Yesterday, Amgen Inc (AMGN) announced that the US Food and Drug Administration (FDA) delayed the approval of its osteoporosis drug denosumab, with a proposed trade name of Prolia.  In response to the Biologic License Applications (BLA) filed by Amgen in Feb 2009 for Prolia, the Complete Response Letter (CRL) issued by the FDA requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. The FDA has asked the company to develop a strategy to evaluate the risks of Prolia. However, the agency did not ask for further clinical trials, which would have resulted in a longer delay.  Management believes that it can satisfy the queries of the FDA. The company intends to market Prolia for the treatment and prevention of postmenopausal osteoporosis (PMO) and bone loss in patients undergoing hormone ablation for either prostate or breast cancer.  Based on ...

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Monday October 19, 2009

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AMGN, PWRM, JNJ, CSRH, GE, CVAT, TEVA, AQNM

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AMGN, Amgen Inc.

AMGN, a biotechnology company, engages in the discovery, development, manufacture, and marketing of human therapeutics based on advances in cellular and molecular biology.

The Food and Drug Administration wants more information about AMGN’s osteoporosis treatment Prolia before granting marketing approval. It delays a drug seen as a potential blockbuster for the company.

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PWRM, Power 3 Medical Products Inc, PWRM.OB

Power3 Medical Products, Inc. is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of

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Osteologix, Inc., a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, yesterday announced that the company has been informed that a positive decision was made in Japan to grant a patent for a key osteoporosis drug. The Japan Patent Office (JPO) has issued Osteologix, Inc. a decision to grant a patent for application number 2006-504379: “Treating Cartilage/Bone Conditions with Water-Soluble Strontium Salts.”

The patent is for NB S101 (strontium malonate), the company’s lead osteoporosis drug candidate. Osteologix expects that the patent will be issued by the end of 2009 with a 20-year term that will expire in 2024. Osteologix has now received patent protection for its novel osteoporosis therapy in the three major pharmaceutical markets, including Europe, the United States and Japan.

Philip J. Young, the president and CEO of Osteologix, stated, “We believe the intellectual property protections established by this patent in Japan,

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Warner Chilcott, a specialty drug maker, recently announced plans to acquire Procter & Gamble Co.’s (PG) prescription drug business for about $3 billion.

Last December, P&G had announced its intention to restrict making new investments in the pharmaceutical division and divest its interest in the healthcare brands. It decided to focus more on over-the-counter products such as Pepto Bismol, Prilosec, Vicks cough medicines and other personal care brands. Management stated that the pressure from generics was also one of the reasons for it to consider divestiture of this business.

Earlier in fiscal 2008, P&G sold its Folgers coffee business to J.M. Smucker Inc. (SJM) and added beauty and grooming businesses to its portfolio. The company’s prescription drugs division comprises products such as Actonel for osteoporosis (which generates more than $1 billion in revenue) and Enablex for the treatment of overactive bladder.

Warner Chilcott, which makes birth control,

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Yesterday, Eli Lilly and Company (LLY) announced that it will not seek approval from the U.S. Food and Drug Administration (FDA) for its phase III pipeline candidate, arzoxifene, which is being developed for the prevention and treatment of osteoporosis in postmenopausal women and the reduction of risk of invasive breast cancer in postmenopausal women with osteoporosis or low bone mass. The company released initial results from a pivotal, five-year, phase III study (GJAD GENERATIONS) which showed that arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women. However, the study failed to meet its main secondary efficacy endpoints. The candidate failed to show a statistically significant difference in endpoints like non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to placebo. Moreover, safety concerns were observed with the use ...

Yesterday, the U.S. Food and Drug Administration's (FDA) advisory panel ruled in favor of Amgen’s (AMGN) osteoporosis drug denosumab (proposed trade name: Prolia), but with certain exceptions.

