Ardea Biosciences is raising about $40 million through a securities purchase agreement to help advance its pipeline of clinical and preclinical products in viral disease, cancer and inflammatory disease.

The Carlsbad, Calif.-based company plans a private placement of about 3 million shares of common stock at $13.25 per share, with the closing expected Friday. Piper Jaffray & Co. acted as lead placement agent, with Cowen and Co. and Oppenheimer & Co. Inc. acting as co-placement agents.

The company's most advanced product is RDEA806, from its line of non-nucleoside reverse transcriptase inhibitor (NNRTI). While there already are three approved NNRTI's on the market, Ardea hopes its compound will avoid some problems those encounter, including development of drug resistance, reproductive toxicity and drug-to-drug interactions.

In September, Ardea reported that results from two Phase I studies of RDEA806 showed the drug was safe and well tolerated at all doses evaluated, with no serious adverse events or clinically significant or ECG abnormalities. Those studies on healthy male volunteers showed that, in vitro and in vivo, RDEA806 appeared unlikely to be an inducer or inhibitor of major P450 enzymes or be affected by CYP3A4, which is responsible for side effects.

The company also is working on a preclinical program in future NNRTIs from a chemical group distinct from the RDEA806 class. The new class, the company said, appears to have even greater activity against a wide range of drug-resistant viral isolates.

On its cancer front, the FDA in October cleared the company to start Phase I testing of RDEA119, a selective inhibitor of mitogen-activated ERK kinase (MEK), in advanced cancer patients. The trial will evaluate RDEA119 for safety, tolerability and pharmacokinetics and will examine biomarkers of therapeutic activity. That drug is the first to emerge from Ardea's MEK program. Preclinical data suggested RDEA119, can be dosed orally and has selectivity and low central nervous system penetration.

Last month, Ardea also announced a clinical program testing RDEA806 in gout. A Phase I trial earlier this year in healthy volunteers showed it was safe and well tolerated, and data revealed a statistically significant, exposure-dependent reduction in serum uric acid (SUA). In the dose group that resulted in the highest plasma drug levels (400-mg modified-release capsule twice daily), there was a 50.9 percent placebo-adjusted reduction in SUA (p < 0.001).

In other financings:

• Agile Therapeutics Inc., of Princeton, N.J., has raised $5.6 million in an extension of its Series E financing round, bringing the total of the round to $17.6 million. Current investors participated in the round, including the Hillman Company, ProQuest Investments, TL Ventures and Novitas Capital (formerly PA Early Stage Partners). Funds will be used to continue clinical development of the company's low-estrogen dose transdermal patch, and to fund the growth of a women's health care portfolio.

• Akela Pharma Inc., of St-Laurent, Quebec, said it will not go ahead with plans for a U.S. public offering of 5.3 million shares of common stock due to unfavorable market conditions for small and micro-cap companies. The company said it will explore other financing options, but still intends a listing on a U.S. exchange. The company had expected the IPO to price between $6 and $8, and net $29.2 million.

• AVI BioPharma Inc., of Portland, Ore., has completed its previously announced registered direct offering of $20.3 million. The closing involves 10.7 million shares priced at $1.90 each, plus warrants to purchase an additional 5.3 million shares at an exercise price of $2.45 each. The firm is developing third-generation NeuGene antisense drugs and products for Duchenne's muscular dystrophy based on its ESPRIT exon-skipping technology. Citigroup Global Markets Inc. acted as the lead placement agent and Oppenheimer & Co. Inc. and Maxim Group LLC served as co-placement agents.

• Cogentus Pharmaceuticals Inc., of Menlo Park, Calif., has completed a private placement financing, raising $62.5 million to support development of its antiplatelet therapy CGT-2168. The Series C financing was led by the Keffi Group, with participation from Prospect Venture Partners, Ridgeback Capital, Apothecary Capital and Pinnacle Ventures. That represents the third round of equity financing for Cogentus, which is focused on developing novel combination medicines that significantly improve upon current treatment options in major therapeutic categories. Jide Zeitlin, founder of the Keffi Group, was named to the board of directors. CGT-2168 is a once-daily oral formulation that combines clopidogrel with a gastroprotectant (omeprazole) to reduce gastrointestinal side effects associated with antiplatelet therapy. Phase III trials are being initiated.

• Corthera Inc., of San Mateo, Calif., closed a $23 million Series C financing. New investor Caxton Advantage Life Sciences Fund joined existing investors Domain Associates and Kleiner, Perkins, Caufield & Byers in the financing round. Corthera will use the financing to advance the clinical development of its lead drug candidate, Relaxin, for the treatment of acute heart failure. The company also announced it has named Stan E. Abel president and chief executive officer. Abel was the chief financial officer and co-founder of Cerexa Inc. and played a key role in the company's sale to Forest Laboratories Inc. in January 2007.

• Helix BioPharma Corp., of Aurora, Ontario, closed on its previously announced C$16.87 million (US$16.56 million) private placement of 10.04 million common shares priced at C$1.68 each. Proceeds will support clinical trials of the company's topical interferon-alpha-2b program as well as research on its urease-based lung cancer candidate.

• Lytix Biopharma, of Tromso, Norway, has completed a private placement of NOK50 million (US$8.9 million). The placement was heavily oversubscribed by Norwegian institutional and private investors and will be used to fund the two areas of the company's business - antimicrobials and cancer therapeutics. Lytix specializes in micro-sized synthetic peptides offering rapid and selective cell lysis and a follow-on vaccination effect.

• Osiris Therapeutics Inc., of Columbia, Md., has closed an $11.8 million private placement of its common stock and eliminated through conversion $18.8 million of debt. No fees or commissions were paid in either transaction. The company agreed to sell 950,000 shares, or $11.8 million, of its common stock at $12.37 per share. Proceeds are intended to develop the company's adult stem cell products, including those currently in Phase III clinical trials, and for general corporate purposes. The shares were placed in Switzerland by Friedli Corporate Finance Inc. Peter Friedli, chairman and the largest stockholder of Osiris, invested $1.2 million. Additionally, Venturetec Inc., a Swiss publicly traded company for which Friedli serves as president, purchased $1.2 million of common stock. Osiris also announced that $18.8 million of its 10 percent, $20 million promissory notes, with accrued interest, have been converted at $13 per share into 1,465,837 shares of common stock, eliminating $3 million in cash interest expense.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., closed the sale of 12 million shares of common stock priced at $26 each to Paris-based Sanofi-Aventis Group, as part of the companies' recently signed potential $1 billion collaboration. As a result, Sanofi will increase its ownership in Regeneron to about 19 percent. Gross proceeds of that sale will total $312 million, and those funds, plus the $85 million up-front fee received from Sanofi earlier this month, will allow Regeneron to end the year with an estimated $840 million to $850 million in cash and securities. The companies agreed last month to collaborate on an antibody deal using Regeneron's VelociSuite technologies. (See BioWorld Today, Nov. 30, 2007.)