US Patent for Autoinjector


 

TIDMMLH 
 
RNS Number : 6590Y 
Medical House PLC 
08 September 2009 
 

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| For Immediate Release               |                   8 September 2009 | 
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The Medical House PLC 
 
 
 US Patent Applications for ASITM Autoinjector Technology 
Notices of Allowance 
 
 
The Medical House PLC ("TMH" or the "Company")(AIM:MLH), the drug delivery 
specialist, is pleased to announce that it has now received its first two 
Notices of Allowance from the US Patent and Trade Mark Office in respect of 
patents relating to its ASITM autoinjector device technology. 
 
 
Ian Townsend, Chairman, The Medical House PLC, said: 
"These are extremely significant milestones for our company as successful US 
patent applications underpin our ability to out-license our ASITM autoinjector 
technology to our international client base. These patent approvals increase the 
likelihood of signing further licensing agreements for this key self-injection 
technology." 
 
 
On 12 August TMH announced that it had received an approach which may or may not 
lead to an offer for the Company. A further announcement will be made in due 
course. 
 
 
Notes to Editors 
 
 
Brief description of ASITM 
 
 
The ASITM autoinjector technology enables patients to undertake a completely 
automated injection, including needle insertion and medication injection to 
needle withdrawal and safe retraction back into the device. When the injection 
is completed, the entire device unit is disposable. With an ASITM autoinjector 
device, patients never see or handle a needle, thereby reducing the anxiety that 
many people have about self-injection and eliminating the risk of accidental 
needlestick injuries. 
 
 
About The Medical House below provides greater details on its products and 
business. 
 
 
Summary of ASITM  Commercialisation Agreements 
 
 
TMH has signed licensing partnerships for the ASITM autoinjector platform with 
Dr. Reddy's Laboratories Ltd. (RDY-NYSE), Catalent Pharma Solutions, Inc. and 
Stallergenes SA (GENP-EPA), together with an undisclosed global pharmaceutical 
partner that licensed the ASITM autoinjector system . 
 
 
-Ends- 
 
 
For further information: 
 
 
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| The Medical House PLC                         |      tel: 0114 261 9011 | 
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| Ian Townsend, Chairman                        | www.themedicalhouse.com | 
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| Bryan Bodek Deputy Chairman                   |                         | 
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|                                               |                         | 
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| Buchanan Communications                       |      Tel: 0207 466 5000 | 
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| Tim Anderson / Stasa Filiplic                 |                         | 
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|                                               |                         | 
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| NomuraCode Securities                         |      tel: 020 7776 1200 | 
| Richard Potts / Wolf Dornbusch                |                         | 
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|                                               |                         | 
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| FinnCap                                       |                         | 
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| Stephen Norcross                              |      Tel: 020 3207 3211 | 
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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. 
 
 
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. TMH recently 
commenced work on the pre-commercial phase of the agreement's development 
programme 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 
   END 
 
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