Biotech Values

[DewDiligence]

NVS, HGSI Ink Albuferon Deal for HCV

[In #msg-11431616 yesterday, I said, “In the HCV arena, NVS has a lot of irons in the fire: a nucleoside polymerase inhibitor (NM283 from IDIX in phase-2b), an immunomodulator to replace interferon (ANA975 from ANDS in phase-1b), and now a non-nucleoside drug-discovery program with GNLB including the first right on anything actually discovered. It’s not hard to see that NVS thinks the future of HCV is likely to be an all-oral cocktail.”

Well, I was right on the first part (NVS has a lot of irons in the HCV fire), but I was evidently wrong on the second part (NVS foresees an all-oral cocktail) because Albuferon, an enhanced form of interferon, is definitely not oral. CC today (Tue) at 9 am ET.]

http://biz.yahoo.com/prnews/060606/nytu079.html?.v=51

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Human Genome Sciences Announces Collaboration with Novartis for Development and Commercialization of Albuferon(TM)

Tuesday June 6, 1:15 am ET

- HGS to receive development and commercial milestone and other payments of up to $507 million -

- Albuferon(TM) expected to enter Phase 3 development in chronic hepatitis C in 2006 -

ROCKVILLE, Md., June 6 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today announced an exclusive worldwide licensing agreement with Novartis for the development and commercialization of Albuferon(TM) (albumin-interferon alpha 2b) for chronic hepatitis C and all other uses.

Under the agreement, HGS and Novartis will co-commercialize Albuferon in the United States, and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization outside the U.S. and will pay HGS a royalty on those sales. HGS and Novartis will share equally in clinical development costs. HGS will receive an upfront fee of $45 million. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $47.5 million when the first patient is dosed in a Phase 3 clinical trial. HGS will have primary responsibility for the bulk manufacture of Albuferon.

"This agreement brings the strengths of a global leader in the pharmaceutical industry to the development and commercialization of Albuferon, a product that could become the best-in-class immunomodulator in treatment regimens for chronic hepatitis C," said H. Thomas Watkins, President and Chief Executive Officer of Human Genome Sciences. "Novartis has demonstrated its commitment to leadership in infectious diseases, and we look forward to working closely together to advance Albuferon rapidly to the market. This collaboration is a significant step forward in our company's progress toward commercialization."

HGS expects to initiate Phase 3 clinical development of Albuferon by the end of 2006.

About Albuferon

Clinical studies to date indicate that Albuferon could offer improved dosing in the treatment of chronic hepatitis C, with efficacy and safety at least comparable to the current standard of care, pegylated interferons. These results demonstrate that Albuferon is well tolerated, remains in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha, and exhibits robust antiviral activity.

Albuferon is a novel, long-acting form of interferon alpha. It is a Human Genome Sciences drug created using the Company's proprietary albumin fusion technology. This technology enables scientists to improve the pharmacological properties of therapeutic proteins by fusing the gene that expresses human albumin to the gene that expresses the active protein. Albuferon results from the genetic fusion of human albumin and interferon alpha 2b. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.

CONFERENCE CALL

HGS management will hold a conference call to discuss this announcement today at 9:00 a.m. Eastern time. Investors may listen to the call by dialing 866/558-6869 or 913/643-4199, passcode 1638413, five to ten minutes before the start of the call. A replay of the conference call will be available for several days by dialing 888/203-1112 or 719/457-0820, passcode 1638413. This conference call also will be webcast. Interested parties who wish to listen to the webcast should visit the Human Genome Sciences website at http://www.hgsi.com. The archive of the conference call will be available several hours after the conference call and will remain available for several days.
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