New patent for APR’s Diclofenac formulation in Canada

Tribute Pharmaceuticals Canada Inc. recently announced that the Canadian Intellectual Property Office has issued a Notice of Allowance for Canadian patent entitled “Diclofenac Formulations and Method of Use.” This patent, developed by APR Applied Pharma Research s.a, is licensed exclusively to Tribute in Canada through a sub-license agreement with Depomed, Inc., which has the exclusive North American rights to Cambia® licensed with APR.

Cambia® (Diclofenac Potassium Powder for Oral Solution) is a non-steroidal anti-inflammatory drug indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older) in US and Canada.

Thanks to APR exclusive “Immediate Release Technology”, for which this patent is granted, Cambia® consistently provides a rapid pain relief in 2 hours as well as a pain-free response lasting up to 24 hours by targeting effectively inflammation, while it comes in a convenient water soluble formulation and has a favorable and tolerable side-effect profile, similar to placebo.

Cambia® sales have been significantly growing in the US market in the last year (+21% in the 3Q of 2015) reaching 28 Mio USD, thus leading to an increase of almost 2% in the MS vs 2014 (source: IMS Health data). Recently, Cambia® has been established as “effective” (Level A) for the therapy of acute migraine attacks by the AHS (America Headache Society), following an evidence-based assessment via a systematic review of Class I studies.

In Canada, the role-out of CHS guidelines communications for Cambia®, as a first choice Rx option in the treatment of migraine attacks – Feb 2015, has doubled the total prescriptions vs 2014 (source: IMS Health data), by replacing other treatment options.

The issuance of this new patent will expand Tribute’s intellectual property protection for Cambia® to 2026 (in US exclusivity is provided until Jan 2023), thus reinforcing the current positive momentum and laying the foundations for the future growth.

Cambia® is a registered trademark and under license from Depomed.

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For further information on Cambia® visit the following website: