Pharmalink AB Receives US Orphan Drug Designation for Nefecon(R) (PL-56)

By Pharmalink Ab, PRNE
Tuesday, October 12, 2010

STOCKHOLM, October 13, 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 Haggblad, Managing director of Pharmalink AB said:
"Today's news marks a significant milestone for Pharmalink, and increases the
commercial value of Nefecon(R) 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(R) 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(R) 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

The concept underlying the renal disease product candidate
Nefecon is a patented invention by Professors Bengt Fellstrom and Roger
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 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. 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 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.

    For further information, please contact:

    Johan Haggblad, Managing Director, +46(0)70-668-0644

    Archimedes Pharma:
    Michael Clark, +44-118-931-5077

    Citigate Dewe Rogerson:
    Chris Gardner/Nina Enegren, +44-207-638-9571

For further information, please contact: Pharmalink: Johan Haggblad, Managing Director, +46(0)70-668-0644, Email: johan.haggblad at,; Archimedes Pharma: Michael Clark, +44-118-931-5077,; Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, +44-207-638-9571

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