Pharmalink Enters Manufacturing Agreement for Nefecon(R)

Informations

• Publié par: Pharmalink-AB
• Nombre de lectures: 25
• Langue: English

Extrait

Pharmalink Enters Manufacturing Agreement for Nefecon(R)

PR Newswire STOCKHOLM, October 31, 2012

STOCKHOLM,October 31, 2012/PRNewswire/ --

Pharmalink AB, a Swedish specialty pharma company, today announces it has entered into a contract with Patheon Inc., a leading provider of contract development and manufacturing services to the global pharmaceutical industry for the manufacturing of Nefecon®, Pharmalink's lead product. Nefecon is being developed as the first on-label medication specifically aimed at addressing the underlying pathology of progressive IgA nephropathy, the most common form of primary glomerulonephritis and a leading cause of end-stage renal disease.

The agreement covers the manufacturing of Nefecon and is an important step in progressing the product towards the market. No commercial terms were disclosed.

Johan Häggblad, Managing Director of Pharmalink, said: "Despite the increasing recognition of IgA nephropathy as a significant cause of morbidity and mortality, no specific medications have been developed and introduced to the market. In that context, our development programme for Nefecon is seen as one of the most significant in IgA nephropathy clinical research. We have already show n positive results in an open-labelled Phase II trial evaluating Nefecon's safety and efficacy and, with Patheon, we will be working with one of the pharmaceutical industry's best- respected manufacturers as Nefecon advances towards pivotal trials."

Nefecon is an enteric formulation of a locally-acting and potent corticosteroid which down regulates the IgA nephropathy disease process in the kidney through suppression of the gastrointestinal immune system, thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. The target group for Nefecon is the approximately 40% patients with the more aggressive form of the disease and who are at risk of developing end-stage renal disease. The ultimate aim is to provide an alternative to dialysis and transplantation. Pharmalink has received orphan drug designation by the US Food and Drug Administration (FDA) for Nefecon.

® Nefeconwas invented at Uppsala University (Sweden) and was acquired by Pharmalink in 2004. Nefecon is delivered using the proprietary TARGIT® drug delivery technology which enables the localized delivery of drugs to the lower small intestine or colonic regions of the gastrointestinal tract. Pharmalink has an exclusive licence to Targit® technology for the development of Nefecon® from Archimedes Pharma.

About Pharmalink

Pharmalink is a Swedish specialty pharma company developing high-value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical development and marketing and the excellence of medical science in Sweden to identify and progress products that address significant unmet medical needs. With a successful history in pharmaceutical sales and marketing, and highly experienced, dynamic management team, Pharmalink is currently focused on the development of valuable, de-risked projects using a repurposing and reformulation strategy. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™, having successfully divested its Xepol® product in 2010. Pharmalink is actively seeking opportunities to acquire or in-licence product opportunities in niche and hospital care indications. Visithttp://www.pharmalink.sefor further information.

About Patheon

Patheon Inc. (TSX: PTI) is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. The company provides the highest quality products and services to approximately 300 of the world's leading pharmaceutical and biotechnology companies. Patheon's services range from preclinical development through commercial manufacturing of a full array of solid and sterile dosage forms.

The company's comprehensive range of fully integrated Pharmaceutical Development Services includes pre- formulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization. The company's integrated development and manufacturing network of nine manufacturing facilities and nine development centers across North America and Europe , enables customer products to be launched with confidence anywhere in the world. For more information please visithttp://www.patheon.com.

For further information, please contact:

Pharmalink AB: Johan Häggblad, Managing Director, [phone] [e-mail] http://www.pharmalink.se

Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, [phone]