Weston, Roche Collaborate on Needle-Free Injector

Weston Medical, the UK-based drug delivery development company and Hoffmann-La Roche (Basel, Switzerland) announced in late July a global alliance involving Roche's PegaSys hepatitis drug and Weston's Intraject, a self-contained needle-less drug injector. PegaSys (pegylated-40k recombinant interferon alfa-2A) is in Phase III trials for weekly treatment of chronic hepatitis C as well as for select oncologic indications. The deal represents the first global license agreement for Intraject, a drug delivery system which is easy to manufacture and offers pharmaceutical companies exciting value-added and patenting advantages.

"This agreement is a milestone in the development of Intraject," said Christophar Samler, CEO of Weston Medical. "We've seen a huge amount of interest in intraject and we expect to make further announcements regarding license contracts in other therapeutic areas as we run up to Weston's planned initial public offering."

Intraject is the first commercially available disposable, needleless injector for delivering liquid pharmaceuticals. The device is light, pocket size and comes as a pre-filled, ready-to-use unit, easy-to-operate injector. Watson claims Intraject requires no preparation or special training.

Patient Benefits of Intraject

• People currently using injectible medications, whether at home or at their physician's office, will be able to use Intraject at home, giving them greater independence and eliminating many doctor visits

• Intraject's compact, accurate jet of medicine results in less pain and tissue damage than conventional needle syringes

• Medicine is distributed more widely in the subcutaneous tissue, leading to improved absorption and outcome

• Fear of needles and needle-stick injuries are eliminated. In the US alone, 200,000 people every year suffer injury or infection from hypodermic needles, requiring further and often costly treatment from a doctor.

• Risk of contamination is far less than with conventional needle injectors

• No needle disposal problem

• Higher compliance - a sticking point with physicians who resent patients who don't take their medicine and insurance companies whose costs are raised by the complications and additional treatments stemming from non-use of drugs.

Benefits to Pharmaceutical Companies

Intraject offers many competitive advantages to pharmaceutical companies who take exclusive licenses for the device for specified formulations, the most important of which are product differentiation and patent extension. The manufacture of Intraject-based pharmaceuticals is straightforward: the device consists of only eleven components, and existing filling machines can be easily adapted to fill the injector. Intraject is capable of sterile storage of drugs and is compatible with a wide range of drugs and formulations.

Using Intraject

Intraject uses a compact energy source that propels a pre-measured quantity of medicine through the skin into the underlying tissue without the use of a needle. Pencil-sized Intraject injectors contain a small pressurised canister, to which is attached a sealed glass capsule containing the medication. To use Intraject, patients remove the protective cap and safety tear band and place the device on the skin. By applying light pressure to the top, the canister forces the immediate release of the medication effectively into the tissue without the pain caused by a needle.

Weston Medical's innovative technology means that, unlike a conventional syringe, no special skills are required to use Intraject. First, the safety tabs are removed. Then the device is lightly but firmly pressed against the skin and this simple procedure means that most people should be able to self inject in less than 5 seconds.

Over the past fifty years over three hundred patent specifications have been filed on needle-less injectors. Most early devices were complex by design and too difficult for patients to use reliably. For example, many existing systems require the user to fit a needle temporarily in order to draw the medicine from a vial, an operation beyond the capability of some patients. Other disadvantages included large size and weight, high servicing costs, inconvenient sterilization procedures, and variable injection performance.

Intraject overcomes these obstacles through its small size and weight, pre-filling the sterile medication, simplicity of use, and straightforward manufacturing and filling. Intraject could be used to deliver all liquid medicines that would normally be delivered by injection. Conventional injections are used to deliver certain types of medicine that cannot be absorbed via the stomach. Currently, more than 40% of medicines must be delivered this way (known as parenteral administration), including most vaccines, hormones, adrenaline, erythropoietin and cell-stimulating agents, acute migraine treatments and many other therapeutic proteins such as thrombolytics.

Weston Medical

Weston is in discussion with leading pharmaceutical and biotechnology companies regarding clinical trials with Intraject. According to Weston interest in the technology has been intense, particularly with pharmaceutical manufacturers who recognize the potential for patient self-medication, relieving time pressures for busy doctors and offering patients greater independence. The benefits of applying this new technology to mass immunization have already been recognized by Medeva plc, who will shortly begin trials using Intraject with their flu vaccine. The first widespread clinical use of the product is expected in 1999.

In addition to working on new versions of Intraject, Weston Medical is developing other innovative drug delivery systems with applications in the major disease areas such as asthma, diabetes and cancer treatment.

The company was co-founded in 1994 by Terry Weston, a biomedical inventor, who still plays a central role in the development of the company and its products. Weston's CEO is Christopher Samler, who was formerly Chief Executive Officer at Imutran Ltd (now a Novartis company).

Inquiries regarding Intraject and Weston Medical are being handled by the firm's marketing representative.

For more information: Joanna Bright or Rachael Lobo, The Workhouse, 5 The Green, Richmond, Surrey TWO 1PL, UK. Tel: +44-18-1948-8388, fax: +44-18-1948-5883.

By Angelo DePalma