Catalent Partners With Biohaven on New Fast-Dissolve Treatment

Catalent recently welcomed the announcement by Biohaven Pharmaceutical Holding Company Ltd. that the US FDA has approved its NURTEC ODT (rimegepant) for the acute treatment of migraine in adults. NURTEC ODT has been developed using Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water, offering people with migraine a convenient, discreet way to take their medication anytime and anywhere they need it. NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting ODT.

Zydis technology is recognized as one of the world’s best-performing ODTs and has well-established advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience. A single oral dose of NURTEC ODT 75 mg can provide fast pain relief and return patients to normal function within 1 hour, while delivering sustained efficacy that lasts up to 48 hours for many patients. NURTEC ODT is the first FDA-approved product for Biohaven, a company dedicated to advancing innovative therapies for neurological diseases.

“Since rapid onset of relief is consistently ranked among the most important attributes of acute migraine medications, along with the benefits of easier administration without water, Zydis is an ideal platform for the delivery of acute migraine treatments,” commented Jonathan Arnold, President, Oral and Specialty Delivery at Catalent. “We are pleased to have partnered with Biohaven on the formulation, and now commercial manufacture, of this important treatment for such a debilitating condition.”

Catalent’s 250,000-sq-ft site in Swindon, UK, houses the company’s Zydis development and manufacturing operation, which produces over 1 billion ODTs annually and employs more than 600 people. NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven’s neuroinnovation portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: calcitonin gene-related peptide (CGRP) receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.