Amgen, Roche battle over Mircera still unsettled
In the long battle for Amgen to prevent generic drug company Roche Holdings from bringing its anemia drug Mircera into the US market, a federal appeals court has ruled that Roche could import its drug as long as it was not for sale, while also returning the case back to the International Trade Commission.
Amgen feels that since Roche applied for Mircera’s approval from the FDA, it was violating Amgen’s patents—for Epogen and Aranesp—because the application proved intent to sell. The FDA has already approved the drug but, according to published reports, it has not been marketed it in the US based on the legal matters involved.
As Drug Store News reported yesterday, Roche agreed to the U.S. District Court for Massachusetts’ conditions in an attempt to get Mircera on the market, including, according to published reports, paying Amgen a higher royalty fee. The court’s approval would give Amgen a new rival in the top selling Anemia market, which has made up more than 40 percent of Amgen’s revenue per year. Roche has agreed to set Mircera’s price at or below Epogen’s for the remainder of the patents that Amgen holds.
Amgen’s patents for its anemia drugs begin expiring in 2013, and, according to reports, Roche plans on waiting until then to sell its drug in the U.S. According to IMS Health, Aranesp had U.S. sales of $3.2 billion last year and Epogen had sales of $3.1 billion.
TMH gets FDA OK for AutoSafety Injector
SHEFFIELD, United Kingdom The Food and Drug Administration has granted 510(k) clearance to The Medical House for its Compact AutoSafety Injector.
This clearance allows for the device, which is used for assisting self–administered subcutaneous injections to enter the market.
According to Ian Townsend, chairman, The Medical House: “This a key milestone achievement for TMH as it is our first ASI device to receive FDA pre-market notification which allows us to market the CASI in the US. It is also a vital approval for the project involving our global pharmaceutical partner and its commercial strategy. We are all delighted with this news and we look forward to reporting more progress for our Drug Delivery Division in due course”.
HealthPort wins top honors at Texas EHR Summit
COLUMBIA, S.C. HealthPort was named one of the top two vendors at a recent event held by the Texas Association of Community Health Center entitled the TACHC EHR Summit last month. The company was one of eight national/international electronic health record companies selected to participate.
More than 15 EHR vendors were initially identified as having a community health center appropriate software solution, but the eight finalists were selected when they incorporated CHC-specific clinical and functional elements and then demonstrated how those elements were used in a CHC setting during a web based pre-screening event.
At the summit, a representative from each vendor captured clinical details in a 15-minute, timed-staged encounter. Immediately following each demonstration, audience participants used a keypad to vote on 6 criteria, providing the vendor and attendees immediate feedback on the look, feel, and functionality of the software.
“It was an honor and privilege to have been selected to attend the TACHC EHR Summit. The strength of our CHC product suite was acknowledged by attendees, illustrating why HealthPort has achieved significant CHC marketshare over the past 20 plus years,” says Kerry de Vallette, senior vice president of solution sales for HealthPort.