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Immediate Release |
27 June 2008 |
Please be aware that they will be an analyst meeting commencing at 11am at the offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE where Tim McCarthy, Chief Executive Officer of Alizyme and Peter Stein, Chief Executive Officer of Norgine will be presenting. Simultaneously to the Analyst meeting there will be a webcast to connect to the webcast please follow the link below
http://mediaserve.buchanan.uk.com/webcasts/livegold/lrframes.htm
ALIZYME PLC
ALIZYME LICENSES COLAL-PRED® TO NORGINE
FOR EUROPE AND OTHER TERRITORIES
Cambridge UK, 27 June 2008: Alizyme plc (LSE: AZM) ("Alizyme") announces that its wholly owned subsidiary, Alizyme Therapeutics Limited, has granted an exclusive licence to Norgine B.V. ("Norgine"), an independent specialty pharmaceutical company, for the rights to COLAL-PRED® for the treatment and/or alleviation of the symptoms of ulcerative colitis in Europe, South Africa, Australia and New Zealand.
Highlights
Norgine is a leading European specialty pharmaceutical company with a focus on gastroenterology
Exclusive licence agreement for COLAL-PRED® in Europe, South Africa, Australia and New Zealand
Upfront payment and development and sales milestones worth €42.75 million (US$67.0 million)
- €2.0 million payable immediately
- €40.75 million payable on future development and sales milestones
Under the terms of the agreement, Norgine is granted an exclusive licence to develop and market COLAL-PRED® in Europe, South Africa, Australia and New Zealand. Alizyme will immediately receive an upfront payment of €2.0 million, followed by additional payments of up to €40.75 million on the achievement of future development and sales milestones. Norgine will be responsible for all commercialisation costs and will pay double digit royalty rates to Alizyme that increase with higher annual net sales levels.
In January 2008, Alizyme announced the completion of patient recruitment into the European pivotal registration Phase III trial of COLAL-PRED® in patients with active moderateߛtoߛsevere ulcerative colitis. Headline trial results are expected to be reported in July 2008.
Ulcerative colitis is an inflammatory disease of the colon that causes symptoms such as abdominal pain, bleeding, cramping, fatigue and diarrhoea. These conditions are characterised by episodes of acute flare of the inflammation, followed by periods of remission. In severe cases, surgery may be required to remove the diseased tissue.
The ulcerative colitis market is currently dominated by anti-inflammatory steroids and 5ߛASA products, which have safety and/or efficacy issues. COLAL-PRED® is the combination of Alizyme's proprietary colonic drug delivery system, COLAL®, and prednisolone metasulfobenzoate sodium ("PMSBS"), an approved steroid in Europe. COLAL-PRED® has a coating that is broken down only in the colon, by locally occurring bacteria. This leads to topical delivery of PMSBS to the colon, rather than systemic delivery. It has been shown in a Phase II clinical trial to provide levels of efficacy comparable to that reported for conventional oral prednisolone, but without the debilitating side effects usually associated with steroids.
Currently around 2 million people in the major pharmaceutical territories around the world suffer from ulcerative colitis with projected sales of COLAL-PRED® in these territories in excess of US$250 million per annum.
Ferghana Partners Group acted as exclusive transaction advisor to Alizyme in relation to the agreement.
Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive Officer said:
Commenting on today's announcement, Peter Stein, Chief Executive Officer of Norgine said:
"We are excited to have entered into this partnership with Alizyme. COLAL-PRED® is a therapeutically and commercially attractive late stage development product that complements and strengthens our portfolio of marketed pharmaceutical therapies addressing gastrointestinal disorders."
For further information, please contact:
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Alizyme plc Tim McCarthy, Chief Executive Officer David Campbell, Finance Director |
Tel: + 44 (0) 1223 896000 |
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UK/Europe Enquiries Buchanan Communications Lisa Baderoon Rebecca Skye Dietrich |
Tel: + 44 (0) 20 7466 5000 + 44 (0) 7721 413 496 |
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US Enquiries Trout Group Tim Ryan Lee Stern |
Tel: + 1 (646) 378 2924 Tel: + 1 (646) 378 2922 |
Further information on Alizyme can be found on the Company's website at www.alizyme.com.
Notes to editor
Alizyme plc
Alizyme is a speciality biopharmaceutical development company, focused on the therapeutic areas of metabolic
disorders, gastrointestinal disorders and cancer supportive care. In addition to COLAL-PRED® it is developing cetilistat for the treatment and management of obesity and related diseases, such as type 2 diabetes and ATL-104 for mucositis, a side effect of cancer therapy.
Norgine B.V.
Norgine is an independent, successful pan-European specialty pharmaceutical company that has been established for over 100 years and has a presence in all the major European markets. In 2007 Norgine's sales were €220 million, the 21st consecutive year of double-digit growth. The company employs over 1,000 people, of whom 350 are in sales and marketing.
Norgine's current focus is on pharmaceutical products that address significant unmet clinical need in areas such as gastroenterology, hepatology and pain management. The company currently markets a range of products in its key
therapeutic areas e.g. MOVICOL® for the treatment of chronic constipation and faecal impaction, MOVIPREP® a new
generation bowel cleansing preparation, KLEAN-PREP® for bowel preparation prior to colonoscopy, and ORAMORPH® for the treatment of moderate to severe pain associated with cancer.
Further information on Norgine can be found on their website at www.norgine.com.
COLAL-PRED®
COLAL-PRED® is a proprietary gastrointestinal product developed by Alizyme for the treatment of ulcerative colitis. It is the combination of Alizyme's proprietary colonic drug delivery system, COLAL®, and prednisolone metasulfobenzoate sodium ("PMSBS"), an approved steroid in Europe.
COLAL-PRED® has a coating that is broken down only in the colon, by locally occurring bacteria. This leads to topical delivery of PMSBS to the colon, rather than systemic delivery. It has been shown in a Phase II clinical trial to provide levels of efficacy comparable to that reported for conventional oral prednisolone, but without the debilitating side effects usually associated with steroids.
COLAL®
COLAL® is a drug delivery technology that enables drugs to be taken orally and then be specifically released when the preparation reaches the colon. Achieving colonic release with conventional oral dosage forms has proved difficult because of the variation between individuals in transit times and conditions within the gastrointestinal tract. COLAL® overcomes this difficulty by covering small pellets containing the drug with a coating of ethylcellulose and a specific form of amylose (derived from starch). This coating prevents drug release in the stomach and small intestine. When the pellets reach the colon the amylose in the coating is broken down by bacterial enzymes and the drug is released.
Ferghana Partners Group
Ferghana Partners Group (New York, Boston, London and Australia) is a specialist investment bank which provides high level, independent corporate finance advice to firms in the life sciences field.
(Note: COLAL® and COLAL-PRED® are registered trademarks of Alizyme Therapeutics Limited)
The identification of compounds for successful research, their progress through development and the obtaining of regulatory approvals or authorisations before marketing, manufacture and/or distribution of products is not certain or a formality.