Clinigen signs agreement with BioQ Pharma

15 December 2016

CLINIGEN GROUP PLC

Clinigen signs Global Access agreement for BioQ Pharma's post-operative pain management product, Ropivacaine Readyfusor

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 a supply and distribution agreement with BioQ Pharma, a developer of large volume ready-to-use infusible products. The deal covers the on-demand supply and distribution of BioQ Pharma's pre-filled Ropivacaine Readyfusor for post-operative pain management in Europe, excluding France and Germany.

Under the terms of the agreement, Idis GA will make the Ropivacaine Readyfusor available, prior to it receiving its national marketing authorisation, on an exclusive on-demand basis to physicians and pharmacists in the UK. Idis GA will also supply the product to other European territories prior to approval and will manage distribution to provide ethical access to the product.

The Ropivacaine Readyfusor is a disposable, single use infusion product which is pre-filled by the manufacturer with 0.2% Ropivacaine, a non-narcotic local anaesthetic. It is a self-contained drug and administration system for delivery at the point of care, activated by a single touch. The Ropivacaine Readyfusor contains a sterile drug that is hermetically sealed until time of use.

The ready-to-use product delivers Ropivacaine at a pre-determined rate to provide pain control for at least 48 hours after surgery.

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

"As the global leaders in providing trusted, ethical access to unlicensed medicines, this agreement means that we can enable healthcare professionals to access the Ropivacaine Readyfusor on-demand for their patients.

"This partnership with BioQ Pharma marks another important supply agreement for Idis GA. It demonstrates the continuing demand from pharmacists and physicians for a compliant route to obtain medicines that are unlicensed or unavailable in their country. There is also an increase in engagement from manufacturers to work with us to help provide continuous access to their products, to better serve patients with unmet medical needs."

Walter Cleymans, Vice President of Europe of BioQ said:

"We are pleased to make Ropivacaine Readyfusor available to patients in Europe with the assistance of Idis GA. The Readyfusor is intended to provide effective pain relief following surgery, while providing a convenient, self-contained, and ready-to-use presentation that should reduce the number of steps needed to administer the drug to the patient."

The Ropivacaine Readyfusor comes completely ready-to-use from the manufacturer, it is intended to help avoid filling errors and breaches in sterility often associated with conventional elastomeric "pain pumps". The Ropivacaine Readyfusor's proprietary design precludes the risk of overdosing due to delivery malfunctions. The product should be prescribed post-surgically for medically appropriate procedures that require at least 48 hours of pain relief. Ropivacaine can be administered as a continuous surgical site infusion or continuous peripheral nerve block.

Healthcare professionals can obtain details about the Ropivacaine Readyfusor pre-filled infusion product by emailing [email protected].

- Ends-

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.

About BioQ Pharma

BioQ Pharma Incorporated is a privately held specialty pharmaceutical company focused on developing and commercializing ready-to-use infusible pharmaceuticals. The Company's infusion platform is intended to address some of the most pressing unmet needs in drug infusion today: cost, medication error, sterility, efficiency, and patient quality of life. BioQ Pharma's objective is to set a new standard of care in the presentation and administration of infusible pharmaceuticals via the Company's proprietary unit-dose infusion systems that can be deployed quickly and conveniently at the point of care with one touch. The Company is ISO13485 certified. BioQ Pharma's existing commercial collaborators and strategic partners include Novartis' Sandoz unit, Cipla, Lee's Pharm, Galen Limited, Lunatus and West Pharmaceutical Services.