Formycon AG signs licensing agreement for its FYB203 biosimilar

Munich – Formycon AG has announced the signing of an exclusive, global out-licensing deal for its FYB203 biosimilar drug, with Santo Holding GmbH as licensing partner. The newly signed agreement will ensure that Formycon has project funding in place all the way through to market introduction.

Under the agreement, Santo Holding will assume responsibility for, and the costs of, all further development activities, production and marketing of the Formycon biosimilar drug. In return, Santo Holding will receive exclusive worldwide marketing rights for FYB203. Pharmaceutical product development through to regulatory approval will remain in the hands of Formycon, while clinical development will be carried out by Bioeq GmbH, which manages biosimilar product development activities on behalf of Santo Holding. Under the terms of the new agreement, Formycon will receive an immediate payment in the amount of several millions, along with ongoing payment for its product development activities through to regulatory approval. The company will, in addition, participate in sales revenue once the project is brought to market, receiving a percentage share in the low double digits. Based on sales projections, the agreement is thus expected to yield Formycon total cumulative revenue well over the hundred million euro mark.

“The signing of this important deal marks a further milestone for our company as well as a major success for our entire team as we work to expand our pipeline of biosimilars for the global market,” declared Dr. Carsten Brockmeyer, CEO of Formycon AG. “We are immensely pleased to have found Santo Holding as a strong, ideal partner for our first two projects. Over the past years, we have driven our company forward through our commitment to investment in long-term research – and this is a strategy which we will continue to relentlessly pursue.”

“With the out-licensing deal for FYB203, we now have financing completely in place for two biosimilar products, all the way through to market launch,” said Dr. Nicolas Combé, CFO of Formycon AG, in commenting on the newly signed agreement. “For our shareholders, this means a project financing expected to yield hundreds of millions of euros in revenue – and without shareholder dilution. This is a resounding validation of our strategy and, in particular, the superb work of our staff. The licensing agreement further strengthens our financial flexibility as we work towards our driving goal: to be the world’s leading developer for the third wave of biosimilar drugs.”

“Biosimilar drugs are making an increasingly significant contribution to patient care by making high-quality biopharmaceuticals accessible to them at a fair price,” added Nicola Mikulcik on behalf of Bioeq GmbH. “Based on our successful work together on our first joint project, likewise bringing this new product to market in partnership with Formycon is a logical step. We anticipate excellent global market opportunities for both of these products.”

Formycon currently has three biosimilar drugs under development, with Santo Holding its product partner for FYB201 and now also FYB203. The company plans to develop the third product, FYB202, through to the end of phase I clinical trials using its own resources.