Fusion Pharma, a resident of the Skolkovo Foundation's Biomedical Technologies Cluster, signed a license agreement with Pharmasyntez to commercialize an innovative antileukemic drug. The licencing deal implies an upfront payment, milestones and royalties.
Drug candidate PF-114 is a third-generation targeted drug developed by the Russian company Fusion Pharma and intended for the treatment of chronic myeloid leukemia (CML), which is not amenable to therapy with first- and second-generation drugs.
Based on the results of a phase one multicenter clinical trial, a dose of PF-114 with an optimal ratio of efficacy and safety was selected in the target group of patients, which will be studied further in a phase three registration clinical trial.
Pharmasyntez will conduct the phase three clinical trial, register the drug and commercialize it in the EAEU countries.
Ghermes Chilov, PhD, General Director of Fusion Pharma: “We have done most of the work on the drug under the status of a Skolkovo resident, which the company has been since 2011. We have been working on PF-114 for ten years now, and we have gone through all stages – from drug design using molecular modeling to in vitro studies, animal studies, and finally, on patients, having previously established industrial manufacturing of the drug product. PF-114 has been shown to be safe and effective in CML patients with resistance to previous therapy in a clinical trial setting. But before the drug is released to the market, there will be a registration clinical trial in accordance with pharmaceutical development standards. We hope that cooperation with Pharmasyntez will be able to bring the development of the project to a new level."
Vikram Punia, President of Pharmasyntez Group of Companies: “The implementation of such a significant project together with the Skolkovo Foundation helps to increase the innovative potential of the entire country. We carefully search for and select such “nuggets” as PF-114 and are ready to make serious financial investments to bring it to the market, because we do not doubt its purpose. "
Ksenia Tyumeneva, Head of the Partnership Projects Department of Pharmasyntez Group of Companies: “The development and launch of innovative drugs on the market is a strategically important area of development for the Pharmasyntez Group of Companies, especially with a high interest in drugs for the treatment of orphan and cancer diseases. According to the agreement, Fusion Pharma grants us exclusive rights to manufacture and sell the drug candidate PF-114. The available research results allow us to hope that PF-114 will take its rightful place in the treatment of CML."
Kirill Kaem, Senior Vice President for Innovation at the Skolkovo Foundation: “Innovative pharmaceuticals are one of the most complex, costly and time-consuming areas of research. At the same time, the success rate for early stage projects is only 2-4% of the total. It is very important that the development of the PF-114 drug for the treatment of CML by Fusion Pharma has found recognition from the industrial partner, Pharmasynthez, and the signed license agreement will provide, as a result of registration studies, patients' access to new therapy. We hope that Fusion Pharma will not stop there and, using the experience of working with PF-114, will initiate the development of new drugs."
Prof. Anna Turkina, head of the Department of Chemotherapy of Myeloproliferative Diseases of the National Medical Research Center of Hematology: “The expert council that worked on the design of the first PF-114 clinical trial included leading foreign experts in the field of CML, which is extremely important for the results gaining international recognition. To date, the drug has passed a multicenter phase one study to assess the efficacy and safety in patients with chronic myeloid leukemia with resistance and/or intolerance to two or more drugs, i.e. in patients with limited therapeutic options. We hope that PF-114 will give another chance to patients with CML for whom other targeted drugs fails."
Prof. Olga Vinogradova, head of the Moscow City Hematology Center: “Our center joined the PF-114 clinical trial, and pretty soon it became clear that the drug could represent a real option for CML patients with resistance or intolerance to previous therapy. It is especially pleasant that this is a domestic development. Our center is interested in active participation in the phase three clinical trial for PF-114”.
Fusion Pharma was founded in 2010 by a group of scientists with expertise in medicinal chemistry and computer-aided drug design and private investors. The company's efforts are focused on the development of an innovative drug for the treatment of resistant forms of chronic myeloid leukemia, including the mutant variant of T315I. Since 2011, the company has been a resident of the Skolkovo Foundation.
Pharmasyntez Group of Companies is the largest domestic manufacturer of medicines for the treatment of socially significant diseases such as tuberculosis, HIV, diabetes mellitus, oncology, hepatitis. In the near future, it launches a wide range of hormonal, orphan and cardiac drugs. Production facilities are represented by five modern high-tech factories in the cities: Irkutsk, Bratsk, Ussuriisk, Tyumen, St. Petersburg. Revenue of Pharmasyntez in 2019 amounted to 22.7 billion rubles, net profit - 5.5 billion rubles, an increase in revenue by 2018 amounted to 36%. which are included in the list of vital and essential medicines. Pharmasyntez is in the TOP-10 of the leading manufacturers in terms of public procurement and ranks third among the fastest growing technology companies in Russia.
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The Skolkovo Foundation is a non-profit organization established in 2010 and acting as the managing company of the Skolkovo Innovation Center. The purpose of the Foundation is to support technological entrepreneurship in Russia and commercialize the results of research activities. The number of Skolkovo residents has already exceeded 2,700. The Fund provides them with a range of services necessary to bring developments to the Russian and international markets. Resident status gives the company tax and customs benefits. In 2019, the residents' revenue amounted to more than 100 billion rubles, and the amount of investments attracted by them exceeded 13 billion rubles. Since 2019, the law allows any organization engaged in research activities on the territory of Russia to gain access to all the services and benefits of the Innovation Center. The Skolkovo Innovation Center is home to the Skolkovo Institute of Science and Technology (Skoltech), which is one of the top 100 young universities in the world according to Nature Index. The infrastructure of the Innovation Center is made up, in particular, of Europe's largest Technopark and research centers of industrial partners. In 2019, three new partner R&D centers were opened in the Innovation Center - Sibur, TMK and Tatneft. On the territory of Skolkovo, a total of more than 750 thousand square meters have already been commissioned. m. residential areas, research and educational centers. Off-budget investments in infrastructure creation exceeded RUB 100 billion. Website: sk.ru.