The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the use of UCB’s CIMZIA® AutoClicks® Prefilled Pen, which is based on core technology licensed from Bespak, in all approved indications.
- This is the first disposable autoinjector approved for use in Europe for a biologic that incorporates Bespak’s proprietary delivery technology
- The underlying Bespak technology enables the delivery of highly viscous biotherapeutics in a safe, easy-to-use, and convenient manner to patients
- This represents the first application of Bespak’s autoinjector technology to the fast growing area of biologics
For more information, please contact:
Dr Lynne Trowbridge / Samantha Cheung / Alex Bannister
T 0207 457 2825
Consort Medical plc
19th September 2016
UCB Receives EMA Regulatory Approval for Pre-filled Pen with Core Bespak Technology
Consort Medical plc (“Consort Medical”, “Consort” or the “Group”) (LSE: CSRT), notes the announcement from UCB that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the use of CIMZIA® AutoClicks® Prefilled Pen in all approved indications. The positive opinion was based on validated data and risk benefit analysis for the AutoClicks® Pen.
The AutoClicks® Pen is based on core technology licensed from Bespak, a Consort subsidiary and an established global market leader in the manufacture of drug delivery devices for pharmaceutical partner companies. This development programme, referred to as INJ570 in the Consort development portfolio, follows the successful approval, launch, and commercialisation of INJ300 for Dr. Reddy’s Sumatriptan autoinjector in 2014.
It is currently expected INJ570 will contribute to the underpinning of the Board’s existing expectations for the Group, which remain unchanged from Consort’s recent AGM Statement published on 7 September 2016.
Jon Glenn, Chief Executive Officer of Consort Medical, commented:
“We are delighted that this sophisticated Autoinjector product, that relies on Bespak technology at its core, has received a positive opinion from the EMA enabling its European roll-out in the very near term. This is another important milestone for Bespak injectable franchise with the approval of our first product into the high value and high growth biologics market.”