Replies to post #29609 on Biotech Values

[swampboots]

GNLB: any guesses about odds of getting the initial 20 million (is 12.5 a shoe in, the up front fee?)?

[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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[DewDiligence]

GNLB Presents Preclinical Data on Non-
Nucleoside HCV Polymerase Inhibitor

[It would be easy to dismiss GNLB as an also-ran in the HCV arena were it not for one thing: they have a partnership with NVS, inked in 2006, to develop a non-nuke polymerase inhibitor for HCV. This is the same class of drug as HCV-796 from VPHM and WYE. The purpose of working on this drug class is to combine it with a nuke and/or a protease inhibitor, similar to what has been done in the treatment cocktails for HIV.]

http://biz.yahoo.com/prnews/070502/sfw098.html?.v=82

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Genelabs Technologies Announces Presentation of Data on Non-Nucleoside HCV Polymerase Inhibitor at 20th International Conference on Antiviral Research Meeting

Wednesday May 2, 7:00 pm ET

REDWOOD CITY, Calif., May 2 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB ) announced today that a presentation was made today at the 20th International Conference on Antiviral Research being held in Palm Springs, California, on a non-nucleoside hepatitis C virus (HCV) polymerase inhibitor discovered by Genelabs.

The oral presentation was given by Christopher D. Roberts, Ph.D., Director of Medicinal Chemistry at Genelabs, entitled "GL59728: A Potent Allosteric Inhibitor of the HCV NS5b RNA Dependent RNA Polymerase with Excellent Pharmacokinetic Properties."

GL59728 is one of a number of non-nucleoside HCV polymerase inhibitors discovered by Genelabs. In the presentation, Dr. Roberts outlined the lead optimization of certain non-nucleoside HCV polymerase inhibitors through an iterative process involving testing for potency in directly inhibiting HCV NS5b polymerase, inhibiting the replication of an HCV sub-genomic replicon, and pharmacokinetic properties.

The optimized lead that emerged from this chemistry approach, one of several taken by Genelabs, is known as GL59728. The IC50 of GL59728 for inhibition of the HCV NS5b polymerase is 16 nanomolar and the EC50 for inhibition of HCV replicon is 170 nanomolar. Further, GL59728 shows excellent oral bioavailability, exceeding 50% in all four species tested, including higher-order species, low clearance and a half-life consistent with once- or twice-daily dosing. The tissue distribution of GL59728 also appears favorable; since its concentration is enhanced several fold in liver, the site of HCV infection, relative to that obtained in plasma. Importantly, GL59728 was also tested in combination with other classes of HCV antiviral compounds, including a nucleoside chain terminator, a protease inhibitor and interferon alpha, and shown to be additive in activity with each.

In June 2006 Genelabs entered into a license and research collaboration with Novartis covering Genelabs' non-nucleoside HCV polymerase inhibitors.

"The data presented today clearly support the further investigation of non-nucleoside polymerase inhibitors for the future treatment of HCV infection," said Ronald C. Griffith, Ph.D., Genelabs' Chief Scientific Officer. "Furthermore, we believe future treatment of HCV is likely to involve combinations of antiviral drugs and these data suggest that combinations of this type of non-nucleoside agent with interferon or other likely therapeutic drugs, such as nucleoside chain terminators or protease inhibitors, may be feasible."

About Genelabs Technologies

Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery capabilities that can support various research and development projects. Genelabs is currently concentrating these capabilities on discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program, while also developing a late-stage product for lupus. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit www.genelabs.com.
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