Clinigen acquires US-approved Totect

For immediate release

2 March 2016

Clinigen Group plc

Clinigen acquires US-approved Totect® (dexrazoxane) from Biocodex to become the only global source for the treatment of anthracycline extravasation 

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has acquired Totect® (dexrazoxane) from Biocodex USA, a product that is patent protected in US, Canada and Mexico.

Totect® is an emergency medicine used to reverse the toxic effects of anthracycline anti-cancer treatment. Occasionally, anthracyclines when administered, accidently leak outside of the vein into surrounding tissue causing severe damage. Totect® reverses this damage, allowing patients to continue their essential anti-cancer treatment.

The acquisition, together with the Group's acquisition of Savene® in 2014, gives Clinigen a complete global footprint for this indication. This market entry strategy enables the Group to access the US, an important market for extravasation, and the opportunity to extend into further indications, such as cardio-protection.

Totect® was acquired for an upfront payment followed by milestone-based instalments over 12 months. Further financial terms of the acquisition are not being disclosed. Under the terms of the agreement, Clinigen's Specialty Pharmaceuticals division will assume full responsibility for Totect's® manufacturing, registration, distribution, and commercialisation in the US. Totect® has method of use patent protection until 2020.

Peter George, Chief Executive Officer, Clinigen Group, said:

"By acquiring Totect® we have become the global supplier of dexrazoxane for extravasation and have gained access to the important US market. This product is a valuable addition to our global dexrazoxane portfolio and another step forward in our specialty pharmaceutical business strategy."

David Moran, Managing Director, Clinigen Specialty Pharmaceuticals, said:

"Following the successful acquisition and revitalisation of Savene®, Totect® was a natural target for us as we continue to focus on acquiring niche, hospital-only therapies with the potential to protect the lives of critically ill patients. Totect® further builds our position in the oncology support area, adding to existing products Savene®, Cardioxane®, Ethyol® and Foscavir®."

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Contact details

About Totect®

Totect® is the first and only approved treatment by the United States Food and Drug Administration for anthracycline extravasation. Extravasation is the accidental leaking of medications administered intravenously from a patient's veins into the surrounding tissues and other areas of the body. Anthracyclines are used to treat many types of cancer and are among the most common cancer therapies. Anthracycline extravasation can result in serious complications for cancer patients including tissue necrosis with skin ulceration. In addition to tissue damage, an anthracycline extravasation may cause damage to the nerves, tendons, muscle and joints.

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 drug 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 programs 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 commercial products.

For more information, please visit www.clinigengroup.com

About Biocodex USA

Biocodex USA is a Silicon Valley-based pharmaceutical company dedicated to providing its customers with meaningful health care solutions, with an emphasis on gastroenterology and oncology supportive care. Flagship products are Florastor®, the #1 selling probiotic worldwide, and Totect®, the only treatment approved by the FDA for anthracycline extravasation in chemotherapy. Biocodex USA is a subsidiary of Biocodex, a family-owned multinational pharmaceutical, research, development, manufacturing and commercial enterprise operating in more than 100 countries. Visit www.biocodex.us for more information.