While the advisory panel unanimously gave its stamp of approval to the injectable drug for prevention of bone fractures in women with postmenopausal osteoporosis, it stated that the drug should only be used by patients facing the highest risk of fractures. The ruling was based on safety and efficacy data from 30 studies of the drug involving more than 12,000 patients.

However, the panel did not approve use of the drug in the prevention and treatment of bone loss in women with breast cancer undergoing hormone ablation. It demanded additional data to ensure that denosumab would not hasten tumor growth in such patients, but supported use of the drug for prostate cancer as it appeared safer for men.

The committee also

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FDA Panel to Review Denosumab The U.S. Food and Drug Administration’s (FDA) Advisory Committee for Reproductive Health Drugs will be reviewing Amgen’s (AMGN) key pipeline candidate, denosumab (proposed trade name: Prolia) on August 13, 2009. Amgen is seeking approval for denosumab for the treatment and prevention of postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The committee will review and discuss the safety, efficacy, and overall risk/benefit profile of denosumab. While the company has presented encouraging phase III results on denosumab demonstrating the candidate’s superiority over Novartis’ (NVS) Zometa in the treatment of bone metastases in patients with advanced breast cancer, we think there could be a delay in approval of the candidate based on the FDA’s concerns regarding the safety profile of the drug. The FDA is concerned that patients using denosumab are ...

Amgen (AMGN) has joined with GlaxoSmithKline (GSK) for the commercialization of one of the most anticipated drugs, denosumab, meant for the treatment of osteoporosis. Osteoporosis is a bone disease leading to increased fracture risk. Glaxo will make an initial payment of $120 million along with royalties for marketing the medicine in Europe. Glaxo has the marketing rights for emerging markets such as China, Brazil, India and South Korea, where the company has a strong presence.

This is a major win for Glaxo (beating 10 other companies), which had been eyeing the emerging markets for quite sometime. Sales growth of pharma products in these areas is far greater than the matured markets. This deal is beneficial to both the companies as Amgen has a strong foothold in the US and Europe while Glaxo has a presence all over the world.

Denosumab is the most prized pipeline candidate for Amgen. Currently, the

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• Amgen (NASDAQ:AMGN) reported better-than-estimated earnings of $1.29 a share, 13 cents above estimates, after yesterday's market close, as the company benefited from its arthritis drug and tax benefits.  The firm raised its full-year earnings outlook to $4.80-$4.95 per share from $4.55-$4.75 per share and consensus estimates of $4.57

• This morning’s report indicate Amgen (NASDAQ:AMGN) and GlaxoSmithKline (NYSE:GSK) have agreed to jointly market an osteoporosis treatment, that could generate $2 billion in annual sales within ten years if given regulatory approval

• Barclays (NYSE:BCS) cut Boeing (NYSE:BA) shares to "equal weight" from "overweight", on delays and undetermined cost overruns in its Dreamliner program. Price targets were cut from $60 to $46

• Goldman Sachs (NYSE:GS) raised its rating on the US steel sector to "buy" from "neutral," noting a faster-than-expected recovery in world markets and a leaner US supply chain. Analysts upgraded US Steel (NYSE:X) in advance of today's earnings release to

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Denosumab Shows Superiority To Zometa On July 7, 2009, Amgen (AMGN) released results from a phase III program testing its experimental osteoporosis drug, denosumab, in a head-to-head trial against Novartis’ (NVS) Zometa (zoledronic acid) for the treatment of bone metastases in just over 2,000 patients with advanced breast cancer. The primary endpoint was to evaluate if denosumab is non-inferior to Zometa with respect to the first on-study skeletal related event (SRE) in patients with advanced breast cancer and bone metastases. Secondary endpoints were to evaluate if denosumab was superior to Zometa with respect to the first on-study SRE, as well as first-and-subsequent on-study SREs, and to assess the safety and tolerability of denosumab compared with Zometa. Patients enrolled in the study were randomized in a 1:1 ratio to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at ...