AZM Alizyme

 

TIDMAZM 
 
RNS Number : 4608S 
Alizyme PLC 
19 May 2009 
 

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| 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               |                                     | 
|                                     |                                     | 
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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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