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THE MEDICAL HOUSE PLC


NHS Drug Tariff approval for first needle free insulin delivery system – the mhi-500 needle free injection device designed and manufactured by The Medical House PLC

NHS provides alternative method of injection of insulin for people with diabetes


The Medical House PLC (“TMH”) the Medical Devices and Equipment Company, announces formal approval has been received from the PPA (Prescription Pricing Authority) for the admission of its needle free insulin injection system (mhi-500) for people with diabetes to the Drug Tariff, which is expected to be effective from 1st January 2003.

This is a significant milestone now making the mhi-500 available free of charge on a prescription basis to the more than 500,000 people with diabetes in the UK who inject insulin daily. Until now only needle-based systems have been on Drug Tariff. The mhi-500 device is the first needle free injection system for liquid pharmaceuticals to be available on the Drug Tariff.

This represents a substantial achievement by TMH and rewards all the investment and efforts made over the last nine months. During that time TMH have had to demonstrate that the mhi-500 provided a safe and cost-effective alternative to traditional methods of injecting insulin. The device also reduces the risk of needlestick injuries and no specific precautionary measures are required for the disposal of consumables.

The mhi-500 has been available on a private basis direct from TMH since receiving CE Mark approval in December 2001. The cost of the device to an individual was £120 with a further £72 per annum being required to pay for consumables. These costs will now be borne by the NHS. TMH will receive broadly similar revenues per unit and will incur a small increase in overheads to reflect higher distribution costs.

TMH is the only supplier to have a needle free insulin delivery system available through the NHS on a free of charge basis, and although take up may be progressive this announcement is expected to have a major impact as needle-wary patients take advantage of an alternative to needles for the first time. In the first instance those patients who have to move to an injection-based treatment from an oral or dietary regime, estimated to be up to 50,000 people a year, will be an obvious initial target market.

Ian Townsend, Chief Executive commented:

“This is a major landmark in the development of our drug delivery business by becoming the first supplier of needle free injection devices on the Drug Tariff and it endorses our ability to produce high quality delivery systems on a cost effective basis.

“We see that this gives TMH a major boost to expand our position initially in the UK diabetes market, which can then be progressed throughout Europe. In Europe it is estimated that there are currently around 35 million people with diabetes.

“We expect this decision to enhance our growing credibility and reputation in the worldwide market as an important supplier of drug delivery systems. We would look to build on our announcement in June 2002 of the exclusive agreement with BioPartners GmbH to develop a needle free system for the delivery of Human Growth Hormone.

“On a personal note, I am particularly pleased as admission of the mhi-500 to the Drug Tariff not only benefits TMH but also the growing number of people who suffer from diabetes, as well as the NHS who have recognised the cost savings and the reduction in needlestick injuries which can ensue from use of this system.”

Debbie Hammond, Care Advisor, Diabetes UK commented:

“There are over half a million people with diabetes on insulin in the UK. Needle free devices for insulin administration may be a useful alternative for people who are uncomfortable with needles and traditional methods of injecting. Diabetes UK welcomes any developments which offer people with diabetes further options for treatment of their condition.”

13 November 2002

Enquiries
The Medical House PLC Tel: 0114 261 9011
Ian Townsend, Chief Executive www.themedicalhouse.com
College Hill Tel: 020 7457 2020
Nicholas Nelson nicholas.nelson@collegehill.com

Notes for editors

The Medical House ("TMH"), quoted on AIM, specialises in the design, manufacture and distribution of medical devices and equipment. Its operations include: Eurocut, a company specialising in the design, development and manufacture of instruments for use in orthopaedic surgery; Creative Medical Design, a leading designer of medical devices and manufacturer of prototypes; and Medical House Products which undertakes the development and subsequent sale of medical devices.

In April 2001, TMH signed an exclusive distribution licence with Bioject Medical Technologies Inc, a US needle free drug delivery company. Under the terms of this agreement, TMH was granted exclusive rights, for an initial five-year term, for the distribution of The Vitajet, a needle-free injection system for the delivery of insulin in the UK, continental Europe and Egypt.

Bioject also selected TMH as its development partner for a second generation of the Vitajet, the mhi-500. Although IPR is shared jointly, TMH has an exclusive licence in perpetuity for the mhi-500 in Europe. The mhi-500 was awarded the CE Mark in December 2001 and deliveries of the device commenced in January 2002.

In June 2002, TMH signed an exclusive agreement with BioPartners GmbH, the Swiss-based international biopharmaceutical company, for the development of a needle free injection system for the delivery of hGH. The device, which is based on new proprietary technology developed by TMH, will initially be designed for the delivery of hGH on a daily basis to both children and adults. It is anticipated that the device will also be available, in due course, for the delivery of various other pharmaceutical products, including insulin, interferons and heparin.


Background

Insulin: The number of people with diabetes and injecting insulin around the world is rising; it is currently estimated 150 million people in the world have diabetes. The World Health Organisation believes that in a decade that number will grow to more than 250 million. In Europe there are currently around 35 million cases of diabetes.a

hGH: is known to act upon many aspects of cellular metabolism, but its most obvious effect is the stimulation of the growth of cartilage and bone in children. hGH has also been used with some success to combat the weight loss and general wasting characteristic of AIDS and cancer.

Interferons: are groups of proteins produced by the body that attack viruses. Interferons used as drugs include alpha-interferon, for hepatitis B and C, human papillomavirus, hairy-cell leukemia, and Kaposi's sarcoma (a cancer associated with AIDS), and beta-interferon, for multiple sclerosis.

Heparin: is an anticoagulant which is extracted from animal tissues and used clinically to delay blood clotting.

BioPartners: is an international biopharmaceutical company based in Switzerland. BioPartners has the expertise, experience and resource to provide the biopharmaceutical industry with consultancy and execution on a global scale. The core areas of service and expertise provided by BioPartners are: production, clinical development, regulatory strategy, marketing / sales and distribution.

For further information, please visit: www.biopartners.ch

 


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