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12:00 AM
Jan 12, 2009
 |  BioCentury  |  Finance

Slimmer pickings

Money managers for the 17th Annual Buyside View don't see many exciting milestones in the short term. The two most important developments in 2009 will be FDA action on Amgen Inc.'s BLA for denosumab to treat and prevent postmenopausal osteoporosis in women and to treat and prevent bone loss in patients undergoing hormone ablation for prostate or breast cancer, and data for Genentech Inc.'s Avastin in adjuvant colorectal cancer.

Amgen submitted its BLA for denosumab last month, while the Avastin event is tipped for about mid-year.

Although a shortage of transformational milestones would have threatened to stall the sector in prior years, money managers are split on whether they need near-term milestones to invest in 2009, or are simply going to be putting in money for the long haul (see "Approval Watch,"A12 & "Late-Stage Milestones", A14).

In the first camp are investors like Isser Elishis of Acqua Capital, who believes near-term milestones are an essential consideration for any potential investment.

"We define liquidity as short-term catalysts," Elishis said. "If there are none for longer than 12 months from now, it's not interesting to us. Catalysts always lead to liquidity."

Diabetes is a space where DEKA Investments' Kai Bruening sees both short- and long-term implications. He is keen to see how FDA will handle both Victoza liraglutide and exenatide once weekly, as this will provide some guidance as to how the agency will treat diabetes drugs going forward.

Victoza is a long-acting analog of glucagon-like peptide-1 (GLP-1) from Novo Nordisk A/S. FDA rescheduled a March 2 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss an NDA for the once-daily compound to treat Type II diabetes to April 2 or 3. The NDA has a March 23 PDUFA date, a deadline that is expected to be stretched by a couple of months.

Amylin Pharmaceuticals Inc. and partner Eli Lilly and Co. hope to submit an NDA for exenatide once weekly in 1H09. The long-acting formulation of Byetta, which uses Medisorb drug delivery technology from Alkermes Inc., is in Phase III testing to treat Type II diabetes.

At Columbus Circle, fund manager Oliver Marti's watchlist includes data for Nexavar sorafenib from Onyx Pharmaceuticals Inc. and Bayer AG, which is in Phase III testing in melanoma. The drug, which is marketed for unresectable hepatocellular carcinoma and advanced renal cell carcinoma (RCC), failed in a Phase III trial in second-line...

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