March 03, 2015 1:57 PM ET

Pharmaceuticals

Company Overview of Apotex Inc.

Company Overview

Apotex Inc., a pharmaceutical company, engages in the research and development, manufacture, distribution, and sale of generic pharmaceuticals in Canada and internationally. It offers medicines in various dosage forms. The company serves patients, healthcare providers, payers, and governments. It offers its products through pharmacies and healthcare facilities. Apotex Inc. has a strategic alliance with Panacea Biotec. The company was founded in 1974 and is based in Toronto, Canada with additional offices in Saudi Arabia. It has facilities in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary, and Vancouver, Canada; and subsidiaries, joint ...

150 Signet Drive

Toronto, ON M9L 1T9

Canada

Founded in 1974

Phone:

800-268-4623

Fax:

800-609-9444

Key Executives for Apotex Inc.

Chief Executive Officer and President
Founder and Chairman of the Board
President of Apotex International
Director of Research and Development
Director of Marketing -Canada
Compensation as of Fiscal Year 2014.

Apotex Inc. Key Developments

US Food and Drug Administration Accepts for Filing of Apotex Inc. Biosimilar Application for Filgrastim

Apotex Inc. announced that, as of February 13, 2015, the US Food and Drug Administration has accepted for filing the company's application for Filgrastim, a biosimilar version of Amgen's Neupogen®. This product has been jointly developed with Intas Pharmaceuticals Ltd. This is the second follow-on biologic FDA submission for Apotex via the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA). Apotex also has a 351k biosimilar application for the long acting pegylated formulation of filgrastim currently under FDA review. Apotex is the only company to date to have two biosimilar filgrastim applications (pegfilgrastim and filgrastim) currently under active review by FDA. Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. The product will be marketed in the United States by ApoBiologix.

US Food and Drug Administration Accepts Filing of Apotex Inc.'s Application for pegfilgrastim

Apotex Inc. announced that the US Food and Drug Administration has accepted for filing the company's application for pegfilgrastim, a biosimilar version of its Neulasta®. The product has been jointly developed with Intas Pharmaceuticals Ltd. The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA). Neulasta® is the long acting formulation of Neupogen® (filgrastim). Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. The company believes it is the first company to have a biosimilar filing accepted for review by FDA for the long acting formulation of the product. According to IMS Health, Neulasta® had approximately $3.6 billion in sales in calendar year 2013.

Panacea Biotec Announces Strategic Alliance with Apotex Inc

Panacea Biotec announced that it has entered into a strategic alliance with Apotex Inc. The strategic alliance was initially established for a drug delivery based drug for which Panacea Biotec had received research fees and the product development is progressing on priority. Panacea Biotec and Apotex have now further expanded the scope of the collaboration by including a second drug delivery based product to the collaboration. Both the products have been developed using Panacea Biotec's proprietary platform nanoparticle, liposomal and microparticle drug delivery systems. The current sales of the innovator products are to the tune of about USD 1 billion. In addition to an upfront and milestone research fee payments from Apotex: Panacea Biotec shall receive a share of the development cost and profit post commercialization of the products shall be shared at a pre-agreed ratio between both companies. Both companies intend to expand the scope of the alliance by adding new drug delivery based complex generic products to the collaboration. Panacea Biotec shall undertake product development and shall manufacture and supply the products to Apotex, while Apotex shall be responsible for regulatory affairs. Hatch Waxman litigation and commercialization activities in the territories.

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