Stockholm, Sweden, October 13th, 2010 – Pharmalink AB, a privately held Swedish pharmaceutical company, has received orphan drug designation by the US Food and Drug Administration (FDA) for its product candidate Nefecon (PL-56) for patients with IgA nephropathy, also referred to as Berger´s Disease. This program is presently in clinical development phase II.
Johan Häggblad, Managing director of Pharmalink AB said: “Today’s news marks a significant milestone for Pharmalink, and increases the commercial value of Nefecon® as it moves towards the market place. We believe this product candidate has great potential in treating IgA nephropathy. The orphan drug designation granted by the US FDA is very encouraging for our team as we now look to start executing on activities leading up to registration trials.”
Pharmalink AB previously announced global patent coverage and highly promising results from a planned interim analysis of an ongoing open Phase II trial which was designed to evaluate the efficacy and safety of Nefecon® in IgA nephropathy, a glomerulonephritis leading to end-stage renal disease (ESRD). The interim results were confirmed in the final results obtained in early 2009. Nefecon® is an oral small molecule product which downregulates the inflammatory process in the kidneys. It is being co-developed by Pharmalink and Archimedes Pharma under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept. Orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 people in the US. It provides companies with market exclusivity and can also lead to certain financial incentives that can help support the development of a specific compound.
The concept underlying the renal disease product candidate Nefecon is a patented invention by Professors Bengt Fellström and Roger Hällgren at Uppsala University, Sweden. It is delivered using Archimedes’ proprietary TARGIT® drug delivery technology which enables the localized delivery of drugs to the lower small intestine or colonic regions of the gut. Archimedes is providing access to the TARGIT platform and providing all trial supplies of Nefecon. Pharmalink is responsible for the management of the clinical trials.
For further information, please contact:
Johan Häggblad, Managing Director, +46 (0)70 668 0644
Michael Clark, +44 118 931 5077
Citigate Dewe Rogerson:
Chris Gardner/Nina Enegren, +44 207 638 9571
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 BusulipoTM, mature for out-licensing to a commercial partner and is actively in-licensing promising new projects to add to its pipeline. In June 2010, Pharmalink sold all intellectual property and assets related to its Xepol programme, the first medical treatment for post-polio syndrome, to Grifols, a group of companies which researches, develops, manufactures and markets products serving healthcare professionals and patients in over 90 countries around the world. Visit www.pharmalink.se for further information.
About Archimedes Pharma
Archimedes Pharma is an international specialty pharmaceutical company focused on the oncology, pain, neurology and critical care sectors. Archimedes Pharma is marketing an expanding portfolio of specialist products to hospital-based prescribers in Europe and has established commercial organizations in the UK, US, France, Germany, Ireland, and Spain.TARGIT is Archimedes Pharma’s proprietary technology for the delivery of drugs to specific regions of the large intestine or the local treatment of disease, an area of great interest to the pharmaceutical industry. The TARGIT system offers the option of delivering high local concentrations of drug, which are ideal for the topical treatment of diseases such as ulcerative colitis, Crohn's disease, irritable bowel syndrome and bacterial infections. The ability of TARGIT to reliably deliver drugs into the lower GIT has been demonstrated in numerous clinical studies.