Neurocrine Biosciences Inc. has a meeting with the Food and Drug Administration regarding why the agency rejected its sleeping pill, which had been predicted to be a billion-dollar blockbuster drug.
The San Diego company said it would meet with federal officials in late August.
“We’re trying to get the really key issues nailed down,” said Chief Executive Officer Gary Lyons in its July 17 second-quarter earnings call with investors.
Executives said the firm may be announcing a possible partnership they called “a very exciting opportunity,” to keep their 200-strong sales force employed. Officials said they have discussed the possibility of layoffs with the sales force they hired and trained to sell Indiplon.
The August FDA/Neurocrine meeting is being held to discuss the 15-milligram tablet form of the drug, which was expected by analysts to be the biggest breadwinner because it has fewer competitors as an extended release sleeping pill.
Neurocrine also has requested a meeting to discuss the 5- and 10-milligram capsule forms of the drug. In May, the FDA deemed the lower doses “approvable,” with, perhaps, the need for additional trials, while the largest dose was rejected altogether. The FDA had cited some concerns about the effect a larger dose could have on patients driving the day after, as well as how the drug would react in elderly patients. The agency, however, also had said it had not reviewed all materials the company submitted.
Executives said during the call that they expect to spend about $30 million to conduct additional tests, if necessary, and resubmit Indiplon in the larger dose to the FDA. Resubmitting the smaller doses would be less expensive, they said.
The firm reported $234.7 million in cash and equivalents.
The company expects its burn rate to be about $100 million for this year, and then $80 million annually for the next few years, executives said in the call.
The burn rate is a measure of how a company spends its cash.
Executives expect to end 2006 with $180 million in cash.
The company reported a net loss of $27.4 million for the three months ended June 30, compared with a net loss of $5.6 million for the same period last year. Neurocrine said the discrepancy is partly due to the adoption of Financial Accounting Standards Board Statement 123R that resulted in a non-cash operating expense of $2.7 million during the quarter.
Second-quarter revenues were $9.2 million compared with $33.2 million for the same period in 2005. The decrease, the company said, is mainly due to lower payments from Pfizer Inc., the firm’s former partner on the sleeping pill, Indiplon. Pfizer terminated its agreement with Neurocrine about a month after the lukewarm FDA news.
Neurocrine expects to report on several early and midphase clinical trials this year and next. The company’s goal is to bring one medicine into clinical development each year. It has six drugs in testing for several ailments, including heart failure, depression, type 1 diabetes and endometriosis.
Incorporated in 1992, Neurocrine has about 575 employees.
The firm’s stock, which trades as NBIX on the Nasdaq exchange, closed at $9.42, down 27 cents, or nearly 3 percent, July 17.
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Award-winner:
A local scientist-turned biotechnology business executive has been recognized for her contributions to the Asian bio-pharmaceutical business community.
Asia Media, which publishes an English-language newspaper targeted toward Asian-Americans in Southern California, recognized Zhu Shen, director of business development at San Diego-based Immusol Inc., with the 2006 Asian Heritage Award in Science, Technology and Research.
Shen, who is originally from China and holds a Ph.D. in biochemistry from the University of Colorado, was drawn quickly to the business side of science after a chance meeting with a woman who organized multicultural trainings for business executives.
Shen began working with the woman and ultimately ended up achieving an Ivy League M.B.A. from Cornell University to pursue her business passions. After holding positions at Bayer and Chiron, and starting her own consulting business, BioForesight, she joined Immusol.
More than 11,000 San Diegans voted on the heritage awards, which are presented to San Diegans of Asian Pacific Islander heritage for contributions to the Asian-American community.
Shen is a director of the board and chairwoman of the Pacific Connection Committee at the Sino-American Biotechnology and Pharmaceuticals Professionals Association, or SABPA, and has organized multiple conferences and forums for the organization.
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Fund-raiser:
The Moores UCSD Cancer Center will employ artist John Van Hamersveld to design the logo for its 13th annual Luau & Longboard Invitational.
Van Hamersveld created the artwork for the mid-1960s movie “Endless Summer,” a film about two surfers who follow summer around the world in different time zones. He has also designed more than 300 music album covers for groups including the Beatles and the Rolling Stones.
The surfing competition is set for Aug. 20 near the Scripps Institution of Oceanography.
Several surfing legends will compete, each in teams of five, to raise money for cancer research. The competition has raised more than $1 million. The event is accompanied by a luau with food, entertainment and a silent auction of surf memorabilia.
Contact Katie Weeks with biotechnology news at
kweeks@sdbj.com
, or call her at (858) 277-6359.
