Biotech Values

[DewDiligence]

Daclizumab Hits Primary Endpoint in Phase-2b Trial

[Two open-label safety extensions of the phase-2 trials are in progress, as is a phase-3 study comparing Daclizumab to Avonex. As far as I can tell, no one ascribes material value to ABT from this program.]

http://www.reuters.com/article/2011/08/09/biogen-abbott-idUSN1E77806L20110809

›Tue Aug 9, 2011 10:32am EDT
By Lewis Krauskopf

NEW YORK, Aug 9 (Reuters) - Biogen Idec Inc (BIIB) and Abbott Laboratories Inc's (ABT) experimental once-monthly injected drug for multiple sclerosis achieved the main goals in a mid-stage trial, the companies said on Tuesday.

Analysts said the drug, daclizumab, showed effectiveness on a par with some of the new medicines for the often disabling neurological disease, but that some of the side effects, such as infections, were worrisome.

A wave of new drugs, including several oral treatments, has brought some optimism for patients suffering from multiple sclerosis, which has no cure, while generating fierce competition in the pharmaceutical industry.

Daclizumab was injected once every four weeks in the Phase IIb study of 600 patients.

According to initial results, daclizumab significantly reduced annualized relapse rates by 54 percent for patients on the 150 milligram dose and 50 percent for those on the 300 mg dose compared with those taking a placebo.

That performance puts daclizumab's effectiveness in line with Novartis AG's newly approved Gilenya and Biogen's experimental drug BG-12, both of which are pills, but below the roughly 67 percent relapse rate for Tysabri, sold by Biogen and Elan Corp, analysts said.

Serious infections occurred in 2 percent of patients on daclizumab compared to none taking the placebo, while more patients in the treatment group had high liver function abnormality tests -- 4 percent versus less than 1 percent in the placebo group. Two deaths occurred with patients in treatment arms of the study.

JP Morgan analyst Geoff Meacham said the safety data were a concern and that he wanted to see more results from the study.

While the data were better than his expectations on the efficacy side, Meacham said in a research note, "it is not yet clear where in the treatment paradigm the agent would fit, particularly with an influx of oral agents entering the MS market."

Leerink Swann analyst Joshua Schimmer estimated that the drug could garner peak annual sales of $400 million to $500 million.

Patients are currently being enrolled in a late-stage Phase III study of the drug [where the comparator is Avonex—see http://www.clinicaltrials.gov/ct2/show/NCT01064401 ]. The companies expect to seek approval for the medicine in 2014, an Abbott spokeswoman said.

Abbott gained the rights to daclizumab when it bought Facet Biotech for more than $700 million last year [#msg-47606240]. Biogen had been developing the drug with Facet, and had earlier failed in a hostile bid for the smaller biotech company.‹