month=07
year=2009
01 July 2009
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For Immediate Release
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1st July 2009
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The
Medical House PLC
Medical
House supplies Merck Serono with new needle-free system for commercial launch
The
Medical House PLC (“TMH”), (AIM:MLH)
the specialist drug delivery company, announces that it has now supplied Merck
Serono, a division of Merck KGaA, Darmstadt, Germany, with an advanced
needle-free jet injector system specifically designed and manufactured to their
specification. The system, known as “cool.click™2” incorporates a number of
features not previously associated with needle-free devices, such as an
innovative dose display. In addition, an enhanced security system allows for
safe injection while the level of noise associated with the injection has been
minimised. Merck Serono will be supplying cool.click™2 to complement its
existing innovative range of devices for self injection of Saizen® [somatropin
(rDNA origin) for injection], the company’s recombinant human growth hormone
indicated for the treatment of growth hormone deficiency in adults and
children, as well as three additional paediatric indications in certain
countries.
Ian
Townsend, Chief Executive, The Medical House PLC, said:
"I
am extremely delighted to report that this new technology is now being launched
commercially; it is the result of a great deal of hard work by the staff at The
Medical House and Merck Serono. I believe that this will prove to be a
significant landmark in the progression of our company as a global player in
the drug delivery market and we look forward to supplying the healthcare
industry with devices and consumables for many years to come."
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Ends -
For further information
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The Medical House PLC
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Ian Townsend, Chief Executive
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Tel: 0114 261 9011
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www.themedicalhouse.com
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Bryan Bodek
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Deputy Chairman
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Tel: 0114 261 9011
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Nomura Code Securities
Richard Potts
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Tel: 020 7776 1200
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Buchanan Communications
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Tim Anderson/Lisa Baderoon/Rebecca Skye
Dietrich
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Tel: 020 7466 5000
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Notes to
Editors:
About
Medical House - Market Background
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 “ASITM”
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 ASITM 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 ASITM 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 ASITM autoinjector 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 ASITM
autoinjector 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’s minimum guaranteed revenues have also
increased to £20.5 million (of which £15 million is projected to be licence
fees). TMH is receiving £3 million of pre-commercialisation licence fees. 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 ASITM disposable
autoinjector technology which is being developed for the global pharmaceutical
company which extended their Agreement with TMH in November 2007. In May 2009, TMH
significantly announced that its global pharmaceutical partner had
received regulatory approval in one of the principal territories to which the
Agreement relates for the drug, 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 ASITM autoinjector 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 other d