United States | Expanding Product Portfolio
With 20 to 30 new product launches each year — and more new products than any other generic company over the last decade — Apotex is aggressively bringing generic products to market.
Among generic manufacturers, Apotex stands alone in opposing anti-competitive patent settlements that delay generic competition, both by litigating against them and in advocating against them to FTC and Congress.
- Authorized Generics: Apotex opposes authorized generics and supports passage of legislation pending in Congress that would ban them during the 180 day exclusivity period
- Generic Biologics: Apotex is working with a broad coalition of interests on securing passage of legislation creating a pathway for the approval of generic biologics
- AMP: Apotex has and continues to partner with pharmacy in lobbying Congress to fix CMS' misguided AMP rule
- Anti-Generic Substitution Campaign in the States: Apotex is partnering with a coalition of organizations to combat the brand industry's nationwide campaign to pass anti-generic substitution in the states
- Foreign Inspections: Apotex supports proposals in Congress to raise money for inspections of foreign API and finished dosage manufacturers through facility registration fees
- Track and Trace: Apotex is dedicated to reaching a workable solution for global supply chain needs and supports the establishment of a federal standard
Product Development
Research at Apotex includes the development of both generic and innovative pharmaceuticals. We currently have more than 600 generic, innovative and biotechnology products in development. New generic products are an important part of our growth and have resulted in the development of substantial expertise in Product Development, BioClinical Development, Regulatory & Medical Affairs and Project Management.
Our research on new chemical entities is conducted by our subsidiary ApoPharma Inc. with a focus on the areas of hematology, neurodegenerative diseases and psoriasis. Extensive research is being done on developing permeant iron chelators for the treatment of several neurodegenerative diseases. Our newest area of research, psoriasis, saw ApoPharma initiate clinical trials in 2008 to evaluate the safety and efficacy of a novel dipeptide that has demonstrated a remarkable safety profile in animal toxicity testing.
Apotex is also very active in the growing area of biotechnology through publicly traded Cangene, Inc.(TSE). It has approvals around the world for the innovative product WinRho SDF, a second-generation hyperimmune globulin. WinRho is the purest form of RhoD immunoglobulin in the world and the only one which is licensed for IV administration in the U.S. Cangene is also funding recombinant DNA research at Canadian universities and has a recombinant research facility. This research will be instrumental in preparing Apotex for future biotechnology products.
R & D expenditures for Apotex in 2007 was over $181 million, representing close to 20% reinvestment of Apotex revenues.