March 7, 2016
By Mark Terry, BioSpace.com Breaking News Staff
North Chicago, Ill.-based AbbVie and Germany-based Boehringer Ingelheim today that they have inked a global collaboration deal to develop and market BI 655066 for psoriasis. AbbVie is paying Boehringer Ingelheim $595 million upfront with additional development and regulatory milestones and royalties if the product makes it to market.
BI 655066 is an anti-IL-23 monoclonal biologic antibody that is currently being studied for psoriasis in a Phase III clinical trial. It is also in a Phase II trial for Crohn’s disease and asthma, and is expected to start a Phase II trial for psoriatic arthritis.
In addition to BI 655066, AbbVie gained the rights to BI 655064, an anti-CD-40 antibody that is currently in Phase I development. It is being studied as a potential treatment for lupus nephritis, Crohn’s disease and ulcerative colitis. Its safety and efficacy is still being investigated.
“This collaboration positions BI 655066 as AbbVie’s lead investigational compound in psoriasis, complementing our robust immunology pipeline,” Michael Severino, AbbVie’s executive vice president and chief scientific officer, said in a statement. “Our expertise in developing and commercializing the world’s leading biologic, combined with Boehringer Ingelheim’s clinical success to-date will enable us to offer patients a new treatment options with the potential to meaningfully improve the standard of care.”Partly in response to the deal, AbbVie lowered its 2016 earnings guidance to exclude one-time items related to the agreement. In January, the company projected profit per share of $4.90 to $5.10. Now the range has dropped to $4.82 to $5.02 per share.
“We have a long track record in immunology through our experience with Humira,” said Severino to Bloomberg Business, “and it’s an area we remain committed to.” He went on to note that Boehringer’s drug data “are truly spectacular and have real potential for differentiation, representing a new treatment option for patients.”
Bloomberg also notes that this is a particularly competitive area. AbbVie’s Humira is dominant with $14 billion in sales in 2015. Johnson & Johnson and Merck & Co. are also working on anti-IL-23 products and Novartis AG ’s IL-17 drug for psoriasis was recently approved. Eli Lilly & Co. and AstraZeneca are also working on IL-17 inhibitors.
However, Humira faces competition from biosimilars, which may be why AbbVie is pushing for a viable backup.
There were also rumors circulating last week that AbbVie and Boehringer were in talks for a cancer partnership. In May, AbbVie acquired Pharmacyclics , which markets Imbruvica (ibrutinib), a first-in-class BTK-inhibitor for the treatment of hematologic cancers.
Boehringer has focused on lung cancer drugs. It markets Giotrif for non small-cell lung cancer, and Vargatef for later-stage patients, and has pipeline products for lung and bowel cancer.
