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Wednesday, May 29, 2024

FDA Accepts Neurocrine’s Resubmitted Application for Insomnia Drug

A resubmitted new drug application for an insomnia treatment developed by Neurocrine Biosciences Inc. has been accepted for review by the Food and Drug Administration.

The San Diego biotech company is seeking approval for 5- and 10-milligram Indiplon capsules to be used by adults, including the elderly.

Neurocrine said it expected the FDA to act Dec. 12.

Neurocrine resubmitted its application June 12 following regulatory decisions that called for additional data regarding clinical trials.

Neurocrine’s troubles began after the FDA rejected Indiplon’s modified release formulation in May 2006. Shortly thereafter, Pfizer Inc. backed out of an agreement to co-market the treatment in the United States. Then, Neurocrine began laying off employees.

The company’s stock, traded as NBIX on Nasdaq, has been slipping since that time. Neurocrine shares closed Aug. 28 down 39 cents, or 3.87 percent, at $9.70.

The National Institutes of Health estimates that 30 percent of Americans report at least one symptom of insomnia a few nights a week. Insomnia is of significant concern because sleep deprivation can influence quality of life and sometimes compromise safety and everyday functions of employees in the workplace.

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Changes At The Top:

Anadys Pharmaceuticals Inc. is under new leadership following a management shake-up.

Steve Worland, head of pharmaceuticals, was promoted to president and chief executive officer following Lawrence Fritz’s departure.

Fritz said he left to pursue other opportunities.

Worland joined Anadys in March 2001 as chief scientific officer, and most recently served as the company’s president of pharmaceuticals.

Before his tenure there, he was a vice president and head of anti-viral research at Agouron Pharmaceuticals Inc., a company acquired by Warner-Lambert Co. in 1999 before merging with Pfizer.

On Aug. 1, the company announced a strategic restructuring following a July 26 decision by Novartis AG to discontinue development of ANA975 for the treatment of hepatitis C.

As part of the restructuring, Anadys cut its work force by 33 percent, halted early-stage discovery efforts and ended development on a hepatitis B therapy.

Executives said the company remains on track to file new drug applications for cancer treatment candidate ANA773 this year and hepatitis C drug candidate ANA598 in the first half of 2008.

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Nanogen Announces $20M Financing Transaction:

On Aug. 27, medical test products developer Nanogen Inc. announced a $20 million registered offering of unsecured senior convertible notes and warrants.

The notes bear an interest rate of 6.25 percent annually and will provide investors the right to convert principal into registered shares of Nanogen common stock at $1.27 a share, a premium of about 12 percent over the Aug. 24 closing price.

Nanogen has the right to force conversion of the three-year notes after two years depending on stock performance.

Investors will also receive warrants to purchase 11 million shares of common stock at an exercise price of $1.14 per share for five years. Additional warrants may be added if these initial warrants are exercised, the company said.

Nanogen said it expected to use the proceeds from the offering for working capital and general corporate purposes.

“This financing provides the company with a vehicle for long term continued investment in the company and allows us to focus on our core objectives of managing the business and improving our EBITDA performance,” said Howard Birndorf, chairman and chief executive of Nanogen, in a written statement. EBITDA is short for earnings before interest, taxes, depreciation and amortization.

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Nobel Prize Winner To Lead Salk:

The Salk Institute for Biological Studies will be led by Nobel laureate and distinguished professor Roger Guillemin while it searches for a permanent replacement for Richard Murphy. The La Jolla-based nonprofit made the announcement Aug. 23.

Murphy retired from Salk on July 1 as president and chief executive after almost seven years. Shortly thereafter, he took a six-month job as a consultant to the California Institute of Regenerative Medicine.

Guillemin, who was appointed interim president, received the Nobel Prize for medicine and physiology in 1977 for discoveries that laid the foundation for brain hormone research. He was also among the first to isolate endorphins, also known as the body’s natural opiate.

“Roger’s distinguished reputation as a Nobel Prize-winning scientist and his 37-year history with the Salk makes him ideal to lead the Institute’s scientific community at this time,” said Irwin Jacobs, chairman of Salk’s board of trustees, in a statement. “His pioneering contributions to science are a reflection of the Institute’s excellence in research and discovery.”

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Biosite Restructures:

Biosite Inc. eliminated 103 jobs Aug. 24 as part of the company’s efforts to restructure following a $1.7 billion merger with Massachusetts-based Inverness Medical Innovations Inc.

The cuts affected 99 employees in San Diego, where it continues to operate under its own name. The other four positions were field based, according to company spokeswoman Susan Morrison.

She said the cuts were “based solely on business needs” to grow the company.

Biosite was part of a bidding war between Fullerton-based Beckman Coulter Inc. and Inverness. The company had an existing merger agreement with Beckman Coulter but later deemed the Inverness offer a superior proposal.

The company was particularly valuable to larger diagnostics companies interested in its BNP blood test for heart failure.

Send biotechnology industry related news to Heather Chambers,

, or call (858) 277-6359, ext. 3125.


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