With ruling, Restasis could soon face generic competition
MARSHALL, Texas — Allergan’s recent patent claims on its Restasis eye drops were thrown out Monday with a ruling from the United States District Court for the Eastern District of Texas. The 135-page decision found that Allergan’s patent protection for the drug ended in 2014, and that “Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection.”
“While Allergan has pointed to evidence of objective considerations such as commercial success and long-felt unmet need, the force of that evidence is considerably blunted by the fact that, based on protection from a succession of patents, Allergan was able to foreclose competition in cyclosporin/glyceride emulsion formulations from the early 1990s until 2014,” the decision said. “And the issuance of the Restasis patents has barred any direct competition for Restasis since then.”
The lawsuit listed Teva, Mylan and Akorn as co-defendants, all of whom are hoping to market generic versions of Restasis. None of the generic versions have been approved by the Food and Drug Administration, but Mylan CEO Heather Bresch welcomed the decision.
“We couldn't be more pleased with today's federal court ruling invalidating the Restasis patents. For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients,” she said.
Allergan said that the decision was not the end of the road for their intellectual property protection efforts around Restasis.
"We are disappointed by the Federal District Court's decision on the Restasis patents. We are carefully reviewing the decision and are considering all options," Allergan chief legal officer Robert Bailey said. "Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients."
Amneal, Impax to merge
BRIDGEWATER, N.J., and HAYWARD, Calif. — In a move that will turn two players into the fifth-largest generics business in the United States, Amneal Pharmaceuticals and Impax Laboratories on Tuesday announced their plan to merge in an all-stock transaction. The combined company, which will be named Amneal Pharmaceuticals, will have a generics portfolio of roughly 165 product families with 150 pending applications before the Food and Drug Administration.
“In the 15 years since our family founded Amneal, we have established the company as a leader in the U.S. generic pharmaceuticals industry, and today marks an important milestone in these efforts,” Amneal co-CEO and co-chairman Chirag Patel said. “This transaction combines the complementary strengths of both Amneal and Impax to create an even stronger company with the diversification, capabilities and resources to deliver enhanced value for patients, new opportunities for our collective employees and increased growth and value creation for shareholders.”
The combined company, which will be 25%-owned by current Impax shareholders, is expected to create double-digit improvements in revenue and adjusted earnings per share over the first three years following the close of the transaction, and cost savings of roughly $200 million in the same time frame.
At the helm will be Amneal’s Chirag and Chintu Patel, who will serve as co-chairmen of the combined company’s board of directors, as well as Impax president and CEO Paul Bisaro, who will assume the role of CEO of the combined company. Impax’s SVP finance and CFO Bryan Reasons will become CFO of the new company, which will have roughly 6,500 employees.
The companies expect that their merger will bring high-quality research and development capabilities to the combined company, as well as strengthened global supply chain capabilities and a growing specialty franchise from Impax, whose treatments for central nervous system disorders include Rytary, Zomig and Emverm.
“We are excited to join with Impax to create one of the most dynamic companies in the pharmaceutical industry,” current Amneal co-CEO and co-chairman Chintu Patel said. “This combination will help us achieve our long-term goals of providing greater access to safe and affordable medicine for people around the world, while also positioning us for continued success.”
The companies expect the transaction to close in the first half of 2018, subject to the satisfaction of customary closing conditions.
RxOwnership’s expanded partnership with NCPA empowers all pharmacists
ORLANDO, Fla. — Expanding its support of independent pharmacy ownership, McKesson’s RxOwnership team has partnered with the National Community Pharmacists Association to sponsor a series of educational programs aimed at current and future pharmacists considering pharmacy ownership at the NCPA Annual Conference here.
“McKesson RxOwnership is dedicated to supporting the future of pharmacy ownership by giving pharmacists the knowledge, support and tools required to achieve their ownership goals,” said Chris Cella, national VP McKesson RxOwnership. “We are particularly excited to expand our partnership with NCPA to include both current and future pharmacists. We feel it is important to empower any and all pharmacists who are interested in owning and operating an independent pharmacy. We are proud to promote programs like this one and our Women in Pharmacy – Own It Program we recently launched.”
The Women in Pharmacy – Own It Program focuses on four key areas: ownership, mentorship, leadership and work/life balance for women. Creating a community of women helping women succeed, the program includes matching pharmacy students with owners and empowering pharmacy ownership.
Serving as the sponsor of the NCPA Pharmacy Ownership Workshops for the eighth year, McKesson added support for the Student Ownership Boot Camp Series. The Pharmacy Ownership Workshop and Student Ownership Boot Camp sessions are designed to provide current pharmacists and pharmacy students with tools to guide them in pharmacy ownership and enhance their current management skills. More than 50% of past Pharmacy Ownership Workshop participants currently own their own pharmacy.
The NCPA’s Student Affairs program fosters interest in community pharmacy ownership and entrepreneurship among the future leaders of their profession. This year, McKesson has sponsored 26 NCPA Foundation Presidential Scholarships, designed to recognize leadership qualities and academic accomplishments.
For the second year, McKesson RxOwnership took part in the official NCPA student education program on Oct. 14. Kim Diemand, VP North Central Region, McKesson RxOwnership, presented “The Importance of a Business Plan to Your Success.” The session reviewed why a business plan is critical to starting and operating an independent pharmacy. RxOwnership is also participating in the Student Chapter Business Card Swap, which gives hundreds of NCPA student members the opportunity to connect with peers and experienced ownership advisors.
In the past year, RxOwnership assisted more than 400 owners in launching a new pharmacy. Since 2008, the RxOwnership team aided in the ownership-transfer process of more than 4,000 pharmacies.