Simpson of Sterling Heights, director of substance abuse programs for the Community Health Awareness Group, has been appointed to represent the education community for a term expiring June 25, 2010.
Calvin R. Trent of Detroit, general manager of the Department of Health and Wellness Promotion and Bureau of Substance Abuse, is appointed to represent state and local government for a term expiring June 25, 2009.
The Hepatitis C Advisory Task Force is responsible for advising the governor and the Legislature on policies regarding hepatitis C and risk reduction and providing an annual report on major risk factors and preventable diseases or conditions including, but not limited to, hepatitis C.
Contact JOE ROSSITER at jrossiter@freepress.com.
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Hepatitis C project launched
http://www.thisislancashire.co.uk
By Pete Magill
HUNDREDS of hepatitis C sufferers in Blackburn and Darwen are set to benefit from the launch of an innovative information scheme.
The new e-learning' resource, pioneered by the borough's primary care trust, is the only one of its kind in the north west.
And it is thought to be the only such project in the UK which offers assistance to those who struggle with written English.
The initiative is part of ongoing hepatitis C education and awareness raising by health professionals and substance misuse workers at Blackburn's Jarman Centre.
Hepatitis C is a disease caused by the hepatitis C virus (HCV) which can cause chronic liver problems.
While it is difficult to provide accurate assessments of the number of sufferers locally, there is a national infection rate of between 0.5 per cent and one per cent, equating to between 800 and 1,600 people in Blackburn with Darwen.
People usually catch hepatitis C through infected blood, such as through transfusions, or via contaminated needles - but the cause of up to a third of cases remains unknown.
The rates of the condition increase substantially in areas where there are higher incidences of people illegally injecting drugs.
Patients will be given expert help on managing the condition, and advice and support before and after hepatitis C testing, under the new scheme.
Rebecca Demaine, the PCT's sexual health services strategic manager, said: "The launch of this unique eLearning resource is a very important step forward in extending the opportunities for getting key messages across about hepatitis C to all sections of our community.
"It will be of benefit to professionals working in occupational and patient education, advising on hepatitis C prevention, management and treatment.
"We will be making the resource widely available to organisations working with people affected by hepatitis C in the Blackburn with Darwen area."
It is hoped that the education programme will particularly prove useful for high-risk groups, including haemophiliacs and drug users.
Part of the benefits on offer include an audio link, translating advice into spoken English for those whose reading skills are poor.
Support is also available in Urdu and Gujerati.
Both features of the course were made possible by input from the media studies department at Accrington and Rossendale College, which assisted with the scheme.
The college provided volunteer speakers and translators, under the production of young graphic designer John Stanyon, who runs his own fledgling enterprise there, Studio Function.
Funding to develop the resource was provided by Blackburn with Darwen Drug and Alcohol Action Team.
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Hepatitis B Prevention Cutbacks In Santa Clara Co
http://cbs5.com
Thuy Vu
Reporting
(CBS 5) SAN JOSE It's called the "silent killer" in the Asian American community: chronic hepatitis B, which can lead to cirrhosis or liver cancer.
"Those people who are chronically infected usually have no symptoms," said Dr. Sam So of the Stanford Asian Liver Center. "Usually by the time they get sick by feeling pain to the belly or becoming jaundiced, it's usually a very advanced disease."
Santa Clara County has the highest rate of babies born to infected mothers in the country.
But county supervisors are slashing the perinatal hepatitis B prevention program to help erase a budget deficit.
In the past few years, the program has been cut from five staff members to two, and now, down to one.
"This is really very disturbing because the Santa Clara county perinatal hepatitis B program used to be a model for the rest of the country," Dr. So said.
"We cannot continue to salvage it without the funding stream from the state, which is the largest funder," Santa Clara Co. Supervisor Liz Kniss said.
About one in ten Asian Americans have hepatitis B, mostly because they weren't vaccinated at birth.
And 92 percent of infected pregnant women in this country are Asian.
Supervisor Kniss says health services will still be provided, with support from county hospitals.
"We still have a public health nurse and surveillance will continue to be done for anyone infected with hepatitis B by our physicians and attending staff," Kniss said.
But Dr. So says there's no way one staff member alone can manage the county's 400 high-risk hepatitis B cases.
"The prevalence of chronic hepatitis B and liver cancer is recognized as the greatest health disparity for Asian Americans in this country," Dr. So said.
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June 28th, 2007
Peregrine Pharmaceuticals Announces Registered Direct Offering of $22.5 Million in Common Stock
http://biz.yahoo.com
TUSTIN, Calif., June 28 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that it has obtained commitments from several institutional investors to purchase approximately $22.5 million in shares of its common stock in a registered direct offering.
