WARSAW, 17 July (APM) - Mabion has announced that additional development and bridging studies that are needed to register MabionCD20, a rituximab biosimilar, in European markets, could be completed as late as the beginning of 2022, reported Parkiet Gazeta Gieldy (p4) on Saturday and Puls Biznesu (p6) on Monday.
Mabion announced the additional operations will require net outlays of 75-85 million zlotys (€17-19 million), which resulted in the company's share price plummeting 30%, reported Parkiet.
The delay could cost Mabion a 40 million zloty (€9 million) refund of an advance, as the agreement with Mylan on the distribution of the drug within the EU could be cancelled.
Other companies are also competing in the sales of this drug in Europe. Apart from Roche itself, Korea's Celltrion and Sandoz have already registered their rituximab biosimilars, while Pfizer has received a European Medicines Agency (EMA) recommendation. The situation is similar in the U.S., where Mabion is also trying to register its drug, added Puls Biznesu.
Rituximab generates global annual sales of $7 billion, concluded Puls Biznesu.
Ryvu Therapeutics plans to raise166 million zlotys (€37 million) on Polish stock market
After the split of the Selvita group into service-centred Selvita and R&D-oriented Ryvu Therapeutics, the shares of both companies are rising on the Polish stock market.
Selvita has raised 90.6 million zlotys (€20 million) for acquisitions of European biotechs, while Ryvu is now issuing shares for 166 million zlotys (€37 million) to finance its research, reported Parkiet Gazeta Gieldy (p2) on Monday and (p6) Wednesday and Puls Biznesu (p5) on Tuesday.
Ryvu plans to invest the funds obtained in research and development, as well as the pre-clinical and discovery phases for various projects. SEL24 has already completed Phase I and the rights to the molecule have been acquired by Italy's Menarini, which will continue developing the drug.
Ryvu has already started Phase I for SEL120, which is to be used in solid tumours, angiomyolipomas and myelodysplastic syndrome and is planning to develop SEL120 in new indications, reported Puls Biznesu on Tuesday and Parkiet Gazeta Gieldy on Wednesday.
According to Pawel Przewiezlikowski, president of Ryvu Therapeutics, despite the rising trend on the Polish stock market, the company is not planning to start work on any Covid-19 vaccine or drug, as it wants to focus on its specialty - oncology. Ryvu's two flagship projects, SEL24 and SEL120, are expected to reach the market no earlier than 2025, concluded Parkiet Gazeta Gieldy on Monday.
Biomed's stock rises in Poland despite share issue
Despite recently issuing shares, Biomed Lublin, a Polish tuberculosis (BCG) vaccine producer, which plans to produce an immunoglobulin drug from plasma from Covid-19 survivors, is still watching its share price increase on the Polish stock market, reported Parkiet Gazeta Gieldy (p5) on Tuesday.
Biomed recently issued six million shares to raise money for developing investments related to the production of the BCG vaccine and the Onko BCG drug, repaying liabilities to the Polish Agency for Enterprise Development (PARP) and other obligations.