Sanofi Pasteur

Acambis shares soar on $548M buyout deal

John Carroll — Mon, 28 Jul 2008 10:38:33 -0400

Shares of Acambis soared after Sanofi Pasteur, the vaccine division of Sanofi-Aventis, announced that it planned to buy the vaccine developer for $548 million. Aside from the smallpox vaccine ACAM2000, which recently won a 10-year, $425 million contract from the U.S. government, Sanofi-Aventis also gains a slate of experimental vaccines for dengue fever, West Nile disease and clostridium difficile, influenza and genital herpes.

Sanofi Pasteur and Acambis are partnered on a variety of development programs already. And the deal underscores just how attractive vaccine companies have become. Sanofi-Aventis "quite liked what we had in Acambis," said Acambis Chief Executive Ian Garland.

- check out Sanofi's release
- read the Wall Street Journal report
- here's the AP story

Sanofi to acquire Acambis for $546M

Maureen Martino — Fri, 25 Jul 2008 14:30:09 -0400

More evidence that the vaccine market is hot: vaccine maker Acambis has agreed to a £276 million ($546 million) by Sanofi-Pasteur, the vaccines division of France's Sanofi-Aventis. The deal represents a premium of 65.2 percent to Acambis' closing share price. Sanofi said that it has a "long and successful partnership with Acambis" and that the deal recognizes the company's "recent advances." Acambis recently won a $425 million, 10-year contract to supply the U.S. government with its smallpox vaccine. Additional programs include vaccines against Japanese Encephalitis and West Nile virus, C. difficile and a promising universal flu vaccine. Sanofi stressed that the Acambis deal would strengthen its pipeline.

The buyout, "...provides Sanofi Pasteur with the opportunity to develop a product line complementary to its existing portfolio and to benefit from the continued contribution from Acambis' key personnel," Sanofi said in a statement. "This mutually beneficial acquisition is a logical step building upon Sanofi Pasteur and Acambis' decade long partnership on key projects to develop and market vaccines of the future."

Just last month Sanofi announced plans to invest $6 billion into vaccine production to meet demand in developing nations. Picking up Acambis will certainly help them achieve that goal.

- check out the press release (.pdf)

Sanofi Pasteur plans C$100M R&D facility in Canada

Wed, 16 Apr 2008 06:59:56 -0400

Score one win for Ontario province in the field of economic development. Sanofi Pasteur, the vaccine arm of Sanofi-Aventis, will build a C$100 million R&D facility in Toronto with the province chipping in C$13.9 million through its Biopharmaceutical Investment Program.

Researchers will target pediatric combination vaccines, pneumococcal protein vaccines and cancer vaccines. Look for the grand opening in 2010.

- check out the AFX report

Related Articles:
Sanofi licenses technology for new TB vaccine. Sanofi report
Maxygen, Sanofi Pasteur ink $24.5M vaccine deal. Sanofi report
Canada's streamlined approval process raises protests. Canada report
Canada's drug market slowing. Market report

Maxygen, Sanofi Pasteur ink $24.5M vaccine deal

Tue, 04 Dec 2007 06:59:56 -0500

Maxygen has agreed to transfer a portfolio of preclinical dengue antigens to Sanofi Pasteur for use developing a second generation vaccine. Maxygen stands to gain up to $24.5 million in the deal. The dengue virus afflicts more than 50 million people worldwide. About a week ago Maxygen announced that it is closing its facility in Denmark in a cost-cutting move.

- check out the release on the deal
- here's the AP report on Maxygen

ALSO: Take a look at Sanofi's pipeline. Report

Related Articles:
New tech drives huge growth in vaccine business. Report
New approach to vaccine development. Report
Vaccine "renaissance" attracts huge new venture investments. Report
Roche drops out of dev deal with Maxygen. Report

ALSO NOTED: BMS hands back drug rights; OncoMethylome in deal with GSK; Celgene shares take a bounce; and much more...

