Good news flowed in at Gilead Sciences (GILD) when Health Canada, the federal department responsible for the maintenance and improvement of health of Canadians, issued a Notice of Compliance to the biopharmaceutical major on its hepatitis C virus (:HCV) combination treatment, Harvoni. Treatment with the HCV combination not only reduces the duration of therapy but also eliminates the need for interferon and ribavirin administration, both being associated with serious side effects.

Harvoni, a once-daily combination treatment of Gilead’s highly successful HCV drug Sovaldi (sofosbuvir: 400 mg) and ledipasvir (a NS5A inhibitor: 90 mg), has been issued the notice for treating adults affected with HCV genotype 1 infection. Such notices are issued by Health Canada to the manufacturing company (in this case, Gilead) after a satisfactory review of the submission.

We note that Gilead had filed the application - New Drug Submission - for Harvoni in Canada on Mar 19, 2014. The application was reviewed on a priority basis. This positive move by Health Canada came close on the heels of the all oral HCV combination therapy gaining FDA approval (read more: Gilead's All-Oral Combo HCV Drug Harvoni Cleared by FDA).

The EU approval of Harvoni is on track with the European Medicines Agency's Committee for Medicinal Products for Human Use recommending the same last month. Gilead is also looking to get the combination therapy approved in Australia and New Zealand. We expect investor focus to remain on updates regarding the cocktail therapy, going forward. AbbVie (ABBV) is also looking to get its HCV combination therapy approved.

Gilead carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care space include Medivation (MDVN) and Emergent BioSolutions (EBS), each sporting a Zacks Rank #1 (Strong Buy).

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