How do the revised rules in the Bipartisan Budget Act of 2015 affect you and your business?
Boulder-based Clovis (Nasdaq: CLVS) was in the final approval stage for the drug, named CO-101. All drugs in development in the United States must go through a rigorous approval process regulated by the federal Food and Drug Administration before they can be sold commercially.
There was no difference in overall survival rates between patient populations taking CO-101 and patients taking an existing pancreatic cancer drug, gemcitabine, the company said in a press statement. Median survival was about six months, the statement said.
Sponsor Generated Content
“We are obviously disappointed with these results, which are unambiguous,” Patrick Mahaffy, president and chief executive of Clovis, said in the press statement.
Clovis workers had started planning how to market CO-101 commercially, the company said last week.
Clovis continues to research other drugs, including CO-1686 to treat lung cancer; rucaparib for ovarian and breast cancers; and a cKIT inhibitor drug to treat gastronintestinal stromal tumors.
In general, CO-1686 is being used in trials in humans, a mid-level step in getting FDA approval to market the drug. Rucaparib is at about the same stage. The CKIT inhibitor is in the discovery phase, the company said. Clovis has an agreement with Boulder-based Array Biopharma Inc. (Nasdaq: ARRY) to work on the gastrointestinal stromal tumor drug.
By midday Monday, Clovis shares had dropped $7.49, or 34.9 percent, to $14, their lowest price since early August. Clovis stock had traded as high as $27.55 in March. The company raised $130 million in an initial public offering of 10 million shares about a year ago.
Mahaffy started the company in 2009 with other former executives of Boulder-based Pharmion Corp., which was sold to Celgene Corp. in Summit, New Jersey, for $2.9 billion in 2008.
Clovis Oncology has additional offices in San Francisco and in Cambridge, in the United Kingdom.