Clinigen to distribute BioQ Pharma’s pain relief drug in Europe

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.

Clinigen chief commercial officer (North America and Europe) Steve Glass 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.”

BioQ Europe vice president Walter Cleymans 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.