Pharmalink Raises SEK100m to Advance Nefecon® Development as New Treatment for Kidney Disease

STOCKHOLM, October 1, 2015 /PRNewswire/ --

Plans Initial Public Offering on Nasdaq Stockholm in 2016 

Pharmalink AB, a specialty pharma company, today announces it has raised SEK100 million (€10.5m / US$12m*) in a mezzanine financing round from all its existing investors, including Investinor and Industrifonden, two of the Nordic region's largest venture investors.

The funds will be used to prepare a Phase 3 clinical development programme for its lead product candidate Nefecon® for the treatment of primary IgA nephropathy, an inflammatory disease of the kidney that in up to 40% patients progresses to end-stage renal disease. A randomized Phase 2b trial of Nefecon® (the NEFIGAN trial) in 150 patients met its primary efficacy endpoint at a planned interim analysis. Final results from the completed NEFIGAN trial are expected in the fourth quarter 2015.

Johan Häggblad, Managing Director of Pharmalink, said: "These new funds will enable Pharmalink to expand to become 'Phase 3 ready' in 2016 ahead of an IPO and thereby make important progress with the development of Nefecon towards the market. The positive results we have seen in the NEFIGAN trial are extremely promising, and the response from kidney disease specialists to these data has underlined the potential we see for Nefecon to become a valuable new treatment option for patients with IgA nephropathy at risk of progressing to renal failure. We look forward to announcing final results from the NEFIGAN trial in the next months and preparing the company for an exciting time ahead."

Pharmalink is planning to undertake an Initial Public Offering on Nasdaq Stockholm in 2016, pending favourable market conditions, primarily to fund the clinical development of Nefecon towards market approval and commercialisation in key territories.

Ann-Tove Kongsnes, Investment Director at Investinor and Non-executive Director of Pharmalink, said: "Pharmalink has a great opportunity to build a leading specialty pharmaceutical company based initially around Nefecon in kidney disease. We are delighted to continue to support the company during this transformational period."

Lennart Hansson, Investment Director at Industrifonden and Non-executive Director of Pharmalink, said: "Through the advancement of Nefecon, Pharmalink has once again demonstrated its ability to identify and address an unmet clinical need with a strong commercial product proposition. We believe that with this funding, Pharmalink can put in place the necessary corporate structure and clinical plan to bring Nefecon to the market."

*Based on exchange rate as at today's date. 

Notes to Editors 

About IgA Nephropathy 

IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage.

IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with IgAN progress to renal failure, often referred to as end-stage renal disease within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets.

Patients suffering renal failure require dialysis or kidney transplantation. IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.

About Nefecon® 

Nefecon is a potential disease-modifying treatment for patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD). Nefecon has shown positive results in an open-labelled Phase 2a trial evaluating safety and efficacy and met its primary efficacy endpoint in a placebo-controlled randomized Phase 2b study (http://www.nefigan.net/). The study recruited ahead of target and schedule and was designed to enable an optimal dose of Nefecon to be selected for a Phase 3 registration trial. Full data of the Phase 2b NEFIGAN Trial is anticipated in the fourth quarter 2015.

Nefecon is an oral formulation of a locally-acting and potent corticosteroid, budesonide, 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. Promising results indicate that treatment with Nefecon may provide clinical benefits to IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon has received orphan drug designation by the US Food and Drug Administration (FDA).

About Pharmalink AB 

Pharmalink is a specialty pharma company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products.

Visit http://www.pharmalink.se for further information.