and sold Zevalin to Spectrum Pharmaceuticals in 2009. Radiolabeled drugs such as Zevalin (and Bexxar) are notoriously difficult to manufacture and administer, which severely limits their sales.
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 (BD) in 1997 and as a result they were forced to divest their Ceprate column to BD. Gutted, the company went under 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 poorly written 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 a class I 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 complexed 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 is an immunostimulatory molecule that boosts the immune response to immunogenic molecules contained within various vaccine preparations. 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 (i.e. a substance that enhance an immune response) along with alum. GlaxoSmithKline got the rights to mpl when it purchased Corixa in 2005 (see above).
So there we have it. A total of about 145 biotech companies (existing ones, plus those that were acquired or went out of business) discovered and/or developed a total of 12 drugs to date over a 30 year period. On a decade-by-decade basis, no drugs were approved in the first 10 years (1980-1989), four were approved in the second decade (1990-1999), five were approved in the last 10 years (2000-2009), and already three have been approved in this decade (2010-2019). 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 the companies still in business are filled with some very promising molecules that are in clinical trials for a variety of medical indications. If and when these get approved, then our overall success rate will go up. Molecules as well as the intellectual property of companies that have been acquired (or gone out of business) may also lead to future drugs that will trace their way back to Seattle. In addition to the 12 drugs discovered or developed here, three other medical biotech discoveries were created and brought to market (Prosorba, Ceprate, and mpl) and two other drugs (Trisenox and Zevalin) were sold by Seattle biotech Cell Therapeutics for a few years each.
Thus, a historical review has Seattle developing about one drug for every 12 companies that are (or were) based here. No company, aside from Immunex/Amgen, was successful in developing more than a single drug during this time period. Of the eight companies that were successful in getting a drug approved, only two, ZymoGenetics and Dendreon, remain independent and based in Seattle. Note also that the sales of these drugs cover a huge range (3 orders of magnitude), from less than $10 million per year to $7.4 billion per year. If the historical trend continues, then 11 out of every 12 of our current companies are likely to never have a drug approved. Given the current economic climate, this seems a reasonable prediction. The success rate for local companies bringing new medicines to market (one in twelve, or eight per cent) is equivalent to the current success rate of drugs making it through the clinical trial process on to FDA approval.
What is abundantly clear is that this is a very tough business. In theory, future drug development prospects should look better than what has been achieved in the past due to the fact that the industry has matured greatly, and companies have better focused their discovery efforts. Having said that, I believe that future successes will depend on three primary factors.
First, researchers must acquire an in-depth understanding of biological processes that are involved in the disease process. Everything flows from the basic and applied research that represents the combined efforts of investigators worldwide. Second, technological breakthroughs are needed that will enable both an understanding of the science as well as a means of converting those insights into innovative medicines. Finally, sufficient financial resources are required to fund these research efforts for an ample length of time, be they public or private. As I have argued previously, I believe the current venture capital funding model is not capable of getting the job done.
