Proving that Ironwood Pharmaceuticals Inc. seeks to grow its pipeline beyond promising irritable bowel syndrome drug linaclotide, the Cambridge, Mass.-based firm picked up rights to a Phase I-stage anti-anxiety compound from Bionomics Ltd. in a deal valued at up to $345 million.

Ironwood will pay an initial $3 million license fee for BNC 210, with up to another $13 million coming over the next two years in research funding. Beyond that, the firms did not disclose specific milestones, but Michael Higgins, chief financial officer, said they would be "linked to value-creating events."

Though modest, the up-front money should bolster Adelaide, Australia-based Bionomics' cash position, which totaled A$16.1 million (US$16.5 million) as of June 30, and CEO Deborah Rathjen said the deal marked the largest in Australian biotech history for a Phase I asset. On top of up-front, milestone and research payments, Bionomics also is entitled to royalties "consistent with industry standards" for any product sales.

Plus, the connection to Ironwood should help "increase Bionomics' visibility with U.S. investors," she told analysts on a conference call.

BNC 210, which also has potential applications in other large indications such as depression, is expected to move more quickly through development under Ironwood, which will be responsible for conducting and funding all further clinical development, including the ongoing Phase Ib trial. But Bionomics also chose Ironwood largely because of its experience in running complex trials with patient-reported outcomes.

Ironwood has won kudos from analysts and investors for its successful pivotal program of linaclotide, which involved the use of a whopping 66 primary and secondary endpoints. The GC-C agonist ended up meeting all of those endpoints and is now under FDA review for irritable bowel syndrome with constipation (IBS-C) and chronic constipation, with a PDUFA date anticipated in June. In September, the firm's European partner, Almirall SA, filed for approval in Europe. (See BioWorld Today, Sept. 15, 2010, and Nov. 3, 2010.)

That expertise in the gastrointestinal trials will be relevant in indications like anxiety and depression, Rathjen noted. "Both are highly symptomatic" and both require the use of the tricky patient-reported outcomes element.

And should Ironwood succeed in getting BNC 201 to market, the company is expected to be able to take advantage of its linaclotide sales force.

"Anxiety is a co-morbidity in a number of prevalent GI conditions," Rathjen said. So BNC 201 sales could be "managed by many of the same high-prescribing primary care physicians Ironwood will be calling on for linaclotide."

For Ironwood, the licensing agreement drives home the company's point that it plans to expand its pipeline. Over the past few years, the firm has made its name – and completed one of the most successful initial public offerings in 2010 – largely thanks to linaclotide. But its executives have assured investors that it would not be a one-compound story.

Last year, the firm gained rights to apply Depomed Inc.'s Acuform gastric retentive drug delivery technology to an early stage program. And Ironwood's Higgins, said on Thursday's conference call that the company, which ended the third quarter of 2011 with about $175 million in cash and equivalents, had projected its non-linaclotide R&D expenses to be about $60 million per year.

That should include sufficient capital to advance BNC 201 quickly as planned, he added, calling Bionomics' drug a "high-priority program."

Shares of Ironwood (NASDAQ:IRWD) gained 39 cents to close Thursday at $11.98.

BNC 210's mechanism has not yet been disclosed, but preclinical data have been promising: BNC 210 was shown to act rapidly and without the typical sedation seen with other anxiety drugs such as benzodiazepine.

"What we've seen so far gives us great hope that this is a drug that will be highly useful for acute treatment and chronic treatment," said Mark Currie, chief scientific officer at Ironwood.

While it was too soon for Currie to offer any specific development timeline, he said the next goal will be to establish human proof of concept, and the company will be turning "our eyes to what the development program will look like and what will give us the strongest label."

With Ironwood taking over work on BNC 210, Bionomics will be focusing on its other pipeline programs. The company is in Phase II testing with vascular-disrupting agent BNC 1-5 in renal cancer, with enrollment slated for completion by the end of this year. A Phase I/II ovarian cancer study is expected to start in the first half of this year.

Bionomics also plans to fast track its Alzheimer's disease program, with the aim of having identified a nicotinic-alpha7 receptor candidate by the end of 2012.

Shares of Bionomics (ASX:BNO) closed flat Thursday at A58 cents.