AZSTARYS, approved and commercialized by Corium, Inc. in the U.S., is an innovative treatment for ADHD patients ages 6 years and older providing rapid and extended duration symptom control as the First and Only Product containing Prodrug of Dexmethylphenidate
Agreement provides up to a total of $105.5 million USD in upfront, developmental and sales milestone payments, as well as royalties on product net sales
SHANGHAI, December 28, 2021 -- Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”), an innovative biopharmaceutical company with a depth of expertise in pediatric drug development, today announced that Ark Biopharmaceutical Limited, a wholly-owned subsidiary of ArkBio, entered into an exclusive license agreement with Commave Therapeutics, SA (Commave), an affiliate of Gurnet Point Capital (GPC), a private investment firm focused on the life sciences and medical technology sectors. The license agreement provides for exclusive rights to develop, manufacture, and commercialize the first-in-class once-daily attention deficit hyperactivity disorder (ADHD) treatment AZSTARYS® (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Under the terms of the agreement, Commave will receive an upfront payment and is eligible to receive regulatory and sales milestone payments, totaling as much as $105.5 million USD, as well as tiered royalty payments based on aggregate annual net sales of AZSTARYS in Greater China.
AZSTARYS, the first and only product containing SDX, an extended-release oral prodrug of d-MPH, was approved by the U.S. Food and Drug Administration (FDA) in March 2021 for the treatment of ADHD symptoms in patients aged 6 years and older. Corium, Inc., a wholly-owned portfolio company of GPC, is leading the U.S. commercialization efforts and launched AZSTARYS in the U.S. in July 2021.
“We are pleased to announce our partnership with GPC to bring a transformative next-generation ADHD treatment to patients and their families in China. There are estimated over 20 million ADHD patients in China and the diagnosis and treatment rates are rapidly growing. AZSTARYS offers a unique profile that can address the increasing recognition of unmet need and greatly benefit Chinese patients, especially pediatric patients,” said Jim Wu, CEO of ArkBio. “AZSTARYS is a valuable addition to our pediatric franchise and we look forward to working closely with GPC to efficiently advance AZSTARYS towards regulatory approval and commercialization in greater China.”
“ArkBio, in addition to Corium in the US, will enable us to take the next step in making AZSTARYS a global brand,” said Dr. Sophie Kornowski, Senior Partner at GPC. “ArkBio’s leadership team has a proven track record of bringing innovative therapies to market, making them the ideal partner to support the development and commercialization of AZSTARYS in China. We are thrilled to be collaborating with an organization that shares our excitement about AZSTARYS as a novel treatment option for patients with ADHD, their caregivers, and their clinicians.”
AZSTARYS is the first and only product containing SDX, a prodrug of dexmethylphenidate, and offers 30-minute onset and 13-hour duration ADHD symptom control. The U.S. FDA approved AZSTARYS in March 2021 for use in patients aged 6 years and older.
As a prodrug, SDX is specifically designed to be pharmacologically inactive until reaching the lower gastrointestinal tract, where, by design, SDX is gradually converted to d-MPH throughout the day. The result is a treatment that provides symptom control both rapidly with the immediate-release d-MPH component and for an extended duration with the SDX component.
Attention-deficit hyperactivity disorder (ADHD) is a common neurodevelopment disorder marked by an ongoing pattern of inability to pay attention or hyperactivity with impulsive behaviors or both, which interferes with functioning or development. ADHD usually is diagnosed during childhood but often continues into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active.
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare fund founded by Ernesto Bertarelli and Chris Viehbacher, who, together, have decades of expertise in an industry for which they share a passion, both as Chief Executives and as investors. Its long-term capital, deployed by a highly experienced team, aims to enable a new generation of companies to grow and to unlock innovative and transformational healthcare solutions.
For more information, please visit www.gurnetpointcapital.com
ArkBio, an innovative biopharmaceutical company with a fully integrated platform addressing unmet medical needs in respiratory and lung diseases, by leveraging ArkBio’s RSV and anti-fibrotic franchises with first-in-disease or best-in-class drug potential, as well as pediatric drug development expertise.