Investment or Acquisition Opportunity

Investment or Acquisition Opportunity
Bioxel Project
TSX:BIP
www.bioxelpharma.com
January 2009
THE OPPORTUNITY
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On December 12, the Québec Superior Court appointed PricewaterhouseCoopers Corporate Finance Inc.
(“PwCCF”) as monitor of Bioxel Pharma Inc. (“Bioxel”). PwCCF will advise Bioxel during the process of
solicitating a strategic partner or a purchaser for its business or assets.
THE COMPANY
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Bioxel is a biopharmaceutical public company focused on the manufacture and distribution of taxane
pharmaceutical ingredients including paclitaxel, docetaxel, 9-DHB and 10-DAB. The Corporation has rolled out
an integrated taxane manufacturing chain that complies with the pharmaceutical industry’s highest standards.
Its customer base consists of generic and ethical pharmaceutical companies that develop and market taxanebased drug products. These drugs are widely used in oncology for the treatments of certain types of cancer,
including breast, lung, ovarian, stomach, prostate, head and neck cancers.
KEY INVESTMENT CONSIDERATIONS
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Bioxel’s docetaxel active pharmaceutical ingredient can be used to produce a generic version and/or a new
drug version of sanofi-aventis’s Taxotere (R) as soon as 2010: the form (Docetaxel Anhydrous), patented
manufacturing process (9-DHB) and formulation (Tween 80-free) make it possible to do so without infringing
any of sanofi-aventis’s patents, a market valued at US$2.8 billion in 2007 (management estimate);
Current products on the market, registered in 35 countries worldwide, include paclitaxel of natural origin, 10DAB and 9-DHB;
High-containment cGMP paclitaxel equipment, operated by a subcontractor at the subcontractor’s FDAinspected site in California;
Harvesting rights to 230,000 km2 of public and private land with a high density of Canadian yew, the world’s
largest natural reservoir for taxanes; and
Tax-losses carry-forward of approximately CA$35 million (income tax receivable of around CA$10.5 million).
INFORMATION MEMORANDUM AND SALES PROCESS
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PwCCF has been appointed as Bioxel’s monitor in relation to the process of solicitating a strategic partner.
All communications should be addressed to PwCCF.
An Investor Presentation is available to parties expressing an interest.
The deadline date to submit a non-binding expression of interest outlining the general terms of the
contemplated transaction is on or before January 21, 2009.
Should you have any questions regarding the opportunity, or desire to discuss specific questions regarding this
opportunity, please contact:
Frédéric Bouchard
Managing Director
Tel.: (514) 205-5079
Fax: (514) 205-5363
[email protected]
Sebastien Nadeau
Vice President
Tel.: (514) 205-5067
Fax: (514) 205-5363
[email protected]
Melania Sztyk
Analyst
Tel.: (514) 205-5673
Fax: (514) 205-5363
[email protected]
Bioxel’s Docetaxel IP Versus Sanofi‐aventis’s Taxotere IP (and Other Competitors) Sanofi‐aventis’s Taxotere IP is protected by three forms of coverage: 1) Composition of matter, protecting the rights to the docetaxel molecule. The first corresponding patent by sanofi‐aventis expires in May 2010 in the US and in Nov. 2010 in most European countries. (US Patent 4814470) Moreover, there are two forms of the docetaxel molecule that can be used in the finished product: • Docetaxel Anhydrous (used by Bioxel) • Docetaxel Tri‐hydrate (used in Taxotere) In addition to the first patent covering the docetaxel molecule, Bioxel has recently found that another patent currently covers the tri‐hydrate form of docetaxel used in Taxotere. This patent begins to expire in 2017 in some areas, continuing until 2019 in most countries (US Patent 6197980). Therefore, only the anhydrous form of docetaxel used by Bioxel will become off patent in 2010. 2) Manufacturing process of the molecule, protecting the rights to the docetaxel synthesis process used for the production of Taxotere. This process is covered by several patents with expiration dates ranging from 2010 to 2020. However, Bioxel can offer a non‐infringing manufacturing alternative to its clients. While sanofi‐aventis uses 10‐DAB as starting material to synthesize docetaxel, Bioxel uses 9‐DHB to perform this process. Bioxel believes that its unique proprietary manufacturing process would not infringe upon any of sanofi‐aventis’s patents on the synthesis of docetaxel. Additionally, to the best of Bioxel’s knowledge, all other docetaxel suppliers use 10‐DAB (used in Taxotere) as a starting material to produce docetaxel. Therefore, Bioxel’s 9‐DHB starting material and resulting manufacturing process is unique in allowing pharmaceutical companies market entry in 2010. 3) Formulation, protecting the rights to the excipient of the formulation, the surfactant Tween 80 (also called polysorbate 80). This patent will expire in 2012 in the US and in most European countries. Bioxel has recently discovered that certain developers of new docetaxel formulations are working on a new regulatory strategy: they are planning to initiate a registrational bioequivalence clinical study to prove that their formulations have at least the same efficacy 2009‐01‐07 and safety as Taxotere. This clinical study would enable fast‐track approval (505(b)(2)) of NDA applications for corresponding new products: to show the efficacy and safety of the new formulation, only one short pharmacokinetics clinical study on about 40 patients would be required, as opposed to a study consisting of three long clinical phases involving hundreds of patients. Therefore, Bioxel’s docetaxel becomes extremely attractive to developers of new docetaxel formulations, making them a new class of potential clients for the company. Using Bioxel’s anhydrous form of docetaxel along with its 9‐DHB manufacturing IP, these developers could be on the market with a generic version of Taxotere in 2010, without infringing any of sanofi‐aventis’s patents. Source: Bioxel Pharma Inc. 2009‐01‐07 MARKET OPPORTUNITY
Confidential
Source: Bioxel Pharma 2008 Investor Presentation
2009-01-06
MARKET OPPORTUNITY (Cont’d)
Confidential
Source: Bioxel Pharma 2008 Investor Presentation
2009-01-06
TANGIBLE ASSETS – Secured Biomass Supply
Quebec, Canada
Confidential
Source: Bioxel Pharma 2008 Investor Presentation
2009-01-06
TANGIBLE ASSETS
-Bioxel owns equipment to manufacture paclitaxel
-Subcontractor owns FDA Inspected cGMP Facility
Confidential
Source: Bioxel Pharma 2008 Investor Presentation
2009-01-06