- Agreement Marks Milestone in Pharmalink's Corporate Development
Pharmalink AB, today announced that it has closed its agreement withGrifols SA for the acquisition of Pharmalink's Xepol(R) programme for thetreatment of post-polio syndrome (PPS). The parties had previously announcedreaching an agreement whereby Grifols would acquire all know-how and globalintellectual property rights related to the use of human immunoglobulin forthe treatment of (PPS) - the concept at the heart of the Xepol programme.
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The agreement covers acquisition of one of Pharmalink's wholly ownedsubsidiaries and includes inter alia US, EU and Japan patents for thetreatment of PPS with immunoglobulins, a US Orphan Drug Designation (ODD) forthe use of immunoglobulin for the treatment of PPS and documentation of anumber of clinical studies carried out in the recent years.
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Johan Haggblad, Managing director of Pharmalink AB said: "This agreementmarks a significant milestone in Pharmalink's corporate development. Indeveloping a concept originally devised by academic researchers at theKarolinska Institute and seeing it through to being acquired by a world classcompany we have demonstrated the considerable value creation made possible bythe Pharmalink model. We are very happy to see Grifols, our long standingpartner, acquire and develop the PPS indication and to have played a part inbringing forward a treatment for this underserved condition."
Grifols will develop the PPS product opportunity using the acquiredassets. Pharmalink will assist in technology transfer and provide contactwith its network of physicians and patient organizations. The purchase priceis undisclosed but divided into an up-front payment and commercial milestonepayments.
The PPS product opportunity is an important means to provide a treatmentto a patient group largely suffering without effective medication and toexpand sales of immunoglobulin in new patient segments.
About PPS
Several decades after suffering acute polio infection survivors commonlydevelop PPS characterized by new or increased muscle weakness, fatigue, andpain. Ongoing denervation is the most often suggested for increased muscleweakness associated with polio infection.
Patients with PPS have increased expression of mRNA for proinflammatorycytokines in cerebrospinal fluid which suggests an inflammatory process inthe central nervous system. Some patients with asymmetrical weakness haveincreased wear and tear on joints and muscles, including breathing muscles.
While rarely fatal, the neurological and muscular symptoms of PPS arelifelong and debilitating.
The most recent polio epidemic culminated in the Western countries around1950. As most infections occur in children, there is nowadays a large pool ofpolio survivors with varying degrees of functional decline. US NationalInstitute of Neurological Disorders and Stroke (NINDS) gives a prevalenceinterval for PPS of 25 to 50% (in primary polio infection survivors), WHOestimates a 40 % prevalence; assuming a prevalence of 30%, only in majorWestern countries there would be around 300,000 PPS patients.
Currently there is no pharmacological treatment for PPS. Severaltherapeutic agents have failed in achieving positive outcomes. Treatmentpractices are based on physiotherapy, non-fatiguing exercise and the use ofassistive devices. The promising results with immunoglobulin may help addressthe unmet medical need of some PPS patients. In several clinical trials leadby a team of physicians at Karolinska Institutet (Sweden) and sponsored byPharmalink AB, immunoglobulin has shown significant and clinically meaningfulresults in endpoints such as pain, walking ability and quality of life (SF-36scores) by down-regulating the inflammatory process in the nervous system ofPPS patients.
About Pharmalink
Pharmalink is a Swedish specialty pharma company developing high valueproducts for niche indications. Pharmalink draws on its extensive experienceof pharmaceutical product development and the excellence of medical sciencein Sweden to identify and progress products that address significant unmetmedical needs. Pharmalink has introduced more than 15 pharmaceutical productsto the market. Using a repurposing and reformulation strategy, Pharmalinkminimizes the risk of product development. The Company's strategy is todevelop drugs to clinical proof-of-concept and then to out-license or divestto a commercial partner. Pharmalink currently has two clinical phasedevelopment projects, Nefecon(R) and BusulipoTM, mature for out-licensing toa commercial partner and is actively in-licensing promising new projects toadd to its pipeline. Visit http://www.pharmalink.se for further information.
About Grifols
Grifols is a Spanish holding company specialized in thepharmaceutical-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 firstcompany in the European sector in plasma derivatives and the fourth inproduction worldwide. In upcoming years, the company will strengthen itsleadership in the industry as a vertically integrated company, thanks torecent investments. In terms of raw materials, Grifols has ensured its plasmasupply with 80 plasmapheresis centers in the United States and in terms offractionation, its plants in Barcelona (Spain) and Los Angeles (UnitedStates) will allow the company to respond to the growing market demand.Nevertheless, the company is preparing for sustained growth in the following8-10 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: [email protected] 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 protected] [email protected]
SOURCE Pharmalink AB
