PHARMACY

FDA approves Teva’s Vantrela ER

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Teva’s Vantrela ER (hydrocodone bitartrate, extended-release) tablets, the company announced Wednesday. The drug, indicated for pain severe enough to require daily, around-the-clock, long-term opioid treatment and patients for whom alternative therapy is inadequate, is formulated with Teva’s proprietary abuse-deterrent technology. 
 
“Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by chronic pain,” Teva president and CEO of global specialty medicines Dr. Rob Koremans said. “Abuse-deterrent treatments provide options for prescribers that may help deter or mitigate abuse while still preserving access to pain medications for the patients that need them most.”
 
Vantrela ER’s abuse-deterrent properties are expected to reduce, but not totally prevent oral, intravenous and intranasal abuse of the drug when tablets are manipulated. As an opioid, Vantrela ER comes with a boxed warning that includes addiction, abuse and misuse, which can lead to overdose and death, as well as serious, life-threatening or fatal respiratory depression. 
 
“While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward,” Teva president of global R&D and chief scientific officer Dr. Michael Hayden said. “We are committed to furthering responsible pain management.”
 

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Lilly to acquire CoLucid Pharmaceuticals

BY David Salazar
INDIANAPOLIS and CAMBRIDGE, Mass. — Eli Lilly on Wednesday announced its planned acquisition of CoLucid Pharmaceuticals. The $960 million all-cash transaction is aimed at growing Lilly’s migraine pain management portfolio and will add a potential near-term launch to its late-stage pipeline. 
 
CoLucid Pharmaceuticals is developing a potential new treatment for migraine, lasmiditan, that if approved would be a first-in-class way to treat migraines without vasoconstriction. In addition to lasmiditan, Lilly is studying tanezumab in collaboration with Pfizer for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain. 
 
“Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine,” Lilly president and CEO David Ricks said. “This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine.”
 
Lasmiditan was first discovered at Lilly and out-licensed to CoLucid in 2005, when pain management wasn’t one of the company’s strategic focus areas. 
 
“We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization,” CoLucid CEO Thomas Mathers said. “We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly's expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients.”
 
Lilly expects the acquisition to close in the first quarter of 2017 and said it expects a financial charge of about $850 million, or about $0.80 per share — the number by which the company’s reported earnings per share guidance is expected to be reduced. 
 

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Concerns over DIR fees top list of concerns for NCPA members

BY Michael Johnsen

ALEXANDRIA, Va. – Ensuring fair compensation and a level playing field are the chief concerns for community pharmacy operators as the 115th Congress begins their deliberations, according to the latest National Community Pharmacists Association member survey.

For the fourth consecutive year, NCPA asked its members to rank their most important legislative and regulatory priorities. The top issue chosen by respondents is to end the retroactive nature of direct and indirect remuneration (DIR) fees by pharmacy benefit managers. The next most important issue is creating greater transparency in generic presrcription drug reimbursements. Rounding out the top three priorities is the inclusion of an any willing pharmacy provision for Medicare Part D ‘preferred pharmacy’ prescription drug plans.

“NCPA’s annual survey of independent community pharmacies helps focus our advocacy efforts, which take on more urgency with a new Congress and president taking office," stated Douglas Hoey, NCPA CEO. "This year’s top priorities are tied to the questionable business practices of lightly-regulated PBM corporations. Complaints about DIR fees have skyrocketed, so it is not surprising that reining in PBM clawbacks would top the list. The second and third highest ranked priorities are long-standing, PBM-generated challenges –  the lack of transparency with generic prescription drug reimbursements and Medicare Part D’s ‘preferred pharmacy’ plans that prevent independent community pharmacy patients from having access to discounted copays," he said.

“Legislative remedies have previously generated bipartisan support, and we will work to get them introduced and passed in the new Congress. In addition, we will work constructively with the Trump Administration, especially officials charged with oversight at HHS, because we believe our solutions are fair-minded and principles they should favor," Hoey added.

Beyond these three leading issues, NCPA will also focus on relaying the value community pharmacists delivery day-in and day-out as both the political landscape, and potentially the healthcare market, change dramatically. "We will make sure the voice of independent community pharmacies is heard," Hoey said. "Our main objective is always to maintain patient access to prescription drug services at community pharmacies and continue pushing for pharmacists to be fully utilized as clinically-trained medication experts who improve health outcomes while reducing costs.”
 

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