Development, Licence and Supply Deal with Catalent and Stallergenes
The Medical House PLC (“TMH”)(AIM:MLH) the drug delivery specialist, is pleased to announce that its is has signed a non-exclusive development, licensing and supply agreement (“Agreement”) with Catalent, the global pharmaceutical service provider with whom TMH signed a marketing collaboration agreement in 2007.
Under the terms of the 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.
The epinephrine autoinjectors are designed for emergency treatment of anaphylactic shock, mostly due to hymenoptera venom or food allergies and for the use by the patients themselves, or by a person close to a 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.
Ian Townsend, Chairman, The Medical House PLC, said:
“We are delighted to have reached this agreement with Catalent and Stallergenes and believe there is tremendous potential for all three parties to prosper from this collaboration. This follows on from the agreement recently signed with Dr Reddy’s and continues the expansion of our income streams from our ASI disposable autoinjector technology.”
Richard Yarwood Group President of Catalent’s Sterile TechnologiesDivision said:
" Catalent is pleased to combine its long-standing experience in product development with The Medical House’s leading-edge technologies.”
Albert Saporta Chairman and CEO of Stallergenes said:
“This agreement with Catalent and The Medical House fits perfectly with our product portfolio offered to allergy specialists and with our philosophy regarding state of the art in licensed complementary products. We expect the European markets to double in size in the coming years. Furthermore this agreement represents a unique opportunity for Stallergenes to set up its own commercial operation in the UK in the near future. This market accounts for 50% of the European market.”
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For further information:
The Medical House PLC | tel: 0114 261 9011 |
Ian Townsend, Chairman | |
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NomuraCode Securities | tel: 020 7776 1200 |
About Anaphylactic shock
Anaphylactic shock is a severe life-threatening reaction that can affect all age groups, leading to uticaria and angioedema, bronchoconstriction and hypotension. Mediator release results in smooth muscle contraction, vasodilation and increased vascular permeability. Intramuscular adrenaline (epinephrine) is a vasoconstrictor, the first line treatment for anaphylactic shock for patient self-administration. Any patient with a severe systemic allergic reaction should be considered for adrenaline self-injection.
About Stallergenes
Stallergenes is a European biopharmaceutical laboratory dedicated to desensitisation therapies for the prevention and treatment of allergy related respiratory conditions, e.g. rhino-conjunctivitis and allergic asthma. A pioneer and leader in sublingual desensitisation treatments, Stallergenes dedicates 18% of its sales to Research and Development and is fully involved in the development of a new therapeutic range, sublingual desensitisation tablets.
Stallergenes is listed in Euronext Paris.
Additional information is available at www.stallergenes.com
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 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.
Publish Date: Tuesday, October 07, 2008