LONDON - Lipids specialist Scotia Holdings plc last week revealed a sleek new look, with development programs cut from 20-plus to six, and several make-or-break clinical trials in place. At a strategic review meeting, the company said its goal was to “maximize commercial value from its intellectual property portfolio,“ taking discoveries to proof of concept and then licensing them on.

The changes have been engineered by Robert Dow, who became CEO in January, replacing David Horrobin, who founded the company.

“We will take ideas to the end of Phase II and at that stage license them to large pharmaceutical companies with the time, money and skills to get the product approved and sold worldwide,“ Dow said. “That is a big difference from Scotia in the past, but if you have £25 million [US$41.6 million] per annum to spend, you have got two choices: Pick one project and hope it works, or take six or eight projects to Phase II.“

Scotia, based in Stirling, Scotland, will focus its efforts on cancer and related areas, with commercial operations - such as sales of the food additive Olibra and of nutritional products - run to generate cash for pharmaceutical development projects.

Photodynamic Therapy A Priority

“We are today, and will be, a pharmaceutical development company,“ said Dow. The company raised £50 million through a convertible bond issue in March, giving it £68 million in cash, which it said will last for three years.

Despite slashing the portfolio by more than two-thirds, in 1998 research and development expenditure is budgeted to rise to £23 million from £22.7 million in 1997. However, this is a significant improvement on the 1998 budget of £30 million proposed before the review.

Dow said all other intellectual property will be licensed out. However, he noted the value of Scotia's portfolio was zero, “unless and until we have an approach from someone who wants a license.“ The company has made £4.3 million from licensing agreements this year, including deals with Horrobin's new company, which has licensed intellectual property in central nervous system indications and asthma. Languishing projects include lipid-based compounds for treating rheumatoid arthritis, restenosis, osteoarthritis and multiple sclerosis.

The priority project is now Foscan, a photodynamic therapy (PDT) agent for which Boehringer Ingelheim GmbH, of Ingelheim, Germany, has a worldwide license, excluding Japan. Product development director Chris Blackwell, one of Dow's new management team members, who joined Scotia in January, said the plan is to file simultaneous regulatory approval papers for Foscan in the U.S. and Europe in the second quarter of 1999. The filing in head and neck cancer is supported by clinical trials in 500 patients, and will be for a new ready-to-use liquid formulation, rather than the existing dry powder form.

Company Still Pursuing Diabetic Drugs

Blackwell said this filing will give the licensees “a sound basis for further development in other indications, including prostate, lung, and laryngeal cancer.“ Scotia also will start to develop a follow-up PDT agent with further enhanced selectivity and deeper necrosis, which will open up further indications, including ovarian cancer. In the next two years, 40 percent of the research and development budget will be devoted to PDT.

Scotia also has financial endorsement from Boehringer Ingelheim for Epakex for the treatment of AIDS-related and cancer-related cachexia. The pharmaceutical company is paying £200,000 for trials in both indications, and has first option on a license if these are successful. In cancer cachexia, a proof-of-concept study will complete patient recruitment by the middle of 1999, while trials in AIDS-related cachexia are due to begin in the first half of 1999.

After looking hard at the rationale and the data available, Dow said, the company decided to continue development of lipids as anticancer agents. Scotia also is pursuing diabetic peripheral neuropathy, despite its failure last year to get approval for Tarabetic in this indication. It has two patented candidates for development.

“We will put both of them through one animal model, which will give us results by the end of this year. If we decide to take one forward we will then seek partner support,“ Dow said. *