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FDA-Approved Device to Help Surgeons’ Efficiency, Cytori Says

San Diego-based regenerative medicine company Cytori Therapeutics Inc. said Jan. 8 that it received U.S. regulatory clearance to market its PureGraft system, a bedside device capable of removing, purifying and re-injecting a patient’s fat tissue in about 15 minutes.

Shares of Cytori, which have traded between $1.42 and $7.78 in the past 52 weeks, closed up 12 percent at $7.26 that day. The stock is listed under the symbol CYTX on Nasdaq.

Cytori, which has built a business out of tools used for harvesting adult stem cells, said the latest regulatory decision positions it as the only company with an FDA-approved device that can perform cosmetic body contouring procedures using a patient’s own fat.

The company said it will begin marketing PureGraft to plastic and reconstructive surgeons in the United States in the first quarter of the year. It said it will formally introduce the product in April at the American Society for Aesthetic Plastic Surgery’s annual meeting.

Dr. Marc Hedrick, Cytori’s president, who first discovered useful applications for adult stem cells harvested from leftover liposuction fat while at UCLA, said the product offers physicians improved efficiencies in the operating room and decreased surgery time.

More than 46,000 fat grafting procedures were performed in the U.S. in 2008, according to the most recent data by the American Society of Plastic Surgeons.

Cytori said it is also seeking European regulatory clearance to market the device overseas, with an answer anticipated in the first quarter.

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GSK Pays Amira: San Diego-based Amira Pharmaceuticals has triggered a milestone payment under its collaboration with drug giant GlaxoSmithKline plc.

The company said Jan. 7 that it successfully created experimental drug AM103 in pill form, a step toward eventually developing the drug as a once-daily oral asthma treatment.

“Achieving this milestone further demonstrates the success of our partnership with GSK and provides a meaningful economic benefit to Amira,” said Hari Kumar, Amira’s chief business officer.

Amira did not disclose the value of the milestone payment. Altogether, the privately held company could amass $425 million from its GSK partnership if it successfully meets all its milestones, including FDA approval. The two signed a deal in February 2008 that gave GSK exclusive rights to develop, manufacture and commercialize AM103 and other FLAP inhibitors. Amira is entitled to receive tiered royalty payments based on commercial sales.

The experimental drugs are thought to control the production of leukotrienes, which exacerbate inflammatory diseases such as asthma. The FLAP gene has also been tied to increased risk of heart attack and stroke.

Founded in 2005, Amira describes itself as a small molecule pharmaceutical company focused on the discovery and early development of compounds to treat inflammatory disease.

• • •

So Far, So Good, Ardea Announces: Ardea Biosciences Inc., maker of an experimental gout drug, reported positive results Jan. 7 in a midstage study testing its drug in combination with standard treatment.

Shares of Ardea, traded under the symbol RDEA on Nasdaq, rose on the news that its drug, dubbed RDEA594, could reduce levels of uric acid when combined with another drug, allopurinol, more than allopurinol alone. Shares of Ardea closed at $15.35, up 9 percent, on Jan. 7. The stock’s 52-week range was $8.78 to $21.35.

“Given its complementary mechanism of action, we believe that RDEA594 is well positioned to meet a significant unmet medical need for patients who do not adequately respond to, or who are intolerant to, currently available gout medications,” said Barry Quart, Ardea’s CEO.

Gout is a painful type of arthritis caused by excess levels of uric acid in the blood that build up and crystallize in joints and tendons, often the feet.

In a separate study, Ardea said a combination of its drug and the currently marketed drug febuxostat lowered acid levels by 70 percent, more than either of the two drugs achieved on their own.

• • •

Prometheus Secures $260M In Financing: San Diego-based Prometheus Laboratories Inc., a specialty pharmaceutical company that pairs its drug offerings with diagnostics, said Jan. 7 that it has secured $260 million in financing.

The credit facility consisted of a $210 million term loan and a $50 million revolving credit line. Prometheus said it would use the proceeds to finance product acquisitions and refinance its existing debt.

Send biotechnology news to Heather Chambers at hchambers@sdbj.com.

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