AEterna Zentaris has announced the termination of its agreement with Sanofi-Aventis signed in March 2009 for the development, commercialization and licensing of cetrorelix in benign prostatic hyperplasia, for the US market, following the company’s recent announcement of the results for its European Phase 3 study for cetrorelix in BPH.

Sanofi-Aventis has agreed to buy health-care company Chattem for about $1.9 billion in cash. Chattanooga is a maker of consumer health-care products such as Gold Bond skin care creams and Icy Hot pain relief medecine.

This week’s deal review shows no signs of a holiday showdown.  In Canada, BioMS’ deal with Spectral Diagnostics was interesting as a possible indicator of more to come and internationally, 5 new pharma deals were announced this morning including a $430 million deal that OncoGenex landed from Teva joining new links between Athersys and Pfizer, Lilly and Incyte, sanofi-aventis and Chattem and Seattle Genetics and GSK.  Check out the past week’s Canadian deal-making (and breaking)

Thallion Pharmaceuticals Inc. (TSX: TLN) signed a binding LOI with French company LFB Biotechnologies for the development of Shigamabs, Thallion’s product candidate for the treatment of Shiga toxin-producing bacterial infection. The partnership is subject to executing definitive agreements anticipated in first quarter of 2010, but the LOI provides for immediate funding by LFB of costs associated with the Shigamabs program. Under the agreement, LFB will receive commercial rights in Europe and South America, while Thallion retains rights to North America and the rest of the world.  Thallion can receive payments of up to approximately $150 million, including an up-front licensing fee of up to approximately $2.3 million, plus royalties. Thallion will continue to be responsible for the development of Shigamabs, while LFB will be responsible for manufacturing and supply.  

Thallion also sold a subordinated promissory note it was holding back to the issuer — Caprion Proteomics Ltd. – for an immediate cash payment of $1,850,000. The note was originally issued by Caprion to Thallion as part of the proceeds pursuant to the sale of Thallion’s proteomics business. Thallion will continue to retain its approximate 16% equity stake in Caprion.  

Other Licensing and Commercial Agreements 

TSO3 Inc. (TSX: TOS) announced a supply and distribution agreement with 3M Company (NYSE: MMM) for TSO3’s sterilizer systems. Terms of the deal were not disclosed, but do include some up-front license fee and milestone payments for regulatory clearance achievements as well as minimum annual purchases. TS03 Inc. also announced Health Canada approval of the sterilizer system for sale in Canada. The device will be made available through 3M Canada’s distribution in 2010. 

YM Biosciences (TSX: YM) and Therapure Biopharma announced that Therapure will provide fill and finish services for nimotuzumab, YM’s oncology monoclonal. 

Victhom Human Bionics Inc. (TSX: VHB) restructured its agreements with partner Ossur and sold certain Biotronix assets to Ossur for US$500,000.  Ossur will now take over the final stage of development and preparation for the commercial launch of the second generation Power Knee.

Securities

Resverlogix Corp. (TSX: RVX) signed a non-binding term sheet for a standby equity distribution agreement with a Yorkville Advisors fund. Resverlogix will have the option, at its discretion, to issue and sell up to $25 million of its common shares to to the fund, which would be obligated to buy up to $500,000 of any such shares in any ten-day period at a discount to market price. Full details as to the terms of the agreement will be disclosed on closing.

Medicago Inc. (TSXV: MDG) announced that it has converted its 16,100,000 subscription receipts (TSXV: MDG.R) into an equal number of units (one common share plus 1/2 of a $1.00 warrant exercisable through November 26, 2010). Following the conversion, Philip Morris will hold 39.35% of the outstanding common shares of Medicago and 50.3% of the common share purchase warrants.

M&A

SemBioSys Genetics Inc. (TSX: SBS) won approval from its securityholders for its plan of arrangement involving a reorganization with Cathedral Energy Services Income Trust and closed the deal later in the week.

Board Changes at LAB Research as Solidarity Fund QFL Nominees Come In

LAB Research Inc. (TSX: LRI), a Canadian-based non-clinical contract research organization, announced the nomination of Mr. Yvan Landry as a new Board member, and the resignation of Mr. Richard Lacombe. Mr. Landry is a certified management accountant and employee of the Solidarity Fund QFL, which has the right to nominate two individuals to the Board of LAB, including one employee of the Fund.  

Bad News Last

Ambrilia Biopharma (TSX: AMB) shut its facility and let a bunch of its remaining people go this week.  

ALERT B&C Corporation (TSXV: ACB) announced that it’s closing its Montreal facilities and eliminating the employee positions to conserve cash.

Transition Therapeutics (NASDAQ: TTHI, TSX: TTH) and Elan are pulling the two higher dose arms of the Phase II trial of ELND005 following adverse events.  The entire trial ends in April and the companies will reassess at that point.

Æterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ) and sanofi-aventis U.S. (NYSE: SNY) are terminating their development and commercialization license for cetrorelix, following the results for its European Phase 3 study for cetrorelix in BPH.

Thanks again to Jacob Cawker for help with this week’s deal review!

Sanofi-Aventis is recalling 800,000 doses of H1N1 vaccine meant for children younger than 3 because the vaccine has lost potency.

Hmmm…

From CNN:

The French manufacturer Sanofi Pasteur is voluntarily recalling about 800,000 doses of vaccine meant for children between the ages of 6 months and 35 months.

The company and the Centers for Disease Control and Prevention emphasized that the recall was not prompted by safety concerns, and that even though the vaccine isn’t quite as potent as it’s supposed to be, children who received it don’t have to be immunized again against H1N1.

The CDC emphasized that there is no danger for any child who received this type of vaccine.

When asked what parents should do, CDC spokesman Tom Skinner said, “absolutely nothing.” He said if children receive this vaccine, they will be fine.

Read more from the CDC

On December 10 2009 Sanofi-aventis and Alopexx Pharmaceuticals signed a collaboration agreement and option for a license on a first-in-class human monoclonal antibody, currently in pre-clinical development, for the prevention and treatment of S. aureus, S.epidermidis, E. coli, Y. pestis ( the bacterium that causes plague) and other serious infections. Alopexx is to bring the product into Phase I clinical trials during 2010, with an option for an exclusive worldwide license for sanofi-aventis at that point in time for development and a commercialisation license of the product. Alopexx is to receive an upfront payment and research funding from Sanofi-aventis and is eligible for development, regulatory and commercial milestone payments which could reach US$375 million in total, as well as royalties on sales of products commercialised under the license and collaboration.

TODAY’S NEWS

So…is Roche’s Tamiflu really that effective? – The effectiveness of Roche Holding AG’s Tamiflu in treating flu complications in healthy adults can’t be determined because the Swiss drugmaker wouldn’t supply data from eight studies, an independent research group said…more

The pharma layoff toll in 2009. Ugly.

Pfizer to move into biosimilars? Not a bad long-term strategy, actually: focused diversification – Pfizer Inc., which became the biggest drugmaker selling widely prescribed pills such as the Lipitor heart medicine, is preparing to enter the business of making cheaper copies of pricey, injectable drugs from biotechnology…more

Do those anti-depressants work? Maybe at a deeper level than previously thought – Antidepressant medications taken by roughly 7% of American adults cause profound personality changes in many patients with depression, far beyond simply lifting the veil of sadness, a study has found. Researchers saw strong drops in neuroticism and increases in extroversion in patients taking antidepressants, two of five traits thought to define personality and shape a person’s day-to-day thoughts and behavior. The findings are striking, researchers said, because psychologists have long thought that such fundamental traits are moorings of an adult’s personality that shift very little over a lifetime…more

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On December 9 2009 Generex Biotechnology Corporation signed a long-term agreement with Sanofi-Aventis Deutschland GmbH for the manufacture and supply of recombinant human insulin crystals for commercial and clinical trial use in Generex’s proprietary buccal insulin spray product, Generex Oral-lyn(TM). The financial terms of the arrangement were not disclosed.

The Supply agreement provides Generex with a source of insulin for major regulatory markets including the United States and Canada and a number of other regions where the Company is pursuing regulatory approvals for Generex Oral-lyn. Generex’s regulatory team will commence the process of updating any and all current submissions to include Sanofi-aventis’ insulin crystal which will be formulated in the Generex Oral-lyn commercial product.