Mon, 26 Nov 2007 06:59:50 -0500

> Bristol-Myers Squibb has returned the rights to vinflunine to Pierre Fabre. The therapy was studied as a treatment for bladder cancer. Release

> Belgium's OncoMethylome Sciences has forged a pact with GlaxoSmithKline to develop DNA methylation biomarkers for use in developing personalized cancer therapies. Release

> Shares of Celgene got a bounce this morning after a Banc of America analyst give a thumb's up to the company's expanded line-up of cancer therapies with its acquisition of Pharmion. Katherine Kim concludes that Revlimid can earn $3.5 billion a year. Report

> Sanofi Pasteur says it's spending about $104 million on a Chinese manufacturing plant in hopes of launching flu shots locally by 2012. Report

> A new regulatory report gives us a peek at the recall of Roche's HIV remedy Viracept--and it's not a pretty picture. Report

> The FDA also plans to review Roche's Tamiflu and GlaxoSmithKline's Relenza at its advisory committee confab Nov. 27-28. At issue: the anti-influenza drugs' potential neurological side effects in kids. Report

The FDA is taking a second look at the safety of three asthma drugs used in kids: GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil. Report

> QRxPharma has begun treating patients as part of the Phase III development program for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy. Release

> An M.D. and former speaker-on-behalf-of-a-drug tells his story in the New York Times Magazine, and it's an illuminating, behind-the-scenes look at how Dr. Daniel Carlat (photo) became Dr. Drug Rep.

And Finally… In a major study, transcranial magnetic stimulation proved effective in treating major depression. Report

Sanofi buys into Acambis' West Nile vaccine program

Tue, 13 Nov 2007 06:59:57 -0500

Sanofi Pasteur is buying into Acambis' program for a novel West Nile vaccine. Acambis snares $10 million up front with $70 million in development and sales milestones. There's more money that can be tapped for development costs as well as from royalties. ChimeriVax-West Nile is in a Phase II trial right now and showed signs of efficacy in an earlier dose-ranging Phase II trial. Any successful vaccine would be employed against an endemic disease that has killed 92 people so far this year in the U.S. and is a particular threat for people over the age of 50.

"Having entered into this unique collaboration with one of the world's leading vaccine companies, we intend to be the first to bring a West Nile virus vaccine to market," said Acambis CEO Ian Garland. "Acambis will conduct the vaccine development, further validating our competence and capabilities in clinical development and vaccine manufacture. This contract is an important step in executing on our financing strategy for the company."

- check out the release on the deal
- read the report from Silicon Fen Business Report for more

Related Articles:
Acambis' universal vaccine begins human clinical trials. Report
Acambis shares plunge after U.S. nixes contract. Report
Acambis completes vaccine BLA. Report
Acambis researching single-shot solution to flu. Report

Press Release: FDA Advisory Committee Recommends Licensure Of New Pediatric Combination Vaccine

Maureen Martino — Fri, 26 Jan 2007 13:25:16 -0500

FDA Advisory Committee Recommends Licensure Of New Pediatric Combination Vaccine

Sanofi pasteur, the vaccines business of the sanofi-aventis Group, is pleased that the members of an advisory committee to the U.S. Food and Drug Administration (FDA) voted nearly unanimously today that the company's pentavalent combination vaccine for use in pediatric patients is both safe and efficacious. Pentacel(R) (DTaP-IPV-Hib) vaccine(1) protects against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b (Hib).

BETHESDA, MD, USA | Jan 25, 2007 | Sanofi pasteur, the vaccines business of the sanofi-aventis Group, is pleased that the members of an advisory committee to the U.S. Food and Drug Administration (FDA) voted nearly unanimously today that the company's pentavalent combination vaccine for use in pediatric patients is both safe and efficacious. Pentacel(R) (DTaP-IPV-Hib) vaccine(1) protects against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b (Hib).

According to the current Recommended Childhood and Adolescent Immunization Schedule from the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC), up to 23 injections are needed through 18 months of age. The use of Pentacel vaccine could reduce that number of shots by seven.

The regulatory submission of Pentacel vaccine is based on results of clinical studies involving more than 5,000 children in multi-center trials(2) conducted in the U.S. and Canada. Pentacel vaccine is licensed for pediatric use in nine countries, including Canada, where it has been used universally in infants and young children since 1998 for the prevention of diphtheria, tetanus, pertussis, polio and Hib. Over 12.5 million doses of Pentacel vaccine have been distributed in Canada.

Pentacel vaccine is the first DTaP-based combination vaccine candidate for use in infants in the U.S. that includes both polio and Hib vaccine components. The diphtheria, tetanus, and pertussis components in Pentacel vaccine are based on the formulation in DAPTACEL(R) -- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine) -- which was introduced by sanofi pasteur in the U.S. in 2002. In clinical trials, Pentacel vaccine was administered as a four-dose series -- at 2, 4, 6, and 15-18 months of age -- concomitantly with other recommended childhood vaccines.

