CSRT.L Regulatory News (CSRT)

Consort Medical plc

19 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."

The full text of the UCB announcement is reproduced below:

UCB receives positive EU CHMP opinion for CIMZIA® (certolizumab pegol) AutoClicks® Prefilled Pen

Brussels, Belgium - September 19, 2016 - UCB has announced 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.

"At UCB, we have made it a priority to develop a true understanding of the real world challenges for people living with severe rheumatologic conditions and to determine the best solutions. The availability of the AutoClicks® Prefilled Pen will allow us to provide different administration options for patients treated with CIMZIA®. Patients have personal preferences for self-injection devices depending on their experience and individual needs, so having a pen and syringe will better support patients," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB.

UCB is committed to providing value to patients and meeting their unique needs. As part of this commitment, UCB continued its partnership with OXO®, a company known for its smart, consumer friendly designs, to develop the AutoClicks® Pen, based on core technology licensed from Bespak. The AutoClicks® Pen provides a button-free delivery system and a wide non-slip grip that keeps patient hand disability in mind. It has a large viewing window that shows the progress of the injection and it makes a clicking noise at the start of the injection and again when the injection is complete, giving patients confidence to know they have received their full dose of CIMZIA®.

Research was conducted to ensure that the AutoClicks® Pen would meet the needs of patients living with autoimmune diseases like rheumatoid arthritis. In a comparative usability study with 76 moderate to severe rheumatoid arthritis (RA) patients simulating an injection using an injection pad, the RA patients gave the highest rankings to the AutoClicks® Pen as the most preferred pen. Patients in the study also evaluated the AutoClicks® Pen on a seven point scale for its ease of use and their willingness to use it in the future, giving it the highest score on the scale compared to Enbrel® (etanercept), Humira® (adalimumab) and Simponi® (golimumab) anti-TNF pens (p˂0.05).2 The patients in the study had no prior experience using an anti-TNF pen. All identification was removed from the pen devices and the instructions for use. Devices tested at time of study were approved for use in the UK.1

- ENDS -

Enquiries:

Consort Medical plc is a leading, global, single source drug and delivery device company (CDMO). We are at the leading edge of innovation and we are committed to investing in patient, clinician and customer driven innovation to create new treatments, new markets and new opportunities.

Our businesses

Bespak is a global market leader in the manufacture of drug delivery devices for pharmaceutical partner companies, including respiratory, nasal, and injectable products, and the manufacture of devices for the point of care diagnostics market. www.bespak.com.

Aesica is a leading provider of finished dose and active pharmaceutical ingredient (API) development and manufacturing services to pharmaceutical partners. www.aesica-pharma.com.

We employ more than 2000 people globally of which 1400 are located in the UK. We have UK facilities in King's Lynn, Cambridge, Nelson, Milton Keynes, Cramlington, Queenborough and Hemel Hempstead, German facilities in Monheim and Zwickau and a facility in Pianezza, Italy. Consort Medical is a public company quoted on the premium list of the London Stock Exchange (LSE: CSRT). www.consortmedical.com.

About CIMZIA®

CIMZIA® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

About CIMZIA® in the EU/EEA

In the EU, CIMZIA® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

CIMZIA® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

CIMZIA®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.3

CIMZIA® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:4

· Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).

· Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.4

For full full safety and prescribing information please consult the document in the following link. European SmPC date of revision 17th December 2015.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

CIMZIA® is a registered trademark of the UCB Group of Companies.

REFERENCES

1. UCB. Data on file (Comparative Usability and Validation Study for CIMZIA® pre-filled pen - Study Report, Sections 8.2.1.1, 8.2.2.4, and 8.2.2.5). 2013.

2. Domanska B et al. Ann Rheum Dis. 2016;75(Suppl2):1002. Abstract AB0300

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news