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Mylan’s Frova ANDA moves forward following settlement agreement with Endo Pharmaceuticals

BY Michael Johnsen

PITTSBURGH — Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan’s filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg. This product is the generic version of Frova, which is used to treat acute migraine headaches in adults. 

As a result of the decision, the Court has vacated its Jan. 28, 2014, decision in favor of Endo regarding the parties’ patent litigation over this product, which could have prevented Mylan from launching its generic version of Frova until after the expiration of U.S. Patent 5,464,864 patent on Nov. 7, 2015. By enforcing the settlement, Mylan can launch its product pursuant to the terms of the settlement, contingent upon final FDA approval.

For the 12 months ended Dec. 31, 2013, frovatriptan had U.S. sales of approximately $66.4 million, according to IMS Health.

 

 

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Pfizer CEO elected as PhRMA chairman

BY Michael Johnsen

WASHINGTON — Ian Read, chairman and CEO of Pfizer, Inc, was elected chairman of the Pharmaceutical Research and Manufacturers of America Friday at the trade association’s annual meeting. Also elected were Kenneth Frazier, chairman, president and CEO of Merck, as chairman-elect of the PhRMA board of directors, and George Scangos, CEO of Biogen Idec, as board treasurer.

Read succeeds Robert Hugin, chairman and CEO of Celgene Corp., as PhRMA’s chairman.

“Bob Hugin is a true champion of the value that innovative medicines deliver to patients, public health and our economy. Over the past year, his tireless efforts to create new dialogues with partners in the patient community and enthusiasm for better conveying the value of our sector have greatly enhanced our advocacy for forward-looking policies that promote innovation and provide patient access to new medicines,” stated PhRMA president and CEO John Castellani.

“At a time when collaborative medical science and healthcare delivery in the U.S. and around the world are rapidly evolving, we are fortunate to have Ian Read as chairman,” Castellani added. “His vision for the future of our healthcare system will help guide PhRMA as we embark on the many challenges and opportunities ahead.”

Read began his career with Pfizer in 1978 as an operational auditor. Read worked in Latin America through 1995, in roles including CFO, Pfizer Mexico, and country manager, Pfizer Brazil. In 1996, he was appointed president of Pfizer’s International Pharmaceuticals Group, with responsibility for Latin America and Canada. He became EVP, Europe, in 2000, and was named a corporate VP in 2001, assuming responsibility for Canada, in addition to Europe, in 2002. Read later became accountable for operations in both the Africa/Middle East region and Latin America. In 2006, he became SVP, Pfizer, and group president of the Worldwide Biopharmaceutical Businesses, which he led through December 2010. In that role, he oversaw five global business units — Primary Care, Specialty Care, Oncology, Established Products and Emerging Markets.

“Our highest priority and purpose as an industry is to deliver life-saving medicines to those who need them most. We are poised to enter another golden era of innovation, transforming the way we do research and development to speed the discovery of innovative new medicines,” Read said. “To be successful in our purpose, we must have a reputation that ensures the full support of all segments of civil society. We are judged, ultimately, by our actions and we must work hard to earn the trust and respect of our regulators, legislators, healthcare professionals, R&D partners and most importantly the patients who depend on us, now and into the future.”

Frazier previously served as president of Merck with responsibility for the company’s three major divisions: Global Human Health, Merck’s sales and marketing division for pharmaceutical and vaccine products; Merck Manufacturing, the company’s manufacturing and supply division; and Merck Research Laboratories, Merck’s research organization. Frazier held a broad range of senior management positions since joining Merck in 1992 as VP, general counsel and secretary of the Astra Merck Group. He received his Bachelor’s degree from Pennsylvania State University and holds a J.D. from Harvard Law School.

“The outstanding contributions being made to society by the biopharmaceutical companies who make up PhRMA’s membership inspire me every day. I am enthusiastic about my new responsibilities and look forward to supporting PhRMA’s ongoing efforts to advance healthcare for patients, caregivers and society,” Frazier said.

Scangos was appointed CEO of Biogen Idec in June 2010. He joined Biogen Idec from Exelixis, where he served as president and CEO since October 1996. From 1987 to 1996, Scangos held various positions at Bayer, including SVP of R&D, and president of Bayer Biotechnology, where he was responsible for research, business development, process development, manufacturing, engineering and quality assurance of Bayer’s recombinant products. Before joining Bayer in 1987, Scangos was professor of Biology at Johns Hopkins University. Scangos received a B.A. in Biology from Cornell University, and a Ph.D. from the University of Massachusetts.

“We are entering an era of medical innovation that offers a real chance to find therapies for some of the most challenging diseases, from Alzheimer’s, to ALS, to many of the cancers that now have few or no treatments. Success will require not only superior science but also sound public policy. I look forward to working with my industry colleagues, policymakers, and others toward a world where patients can reap the full promise of what our industry has to offer,” Scangos said.

 

 

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American Crew founder David Raccuglia returns as creative consultant

BY Antoinette Alexander

DENVER — Men’s grooming brand American Crew has announced the return of company founder David Raccuglia as a key creative consultant.

In his new role, Raccuglia will take his place behind the camera as the photographer of American Crew, and will lead additional photography projects with other Revlon brands. He will use his category expertise with the marketing and education teams to further the brand’s commitment to innovation and imagery for both American Crew and Style Masters, a Revlon professional brand.

"We welcome David back to the Revlon family, and look forward to his creative expertise to expand our professional brand portfolio," stated Martin Flaherty, GM, Revlon Professional Brands, USA.

Raccuglia launched American Crew in Chicago in 1994. The initial six products — Daily Shampoo, Daily Conditioner, Texture Creme, Firm Hold Styling Gel, Light Hold Styling Gel and Pomade — were met with rave reviews. During his time away from the company, Raccuglia continued his work as a fashion photographer and an industry authority on men’s grooming.

 

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