Interim Management Statement
19 5월 2009 - 3:00PM
UK Regulatory
TIDMAZM
RNS Number : 4608S
Alizyme PLC
19 May 2009
+-------------------------------------+----------------------------------------+
| For Immediate Release | 19 May 2009 |
+-------------------------------------+----------------------------------------+
ALIZYME PLC
INTERIM MANAGEMENT STATEMENT
Cambridge UK, 19 May 2009: Alizyme plc ("Alizyme" or "the Company") (LSE: AZM)
today publishes its Interim Management Statement ("IMS") for the period from 1
January 2009 to 18 May 2009. The IMS provides an update of the Company's
operations for the period.
Operational
Cetilistat (obesity and type 2 diabetes)
Cetilistat is continuing through its Phase III clinical development in Japan
with our partner Takeda Pharmaceutical Company Limited. Details of the study are
available on Takeda's website (see link below).
Cetilistat has successfully completed an extensive Phase I and Phase II clinical
development programme and has been prepared for the commencement of Phase III
development outside of Japan.
Negotiations are progressing with potential partners to license cetilistat for
territories outside of Japan.
COLAL-PRED (ulcerative colitis)
Norgine BV, Alizyme's partner for COLAL-PRED in Europe, South Africa, Australia
and New Zealand, is primarily responsible for further development and submission
of a Marketing Authorisation Application ("MAA") for the EU. The strategy for
the submission of the EU MAA is being progressed with Norgine in conjunction
with ongoing discussions with regulatory authorities.
Prometheus Laboratories Inc, Alizyme's partner for COLAL-PRED in North America,
is progressing a Phase II study in the US, whilst TSD Japan Inc, Alizyme's
partner in Japan, is progressing a Phase I study in Japan. Details of the
Prometheus Phase II study are available at 'www.clinicaltrials.gov' (see link
below).
ATL-104 (mucositis)
Having successfully completed a Phase IIa 'proof of concept' clinical trial in
patients with lymphoma and myeloma, the preparation for a further Phase II
study, this time in head and neck cancer, and the transfer of the recombinant
protein to a large scale manufacturer in advance of Phase III development and
potential commercial supply will continue when financial resources permit.
Financial
The Company had cash, cash equivalents and money market investments of GBP2.2
million at 31 December 2008. Subsequently, in Q1 2009, an R&D tax credit of
GBP1.4 million was received by the Company. Internal overhead costs have been
substantially reduced from previous years, as has external research and
development expenditure. Furthermore, in order to ensure that overall Board
remuneration is in line with the generally reduced costs going forward, in March
2009 the Directors waived one third of their future entitlement to remuneration
and fees, with effect from 1 April 2009. Headcount also reduced from 13 to 11 in
the period.
There remains a material uncertainty over the Company's ability to continue as a
going concern, as previously reported in the 2008 Annual Report, published on 30
April 2009.
Other than disclosed above, there have been no material changes to the financial
position of the Company since 31 December 2008.
Board changes
Roger Lloyd and Richard de Souza were appointed as Non-Executive Directors with
effect from 1 April 2009. At the same time Bill Edge resigned as a Non-Executive
Director. On 23 April 2009 Mr Alan Goodman joined the Board as a Non-Executive
Director and it is intended that he will assume the role of Chairman at the
conclusion of the forthcoming Annual General Meeting, when Sir Brian Richards
will retire as a Director.
Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive
Officer said:
"The year to date has seen our commercial partners progress the clinical
development of our licensed products. We remain focused on the further
commercialisation of our product portfolio."
For further information, please contact:
+-------------------------------------+-------------------------------------+
| ALIZYME PLC | Tel: + 44 (0) 1223 896000 |
| Tim McCarthy, Chief Executive | |
| Officer | |
| | |
+-------------------------------------+-------------------------------------+
| BUCHANAN COMMUNICATIONS | Tel: + 44 (0) 20 7466 5000 |
| Lisa Baderoon | |
| Rebecca Skye Dietrich | |
| | |
+-------------------------------------+-------------------------------------+
This Interim Management Statement is published in accordance with the UK Listing
Authority's Disclosure and Transparency Rules, in respect of the period from 1
January 2009 to 18 May 2009.
Except for the historical information presented, certain matters discussed in
this statement are forward looking statements that are subject to a number of
risks and uncertainties that could cause actual results to differ materially
from results, performance or achievements expressed or implied by such
statements. These risks and uncertainties may be associated with product
discovery and development, including statements regarding the Company's
clinical development programmes, the expected timing of clinical trials
and regulatory filings. Such statements are based on management's
current expectations, but actual results may differ materially.
Further information on Alizyme can be found on the Company's website:
www.alizyme.com
Details of Takeda's Phase III study for cetilistat (ATL-962) can be found at:
http://www.takeda.com/pdf/usr/tosp301/ATL-962_CCT-002_Pr_E_2_962_6.pdf
Details of Prometheus's Phase II study for COLAL-PRED can be found at:
http://www.clinicaltrials.gov/ct2/show/NCT00676832?term=prometheus&rank=8
This information is provided by RNS
The company news service from the London Stock Exchange
END
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