Caretek Medical Announces Lead Drug Candidate For ImplaJect(R) Development

Main Category: Headache / Migraine
Article Date: 12 Mar 2006 - 0:00 PDT

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Caretek Medical Ltd, an Oxford-based company developing an innovative needle-free drug delivery system known as ImplaJect(R), today announced the selection of Sumatriptan Succinate as its lead drug compound at the Needle-Free and Auto Injector Conference in London. Sumatriptan is currently prescribed in tablet form to treat migraine, a common condition that affects around 12% of the UK population, and Caretek now plans to develop a solid form of the drug that will be suitable for patients to inject using the company's patented ImplaJect(R) device. The development should enable many thousands of migraine sufferers to enjoy fast, effective relief from their symptoms.

Migraine is treated with tablets or nasal sprays and when these do not work, or sufferers need faster relief, injections are used. The market for the sole existing injectable migraine drug, a form of Sumatriptan that is known as Imigran in the UK and Imitrex in the USA and delivered via needle and syringe, was approximately $220 million in 2005. In recent focus group discussions with Imigran users, the migraine sufferers showed enthusiasm for Caretek's needle-free device, which is easier to assemble, use and dispose of than their current medication, and could provide fast, reliable relief for their symptoms. Focus groups of GPs have endorsed ImplaJect(R) as an effective delivery system that is particularly suitable for home use by patients or carers with minimal training.

Dr Charles Potter, Caretek's founder and Chief Executive Officer, is also the inventor of ImplaJect(R). Making the announcement, he said: "We have demonstrated that we can develop generic products such as Sumatriptan with much shorter development times than for new drugs. We hope to start clinical trials later this year with the objective of launching a new product that is suitable for use with ImplaJect(R) onto the market in 2008."

Dr Andrew Dowson, Director of the Headache Service at King's College, London, and Chairman of the Migraine in Primary Care Advisor Group (MIPCA), has helped Caretek to set up its work with focus groups. Welcoming the announcement, Dr Dowson, said: "The development of Sumatriptan for use with the ImplaJect(R) device could mark an important step forward in the treatment of migraine. Only 50% of migraine sufferers respond to existing over the counter treatments and, on prescription, needle and syringe devices are not widely used. ImplaJect(R) is a much more user-friendly injectable option and does not carry the hazards of disposal and needle prick injuries associated with syringes.

This new product could meet the significant unmet needs of a wide group of people, ranging from those who have not yet used triptan drugs to severe migraine sufferers who need the faster drug absorption time that injections can provide - Sumatriptan's speed of effect is 10 minutes after injection, compared with 30 minutes in tablet form. It can also enable GPs to deliver more individualised patient care."

Caretek hopes that Sumatriptan will be the first of a range of solid form drugs developed for use with the ImplaJect(R) device, and is exploring collaborations with pharmaceutical companies.

Dr Potter explained: "We undertook studies on a number of potential drug candidates before selecting Sumatriptan as a first product to focus on and develop for use with ImplaJect(R). However, there is huge potential to develop other products - many drugs, such as insulin, vaccines and emergency pain relief, cannot be administered by mouth because they will not be adequately absorbed in the body or will not act quickly enough so they are delivered in liquid form via needle and syringe. This is an uncomfortable process that carries a risk of infection as well as the significant costs of cool storage of liquid drugs and needle disposal - a major issue as 15 billion needles are used worldwide every year.

ImplaJect(R) could provide a user-friendly and cost-effective alternative method to deliver many protein-based drugs in solid form. We are interested in exploring partnering opportunities to co-develop the technology for both generic and proprietary medicines."

Caretek Medical Ltd is based at Milton Park, Oxfordshire, UK. The Company was incorporated in 2001 and is focused on the commercialisation of the ImplaJect(R) technology for a range of drug applications. The inventor of the ImplaJect(R) technology and founder of Caretek Medical is Dr Charles Potter, Chief Executive Officer. Caretek attracted seed funding in 2003 from Oxford Technology VCT, followed by first round equity funding in February 2005 from Oxford Technology VCT and a number of business angels, and £2.1 million from Oxford Technology VCT 4 and local business angels in December 2005.

The ImplaJect(R) Technology

The ImplaJect(R) technology is a needle-free drug delivery system that delivers a drug in a solid dosage form into the skin. ImplaJect(R) uses a spring mechanism to push solid drugs through the skin into the underlying tissue where they dissolve and are released into the patient's bloodstream. The device is very easy to use and minimal training is required making it ideal for the self administration of drugs in the home environment. In the clinic volunteers stated that they preferred an administration with the ImplaJect(R) system rather than an injection with a standard needle and syringe.

Storing drugs in a solid dosage form typically makes them more stable and therefore refrigeration may not be essential, as is often the case with liquid formulations. Solid dosage form also enables both immediate and / or controlled release of the drug into the blood stream, reducing the need for multiple injections.

The ImplaJect(R) system has the potential to generate substantial cost savings by eliminating the need to make arrangements for refrigerated storage of liquid drugs and for needle disposal - a major issue as 15 billion needles are used worldwide every year. It could also benefit patients with needle phobia and healthcare staff who suffer needle stick injuries, estimated at 600,000 to 800,000 annually, with the risk of HIV or Hepatitis infection.

For further information: http://www.caretekmedical.co.uk

Sumatriptan Succinate

Sumatriptan is one of a class of migraine-specific triptans; these are serotonin agonists, acting on a biochemical pathway in the brain to control the symptoms of migraine.

MIPCA (Migraine in Primary Care Advisors Group)

MIPCA is the premier society in the UK dedicated to the management of headache in primary care, and has strong links with the Migraine Action Association (the UK patient support group), academic societies and governmental groups. It works through research and education to set standards for the care of headache sufferers and is a founder member of the Headache UK umbrella group, which promotes the importance of headache at a national level, both medically and politically. MIPCA currently has almost 1,000 members, mostly GPs, but with significant numbers of nurses, pharmacists and other practitioners.

For further information: http://www.mipca.org.uk

Oxford Technology VCT

The Oxford Technology VCTs exist to provide capital to start-up technology companies near Oxford. Oxford Technology 4 VCT, which is quoted on the London Stock Market, is the fourth such fund, and has issued a prospectus to raise additional capital early in 2006. All UK taxpayers who invest in VCTs receive a tax rebate of 40% of their initial investment, so that an investment of £10,000 has a net cost of £6,000 to a UK taxpayer who pays at least £4,000 of income tax.

For further information: http://www.oxfordtechnology.com