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11 March 2008 FDA Approval for Autoinjector
The Medical House PLC (“TMH” or the “Group“), (AIM:MLH) the drug delivery specialist, is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Group’s Compact AutoSafety Injector (CASI).This clearance 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 which are presented in standard 1ml long pre-filled syringes with staked needles. The CASI is a version of TMH’s ASI disposable autoinjector which is being developed for the global pharmaceutical company which extended its Agreement with TMH in November 2007, a deal which included an immediate payment of £2m. Ian Townsend, Chairman, The Medical House PLC, said: “This a key milestone achievement for TMH as it is our first ASI device to receive FDA pre-market notification which allows us to market the CASI in the US. It is also a vital approval for the project involving our global pharmaceutical partner and its commercial strategy. We are all delighted with this news and we look forward to reporting more progress for our Drug Delivery Division in due course”.
-Ends- The Medical House PLC Nomura Code Securities Limited 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” 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 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. 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. TMH signed its first licensing deal for the ASI in June 2006 with Martindale Products and Specials, part of Cardinal Health Inc, in an initial five-year contract to supply the ASI system for use with an, as-yet, undisclosed pharmaceutical product, in the United Kingdom. The combined product is to incorporate TMH’s ASI and Martindale’s pre-filled syringe, The agreement has projected revenues for TMH of £3m over an initial supply period of 5 years. In December 2005, TMH announced an agreement with a European Government Agency to develop a disposable autoinjector for emergency administration of specific pharmaceutical compounds, based on TMH’s ASI autoinjector. Within this project, TMH’s client is making the required capital investment and covering the costs of design and development. In March 2007, it was announced that TMH had been commissioned by this Agency to enter into a second phase of development within the project, which involves TMH developing and manufacturing devices, according to defined operational and functional requirements, for technical assessment, over an anticipated 12 months project duration. Within the second phase of the project, TMH will receive up to £1m, subject to achieving agreed milestones, in relation to the cost of the project including associated design and development activities. In September 2004, TMH signed an agreement with Serono to develop and supply a new needle-free injector for use with its human growth hormone. This licence and supply agreement is for an initial period of 5 years with projected revenues for TMH of £4.3m. For more information, visit www.themedicalhouse.com. END |
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