Aucta Pharmaceuticals Announces Licensing of Vigabatrin for Oral Solution in China
Aucta Pharmaceuticals, Inc. (Aucta), a technology based company focusing on the development and commercialization of Branded Specialty Products, announced that the Company has entered into an exclusive license agreement with Jiangsu Wanbang Biopharmaceuticals Group Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., to license its China marketing rights for its U.S. FDA approved Vigabatrin for Oral Solution.
Fosun Pharma is a leading healthcare group in China with extensive healthcare business interests worldwide. It is listed on both the Shanghai Stock Exchange and the Hong Kong Stock Exchange.
Aucta’s Vigabatrin for Oral Solution product was approved by U.S. FDA and launched in the U.S. market in July 2018. Vigabatrin for Oral Solution is one of the very few FDA approved effective treatment of infantile spasms (IS) and certain percent of adults with complex partial seizures (CPS) whose seizures remain uncontrolled in spite of having many antiepileptic therapies already available. Vigabatrin for Oral Solution and is not currently approved in China. Aucta is in the process of seeking its import drug license (IDL) with National Medical Products Administration (NMPA) (formerly China Food and Drug Administration or CFDA).
Vigabatrin for Oral Solution will fulfill a significant unmet medical need for pediatric patients with infantile spasms in China who require an NMPA approved medicine to effectively manage their condition. It is estimated there are more than 10,000 new-borns every year in China who have the condition of infantile spasms that would need an effective disease management. Vigabatrin for Oral Solution has the advantage of being body-weight adjustable and ease of dosing for the intended patient population.
Shoufeng Li, Chief Executive Officer of Aucta Pharmaceuticals said: “We are excited to be partnering with Fosun, one of the leading and distinguished pharmaceutical firms in China. China represents a significant market opportunity for our product. We look forward to working closely with Fosun’s talented commercial team to bring this innovative treatment forward and to address the unmet medical need in infantile spasms and seizure treatment.”
Yifang Wu, President & Chief Executive Officer of Fosun Pharma, said: “We are very excited to collaborate with Aucta, one of the emerging specialty pharma companies. The licensed product will bring a lot of strategic synergies with our current CNS business, addressing critical unmet needs in the China market. Aucta’s product is one of the most suitable forms for the targeted patient population. The collaboration with Aucta will contribute to the strategic leading position of Fosun Pharma in this area in China, and also help us to enrich the pipelines for rare disease medical solutions.”
Vigabatrin has a black-box warning of potential vision loss. It can cause permanent vision loss in infants, children and adults. Vigabatrin induced vision loss includes progressive and permanent bilateral concentric visual field constriction in 30 percent or more of patients on the therapy that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. There are also some reports that Vigabatrin can damage the central retina and decrease visual acuity.
The onset is unpredictable and can occur within weeks of starting treatment, or sooner, or at anytime during treatment even after months or years.