Ark Therapeutics Grp AKT Interim Management Statement

  Ark Therapeutics Grp (AKT) - Interim Management Statement

RNS Number : 6044Q
Ark Therapeutics Group PLC
08 November 2012




                          Ark Therapeutics Group plc

                                      

                         Interim Management Statement

                                      

8 November 2012 -  Ark Therapeutics Group plc  ("Ark" or the "Company")  today 
publishes its interim management statement for the period from 1 July 2012  to 
date. 



Highlights



Corporate



· Dr David Venables appointed  to the Board in  April 2012 and as  Chief 
Executive Officer on 1 August 2012 following Martyn Williams' resignation as a
Director and Chief Executive Officer on 31 July 2012



Manufacturing



·  Notice  of   award  of  Australian   patent  for  Ark's   proprietary 
Baculo-Lenti manufacturing process received in July 2012



· Manufacturing partnership  entered into with  a leading European  gene 
therapy company in July 2012



· Letter of Intent signed in August 2012 with EMD Millipore Corporation,
USA ("EMD  Millipore") to  enter  into a  collaborative agreement  to  jointly 
develop bioprocessing capabilities



·  Continued   success  of   manufacturing  partnership   with   PsiOxus 
Therapeutics Ltd ("PsiOxus") announced in September 2012



· Manufacturing agreement signed in  October 2012 with Laurantis  Pharma 
Oy ("Laurantis") for the production of Lymfactin™



Pre-clinical



· Notice of allowance  of US patent for  arginine derivatives with  NP-1 
antagonist activity issued in August 2012



Business Update



Following the appointment of Dr David Venables as Chief Executive Officer on 1
August 2012, the  organisation is  fully focused upon  becoming a  profitable, 
revenue-generating  contract  viral  development  and  manufacturing  services 
business.



We are pleased to report real progress in the delivery of our vision to become
a leading  contract  development  and manufacturing  partner  for  viral  drug 
development. In July  we announced that  we had entered  into a  manufacturing 
partnership  with  a   leading  European  gene   therapy  company  to   supply 
manufacturing and development services in respect of the partner's therapeutic
vaccine  product.  As  well  as  providing  state-of-the  art   manufacturing 
capabilities at our GMP manufacturing facility in Kuopio, Finland we are  able 
to bring  our  partner  the  benefit  of  our  own  experience  in  developing 
adenoviral-based medicines.  This  substantive partnership  provides  further 
validation of the strong  scientific and technological capabilities  available 
at Ark.



In August we announced that we had signed a non-binding letter of intent  with 
EMD Millipore  to enter  into  a collaborative  agreement to  jointly  develop 
bioprocessing capabilities.  Key  elements  of  the  collaboration  focus  on 
production optimisation of viral based  bioengineered vaccines and other  live 
viral products for pilot  and production scale and  the installation of  these 
processes at our manufacturing facility  in Kuopio. Additionally, the  parties 
plan to establish a GMP BSL-2 suite  in the Kuopio facility equipped with  EMD 
Millipore's process  technology  to enable  Ark's  wider routine  use  of  EMD 
Millipore process technology in its manufacturing services business.



In  September  we  were  delighted  to  report  that,  under  the  partnership 
arrangement with  PsiOxus announced  in September  2011, we  had  successfully 
completed the cGMP manufacture and release of drug product to PsiOxus for  use 
in a Phase I  clinical trial of the  oncolytic vaccine ColoAd1. The  material 
was manufactured under stringent timelines using Ark's proprietary  suspension 
based single use process ("ATOSUS") and, by using this proprietary  production 
platform, manufacture of toxicology material followed by clinical material  of 
the required  product quality  was achieved  within less  than twelve  months, 
saving significant time  from the  typical CMC  development and  manufacturing 
timelines.



In October we announced that Ark  had been selected to manufacture and  supply 
Lymfactin^TM to Laurantis  under a  conditional agreement.  The agreement  is 
subject to Laurantis  receiving regulatory  approval to commence  its Phase  I 
clinical trial. Lymfactin^TM  uses an adenoviral  vector to deliver  vascular 
endothelial growth factor  (VEGF-C) during transplantation  of lymph nodes  in 
order to avoid lymphedema. Ark has worked in close partnership with Laurantis
since 2009 in the development of this exciting research programme,  commencing 
with the preparation and provision of the CMC dossier, and are delighted  that 
Laurantis has chosen Ark as its  preferred manufacturer of the first  clinical 
batch of  Lymfactin™. This  is  further validation  of Ark's  unique  complete 
manufacturing service and clear demonstration of its full understanding of the
regulatory process for bio-therapeutics development.



