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Algeta Brings in $35M Privately for Alpharadin Work in HRPC
(BioWorld Today Via Acquire Media NewsEdge) Financings Roundup
As it prepares to expand its ongoing Phase III study of Alpharadin to include prostate cancer patients in the U.S., Norwegian biotech Algeta ASA is padding its coffers with a NOK245 million (US$35 million) private placement round.
The round was led by Abingworth LLP, and its completion is subject to approval at the company's general meeting next month, at which time the board plans to propose a subsequent repair offering to existing shareholders that could pull in an additional $5 million. The company last raised money when it went public on the Oslo Stock Exchange in early 2007 with a $41 million offering.
"We're very pleased that we were able to raise this kind of financing in this economic environment," Thomas Ramdahl, Algeta's executive vice president and chief technology officer, told BioWorld Today. He attributed investor support to a "very high confidence in our data" surrounding Alpharadin, a next-generation alpha-emitting agent that moved into a large Phase III study last year in hormone-refractory prostate cancer (HRPC) patients with bone metastases.
Proceeds are expected to support completion of that trial, designated ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer), which could serve as the basis for potential marketing applications of the drug in skeletal metastases of prostate cancer origin. The study, which began enrollment last year, recently was cleared by the FDA to include U.S. HRPC patients following an end-of-Phase II meeting.
A total of 750 patients are expected to be recruited and randomized to receive either Alpharadin plus standard of care or placebo plus standard of care. Enrollment will take about two years, and Algeta anticipates that the trial will be fully enrolled in the third quarter of 2010, Ramdahl said.
The primary endpoint is overall survival, and secondary endpoints include progression-free survival. The Oslo, Norway-based firm is hoping the Phase III results will mirror the company's earlier Phase II studies, which demonstrated that Alpharadin delayed disease progression in patients and improved overall survival. Survival data presented at an oncology conference in 2007 showed that 10 of 33 patients (30 percent) in the Alpharadin-treated arm were alive at the 24-month follow-up point vs. four of 31 (13 percent) in the placebo arm. (See BioWorld Today, Sept. 26, 2007.)
Though HRPC has proved a tough nut to crack - German firm GPC Biotech AG's satraplatin failed to yield an overall survival benefit when combined with prednisone in a 2007 Phase III trial, despite previously showing promising progression-free survival data - Algeta is "quite confident" as it moves further into its Phase III study of Alpharadin, Ramdahl said.
The drug is designed specifically to target skeletal metastases, which produce painful and debilitating effects in cancer patients and for which few treatment options exist. Alpharadin is a bone-seeking radiopharmaceutical based on the alpha particle emitter radium-223. In addition to improving survival, Algeta said the drug also has demonstrated an ability to reduce levels of prostate-specific antigen and has a safety profile that's similar to placebo.
Ramdahl said an interim futility/efficacy analysis will be conducted at full enrollment. Final data analysis will be dependent on a certain number of outcome events and could be available in the first half of 2012, he said. In the meantime, the firm intends to seek a partner for the program, hopefully this year. "We want to [partner in] selected territories and keep some territories for ourselves," Ramdahl said.
Funding from the latest round should carry Algeta at least a couple of years, though the cash runway could be extended upon a partnering deal or deals. Beyond supporting the ongoing Alpharadin trial, proceeds also will be used for additional trials in anticipation of label expansions for Alpharadin, trials of the drug in skeletal metastases in breast cancer patients, further pipeline developments and for general corporate purposes. The private placement took place through a book-building process managed by ABG Sundal Collier and CnB NOR Markets. In connection to the financing, Joe Anderson, of Abingworth, will be nominated to the company's board at the March general meeting.
Shares of Algeta (OSE:ALGETA) fell NOK2.60, or 17 percent, to close Wednesday at NOK12.80.
In other financings news:
? Kythera Biopharmaceuticals Inc., of Los Angeles, said investors elected to exercise their rights early to add another $10 million as part of the company's $40 million Series C round reported in May. All existing investors participated, including Versant Ventures, ARCH Venture Partners, Prospect Venture Partners, BBT Capital Management/Apothecary Capital, JAFCO, PFM and Altitude Life Science Ventures. The additional funds are expected to help the company develop its two clinical-stage compounds, including ATX-101, which aims to reduce fat deposits in the chin. Funds also will be used to support work on the firm's preclinical pipeline. (See BioWorld Today, May 20, 2008.)
? NanoBio Corp., of Ann Arbor, Mich., acquired $12 million in series B equity financing with Perseus LLC and other existing investors. The funds will be used to complete a Phase I study investigating a novel topical treatment for acne, preclinical studies on a nebulized therapy for cystic fibrosis, and a Phase I study for an intranasal seasonal influenza vaccine.
? Opsona Therapeutics Ltd., of Dublin, Ireland, completed an ?18 million (US$22.5 million) Series B financing round to support clinical trials in areas of inflammatory disease, including rheumatoid arthritis, lupus and transplantation. The company is developing small-molecule products designed to modulate the innate immune system, with the lead program, OPN-305, a monoclonal antibody to a Toll-like receptor target, set to start pivotal clinical trials in 2010. Novartis Venture Fund, Fountain Healthcare Partners, Inventages Venture Capital and Seroba Kernal Life Sciences participated in the financing, and Opsona added Florent Gros, of Novartis Venture Fund, and Manus Rogan, of Fountain Healthcare, to its board.
? Pressure BioSciences Inc., of South Easton, Mass., said it received $1.8 million from the sale of 156,980 units in a private placement. Each unit, priced at $11.50, comprised one share of nonvoting Series A convertible preferred stock and a warrant to purchase either 10 shares of common stock at $1.25 or one share of Series A convertible preferred stock at $12.50 each, expiring 15 months from the closing, and a warrant to buy 10 shares of common stock at $2 each. Also, in connection with the private placement, the firm received $200,000 from one of its distributors to be held in an escrow account for use as payment on anticipated future purchases of the company's pressure cycling technology instrument and consumables products. Shares of Pressure BioSciences (NASDAQ:PBIO) closed unchanged at 90 cents Wednesday. n
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