Mylan first to launch generic Sustiva
Mylan has launched its generic of Bristol-Myers Squibb’s Sustiva (efavirenz) tablets. Mylan’s generic Sustiva is the first copycat of the drug, which is indicated to treat HIV-1 alongside other antiretroviral agents in adults and children at least 3 months old weighing at least 3.5 kg.
“With the launch of efavirenz, Mylan marks an important achievement in bringing more affordable treatment options to the HIV patient community,” Mylan CEO Heather Bresch said. “Our global commitment to improving access to antiretroviral medicines for this important patient population spans more than a decade, and the U.S. launch bolsters our leadership in producing high-quality ARVs and positions us to continue to lead this important category in the future.”
The Food and Drug Administration noted in its approval of Mylan’s generic Sustiva that it is eligible for 180 days of market exclusivity, as it was one of the first substantially complete generics submissions for the product.
Mylan’s generic will be available in 600-mg dosage strength tablets. The product had U.S. sales of roughly $113 million for the 12 months ended Dec. 31, 2017, according to IQVIA data. Roughly 1.1 million patients in America live with HIV.
Boehringer Ingelheim names new U.S. head
Boehringer Ingelheim has named a new U.S. president and CEO and announced the retirement of Paul Fonteyne, who currently holds the position, effective March 1. The Ingelheim, Germany-based company has promoted Wolfgang Baiker — currently senior vice president of human pharmacy supply and global quality and head of its biopharma business unit — to succeed Fonteyne, also effective March 1.
Baiker joined Boehringer Ingelheim in 1989 as the section head for clinical development in Germany, holding various senior leadership roles in the ensuing years, including head of global development and as a member of the company’s global human pharma executive committee. Baiker, who holds an MD, Ph. D and MBA, also has held several leadership roles within clinical development and clinical research at the company’s Ridgefield, Conn., U.S. headquarters.
“This is the perfect time for Wolfgang Baiker to become Boehringer Ingelheim’s next U.S. president and CEO,” Fonteyne said. “Wolfgang is a strong and experienced leader and our U.S. business is in a great position, poised for continued growth. Our industry and the U.S. market, in particular, is developing and changing at an incredible pace. Wolfgang has a unique ability to help the company anticipate and navigate this dynamic landscape. His strong track record in leading highly-successful teams makes him the perfect choice to continue the strong legacy of Boehringer Ingelheim in the United States.”
Fonteyne will work for the remainder of the year at the head of Boehringer Ingelheim’s animal health business, overseeing the integration and normalizing of operations following its acquisition of Merial from Sanofi. He will remain chairman of the Boehringer Ingelheim USA board. Fonteyne has served as president and CEO since 2012, which followed a three-year stint as head of corporate marketing in Ingelheim, overseeing the launch of Pradaxa and Tradjenta while growing the human pharmaceuticals portfolio, the company said.
Innovation founder, chairman Boyer dies
Innovation has announced that its founder and chairman Joseph “Harry” Boyer has died. Boyer, who started the PharmASSIST maker in 1972 as Innovation Associates, passed away at his home in Johnson City, N.Y., on Jan. 30 following a long illness.
When Boyer started the company, it was as a research and development engineering, technical services and manufacturing firm. In 1995, Boyer shifted the focus to pharmacy automation, introducing the PharmASSIST technology at the National Association of Chain Drug Stores’ Pharmacy and Technology conference in Boston. Since then the company has grown into a solutions company for high-volume pharmacies in need of automation that has seen more than 2000 installations worldwide.
While leading the company, Boyer received various accolades, including the New York State Small Business Person of the Year and the Broome County Chamber of Commerce Small Business Person of the Year awards, both of which he received in 2004. He also created a strategic partnership with Binghamton University’s Thomas J. Watson Institute of Systems Excellence, through which Innovation and the university have collaborated on big data analysis, visual process simulation and artificial intelligence. In 2011, in recognition of Boyer’s efforts, the university awarded him the Binghamton University Technical Innovator of the Year award.
“Mr. Boyer was a longstanding and steadfast champion of our academic endeavors. He has positively impacted the lives of numerous students, faculty, and staff,” Binghamton WISE dean Krishnaswam (Hari) Srihari said. “Personally, I would consider him to be a mentor and a friend, a person whose life was an example for all of us. He will be sorely missed.”
Services will be held at Johnson City’s J.F. Rice Funeral Home on Feb. 2 from 3 p.m. to 6 p.m. followed by a funeral mass at St. James Catholic Church on Feb. 3 at 10 a.m. The family requested that donations to the Alzheimer’s Association be considered in lieu of flowers.