BTG partnership extended with new GA agreement

25 October 2016

Clinigen and BTG extend global partnership with new exclusive Global Access agreement

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Idis Global Access (GA) division, has signed an exclusive supply agreement with BTG plc (LSE: BTG), a specialist healthcare company, to manage BTG's critical care portfolio across the whole of Europe and now into new territories in Asia.

This agreement extends the four-year partnership Clinigen has with BTG to provide early access programmes.

The existing partnership focuses on supplying select countries in Europe using a Managed Access programme to enable healthcare professionals to access BTG's antidote products for patients who have no other treatment options available to them.

The new agreement increases the geographic scope of the partnership to include all of Europe, as well as the supply of DigiFab® in the UK on a commercial basis. It also includes some emerging markets in South East Asia.

This extended Global Access partnership builds on Clinigen's international footprint following the acquisition of Link Healthcare in 2015. It will allow more healthcare professionals across the world and in countries not previously covered by Clinigen, to access BTG's critical care medicines on-demand.

The products covered by the partnership are: DigiFab® (digoxin immune fab) an antidote for life-threatening or potentially life-threatening digoxin toxicity or overdose; and Voraxaze® (glucarpidase) an enzyme for the treatment of toxic plasma methotrexate concentrations in the blood, caused by high-dose methotrexate chemotherapy.

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

"This is a notable exclusive supply agreement for Idis GA. It not only expands our existing partnership with BTG but it is also the first agreement that capitalises on the complementary nature of our Managed Access and Global Access divisions. It demonstrates the value of our unique, synergistic businesses which enables us to provide safe and ethical access to a medicine throughout its lifecycle - from development to approval, to launch and beyond.

"The extended partnership enables us to leverage our global expertise and networks to enable physicians to access the right medicine at the right time to better treat their patients."

Healthcare professionals can obtain details about DigiFab and Voraxaze by emailing [email protected].

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About DigiFab®

DigiFab (digoxin immune fab) is indicated for the treatment of known (or strongly suspected) life-threatening digoxin toxicity associated with ventricular arrhythmias or bradyarrhythmias unresponsive to atropine where measures beyond withdrawal of digoxin and correction of serum electrolyte abnormalities are considered necessary.

About Voraxaze®

Voraxaze (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Voraxaze breaks down methotrexate into inactive metabolites which are then eliminated from the body by routes other than the kidney (primarily the liver). Voraxaze is the first and only drug available to reduce toxic plasma methotrexate levels.

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 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