TMH autoinjector to reach US after FDA go-ahead
allow injections to be safely undertaken by patients or
non-clinicians has received FDA approval allowing its creators
access to the lucrative US market.
The 510(k) clearance granted by the US.Food and Drug Administration (FDA) means the Compact AutoSafety Injector (CASI) now has pre-market notification status, adding to its well-established European strategic arm. If the European autoinjector market is anything to go by its makers, The Medical House (TMH) could find themselves tapping into a rich vein as a result of an immature US market eager to take up this new technology. According to market analysts Frost and Sullivan the European industry earned revenues of $31.6m in 2006 and estimates this to reach $60.1m in 2013. 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. The ASI is TMH's first autoinjector system, applicable both to elective therapies and emergency use. The company had already built a base in needle-free injection devices, which are in use and have netted agreements with the Swiss companies Serono and BioPartners (both for delivery of human growth hormone). "The FDA's pre-market notification is 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," said Ian Townsend, TMH's chairman. 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 global pharmaceutical company. Under new terms, in which the duration was increased from five to six years, TMH agreed to a provision for further extension to approximately 16 years. Additionally, TMH's projected revenues were increased from £27m to £34m (of which £23m is for technology access, or licence, fees). TMH recently commenced work on the pre-commercial phase of the agreement's development programme resulting in additional development monies to TMH of approximately £900,000 over the next 18 months. At the present time there are only five or six companies worldwide with autoinjector technology, which include DEY, Verus and Gilson. These companies remain at the forefront at a time of increasing demand for the devices from the pharmaceutical industry. In an interview with Townsend for in-PharmaTechnologist.com last year, he re-emphasised the edge ASI had on its competitors citing its simplicity of design, reliability and ease of use. He added the device incorporated only five or six components, offering a cheap, easy-to-assemble alternative to other autoinjectors, most of which require 10-20 components.
