Press Releases
Interim Management Statement
Dated: Tuesday 19 May 2009
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 £2.2 million at 31 December 2008. Subsequently, in Q1 2009, an R&D tax credit of £1.4 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
Tim McCarthy, Chief Executive Officer
Tel: + 44 (0) 1223 896000
BUCHANAN COMMUNICATIONS
Lisa Baderoon
Rebecca Skye Dietrich
Tel: + 44 (0) 20 7466 5000
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

