Boehringer Ingelheim will not exercise its option to license a cardiovascular antibody from Athera Biotechnologies under a June 2013 agreement, Athera said today.

Athera—which is 65% owned by Karolinska Development—added that it would continue clinical development efforts for the antibody, named PC-mAb, despite termination of the deal.

Athera said the decision resulted from “re-evaluation of Boehringer Ingelheim's R&D strategy.” A Boehringer spokeswoman for the company's cardiovascular efforts, Julia Meyer-Kleinmann, told GEN today that the re-evaluation extended only to the Athera collaboration and did not signal a shift away from the broader CV therapeutic area.

“We will not in any way cut down on our own R&D in cardiovascular,” Meyer-Kleinmann said, citing as one example ongoing clinical activity for Pradaxa (dabigatran etexilate).

In June, Boehringer launched the RE-CIRCUIT™ trial (Randomized Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of different peri-proCedUral antIcoagulation sTrategies), designed to evaluate uninterrupted treatment with Pradaxa, compared to warfarin, in patients with paroxysmal or persistent non-valvular atrial fibrillation who are scheduled to undergo a first ablation procedure.

And in July, Boehringer and Zealand Pharma said they will expand their three-year-old collaboration to develop new peptide medicines, with Boehringer agreeing to license one of Zealand’s preclinical therapeutic peptide projects in a deal that could net the Danish company up to €295 million ($367.5 million). As part of that deal, the companies agreed to develop an additional peptide drug against what they called an undisclosed “cardio-metabolictarget.

“BI regularly undergoes the evaluation of its R&D and pipeline activities. As a consequence of such refocusing, we have decided to not execute the option that we had for a potential partnership with Athera,” Meyer-Kleinmann added.

Boehringer Ingelheim obtained an exclusive option in June 2013 to acquire Athera’s entire new preclinical antibody program. The program focuses on PC-mAb, a fully-human monoclonal antibody designed to target phosphorylcholine. PC-mAb is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death. Those events include myocardial infarction patients and patients with peripheral arterial disease undergoing vein graft surgery.

“We are confident that Boehringer Ingelheim, with its vast experience and resources within the cardiovascular field, is the ideal partner for this innovative program”, Torbjörn Bjerke, CEO and president at Karolinska Development, said last year.

While Boehringer’s option fee and other financial terms were not disclosed, Athera added: “This transaction is in line with market average terms for programs at similar stages of development.”

“Boehringer Ingelheim’s vast experience and resources within the cardiovascular field has significantly contributed to the successful progress of PC-mAb into the clinical development stage,” Athera CEO Carina Schmidt said in today’s statement.

In a partnering newsletter in January, Boehringer ballyhooed the option agreement as “further demonstration of Boehringer Ingelheim’s growing commitment to biotherapeutics.”

Boehringer’s decision not to exercise its option comes less than a month after Athera disclosed that it dosed its first patients in a Phase I study of PC-mAb for cardiovascular disease. Athera said Oct. 21 that the Phase I study will include up to 48 healthy volunteers in a single ascending dose protocol with safety outcome measures and is performed in Uppsala by CTC Clinical Trial Consultants.

Development costs for PC-mAb, which is Athera’s lead product candidate, are co-financed by a €6 million (about $7.5 million) grant awarded through EU’s Seventh Framework Programme for Research (FP7) to the consortium CARDIMMUN. Members of CARDIMMUN include Athera and CTC, as well as Leiden University Medical Center (LUMC), Turku PET Center (Turku University), and Smerud Medical Research.

Last year, Athera said preclinical activities and clinical trials aimed at demonstrating proof-of-concept would be funded under a total budget of nearly €8 million (nearly $10 million) over three years.

Schmidt added that her company will continue to work to generate proof-of-activity data – as well as “initiate activities to secure a new strategic partner” for later phases of clinical development and commercialization.

Karolinska Development’s 65% stake in Athera includes indirect ownership through KCIF Co-Investment Fund KB. Karolinska Development is a public biotech investor company that originates from the Karolinska Institute

 








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