In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents.   Generics manufacturers can do so either by accepting the terms of the patents, or by filing a Notice of Allegation (NOA) alleging, amongst other things, that they will not infringe the patent or that the patent is invalid.

Three recent decisions litigated in this context contain important notes for pharma companies, biotech companies, generics companies and their patent attorneys and agents. 

1. The Patent Act (post-1996) Imposes a Duty of Candour and Good Faith. In Lundbeck Canada Inc. et al  v. Ratiopharm Inc., Lundbeck’s patent was invalidated because the patent agents failed to “fully and fairly describe[]” the prior art in responding to an obviousness rejection raised by the patent examiner.  This decision may take on a broader impact, particularly if it is interpreted to require Canadian applicants to affirmatively inform examiners of aspects of the prior art that are both favourable and unfavourable.
2. Formulation Patents Must Claim All Medicinal Ingredients.  In Bayer Inc. v. Canada (Minister of Health) et. al., Bayer’s patent was held to be ineligible for listing on the Patent Register, despite reading on the product.  Where the approved product contains a formulation with more than one medicinal ingredient, only patents that claim formulations containing all of the approved medicinal ingredients may be listed on the Patent Register, regardless of whether the product is covered by the patent claims.
3. Disclaimers Can Be Validly Filed After Receipt of a NOA.  In sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, sanofi responded to Hospira’s NOA by filing a disclaimer in respect of a portion of one of sanofi’s listed patents.  Hospira argued that the Court should consider the sanofi patent as it read on the date the NOA was served and not as it read after the disclaimer was filed.  Although the court held (in favour of sanofi) that the patent should be read as of the date of the hearing, it also held that sanofi’s particular disclaimer was invalid because the patentee had not unequivocally testified that the disclaimer was a result of claiming too broadly in the patent as issued. Such an admission was necessary to the validity of the disclaimer.  The court also held that having attempted a disclaimer, sanofi could not subsequently assert against Hospira the portions of the patent it had attempted to disclaim.

Thanks to Kavita Ramamoorthy and the whole Life Sciences team.

How many partners does Sanofi-aventis have?

Like many pharmaceutical companies Sanofi-aventis does not reveal its exact number of alliances, but in 2008 the company’s Anuual Report indicated the company was stepping up the number of alliances it would like to enter. Some idea of how busy the company is in the alliance space is the fact that the company announced the signing of seven key alliances in the seven months between May and November 2009.

In its Annual Report for 2008 the company listed that its income from alliance agreements was €472 million in 2008, €323 million in 2007 and €382 million in 2006.

According to the company’s partnering brochure more than 25% of the products in Sanofi-aventis’s pipeline were developed through partnerships and more than 30% of its net sales in 2008 came from products developed through partnerships or alliances. Presently 27% of the molecules now in development at Sanofi-aventis originate from external collaborations.

Three of the company’s leading products were developed and are marketed through partnerships with other companies: Bristol-Myers Squibb, Procter & Gamble and Teva Pharmaceuticals.

Sanofi-aventis’ current assets in terms of receivables (source: SEC Form 20-F, 2008)

* This line mainly comprises amounts due from alliance partners, advance payments to suppliers, sales commission receivable, and amounts due from employees.

How does Sanofi-aventis form alliances?

Sanofi-aventis has a team dedicated to sourcing and managing alliances. These teams are based in the following departments: R&D External Innovation and Corporate Business Development.

In November 2009 Christopher Viehbacher, the Chief Executive of Sanofi-Aventis, indicated that the company was looking to up aventure capital fund to help develop strategic partnerships with drug-developers.

Who are Sanofi-aventis’s partners?

Ajinomoto, Becton Dickinson, BioWa, Bristol-Myers Squibb, Coley, Crucell, DNDi, Dyax, Exelixis, Genfit, Human Genome Sciences, Johns Hopkins University, Novozymes, IDM, Immunogen, Innogenetics, Inserm, Institutes of Biological Sciences (Shanghai), Institute of Hematology and blood diseases Hospital in Tianjin (China ), Intercell, Kyowa Hakko Kirin, Malaria Venture, Maxigen, Merrimack, Micromet, Oxford BioMedica, Procter & Gamble, RainDance Technologies, Regeneron, Salk Institute, SSI, Taiho Pharmaceutical Co Ltd, Teva Pharmaceutical, UCB, University Louis Pasteur, University of Pennsylvania, Vactech, Wayne State University, Wellstat Therapeutics and Zealand Pharma,

Some key collaborations has Sanofi-aventis entered into over the past few years?

