BARCELONA, Spain, May 20 Today, Grifols SA announced that it has reached an agreement with the Swedish company Pharmalink AB to acquire various forms of intellectual property (IP) associated with the treatment of post-polio syndrome (PPS). The acquisition is expected to be finalized in the next few weeks and will include documentation, know-how, and Swedish regulatory approvals under the trade name Xepol. Furthermore, Grifols also acquires U.S., European and Japanese patents for a specific PPS treatment method utilizing human immunoglobulin and unrestricted use of existing Pharmalink clinical trial data supporting the treatment method.
Acquisition of the PPS drug development project creates new clinical research and therapeutic treatment areas for Grifols. "Exploring the treatment of PPS consistent with our mission of developing therapies for chronically ill and underserved patient populations," said Ramon Riera, Director of Global Sales and Marketing for Grifols. Currently there are no therapies approved for the treatment of PPS.
PPS is widely recognized as a rare disease and the U.S. FDA has granted orphan drug designation for the use of human immunoglobulin in the treatment of PPS. "The promise of research on potential treatments for post polio syndrome is welcomed by the thousands who experience its debilitating symptoms, and we hope that it is fulfilled," said Joan L. Headley, Executive Director of St. Louis, Missouri based Post-Polio Health International (PHI), the leading organization working to enhance the lives and independence of polio survivors. "It has been challenging to find treatments for this condition. We are pleased that Grifols is investing in the PPS community," Headley added.
Previous clinical trials on the use of human immunoglobulin for the treatment of PPS have been sponsored by Pharmalink using Grifols' proprietary intravenous immunoglobulin. Grifols' acquisition of the Pharmalink PPS project will give Grifols unrestricted use of those data and set the stage for Grifols to investigate clinically relevant research questions growing out of prior studies.
The acquisition also includes U.S., European and Japanese patents which will effectively give Grifols exclusive rights to the treatment method.
Several decades after suffering acute polio infection survivors commonly develop PPS characterized by new or increased muscle weakness, fatigue, and pain. Ongoing denervation is the most often suggested for increased muscle weakness associated with polio infection. Patients with PPS have increased expression of mRNA for proinflammatory cytokines in cerebrospinal fluid which suggests an inflammatory process in the central nervous system. Some patients with asymmetrical weakness have increased wear and tear on joints and muscles, including breathing muscles. While rarely fatal, the neurological and muscular symptoms of PPS are lifelong and debilitating.
The most recent polio epidemic culminated in the Western countries around 1950. As most infections occur in children, there is nowadays a large pool of polio survivors with varying degrees of functional decline. U.S. National Institute of Neurological Disorders and Stroke (NINDS) gives a prevalence interval for PPS of 25 to 50% (in primary polio infection survivors), WHO estimates a 40 % prevalence; assuming a prevalence of 30%, only in major Western countries there would be around 300,000 PPS patients.
Currently there is no pharmacological treatment for PPS. Several therapeutic agents have failed in achieving positive outcomes. Treatment practices are based on physiotherapy, non-fatiguing exercise and the use of assistive devices. The promising results with immunoglobulin may help address the unmet medical need of some PPS patients. In several clinical trials lead by a team of physicians at Karolinska Institutet (Sweden) and sponsored by Pharmalink AB, immunoglobulin has shown significant and clinically meaningful results in endpoints such as pain, walking ability and quality of life (SF-36 scores) by down-regulating the inflammatory process in the nervous system of PPS patients.
Pharmalink is a Swedish specialty pharma company developing high value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical product development and the excellence of medical science in Sweden to identify and progress products that address significant unmet medical needs. Pharmalink has introduced more than 15 pharmaceutical products to the market. Using a repurposing and reformulation strategy, Pharmalink minimizes the risk of product development. The Company's strategy is to develop drugs to clinical proof-of-concept and then to out-license or divest to a commercial partner. Pharmalink currently has two clinical phase development projects, Nefecon® and Busulipo(TM), mature for out-licensing to a commercial partner and is actively in-licensing promising new projects to add to its pipeline. Visit www.pharmalink.se for further information
Grifols is a Spanish holding company specialized in the pharmaceutical-hospital sector and is present in more than 90 countries. Since 2006, the company has been listed on the Spanish Stock Exchange ("Mercado Continuo") and is part of the Ibex-35. Currently it is the first company in the European sector in plasma derivatives and the fourth in production worldwide. In upcoming years, the company will strengthen its leadership in the industry as a vertically integrated company, thanks to recent investments. In terms of raw materials, Grifols has ensured its plasma supply with 80 plasmapheresis centers in the United States and in terms of fractionation, its plants in Barcelona (Spain) and Los Angeles (United States) will allow the company to respond to the growing market demand. Nevertheless, the company is preparing for sustained growth in the following 8-10 years and has launched an ambitious investment plan. Visit www.grifols.com for more information.
SOURCE Grifols SA