Amgen and the War on Bone Tumors (AMGN)
Amgen Inc. (NASDAQ: AMGN) has submitted a BLA, a Biologics License Application, to the U.S. FDA for denosumab. The BLA submission summarizes trial data as a “clinical experience from nearly 6,900 patients across 18 clinical studies” including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).
Denosumab is a subcutaneous RANK Ligand inhibitor and the aim here is to slow or stop he spread of tumors into the skeleton. Bone metastasesis a serious concern for many patients with advanced cancer.
If cancer reaches into the bone structure, the growing cancer cells weaken and destroy the bone around the tumor. After that occurs, patients can end up with easy fractures, spinal cord compression, and/or the need to receive radiation or surgery to bone.
The RANK/RANKL pathway is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. Denosumab is the first therapy to target this important pathway.
Amgen said that it intends to submit marketing applications in the European Union, Switzerland, Canada and Australia, and also in Japan, all in a short period of time, with its licensing partner, Daiichi-Sankyo, under a collaboration and license agreement for the development and commercialization of denosumab in Japan.
This BLA represents the second marketing application for denosumab that has been submitted to FDA; denosumab is currently being reviewed under the trade name Prolia™ for conditions related to bone loss. For that application, the FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.
Roger M. Perlmutter, M.D., Ph.D., EVP ofR&D said, “We believe that denosumab will offer substantial benefit to cancer patients suffering from bony metastases. Denosumab, administered monthly as a 120 mg dose subcutaneously, demonstrated consistently similar or greater efficacy in clinical trials when compared to zolendronic acid, offering the potential to improve on the current standard of care. One potential advantage of denosumab is that dose adjustments resulting from declining renal function are not necessary.”
Amgen shares closed down 2.25% at $54.63 (unofficial closing bell price) on only about 4.8 million shares.
JON C. OGG
Amgen beats Q2 estimates, announces Glaxo partnership for denosumab (AMGN, NVS, GSK)
Amgen Inc. (Nasdaq: AMGN) shares are up about 3 percent to $62.66 after hours, on better-than-expected top and bottom-line result that helped to overshadow disappointing sales of its blockbuster Neulasta.
Next up for the company is an August FDA panel meeting to discuss its osteoporosis drug candidate denosumab. The candidate did so well in a head-to-head Phase III trial vs. the current standard drug, Novartis Inc.’s (NYSE: NVS) Zometa earlier this month that the Amgen’s drug may become the new standard for osteo patients with breast cancer.
“We are optimistic about our financial performance in 2009 and are focused on making denosumab a success,” said Kevin Sharer, chairman and chief executive officer.
Separately, Amgen announced it will collaborate with GlaxoSmithKline (NYSE: GSK) to commercialize denosumab in Europe, Australia, New Zealand and Mexico for postmenopausal osteoporosis.
Financial terms of the partnership include an initial payment and near-term commercial milestones to Amgen totaling $120 million, as well as ongoing royalties.
In Europe, Amgen and GlaxoSmithKline will share profits after accounting for expenses associated with the partnership.
In emerging markets, GlaxoSmithKline will be responsible for all commercialization expenses and purchase denosumab from Amgen to meet demand.
The strong trial results earlier this month appear to be raising hopes that Denosumab also will perform well in two upcoming Phase III trials. One is for solid tumor/multiple myeloma in which results could be available later this year. The other is a trial of prostate cancer patients in which the disease has spread to the bone.
Amgen posted earnings of $1.29 a share, or 13 cents better than analyst expectations. Revenue fell 1.4 percent vs. year-ago results to $3.71 billion, aove the $3.58 billion analyst consensus.
The company guided higher for fiscal 2009, and now sees per-share earnings in a range of $4.80 to $4.95 a share, above the $4.57 analyst consensus. It also sees revenue for the fiscal period trending toward the upper end of its previously provided guidance range of $14.4 billion to $14.8 billion, which is above consensus of $14.33 billion.
One of the only disappointments was with sales of Neulasta, which often is prescribed for chemotherapy patients to boost their white cell counts. Quarterly sales were $831 million, vs. $875 million analyst expectations.
Most of its other best-selling drugs, including Enbrel for rheumatoid artritis, came in with results above or near analyst estimates. — Mike Tarsala
Amgen trial success comes at the expense of Novartis (AMGN, NVS)
Amgen Inc’s (Nasdaq: AMGN)’s osteoporosis drug Denosumab did so well in a head-to-head Phase III trial vs. the current standard drug, Novartis Inc.’s (NYSE: NVS) Zometa, that the Amgen’s drug may become the new standard for patients with breast cancer.