In line with the implementation of our strategic plan we aim to secure further
high quality development and manufacturing contracts and partnerships and have
identified and  generated an  increasing  number of  leads to  supplement  our 
growing order book.



Development Programmes



We have implemented our objective of stopping all funding of in-house  product 
development whilst  continuing  to seek  external  partners. We  are  actively 
engaging in discussions with other companies for potential partnership on  our 
early and late-stage development programmes, including Cerepro®, NRP-1 and our
VEGF-D programme in fetal growth retardation.



Board and Management



As reported in our interim  results on 29 August  2012, Dr David Venables  was 
appointed to the  Board in  April 2012  and as  Chief Executive  Officer on  1 
August 2012 following  Martyn Williams'  resignation as a  Director and  Chief 
Executive Officer on 31 July 2012.



Cash



As we  reported  in  our  interim  results, the  Company  had  cash  and  cash 
equivalents of £4.9m at 30 June 2012. The Board continues to review  detailed 
cash forecasts on a regular basis.



As a result of the cost saving initiatives reported in our interim results  we 
have reduced  staff numbers  and  closed down  a  number of  non-core  product 
initiatives. The  Board expects  that these  initiatives will  result in  cost 
savings of approximately £2m on an annualised basis.





Dr David Venables, CEO of Ark, commented:



"I am  deeply  encouraged by  the  progress we  have  made since  the  Company 
transitioned to a services orientated revenue-generating business earlier this
year and would  like to  thank management,  staff and  shareholders for  their 
continued support of our new business model."





Enquiries



Ark Therapeutics Group plc                 Tel: +44 (0)20 7388 7722
Dr David Venables, Chief Executive Officer
Iain Ross, Executive Chairman
FTI Consulting, Inc.                       Tel: +44 (0)20 7831 3113
Ben Atwell/Susan Stuart

Ark Therapeutics Group plc



Ark Therapeutics  Group  plc  is  a leading  viral  product  focused  contract 
development  and  manufacturing  services   company  with  world-class   viral 
research, development and GMP manufacturing operations in Finland and the  UK. 
Ark's business model  is to  offer product development  and GMP  manufacturing 
contract services for viral  products, including the  areas of viral  mediated 
gene therapy, oncolytic  viral vaccines, live  and attenuated viral  vaccines, 
viral vectored vaccines and virus like particles. Ark's capabilities span from
translational research through preclinical  and clinical product  development, 
in addition to process and analytical development, GMP manufacture and sterile
filling  from  pre-clinical  through  to  commercial  product  supply.   These 
capabilities have  been  established  through the  development  of  Ark's  own 
products through to  Marketing Authorisation Application  registered with  the 
European Medicines Agency. Following  a change in  business strategy in  2011, 
Ark  is  now   building  its   business  through   contract  development   and 
manufacturing services  and  is seeking  external  partners to  advance  those 
products it previously had under development.



Ark's shares were  first listed  on the London  Stock Exchange  in March  2004 
(AKT.L).





This announcement  includes  "forward-looking statements"  which  include  all 
statements other  than  statements  of historical  facts,  including,  without 
limitation, those regarding the Group's financial position, business strategy,
plans  and  objectives   of  management  for   future  operations   (including 
development  plans  and  objectives  relating  to  the  Group's  products  and 
services), and  any  statements  preceded  by, followed  by  or  that  include 
forward-looking  terminology  such   as  the   words  "targets",   "believes", 
"estimates",   "expects",   "aims",    "intends",   "will",   "can",    "may", 
"anticipates", "would",  "should",  "could"  or  similar  expressions  or  the 
negative thereof. Such  forward-looking statements involve  known and  unknown 
risks, uncertainties and  other important factors  beyond the Group's  control 
that could cause the actual results, performance or achievements of the  Group 
to be materially  different from future  results, performance or  achievements 
expressed or implied by such forward-looking statements. Such  forward-looking 
statements are based on numerous assumptions regarding the Group's present and
future business strategies and the environment in which the Group will operate
in the future. Among the important factors that could cause the Group's actual
results, performance  or  achievements  to differ  materially  from  those  in 
forward-looking  statements   include   those  relating   to   Ark's   funding 
requirements,  regulatory  approvals,  clinical  trials,  reliance  on   third 
parties,  intellectual  property,  key  personnel  and  other  factors.  These 
forward-looking statements speak only as at the date of this announcement. The
Group expressly disclaims  any obligation  or undertaking  to disseminate  any 
updates or  revisions  to any  forward-looking  statements contained  in  this 
announcement to reflect  any change  in the Group's  expectations with  regard 
thereto or any change in events, conditions or circumstances on which any such
statements are based. As a result of these factors, readers are cautioned  not 
to rely on any forward-looking statement.



                     This information is provided by RNS
           The company news service from the London Stock Exchange

END


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