Quick FDA Approval Gives Amgen Drug Competitive Edge

0

Amgen Inc.’s first cancer drug, Vectibix, is on track to become the fastest commercial launch in the Thousand Oaks biotech giant’s 25-year history.


The colorectal cancer treatment, which won U.S. Food and Drug Administration approval on Sept. 27 after regulators agreed to expedite the review process in mid-June, is likely to be on the shelves of major drug wholesalers before Oct. 10. In an industry where reviews can stretch more than a year, Vectibix is setting a blistering pace.


“This is a very big day for us strategically, because now we’re in the tumor shrinking business,” said Cynthia Schwalm, vice president and general manager of Amgen Oncology.


Several factors worked to give Amgen a fast start. In August 2005, the FDA gave the drug generically known as panitumumab a “fast track” designation usually reserved for drugs with the potential to address unmet medical needs. That enabled Amgen to start submitting clinical trial data and other information incrementally starting in December rather than wait until its entire submission package was complete.


Then in June, the company was given a date by which it could expect to hear yea or nay from the government. Because Amgen staff were in close contact with FDA evaluators, they were confident enough that things were going well to give the go-ahead to start filling vials of Vectibix. All that was needed before boxing the drug was the approved language for the label, which arrived with last week’s approval.


The drug will compete with ImClone Systems Inc.’s Erbitux, a similar antibody-based treatment that has been on the market for more than two years. Analysts are giving an edge to Vectibix, not only because of its therapeutic advantages and affordability compared to Erbitux, but Amgen’s superior marketing muscle. The drug will be priced 20 percent lower than Erbitux and also will require injections every two weeks rather than weekly; that will price it at about $8,000 per month before insurance.



White’s Marketing Breakout


Despite the slogan emblazoned on its marketing material, White Memorial Medical Center shouldn’t be “L.A.’s best-kept health secret” any longer at least not to readers of the Sunday Los Angeles Times.


White paid extra for premium placement in the Sept. 24 edition of a poster-size flyer touting the Adventist Health-owned hospital’s new $200 million 354-bed patient tower and its respected orthopedic and cardiac care units. The four-color ad was sent to every Times subscriber and newsstand in an 11-mile radius.


It’s the latest in a $500,000 marketing campaign that began in May, designed to position the mid-size, non-profit community hospital in East L.A. as a larger regional player.


“It’s expensive to advertise and develop any kind of a brand awareness in Los Angeles, so we really wanted a high-impact piece,” said Mark Newmyer, vice president for marketing.



Who To Drew’s Rescue?


While Los Angeles County officials are being tight-lipped over which hospital operator might be asked to take over management of troubled Martin Luther King Jr./Drew Medical Center, at least one well-known hospital chain has discussed the idea with county officials, according to local health industry sources.


Catholic Healthcare West, the state’s largest non-profit hospital owner, has been in contact with county officials. This could make sense strategically for the San Francisco-based chain since it already operates five hospitals in the county, including California Hospital Medical Center and Glendale Memorial Hospital.


A local CHW official confirmed that the county had approached them and discussions were ongoing. A spokesman for the county Department of Health Services declined to name other hospital groups that might be in the running.


The U.S. Centers for Medicare and Medicaid Services informed King/Drew and county officials on Sept. 22 that the hospital had failed a crucial inspection this summer and would lose $200 million a year in federal funding about half of its budget. County officials have since been scrambling to come up with a new management structure that would satisfy the Feds and keep the hospital and its badly needed emergency room open.


In addition to outside management, the county also is considering shifting control of King/Drew to another county hospital, such as Harbor-UCLA Medical Center near Torrance. Jim Lott, spokesman for the Hospital Association of Southern California, said that may end up the quickest and most politically palatable option.


“It’s clear that we need to maintain the emergency medical services provided by King/Drew,” said Lott, noting that the county already has lost nine emergency rooms in the past five years and is on the verge of losing another in Inglewood.



Another Anodyne Acquisition


Anodyne Medical Device Inc., a Los Angeles based company formed in February to roll up medical support surface firms, has announced another strategic acquisition.


The company said it has bought Corona-based Anatomic Concepts Inc. which designs, manufactures and distributes mattresses, mattress overlays, operating room table pads and related accessories. The purchase price was not disclosed.


Medical support surfaces are used in the prevention and treatment of pressure wounds experienced by patients with limited mobility. Chief Executive Mark Bidner said Anatomic’s operating room positioning devices fill an important hole in Anodyne’s product line.


Anodyne’s first acquisitions were of two other leading companies in the sector: AMF Support Surfaces Inc. in Corona and SenTech Medical Systems Inc. in Coral Springs, Fla. The company is backed by two private investment firms, Compass Group International LLC and Hollywood Capital Inc., both of which target companies in the $5 million to $30 million revenue range.



Staff Reporter Deborah Crowe can be reached at (323) 549-5255, ext. 232, or at [email protected].

No posts to display