Biotech Values

[DewDiligence]

AMGN pulls out of Alfimeprase partnership with NUVO:

[NUVO’s own PR boasts that NUVO will “gain worldwide rights” to Alfimeprase (LOL). And perhaps BI was right about Mark Monane being a lightweight: Monane is quoted below saying, “With a drug like this it is better to have a bigger percentage.” He conveniently omits the fact that NUVO now has to pay 100% of the clinical development costs and also pay milestones and royalties to AMGN. A thrombolytic drug, Alfimeprase works more quickly than other clot busters, but it suffers from having a narrow therapeutic window.

I’m not surprised with AMGN’s action. When NUVO released its phase-2 data, I was not impressed (#msg-4270154). Evidently, AMGN wasn’t either.]

http://tinyurl.com/5ad68

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Amgen cedes cardiovascular drug rights to Nuvelo

Mon Nov 1, 2004 08:57 PM ET

LOS ANGELES, Nov 1 (Reuters) - Nuvelo Inc. (NUVO.O) on Monday said Amgen Inc. (AMGN.O) decided not to pursue rights to commercialize experimental thrombolytic agent alfimeprase.

As a result, Nuvelo gains worldwide right to the late-stage drug, while Amgen will be paid previously negotiated milestones and royalties.

"With a drug like this it is better to have a bigger percentage," said Mark Monane, an analyst at Needham & Co. [See my comment in the preface.]

The drug is a protein that works by breaking up the fibrin that holds blood clots together.

Alfimeprase was originally identified by Amgen, which in January 2002 entered into an agreement with Nuvelo (then known as Hyseq Pharmaceuticals Inc.) to develop and commercialize the drug.

Under the agreement, Nuvelo was responsible for clinical development and Amgen was responsible for leading manufacturing activities.

Amgen had the option to take on commercialization rights, under which both companies could participate, but it declined that option following completion of a Phase 2 trial in acute peripheral arterial occlusion, also known as "leg attack."

In Phase 2 trial alfimeprase broke up blood clots at rates of up to 76 percent and restored arterial flow at rates of up to 60 percent.

"The news today is that Amgen decided to stay with what they decided in 2002," said Dr. Ted Love, Nuvelo's chief executive. "Alfimeprase is a cardiovascular product -- it is not a strategic fit for them." [Spin!]

Nuvelo, based in Sunnyvale, California, said it is finalizing with U.S. regulators the design of a Phase 3 trial of alfimeprase, which it expects to launch in the first quarter of next year.

Love said Nuvelo is focused on becoming a fully-integrated biopharmaceutical company that will sell alfimeprase in the United States.

Monane said he expects the drug to reach the market in 2008.

"Given the number of products we have in our pipeline, the drug would not have received the kind of attention Nuvelo could give to it," said Christin Cassiano, a spokeswoman for Amgen.
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