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Amylin’s Drug Byetta Misses Mark

In its recent third-quarter financial disclosure, San Diego-based Amylin Pharmaceuticals, Inc., reported that its diabetes drug Byetta, which analysts have projected to be a multibillion-dollar-a-year “blockbuster” status drug, fell behind sales predicted by analysts.

Byetta brought in $18.1 million in its first full quarter on the market. According to the biotechnology trade journal BioCentury, two analysts , one from SG Cowen and another from First Albany , expected Byetta to earn between $2.6 million and $9.5 million more than it did in the quarter. Another analyst quoted by Forbes.com estimated about a million more in sales. Still, word is that the drug’s long-acting release form, not yet approved by the Food and Drug Administration, could spark a renewed interest from investors.

The company’s third quarter net loss was deeper than expected at $69.5 million, compared with $34.1 million for the same time in 2004.

On the positive side, the company’s overall third-quarter revenue was more than twice as much as the same quarter last year , $25.9 million this year compared to $13.4 million in 2004. The company was not selling any of its products until this year, but received $5 million from pharmaceutical giant Eli Lily & Co., Amylin’s partner in Byetta, in the third quarter of 2004 for milestone payments.

The FDA approved Byetta in April and the company’s other diabetes drug, Symlin, the month before. Symlin posted $3.8 million in sales this quarter, according to the Amylin’s filing with the Securities and Exchange Commission.

Lily received $7.2 million of the third quarter revenue brought in by Byetta, which is approved to improve glucose control in patients with type 2 diabetes.

Investors sold off stock after the third quarter earnings report. Shares dropped about 11 percent, or $4.12, in after-hours trading Oct. 26 , the day of the earnings announcement. The company’s stock closed that week at $33.52. Amylin stock closed at $33.27 on Nov. 1.

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China Contract:

Invitrogen Corp., one of San Diego’s few profitable life science companies, recently obtained a contract with the National Center for Drug Screening in Shanghai, China.

The organization approves new drugs in China. The two research entities are calling the partnership, announced Oct. 31, a research and drug discovery collaboration and did not disclose financial terms of their agreement.

Researchers will employ Carlsbad-based Invitrogen’s technologies for studying proteins.

The company had revenues of more than $1 billion in 2004. It was founded in 1987 and has about 4,500 scientists globally.

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New VP:

San Diego-based Neurocrine Biosciences, Inc., a company that is developing indiplon, a drug for insomnia with pharmaceutical giant Pfizer, Inc., announced a new vice president of clinical development Oct. 31. It also announced its third quarter earnings report recently. While net income is up, research and development expenses are lower than this time last year. However, as Neurocrine prepares for the possibility to market indiplon, expenses have more than doubled to $13 million from $5.4 million for sales, administrative and general costs.

Newly appointed Chris O’Brien has managed clinical trials, registration and post-marketing trials with relation to drugs for neurology, pain and autoimmune diseases at Dublin, Ireland-based Elan Corp. and Washington, D.C.-based Prestwick Pharmaceuticals. He also served as the medical director for nine years at The Colorado Neurology Institute. O’Brien has a medical degree from the University of Minnesota.

He was granted 55,000 options of stock as part of his hiring agreement, according to the company. Shares closed at $54.14 on Nov. 1, up nearly 3 percent.

Chief Executive Officer Gary Lyons told the Business Journal that as the company grows, it’s important to have someone in charge of clinical trials who has a neurology and academic background.

Neurocrine focuses on neurological and endocrine disorders including insomnia, anxiety, diabetes, depression and multiple sclerosis, among others. It has five compounds in clinical trials and three expected to enter trials in the next year, according to the company.

According to Neurocrine’s third quarter filing with the Securities and Exchange Commission, income was $26.2 million for the period ending Sept. 30, 2005. For the same period last year, Neurocrine reported a loss of $1.6 million. The stark difference is mainly due to $50 million in milestone payments from Pfizer related to the FDA’s willingness to review a new drug application for indiplon tablets. The company expects answers from the FDA in the spring, Lyons said.

Because of decreased costs in development of indiplon, research and development expenses plunged from $32.3 million in the third quarter of 2004 to $26.6 million in the same period in 2004.

Contact Katie Weeks with biotechnology news at kweeks@sdbj.com, or call her at (858) 277-6359.


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