Glaxo Strikes Imitrex Needle-Free Drug Delivery Deal With Weston

Glaxo Wellcome will begin clinical trials with sumatriptan delivered via Weston Medical's Intraject needle-free technology in early 2000, with a product launch anticipated for 2003.

Glaxo announced Oct. 13 that it has acquired an exclusive global license to use Stradbroke, U.K.-based Weston Medical's needle-free Intraject technology for delivery of Glaxo's injectable sumatriptan (Imitrex/Imigran) formulation.

In addition to sumatriptan, Glaxo markets the oral migraine therapy Amerge (naratriptan), which is positioned as an alternative to sumatriptan for patients who require repeat dosing (¹ (Also see "Merck Maxalt-MLT Quick-Dissolve Tab To Be Available In Mid-August" - Pink Sheet, 6 Jul, 1998.)).

Glaxo also has a glycine antagonist (GV-196771) in Phase II development for the treatment of neuropathic pain.

Glaxo's deal with Weston is similar to the company's March 1998 alliance with PowderJect to use the Oxford-based company's needle-free drug delivery system in the development of DNA vaccines for several indications, including hepatitis B, HIV and cancer (² (Also see "European Biotechs Question Sustainability Of Platform Technologies" - Pink Sheet, 26 Apr, 1999.)).

Weston describes its Intraject delivery system as using "a compact energy source to propel a pre-measured quantity of the liquid drug through the skin." The needle-free device is the size of a pen and comes pre-filled.

The firm touts Intraject's "advantages for self-medication and eliminating needlephobia" as well as the product's potential contribution to "relieving time pressures for busy doctors."

In addition to the deal with Glaxo, Weston has Intraject licensing agreements with several other companies.

Under a collaboration announced in July 1998, Roche has a global license to use Intraject for delivery of the hepatitis C treatment Pegasys (peginterferon alfa-2a), for which Roche expects to file a BLA in 2000 (³ (Also see "Principia Developing Albumin-Fused Human Growth Hormone, Interferon Alfa" - Pink Sheet, 23 Aug, 1999.)).

A deal struck in February with Pharmacia & Upjohn provides a global license for Intraject delivery of the low molecular weight heparin Fragmin (dalteparin). Weston expects to reach a device development milestone by the third quarter of 2000. While Weston had previously projected availability of the prefilled Intraject Fragmin system in 2001, the company noted that the potential launch date for the product is undetermined at this time.

Medeva licensed Intraject from Weston in September 1997 for delivery of flu vaccines in Europe. The companies expect the project to enter clinical development in the first or second quarter of 2000.

Under an August collaboration, Intraject is licensed to "a leading Japanese company for an undisclosed compound." Intraject "will be used for the delivery of one of the largest selling injectable drug treatments in Japan," Weston reported.

The U.K. firm is currently in negotiations with five large pharmaceutical companies to secure collaborations for Intraject formulations of currently marketed therapies.

Weston expects to announce shortly a deal to develop an Intraject formulation of a large protein which generates annual revenues in the $1 bil. range.

In addition to Intraject, Weston is developing other drug delivery systems "with applications in major disease areas such as asthma, diabetes and cancer," the company said.

In January, Weston received a fourth round of funding from the European venture capital company 3i, along with investments from Nomura Securities International and Phildrew Ventures, the U.K. venture capital arm of UBS Securities. Seed capital for the company's establishment in 1994 was provided by 3i.

Weston was co-founded by biomedical engineer Terry Weston, who is currently the company's medical managing director and director of research. Weston was previously an independent biomedical inventor whose device inventions included an inhaler sold to Boehringer Ingelheim.

Weston CEO Christopher Samler was formerly head of Imutran, a firm focusing on the genetic engineering of animal organs. Imutran was sold to Novartis in 1996. Weston has more than sixty employees.