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For Immediate Release 22 February 2005 The Medical House PLC The Medical House signs 10 year license and supply agreement with BioPartners GmbH for needle-free delivery system for human growth hormone The Medical House PLC (“TMH”), (AIM:MLH) the orthopaedic devices and drug delivery company and BioPartners GmbH the global biopharmaceuticals company are pleased to announce a 10 year agreement for license and supply of The Medical House's GH1 reusable, spring-powered, needle-free delivery system for the delivery of BioPartners’ human growth hormone product, ValtropinÔ. This deal follows from the development agreement between the companies which was signed in June 2002. The GH1 received CE mark regulatory approval in 2003. The agreement is on an exclusive world-wide basis for an initial period of 10 years. Sales volumes of needle-free devices give The Medical House a projected income for the contract of £14 million, of which £3 million relates to the first five years. These figures exclude consumable items, such as nozzles and adaptors, which need to be replaced on a regular basis. BioPartners has submitted an application for marketing authorisation (MA) to the European Medicines Evaluation Agency (EMEA) for Valtropin™. This is the second MA application submitted by BioPartners to the EMEA for a biosimilar product. The company submitted an application for its interferon alpha product last year, which is also currently being evaluated by the agency. The two companies are also exploring the use of The Medical House’s new drug delivery systems, including the disposable AutoSafety Injector (ASI), with BioPartners’ sustained release formulations of biopharmaceuticals.
Ian Townsend, Executive Chairman, The Medical House PLC,
said:
The Medical House PLC For further information on BioPartners please contact: Shairose Ebrahim at Zæbra Consulting:
TMH has progressively been developing needle-free devices which are already successfully used in the market. TMH's device, the SQ-PEN, has great potential in drug delivery worldwide. TMH also has several distribution agreements in place for the insulin market for its range of reusable needle-free injectors. TMH announced in November 2002 that it had received approval from the PPA (Prescription Pricing Authority) for the admission of the mhi-500 needle-free insulin injector to the NHS Drug Tariff, to be effective from 1 January 2003. This has enabled the mhi-500 device and the related consumables to be prescribed on a free-of-charge basis to the more than 500,000 people with diabetes in the UK who inject insulin daily. This makes TMH's device the first needle-free injection system for liquid pharmaceuticals to be available on the Drug Tariff. TMH currently has distribution agreements already in place for its needle-free injection systems for insulin use covering: Australia; the Southern Africa Development Communities (including South Africa, Angola, Namibia, Botswana, Zambia, Swaziland, Zimbabwe, Malawi, Mozambique and Lesotho); Israel; the Benelux countries (Belgium, Holland and Luxembourg), Turkey; Canada; Egypt, New Zealand, China, Poland, Pakistan, Morocco and Ireland. In February 2004, TMH announced a license and supply agreement with Dechra Plc for needle-free injection system for use with pet animals. In January 2005 TMH announced an agreement which it has signed with Serono, to develop and license a new needle-free delivery system for the delivery of Serono's human growth hormone products. The market for Human Growth Hormone drugs is expected to reach $2.2 billion by 2006 according to AS Insights. Historically the majority of the Group’s turnover has come from its orthopaedic company, Eurocut Limited, which designs and manufactures instruments and systems used in orthopaedic procedures for many of the world’s leading orthopaedic companies. Eurocut was established in 1988 and now has a reputation as one of Europe’s leading orthopaedic instrument businesses. In January 2004, the company moved into significantly enlarged premises enabling it to expand sales significantly. This enables Eurocut to take advantage of a growing orthopaedic market which has an increasing demand for ever more complex instrumentation to carry out minimally invasive and image guided procedures. In January 2005, TMH signed a long-term supply agreement with De Puy, the orthopaedics division of Johnson and Johnson.
BioPartners 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 was founded by Global Healthcare Partners and Credit Suisse First Boston. Global Health Care Partners currently consists of some of the most respected and recognised figures in the international pharmaceutical industry. These include Henry Wendt, former Chairman of SmithKline Beecham and current Non-Executive Director of BioPartners and Ted Roberts, former Head of Pharmaceuticals of Merck KGaA and current Chairman of BioPartners. BioPartners has partnered with LG Life Sciences, the leading
South Korean manufacturer of biopharmaceuticals and German manufacturer
Rentschler Biotechnologie, for the development and manufacture
of its portfolio of drugs.
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