Actavis applies for approval of generic version of Absorica
DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.
The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy’s Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.
In response to the filing, Ranbaxy, Galephar Pharmaceutical Research and Cipher Pharmaceuticals sued Ranbaxy for patent infringement earlier this week in the U.S. District Court for the District of New Jersey, hoping to prevent Actavis from launching its drug before the September 2021 expiration of one of their patents. Under the Hatch-Waxman Act of 1984, the lawsuit puts a stay of FDA approval on Actavis’ product for 30 months, or until the companies settle.
Actavis said it was likely the first company to seek approval for a generic version of Absorica, which had sales of about $97 million during the 12-month period that ended in September, according to IMS Health.
Adheris acquires Catalina Health
BURLINGTON, Mass. — A division of inVentiv Health has acquired Catalina Marketing’s medication adherence services subsidiary, inVentiv said Thursday.
The acquisition of Catalina Health by Adheris makes Adheris the largest provider in the nation of tailored, direct-to-patient medication adherence programs, inVentiv said. Catalina Health president Renee Selman will lead the combined company. Financial terms of the deal were not disclosed.
Before Catalina, Selman served in various leadership positions with Johnson & Johnson, including worldwide president of Ethicon Women’s Health and Urology. Jim Rotsart, currently Adheris’ general manager and EVP, will become EVP of inVentiv Health Patient Outcomes.
"Improving patient outcomes is our number-one priority," inVentiv president for health patient outcomes Mark Dmytruk said. "A coordinated adherence approach – reaching individual patients across multiple touch points with customized messages based on predictive analytics – improves adherence in ways other organizations simply cannot match."
Both companies work through pharmacies across the country to deliver adherence communications to millions of people, and thanks to the acquisition, Adheris now has "unmatched" reach through a network of more than 40 pharmacy partners with 30,000 pharmacies and 65% of all retail prescriptions. Adheris is also growing its physician office network to complement its pharmacy network.
Patients will be able to receive communications in the doctor’s office from their providers, followed by face-to-face communication with the pharmacist, as well as refill reminders through channels such as mobile. Adheris said that by combining its predictive analytics expertise with that of Catalina Health, it will offer "stronger and more effective" messaging based on a better understanding of consumer preferences and needs and allow Adheris to provide clients with a single vendor for the purchase of multiple services.
University of Arizona College of Pharmacy switches to IBM Linux system for big data management
ARMONK, N.Y. — The University of Arizona College of Pharmacy is switching from a MacOS-based platform to an IBM system running Linux to manage growth of big data.
IBM said Wednesday that the Tucson, Ariz., college was using an IBM zEnterprise mainframe running the IBM DB2 database software on Linux to analyze and process 3 million medical claims per week. A business partner of IBM, Sirius Computer Solutions, helped the college move to the new system, which reduces the time it takes to process medical claims by 60%.
The college’s Medication Management Center, a pharmacist-run center that provides personalized medication therapy management services, has more than 2.5 million members, making it necessary to have the ability to quickly and efficiently analyze so-called "big data," including medical records, medication information and claims. Previously, the college relied on a Mac Pro server to manage data, but its input-output capabilities were not sufficient, and the system became slow.
"Among the number of reasons we chose IBM’s zEnterprise platform was its reliability and almost unlimited scalability," college MTM Center associate director Kevin Barber said. "zEnterprise allows us to focus on the applications and service we deliver to our patients and not on the constant maintenance of our hardware and software technology."