Alvogen has obtained marketing approval for Qsymia (phentermine and topiramate extended-release) from the South Korea Ministry of Food and Drug Safety (MFDS) in partnership with VIVIS Inc. (Nasdaq:VVUS). Under an agreement between the parties from 2017, Alvogen is responsible for obtaining and maintaining regulatory approvals and sales and marketing activities in Korea.
Petar Vazharov EVP Sales and Marketing of Alvogen APAC region says “Alvogen Korea has traditionally a strong position in anti-obesity therapies and brand awareness. The approval of Qsymia® is an important upgrade to the existing portfolio and is our response to the increasing competition from a newer generation of anti-obesity products in the Korean market. The product was approved by USFDA in 2012 for long term weight management. As we are celebrating the approval, our team in Korea is actively preparing for the product launch.”
John Amos, Chief Executive Officer at VIVUS added: “Approval to market Qsymia in Korea is an important milestone in our strategy for realizing additional value from Qsymia in international markets and underscores the benefits of our partnership with Alvogen. We believe that Alvogen has the critical expertise and established relationships needed to position Qsymia for success as an important tool for managing body mass index in the Korean market. We continue to advance additional initiatives in the United States and other countries that are expected to drive additional Qsymia sales and revenues.”
About VIVUS VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about VIVUS, please visit www.vivus.com.
About Qsymia Qsymia is approved in the United States and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia. Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus. The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.