Planegg-Martinsried – Klinge Biopharma GmbH (“Klinge”), licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon’s biosimilar candidate to Eylea®1 (Aflibercept), has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the Middle East and North Africa (“MENA region”).

MS Pharma is a leading regional pharmaceutical company in the MENA region and specializes in the distribution of biotechnological as well as generic drugs. The company will have exclusive rights to license, commercialize and produce FYB203 locally at its new Biosimilars site in Saudi Arabia for the countries covered by the agreement. Commercialization rights for all other territories remain with Klinge. Formycon is entitled to participate in all Klinge income from the agreement with MS Pharma in the mid-single to low-double-digit-percentage range.

MS Pharma is also marketing Formycon’s ophthalmic Lucentis®2 biosimilar FYB201 in the MENA region and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space.

In June 2023, Formycon announced that the biologics license application (“BLA”) for FYB203, has been submitted to the U.S. Food and Drug Administration (“FDA“). The agency assigned a target action date of June 2024. Moreover, FYB203 has been submitted end of 2023 to the European Medicines Agency (“EMA”), expecting regulatory approval beginning of 2025. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.

Eylea® (Aflibercept) is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea® reached global sales of around US$ 9 billion[i], underlining its status as the currently best-selling drug in the field of anti-VEGF therapies.

“We are delighted that our licensee Klinge Biopharma chose a strong, experienced, and renowned partner for the MENA region. MS Pharma has vast experience in the field of ophthalmology, as we have already learned from our collaboration in the commercialization of our other biosimilar FYB201. Both ophthalmic biosimilars address an important and growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options in the whole region”, said Nicola Mikulcik, CBO of Formycon AG.

“Our partnership with Klinge Biopharma and the addition of an Aflibercept biosimilar to our product line is a milestone in MS Pharma’s journey to enhance healthcare accessibility in the MENA region,” said Kalle Kand, CEO of MS Pharma. “This agreement not only strengthens our biosimilar portfolio but also reinforces our capability to support local production, ultimately contributing to the regional economy and healthcare system.”

1Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

2Lucentis® is a registered trademark of Genentech Inc.

Alira Health has acted as the exclusive financial and strategic and the lawyers of honert Munich as legal advisors to Klinge Biopharma.

[i] Regeneron Reports Fourth Quarter and Full Year 2023 Financial and Operating Results | Regeneron Pharmaceuticals Inc.