Theratechnologies Inc. is raising C$52.5 million (US$44.8 million) in a financing expected to take company through Phase III trials of its lead product in HIV-associated lipodystrophy.

Montreal-based Theratechnologies three weeks ago began the second of two Phase III trials of TH9507 in HIV-associated lipodystrophy, following positive data released three months ago from the first study. The company's stock has more than tripled since the data were released in mid-December, providing Theratechnologies an opportunity to complete a financing on favorable terms.

Theratechnologies on Monday filed a final short-form prospectus with regulatory authorities in all provinces of Canada in connection with an agreement entered into with underwriters for the sale of 6.25 million shares at C$8.40 per share.

Luc Tanguay, senior vice president and chief financial officer at Theratechnologies, said the company has a number of earlier-stage programs, but almost all the focus at the company - and its spending - will be on the confirmatory Phase III trial of TH9507, a stabilized analogue of the growth hormone-releasing factor. "Now we have well over two years of cash," he said. "It allows us to complete development of our main product."

On Jan. 31 the company began the confirmatory Phase III trial, a double-blind, randomized, placebo-controlled study to be conducted in about 400 patients at more than 60 centers in the U.S., Canada and Europe. The primary endpoint is a reduction of visceral adipose tissue, a risk factor for cardiovascular disease and Type II diabetes. The design is identical to the previously reported positive study, except for the inclusion of sites in Europe.

Tanguay said an estimate from a few years ago showed about 250,000 HIV patients - out of 1.7 million overall HIV patients - in North America and Europe suffer from lipodystrophy, which is characterized by fat accumulation in the abdomen as well as lipid and carbohydrate disorders. The condition is associated with anti-retroviral therapy regimens, the company said.

The first Phase III trial, powered to show an 8 percent reduction in visceral adipose tissue versus placebo after 26 weeks, showed a 20 percent reduction versus placebo (a 15 percent reduction from baseline versus a 5 percent increase in the placebo group). Cholesterol profiles for the drug group also improved during the treatment period. (See BioWorld Today, Dec. 20, 2006.)

The new trial is expected to complete enrollment in the third quarter. Results were projected to be available in the first quarter of 2008. The study is being conducted under an FDA special protocol assessment.

Theratechnologies' stock (TSX:TH) had closed at C$2.75 for three straight days before gaining 75 percent Dec. 19 upon release of data from the first Phase III trial. It has climbed steadily since, and gained another C$0.43 Tuesday to close at C$9.26.

The company reported C$35.7 million in cash on Nov. 30, the end of its fiscal 2006 year, giving it about C$88 million on a pro-forma basis. Its loss for the year was about C$25.9 million. Theratechnologies had about 46.9 million shares outstanding on Nov. 30.

Theratechnologies may partner TH9507 in North America, Tanguay said, but not in a traditional outlicensing arrangement. The company intends to be involved in commercialization in the U.S. and Canada, he said, and also wants to maintain ownership of the product for development in other indications. He said the company remains open to various commercialization approaches, and to more-traditional partnering options in Europe.

Among indications for which TH9507 may be tested later is cystic fibrosis and adult growth hormone deficiency. Theratechnologies also has a preclinical peptide for acute renal failure, and early stage programs in glaucoma, diabetes and pre-term labor. Theratechnologies has granted Johnson & Johnson rights to a therapeutic peptide for diabetes, while Pharmaceuticals Development Corp. gained an option last year to license Theratechnologies' prostaglandin F2-alpha receptor antagonist program.

The syndicate of underwriters for the financing is being led by BMO Capital Markets, and includes Canaccord Capital, National Bank Financial, Desjardins Securities and Jennings Capital. They would have an option to purchase up to 625,000 additional shares to cover overallotments. The deal is expected to close Feb. 27.

In other financing news:

• Medarex Inc., of Princeton, N.J., said it sold about 2.5 million shares it held of Genmab A/S, of Copenhagen, Denmark, for net proceeds of about $150 million. The sale of Genmab shares was expected to reduce Medarex's equity ownership in Genmab to about 11 percent.

• pSivida Ltd., of Perth, Australia, said it is raising A$11.5 million (US$9 million) in a private placement, subject to shareholder approval. The company plans to sell 50 million shares at A$0.23 per share. Each share would include two options exercisable for four years at A$0.23 per share. HPC Capital Management Corp. is the placement agent.

• Bavarian Nordic A/S, of Kvistgard, Denmark, said it will publish today a prospectus for a rights issue, under which shareholders will have rights to subscribe to new shares at the ratio of 1-to-5. Proceeds from the rights issue are expected to total DKK465 million (US$82 million). Funds are expected to be used for manufacturing of the smallpox vaccine Imvamune - for which the company expects to receive a contract from the U.S. Department of Health and Human Service - and for other programs.

• GenTel BioSciences Inc., of Madison, Wis., said it raised more than $2 million in a financing led by NEW Capital Fund LP and Wisconsin Investment Partners LLC. GenTel is a privately held protein chip-based life sciences company.

• Microbix Biosystems Inc., of Toronto, said it is raising C$0.5 million (US$0.43 million) through the sale of a 9 percent convertible debenture to an existing shareholder. The principal amount is convertible into common shares at C$0.90 per share for 10 years. The company has existing debentures with the same terms. Funds will be used for continued development of its urokinase cancer program and its Sperm Sexing reproductive technology.

• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., completed a previously announced registered direct offering, resulting in gross proceeds of $36 million. The company sold about 4.2 million shares, and warrants to purchase 1.1 million shares at $8.44 per share. Lazard Capital Markets LLC was lead placement agent. Needham & Co. LLC and ThinkEquity Partners LLC were co-placement agents. (See BioWorld Today, Feb. 14, 2007.)

• SemBioSys Genetics Inc., of Calgary, Alberta, completed a previously announced underwritten public offering of about 4.25 million shares at C$3 per share, for gross proceeds of about C$12.75 million (US$10.9 million). Concurrently, certain shareholders sold 2.75 million previously issued shares at C$3 per share in a secondary offering. The offerings were completed through a syndicate of underwriters led by Raymond James Ltd. Underwriters have an option to purchase up to 1.05 million additional shares at the same price. Proceeds will be used to advance development of plant-manufactured insulin and other therapeutics, and for costs related to its non-transgenic oilbodies products for use as ingredients in topical applications and food products.

• Vion Pharmaceuticals Inc., of New Haven, Conn., completed a previously announced private placement of $60 million of 7.75 percent convertible senior notes due 2012, and warrants to purchase up to 7.8 million shares of common stock. The notes initially are convertible into common stock at $1.92 per share. For each $1,000 principal amount of the notes, investors received three-year warrants to purchase 130 shares of Vion common stock at an initial exercise price of $2 per share.