Under the terms of the transaction, Peregrine will receive approximately $22.5 million in gross proceeds in exchange for up to 30,000,000 shares of its common stock. Net proceeds following the payment of sales commissions and other expenses of the offering are expected to be approximately $20.9 million. Rodman & Renshaw, LLC acted as the exclusive placement agent in connection with this transaction. The offering is expected to close on or about July 3, 2007, subject to the satisfaction of certain closing conditions.
Peregrine intends to use the net proceeds to fund its research and development programs and related costs, primarily for conducting clinical trials of bavituximab for the treatment of cancer and hepatitis C virus infection. The company plans to initiate several Phase II studies evaluating bavituximab in combination with chemotherapy for the treatment of solid cancers, to conduct clinical studies evaluating bavituximab for the treatment of chronic HCV infection, including in patients co-infected with HCV and HIV, and to complete an ongoing Phase II study of Cotara® for the treatment of glioblastoma multiforme. The company also intends to use the proceeds to further strengthen its product and business development infrastructure, and for other general corporate purposes.
A shelf registration statement relating to the common stock to be issued in the offering has been filed with the Securities and Exchange Commission and became effective as of January 23, 2007. A prospectus supplement related to the offering will be filed with the Securities and Exchange Commission. Copies of the prospectus supplement and accompanying base prospectus may be obtained directly from Rodman & Renshaw, LLC, 1270 Avenue of the Americas, 28th Floor, New York, NY 10020, Fax: 212-430-1711. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of our common stock. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to the risk that the Company will not use the proceeds from the offering for the intended purpose and that the proceeds that the Company receives from the offering will not be sufficient for the Company to accomplish its intended goals. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006 and the quarterly report on Form 10-Q for the quarter ended January 31, 2007. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts:
GendeLLindheim BioCom Partners
Investors
info@peregrineinc.com
(800) 987-8256
Media
Barbara Lindheim
(212) 918-4650
Source: Peregrine Pharmaceuticals, Inc.
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Energex System's Experimental Non-Pharmacological Treatment Exceeds Expectations in Reducing Liver Inflammation in Refractory Hepatitis C Patients
http://biz.yahoo.com
EMERSON, N.J.--(BUSINESS WIRE)--Energex Systems, Inc. announced today that its experimental therapy known as HemoModulation was effective in reducing viral load and liver inflammation in non-responding Hepatitis C patients. The trial was conducted under an Investigational Device Exemption (IDE) that was granted by the Federal Food and Drug Administration (FDA) in February 2006.
Hepatitis C (HCV) is a viral infection of the liver and a major cause of chronic liver disease, including cirrhosis and liver cancer, and is now recognized as the leading cause of liver transplantation in the United States. HCV is spread primarily by direct contact with human blood. The World Health Organization estimates that about 170 million people are infected with HCV, about 3% of the world's population. Approximately 5 million Americans are infected with HCV, and there are 8,000-10,000 such deaths each year in the United States.
The company's experimental treatment involves exposing a very small amount of an infected subject's blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time. During the process, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The hypothesis is that UV-inactivated virus will serve as an autologous vaccine and stimulate the immune system of the subject against their own strain of virus. The process takes 20-30 minutes.
In this second trial conducted by the company, liver biopsies of the subjects were examined, graded and preserved for comparison to post treatment biopsies. Analysis and comparisons of the pre and post treatment biopsies established significant improvement in grades of inflammation of 3 of the 8 subjects (7-3, 7-4, 7-3) that completed treatment.
"Our pre-trial expectation was grade improvement in 1 of the 8 subjects and we clearly exceeded that expectation," said Thomas R. Petrie, the company's Director of Research, Development and Engineering.
Energex Systems is dedicated to improving patient quality of life by developing and commercializing novel technologies and processes that are intended to provide safer, more effective options to patients in areas with substantial unmet medical needs within the fields of immunotherapy, blood safety and musculoskeletal pain.
Contact:
Energex Systems, Inc.
Thomas J. Fagan, President, 201-261-0099 ext.11
Fax: 201-261-8939
tfagan@energexsystems.com
Source: Energex Systems, Inc.
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Needle-Stick Injuries Are Common But Unreported By Surgeons In Training
http://www.medicalnewstoday.com
A survey of nearly 700 surgical residents in 17 U.S. medical centers finds that more than half failed to report needle-stick injuries involving patients whose blood could be a source of HIV, hepatitis and other infections.
Authors of the report - appearing in the June 28 issue of The New England Journal of Medicine - say most residents in the survey falsely believe that reporting and getting timely medical attention won't prevent infection. Residents also say reporting takes "too much time" and interrupts their work.