• In October 2009 Sanofi-aventis and Micromet signed a global collaboration and license agreement to develop a BiTE® antibody against an antigen present at the surface of carcinoma cells. BiTE antibodies are novel therapeutic antibodies that activate patients’ T cells to seek out and destroy cancer cells. Under the agreement Micromet is responsible for the discovery, research and development of the BiTE antibody through the completion of phase 1 clinical trials under the supervision of a Joint Steering Committee. Sanofi-aventis will then have the full responsibility for the further development, as well as for the worldwide commercialization of the BiTE antibody. Micromet received an upfront cash payment of 8 million euros and is eligible for development and regulatory milestone payments of up to 162 million euros, royalties on worldwide product sales and will receive additional performance-based sales milestones of up to 150 million euros.
• In October 2009 Sanofi-aventis and Wellstat Therapeutics entered a global licensing agreement on PN2034, a novel oral first-in-class, insulin sensitizer, for the treatment of Type II Diabetes, currently in Phase II clinical testing. Under this agreement, Sanofi-aventis received an exclusive worldwide license to develop, manufacture and commercialise PN2034 and related compounds. Wellstat Therapeutics received an upfront cash payment for the development, manufacturing and commercialisation rights, and is eligible for $350 million in development and regulatory milestone payments. Wellstat Therapeutics is also to receive royalties on the worldwide product sales and performance based sales milestones.
• In October 2009 Sanofi-aventis and Merrimack Pharmaceuticals entered an agreement whereby Sanofi-aventis woul receive an exclusive worldwide license to develop, manufacture and commercialise MM-121, a first-in-class, fully human monoclonal antibody in phase 1 clinical testing designed to block signaling of the ErbB3 (also known as HER3) receptor, for the management of solid malignancies. Under the agreement, Merrimack retained potential co-promotion rights in the US. Merrimack received an upfront cash payment of US$60 million for the research, development, manufacturing and commercialisation rights and is eligible for development and regulatory milestone payments up to US$410 million on MM-121, royalties on the worldwide product sales and could receive additional performance milestones of up to US$60 million on worldwide sales. Merrimack is participating in the development of MM-121.
• In May 2009 Sanofi-aventis and Exelixis entered a global license agreement for XL147 and XL765 and an exclusive collaboration for the discovery of inhibitors of phosphoinositide-3 kinase (PI3K) for the management of solid malignancies. The agreement granted Sanofi-aventis an exclusive worldwide license to both compounds which are currently in phase 1 clinical trials. Sanofi-aventis has sole responsibility for all subsequent clinical, regulatory, manufacturing and commercial activities while Exelixis is to participate in ongoing and future clinical trials. The two companies are combining their research efforts to establish several preclinical programmes related to isoform-selective inhibitors of PI3K with Sanofi-aventis taking sole responsibility for all subsequent clinical, regulatory, commercial and manufacturing activities of the products that result from the collaboration and Exelixis taking responsibility for conducting certain clinical trials. Exelixis received an upfront cash payment and is eligible for development and regulatory milestone payments that could reach over $1 billion in aggregate for existing and future programmes. In addition, Exelixis is entitled to receive royalties and commercial milestones on sales when products are commercialised.
• In May 2009 Sanofi-aventis and the non-profit Drugs for Neglected Diseases initiative (DNDi)signed an agreement for the development, manufacturing and distribution of fexinidazole, a promising new drug for the treatment of human African trypanosomiasis, also known as sleeping sickness, a fatal disease that threatens 60 million people in Sub-Saharan Africa.
• In May 2009 Sanofi-aventis and Kyowa Hakko Kirin Co Ltd signed a collaboration and licensing agreement whereby Sanofi-aventis received worldwide rights to Kyowa Hakko Kirin’s anti-LIGHT fully human monoclonal antibody. Presently in the preclinical stage the antibody is expected to be a first in class therapy for ulcerative colitis and in Crohn’s disease. Under the agreement the antibody might also be pursued for other indications such as rheumatoid arthritis. Sanofi-aventis has exclusive rights to develop the product worldwide, except in Japan and Asian countries where both parties will co-develop the product. Kyowa Hakko Kirin retained the rights to market the product in Japan and in Asia, while sanofi-aventis gained exclusive rights to market and sell the product in the rest of the world. Each party has an option to co-promote the product in the territory of the other party. Kyowa Hakko Kirin received an upfront payment and is eligible for a totla of US$315 million in development milestone payments as well as royalties on sales when the product is commercialised.
• In December 2008 Sanofi-aventis signed a global licensing and collaboration agreement with Novozymes for the development and commercialisation of a new antibiotic named plectasin NZ2114 that targets the treatment of severe infections such as pneumonia and septicemia. Sanofi-aventis gained an exclusive worldwide license for the development, registration, and commercialisation of the drug. Both companies are working jointly to develop and implement industrial-scale manufacturing of the drug using a recombinant process that builds on Novozyme’s proprietary expression technology. Milestone payments under the agreement could reach up to US$64 million.
• In February 2008, Sanofi-aventis obtained an exclusive worldwide license for the development and commercialisation of Dyax Corporation’s fully human monoclonal antibody DX-2240, as well as a worldwide non-exclusive license to Dyax’s proprietary Phage Display technology. In return Dyax is eligible to receive up to US$270 million in license fees and milestone payments if the antibody is successfully commercialised for three indications and in one indication for the first antibody candidates developed by Sanofi-aventis alone using the Phage Display technology.
• In December 2007 Ssanofi Pasteur signed an exclusive collaboration and commercialisation agreement with Crucell NV for Crucell’s rabies monoclonal antibodies. Under the terms of the agreement, Crucell
  was to continue to develop and manufacture the product. The contract includes milestone payments that could reach US$53 million.
• In March 2007 Sanofi-aventis and Oxford BioMedica entered into an exclusive global license agreement to develop and commercialize TroVax® for the treatment and prevention of cancers. Under the agreement Oxford BioMedica could receive up €450 million in milestone payments and is also entitled to escalating royalties on global sales of TroVax®, and to sales milestone payments if and when net sales of TroVax® reach certain levels.
• In November 2007 Sanofi-aventis signed an agreement with Regeneron to discover, develop and commercialise fully-human therapeutic antibodies. Sanofi-aventis is to provide up to $416 million for research funding over the next five years. Sanofi-aventis has an option to extend the research agreement for an additional three years. Under the terms of the development agreement, Sanofi-aventis is to fund 100% of the development costs. Once a product begins to be marketed, Regeneron will repay out of its profits (provided they are sufficient) half of the development costs borne by Sanofi-aventis. In addition, Regeneron is entitled to receive up to a total of US$250 million of sales milestone payments when the collaboration achieves certain aggregate annual excluding US sales levels. The two companies extended the alliance in November 2009 taking the collaboration up to 2018 and increasing Sanofi-Aventis’s funding of the project to US$160 million a year.
• In September 2003, Sanofi-aventis signed a collaboration agreement with Regeneron in oncology to develop the Vascular Endothelial Growth Factor (VEGF) Trap program. Under the agreement Regeneron is entitled to development milestone payments and royalties on VEGF Trap sales that could reach US$400 million if all indications specified in the contract obtain approval in the United States, Europe and Japan. Sanofi-aventis is to pay 100% of the development costs of the VEGF Trap. Once a VEGF Trap product starts to be marketed, Regeneron will repay 50% of the development costs (originally paid by Sanofi-aventis) in accordance with a formula based on Regeneron’s share of the profits, including royalties received in Japan. In 2005, the VEGF Trap program was extended to Japan, and the treatment of ocular pathologies was excluded from the scope of the collaboration agreement.

The CEO of Sanofi-Aventis recently laid out a new plan for encouraging innovation within his company that differs drastically from the one that formerly existed there, and which differs from the typical model employed in most pharmaceutical companies.  The question is, will it stick?

Chris Viehbacher made a strong commitment to open innovation in his statement to the Financial Times, saying Sanofi-Aventis historically had “not a lot of external partnerships”, nor “[any] contact with our commercial organizations,” which along with the admitted complexity of the organization, combined to “kill the innovative spirit.”

Viehbacher’s commitment to change comes not long after Pfizer’s co-development of an online community to accelerate clinical research.   Two of the biggest pharmaceutical companies in the world are now actively or committed to relying on open innovation in significant ways; one (Pfizer) to expedite the time to market, and the other (Sanofi-Aventis) to ostensibly improve the quantity and quality of ideas coming out of their R&D.  It appears that, while some companies are willing to take advantage of the poor economy to acquire companies which are then grafted onto the buyer, others are making more substantive changes that require patience (but tend to cost less).  To apply a baseball metaphor, some companies are the Yankees, acquiring expensive but proven free agents (that are further along in their careers), while others are like the Red Sox, with money to spend but still willing to develop young players via smaller-scale acquisitions (i.e. the amateur draft).

The main sign of Sanofi-Aventis’s commitment to this plan is their lack of blockbuster acquisitions.  This stands in sharp contrast to Merck’s acquisition of Schering-Plough, among other major acquisitions in 2009.  Sanofi-Aventis will be an interesting company to watch over the next 6-12 months, because their message should attract many small companies with interesting ideas who would normally refuse to deal with a company of their size for fear of being swallowed completely.  Instead, Mr. Viehbacher seems to be saying, “We will nurture you from afar instead of possibly tainting your idea with our corporate philosophy which demands that all ideas be driven towards billion-dollar drugs or the discard pile.”

What happens when the economy recovers or the next blockbuster comes along (or doesn’t)?  Will the CEO stick to this philosophy?  Reverting back to the baseball metaphor, what if Mr. Viehbacher, under pressure from their board of directors and shareholders to extract value from these companies that were allowed to innovate away from corporate pressures (especially since pharmaceutical R&D is a notorious time and money sink), pulls a Steinbrenner and begins micro-managing these companies?  Many corporate strategies over the past year were initiated as moves of desperation to keep their company afloat, or to get some publicity; the fact that a positive change may have occurred was welcome but incidental.  The economic downturn probably got more companies thinking about innovation only as a way to seem innovative.  Sanofi-Aventis, through the statements of its CEO, seems committed to this new direction, which is encouraging, but I’ll be a believer when their actions follow suit.

Are you interested in biology?

The Sanofi-Aventis BioTalent Challenge (SABC) encourages young Canadians to pursue studies and careers in the exciting field of biotechnology.

Apply at:

http://sanofibiotalentchallenge.ca/

It’s Thanksgiving week! We’ll plan on publishing the Daily on Monday/Tuesday, then take the rest of the week off from news reporting. Unless somebody buys somebody else. That, we’ll report!

TODAY’S NEWS

Sanofi chief wants to do things differently. Liked this juicy quote:  Mr Viehbacher added: “The best scientists are often lousy leaders [and] managers. You had a research and development god who hoped a blockbuster emerged. When it didn’t, you merged. The model was flawed. I think the mistake we made in our industry was, we made R&D organisations that were very big, very complex, very difficult to manage, and we killed the innovative spirit”…more

Morphine – kill pain, grow tumors?? – Two new studies add to growing evidence that morphine and other opiate-based painkillers may promote the growth and spread of cancer cells…more

Pfizer reaps one of the consequences of merging: inherited lawsuits – Two Pfizer Inc. units’ hormone- replacement therapy drugs caused an Illinois woman’s breast cancer, making them liable for at least $6.3 million in damages, a Philadelphia jury ruled today…more

B-I hoping to take a big bite out of warfarin – Just 2.4 percent of patients given Pradaxa for six months after their initial treatment developed clots in the legs and lungs, similar to the 2.2 percent rate for those given the generic drug warfarin, according to an abstract of the so-called Recover study posted on the American Society of Hematology Web site last week. There was no increased risk of major bleeding, a complication of blood-thinning treatments…more

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About

- Share ownership (January 2009): 11.29% by Total ; 8.99% by L’Oréal (30.8% by the Bettencourt Family, 29.6% by Nestlé).
- Share ownership (January 2008): 12.70% by Total ; 8.66% by L’Oréal.
- Share ownership (March 2007): 13.12% by Total ; 10.52% by L’Oréal.
- Share ownership (January 2006): 12.74% by Total ; 10.21% by L’Oréal.
- Share ownership (January 2005): 12.65% by Total ; 10.13% by L’Oréal.
- Sanofi-Synthélabo Share ownership (January 2004): 24.35% by Total ; 19.52% by L’Oréal.
- Sanofi-Synthélabo Share ownership (after the merger): 35.3% by Total ; 19.52% by L’Oréal.
- Full member of the European Federation of Pharmaceutical Industries and Associations.

