Vimizim receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome), which is a rare disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS).
Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. The absence of the enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States. Vimizim also is the first drug to receive the Rare Pediatric Disease Priority Review Voucher, which seeks to encourage development of new drugs and biologics that prevent and treat rare pediatric diseases.
“This approval and rare pediatric disease priority review voucher underscores the agency’s commitment to making treatments available to patients with rare diseases,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “Prior to today’s approval, patients with this rare disease have had no approved drug treatment options.”
Vimizim is marketed by BioMarin Pharmaceutical.
Hy-Vee acquires Amber Pharmacy
WEST DES MOINES, Iowa — Hy-Vee on Monday announced that it has entered into an agreement to purchase Amber Pharmacy, a specialty pharmacy solutions provider based in Omaha, Neb. Hy-Vee and Amber Pharmacy have been partners in Hy-Vee Pharmacy Solutions since 2010. This acquisition allows Hy-Vee to expand its current specialty pharmacy business, providing customers with increased specialty options, access and affordability.
"The partnership between Hy-Vee and Amber Pharmacy has been very successful over the last four years," stated Randy Edeker, chairman, CEO and president of Hy-Vee. "Specialty pharmacy continues to experience tremendous growth. Amber Pharmacy’s talented team, innovative practices and commitment to customer service will allow us to respond to that growth while meeting and exceeding our customer needs."
Amber Pharmacy will maintain its existing name and operations, including headquarters in Omaha and locations in Chicago, Dallas and Philadelphia. The specialty pharmacy company will operate independently and will continue to be led by current president Michael Agostino, retaining all employees.
"The Kaplan family’s history with Hy-Vee, along with their commitment to customer service, health and wellness, makes them an ideal partner to grow Amber Pharmacy’s presence," said William Kaplan Sr. "Together, we will continue to be trusted partners with our patients, healthcare providers, insurance payers and manufacturers."
Hy-Vee established Hy-Vee Pharmacy Solutions in 2010. The company was founded to provide Hy-Vee employees with specialty pharmacy services more efficiently and economically. Since that time, Hy-Vee Pharmacy Solutions has grown and specialty pharmacy has become an important focus for Hy-Vee and service for its customers.
The purchase price was not disclosed, but the acquisition was approved by the boards of both companies and pending regulatory approval should close within the next 30 days.
Diplomat Specialty Pharmacy initiates content partnership with NASP
FLINT, Mich. — Diplomat Specialty Pharmacy on Monday announced that it has initiated a content partnership with the National Association of Specialty Pharmacy.
The new partnership will support Diplomat’s recently launched web platform, diplomat.is, and its goal to be a leading resource for specialty pharmacy. Additionally, the partnership will further establish NASP’s position as a leading voice in specialty pharmacy and clinical news.
“Our goal is to build partnerships within the industry and foster an environment of collaboration to enhance education and improve the care that patients receive,” stated Gary Cohen, NASP CEO. “We support efforts by our industry partners that allow pharmacists and other stakeholders to gain additional education and knowledge about targeted specialty therapeutic categories.”
The partnership agreement also presents the potential for future growth and opportunities for Diplomat to provide educational materials as well.
“Our partnership with NASP will allow us to share rich, deep content supported and developed by industry experts,” stated Jenny Cretu, VP IT and marketing at Diplomat. “NASP is committed to providing the highest quality of information for continued education and awareness and we are excited to bring this to our Diplomat patients and partners.”