Pharmalink
AB, a privately held Swedish
pharmaceutical company, has received orphan drug designation from the 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 compound.
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.