Jean-Marc Bruel (1936-)
- Board of Directors since 2004 (-2010).
- President and Chairman of Firmenich S.A. and Board of Villette-Entreprises Foundation.
- Vice-Chairman (1992) and President (1987-1992) of Groupe Rhône-Poulenc.
- Board of Directors at Rhodia S.A. (2002).
- Supervisory Board of Banque Paribas.
- Director of Surveillance of Aventis, Ecole Centrale de Paris, and Institut Curie.

Klaus Pohle (1938-)
- Board of Directors since August 2004 (-2012).
- Chairman of the German Accounting Standards Board (GASB).
- Vice-Chairman of the Supervisory Board of Hypo Real Estate Holding AG (Germany).
- Director of Labelux Group GmbH (Austria).
- Supervisory Board and Chairman of the Audit Committee of DWS Investment GmbH (Germany).
- Director and Chairman of the Audit Committee of Coty Inc., New York.

Jean-René Fourtou (1940-)
- Board of Directors since 2004 (-2012).
- Board of Directors of Nestlé (since 2006); Cap Gemini SA (since 2002), France; NBC Universal, USA; Maroc Télécom, Morocco; Schneider Electric; La Poste; Pernod-Ricard SA; and Rhodia.
- Chairman of the Supervisory Board of Canal+ Group, France.
- Vice Chairman of the Supervisory Board of AXA Group.
- Consulting Engineer in organizational management at Bossard & Michel (1963-1972).
- CEO of Bossard Consultants (1972).
- Chairman and CEO of the Bossard Group (1977-1986).
- Chairman and CEO of Rhône-Poulenc Group (1986-1999).
- Chairman (1992-1993) and Honorary Chairman of the Association of Companies for the Environment.
- Chairman (1992-1994) and Honorary Chairman of the French Movement for Quality.
- Vice Chairman of the Management Board and Managing Director of Aventis (1999-2002).
- Director of European Aeronautic Defence and Space Company (2000).
- Chairman and CEO (2002-2005) and Chairman of the Supervisory Board (2005) of Vivendi.
- Chairman (2003-2004) and Honorary Chairman of International Chamber of Commerce.
- Commander of the Legion of Honour in 2008, Officer of the Legion of Honour in 1996 and Commander of the National Order of Merit in 2003.
- Commander of the Order of Ouissam Alaouite (Morocco, 2005) and Commander of the Order of Ouissam al Moukafaa al Watanya (Morocco, 2005).

Jean-Francois Dehecq (1940-)
- Chairman of the Board of Directors (-2011).
- President of Sanofi-Synthélabo Daiichi Pharmaceuticals Co. Ltd.
- Permanent Representative of Sanofi-Synthélabo at the Board of Sanofi-Synthélabo Recherche (France), Director of Fujisawa Sanofi-Synthélabo (Japan), and Sanofi-Synthélabo Inc. (United States).
- President of The European Federation of Pharmaceutical Industries and Associations.
- Director of Finance at Management (France), Financière Yves Rocher (France) and Laboratoires Daiichi Sanofi-Synthélabo (France).
- Chairman of Policy Committee of the French Strategic Investment Found.
- Director of Air France, Air France-KLM, (since 1995); Agence Nationale de la Recherche; Pechiney (since 1994); Balmain (Belgium); Paris EUROPLACE; and Veolia Environnement (since 2006).
- Member of IFPMA (International Federation of Pharmaceutical Manufacturers Associations); and Fondation Francaise pour la Recherche sur l’Epilepsie.
- Chairman of Association Nationale de la Recherche Technique.
- Graduate and Chairman of the Board of Directors of ENSAM (Ecole Nationale Superieure d’Arts et Metiers).
- Supervisory Board of the Agency for Industrial Innovation.
- After teaching mathematics at the Saint-Vincent de Senlis Catholic College, secondary school, (1964-1965), became a trainee in scientific research in the Army’s Nuclear Propulsion Department.
- Economics departments (1965-1969) and assistant to management (1969-1970) at Elf Aquitaine.
- Operating engineer at the Lacq Factory (1970-1971).
- Managing Director (1971), Managing Director (1982-1988) and Vice-President of Sanofi.
- Executive Vice President of Health at ELF Aquitaine Group (1988).
- President and Director-General of Sanofi-Synthelabo (1999).
- President and Director-General (until December 2006) and President (January 2007) of Sanofi-Aventis.
- Former Director of Alcan France S.A.S.

Gerard Van Kemmel (1940-)
- Board of Directors since 2003 (-2012).
- Director of Groupe Eurotunnel, Eurotunnel NRS Holders Company Limited (UK), and GET SA (since 2008).
- Audit Committee and Director of Europacorp (since 2008).
- President of Europe Middle East Africa Division (2001) and President Europe (2002-2004) of Novell Inc.
- Senior Vice President (1997-1999), Chief Operating Officer and Executive Vice President (1999-2001) of Cambridge Technology Partners Massachusetts Inc.
- Technical Advisor to the French Minister of Finance (1996-1997).
- Chairman of Continental Europe for Peter Chadwick Holdings Limited (1997).
- 1966-1996: Many positions at Andersen Consulting.
- Graduated from Hautes Etudes Commerciales in Paris and MBA from Stanford Business School.

Gunter Thielen (1944-)
- Board of Directors since 2008 (-2011).
- Chief Executive Officer of Thiel Logistik AG.
- Chairman and Chief Executive Officer of Bertelsmann AG.
- Non-Executive Director of RTL Group S.A. (2002-2007).
- Supervisory Board of Arcandor AG; Sixt Aktiengesellschaft (2008); Leipziger Messe GmbH; Groupe Bruxelles Lambert; Hannoversche Leben VVaG; Saar LB; and Gruner & Jahr Ag & Druck-und Verlagshaus.
- Chairman of the Board and Director of Arvato AG.
- Executive Board of Berryville Graphics Inc.; Cobrhi S.A.; Bertelsmann Holding Spain S.A. (Sony Music Entertainment Inc.).
- Head of Management of Maul-Belser (1980).

Igor Landau (1945-)
- Board of Directors since 2004 (-2011).
- Board of Directors of HSBC France.
- Supervisory Board of Adidas AG (deputy chairman) and Allianz.
- President of La Compagnie du Roneo (1968–1970).
- Consultant of McKinsey & Company (1971–1975).
- Deputy to President in health division (1975–1977), executive vice president in health division (1977–1980), president of health division (1980–1992), and president (1992–1998) at Rhône-Poulenc Group.
- President of pharmaceutical division and board member (1998–2002) and chairman and CEO (2002–2004) of Aventis.

Arthur Charles Valerian Douro (1946-)
- Board of Directors since 2002 (-2010).
- Director of Pernod-Ricard SA; Compagnie Financière Richemont AG (Switzerland); GAM Worldwide (UK); and Abengeo Bioenergy (Spain).
- Commissioner of English Heritage.
- Senior Advisor of Calyon (UK).
- Chairman of Richemont Holdings Limited; Framlington Group; Kings College London; Sun Life & Provincial Holdings, AXA, (1995-2000); and Dunhill Holdings.
- Deputy Chairman of Vendôme Luxury Group.
- Non-Executive Director of Compagnie Financiere Richemont AG (2000).
- Member of the European Parliament (1979-1989).
- MA degree from Oxford University.

