Apotex Generics Company Intelligence Report

• Publication date: January 2011

Espicom's generics company reports 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, s...

Espicom's generics company reports 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.

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. The final shipment occurred in September 2009.

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.

In March 2010, the FDA issued Apotex with a Warning Letter, following an inspection of the firm's Toronto facility in the summer of 2009. This followed an Import Alert issued by the FDA in September 2009, following an earlier Warning Letter regarding an inspection of Apotex' Etobicoke facility.

Generic Drug Industry in Canada

Table of Contents

Executive Summary 1
Introduction 2
Products 3
Apotex ANDA Approvals, January 2002 – September 2010 4
ApoTriavir 6
Second and last Apotex CAMR shipment leaves for Rwanda 7
Plavix (clopidogrel) 8
sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action 9
sanofi-aventis wins Canadian clopidogrel patent case against Apotex 10
Apotex overturns Australian clopidogrel patent 10
Recent product approvals 11
Losartan and losartan / hydrochlorothiazide (US) 11
Atorvastatin (Canada) 11
CHMP adopts positive opinion on Apotex olanzapine product 11
Financial results 11
Cangene 11
Cangene: Fiscal Year Results, in C$000s 12
Cangene: Fiscal Year Results, in US$000s 12
Biopharmaceutical operations 12
Cangene: Biopharmaceutical Operations Fiscal Year Results, in C$000s 12
Cangene: Biopharmaceutical Operations Fiscal Year Results, in US$000s 12
Major developments 13
Apotex receives FDA warning letter 13
Mergers, acquisitions and agreements 15
Apotex sells group of products to AA Pharma 15
Apotex signs fentanyl agreement with Hisamitsu 15
Cangene acquires US commercialisation rights for HepaGam B 15
Litigation 15
Appellate court upholds budesonide injunction against Apotex 15
Mylan to appeal court paroxetine decision 16
Daiichi Sankyo settles cevimeline patent litigation with Apotex 17
AstraZeneca loses Canadian generic esomeprazole NOC request 17
Rosuvastatin patent upheld in court 18
Allergan sees brimonidine patent infringement victory 18
Unigene's Fortical patent valid 19

Generic Drug in Canada

Canada Generic Drug Sales, Us$bn, % Chg Y-o-y

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2021
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn

• $ 250
• Industry data
• January 2013

Yearly, From 2005 To 2021
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn, 5 Year Trailing Cagr, %

• $ 250
• Industry data
• January 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn, 5 Year Forward Cagr, %

• $ 250
• Industry data
• January 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn, 10 Year Forward Cagr, %

• $ 250
• Industry data
• January 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada