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Medical House PLC (MLH)

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Thursday 09 October, 2008

Medical House PLC

FDA Approval

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 UFood 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

Richard Potts / Wolf Dornbusch

tel: 020 7776 1200


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 €147 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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