Owe Bicker, M.D., Ph.D. (1946-)
- Board of Directors since 2008 (-2012).
- Professor of University of Heidelberg Medical School.
- Managing Director of Behringwerke AG.
- Executive Chairman of Scil Holding GmbH.
- Chairman of the Supervisory Board of Dade Behring Holding GmbH (2005).
- Supervisory Board (2005) and Deputy Chairman of Supervisory Board at Epigenomics AG.
- Board of the University Marburg.
- Board of Trustees of the Aventis Foundation.
- Non-Executive Director of Oxford GlycoSciences Plc.
- Board member of HoechstMarionRoussel AG; Bertelsmann Stiftung (2008); and Boehringer Mannheim GmbH (Roche AG).
- Advisory Board at CVC Capital Partners Ltd.
- Supervisory Board member of Future Capital, and Definiens AG.
- Director of MedImmune Limited (1999).

Robert Castaigne (1946-)
- Board of Directors since 2000 (-2010).
- Begining Career (1972); Secretary of the Executive committee (1985-1990); Vice Chief Financial Officer and Member of the Steering committee (1990-1994); Chief Financial Officer (1994-2008) of Total S.A.
- Chairman of the Board of Directors of Total Chimie and Total Nucléaire.
- Director of Hutchinson S.A.; Petrofina; TEP Algérie; Omnium Insurance and Reinsurance Company Limited; Société Financière d’Auteuil; Eramet S.A. (1999); and Compagnie Générale de Géophysique-Veritas (1992-2004).
- Non-executive director of Vinci (2007), and Compagnie nationale à portefeuille (2008).
- Director of Total Nigeria Ltd.; Total Fina Elf Exploration Norge; Total Fina Elf Holdings UK; Total Fina Elf Exploration UK; Total Gabon; Total Gestion Filiales; Atofina Petrochemicals Inc.; Elf Aquitaine.

Thierry Desmarest (1946-)
- Board of Directors since 2000 (-2011).
- Management positions (1981), President of Exploration & Production, Chief Executive Officer (1995-2007) and Chairman of Total S.A.
- Director of Bombardier Inc. (2009); Air Liquide Tunisie (1999); Paris EUROPLACE; Air Liquide Canada Inc.; Renault SAS; and Renault SA.
- Chairman and Chief Executive Officer of Paulstra CRC Corporation.
- Supervisory Board of Areva.
- Advisory Council of Banque de France.
- Technical Advisor at the Ministry of Industry and the Ministry of Economic Affairs of the Government of France.

Lindsay Owen-Jones (1946-)
- Board of Directors since 1999 (-2012).
- Director of Ferrari S.P.A.; BNP Paribas (1989); and Gesparal.
- Director (1994-2001) and Vice Chairman of Supervisory Board (2001-2009) of L’Air Liquide SA.
- Chairman of Galderma Pharma S.A., Switzerland.
- Chief Executive Officer of L’Oréal Group and its subsidiary L’Oreal S.A. (1988-2006) and Chairman (2006).
- President of L’Oréal USA (1981-1984).
- Chief Executive of L’Oréal Italy (1978-1981).
- MBA from Oxford University in 1968.
- Commander of the Légion d’Honneur and Commander and Knight Commander of the British Empire.

How big is Big Pharma? In case you have ever wondered just how much revenue is generated in Big Pharma and from which countries it derives from, here is a great visual of revenue generated and expenditures in the pharmaceutical industry and from which global region in 2008. Pfizer, GSK, Johnson & Johnson, Bayer, Roche Group and Sanofi Aventis make up the big dogs in this industry. Considering most industries are in a financial meltdown, the pharmaceutical industry continues to grow and prosper, which is only good news for job market.

Growth is Strong in the Pharmaceutical Industry

* Information from Pharma News.

About

- Share ownership (January 2009): 11.29% by Total ; 8.99% by L’Oréal (30.8% by the Bettencourt Family, 29.6% by Nestlé).
- Share ownership (January 2008): 12.70% by Total ; 8.66% by L’Oréal.
- Share ownership (March 2007): 13.12% by Total ; 10.52% by L’Oréal.
- Share ownership (January 2006): 12.74% by Total ; 10.21% by L’Oréal.
- Share ownership (January 2005): 12.65% by Total ; 10.13% by L’Oréal.
- Sanofi-Synthélabo Share ownership (January 2004): 24.35% by Total ; 19.52% by L’Oréal.
- Sanofi-Synthélabo Share ownership (after the merger): 35.3% by Total ; 19.52% by L’Oréal.
- Full member of the European Federation of Pharmaceutical Industries and Associations.

Christopher A. Viehbacher
- Chief Executive Officer since December 2008.
- Career beginning at PriceWaterhouseCoopers.
- 1988-2008: At GlaxoSmithKline. Last position: President, Pharmaceutical Operations North America, member of the board and Co-Chairman of the Portfolio Management Board.
- Board member of PhRMA in the United States.
- German and Canadian nationalities and knight of the French Legion of Honor in 2003.

Jérôme Contamine
- Executive Vice President and Chief Financial Officer since March 2009.
- Graduate of Ecole Polytechnique, France’s most prestigious engineering school, and ENSAE, the national statistics and economics engineering school, affiliated with the Ministry of Finance (1982).
- Graduated from the elite Ecole Nationale d’Administration opting for the Court of Audit of France in 1984.
- Advisor to the Chief Financial Officer (1988) and Group Finance Director & Treasurer (1991) at Elf Aquitaine.
- General Manager of Elf Petroleum Norway (1995).
- Deputy Vice President of Elf Upstream Division for Europe and the U.S.
- Head of the taskforce for integration with Total (1999), in charge of the reorganization of the merged entity, TotalFinaElf.
- Vice President Europe and Central Asia Upstream Division of Total (2000).
- CFO and Deputy General Manager of Vivendi Environnement (2000).
- Senior Executive Vice President, Deputy General Manager and Chief Financial Officer of Veolia Environment (2003).

Hanspeter Spek
- Executive Vice President Pharmaceutical Operations since August 2004.
- Management training program at Pfizer International, and joined Pfizer RFA as a junior product manager and various positions.
- Marketing Director at Sanofi Pharma GmbH, a German subsidiary of Sanofi, in 1985, and various positions in Germany and France.
- Senior Vice President Europe following the merger with Synthélabo in 1999.
- Executive Vice President International Operations (2000-2003).
- Worldwide operations of Sanofi-Synthélabo (2003-2004).

Marc Cluzel
- Senior Vice President Research and Development (Scientific and Medical Affairs) since January 2007.
- Researcher at Johns Hopkins University (Baltimore) and Guy’s Hospital (London).
- At Sanofi Recherche as Clinical pharmacologist (1991), Senior Project Director (1993), Vice President Research Projects Management (1996), Vice President International Development (2001).

Laurence Debroux
- Senior Vice President Chief Strategic Officer since February 2009.
- Graduate of Ecole des Hautes Etudes Commerciales.
- Career begining at Merrill Lynch in London.
- Finance Department of the Elf Aquitaine Group, Total, (1993-1996).
- Corporate Treasurer (1996), Head of Financing/Treasury (1997), Head of Strategic Planning (2000-2004), Deputy Chief Financial Officer (2004-2007), Senior Vice President Chief Financial Officer (2007) at Sanofi Group.

Karen Linehan
- Senior Vice President Legal Affairs and General Counsel since March 2007.
- Bachelor of arts and juris doctorate degrees from Georgetown University.
- Congressional staff of the Speaker of the U.S. House of Representatives (1977-1986).
- Associate in a law firm in New York (1986-1996).
- Assistant General Counsel of US Sanofi subsidiary (1996) and positions at Sanofi Group within the Legal Department like Vice President Deputy Head of Legal Operations.

Philippe Luscan
- Senior Vice President Industrial Affairs.
- Graduated from Ecole Polytechnique and Ecole des Mines of Paris in biotechnologies.
- Head of production at Danone (1987).
- Head of site at Sanofi Chemistry in Sisteron (1990), Head of industrial affairs at Sanofi in the United States, Vice President Supply Chain, Vice President Chemistry (2006).

Gilles Lhernould
- New position of Senior Vice President Corporate Social Responsibility since October 2009.
- Senior Vice President Human Resources (2008-2009).
- Variety of positions within the Sanofi Group, Director of Operational Human Resources for Sanofi, Vice President of Information Systems, Senior Vice President Industrial Affairs (2001).
- Manufacturing supervisor at Laboratoires Bruneau.
- Diploma in pharmacy and masters degree in industrial pharmaceutics.

