Pseudomonas aeruginosa infections in patients with cystic fibrosis. The FDA approved the drug for sale in late 1997. Developing the drug for use as an inhalation therapy for CF was a novel use for tobramycin, which was discovered in 1975. PathoGenesis was subsequently acquired by Chiron in 2000, which in turn was purchased by Novartis in 2006.
Corus Pharma developed an inhaled form of the antibiotic aztreonam lysine for the treatment of bacterial infections in the lungs of cystic fibrosis patients. The discovery of aztreonam dates back to 1982. Gilead Sciences purchased Corus Pharma in 2006 as a result of Corus’s development work with this drug. Gilead went on to win FDA approval in February 2010 for the inhaled form of aztreonam lysine, which is sold under the brand name Cayston.
Immunex began selling Novantrone (mitoxantrone hydrochloride) after American Cyanamid (later Wyeth, now Pfizer) acquired a majority ownership position in Immunex in 1993. The drug had been used since 1987 for the treatment of acute nonlymphocytic leukemia. In 1997, Immunex got expanded FDA approval to use Novantrone for the treatment of pain in late stage prostate cancer patients. Immunex rode the expanded use wave again in 2000, when they received FDA approval to use Novantrone for yet another new indication: to reduce neurological disability and/or the frequency of clinical relapses in MS patients. In late 2002, Amgen sold the U.S. rights to Novantrone for several indications in Serono, who then turned around four months later and sold the rights to OSI Pharmaceuticals.
Two Drugs Acquired and Developed by Seattle Based Biotechs
Corixa acquired Bexxar (tositumomab) by purchasing its developer, Coulter Pharmaceuticals, for $900 million in 2000. Coulter had an agreement with SmithKline Beecham (now GlaxoSmithKline) to share marketing and profits for the drug. The FDA approved Bexxar in late 2003 for the treatment of follicular non-Hodgkin’s lymphoma. Bexxar is a monoclonal antibody linked to radioactive iodine that is directed against the cell surface CD20 protein. Difficulties with the “commercial acceptance” of this difficult-to-administer radiolabled drug led Corixa to transfer Bexxar marketing and development rights to Glaxo in 2004. GlaxoSmithKline subsequently acquired Corixa in 2006, primarily for its vaccine adjuvants (see below).
Vectibix (panitumumab) is a monoclonal antibody that blocks the binding of epidermal growth factor to its receptor. As a result, it slows down the growth of tumor cells that express this receptor. Immunex had signed an agreement in 2000 to co-develop this antibody with Abgenix (who had engineered it) and the two companies were working on it together when Amgen acquired Immunex. Amgen won FDA approval of Vectibix in 2006 for the treatment of colorectal cancer. Amgen later acquired Abgenix in 2006 in order to obtain the entirety of Vectibix revenues as well as eliminate the need to pay royalty payments to Abgenix on their monoclonal antibody denosumab (see Prolia above). In one of the first examples of the utility of cancer biomarkers, it was found that Vectibix did not work in the 40 percent of colon cancer patients who have a mutation in a gene called K-RAS.
Drugs Bought and Sold by Seattle Based Biotechs, But Not Developed Here
Cell Therapeutics acquired Trisenox (arsenic trioxide) by purchasing PolaRx in 2000. CTI received FDA approval for Trisenox that same year for the treatment of the relatively rare disease acute promyelocytic leukemia (APL); there are only about 1,000-1,500 cases in the US per year. Cell Therapeutics wound up selling Trisenox to Cephalon in 2005. This made sense since it was reported that the company spent $100 million on Trisenox during this time, while netting only $67 million in sales.
Cell Therapeutics also purchased Zevalin (ibritumomab tiuxetan) from Biogen Idec in 2007. Like Bexxar (see above) Zevalin is a radiolabeled monoclonal antibody directed against CD20 for the treatment of non-Hodgkin’s lymphoma. Zevalin is coupled to radioactive yttrium, whereas Bexxar is coupled to radioactive iodine. Zevalin had been approved by the FDA in 2002. When sales turned out to be less than hoped for, Cell Therapeutics turned around