Clinigen Group announced its Idis Global Access division, has signed three further exclusive agreements to manage the supply and distribution of critical medicines on demand.
The three agreements and relevant territories are:
Mitsubishi Tanabe Pharma Europe: The new agreement builds on the current relationship with Clinigen’s Idis Managed Access division 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 who require parenteral antithrombotic therapy.
Under this new agreement, Idis 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.
Shionogi & Co: The agreement with Shionogi is to provide healthcare professional’s access to Senshio in Germany. Senshio, prescribed in tablet form, is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy 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.
Romark Laboratories: Idis signed a two year extension for the exclusive supply and distribution of Romark’s Alinia into all territories outside of the US and Latin America. Alinia is indicated for the treatment of diarrhea 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. These three varied contracts, including the conversion of a Managed Access programme, 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,” Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said.