Biotech Values

[DewDiligence]

Here’s ZGEN’s own PR on starting the phase-2 Lambda trial. The primary
endpoint is the rate of cEVR for Lambda+ribavirin vs Pegasys+ribavirin.
cEVR an imprecise HCV metric that means slightly different things to
different people. I infer from the context that ZGEN is defining cEVR as
the intersection of RVR and EVR, i.e. undetectable virus at both 4 weeks
and 12 weeks. (If this is wrong, someone please post a correction.)

http://finance.yahoo.com/news/ZymoGenetics-Initiates-Phase-bw-3601475815.html?x=0&.v=1

›ZymoGenetics Initiates Phase 2 Clinical Trial of PEG-Interferon lambda in Hepatitis C with Bristol-Myers Squibb

PEG-Interferon lambda is a Targeted Type 3 interferon in development for Hepatitis C

6:00 am EDT, Tuesday October 27, 2009

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced the initiation of a Phase 2 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 milestone payment to ZymoGenetics from Bristol-Myers Squibb Company (NYSE: BMY), pursuant to the terms of a previously announced collaboration agreement.

“In the Phase 1b clinical trial, PEG-Interferon lambda demonstrated robust antiviral activity and was well tolerated in patients with genotype 1 hepatitis C,” said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Because PEG-Interferon lambda binds to a unique receptor, it has the potential to treat HCV without many of the treatment-limiting side effects associated with current interferons.”

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). [See comment in the prologue of this message about cEVR.] Sustained virological response (SVR) defined as undetectable levels of HCV 24 weeks after treatment will also be assessed.

PEG-Interferon lambda

PEG-Interferon lambda (IL-29) is a novel type 3 interferon in development for hepatitis C. The native human protein Interferon lambda is generated by the immune system in response to viral infection. In a Phase 1b clinical trial in patients with relapsed HCV, administration of PEG-Interferon lambda over four weeks in combination with ribavirin was shown to be well-tolerated and resulted in significant antiviral activity.‹