16 March 2006

CE Mark Approval for BioPal® Needle-free Valtropin® Delivery System

The Medical House (TMH) (AIM:MLH) today confirms that the BioPal® needle-free device for delivery of human growth hormone has received CE Mark regulatory approval, enabling this system to be marketed as a medical device within the European Union.

This follows the recent announcement from TMH’s licensee partner for the BioPal® system, BioPartners GmbH, the global biopharmaceutical company, that it has received a positive opinion from the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) for BioPartners’ biosimilar human Growth Hormone product Valtropin®.
TMH and BioPartners signed a 10-year license and supply agreement in February 2005 for the BioPal® needle-free injector, developed under an earlier agreement between the two parties. Sales volumes of needle-free devices give The Medical House a projected income for the 10-year contract of £14 million, of which £3 million relates to the first five years. These figures exclude accessories, such as nozzles and adaptors, which need to be replaced on a regular basis.
The BioPal® is a reusable, spring-powered device for the delivery of Valtropin®. The BioPal® enables a fine stream of Valtropin® to penetrate a patient’s skin without a needle, by utilising a powerful spring and specially-designed precision nozzle. This stream is delivered at a speed which allows it to be deposited in the subcutaneous layer of tissue.

Ian Townsend, Executive Chairman, The Medical House, said:
“Achieving CE Mark approval is a critical step in the development of any medical device technology, as it is a pre-requisite to devices being placed on the market. It is particularly significant that this marketing approval has coincided with the positive opinion which BioPartners’ Valtropin® has received from the European drug regulation agency. This represents a very important milestone in our collaboration with BioPartners and we are now looking forward to the commercial launch of this combined system.”

Jean-Noël Treilles, CEO, BioPartners, said:
“The CE Mark approval granted to BioPal® is another key milestone in our efforts after the positive opinion received from EMEA by BioPartners for Valtropin last week. We anticipate the approval for Valtropin®, and thanks the outstanding co-operation with The Medical House we are looking forward to providing healthcare professionals and patients with a full service: a new drug, economically priced, and a modern, state-of-the-art needle free device.”

For further information:
The Medical House PLC Tel: +44 (0)114 261 9011
Ian Townsend, Chairman www.themedicalhouse.com

Buchanan Communications Tel: + 44 (0) 20 7466 5000
Tim Anderson / Rebecca Skye Dietrich

Notes to Editors:

About The Medical House (TMH)

In February 2005, TMH announced a 10-year agreement which it has signed with BioPartners GmbH, to supply its needle-free system for the delivery of BioPartners’ human growth hormone products.

TMH has progressively been developing a range of needle-based and needle-free devices, which include its own-branded reusable needle-free insulin injector, the SQ-PEN, available free-of-charge to patients in the UK on NHS prescription.

In February 2006, TMH announced Martindale Products and Specials (a subsidiary of global healthcare group Cardinal Health Inc.), as its partner for the initial deal on its ASI disposable AutoSafety Injector.

In December 2005, TMH announced an agreement with a European Government Agency to develop a solution for emergency application of particular pharmaceutical products. Within this project, TMH’s client will make the required capital investment and cover the costs of design and development.

In September 2004, TMH signed an agreement with Serono to develop and supply with a new needle-free system for use with their human growth hormone. The market for human growth hormone drugs is expected to reach $2.2 billion by 2006 according to AS Insights.

TMH also has several distribution agreements in place for the insulin market for its range of reusable needle-free insulin injectors and in November 2002 it announced that it had received approval from the PPA (Prescription Pricing Authority) for the admission of its first needle-free insulin delivery device to the NHS Drug Tariff. This has enabled the device and the related consumables to be prescribed on a free-of-charge basis to more than 500,000 people with diabetes in the UK who inject insulin daily. This was the first needle-free injection system for liquid pharmaceuticals to be available on the UK NHS Drug Tariff.

More information about the company can be found at www.themedicalhouse.com.

About BioPartners

Headquartered in Baar, Switzerland with an affiliate in Germany, BioPartners (www.biopartners.com) is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. BioPartners’ mission is to develop patentable and innovative formulations of “first generation” biopharmaceuticals as well as advanced delivery systems that may improve patient compliance to its product portfolio. BioPartners is developing a comprehensive range of biopharmaceutical products that may offer life-saving therapeutic benefits across many therapeutic areas, including oncology, virology, haematology, endocrinology and neurology.
BioPartners has submitted a second dossier to the EMEA and has two products in the pipeline currently in clinical Phase III.

More information about the company can be found at www.biopartners.com.
Tel: + 41 (0) 41 766 2080.