Posted: 21 June 2013
Saint-Petersburg, June 21, 2013: Today during the Saint-Petersburg International Economic Forum-2013 Dompé, one of Italy’s leading biopharmaceutical companies, and SatRx, a Russian biotechnology company specialised on the development of innovative medicines used in solid organ transplantation and for the treatment of metabolic diseases, such as diabetes and obesity, announced that they have signed a collaboration agreement for the clinical development of Reparixin, an innovative drug discovered by Dompé, to improve efficacy of liver transplantation. The alliance between the companies focuses on Phase II-III clinical trials which are the final stages of clinical development prior to drug marketing.
Reparixin acts on the body’s immune response, reducing the anti-inflammatory reaction that is associated with short-term graft rejection and affects future graft function. The international multi-center randomized Phase III trial to assess efficacy of Reparixin in islet transplantation is lead by Dompe. Its innovative mechanism of action is believed to have the ability to inhibit the short-term rejection reaction of the recipient’s immune system and hence facilitate graft implantation.
The multi-center, open-label, randomized Phase II-III trials are prepared to assess the efficacy and safety of Reparixin in the prevention of early allograft dysfunction in liver transplanted patients. Patients for liver transplantation will be recruited into the clinical trial that is scheduled to start in September 2013.ReparixinisexpectedtobeofficiallylaunchedintheRussianmarketin 2016.
“Dompé is always looking for strategies that put patients and improvement of their quality of life at the centre – explains Eugenio Aringhieri, CEO, Dompé Group. This is why we focus our R&D efforts on rare diseases, which require targeted treatments and for which often there is no treatment available. The alliance with SatRx is to be seen in this perspective. It is designed to bring innovation into an area, liver transplantation, where treatment can have a markedly positive impact on the lives of patients, as well as strengthen our presence internationally and in the Russian market. This is possible thanks to our drug Reparixin that with its innovative mechanism of action can provide a treatment opportunity to improve liver transplantation outcomes.”
Made under The Strategy of Development of the Pharmaceutical Industry of the Russian Federation (“Pharma 2020 Strategy”) programme that Ministry of Industry and Trade of The Russian Federation has sponsored since 2009, the alliance lays the groundwork for a new indication for Reparixin, and confirms Dompé as a vibrant group with excellent prospects. The “Pharma 2020 Strategy” programme aims at boosting the competitiveness and innovativeness of the Russian pharmaceutical industry both in terms of R&D and production. This important development program is generating in the country a sort of positive "flywheel" that is attracting major pharmaceutical groups around the world, with the goal of creating partnerships that allow a steady growth of pharmaceutical R&D and production in Russia.
“SatRx, a ChemRar company, is truly dedicated to development of innovative medicines in the field of cardiometabolic disorders and transplantology and committed to providing doctors and patients with effective first-in-class treatments. – says Nikolay Savchuk, SatRx Chairman.Transplantology is a rapidly advancing clinical field of utmost importance in Russia. The need for solid organ transplants like liver is underestimated and accounts for hundreds of deaths annually due to waiting lists and allograft shortage. The idea of introducing Reparixin in this indication to therapeutic armamentarium of transplantologists was actively supported by Russian key opinion leaders. We hope that successful collaboration with Dompé granting exclusive license to develop and commercialize Reparixin in Russia, EurAsEc and several other countries for prevention of early allograft dysfunction after liver allotransplantation will offer an effective solution for extension of donor criteria and improvement of outcomes thus making it possible to help hundreds of severely ill patients for whom allotransplantation is the last resort“.
Reparixin is an inhibitor of the CXCR1 receptor activated by interleukin-8 (IL-8) which plays a fundamental role in the development of the body’s anti-inflammatory response. Specifically, Reparixin acts by inhibiting the CXCR1 and CXCR2 receptors for interleukin-8 (IL-8) which plays a key role in the inflammatory cascade as it calls in and facilitates the action of specific white blood cells that destroy non-self cells, including transplanted cells.
Discovered at Dompé’s Italian labs, the investigational drug is currently in the final stage of clinical development as treatment to improve the efficacy of pancreatic islet transplantation in type 1 diabetes.
Reparixin in islet transplantation was granted Orphan Drug status by the FDA and the EMA. Its innovative mechanism of action is believed to have the ability to inhibit the short-term rejection reaction of the recipient’s immune system and hence facilitate liver graft implantation.
About Liver transplantation
Liver transplantation is currently the last resort treatment for varied liver diseases due to congenital metabolic defects, liver failure resulting from a viral infection or cirrhosis, fulminant hepatitis, as well as for some primary liver cancers (hepatocellular carcinoma). Every year about 13,000 liver transplants are performed worldwide (Liver-Products.com).
A leading pharmaceutical company in Italy, Dompé develops innovative treatment solutions for diseases that have a high social impact and are often orphan diseases. Based in Italy with HQ in Milan, Dompé focuses on Research in areas where there are still unmet treatment needs such as juvenile diabetes, ophthalmology and oncology. Its industrial site in L’Aquila (Abruzzi) has biotechnology facilities for the production of monoclonal antibodies and the development of Primary Care drugs that are sold internationally. In 2012, Dompé acquired Anabasis, an Italian biotech company that develops innovative drugs based on rhNGF (whose discovery earned Professor Rita Levi Montalcini the Nobel Prize for Medicine) for serious eye diseases for which there are no effective treatments available.
For more information: www.dompe.com
Since 2010, SatRx LLC is a specialist private biotechnology company focused on drug discovery, development and commercialization of novel treatments for cardiovascular and transplantology therapies. For more information: www.satrx.ru
Forward looking statements
This press release may contain forward looking statements. Dompé and SatRx both believethe expectations reflected in forward looking statements are reasonable and built on sound assumptions. However, by their very nature, forward looking statements are subject to uncertainties including those inherent in R&D and those associated with decisions made by regulatory authorities. Hence, forward looking statements are not a guarantee of future results which may be different.
http://www.liver-products.com/liver-therapy/liver-transplantation.html looked up on 10/04/2013
Dompé Group, Italy
Public Affairs & Corporate Communications Manager
+39 02 58383556
+39 334 6550628
СhemRar Group, Russia
Head of Public Affairs & Corporate Communications
+ 7 (495) 925 30 74