Dive Brief:
- In yet another setback, Teva Pharmaceutical Industries Ltd.'s asthma drug Cinqair missed its primary endpoints in a pair of late-stage clinical trials testing a subcutaneous administration of the antibody in patients with uncontrolled asthma and elevated blood eosinophils.
- In one, a registrational Phase 3 study, subcutaneous Cinqair failed to significantly reduce the frequency of clinical asthma exacerbations (CAE) in patients with uncontrolled asthma and blood eosinophils higher than 300/mcL, the company said Monday.
- In the other, a Phase 3 claim-support study, the drug failed to reduce oral corticosteroid (OCS) use in OCS-dependent asthma patients. Both studies administered 110 mg of Cinqair through a pre-filled syringe — a different means of administration from Cinqair's current approval as an intravenous infusion.
Dive Insight:
A subgroup of patients in the registration study with baseline blood eosinophils equal to or greater than 400/mcL did see significantly reduced CAE risk, similar to patients with those CAE levels in Phase 3 trials supporting Cinqair's initial approval, the company said.
Asthma has been a brighter spot in an otherwise difficult few years for the Israeli drugmaker. Four patents for its multiple sclerosis drug Copaxone (glatiramer acetate), for example, were recently invalidated, paving the way for competition, including Mylan N.V.'s newly approved generic version.
Teva is also caught up in a federal lawsuit over generic price fixing and continues to struggle with high debt incurred from the $40 billion purchase of Allergan plc's generics unit.
In November, Teva lowered its 2017 revenue forecast to between $22.2 billion and $22.3 billion, from the previously projected $22.8 billion to $23.2 billion. The news sparked a sell-off of Teva stock, causing the share price to drop by more than half and fueling concerns about its ability to pay down its debt.
To stabilize its business, Teva said recently it will restructure its commercials operations and wrap its specialty and generic drug R&D units into a single global group. The massive overhaul plan also includes divesting non-core products and shuttering or selling numerous R&D facilities, as well as manufacturing and office sites. About 14,000 positions will be eliminated.
Speaking at the J.P. Morgan Healthcare Conference earlier this month, Kåre Schultz, Teva's latest CEO, said the goal is to close about half of the company's 80 manufacturing sites. The two-year restructuring is expected to reduce annual expenses to about $13 billion, from the current $16 billion.
Teva said it is reviewing results of the two studies to determine next steps.