MLH Medical House

    RNS Number : 4630F
  Medical House PLC
  09 October 2008
   

 For Immediate Release  9 October 2008

    The Medical House PLC

     FDA Approval


    The Medical House PLC ("TMH")(AIM:MLH) the drug delivery specialist, is pleased to announce that it is has received 510(k) clearance
from the US Food and Drug Administration (FDA) for a variant of TMH's  proprietary disposable AutoSafety Injector (ASI-2) being developed
under its agreement with Dr Reddy's Laboratories. 

    This clearance permits the placing of this device in the US market for assisting the self- administered subcutaneous injection of fixed
doses of non-viscous FDA-approved products which are presented in standard 1ml long pre-filled syringes with staked needles.


    Ian Townsend, Chairman, The Medical House PLC, said: 
    "We are very pleased to be able to announce this approval which augurs well for the future of not only this version of the AutoSafety
Injector being developed for Dr Reddy's but also for future variants of this key platform technology."



    -Ends-



    For further information:

 The Medical House PLC        tel: 0114 261 9011
 Ian Townsend, Chairman  www.themedicalhouse.com

 NomuraCode Securities        tel: 020 7776 1200
 Richard Potts / Wolf
 Dornbusch

    About The Medical House 

    There is a growing trend in the pharmaceutical industry towards the use of disposable autoinjectors, incorporating pre-filled syringes,
which facilitate patient self-injection, as a means of creating competitive advantage for injectable drugs, including a number of
significant new biologic products. TMH's "ASI" disposable autoinjector technology allows injections to be easily and safely undertaken by
patients or by other non-clinicians such as family members and colleagues and are suitable for both elective therapies and emergency
situations.  

    In October 2008 TMH announced a non-exclusive development, licence and supply agreement with Catalent Pharma Solutions and Stallergenes
to develop and distribute a variation of the company's core disposable autoinjector technology for use with epinephrine. Under the terms of
this agreement, TMH will customise its proprietary, patented ASI disposable autoinjector device technology, according to an agreed
specification and will be combined with epinephrine supplied by Catalent to create epinephrine autoinjectors for both adult and paediatric
use.

    These epinephrine autoinjectors are intended for the emergency treatment of anaphylactic shock, mostly due to hymenoptera venom or food
allergies and for the use by patients themselves or by a person close to the patient in the event of an emergency.
    The newly-created product will be distributed exclusively by Stallergenes who are a European biopharmaceutical company, with annual
sales in 2007 of EUR147 million, dedicated to desensitisation therapies for the prevention and treatment of allergy-related conditions. The
Agreement covers 13 European countries, including the United Kingdom and incorporates provision for extension to additional territories.


    In July 2008, TMH announced that it has signed a non-exclusive development, licensing and supply agreement with the global
pharmaceutical company Dr Reddy's Laboratories ("Dr Reddy's"). Under the terms of the Agreement, TMH will customise its proprietary,
patented ASI disposable autoinjector device technology, which will be combined by Dr Reddy's with an undisclosed drug, to create a new
self-injectable product. The Agreement covers an initial 5 year term of supply, within USA, European Union and Canada, with an option for Dr
Reddy's to extend the Agreement to the rest of the world, on mutually agreed terms. The duration of the Agreement may also be extended,
again by mutual agreement. The development costs associated with customisation will be paid to TMH in addition to reimbursement of all
agreed external costs. First commercial supply of the customised ASI device is expected to be in 2009-10 and TMH will receive a technology
access fee during the term of the agreement. TMH's projected income over the first 5 years is estimated at �5m. 

    In November 2007, TMH announced that it has agreed to extend the term of the development, licensing and supply agreement for the ASI
which it signed in December 2006 with a leading global pharmaceutical company. Under new terms, the minimum duration has been increased from
five to six years, with TMH agreeing to a provision for further extension to approximately 16 years. Additionally, TMH's projected revenues
are increased from �27 million to �34 million (of which �23 million is for technology access, or licence, fees). TMH's minimum guaranteed
revenues have also increased to �20.5 million (of which �15 million is in licence fees). TMH is receiving �3 million of
pre-commercialisation licence fees. TMH recently commenced work on the pre-commercial phase of the agreement's development programme and
this will result in additional development monies to TMH of approximately �900,000 over the next 18 months. In March 2008, TMH announced
that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Compact AutoSafety Injector (CASI), which permits the placing of this device in the US market for assisting the
self-administered subcutaneous injection of fixed doses of FDA-approved drug products presented in standard 1ml long pre-filled syringes
with staked needles. The CASI is a version of TMH's ASI disposable autoinjector technology which is being developed for the global
pharmaceutical company which extended their Agreement with TMH in November 2007. In May 2008, TMH announced that its global pharmaceutical
partner had received regulatory approval in one of the principal territories to which the Agreement relates for a drug, a different
formulation of which is in development for use with TMH's technology. 

    Also in November 2007, TMH announced that it has signed a strategic marketing agreement with Catalent Pharma Solutions (formerly the
Pharmaceutical Technologies and Services segment of Cardinal Health, Inc), a leading global provider of advanced technologies and
outsourcing services to pharmaceutical and biotechnology companies. Under the terms of this agreement, the companies will jointly promote
and market TMH's ASI system in combination with Catalent's services and technologies, which include sterile filling of pre-filled syringes.
Catalent offers extensive capabilities for the development, manufacture and packaging of pharmaceutical and biotechnology products, and
brings to the collaboration extensive customer relationships in nearly 100 countries, and an experienced business development team operating
in the world's leading pharmaceutical markets. The companies are also exploring opportunities to jointly develop specific drug & device
combination products, suitable for out-licensing and/or marketing partnerships with pharmaceutical industry partners.

    Additional information is available at www.themedicalhouse.com


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