- Preparation of FDA and EMA submission for FYB201
- Positive conclusion of the pilot phase for FYB202
- Preclinical study for FYB203 confirms comparable intraocular pharmacokinetics of alternative formulation
- Change in EU patent law allows earlier production of biosimilars
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published news on its development portfolio.
For FYB201, a biosimilar candidate for Lucentis®* (ranibizumab), Formycon and Bioeq IP AG successfully concluded a Type IV Pre-Submission Meeting in December 2018 with the US Food and Drug Administration (FDA). The FDA submission of FYB201 is expected for the beginning of the fourth quarter of this year. The submission to the European Medicines Agency (EMA) is scheduled for the first quarter of 2020. If the submissions progress as planned, marketing authorization approvals in the US and the EU are expected in 2021. Formycon’s licensing partner Bioeq IP AG is responsible for the worldwide commercialization of FYB201. Formycon will receive sales dependent royalties after successful product launch. The overall market for the reference drug Lucentis®* (ranibizumab) has, according to the manufacturer, increased over the previous year by 9% to a total of US$ 3.7 billion, and this growth is continuing. This is also confirmed by the quarterly figures from Q1/2019. According to these figures, global sales of the ophthalmic drug grew by around 10% (USA +11%) compared to the first three months of 2018.
In the FYB202 program, a biosimilar candidate for Stelara®** (ustekinumab), which is developed in a joint venture with Aristo Pharma GmbH, the achievement of key milestones marked the successful conclusion of the pilot phase. During scientific advice meetings with the FDA and the EMA, further development steps up to submission of the marketing authorization dossier were discussed. The start of the phase I clinical trial is planned for mid of this year. Formycon holds a 24.9 percent share in the joint venture (FYB 202 GmbH & Co. KG). With the conclusion of the pilot phase, the previous and future development costs will be borne in accordance with the shareholding quota. To date, Formycon has invested around Euro 21 million in the development of FYB202. In 2018, total turnover for the reference drug Stelara® increased, according to the manufacturer, by 30 percentage points and stood at a total of US$ 5.2 billion. Global sales in the first quarter of 2019 also rose by a further 32% compared to Q1/2018.
With FYB203, a biosimilar candidate for Eylea®*** (aflibercept), also significant progress has been achieved. The preclinical study with FYB203 in an alternative formulation was able to demonstrate comparable intraocular pharmacokinetics to the reference product Eylea®. The next stage will focus on the preparation of the phase III clinical trial, which is scheduled to begin mid of 2020. Briefing documents for scientific advice are currently prepared in order to coordinate the future development strategy with the FDA and the EMA. Formycon’s global licensing partner for FYB203 is Santo Holding GmbH. Formycon receives sales-related royalties while successful course of the project. In 2018, the reference drug Eylea® significantly increased its global sales. According to the manufacturer, these stood at just under US$ 6.7 billion, equivalent to a rate of increase of around 13% compared to the previous year.
“Thanks to our team’s commitment and expertise, we were able to significantly advance our lead candidate FYB201 as well as FYB202 and FYB203, and achieve further key interim goals. The positive results from the Columbus AMD phase III study and the FDA pre-submission meeting support the product quality of FYB201 and illustrate that we are on the right path with our strategy. Together with our licensing partner Bioeq IP AG, we are in close consultation with the relevant medicines authorities, putting in place the necessary requirements for an approval and successful product launch of FYB201. This will take us closer to our goal of improving the global supply of important medicines to patients with serious conditions”, explains Dr. Stefan Glombitza, COO of Formycon AG.
A legal innovation to EU patent law, adopted by the European Parliament and expected to enter into force on July 1, 2019, strengthens European biosimilar manufacturers. Previously, the production of biosimilars and generic drugs in the European Union was prohibited while SPCs (Supplementary Protection Certificates) were still in force that effectively extend patents for medicines by up to 5 years, provided the reference drug was still protected by a SPC. Based on the SPC Waiver Program, European biosimilar manufacturers will now, from July 1, 2022, be able to commence production during the SPC period under certain conditions for export to third-party countries in which the relevant protective rights have already expired and manufacture six months before the SPC expiry to generate stocks for the market launch in Europe.
Dr. Carsten Brockmeyer, CEO of Formycon AG, welcomes this new ruling: “We are delighted that this hurdle, which significantly hampered the domestic production of medicines and therefore Europe’s competitiveness in this field, has now been removed. From mid-2022, this will make life significantly easier for Formycon, since production of the biosimilars will then no longer necessarily have to be outsourced to outside of the EU.”
* Lucentis® is a registered trademark of Genentech Inc.
** Stelara® is a registered trademark of Johnson & Johnson
*** Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.