Roberto Pucci
- Senior Vice President Human Resources since October 2009.
- Executive Vice President Human Resources for the Fiat Group in Torino, Italy (2007).
- Senior Vice President Human Resources at Case New Holland, a U.S. subsidiary of the Fiat Group (2005).
- Director Compensation & Benefits (1999) and Vice President Human Resources Europe (2003) for Agilent Technologies, a spin off from Hewlett-Packard.
- Various positions in Human Resources in Switzerland and Italy including HR Manager for the European Headquarter and Human Resources Director in Italy at Hewlett-Packard (1987).
- External auditor at Coopers & Lybrand in Geneva, Switzerland (1985).
- Law degree from the University of Lausanne, Switzerland.

Philippe Fauchet
- Senior Vice President Business Development since January 2009.
- Graduate of Ecole des Hautes Etudes Commerciales, and law degree.
- At a subsidiary of Renault (1982-1984).
- Number of posts in France, Japan and Korea at Roussel Uclaf (1984).
- Vice President of the Asia-Pacific region for Hoechst Marion Roussel.
- At Sanofi (1996), head of the Eastern Europe region (1997), Vice President Eastern Europe for Sanofi-Synthélabo (1999), head of Sanofi-Synthélabo’s Japanese operations (2001), Senior Vice President Pharmaceuticals Operation Japan (2005).
- Advisor to the French Foreign Trade Commission.

Marie-Hélène Laimay
- Senior Vice President Audit and Internal Control Assessment since August 2004.
- Auditor with Ernst & Young (1982-1985).
- Sanofi (1985) in a variety of financial positions, Vice President Internal Audit (2000-2002), Senior Vice President Chief Financial Officer (2002-2004).

Christian Lajoux
- Senior Vice President Pharmaceutical Operations France since August 2004.
- Degree in psychology, Master Degree in Philosophy from Nancy University, and Advanced Management degree from Paris IAE.
- Variety of positions at Sandoz, including Division Director.
- Sanofi Winthrop (1993), various positions including Director of Operations and Managing Director of Sanofi Winthrop France, Senior Vice President France (1999-2003), Senior Vice President Europe (2003-2004).
- Chairman of the French Pharmaceutical Companies Association (LEEM, Les entreprises du médicament) since July 2006.
- Member of the French Council for Heatlh Insurance.
- President of the French Federation of Health Industries.
- Board Member of INSERM, the National Institute for Health and Medical Research, and AFSSAPS, the French Health agency.
- Officer of the Legion of Honour.

Jean-Pierre Lehner
- Senior Vice President Chief Medical Officer since February 2009.
- Medical degree from the School of Medicine University of Paris, France.
- Chef de Clinique, assistant of Paris Hospitals, Department of Cardiology, Hôpital Bichat, Paris, France (1977-1981).
- Medical Director at Roussel Laboratories (1981-1986).
- Medical Director of Roussel-Uclaf (1986-1992).
- Senior Director of Clinical Investigations of Sanofi Recherche (1992-1996).
- Scientific Senior Director of Sanofi Winthrop (1996-2002).
- Vice President Medical Affairs Europe of Sanofi-Aventis (2003-2005).
- Senior Vice-President Medical & Regulatory Affairs of Sanofi-Aventis since 2005.

Wayne Pisano
- Senior Vice President Vaccines since August 2007.
- Bachelor’s degree in biology from St. John Fisher College, Rochester, New York, and MBA from the University of Dayton, Ohio.
- Various marketing and sales positions with Reed & Carnrick Pharmaceuticals and Sandoz/Novartis.
- Vice President U.S. Marketing (1997), Senior Vice President of US Marketing & Sales, Executive Vice President North America and Senior Vice President Global Commercial Operations at Sanofi Pasteur.

Jean-Philippe Santoni
- Senior Vice President Industrial Development and Innovation within the Industrial Affairs since June 2009.
- Senior Vice President International Development R&D.
- Vice President International Clinical Development at Sanofi-Aventis.
- Vice President International Clinical Operations at Sanofi-Synthélabo.
- Cardiovascular Development Director at Synthélabo (1990).
- At Servier (1984).
- Master of Sciences and post-graduate degree in statistics applied to medicine.

Laure Thibaud
- Senior Vice President Communications since June 2009.
- Global Executive Vice President Communications and Sustainable Development of the AXA Group (2007).
- 1990-2007 at GSK Group: Head of Public Relations and Director of Communications in France; Vice President Communications Europe in London; Vice President External Affairs Europe in Brussels.
- Communication Manager for Alain Afflelou.

Gérard Le Fur
- Executive Vice President, Scientific and Medical Affairs (2004) and Chief Executive Officer (2007) at Sanofi-Aventis.
- Senior Executive Vice President (2003) at Sanofi-Synthelabo.
- Associate Director of Research and Development (1986), Director of Research and Development (1995) and Managing Director in charge of Scientific Departments (1998) at Sanofi.
- Corresponding Member of the French Academy of Sciences.
- Director of Biology at Laboratoires Rhone-Poulenc.
- Chief of Laboratories and Assistant Director of Research and Development at Laboratoires Pharmuka.

Timothy Rothwell
- Board of directors of Antigenics Inc.; PhRMA; the Institute of Medicine’s Evidence-Based Medicine Roundtable; and the CEO Roundtable on Cancer.
- President, chairman and CEO of Sanofi-Aventis U.S. (2004-2009).
- US president and chief executive officer at Sanofi-Synthelabo (2003).
- Executive Vice President and President of Global Prescription Business of Pharmacia Corporation (2001-2003).
- Executive Vice President and President Global Pharmaceutical Operations of Pharmacia & Upjohn Inc. (1998-2000).
- Senior management positions at Rhne-Poulenc Rorer (1995-1998) and Bristol-Myers Squibb Co (1989-1991).
- Begining career (1972), operational positions and Chief Executive Officer and President of the U.S. pharmaceutical business of Sandoz Pharmaceuticals.
- Bachelor of arts from Drew University in New Jersey and law degree from Seton Hall University in New Jersey.

Nigel Brooksby
- General Manager and Managing Director of Sanofi-Aventis UK since September 2004.
- Head of Sanofi-Synthelabo in the UK.
- Joined Sanofi in 1992 after working for Pfizer.
- Chairman of Commercial Affairs Group, Board of Management (1999), and President (2006) of the Association of the British Pharmaceutical Industry.

David J. Williams
- Board of directors of Xcellerex Inc. and Executive Board of VaxInnate since 2009.
- Chairman and Chief Executive (2002-2008) and Chief Operating Officer (1998-2002) of Sanofi Pasteur. Joined as finance manager in 1978.
- Audit and Healthcare Consulting Group at Pricewaterhouse Coopers.
- Board of Directors of the International AIDS Trust, the Biotechnology Industry Organization, AllOne Health Group Blue Cross of Northeastern Pennsylvania and the Hospital Service Association of Northeastern Pennsylvania.
- Led the Vaccine Policy Working Group of PhRMA, the U.S. pharmaceutical industry’s trade association.
- First liaison member of the Advisory Committee on Immunization Practices to the U.S. Centers for Disease Control and Prevention, which sets immunization policy in the United States.
- Undergraduate degree by the University of Scranton, past member of the Board of Trustees and Board of Regents.
- Founding member of the Partnership for Prevention and founding board member of the Medical Education Development Consortium.
- Spending his retirement serving as a consultant to several vaccine and biotech companies.

Robert Becker
- Vice President and Business Development of VaxInnate Corporation since December 2005.
- Vice President of Corporate Development of Sanofi Pasteur until December 2005 (joined in 1990).
- Junior facility positions at Loyola University Chicago and University of Illinois in the field of Immunology.
- Ph.D. in Microbiology and Immunology from the University of Kansas and MBA from Columbia University.

