Clinigen Forms Supply and Distribution Pacts

Clinigen Group, through its Idis Global Access division, has signed three supply and distribution agreements.

The new agreement with Mitsubishi Tanabe Pharma Europe (MTPE) builds on the current relationship to provide early access to argatroban where the product has no regulatory approval. Argatroban is indicated for anticoagulation in adult patients with heparin-induced thrombocytopenia type II (HIT) who require parenteral antithrombotic therapy. Under this new agreement, Idis GA will supply and distribute argatroban on an exclusive, unlicensed, on demand basis in all countries where there is no Marketing Authorization or where MPTE has no direct presence.

An agreement with Shionogi & Co. Ltd. was formed to provide access to Senshio in Germany. Senshio, prescribed in tablet form, is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy. Idis GA will make Senshio available on an on demand basis to physicians and pharmacists in Germany where the product is approved but not commercially available, and in the UK where the product is approved and has been commercially launched.

Lastly, Idis GA signed a two year-extension for the exclusive supply and distribution of Romark Laboratories’ Alinia into all territories outside of the U.S. and Latin America. Alinia is indicated for the treatment of diarrhoea in children caused by intestinal infection by the parasites, Cryptosporidium parvum or Giardia lamblia.

“These exclusive agreements demonstrate Idis Global Access’ ability to support international pharma companies, such as Mitsubishi, Shionogi and Romark, to meet on demand access for their medicines,” said Steve Glass, chief commercial officer, North America and Europe, Clinigen. “These three varied contracts, including the conversion of a managed access program, demonstrate the positive steps we are taking in building this business to become the go-to leader in ethical access to unlicensed or unavailable medicine.”