Sanofi pasteur's U.S. operations in Swiftwater, PA has long been committed to providing vaccines to prevent childhood diseases. In 1987, it licensed the first Haemophilus influenzae type b (Hib) conjugate vaccine. And in 1996, it was the first company to license a diphtheria, tetanus, and acellular pertussis vaccine for use in infants -- Tripedia(R), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed. In 2005, sanofi pasteur continued its tradition of innovation by introducing Menactra(R), Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine to protect against meningococcal disease in adolescents and adults, 11-55 years of age, and ADACEL(R), Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed as a booster dose for protection against tetanus, diphtheria and pertussis in both adolescents and adults 11-64 years of age.

About Diphtheria

Diphtheria is a disease caused by a bacterium, Corynebacterium diphtheriae, that usually affects the tonsils, throat, nose and/or skin. It is passed from person to person by droplet transmission, usually by breathing in diphtheria bacteria after an infected person has coughed or sneezed. Although diphtheria disease is rare in the U.S., it appears that C diphtheriae continues to circulate in areas of the country with previously endemic diphtheria. Diphtheria also occurs in many other parts of the world.

About Tetanus

Tetanus is a severe, frequently fatal disease caused by an exotoxin produced by Clostridium tetani, a bacterium that is found in the environment. Tetanus is not transmitted from person to person. Rather, Clostridium tetani enters the body through an open wound, including lacerations, abrasions and puncture wounds. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. The muscle spasms usually start in the jaw (which is why the disease is sometimes called "lockjaw") and neck and may spread to many other muscles, leading to generalized paralysis.

About Pertussis

Pertussis, a highly contagious disease of the respiratory tract, is caused by exposure to bacteria (Bordetella pertussis) found in the mouth, nose and throat of an infected person. Pertussis is primarily spread by direct contact with discharge from the nose or throat of infected individuals. Classic -- or severe pertussis -- as defined by the World Health Organization, consists of at least 21 days of cough illness (with the cough coming in spasms or paroxysms), associated whoops or post-cough vomiting, and laboratory confirmation. Despite widespread vaccination, reports of pertussis outbreaks continue to in the U.S. At particular risk are newborns and babies who have not yet been fully vaccinated against pertussis, iii who are more likely to have severe pertussis, and who face the possibility of serious complications and death. Over the last decade, 80% of pertussis deaths have occurred in infants under 6 months of age.(3)

About Polio

Poliomyelitis (polio) is a highly infectious disease caused by a virus that invades the nervous system and can cause severe paralysis. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck, and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralyzed, 5-10% dies when their breathing muscles become immobilized. Polio mainly affects children under five years of age. Naturally occurring polio was eliminated in the U.S. in 1979 and in the Western Hemisphere by 1991; however, worldwide efforts are continuing towards eradication of this contagious and devastating disease.

About Hib

Haemophilus influenzae type b (Hib) disease is caused by a bacterium that enters the body through the nose or throat and then can spread to cause meningitis (an infection of the coverings of the brain and spinal cord), blood stream infection, pneumonia, infection of the epiglottis, and other serious infections. Hib disease can cause mental retardation in young children and be a life-threatening infection. The Hib bacterium is still circulating in the U.S. today.(4) Ongoing vaccination is critical in preventing a resurgence of Hib, which was the leading cause of bacterial meningitis in children under five years of age before vaccines were introduced.

About sanofi-aventis

Sanofi-aventis is one of the world's leading pharmaceutical companies. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold more than a billion doses of vaccine in 2005, making it possible to protect more than 500 million people across the globe. The company offers the broadest range of vaccines, providing protection against 20 bacterial and viral diseases. For more information, please visit: http://www.sanofipasteur.com

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.

(1) The true name for Pentacel(R) vaccine is: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined

(2) Herz A, Black S, Shinefield H, Noriega F, Greenberg, D. Safety of DTaP-IPV//PRP-T (PENTACEL) administered at 2, 4, 6, and 15 to 18 months of age. Annual meeting of the Pediatric Academic Societies 2005

(3) Vitek CR, Pascual FR, Baugham, AL, Murphy TV. Increase in deaths from pertussis from young infants in the United States in the 1990s. Pediar Infect Dis J. 2003:22:628:634.6

(4) Donnelly, M.J, Herold, B.C., Jenkins, S.G., Daum, R.S. Obstacles to the elimination of Haemophilus influenzae type b disease: Three illustrative cases. Pediatrics. Vol. 112, No. 6, December 2003, pp. 1465-1466

FDA experts give thumbs up to Pentacel

Thu, 25 Jan 2007 19:01:35 -0500

An expert panel for the FDA has concluded that Pentacel, a five-in-one vaccine made by Sanofi-Pasteur, is safe and effective. The injection is designed to prevent diphtheria, tetanus, whooping cough, polio and bacterial infection caused by Haemophilus influenzae Type B. The group did recommend follow-up studies in the event that the FDA formally approves the jab. The vaccine could replace seven of the 23 injections received by children.