Michel Gréco
- Board of Directors of Immutep S.A. (2005), the International AIDS Vaccine Initiative, the Aeras Global Tuberculosis Vaccines Foundation, Intercell AG (Austria), ID Biomedical Corporation (2002), and the International Vaccine Institute.
- Chair of WHO’s Initiative for Vaccine Research Advisory Committee and Strategic Advisory Group of Experts.
- President of the European Vaccine Manufacturers.
- Chairman of IFPMA biological group.
- Member of the European Union Task Force on Bioterrorism.
- Board member of the French Pharmaceutical Association and president of its European Affairs Commission.
- Supervisory Board, Deputy Chief Executive Officer, President and Chief Operating Officer of Aventis Pasteur (1998-2003).
- President and Chief Executive Officer (1994-1998) of Pasteur Mérieux MSD, a European joint venture between Aventis Pasteur and Merck and Co.
- Master’s degree from Institut d’Etudes Politiques de Paris and MBA from the Richard Ivey School of Business Administration University of Western Ontario.

MUST READ!
A Surge of Miscarriage Reports From Pregnant Women After Taking Swine Flu Vaccine Hits The Internet – Tell Every Pregnant Woman You Know!

Organic Health Advisor
November 11, 2009

In the very short video posted below, you will see one health expert explain to Sean Hannity that even the swine flu vaccine package insert says that it is safe for pregnant women…

The following video highlights a retraction made by a medical doctor, Dr. Roby Mitchell, after he initially advised a group of nurses to take the H1N1 Swine Flu vaccine. Once he had read the actual package insert which comes with the vaccine and realized that the vaccine makers themselves admit it is untested and may cause a myriad of disorders to include paralysis, neurological damage, possible sterilization and may cause fetal harm in pregnant women (one of the high priority groups targeted to get the vaccine), he retracted his advice so that they would have informed consent. 1

Here are a few screen-shots from the FLUVIRIN package insert:

The reality is that if you are pregnant, you need to hear what both sides have to say before ever subjecting your baby to the swine flu vaccine. You do NOT want to end up like one of the mothers above. Please help us out by sharing this information with as many people as you can. If you know of any additional H1N1 swine flu vaccine miscarriage horror stories please post them below in the comments section.

On November 10 2009 Christopher Viehbacher, the Chief Executive of Sanofi-Aventis SA indicated to a “partnering meeting” hosted at a Sanofi facility in Cambridge, Massachusetts, the company is interested in setting up a venture capital fund to help develop strategic partnerships with drug-developers. This is part of the company’s drive to move away from the traditional boom-and- bust cycle of searching for blockbuster drugs and the erosion of sales with the loss of patent protection.

Sanofi-Aventis and Regeneron Pharmaceuticals Inc announced on November 11 2009 that they have expanded their alliance to discover and market therapeutic monoclonal antibodies. From the beginning of 2010 Sanofi-Aventis is to increase its funding commitment from $100 million to US$160 million a year. Sanofi-Aventis’ funding commitment will now extend through 2017; the collaboration had been set to expire at the end of 2012. Sanofi-Aventis has an option to extend the discovery programme for up to an additional three years for further antibody development and preclinical activities.

The companies aim to advance to clinical development an average of between four and five antibodies per year. Since the collaboration started in November 2007, Sanofi Aventis and Regeneron have advanced four antibodies into clinical development and have filed and IND for a fifth. Among the four antibodies in clinical development, three are antibodies to (1) the Interleukin-6 receptor (IL-6R), being developed for rheumatoid arthritis treatment, (2) Nerve Growth Factor, being developed for pain treatment, and (3) Delta-like Ligand 4 (Dll4), being developed to treat advanced malignancies. The targets of the two other antibodies were not disclosed.

Business

2009
- Acquisition of Mérieux Alliance’s French subsidiary ShanH, which owns a majority stake in Shantha, based in Hyderabad, India.
- Shantha Biotechnics awarded contracts by a United Nations agency for supplies of pentavalent vaccine SHAN5 (combination vaccine of Diphtheria, Pertussis, Tetanus, Haemophilus influenza B, and Hepatitis B). The contracts, worth $340 million, cover the period 2010-2012.

2008
- Exclusive collaboration and commercialization agreement with Crucell N.V. for Crucell’s rabies monoclonal antibodies, next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis.
- Collaborative research and license agreement with the Statens Serum Institut of Denmark for the development and marketing of a new vaccine against tuberculosis.
- FDA licenses DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) for the 5th consecutive dose for children 4 years through 6 years of age. Licensed in 2002 for 4 consecutive doses, administered at 2, 4, 6, and 15 to 20 months of age.
- FDA licenses Pentacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for use in infants and children 6 weeks through 4 years of age. Four-dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. According to the current Recommended Childhood Immunization Schedule of the U.S. Centers for Disease Control and Prevention, up to 23 injections are needed by the time a child reaches 18 months of age with single-entity vaccines. Pentacel vaccine could reduce that number of shots by 7.
- 6 million doses of StamarilTM1 yellow fever vaccine shipped upon UNICEF’s request to respond to the yellow fever epidemic in Latin America. Brazil received 4 million doses and Paraguay, 2 million.
- New, state-of-the-art research facility at the company’s historic Connaught Campus in north Toronto, Ontario, Canada, to boost innovation in vaccine research. The Government of Ontario will contribute 13.9 million Canadian dollars through the Biopharmaceutical Investment Program.
- Sanofi Pasteur acquires Acambis for £285 million.
- First international vaccine company to enter the Japanese pediatric vaccine market with ActHIB, marketed by Daiichi-Sankyo Co. Ltd.
- Sanofi Pasteur and Chumakov Institute russian academy medical sciences providers of inactivated polio vaccine IMOVAX PolioTM for Russia National “Project Health”.

2007
- Agreements with Acambis to license a single dose vaccine against Japanese encephalitis, ChimeriVax, in endemic countries of Asia Pacific, including Thailand, the Philippines, Malaysia, Indonesia, China, Japan, and parts of Australia, and for the development of a vaccine to prevent West Nile virus disease.
- Partnership with Institut Pasteur to develop a vaccine against malaria.

2006
- Partnership with the Pediatric Dengue Vaccine Initiative to help develop and make a Dengue vaccine widely available.
- Agreement with Emergent Biosolutions to jointly develop a new vaccine for Meningitis B.

2005
- Agreement with Eisai Co. Ltd. to license novel adjuvant, E6020, for use in the development of new vaccines.
- Agreement with Becton, Dickinson and Company to license Micro-Delivery technology for use in the administration of human vaccine products.

Origins
- 1897: Marcel Mérieux creates the Mérieux Biological Institute in Lyon. Richard Slee creates the Pocono Biological Laboratories, in Swiftwater, Pennsylvania in the U.S.
- 1914: John FitzGerald creates Connaught Laboratories, part of the University of Toronto.
- 1968: Rhône-Poulenc acquires 51% of the capital of the Institut Mérieux.
- 1974: Pasteur Institute creates Pasteur Production, a subsidiary specializing in manufacturing vaccines.
- 1978: Connaught Laboratories in Canada acquires the vaccine manufacturing facility (Merrell-National Laboratories) at Swiftwater, Pennsylvania, U.S.
- 1985: Pasteur Production, the vaccines branch of the Institut Pasteur, is acquired by the Mérieux Institute, and Pasteur Vaccins is created.
- 1989: The Mérieux Institute acquires the Connaught Laboratories in Canada and its subsidiaries and becomes a world leader in human biology.
- 1990: Creation of Pasteur Mérieux Serums & Vaccins.
- 1994: Pasteur Mérieux Sérums & Vaccins becomes a wholly owned subsidiary of Rhône-Poulenc.
- 1996: Pasteur Mérieux Connaught, new name of Pasteur Mérieux Serums et Vaccins.
- 1999: Rhône-Poulenc and Hoechst unite their Life Sciences activities in Aventis. Pasteur Mérieux Connaught changes its name to Aventis Pasteur.
- 2004: Merger of Aventis with and into Sanofi. Aventis Pasteur, the vaccine division of the Sanofi-Aventis Group, changes its name to Sanofi Pasteur.

