PHARMACY

Teva to strengthen CNS portfolio with Auspex acquisition

BY Ryan Chavis

JERUSALEM and LA JOLLA, Calif. — Teva Pharmaceutical Industries and Auspex Pharmaceuticals on Monday announced a merger agreement under which Teva will acquire Auspex in an all-cash transaction with an enterprise value of $3.2 billion. In addition to enhancing Teva’s revenue and earnings growth profile, the deal will strengthen its central nervous system franchise thanks to Auspex’s portfolio of medications for people dealing with movement disorders. 
 
"The acquisition of Auspex is a significant step in strengthening Teva’s leadership position in CNS and advances us into underserved movement disorder markets. We look forward to accelerating the development and commercialization of the Auspex portfolio based on our infrastructure, capabilities and strong commercial and R&D position in CNS. As we have outlined recently, one of our key priorities for 2015 is to support Teva’s mid- to long-term growth and create value for our shareholders with business development opportunities that are closely aligned with our core therapeutic areas. This transaction represents a first major step with regards to that commitment and we expect to continue this focus in the future,” said Erez Vigodman, president and CEO of Teva.
 
According to the companies, Auspex’s lead investigational product SD-809 (deutetrabenazine) is being developed for the potential treatment of chorea associated Huntington’s disease, tardive dyskinesia, and Tourette syndrome. 
 
Auspex’s lead candidate, SD-809, offers compelling efficacy and safety benefits to patients, as demonstrated by the impressive Phase 3 topline data in Huntington’s disease announced in December 2014,” said Michael Hayden, MD, PhD, Teva’s president of global research and development and chief scientific officer. “Teva is well positioned to realize the robust IP potential of these investigational products with Auspex’s deuterated technology which could represent a significant breakthrough for patients who often have no sustainable symptom relief from their disease.”
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PHARMACY

At the scene of NACDS RxIMPACT Day

BY DSN STAFF

Images courtesy of NACDS

WASHINGTON — More than 350 pharmacy advocates headed to Capitol Hill for the seventh annual NACDS RxIMPACT Day to further reinforce the recognition by lawmakers of the evolving role of pharmacy in patient care and educate members of Congress about pro-patient, pro-pharmacy policy.

During this year’s event, held Wednesday and Thursday, pharmacy advocates conducted more than 450 meetings with members of Congress, meeting with every member of Congress who serves on a Congressional healthcare committee, and with every member of Congress who was newly elected in November 2014.

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FDA revisits label changes with public meeting

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Friday is hosting a public meeting on supplemental applications proposing labeling changes for approved drugs and biological products, the agency noted. The purpose of the meeting is to provide a public forum for the FDA to listen to comments on the proposed rule on “changes being effected” supplements that was published in the Federal Register of Nov. 13, 2013, and alternatives offered to this proposed rule.
 
"The Generic Pharmaceutical Association applauds the FDA for today's public meeting in response to comments from dozens of health care stakeholders, minority providers and legislative membership organizations, supply chain participants, and many others troubled about the FDA Proposed Rule on generic drug labeling," said Ralph Neas, GPhA president and CEO. "These groups continue to voice concerns about how the Proposed Rule would allow generic companies to unilaterally update labels without prior FDA approval, elevating patient safety risk, raising costs and causing confusion among prescribers and providers."
 
GPhA advocates the Expedited Agency Review, an alternative proposal that's also supported by the Pharmaceutical Research and Manufacturers of America that meets the FDA objective to strengthen and expedite the labeling process but does so without provisions that could have unintended safety consequences for patients, providers, taxpayers, payors or others.
 
"The EAR would establish defined time parameters for FDA to take action on a label change made:
1) following FDA’s receipt and review of 'new safety information' from a multi-source application holder; or 2) following review of data received through the Sentinel System and/or other databases including global sources that are suggestive of a need for a label change," Neas said. "Moreover, the EAR calls for the adoption of e-labeling technology to make new information available in real time. The Proposed Rule relies on updates to paper labels that can take months or even years to be incorporated."
 
The FDA is also reopening the comment period for the proposed rule until April 27, 2015, to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.
 
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