FDA rejection of lower-dose Copaxone will likely ward off generic competition
NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker’s application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.
In its response to Teva, the FDA noted that it could not approve the application for a lower-dose from of Copaxone as the drug’s mechanism was not fully understood. "Unless you can provide a convincing argument that the new higher concentration/lower volume formulation does not have an impact on efficacy, an adequate and well-controlled efficacy study will be needed to support efficacy of this new formulation," the FDA noted.
“This response supports Teva’s belief that even slight changes to a glatiramoid like Copaxone can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound,” the company noted.
"The FDA’s letter highlighted the high hurdle potential generic manufacturers of Copaxone face in gaining approval," JP Morgan analyst Chris Schott noted in a Dec. 23 research note.
SXC-MedfusionRx acquisition officially closed
LISLE, Ill. — SXC Health Solutions announced Wednesday that it had completed its acquisition of independent specialty pharmacy provider MedfusionRx in a deal worth $100 million in cash, with an additional $5.5 million subject to the achievement of certain performance targets in fiscal year 2012.
The waiting period under the Hart-Scott-Rodino Act expired Dec. 24.
"We are very pleased to welcome MedfusionRx’s employees and customers into the SXC fold," said SXC president and CEO Mark Thierer. "This acquisition will help transform our specialty pharmacy business by expanding our presence and enhancing our capabilities in this rapidly growing segment of the PBM industry. We are excited with the growth prospects of this acquisition and look forward to capitalizing on our revenue and cost-saving synergy opportunities."
MedfusionRx specializes in bleeding disorders, growth hormone deficiency, multiple sclerosis, rheumatoid arthritis, plaque psoriasis, Crohn’s disease and hepatitis C, as well as medications for patients with cancer and in the preventive treatment of RSV. The company operates a satellite pharmacy in Alabama and six additional pharmacies in Tennessee, Mississippi, West Virginia, Texas, Louisiana and Kansas.
Report: More than a quarter of U.S. kids take at least one chronic med
NEW YORK — More than 25% of children and teens take at least one medication on a daily basis, and nearly 7% are on two or more drugs, the Wall Street Journal reported Tuesday, citing 2009 data from Medco Health Solutions. Drawing additional data from IMS Health, the article noted that prescriptions for hypertension in people under the age of 20 years could reach 5.5 million for 2010 by the time year-end results are tabulated, which would mark a rise of 17% since 2007.
The rise in prescription drug use among children has been attributed to increasing awareness among physicians and parents of available therapeutic options for kids and teens, earlier screening and diagnosis of chronic disease, and a rise in unhealthy eating and exercise habits among kids. That has many healthcare professionals concerned. While much is known about the effects of drugs to treat such conditions as asthma and attention-deficit hyperactivity disorder, much less is known about the long-term effects of many other chronic care drugs on children — these drugs have been tested on adults, not kids, many experts have warned.