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Last updated on April 19, 2014 at 9:20 EDT

Pharmalink Enters Manufacturing Agreement for Nefecon(R)

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(R),
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 Haggblad, 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 shown 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(R) is delivered using the proprietary TARGIT(R) 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(R)
technology for the development of Nefecon(R) 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(R) and Busulipo(TM), having successfully divested its Xepol(R)
product in 2010. Pharmalink is actively seeking opportunities to acquire or in-licence
product opportunities in niche and hospital care indications. Visit
http://www.pharmalink.se for 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 visit http://www.patheon.com.

For further information, please contact:

        Pharmalink AB:
        Johan Haggblad, Managing Director, +46(0)70-668-0644
        johan.haggblad@pharmalink.se

http://www.pharmalink.se
        Citigate Dewe Rogerson:
        Chris Gardner/Nina Enegren, +44(0)207-638-9571

SOURCE Pharmalink


Source: PR Newswire