In 2011 Medical Need secured the exclusive license and distribution rights for the product Decuprate™ in Europe from Tactic Pharma LLC, both prior to and after Marketing Authorization. Medical Need has during the first part of 2012 invested in the manufacturing of the product to meet the need for product in clinical trials and any requests for clinical use of the product under special permission, so called named patient use.
Wilson Therapeutics AB (“Wilson”) has acquired Decuprate™ from Tactic Pharma LLC. Wilson Therapeutics is a newly established company aiming at advancing Decuprate™ through clinical development for the treatment of Wilson’s disease. Wilson Therapeutics is backed by the Europe based venture capital firm HealthCap and Medical Need as well as Tactic Pharma will each become shareholders in Wilson Therapeutics. The Board of Directors will include representation from HealthCap, Tactic and Medical Need and consist of Directors with vast experience from the pharmaceutical industry, product development and commercialization of pharmaceuticals. Medical Need will be represented on the Board of Directors by its CEO, Dr Peder Walberg.
“We are delighted to have reached an agreement on the path towards regulatory approval for this important contribution to the treatment of Wilson’s Disease”, says Dr. Walberg, CEO of Medical Need, and continues: “Combining the in-depth product knowledge of Tactic Pharma with the vast industry experience and financial strength of Health Cap plus Medical Need’s expertise in the field of orphan and niche pharmaceuticals creates a very strong team. Like many orphan conditions, Wilson’s disease is still an area with clear unmet medical needs and Decuprate™ has the potential to add significant value for the Wilson’s disease patients.”
ABOUT WILSONS DISEASE
Wilson’s disease, also known as hepatolenticular degeneration, is an inborn error of metabolism resulting in a disturbed copper-excretion mechanism. In affected patients, copper gradually accumulates in the body, including the liver and the central nervous system. The clinical presentation includes a broad range of symptoms, particularly common are liver impairment and neurological manifestations. The disorder typically presents in adolescence or early adulthood and requires life-long pharmaceutical intervention. If untreated, the disease is progressive and results in severe disability and death.
Decuprate™ is the proprietary bis-choline salt of tetrathiomolybdate, which presents superior stability and characteristics compared to other tetrathiomolybdate salts. Tetrathiomolybdate (TM) is a very strong copper chelator with nano-molar affinity and does not bind any other physically relevant divalent cat-ion. TM has been tested in several clinical trials in Wilson’s disease (n=120) and was shown to rapidly bind and remove the excess copper, typically within weeks. In a comparative trial vs. standard of care in acutely presenting Wilson’s disease patients with neurological symptoms, TM has been shown to be significantly better at preserving neurological function. Decuprate™ has also been tested in oncological trials including approximately 150 patients treated up to three years, and was found to be safe and tolerable while efficiently lowering copper levels with once daily dosing. Key side effects relate to over-excessive copper-depletion, resulting in bone marrow suppression, and were rapidly reversible with a decrease of the daily dose.
ABOUT MEDICAL NEED EUROPE AB
Medical Need is a privately owned and self-financed pharmaceutical company based in Sweden, focusing on the development, registration, marketing and distribution of niche specialty pharmaceutical products and orphan drugs in Europe. It has local representation in several European countries, with central functions like medical affairs, regulatory affairs, pharmacovigilance, logistics, customer service, partnership development, marketing, finance and management located to Stockholm. Medical Need’s vision is to be eminent in identifying and addressing medical needs of individual patients, people suffering from rare diseases and/or specific situations in health care, in close collaboration with research organizations, industrial partners, health care, patient organizations and other key stakeholders.
ABOUT WILSON THERAPEUTICS AB
Wilson Therapeutics is a newly established Swedish orphan drug company focused on developing novel treatments for Wilson’s Disease
HealthCap is a family of multi stage venture capital funds, investing globally in life sciences. With committed capital exceeding € 900 million, HealthCap is one of the largest specialized providers of venture capital within life sciences in Europe.