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Drug Discovery in Seattle 2015: An Updated History

Opinion

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arsenic trioxide during this time, while netting only $67 million in sales. Cephalon was eventually acquired by Teva in 2011.

Cell Therapeutics also purchased ibritumomab tiuxetan (Zevalin) from Biogen in 2007. Like tositumumab (see above), ibritumomab tiuxetan is a radiolabeled monoclonal antibody drug, which are notoriously difficult to manufacture and administer, and thus tough to sell.  The antibody is directed against the CD20 protein. The FDA had approved ibritumomab tiuxetan in 2002 for the treatment of non-Hodgkin’s lymphoma, but when sales turned out to be less than hoped for, Cell Therapeutics turned around and sold it to Spectrum Pharmaceuticals in 2009.

Other Local Biotech Approvals That Were Medical Devices, Not Drugs

The Prosorba Column, developed by Imre Corp, was approved by the FDA in 1987. The column, which consisted of protein A bonded to a bead, was developed to treat patients with idiopathic thrombocytopenic purpura (a bleeding disorder) by removing circulating immune complexes from their blood. Imre moved to San Diego and changed its name to Cypress Bioscience in 1996, and the Prosorba Column went out of production in 2006.

CellPro developed the Ceprate column for purifying blood stem cells so they can be reinfused into patients following chemotherapy; the FDA approved it in 1996. Unfortunately, CellPro lost a patent infringement lawsuit to Becton Dickinson in 1997 and as a result was forced to sell its Ceprate column to that company. Gutted, the company went bankrupt in 1998. (An interesting side note: CellPro’s CEO, Rick Murdock, was one of the first people treated with the Ceprate column following his diagnosis with a rare case of mantle cell lymphoma. This fascinating story was recounted in the book Patient Number One by Murdock and David Fisher.)

Iamin, a hydrogel wound dressing, was developed by Kirkland-based Procyte. It was approved by the FDA in 1996, although not as a drug, but as a medical device. Iamin is sold as a wound care product, although the company is prohibited from claiming that it is a wound “healing” drug. The active ingredient in Iamin is a tripeptide that is combined with copper. It is now available over the counter.

Though not technically a drug per se, Corixa helped develop mpl (monophosphoryl lipid A), a vaccine adjuvant that it acquired by purchasing Ribi ImmunoChem Research in 1999. Mpl boosts the body’s response to immune system-stimulating molecules contained within various vaccine preparations. GlaxoSmithKline’s Cervarix, the first vaccine that was developed to treat cervical cancer, was the first vaccine licensed by the FDA that included mpl as a component of an adjuvant (a substance that enhances an immune response) along with alum. GlaxoSmithKline acquired the rights to mpl when it purchased Corixa in 2005 (see above).

Sorting Out The Numbers

So there we have it: a total of about 220 biotech companies (existing ones, plus those that were acquired, moved, or went out of business) discovered, developed, or found a new use for a total of 16 drugs over the past 35-years. On a decade-by-decade basis, no drugs were approved in the first 10 years (1980 to 1989), four were approved in the second decade (1990 to 1999), five were approved in the third decade (2000 to 2009), and seven have already been approved so far in this decade (2010 to 2019). The rate of FDA approvals for drugs arising from Seattle appears to be accelerating as the industry matures and the number of companies here has increased. The pipelines of some Seattle companies are filled with some very promising molecules that are in clinical trials for a variety of medical conditions. If and when these get approved, then our overall success rate will go up. In addition to the drugs discovered or developed here, three other biotech discoveries were created and brought to market (Prosorba, Ceprate, and mpl) and two other drugs (arsenic trioxide and ibritumomab tiuxetan) were sold by a Seattle biotech, Cell Therapeutics, for a few years each.

Molecules and intellectual property obtained from Seattle companies (via acquisition) may also lead to future drugs that will trace their way back to our region. Zymogenetics is the current “poster child” for companies whose scientific discoveries wound up earning lots of money not for itself, but for other companies. According to its website, “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 of Recothrom (only $30 million in 2009, before Zymogenetics was acquired), it’s unfortunate that the company could not have held on to one or more of these other unnamed molecules.

No company, aside from Immunex/Amgen, was successful in developing more than a single drug from scratch during this time period. Of the twelve companies that were successful in getting a drug approved, only Seattle Genetics, Omeros, and Cell Therapeutics (now known as CTI Biopharma) remain independent and based in Seattle. All three companies are publicly traded, and each of them lost money last year. Note also that the worldwide sales of drugs in 2014 that were discovered or developed in Seattle cover a huge range (over 3 orders of magnitude), from less than $7 million per year (Pixuvri) to more than $8.78 billion per year (etanercept).

What’s abundantly clear to even the casual observer is that biotechnology is a very tough business. Some drugs will not recover their development costs and become profitable even if you can get them approved. Looking ahead, future drug development prospects in Seattle (and elsewhere) should be better than what has been achieved in the past. The industry has matured and many companies have better focused their discovery efforts.

Having said that, I believe that future successes will depend on four primary factors:

First, researchers must continue to acquire an in-depth understanding of the biology that is involved in the disease process. Everything flows from the basic and applied research that represents the combined efforts of investigators worldwide. These discoveries are likely to increasingly arise from academia as R&D-based businesses are transformed into A&D (acquisition and development) companies. Second, technological breakthroughs are needed that will enable the conversion of biological insights into innovative medicines. Third, significant business acumen is required to turn biologically effective molecules into FDA approvable drugs. Finally, sufficient financial resources are required to fund each of these efforts for an ample length of time in order to achieve success. The challenges are many, but the prospects for the development of new drugs have never been brighter.

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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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