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Spencer A Brown / SFBT file 2007
Theravance Inc.
South San Francisco
Drug: Anoro Ellipta.
AKA: Umeclidinium and vilanterol.
Indication: Chronic obstructive pulmonary disorder.
Date: Dec. 19.
Capping an amazing drug approval year for Rick Winningham-led Theravance, Anoro Ellipta is a once-daily treatment to treat airflow obstruction in COPD patients. Partner GlaxoSmithKline, which also owns nearly a third of Theravance, is set to release the drug-inhaler combination in first-quarter 2014. Anoro and its sibling, Breo Ellipta, will ease GSK’s pain when Advair, which pulled in $3.9 billion in the first nine months of 2013, goes generic.
By one measure, Bay Area companies produced seven of the 27 new drugs approved by the Food and Drug Administration this year.
Those are new molecular entities and new therapeutic biological products — a fair accounting of innovation since those truly are new drugs that involved extensive work to get from lab bench to bedside.
But if you look at all FDA approvals in 2013, the Bay Area’s share nearly doubles to 13. These include new combinations of old drugs and new disease indications for existing drugs. Maybe it doesn’t cost as much to run these drugs through the clinical trial process, but the investment remains mighty and the regulatory risk is just as high.
SEE THE SLIDESHOW at left for the Bay Area’s drug approval Class of 2013.
Under that same measure, the Bay Area had 16 drug approvals last year.
What’s more, there are more on the horizon. At least three other drugs — San Rafael-based BioMarin Pharmaceutical Inc.’s (NASDAQ: BMRN) Vimizim in the rare disease MPS IVA, Redwood City-based AcelRx Pharmaceutical Inc.’s (NASDAQ: ACRX) pain drug delivery system Zalviso and the Nektar Therapeutics Inc. (NASDAQ: NKTR) and Astellas Pharma drug naloxegol, designed to treat opioid-induced constipation — are scheduled for FDA decision’s next year.
Ron Leuty covers biotech, higher education and China for the San Francisco Business Times.