Article preview reprinted from Start-Up - April, 2009
As Amgen gears up to launch osteoporosis candidate denosumab, a host of smaller players are working on what they see as the next-generation therapies: those that help build up new bone.
Building Bone: Next-Generation Osteoporosis Therapies
In a sense, it's easy to see why most companies would want to steer away from trying to develop a new drug for osteoporosis. There are dozens of drugs out there already—most notably the bisphosphonates, led by Merck & Co. Inc.'s alendronate (Fosamax). Now generic, Fosamax prices have plummeted; other bisphosphonates will follow. Meanwhile, Big Pharma competitors market a range of alternatives, including longer-acting bisphosphonates, such as Novartis AG's once-yearly zoledronic acid (Reclast), plus products with other mechanisms of action, including selective estrogen receptor modulators (SERMs) like Eli Lilly & Co.'s raloxifene (Evista), blood calcium lowerers like calcitonin (sold by Novartis as Miacalcin) and Lilly's bone-building teriparatide (Forteo). Very soon, there'll likely be another heavy hitter: Amgen Inc. is about to barge into the space with denosumab, a first-in-class large molecule whose success is critical to the company's future. (See "Amgen's D-mab: The New EPO," IN VIVO, March 2009.)
If the competitive landscape isn't scary enough, take a look at the regulatory one: the FDA has held up two of the newest SERMs aimed at osteoporosis, Wyeth/Ligand Pharmaceuticals Inc.'s bazedoxifene (Viviant) and Pfizer Inc.'s lasofoxifene (Fablyn). Even with an 8,500-patient study and a three-year risk evaluation plan, Fablyn has been turned down twice—most recently in January 2009, and initially in February 2005. The problems with these SERMs include increased risk of blood clots, stroke, and cancer. So it's not difficult to see why Pfizer's quitting the area altogether: following official EU approval for Fablyn earlier this year, the company's now seeking an out-licensing partner.
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Companies mentioned in this article:
Amgen Inc.
Amylin Pharmaceuticals Inc.
AstraZeneca PLC
Aursos Inc.
Baylor University
Baylor College of Medicine
Celgene Corp.
Columbia University
New York-Presbyterian Hospital
Eli Lilly & Co.
Emisphere Technologies Inc.
Galapagos NV
GlaxoSmithKline PLC
Ipsen
Japan Tobacco Inc.
Johnson & Johnson
Ligand Pharmaceuticals Inc.
Medivir AB
Merck & Co. Inc.
MicroChips Inc.
MorphoSys AG
NPS Pharmaceuticals Inc.
Nektar Therapeutics Inc.
Novartis AG
Novartis Pharma AG
Nycomed International Management GMBH
OsteoCorp Inc.
OsteoGeneX Inc.
Osteologix AS
Pfizer Inc.
Pradama Inc.
Radius Health Inc.
Servier SA
Therosteon BV
TransPharma Medical Ltd.
UCB Group
UCB SA
Unigene Laboratories Inc.
University of Louisville
Wyeth
Zelos Therapeutics Inc.
Zosano Pharma Inc.
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