STOCKHOLM, June 30, 2010 /PRNewswire/ --
- Agreement Marks Milestone in Pharmalink's Corporate Development
Pharmalink AB, today announced that it has closed its agreement with Grifols SA for the acquisition of Pharmalink's Xepol(R) programme for the treatment of post-polio syndrome (PPS). The parties had previously announced reaching an agreement whereby Grifols would acquire all know-how and global intellectual property rights related to the use of human immunoglobulin for the treatment of (PPS) - the concept at the heart of the Xepol programme.
The agreement covers acquisition of one of Pharmalink's wholly owned subsidiaries and includes inter alia US, EU and Japan patents for the treatment of PPS with immunoglobulins, a US Orphan Drug Designation (ODD) for the use of immunoglobulin for the treatment of PPS and documentation of a number of clinical studies carried out in the recent years.
Johan Haggblad, Managing director of Pharmalink AB said: "This agreement marks a significant milestone in Pharmalink's corporate development. In developing a concept originally devised by academic researchers at the Karolinska Institute and seeing it through to being acquired by a world class company we have demonstrated the considerable value creation made possible by the Pharmalink model. We are very happy to see Grifols, our long standing partner, acquire and develop the PPS indication and to have played a part in bringing forward a treatment for this underserved condition."
Grifols will develop the PPS product opportunity using the acquired assets. Pharmalink will assist in technology transfer and provide contact with its network of physicians and patient organizations. The purchase price is undisclosed but divided into an up-front payment and commercial milestone payments.
The PPS product opportunity is an important means to provide a treatment to a patient group largely suffering without effective medication and to expand sales of immunoglobulin in new patient segments.
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. US 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(R) and BusulipoTM, mature for out-licensing to a commercial partner and is actively in-licensing promising new projects to add to its pipeline. Visit http://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.
For further information, please contact: Pharmalink AB: Johan Haggblad, Managing Director, +46(0)70-668-0644 Email: firstname.lastname@example.org http://www.pharmalink.se Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, +44-207-638-9571 Grifols SA: Raquel Lumbreras Lanchas/Borja Gomez Vazquez Tel : +34-91-311-92-89/+34-91-311-92-90 Mobile: +34-659-57-21-85 Email: email@example.com firstname.lastname@example.org
SOURCE Pharmalink AB