Replies to post #71327 on Biotech Values

[DewDiligence]

Congrats to ZGEN longs. BMY, one of the premier antiviral companies, ought to be an excellent partner for IFN-Lambda.

[DewDiligence]

Here’s ZGEN’s “Lambda” PR for archival purposes. The CC is
tomorrow at 8:30am ET; that’s very early in Seattle, but this
deal is important enough to set the alarm clock :- )

The most interesting detail of the deal terms is the $287M of
clinical/regulatory milestones for non-HCV indications. What
are these? HBV is surely one of them; however, HBV by itself
would not seem justify such a large dollar amount, so there is
presumably something else. Cancer?

http://finance.yahoo.com/news/BristolMyers-Squibb-and-bw-14034564.html

›Bristol-Myers Squibb and ZymoGenetics Enter Global Collaboration on Novel Hepatitis C Compound

PEG-Interferon lambda is a Novel Type 3 Interferon in Phase Ib trials

Monday January 12, 2009, 4:14 pm EST

PRINCETON, N.J. & SEATTLE--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY ) and ZymoGenetics, Inc. (Nasdaq: ZGEN ) today announced a global collaboration for PEG-Interferon lambda, a novel type 3 interferon currently in Phase Ib development for the treatment of Hepatitis C, and its related development program.

Under the terms of the collaboration, Bristol-Myers Squibb agreed to pay ZymoGenetics an upfront cash payment of $85 million for the development and commercialization rights to PEG-Interferon lambda, and to pay an additional license fee of $20 million in 2009. ZymoGenetics could receive additional payments of up to $430 million based on pre-defined development and regulatory milestones for PEG-Interferon lambda in Hepatitis C, up to $287 million in development and regulatory milestones for other potential indications [what are these? comments welcome], and up to $285 million based on pre-defined sales-based milestones.

The companies have agreed to co-develop PEG-Interferon lambda in the United States and Europe and will share development costs. It is anticipated that ZymoGenetics will conduct a significant portion of continuing Phase I and certain Phase II development activities. ZymoGenetics will have the option to co-promote in the United States and to share profits on product sales with Bristol-Myers Squibb. ZymoGenetics may opt out of the co-development, co-promotion and profit sharing arrangement in the United States, in which case ZymoGenetics will receive double-digit royalties on PEG-Interferon lambda sales worldwide. [This opt-out feature is becoming a de facto standard for biotech-pharma commercial collaborations; it often turns out to be better for the biotech partner to receive royalties than to split profits and losses.]

Outside the United States, Bristol-Myers Squibb will be responsible for commercialization and ZymoGenetics will receive double-digit royalties on product sales.

“We welcome the opportunity to combine ZymoGenetics’ strong foundation in discovering and developing therapeutic proteins, with our own internal research and development expertise in working on this innovative Hepatitis C therapy that has the potential to help patients prevail over this serious disease,” said Francis Cuss, MD, Senior Vice President, Discovery and Exploratory Clinical Research, Bristol-Myers Squibb. “The profile of PEG-Interferon lambda offers the possibility of improvements in the safety and effectiveness of combination treatment for Hepatitis C and makes it an ideal fit with our emerging portfolio of small molecule anti-virals.”

“We believe Bristol-Myers Squibb is the ideal partner for ZymoGenetics and that we share the vision that PEG-Interferon lambda could become an important part of treating patients with Hepatitis C,” said Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics. “We look forward to a productive partnership focused on bringing PEG-Interferon lambda to Hepatitis C patients as rapidly as possible.”

PEG-Interferon lambda (IL-29) is a novel type 3 interferon currently in Phase Ib development for Hepatitis C. The native human protein Interferon lambda is generated by the immune system in response to viral infection. PEG-Interferon lambda has the potential to be uniquely differentiated from available interferon therapy because Interferon lambda mediates anti-viral activity through a receptor that is distinct from that used by Interferon alpha and is present on fewer cell types within the tissues of the body. As a result, the possibility exists for more targeted delivery of interferon therapy and an improved therapeutic index.

The effectiveness of the agreement is subject to antitrust clearance by the United States Federal Trade Commission and Department of Justice, under the provisions of the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary regulatory approvals.

…Conference Call and Webcast Information

ZymoGenetics will conduct a conference call/webcast on Tuesday, January 13, at 8:30 a.m. Eastern Time. The call and webcast may be accessed at www.zymogenetics.com or by dialing 877-407-0778 (International: 201-689-8565). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live audio webcast and slide presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 60 days. For replay, please visit www.zymogenetics.com or use the following information:

* U.S. callers: 877-660-6853
* International callers: 201-612-7415

Replay passcode account #: 286

Conference ID #: 309378‹

[Preciouslife1]

Transplantation: Liver-transplantation outcomes poor for IFN-treated patients with HCV

http://www.nature.com/nrgastro/journal/v6/n4/full/nrgastro.2009.24.html
Nature Reviews Gastroenterology and Hepatology 6, 194 (April 2009) | doi:10.1038/nrgastro.2009.24
Lisa Richards


Original article Smallwood, G. A. et al. Does interferon use before liver transplant influence hepatitis C outcomes following transplantation? Transplantation 86, 1795–1798 (2009).

IFN treatment in HCV-infected patients before liver transplantation is associated with poor outcomes and aggressive recurrence of HCV after transplantation, according to Smallwood and colleagues at Emory University School of Medicine, Atlanta, GA.

Outcomes have worsened and survival has decreased in the past decade for patients with HCV who have undergone liver transplantation. Smallwood and colleagues considered the role of IFN therapy, which is now widely available to patients with HCV: "...we recognized that many more patients were coming to liver transplant [sic] after being treated for HCV with these [IFN]-based therapies," Smallwood explained.

The researchers evaluated 131 patients with HCV who underwent liver transplantation after 1998 for whom data on exposure to IFN-based therapies was available. A total of 45 of these patients received IFN therapy before transplantation. Survival and outcomes, such as time to recurrent HCV following liver transplantation, of grafts and patients were monitored.

Patients who received IFN-based therapy before transplantation had a shorter time to and more aggressive recurrence of HCV following liver transplantation than those who had never received IFN treatment. The researchers also found that survival of grafts and patients was notably decreased in patients who had received IFN therapy before transplantation.

...survival of grafts and patients was...decreased in [those] who had received IFN trerapy...
According to Smallwood, in the past, very few patients who underwent liver transplantation had been treated for HCV, whereas now many patients have received antiviral therapy, and the number of patients with HCV who receive transplants has increased. The present study identifies IFN-treated patients with HCV as a population that is likely to have a poor response to orthotopic liver transplantation. "Future research should be geared [towards] the optimal time to treat patients for HCV following liver transplantation as well as the prevention of rejection in this at-risk population," Smallwood recommends.

PL1.1