RNS Number : 6733X
Alizyme PLC
27 June 2008
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 EUR42.75 million (US$67.0
million)
- EUR2.0 million payable immediately
- EUR40.75 million payable on future development and sales milestones
* Double digit royalty rates that increase with higher annual net sales levels
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 EUR2.0
million, followed by additional payments of up to
EUR40.75 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 moderate*to*severe 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
5*ASA 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:
*We are delighted to enter into this agreement with Norgine for the commercialisation of
COLAL*PRED®. We believe that Norgine, with its
focus on gastroenterology and a strong and balanced pan-European presence, is uniquely
positioned to maximise the commercial potential of
COLAL*PRED® in Europe as well as in the other territories included in this deal.*
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:
Alizyme plc Tel: + 44 (0) 1223 896000
Tim McCarthy, Chief
Executive Officer
David Campbell, Finance
Director
UK/Europe Enquiries
Buchanan Communications Tel: + 44 (0) 20 7466 5000
Lisa Baderoon + 44 (0) 7721 413 496
Rebecca Skye Dietrich
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 EUR220 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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