Key Developments For Zymogenetics Inc
Zymogenetics Inc (ZGEN.O) (Consolidated Issue listed on NASDAQ Global Market)
King Pharmaceuticals, Inc. Sues ZymoGenetics, Inc. Alleging Trademark Violation-Reuters
Reuters reported that King Pharmaceuticals, Inc. has sued ZymoGenetics, Inc. seeking damages and injunctive relief, alleging trademark infringement among other things, and a U.S. court has temporarily restrained Zymogenetics from marketing a product, according to a regulatory filing. ZymoGenetics said in the filing that the three temporary restraining orders (TROs), passed on November 3 without hearing its side, were prohibiting it from engaging in certain marketing or promotional conducts related to Recothrom, its hemostasis aid. ZymoGenetics said King, in the suit filed in a federal court in Tennessee, alleged Zymogenetics of engaging in unfair competition, false advertising, trademark infringement and other related claims. A hearing on King's motions for preliminary injunctive relief is scheduled for November 16, and ZymoGenetics will oppose King's request for preliminary injunctive relief, it said.
PT Bristol-Myers Squibb Indonesia Tbk and ZymoGenetics Present Final Phase 1b Results For PEG-Interferon Lambda In Hepatitis C
PT Bristol-Myers Squibb Indonesia Tbk and ZymoGenetics, Inc. presented final results from a Phase 1b clinical trial of PEG Interferon lambda administered with ribavirin in relapsed and treatment naïve hepatitis C virus (HCV) patients. The poster included data on 56 patients in the study. Antiviral activity was observed at all dose levels tested. The Phase 1b clinical trial was designed to evaluate the safety and antiviral activity of PEG-Interferon lambda when given as a single agent or in combination with ribavirin in genotype 1 HCV patients with relapsed disease and in treatment-naïve patients. PEG-Interferon lambda demonstrated antiviral activity at all dose levels tested in both relapse and treatment naïve HCV patients. A majority of patients across all treatment arms achieved a greater than 2 log reduction in HCV RNA. The most common adverse events were fatigue (29%) and nausea (13%). There were minimal effects on neutrophil counts. Minimal constitutional symptoms or hematologic effects were observed with PEG-Interferon lambda given as a single agent or in combination with ribavirin. The majority of adverse events and laboratory changes were grade 1 or 2. Dose-limiting elevations in ALT or AST, with or without an increase in bilirubin, were dose-dependent and reversible. Overall, the results of the study support moving to dose-ranging Phase 2 studies in treatment-naïve HCV patients.
ZymoGenetics, Inc. Initiates Phase II Clinical Trial Of PEG-Interferon Lambda In Hepatitis C With Bristol-Myers Squibb
ZymoGenetics, Inc. announced the initiation of a Phase II clinical trial of PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection (the EMERGE study). The first patient has been dosed in the study, triggering a $70 million payment to ZymoGenetics from Bristol-Myers Squibb Company, pursuant to the terms of a previously announced collaboration agreement. The EMERGE study is an international, randomized multi-center clinical trial that will enroll approximately 50 patients in the first, open label portion that will explore a wide range of doses to be tested in the second part of the study. The second part of the study is designed to enroll approximately 500 patients. Weekly subcutaneous doses of PEG-Interferon lambda will be administered for up to 48 weeks. The study will assess the safety and antiviral efficacy of PEG-Interferon lambda compared to PEGASYS. All patients will also receive daily ribavirin. The primary endpoint of the trial is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy (cEVR). Sustained virological response (SVR) defined as undetectable levels of HCV 24 weeks after treatment will also be assessed.
ZymoGenetics, Inc. Reaffirms FY2009 Revenue Guidance-Conference Call
ZymoGenetics, Inc. reaffirmed its fiscal 2009 revenue guidance to be in the range of $80 to $85 million.
ZymoGenetics, Inc.'s Arthritis Drug Hits Roadblock-Reuters
Reuters reported that ZymoGenetics, Inc. said preliminary results from a mid-stage trial of its experimental rheumatoid arthritis drug did not support a direct move to late-stage trials. The Company said the drug atacicept failed to meet the pre-specified level of disease-control activity. ZymoGenetics's licensee Merck Serono, a unit of German drugmaker Merck KGaA, was developing atacicept as a treatment for systemic lupus erythematosus, multiple sclerosis and rheumatoid arthritis. ZymoGenetics said further exploratory analyses was on and Merck Serono has not made any decision regarding rheumatoid arthritis as a potential indication for atacicept. The Company said trials for lupus and multiple sclerosis indications are currently ongoing.
