APT Pharmaceuticals Inc., which secured rights to a late-stage, orphan product for lung transplant rejection from Novartis AG earlier this year, is ramping up for a large Phase III study next year, thanks to $22 million private financing.

The company's Series A-2 round was led by Menlo Park, Calif.-based Versant Ventures and Greenwich, Conn.-based Great Point Partners and included existing investors Vivo Ventures and Charter Life Sciences, both of Palo Alto. To date, APT has pulled in about $30 million to support its strategy of "low-risk drug development," while creating products for areas of unmet need, such as lung transplant rejection and lung diseases, said Stephen Dilly, president and CEO.

"There's a very small number of clinical centers [that conduct] lung transplants," he told BioWorld Today, "and those centers also treat diseases that lead to lung transplants. So our business plan is to really focus on that niche market and develop multiple molecules for that market."

To that end, APT picked up rights in May to Pulminiq, an inhaled cyclosporine aimed at increasing survival and preventing chronic rejection in combination with standard immunosuppressive therapy following lung transplant. That product previously had been in the hands of Emeryville, Calif.-based Chiron Corp., where Dilly had served as chief medical officer - two other AP T executives, Chief Operating Officer Howie Raff and Gregory Baigent, vice president of its pulmonary transplant program, also are Chiron alums - until Novartis reacquired the program in 2006 through its $5 billion buy-out of Chiron. While part of Chiron's development program, Pulminiq was deemed approvable by the FDA, though the agency requested additional clinical efficacy data.

Between the familiarity with the product and the FDA's requirements contained in the approvable letter, "we know exactly what we need to do" to get Pulminiq across the finish line, Dilly said. "We're preparing to go into our Phase III study in the first quarter of 2008." That study is expected to involve several hundred newly transplanted patients and will compare Pulminiq to placebo, with patients in both groups also receiving best standard of care. Data is anticipated in a "three- to four-year time horizon," and pending success, APT expects the drug "to reach market fairly soon after that," he added.

Money from the Series A-2 round should "comfortably sustain us for two years," Dilly said, and, by that time, the Pulminiq trial is expected to be fully enrolled, or close to it, and APT hopes to have data for its inhaled antibiotic program. In short, the firm was "trying to build a big enough war chest to take our assets through a value infection before we go out to raise more money."

APT aims to build a pipeline of repositioned drugs, including molecules that have gained approval outside the U.S. The company also is looking to move existing molecules into inhalable formulations and looking for new indications for approved drugs. Part of its approach includes taking existing antibiotics, which are administered either intravenously or orally, and reformulate them to be administered directly into the lungs for treating strains of bacteria in diseases such as cystic fibrosis and bronchiectasis and in lung transplants patients. Those should "follow on nicely behind Pulminiq," Dilly said. He added that clinical efficacy data from those programs are expected in 12 to 18 months.

Along with the financing, APT named Camille Samuels, of Versant Ventures, and David Kroin, of Great Point Partners to its board. The company also recently appointed Ralph Niven chief technology officer.

In other financings news:

• Anadis Ltd., of Melbourne, Australia, concluded a private placement, raising $600,000 from U.S. and Australian investors. That funding follows a $5 million equity credit line signed earlier this year and will allow the company to accelerate its research and development program, including the strengthening of its portfolio through industry partnerships. Funds will be used to initiate a number of clinical trials, as well as to support business development activity. Anadis focuses on development and manufacturing of antibodies formulated from colostrums of dairy cows that have been immunized with its vaccines and then tracked for safety.

• Hyperion Therapeutics Inc., of South San Francisco, closed up to $15 million in debt financing from Comerica Bank and Life Sciences Capital. That funding, in addition to the $40 million Series B financing reported in September, should enable the firm to advance clinical trials of GT4P in urea cycle disorder and hepatic encephalopathy, and trials of Ammonul for use in hepatic encephalopathy. Money also will support U.S. sales and marketing efforts for Ammonul and Buphenyl. In addition to the financing, Hyperion made several appointments to its executive team: Marvin Garovoy, senior vice president of clinical development; Sharron Gargosky, chief scientific officer and senior vice president of corporate development; Klara Dickinson, senior vice president of regulatory affairs and compliance; Kevin Weber, senior vice president of global strategy and operations; Wayne David, vice president of clinical operations; Hoi Leung, vice president of biostatistics; George Jue, vice president of financing and controller; and James Kaser, vice president of global sales. (See BioWorld Today, Sept. 6, 2007.)

• Living Cell Technologies Ltd., of Melbourne, Australia, is raising A$2.4 million (US$2.1 million) in a private placement to support clinical trials of DiabeCell, the company's Type I diabetes product, in Russia and New Zealand, as well as to fund the ongoing expansion of the pig breeding herd to meet clinical requirements. LCT signed a non-binding letter of intent for the purchase of 22.4 million ordinary shares by U.S. investor NaviGroup Management Ltd., initially for A$2.4 million, with a 90-day period for one or more additional placements. The total financing could raise up to A$9.8 million.