George W. Bush to deliver keynote speech at Armada summit
FLORHAM PARK, N.J. — Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.
The conference, which will take place May 10 to 13 at the Wynn Hotel in Las Vegas, is considered one of the top conferences in the U.S. drug industry.
“We are honored that President Bush will be speaking at our conference,” Armada CEO Lawrence Irene said. “As the largest gathering of industry stakeholders, our annual meeting offers the ideal agenda to gain a valuable insight into the rapidly growing specialty pharmacy channel. One of the highlights of our conference will certainly be the keynote address by [former president] Bush.”
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.