Almirall and Paratek enter into a License Agreement for Seysara® in China
• Almirall has been commercializing sarecycline (acne) in the US since January 2019. The drug was approved by the FDA in October 2018, following the acquisition of the US medical dermatology portfolio from Allergan.
• Seysara® to become the first dermatology product of Almirall’s strategic portfolio in China.
• Seysara® Phase 3 study expected to start in 2020.
• Submission to regulatory body in 2023.
Almirall, S.A. (ALM) has today announced that Seysara® (sarecycline), an innovative first in class tetracycline-derived oral antibiotic for the treatment of inflammatory lesions of moderate to severe non-nodular acne vulgaris, is expected to be submitted to NMDA in 2023. Almirall has the commercialization rights for the medicine in the US, and will develop it for acne in China under a License Agreement from Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK).
Under the terms of the agreement entered into between Almirall and Paratek, Almirall will be responsible for development, registration and commercialization of the product in China in exchange for royalties calculated as a percentage of net sales once the product is launched onto the market.
Seysara® represents the first dermatology product for Almirall to entry and for building the company’s strategic dermatology portfolio in China.
“At Almirall we are convinced that the launch of Seysara® in China will be a big step forward for many patients with acne in the country. Moderate to severe acne is a widespread issue in China, and Seysara® will bring a new and innovative solution to these patients”, Peter Guenter, CEO, Almirall, added.
Seysara® is an oral tablet taken once daily with or without food. It has shown significant reduction of inflammatory lesions as early as three weeks after the start of treatment and is generally safe and well tolerated. Seysara® is an innovative treatment for patients with moderate to severe acne.
The Food and Drug Administration (FDA) approved Seysara® in October 2018. In order to prove the efficiency and safety of the medicine in China, Almirall will conduct a Phase III and PK study among Chinese population starting in 2020.