Pharmalink AB Completes Phase II Clinical Study With Renal Disease Drug Nefecon(R)

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 30 Apr 2009 - 1:00 PDT

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Pharmalink AB announced that it has completed its open Phase II trial evaluating the efficacy and safety of Nefecon(R) in IgA nephropathy, a glomerulonephritis leading to end-stage renal disease. Nefecon is an enteric formulation of a locally acting corticosteroid which downregulates the inflammatory process in the kidneys through suppression of the gut immune system.

Sixteen patients at trial centers in Sweden were treated for six months followed by a three month follow up period. Full results will be presented at the World Congress of Nephrology 2009, 22-26 May in Milan (Smerud et al, Enteric Budesonide Ameliorates Albuminuria and Glomerular Filtration Rate in IgA Nephropathy Patients) and at the satellite meeting, IgA Nephropathy, 26-28 May in Stresa, Italy.

"It is very gratifying to have completed this important stage in the development of Nefecon," said Johan Haggblad, Managing Director of Pharmalink. "We hope to bring a new licensed treatment where other therapies have failed and will now focus on preparing for pivotal trials and on seeking a development partner to bring Nefecon through Phase III and to the market."

Nefecon is being co-developed by Pharmalink and Archimedes Development Ltd ("Archimedes") a subsidiary of Archimedes Pharma Ltd under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept. The concept underlying the renal disease product candidate Nefecon is a patented invention by Professors Bengt Fellstrom and Roger Hallgren at Uppsala University, Sweden. It is delivered using Archimedes' proprietary TARGIT(R) 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.

About Pharmalink

Pharmalink AB is a privately held Swedish specialty pharma company that develops proprietary pharmaceutical products in fields of unmet medical need. Pharmalink has adopted a reformulation/repurposing strategy and has a vast international network of physicians, biotech companies, CMOs, CROs and specialist consultants. Pharmalink has a track record of introducing more than 15 pharmaceutical products to market. Pharmalink currently has three clinical phase development projects mature for out-licensing: Nefecon(R), an effective treatment of IgA nephropathy; Xepol(R), the first effective treatment of neurology indication post-polio syndrome; and Busulipo(TM), a safer alternative for myeloablation prior to bone marrow transplantation. Pharmalink also seeks to refill its development pipeline by in-licensing.

About Archimedes Pharma

Archimedes Pharma ("Archimedes") is a pan-European specialty pharmaceutical company marketing and selling an expanding portfolio of specialist products to hospital-based prescribers in major European territories.

Archimedes is also developing a robust, high value pipeline of in-house products in pain, Parkinson's disease and critical care. It applies its world-class drug delivery technologies to proven molecules which have yet to achieve their market potential due to their current mode of delivery. This approach reduces the company's development risk, while delivering significant clinical and commercial benefits. The Group's lead development product is NasalFent(R), an innovative and highly differentiated fentanyl citrate nasal spray, for the rapid relief of breakthrough cancer pain.

Archimedes technologies - ChiSys(R), PecSys(TM) and TARGIT(R) - are used in a number of partnered products in late-stage clinical development.

TARGIT is Archimedes' 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.

Source: Pharmalink AB

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