Biotech Values

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FDA wants input on Amgen bone drug risks

http://www.reuters.com/article/marketsNews/idAFN1135758320090811?rpc=44

* Panel asked to weigh serious infections, cancers

* Analysts expect panel to back denosumab

* Advisory panel to review drug Thursday

* Amgen shares gain 2.56 percent (Updates share price)

By Lisa Richwine

WASHINGTON, Aug 11 (Reuters) - Serious infections and cancers must be considered as U.S. advisers weigh the future of Amgen Inc's (AMGN.O: Quote, Profile, Research, Stock Buzz) most important experimental medicine, drug reviewers said in documents released on Tuesday.

Shares of the world's largest biotechnology company rose 2.56 percent to close at $62.81 on Nasdaq. Analysts said the safety issues were known to investors and they expected an advisory panel to recommend approval of the drug, denosumab.

Amgen is seeking U.S. Food and Drug Administration approval to sell the injection under the name Prolia in an $8 billion market for osteoporosis drugs.

The company's studies raised questions about the risk of serious infections, new cancer cases and other problems seen in denosumab patients, FDA reviewers said in a memo prepared for an advisory panel review on Thursday.

"Of particular concern, in light of these safety issues, is whether the risk/benefit balance for the osteoporosis prevention indication, both for patients with and without cancer, supports approval," FDA staff said.

BMO Markets analyst Jason Zhang said the safety issues were "not surprising" and he felt the panel likely would vote in favor of the drug. Zhang expects denosumab to garner annual sales of $2.4 billion by 2012.

"People always worry about cancer and malignancies, but when you look at the incidence (with denosumab), you can't really have statistical analysis because they are so rare," he said.

Zhang also said investors may be comforted by the fact that FDA reviewers did not recommend a strict risk management program for the drug.

Cowen & Co analyst Eric Schmidt said the FDA documents "read fairly cautiously" and "it doesn't seem like the FDA has yet made up its mind about the risk/benefit of the drug."

He said he expected the panel would recommend approval, echoing the general consensus of other analysts. A pressing uncertainty is whether the panel will recommend a risk management program (REMS) or other potential warnings.

"If a stringent REMS program were required here, the stock could be down $3 or $4 on that," Schmidt said.

Denosumab is seen as the best hope of jump-starting Amgen's growth after safety concerns deflated sales of its flagship anemia drugs.

Amgen shares were trading nearly 40 percent above their year low of $44.96 at the end of April, but remain sharply down from the $80-plus level reached in late 2005.

Amgen is aiming to sell denosumab for treating and preventing the bone-thinning disease osteoporosis in women past menopause, and for treating and preventing bone loss from hormone ablation therapy for breast or prostate cancer.

Denosumab is the first in a new class of genetically engineered proteins that target RANK ligand, a protein that activates bone-destroying cells.

Amgen's studies showed the drug reduced fractures and increased bone density. FDA reviewers said that benefit must be weighed against an increased risk of serious skin infections, particularly in the setting of osteoporosis prevention.

Skin infections leading to hospitalization occurred in 0.4 percent of women given the drug for osteoporosis, compared with 0.1 percent who got a placebo.

Women in the osteoporosis studies also had a "slightly increased incidence" of breast, pancreatic, gastrointestinal and reproductive cancers, FDA staff said.

Amgen is banking on its clinical results as well as a patient-friendly dosing schedule of twice-yearly injections to help it compete with other osteoporosis drugs, including low-cost generics. Denosumab reduced the risk of spine fractures by 68 percent.

"The overall safety and efficacy of denosumab offer a meaningful alternative to existing therapies," the company said in a summary prepared for the advisory panel.

The agency usually follows panel advice when making final approval decisions. A ruling is due by Oct. 19, but the agency has missed several drug deadlines in the past year.

Denosumab would compete with osteoporosis medicines such as Novartis AG's (NOVN.VX: Quote, Profile, Research, Stock Buzz) Reclast, Actonel from Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) and Procter & Gamble Co (PG.N: Quote, Profile, Research, Stock Buzz), and Boniva from Roche Holding AG (ROG.VX: Quote, Profile, Research, Stock Buzz) and GlaxoSmithKline PLC (GSK.L: Quote, Profile, Research, Stock Buzz).

Global sales of osteoporosis drugs hit about $8.4 billion in 2008, according to data from IMS Health.

Glaxo made a deal with Amgen in July to sell denosumab in Europe and emerging markets for osteoporosis.