"The fact that we have so many residents who fail to understand the importance of timely reporting of needle-stick exposures in order to protect themselves from serious medical consequences clearly illustrates the breadth of this problem and the need for hospitals to develop systems to address it," says contributing author Mark S. Sulkowski, M.D., of the Division of Infectious Diseases at Johns Hopkins.
Lead author Martin Makary, M.D., M.P.H., a surgeon at The Johns Hopkins Hospital, says that while residents must take more responsibility, it's also up to hospitals to take "immediate steps to improve safety and care for health care workers to reduce the spread of HIV and hepatitis infection."
Makary says injuries could be greatly reduced by hospitals' increasing the use of nurse practitioners and physicians assistants to reduce surgical workloads and adopting sharpless surgical techniques such as electric scalpels, clips and glues.
"Twenty percent of all general surgery operations could be done without using any sharp instruments," he says.
Furthermore, Makary says, residents would more likely report exposures if hospitals used timely reporting mechanisms (e.g., internal hotlines and response teams), routine prompts (e.g., postoperative checklists that monitor exposures), and peer-to-peer education to create a local culture that encourages speaking up.
"We know also that many residents resist reporting because the training culture suggests that needle sticks 'go with the territory' and reporting them may lower peer esteem," Makary notes.
The survey, which took place in 2003, revealed that 99 percent of surgeons-in-training suffered an average of eight needle-stick injuries in their first five years. Of these surgeons, only 49 percent reported injuries to an employee health service. Of those who reported, 53 percent had experienced an injury involving a patient with a history of intravenous drug use and/or infected with HIV, hepatitis B (HBV) or hepatitis C (HCV).
"We did not realize the extent to which health care workers are at risk - a risk that is preventable," says Makary, a surgeon who studies medical errors and health care quality. Makary says improved techniques that reduce the number of needle sticks and timely treatment for those who are injured could all but eliminate the risk of getting infected with disease.
Makary says 57 percent of surgical residents reported a feeling of being "rushed" as the primary cause of the injury. He adds that 42 percent said they did not report the injury because it took "too much time" and 28 percent said there was "no utility in reporting."
In fact, says Sulkowski, early reporting and treatment with antivirals can prevent the establishment of infection in people exposed to HIV and HBV and can eradicate evidence of virus in more than 90 percent of people with acute HCV infection.
Previous studies suggest that an estimated 600,000 to 800,000 needle-stick injuries are reported each year by U.S. health care workers. Furthermore, a recent study of a general surgical service in an urban academic hospital revealed that 20 percent to 38 percent of all procedures involved patients with bloodborne pathogens.
Additional researchers from Johns Hopkins include Peter J. Pronovost, M.D., Ph.D., and J. Bryan Sexton, Ph.D., of the Department of Anesthesiology and Critical Care Medicine, and Marta M. Gilson, Ph.D., of the Department of Surgery.
http://www.jhmi.edu
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Liver donor complications underreported
http://www.reutershealth.com
By Karen M. Dente, MD
RIO DE JANEIRO (Reuters Health) - People who donate a portion of their liver can experience serious complications and even death, but these problems often go unreported, according to findings presented here at the 13th Annual International Congress of the International Liver Transplantation Society.
Live donation can be risky, said Dr. Timothy Pruett, of the University of Virginia Health System, Charlottesville. Rehospitalization occurs in a significant number of people, with about 40 percent of people having some sort of complication and a few dying following donation, according to estimates he cited.
"Exact data on (serious complications and death) are not known," said Dr. Burkhardt Ringe, of the Center for Liver, Biliary and Pancreas Disease at Drexel University College of Medicine in Philadelphia. Despite four reviews published in 2006, there are no accurate data on the number of donor deaths.
Ringe and his group reviewed medical studies published since 1989, ranging from anecdotal reports to sophisticated surveys, in an attempt to update the worldwide living donor death rate. Their goal was to assess the accuracy of the information as they assigned certainty levels to each source identified, ranging from direct reporting of fatalities by the center to indirect publication by an author not involved in the care, and information based on personal or verbal communication.
At the congress, Ringe reported a donor death at his center that has not been reflected in the latest death reports.
It is estimated that more than 10,000 living donor transplants having been performed worldwide, and that the donor death rate ranges from 0.1 to 0.3 percent.
"I think it is important to report every donor (death), regardless of whether it occurs early or late," said Ringe. "To maintain truly informed consent and public confidence in the procedure, it is imperative that all deaths of living donors be reported by the transplant program where the fatality occurred."