Vaccine History
- 1907: Producción de sueros.
- 1922: Primera vacuna antitétanica.
- 1939: Nueva aplicación de la reacción percutánea.
- 1939: Primera utilización de la tuberculina de Mérieux.
- 1946: Suero contra pertussis.
- 1953: Vacuna contra la fiebre amarilla.
- 1955: Primera vacuna contra la poliomielitis inactivada inyectable de Salk.
- 1960: Primera vacuna contra la poliomielitis inactivada inyectable de Lépine.
- 1962: Primera vacuna oral contra la poliomielitis a virus vivos atenuados de Sabin.
- 1963: Prueba de multipunción de tuberculina.
- 1968: Vacuna contra el sarampión.
- 1968: Vacuna contra la gripe.
- 1970: Vacuna contra la rubéola (sobre células diploides humanas).
- 1974: Primera vacuna contra las infecciones por meningococos de grupo A.
- 1975: Primera vacuna contra las infecciones por meningococos de los grupos A+C.
- 1975: Vacuna antidiftérica, antitetánica, antipertúsica y antipoliomielítica (inyectable).
- 1977: Primera vacuna antirrábica (sobre células diploides humanas).
- 1981: Primera vacuna de plasma contra la hepatitis B.
- 1982: Primera vacuna contra la poliomielitis inyectable de Salk (sobre células vero).
- 1985: Primera vacuna antirrábica (sobre células vero).
- 1986: Vacuna triple viral (contra el sarampión, la parotiditis y la rubéola).
- 1987: Vacuna contra la hepatitis B (basada en ingeniería genética).
- 1987: Primera vacuna conjugada contra infecciones por Haemophilus influenzae tipo b.
- 1988: Primera vacuna oral contra la poliomielitis de Sabin (células vero).
- 1988: Primera vacuna antitifoidea (polisacáridos).
- 1992: Vacuna acelular contra pertussis con toxoides antidiftérico y antitetánico para adultos.
- 1993: Vacuna antidiftérica, antitetánica, antipertúsica (de germen entero) y contra infecciones por Haemophilus influenzae tipo b.
- 1993: Primera vacuna pentavalente antidiftérica, antitetánica, antipertúsica (de germen entero), antipoliomielítica y contra infecciones por Haemophilus influenzae tipo b (galardonada con el premio Galien en 1994).
- 1996: Vacuna contra la hepatitis A.
- 1997: Primera vacuna pentavalente con pertusis acelular.
- 1998: Vacuna antidiftérica, antitetánica, antipertúsica (acelular) y antipoliomielítica.
- 1999: Vacuna de refuerzo antitetánica, antidiftérica y antipoliomielítica para adultos.
- 2004: Primera vacuna tetravalente conjugada contra infecciones por meningococos.

FLUPAN
- Sanofi Pasteur: Only vaccine manufacturer to participate in FLUPAN.
- FLUPAN: Collaborative research project funded by the European Commission in September 2001, specific RTD programme “Quality of Life and Management of Living Resources”, directed towards improved preparation for an influenza pandemic.
- FLUPAN partners: National Institute for Biological Standards and Control, UK; University of Reading, UK; Istituto Superiore di Sanita, Italy; Heath Protection Agency, UK; Sanofi Pasteur, France; University of Bergen, Norway.

Earnings Guidance
- Revenue: €2,861 million in 2008 (+9.6% over 2007).
- Net sales: €2,533 millions in 2006 (+22.7% over 2005).
- Sales Growth in 2008: Pediatric Vaccines (+21.9%).
- Sales of Menactra, meningitis vaccine, in 2007: 415 million euros (+87%). In 2008/2009, production capacities should reach 8 to 10 million doses and 20 million by 2010.
- Vaccines Production Doses: >1.6 billion in 2007 ; >1 billion in 2006.
- More than 1 million euros invested every day in R&D.
- Nearly 1.5 billion euros invested in 5 years in production capacity.

Production
- 2 facilities in Swiftwater, Pennsylvania, United States. In total, approximately 150 million doses of trivalent seasonal influenza vaccine per year.
- 1 facility in Val De Reuil, France. Capacity of 120 million doses per year.
- All facilities designed and built to be able to switch from seasonal influenza vaccine production to pandemic influenza vaccine production.
- Seasonal Influenza Vaccine Production Doses: 180 million in 2007 (40% of world market).
- More than 45% of the influenza vaccines distributed for the 2008/2009 influenza season in the United States.

2009
- FDA licenses new facility in Swiftwater. Capacity of approximately 100 million doses of seasonal influenza vaccine per year.
- Sanofi Pasteur receives seed virus and order to produce new influenza A(H1N1) vaccine by U.S. Government.
- INTANZA/IDflu, first intradermal influenza vaccine, approved in the European Union.
- Agreement with the Mexican authorities to build new facility. Signed in Mexico City during French President Nicolas Sarkozy’s State Visit. Sanofi Pasteur to manufacture influenza vaccine in collaboration with Birmex, a Mexican federal vaccine manufacturer.
- EMERFLU, pandemic influenza vaccine for humans, approved in Australia.
- Sanofi Pasteur receives order from French Government to produce novel influenza A(H1N1) vaccine. 28 million doses and option for an additional 28 million doses.
- Agreement with Butantan Institute for the production and supply of a vaccine against the novel A(H1N1) influenza virus for the Brazilian Government. Initial supply of 1 million doses in final presentation and 17 million doses in bulk form. The agreement includes an option for an additional 15 million doses.
- FDA licensure of Influenza A (H1N1) 2009 Monovalent Vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
- Additional order from the U.S. Department of Health and Human Services to produce vaccine to help protect against the Influenza A (H1N1) 2009 virus. The new order is for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose. Committed to the U.S. government a total of 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine.

2008
- The U.S. Department of Health and Human Services (HHS) accepts $192 million of H5N1 bulk vaccine antigen to produce approximately 38.5 million doses of vaccine. Multi-year contract with HHS as part of its pandemic program.
- Donation of 60 million doses of H5N1 vaccine to the World Health Organization over 3 years for the establishment of an H5N1 vaccine global stockpile.

2007
- $77.4 million contract by the U.S. Department of Health and Human Services to retrofit existing influenza vaccine manufacturing facility. The new $150 million, 13,000 square-meter vaccine manufacturing plant is designed to more than double the site’s capacity to over 100 million doses of influenza vaccine per year.
- FDA licenses H5N1 vaccine, 1st avian influenza vaccine for humans in U.S.
- Support and ready to supply a significant number of doses of H5N1 vaccine
for the establishment of an international stockpile through a World Health Organization partnership.
- Agreement with the Chinese authorities to build a facility to manufacture influenza vaccine, during an official ceremony attended by Hu Jintao, President of the People’s Republic of China, and Nicolas Sarkozy, President of the French Republic, in China for a State Visit.

2006
- Deliver of more H5N1 vaccine to the U.S. National Institutes of Health, part of the U.S. Department of Health and Human Services, including investigational doses formulated with an adjuvant, aluminum hydroxide, for U.S. government pandemic initiatives.
- Completed production of additional bulk-concentrate of the H5N1 vaccine antigen for the U.S. government stockpile valued at $50 million to support U.S. Department of Defense requirements.
- Contract with the Office of Public Health and Emergency Preparedness, a division of the U.S. Department of Health and Human Services, for the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine.
- Stock supply to the Italian Ministry of Health of pre-pandemic vaccine against the H5N1 avian influenza virus strain.
- Contract by the French Ministry of Health to produce pre-pandemic H5N1 vaccine to create a 1.4 million dose stockpile. By this agreement, the company could also provide enough vaccine to protect up to 28 million people in the event of a pandemic.
- Contracts with other governments in Europe, Australia and worldwide for the supply of vaccine in the event of a pandemic influenza outbreak.
- Completed shipping 50 million doses of influenza vaccine (Fluzone, Influenza Virus Vaccine) to the U.S. market.
- Completed production of more than 170 million doses of influenza vaccine.

2005
- Contracts by the U.S. Department of Health and Human Services to accelerate the development of a cell-culture influenza vaccine in the U.S., $160 million investment
for a new influenza vaccine manufacturing facility, which double its U.S. production capacity, and to produce a stockpile of the H5N1 vaccine valued at $150 million.
- FDA approves new Fluzone influenza vaccine formulation that does not contain a preservative at any stage in the manufacturing process, for populations 6 months and older.

2004
- Contract with the U.S. National Institute of Allergy and Infectious Diseases to produce 8,000 investigational doses of the H5N1 influenza strain.
- Contracts with the U.S Department of Health and Human Services to produce 2 million doses of bulk vaccine derived from the H5N1 viral strain and to expand and safeguard the egg supply needed to produce influenza vaccine and to formulate each year investigational doses for a potential pandemic influenza vaccine.

Fluzone