Pharmalink Raises SEK96 Million to Undertake Pivotal Studies with Lead Programs in Cancer Therapy and Renal Disease

STOCKHOLM, October 4, 2013 /PRNewswire/ --

Pharmalink AB, a specialty pharma company focused on orphan and niche products, today announces it has raised SEK96 million (€11m / US$15m) in a Series C financing round. The round was co-led by two of the Nordic region's largest venture investors: Investinor, which is a new investor in Pharmalink, and Industrifonden, a current investor. Other existing investors also participated.

The new funds will be used to:

• Prepare for pivotal studies with Busulipo™, a best-in-class conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT),and advance the product towards market approval,
• Complete the pivotal Phase IIb study with Nefecon®, a potential disease-modifying treatment for patients with primary IgA nephropathy at risk of developing end-stage renal disease,
• Seek commercial partners for its products outside the Nordic region, and
• Facilitate in-licensing or acquisition of additional opportunities for commercialisation in the Nordic region.

Johan Häggblad, Managing Director of Pharmalink, said: "We are very pleased to have successfully raised these new funds. Our lead programs with Busulipo and Nefecon have progressed well and we are now focused on completing the final stages of their development and preparing for submissions to regulatory authorities. Moving into this new phase, we are looking to enhance our product portfolio in oncology and inflammation and have identified several complementary niche and orphan product opportunities that are available for commercialisation in the Nordic region. With the support of our investors, we look forward to building on our development expertise and sales and marketing heritage, and establishing Pharmalink as a leading specialty pharma company in Northern Europe."

Ann-Tove Kongsnes, Investinor, said: "We are delighted to support Pharmalink as it embarks on this next stage of its development. The Company has significant experience in developing and commercialising specialty pharma products, and in Busulipo and Nefecon, it has two more products with great potential to be successful. We hope that the perspective we bring from Norway, where we have deep contacts within centres of excellence such as the Oslo Cancer Cluster, can lead to additional opportunities for development for the company.  We are particularly pleased to co-invest with Industrifonden, with which we have recently announced a collaborative investment strategy to advance life sciences in the Nordic region."

Lennart Hansson, Industrifonden, said: "Pharmalink has demonstrated its development expertise and commercial awareness through the development and sale of Xepol in 2010 and the development of Busulipo and Nefecon, which are both approaching key development milestones. In this company and management team, we see an opportunity to create a fast-growing and sustainable specialty pharma company based in the Nordic region."

About Busulipo™ and Nefecon®

Busulipo™ has been developed by Pharmalink to provide a best-in-class conditioning agent for use prior to hematopoietic stem cell transplantation (HSCT), also often known as bone marrow transplantation. It is a liposome/lipid complex formulation that improves the safety and stability of the chemotherapy agent busulfan, and is aimed at becoming the new gold standard for use in conditioning prior to HSCT.

An early Busulipo formulation has successfully undergone clinical trials with more than 90 patients treated. The Company is currently preparing the pivotal clinical trialwith an optimised formulation of Busuliponeeded for registration and introduction into key global markets.

Nefecon® is a disease-modifying medication and the first specifically aimed at addressing the underlying pathology of progressive IgA nephropathy, the most common form of primary glomerulonephritis and a cause of end-stage renal disease. Early treatment may provide an alternative to dialysis and transplantation for this patient group.

Nefecon is an enteric formulation of a locally-acting and potent corticosteroid that down-regulates the 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. It has received orphan drug designation by the US Food and Drug Administration (FDA).

Nefecon has shown positive results an open-labelled Phase II trial evaluating safety and efficacy. Pharmalink is now focussed on undertaking two pivotal clinical trials of Nefecon, which would be the basis for a market authorisation application. The first of these studies, a Phase IIb multi-center, randomized, double-blinded placebo-controlled study, began in December 2012. Results are expected in 2015 and will support a pivotal Phase III trial.

http://www.pharmalink.se

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 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 focused on the development and commercialization of valuable, de-risked projects. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™. 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 Industrifonden

Industrifonden is one of Sweden's largest and most experienced investors atearly stage and in growth companies and manages an evergreen fund of approximately 3.5 billion (EUR420m). It has for the last 30 years had a leading role in the development of Swedish life science companies. Founded by the Swedish government in 1979, Industrifonden is an independent venture capital fund that operates on a strictly commercial basis and receives no further government funding. Revenues are returned to the business for new investments. (http://www.industrifonden.se)

About Investinor

Investinor is Norway's largest investor in venture and expansion capital, and manages a NOK4.2 billion (EUR525m) evergreen fund.  Investinor was founded in 2008 and is funded by the Norwegian government. It invests directly in promising unlisted companies and on the same terms and conditions as private investors, with a clear exit strategy for all investments.  (http://www.investinor.no)