Denosumab was superior to Zometa by about 18 percent in delaying the time to the first bone fracture, radiation or surgery, or spinal cord compression in patients with breast cancer in which the disease has spread to the bone. Denosumab also delayed the time to the first and subsequent such skeletal-related events by 22 percent, among more than 2,000 patients involved in the late-stage study.
The strong trial results appear to be raising hopes that Denosumab also will perform well in two upcoming Phase III trials. One is for solid tumor/multiple myeloma in which results could be available later this year. The other is a trial of prostate cancer patients in which the disease has spread to the bone.
Among the various classes of breast cancer patients, it’s possible that swapping out Zometa for Denosumab could result in more than $1 billion of incremental revenue for Amgen over the next three to five years.
As far as safety data goes, the company said the overall incidence of adverse events was consistent with what has previously been reported. But osteonecrosis of the jaw, which had not been observed in previously reported Phase III studies of the drug, was seen in about 1 percent of cases — roughly the same as in Zometa.
Overall, the data appears to open up a large potential market share opportunity for Amgen at the expense of Novartis. – Mike Tarsala.
Full 2009 ASCO Cancer & Oncology Primer (ABII, AEZS, ALTH, AMGN, APPA, ARQL, BMY, CLDX, CELG, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, MITI, OGXI, OSIP, PPHM, PFE, ROSG, SNTA, TRBN, ZIOP, ZGEN)
We have already seen a massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, which is scheduled to start this weekend. ASCO is usually thought of as the Holy Grail of cancer conferences and these abstracts and presentations are viewed by investors, analysts, clinicians, doctors, and by cancer patients.
We compiled a brief synopsis for the following drug and biotech companies: Abraxis BioScience, Inc. (NASDAQ:ABII), AEterna Zentaris Inc. (NASDAQ: AEZS), Allos Therapeutics, Inc. (NASDAQ: ALTH), Amgen Inc. (NASDAQ: AMGN), A.P. Pharma, Inc. (Nasdaq: APPA), Arqule Inc. (NASDAQ: ARQL), Bristol-Myers Squibb (NYSE: BMY), Celldex Therapeutics (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), Micromet, Inc. (NASDAQ: MITI), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Rosetta Genomics (NASDAQ:ROSG), Synta Pharmaceuticals (NASDAQ: SNTA), Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), ZIOPHARM Oncology (NASDAQ: ZIOP), and ZymoGenetics, Inc. (NASDAQ: ZGEN).
Be advised that some of the data may have been changed since the first abstracts came out, but this is an expansive list of companies with data.
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Amgen Gets The Gorilla Off Its Neck (AMGN)
Amgen Inc (NASDAQ: AMGN) came out with its much awaited data after the close and shares are rocking higher on the news. The biotech giant said that its pivotal 3-year trial of experimental osteoporosis drug Denosumab met the target goals by significantly reducing the risk of bone fracture in post-menopausal women.
The patients treated with denosumab showed a statistically significant reduction in the incidence of new vertebral fractures over the arm given the placebo.
Amgen also noted that the group receiving Denosumab also experienced a statistically significant reduction of new non-vertebral and hip fractures.
The groups receiving Denosumab and the placebo also saw similar side effects and at roughly the same frequency, with side effects including serious infections and malignancies.
Shares are up a monster 11% and back over $60.00 for the first time in more than a year.
Jon Ogg
July 25, 2008
Amgen (AMGN) Claims Osteoporosis Break-Through
Amgen (AMGN) claims that it has developed a new and better drug treatment called denosumab for osteoporosis. The current drug of choice is Fosamax from Merck (MRK).
According to the AP “The one-year, Phase III clinical trial showed post-menopausal women gained more bone mass after transition to denosumab.”
A generic version of Fosamax is marketed by Teva (TEVA).
The news can’t be viewed as good for Merck
Douglas A. McIntyre
Amgen (AMGN) Claims Osteoporosis Break-Through
Amgen (AMGN) claims that it has developed a new and better drug treatment called denosumab for osteoporosis. The current drug of choice is Fosamax from Merck (MRK).
According to the AP “The one-year, Phase III clinical trial showed post-menopausal women gained more bone mass after transition to denosumab.”
A generic version of Fosamax is marketed by Teva (TEVA).
The news can’t be viewed as good for Merck
Douglas A. McIntyre
