BioWorld International Correspondent

LONDON - BTG plc completed its transformation from broad-based technology licensing company to life sciences specialist, and now boasts a pipeline of 14 clinical programs and £43 million (US$81.9 million) cash for further development and in-licensing.

The London-based company has reached the point at which recurring royalties exceed its costs. Currently, it is in late-stage due diligence on the in-licensing of a number of individual products, and is actively looking for new platforms and portfolios to further extend the pipeline, Louise Makin, CEO, said at an annual R&D update meeting last week. "This is a very different company from the BTG of two years ago," she said. "This is a really sound business with an increasing surplus and in a position to fund really good R&D."

Its financial strength means BTG is in a position to try and retain more value from its programs and has adopted a policy of being flexible about deal structures and the point of out-licensing.

BTG has rights to royalties on five marketed products and another in registration. The development pipeline consists of products out-licensed to partners who are paying all development costs, and an in-house portfolio.

The star out-licensed product in development is Campath (alemtuzumab), marketed by Genzyme Corp., of Cambridge, Mass., approved for second-line treatment of chronic lymphocytic leukemia. Genzyme has said it will apply to extend the label to first-line treatment in 2007, and it has six further trials of the antibody in cancer ongoing.

Perhaps more significantly for BTG, Genzyme is developing Campath for the treatment of relapsing/remitting multiple sclerosis. Results of Phase II trial in which Campath was tested against the existing treatment Rebif were published in September. They showed patients treated with Campath had a reduction of 75 percent in the risk of relapsing compared to Rebif.

"Genzyme is very excited by these studies and is working very hard to put in place a Phase III to start in 2007," said Russ Hagan, Head of R&D at BTG. "There is a lot going on with the development of Campath, and Genzyme has said it is one of its two most significant programs going into 2007."

Another licensee, TolerRx Inc., also of Cambridge, has announced plans to move TRX4, a monoclonal antibody targeting the CD-3 receptor, into Phase III in Type I diabetes by the end of this year, following positive Phase II results and a $35 million fund raising in August.

Hagan said the antibody has been shown to induce long-term antigen immunotolerance without the side effects that usually occur with long-term immunosuppression. "The Phase II trial of TRX4 in Type I diabetes showed it significantly reduced the need for insulin by allowing the body to protect beta cells that are at risk of dying."

In the in-house portfolio, lead product Varisolve, an injectable microfoam for treating varicose veins, completed a European Phase III in 435 patients with a one-year follow-up, and the results are due to be published next month.

However, BTG will not apply to register the product in Europe because the FDA has forced it to carry out a Phase II safety study to rule out the possibility that Varisolve causes circulating microbubbles in the blood patients with a known susceptibility. European regulators are expected to want access to the data from the trial. The company will start the U.S. study, in 50 patients who will be examined by Magnetic Resonance Imaging before and after treatment, in 2007.

The rest of the in-house portfolio is focussed on central nervous system disorders and cancer. The lead program, Plevitrexed, a thymidylate synthase inhibitor, recently completed a Phase I/II trial in gastric cancer, and BTG now is looking to out-license it.