Clinigen makes 3 exclusive compassionate-use deals

Pills in pill container
Clinigen signed exclusive compassionate use management agreements with Mitsubishi Tanabe, Shionogi and Romark. Getty/Viperfzk

Clinigen has signed exclusive agreements with Mitsubishi Tanabe, Shionogi and Romark to cooperate on expanded access to their medicines.

Clinigen manages the deals through its Idis Global Access (GA) division, which works with healthcare professionals, mainly pharmacists, around the world to supply unlicensed or not-yet-launched medicines for individual patients.

The deal with Mitsubishi Tanabe’s European unit focuses on argatroban, an anticoagulant for adult patients with type 2 heparin-induced thrombocytopenia who require parenteral antithrombotic therapy. The new contract builds on an ongoing relationship with Clinigen’s Idis Managed Access division, which, unlike the GA division, serves pharma companies by managing their company-initiated compassionate use programs. For this new agreement, Idis GA will supply and distribute the medication on demand in all countries where it is not marketed.

The Shionogi deal involves Senshio, a drug for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in women who are not suitable for local vaginal oestrogen therapy. Idis GA will supply the med to physicians and pharmacists in Germany, where it is approved but not commercially available. It will also supply it in the U.K., where the med is already marketed.

Idis also extended the deal with Romark for another two years for the exclusive offering of Alinia in countries outside of the U.S. and Latin America. The medication is used to treat diarrhea in children caused by intestinal infection by the parasites, Cryptosporidium parvum or Giardia lamblia.

After its 2015 acquisition of Idis, Clinigen has become a global leader in managed access. In January, the company initiated a U.S. managed access program for Tesaro’s PARP inhibitor niraparib (now marketed under the brand name Zejula) for patients with recurrent ovarian cancer, prior to an FDA approval in late March. In May, it partnered with Tesaro again to offer early access to niraparib in Europe.

Other managed access programs it formed this year include one with Onxeo for the supply of belinostat for European patients with relapsed or refractory peripheral T-cell lymphoma, and another European one in March with Diurnal for use of Infacort in children with adrenal insufficiency and Chronocort for patients with congenital adrenal hyperplasia.