AbbVie drops Halozyme formulation of blockbuster Humira after disappointing trial

Halozyme scientist working in lab

Halozyme Therapeutics has suffered a disappointment as the first phase of a $1 billion-plus collaboration with AbbVie ended in failure.

Halozyme said in a statement that a project involving its Enhanze drug delivery technology and a "tumor necrosis factor (TNF) alpha target" had been abandoned, and a spokesman confirmed that the drug in question was indeed a new formulation of AbbVie's multibillion-dollar brand Humira (adalimumab) which started clinical testing in January.

He added that AbbVie has not divulged the exact nature of the deficiencies in the trial, saying the drugmaker had only "informed us that the early study did not meet the profile they had targeted."

AbbVie announced a wide-ranging deal to apply Enhanze to up to nine drugs in its portfolio last year, paying Halozyme an upfront fee of $23 million and pledging another $130 million per drug if the formulation met all developmental and commercial milestones, as well as a mid-single digit royalty on net sales.

Asked about the status of other candidates, the Halozyme spokesman was giving nothing away, merely saying "we have not announced new target nominations or the start of new clinical studies with AbbVie."  The company insists that the two partners will "continue to work collaboratively to identify additional targets for co-development."

Enhanze relies on an enzyme (rHuPH20) that can temporarily degrade a chain of natural sugars in the body called hyaluronan, prepping the body for easier drug absorption and opening the door to an easier delivery approach for drugs. 

AbbVie viewed the Enhanze formulation of Humira as a way to defend the $14 billion-a-year drug from future biosimilar competition. Amgen just claimed FDA approval for its Amjevita (adalimumab-atto) version of the drug, although is facing a legal challenge from AbbVie which claims it has U.S. patent protection for Humira until 2022.

Halozyme seemed to shrug off the setback, with its share price barely moving in response to the announcement yesterday. 

The company has been successful in signing up big pharma companies to trial the Enhanze technology, and aside from AbbVie also has partnerships in place with Roche, Baxalta, Pfizer, Janssen, and Eli Lilly. Ahead of the adalimumab disappointment, Halozyme chief executive Helen Torley said analysts had projected sales for all these partnered products could top $25 billion in 2025, and deliver $100 million a year to the company in annual revenues.