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George Marcello in Yellowknife
http://www.corrieretandem.com
By Letizia Tesi
Trip anticipates Step by Step's Sos4000 campaign
The Torch of Life never stops, never falters. It goes from town to town in Canada, brought by George Marcello, the founder of Step by Step, the organ donation advocacy organization. Seven years have passed since Marcello first received it from then mayor Mel Lastman, as a symbol of gratitude for the work done by that organization and of hope for thousands of people awaiting a transplant. It has been kept alit ever since.
Last Saturday it was passed to Greg Davis, the brother of Olympic swimming champion Victor who died in 1989 in a car crash and whose donated organs saved six other people. The ceremony, held at Alberta and St. Claire in Toronto, was organized by Step by Step in collaboration with the Toronto Police Service and with Fred Massai, owner of Freddies No Frills, who also supports Camp Jumoke, an organization helping thalassemic kids.
The Toronto Police got involved because of officer Ojo Tewsdbade, who in two weeks’ time will donate a kidney to his daughter Florence, who suffers from lupus. Greg Davis and Ojo Tewsdbade exchanged the Torch, which on October 1 will be carried on the sixth march, named Sos4000 after the number of Canadians waiting for a transplant, which will touch over 100 Canadian towns.
But the Torch of Life and George Marcello take no break. After Saturday’s initiative, they immediately hit the road again; on Sunday, they were in Yellowknife, for the fourth National Aboriginal Hepatitis-C Conference.
“By now, the Torch of Life is a symbol of hope for all those fighting for their lives against an illness, no matter which,” said Marcello. “It is also a symbol of good luck. I was honoured of participating to this conference.” Marcello opened the opening ceremony holding the Torch, standing beside Fox Morin, organizer of the conference and supporter of Step by Step.
“In 1999 Fox underwent a liver transplant,” told Marcello; “since then, he came to all our marches. In turn, I go to the conferences he organizes to educate Aboriginals on the consequences of hepatitis, the disease that brought Fox near death. Over 350 people suffer from hepatitis-C in the Northwest Territories. Fox’s work with Aboriginals is extraordinary; with his previous conferences he managed to reach and inform close to 1,000 people. It is important to let them know that hepatitis-C can be transmitted by sharing infected crack tools.”
Marcello and Morin carried the Torch during the Aboriginal Sweat, which opened the conference with traditional songs and dances with the participation of all tribal chiefs.
At the end of the conference works, the Torch of Life was handed to an Aboriginal awaiting a liver transplant.
Before starting the sixth Sos4000 relay march, the Torch will also be lit in other cities. “We are planning many initiatives from now to October. We never stop,” said Marcello with enthusiasm and pride. Sos4000 will get youth involved. “In every town, there will be students relaying the Torch. Each of them will become a Torch Champion, an ambassador for our cause. Their support will mean a lot for people waiting for a transplant.”
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June 29th, 2007
Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer
http://pharmalive.com
Nexavar is First Drug Therapy to Demonstrate Significant Survival Benefit in Liver Cancer
WAYNE, N.J. and EMERYVILLE, Calif., June 27, 2007 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc. today announced that a Supplemental New Drug Application (sNDA) for Nexavar(R) (sorafenib) tablets has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer. The companies also confirmed that they are planning a company- sponsored Phase 3 study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.
The sNDA submission is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.
"These results are particularly meaningful considering that death rates from liver cancer continue to increase," said Susan Kelley, M.D., vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "After more than 100 clinical studies of many agents over three decades, Nexavar is the first drug therapy to demonstrate a significant survival benefit for patients with HCC, and, if approved, may fulfill a serious unmet need with a manageable toxicity profile."
HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary liver cancers in adults.(1,2) It is the fifth most common cancer in the world(3) and the third leading cause of cancer-related deaths globally.(4) Over 600,000 cases of HCC are diagnosed globally each year(4) (about 19,000 in the United States(5) and 32,000 in the European Union(6)) and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of HCC.(7)
"This filing exemplifies our commitment to providing valuable therapeutic options for significant unmet needs in cancer treatment," said Hank Fuchs, M.D., executive vice president and chief medical officer of Onyx. "We believe that Nexavar will become the reference standard of care in HCC, and will help advance our development program, which includes clinical trials studying Nexavar alone and in combination with other therapies across many different cancer types, including melanoma, non-small cell lung and breast cancer."
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar(R), a small molecule drug, with Bayer Pharmaceuticals Corporation. Nexavar is approved for the treatment of advanced kidney cancer in more than 50 countries. For more information about Onyx's pipeline and activities, visit the company's web site at: www.onyx-pharm.com.
About Bayer HealthCare
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
About Bayer Schering Pharma AG, Germany
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve quality of life.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2006, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward- looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
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