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Apotex Generics Company Intelligence Report


Description: Apotex is Canada’s largest domestic pharmaceutical manufacturer. It is a private company, with a number of subsidiaries throughout Canada.

Apotex is active in around 115 countries, and has subsidiaries, joint ventures or licensing agreements in Asia, Europe and Latin America. Products are sold under the Apotex brand, and under customer brand names.

In 2006, Apotex received an ANDA approval for clopidogrel bisulphate, the generic form of sanofi-aventis’ Plavix. In a lucrative but controversial and potentially very risky move, Apotex launched its version in August 2006 without waiting for the attendant legal issues to be resolved. Apotex lost the case in July 2007.

In 2007, Apotex became the first company to attempt to utilise Canada’s Access to Medicines Regime, amending Canada’s patent regime to enable generic firms to produce copies of patented drugs for use in least-developed nations. Apotex is to manufacture an antiretroviral fixed dose combination drug for Rwanda, which has raised the request through the framework of the World Trade Organisation’s TRIPS agreement. In May 2008, Apotex got the final go ahead to begin production. However, the company has since suggested that it would not be willing to undergo the process again, as it was too difficult.

Through Cangene, Apotex is active in the biosimilar area. One product, Leucotropin, is under review in Canada, while in the USA, Accretropin was approved in January 2008, but has not been marketed. In April 2008, Apotex entered an agreement to develop Neukine, a recombinant G-CSF, with INTAS Biopharmaceuticals for the European market.

This generics company report will help you to understand the dynamic and complex issues affecting the business of leading generic industry players. These informative reports provide an insight into the company, covering the structure of the business, the most recent quarterly and annual financial results, information on the company's active product lines and ANDA approvals, along with a review of major developments, such as M&A activity, strategic alliances, and litigation.


Contents: EXECUTIVE SUMMARY

INTRODUCTION

PRODUCTS
Apotex ANDA Approvals, 2002-09
Novex Pharma ANDA Approvals, 2002-05
TorPharm ANDA Approvals, 2002-05
Apotex awarded tender from Rwandan Government for ApoTriavir
Apotex to develop biosimilar G-CSF with IBP
Plavix (clopidogrel)
sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action
sanofi-aventis wins Canadian clopidogrel patent case against Apotex
Recent product approvals
rhGH (Cangene)

FINANCIAL RESULTS
Cangene
Cangene: financial results for fiscal years 2004 – 08, in C$000s
Cangene: financial results for fiscal years 2004 – 08, in US$000s
Biopharmaceutical operations
Cangene: biopharmaceutical operations results for fiscal years 2007 – 08, in C$000s
Cangene: financial results for fiscal years 2004 – 08, in US$000s

MAJOR DEVELOPMENTS
Mergers, acquisitions and agreements
BMP Sunstone launches Ferriprox in China
Apotex acquires Lareq Pharma
Topgen
Beijing Med-Pharm
Litigation
Pronova receives omega-3-acid Paragraph IV letters
Dorzolamide and timolol
Apotex prohibited from marketing generic Fortical under Unigene injunction
Apotex gains UK damages in perindopril case
US Federal Court affirms omeprazole ruling
Sanofi-aventis sues Apotex over docetaxel
Pfizer enters settlement agreement with Apotex over atorvastatin

APOTEX GENERIC COMPANIES ANALYSIS
Apotex loses ketorolac appeal
Meda and Apotex settle azelastine dispute
Apotex and GSK win pre-emption case
Pfizer to appeal Federal Court ruling on atorvastatin patent

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