Lupin granted approval for generic Lumigan
BY Ryan Chavis
MUMBAI and BALTIMORE — Lupin received approval from the Food and Drug Administration for its bimatoprost ophthalmic solution, 0.03%, the generic version of Lumigan ophthalmic solution from Allergan. Lupin said its U.S. subsidiary would begin marketing the solution shortly.
The drug is used to reduce elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension, according to the company.
Shire acquires developmental treatment for rare GI disease
LEXINGTON, Mass. — Shire on Tuesday acquired Meritage, a privately held company, for an upfront fee of $70 million and additional contingent payments based on the achievement of development and regulatory milestones. With the acquisition, Shire has acquired the global rights to — and undertaken the further development of — Meritage's phase 3-ready compound, Oral Budesonide Suspension, for the treatment of adolescents and adults with eosinophilic esophagitis, a rare, chronic inflammatory gastrointestinal disease.
"Meritage has worked closely with gastroenterologists, patients and their caregivers to develop Oral Budesonide Suspension, which was the first medication to significantly reduce eosinophilic inflammation and related symptom endpoints in patients with eosinophilic esophagitis in a Phase 2 clinical trial," commented Elaine Phillips, Meritage president and CEO. "The acquisition of Meritage by Shire, a global biotechnology company with GI and rare disease expertise, may benefit physicians and patients by helping develop OBS to potentially become the first approved treatment in the U.S. indicated for this often disabling disease."
"Shire's pipeline and strategic focus on rare diseases is further strengthened with the acquisition of Meritage, which also complements our strong GI capabilities," stated Philip Vickers, Shire head of research and development. "Adding this Phase 3-ready compound to our late-stage portfolio will allow us to leverage our expertise to further develop this important therapy that, if approved, will give hope to patients living with eosinophilic esophagitis."
EoE is a chronic disease that is increasingly being diagnosed in children and adults, with an estimated prevalence in the United States of around 181,000. It is characterized by inflammation and accumulation of a specific type of immune cell called an eosinophil in the esophagus. EoE patients may have persistent or relapsing symptoms related to esophageal dysfunction, which include dysphagia (difficulty swallowing) and food impaction.
OBS is a proprietary viscous oral formulation of budesonide that is designed to coat the esophagus where the drug can act locally. Budesonide is the active pharmaceutical ingredient in several products approved by the FDA, including products for the treatment of asthma, allergic rhinitis, ulcerative colitis and Crohn's disease. Budesonide is a corticosteroid and has an established safety profile in those diseases. The FDA has granted Orphan Drug Status designation to OBS for the treatment of patients with EoE.
Shire obtained the rights to acquire Meritage in connection with its acquisition of ViroPharma in 2014.
Diplomat founder pledges $5 million to Ferris State University College of Pharmacy
BIG RAPIDS, Mich. — Ferris State University on Monday announced a $5 million gift from Phil and Jocelyn Hagerman and the Hagerman Foundation, to the university’s College of Pharmacy. Hagerman is chair and CEO of Diplomat Pharmacy, based in Flint, Mich. The Hagerman gift represents the largest outright gift ever made to Ferris.
“This is a symbol of our commitment to education and our commitment to Ferris,” Phil Hagerman said. “We want to make sure that the pharmacy industry recognizes what an important part Ferris has been in my personal success, my family’s success and in the growth of our company, Diplomat. For myself and my wife, Jocelyn, one of the most rewarding parts of the gift is to support youth. We believe in the pharmacy profession, and we believe in students. One of the goals, for Jocelyn, I and the Hagerman Foundation, is to support education.”
“This is an extraordinary moment in Ferris State University’s history. As a university community, we are all very grateful to Phil and Jocelyn Hagerman, and the Hagerman Foundation, for this wonderful investment in Ferris’ College of Pharmacy, our faculty, staff and most importantly, our students,” stated David Eisler, Ferris president. “For years to come, our entire pharmacy community will enjoy the opportunity to learn and work in the Hagerman Pharmacy Building.”
In addition to the College of Pharmacy building being renamed in honor of the Hagerman family, this gift will fund the Hagerman Family Endowed Scholarship in Pharmacy, the Hagerman Family Pharmacy Scholarship Fund and the Hagerman Endowed Chair for Medical Informatics.
“As Diplomat becomes more and more innovative and the pharmacy industry continues to move into areas of informatics and analytics, I think we’ve come to recognize that academia needs to stay on that cutting edge,” Hagerman said. “By making our contribution and partnering with Ferris, we can create that same kind of innovative pathway for Ferris that Diplomat has been on and in turn, one can fuel the other.”
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