- see this release on Pentacel
- here's the AP report for more information

Related Article:
Sanofi vaccine effective against new bird flu strains. Report

HHS awards H5N1 contracts

Mon, 20 Nov 2006 19:01:38 -0500

The Department of Health and Human Services has awarded a total of $199.45 million to three vaccine makers in order to stockpile 5.3 million additional doses of H5N1 vaccine. The bulk of the money--$117.9 million--has been awarded to Sanofi Pasteur for 3.7 million doses of the drug. Novartis has received $40.95 million for 800,000 doses and GSK also garnered $40.6 million for 800,000 doses. "These newest vaccine purchases supplement the existing stockpile of 5.9 million doses of H5N1 vaccine and build on the department's plans to buy enough vaccine for 20 million people," HHS stated in a press release. At two 90-microgram doses per person, HHS says these purchases provide enough courses to vaccinate nearly 2.7 million people. Initial studies of these vaccines show that they may protect against the bird flu, but the HHS noted that further testing is underway to fully determine their effect.

- see the HHS press release

Related Articles:
Switzerland to stockpile GSK's bird flu vaccine. Report
Novartis wins $220M flu vaccine contract. Report
Sanofi vaccine effective against new bird flu strains. Report

Press Release: HHS Buys Additional Vaccine for Potential Use in an Influenza Pandemic

Maureen Martino — Sun, 19 Nov 2006 09:40:46 -0500

HHS Buys Additional Vaccine for Potential Use in an Influenza Pandemic

HHS Secretary Mike Leavitt today announced the purchase of additional vaccine that could be used in the event of a potential influenza pandemic

The department has awarded contracts totaling $199.45 million to three vaccine makers to manufacture 5.3 million 90-microgram doses of influenza vaccine designed to protect against the H5N1 influenza virus strain. The three awards include a $117.9 million contract to sanofi pasteur for 3.7 million doses, a $40.95 million contract to Novartis for 800,000 doses and a $40.6 million to GlaxoSmithKline for 800,000 doses.

"Having a stockpile of influenza vaccine that may offer protection against the H5N1 virus is an important part of our pandemic influenza preparedness plan," Secretary Leavitt said. "These contracts are a continuation of our aggressive multi-pronged approach to a potentially critical public health challenge."

At two 90-microgram doses per person, these purchases provide enough courses to vaccinate nearly 2.7 million people. Initial clinical studies of H5N1 vaccine in humans have shown that two 90-microgram doses of the vaccine are required to stimulate a level of immune response that researchers anticipate would provide protection for an individual against the H5N1 strains that have been spreading among birds in Asia. However, further clinical testing is underway, including the evaluation of techniques that may reduce the amount of antigen (active ingredient) per dose needed to achieve effective individual protection.

These newest vaccine purchases supplement the existing stockpile of 5.9 million doses of H5N1 vaccine and build on the department's plans to buy enough vaccine for 20 million people. This additional vaccine will be placed in the nation's Strategic National Stockpile where they will be available for use should an influenza pandemic occur.

HHS' effort to stockpile vaccine is part of a broader effort by the department to accelerate the development and production of new technologies for influenza vaccines within the U.S. Earlier this year, HHS announced a $1 billion investment to support the advanced development of cell-based production technologies for influenza vaccines and will help to modernize and strengthen the nation's influenza vaccine production by creating an alternative to producing influenza vaccines in eggs.

The H5N1 strain of avian flu has spread to more than 40 countries and has led to the deaths of hundreds of millions of additional birds, which has heightened concern about the possibility of a human flu pandemic. Furthermore, the number of avian flu cases in humans has reached more than 250 cases in 10 countries. More than half of those persons infected have died. To date, H5N1 avian influenza has remained primarily an animal disease, but should the virus acquire the ability for sustained transmission among humans, the potential for an influenza pandemic would have grave consequences for global public health.