Clovis shares dive as FDA delays drug OK

BOULDER — Shares of Boulder-based Clovis Oncology Inc. lost nearly 70 percent of their value by midafternoon Monday on news that the U.S. Food and Drug Administration’s review and decision whether to approve a drug designed to fight lung cancer probably will be delayed.

The FDA has requested more clinical data on both the 500-milligram and 625-milligram doses of rociletinib, which Clovis has developed as an oral treatment for lung cancer. The FDA review team told Clovis last week that it wanted to focus exclusively on confirmed responses from the drug’s clinical trials, but that the data set it received so far included mostly unconfirmed responses.

A statement from Clovis said it would submit more data by the end of the day, but that it probably would mean the FDA’s scheduled March 30 decision date on approval of the drug would be set back.

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That’s a competitive blow to Clovis because London-based AstraZeneca PLC on Friday won FDA approval for Tagrisso, its own lung-cancer drug. Like rociletinib, Tagrisso focuses on a genetic mutation that blocks the current crop of lung-cancer medications from reaching tumors.

Near the closing bell on Wall Street, Clovis’ stock (NYSE: CLVS) was trading at $31.31, down more than 68 percent from Monday’s opening price but a slight recovery from a 72 percent decline just after noon. AstraZeneca shares (NYSE: AZN) were up more than 4.7 percent at $32.79.

AstraZeneca is collaborating with Boulder-based Array BioPharma (Nasdaq: ARRY), which invented the drug selumetinib and licensed it in 2003 to AstraZeneca for development and commercialization. In September, AstraZeneca bought Amgen’s LakeCentre manufacturing facility at 5550 Airport Road in Boulder for $14.8 million, and company officials said the cite eventually could employ up to 400 people. Amgen (Nasdaq: AMGN) announced last year it was closing its facilities in Boulder and Longmont.

The FDA said that in Clovis’ clinical trials, the number of patients with an unconfirmed response to rociletinib who converted to a confirmed response has been lower than expected, with progression of tumors or failure to show tumor shrinkage greater than 30 percent.

Patrick J. Mahaffy, Clovis’ president and chief executive, said in a prepared statement last month that Clovis was ready to launch rociletinib in Europe late next year and already was building its sales force there.

On Monday, Mahaffy said the company remains “confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer. We will continue to work diligently with the FDA on our (new-drug application) submission.”

Clovis had been upbeat in late September when it announced that the FDA accepted its new-drug application under priority review and the European Medicines Agency accepted its marketing authorization application under accelerated assessment, which shortened that review clock to 150 days from 210 days.

Clovis recently reported a loss of $98.6 million for its third quarter that ended Sept. 30, driving its loss for the first nine months of the fiscal year to $233 million as it raced toward the launch of

rociletinib and another cancer-fighting drug, rucaparib. In July, the company raised net proceeds of $298.5 million through an offering of 4.1 million shares of common stock.

Founded in 2009, Clovis leased 5,844 square feet of space at 2525 28th St. for its headquarters. The building was familiar to Mahaffy because it’s the same space where he operated his former company, Pharmion Corp., before selling it to Celgene Corp. in 2008 for $2.9 billion.