PLANEGG-MARTINSRIED (dpa-AFX) - Formycon is positioning itself for the commercialization of its biosimilar to the blockbuster drug Keytruda by Merck & Co. As announced by the pharmaceutical manufacturer on Thursday, it has entered into an exclusive license and supply agreement for its product, FYB206, covering the Middle East and North Africa (MENA) region. The partner in this deal is MS Pharma. The company's shares saw a strong pre-market surge following the news.
Formycon will receive an upfront payment, the exact amount of which was not disclosed. Additional payments may follow, contingent upon the achievement of certain milestones, with the total expected to be in the high single-digit million-euro range.
"The licensing agreement for the MENA region marks the beginning of our partnership activities for our Keytruda biosimilar candidate," said Nicola Mikulcik, a member of the management board, according to the statement. Formycon's drug is currently in the late stages of clinical development, with pivotal results expected in the first quarter, according to the company.
The biosimilar FYB206 represents a significant hope for the Bavarian company. The original Keytruda drug is one of the world's top-selling pharmaceuticals. The US-based Merck & Co generated nearly $30 billion in revenue last year from the cancer medication (active ingredient pembrolizumab) alone. With the main patents for the drug set to expire in a few years, a rush among biosimilar manufacturers is expected. Formycon has previously stated its intention to be at the forefront of this competition.
