Biotech Drug Discovery in Seattle: A Look Back

6/11/10

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Glaxo Wellcome (now Glaxo SmithKline) as part of a Glaxo/Icos partnership. Glaxo abandoned its interest in tadalafil because it didn’t fit into Glaxo’s corporate strategy at the time. Icos then partnered with Eli Lilly to fund a joint venture to develop and commercialize the molecule; it was FDA approved in 2002 for the treatment of erectile dysfunction. Eli Lilly went on to acquire Icos in 2007 and sadly closed down the company. Cialis was later approved for the treatment of pulmonary arterial hypertension in 2009.

Orencia (abatacept) is a fusion protein that inhibits the activation of T cells and is used to treat rheumatoid arthritis in patients not responding to anti-TNF therapies. It received FDA approval in 2006. What is not well known is that Orencia arose from work done here in Seattle at the BMS Pharmaceutical Research Institute. BMS closed down the Seattle branch of its Research Institute in 1997, and the development work was transferred to other parts of Bristol-Myers Squibb.

Zymogenetics’ Recothrom (recombinant human thrombin) was approved by the FDA in 2008 for the topical treatment of surgical bleeding. It was developed as part of a safety-driven trend in biotechnology in which recombinant human proteins have replaced ones that used to be purified from either animal or human sources. Other examples include insulin, hemophilia proteins, and growth hormone. Interestingly, Zymogenetics points out on one of its websites that “the Company has contributed to the discovery or development of six recombinant protein products currently marketed by other companies. These products have aggregate annual sales of more than $3 billion”. Given the disappointing sales ($30M in 2009) of Recothrom, it’s unfortunate that the company could not have held on to one or more of these other unidentified proteins.

Dendreon’s Provenge (sipuleucel-T) was just approved by the FDA in April of 2010 for the treatment of prostate cancer. Dendreon’s clinical success with Provenge has triggered a tsunami of activity by other biotechs in the area of immunotherapy, which had been out of favor for a long time. It should be noted that Provenge is not a classic drug per se because it is not directly administered to patients. Instead, it is a method of treating a patient’s cells outside of their body, and then reinfusing them to stimulate their immune system.

Amgen’s Prolia (denosumab) was FDA approved in June 2010 for the treatment of postmenopausal osteoporosis; it is also being reviewed by the agency for the treatment of prostate cancer patients who are at high risk of bone fractures. Both Immunex and Amgen invested considerable research efforts into the discovery of a protein, RANK ligand, that plays a key role in the biological process of bone remodeling. This ultimately led to the development by Amgen (after it acquired Immuex) of the monoclonal antibody denosumab, which inhibits the activity of this protein.

New Uses Approved for Three Already Discovered Drugs

PathoGenesis (along with Children’s Hospital in Seattle) developed Tobi, (tobramycin solution for inhalation), for the treatment of … Next Page »

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides strategic advice to clients on their research programs, collaboration management issues, as well as preclinical data reviews. Follow @

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  • Dan Eramian-CTI

    Excellent review of drug development by Seattle based companies. Just a couple of extra facts. CTI sold Trisonex for $68 M with another potential $100 M if certain milestones are met. CTI bought Zevalin for $10M and eventually sold it for $31 M.

  • Gary Keizur

    Stewart; actually Lilly ICOS received an approvable letter for Cialis in April 2002. The JV submitted its complete response in May 2003 and received approval in November 2003. Lilly acquired ICOS for $2.3 billion in January 2007. Worldwide sales of Cialis were $1.4 billion in 2008 and $1.56 billion in 2009.

  • Jonathan Kil

    Stewart, what a wonderful and detailed report demonstrating the lengthy and often winding road to get a drug finally approved. I’m also amazed at how often a Ph-II or Ph-III clinical asset is sold or repositioned until it finally hits.

  • http://www.lymanbiopharma.com Stewart Lyman

    Thanks to Dan and Gary for filling in a few details on the transactions that they covered, and to Jonathan (and many others) for the positive feedback I received on this trip down memory lane. I’ll make a note to revisit and update this piece at the end of the current decade.