Wednesday, June 21, 2017 - 08:00

Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, announces that its Idis Global Access (‘Idis GA’) 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 as follows:

Mitsubishi Tanabe Pharma Europe Ltd (‘MTPE’)

The new agreement with MTPE 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 (‘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 Authorisation or where MTPE has no direct presence.

Shionogi & Co Ltd (‘Shionogi’)

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 (‘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.

Romark Laboratories (‘Romark’)

Idis GA 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 diarrhoea in children caused by intestinal infection by the parasites, Cryptosporidium parvum or Giardia lamblia.

Idis GA is the market leader in providing hospital pharmacists with compliant on demand access to medicines.

Healthcare professionals can obtain details about any of the products mentioned above by emailing customer.services@clinigengroup.com.

Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:           

“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.”

- Ends -

Contact details

 

Clinigen Group plc

Tel: +44 (0) 1283 495 010

Shaun Chilton, Group Chief Executive Officer

Steve Glass, Chief Commercial Officer

(North America and Europe)

 

 

 

Instinctif Partners

Tel: +44 (0) 20 7457 2020

Melanie Toyne-Sewell / Alex Shaw

Email: clinigen@instinctif.com

 

Notes to Editors

 

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

 

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

 

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

 

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programmes for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

 

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital products.

 

For more information, please visit www.clinigengroup.com

 

Mitsubishi Tanabe Pharma Europe Ltd

Mitsubishi Tanabe Pharma Europe Ltd is the European Headquarters of one of Japan’s largest pharmaceutical companies, Mitsubishi Tanabe Pharma Corporation.

 

Mitsubishi Tanabe Pharma Corporation is a research-based pharmaceutical company, created through the merger of Tanabe Seiyaku Co., and Mitsubishi Pharma Corporation on 1st October 2007, based in Osaka, Japan.

 

Mitsubishi Tanabe Pharma Corporation is committed to becoming a global research-driven pharmaceutical company, which continuously brings new medicines to market that meet global needs. As part of the company's worldwide expansion, organisations have been established in Europe (Mitsubishi Tanabe Pharma Europe Ltd) and Germany (Mitsubishi Tanabe Pharma GmbH).

 

For more information, please visit the Mitsubishi Tanabe Pharma Corporation website.

 

Shionogi & Co Ltd

Shionogi & Co., Ltd. Is a major research-driven pharmaceutical company dedicated to placing the highest value on patients based on its corporate philosophy of “supply the best possible medicine to protect the health and wellbeing of the patients we serve.” Shionogi’s research and development currently targets two therapeutics areas: infectious diseases and pain/CNS disorders. In addition to in-house research activity, Shionogi is focusing on utilization of outer resources from collaborative research with partners such as academia and other companies. Contributing to the health and QOL of patients around the world is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp/en.

 

About Romark Laboratories

Romark Laboratories, L.C. is a vertically integrated biopharmaceutical company committed to the discovery and development of innovative small molecule drugs for treating infectious diseases and cancers. The Company markets Alinia® (nitazoxanide) tablets, 500 mg in the United States through a specialty sales force focused on gastroenterologists and primary care physicians.

 

Romark is developing a class of small molecule drugs called thiazolides. The Company’s product, NT-300 (nitazoxanide), is presently undergoing Phase 3 clinical development on a global basis for treatment of acute uncomplicated influenza. The NT-300 development program is being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services. Other new drugs from the Company’s platform technology are proposed for treatment of viral diseases and cancers.

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