FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, PENTACEL(TM)
Lyon, France et Swiftwater, Pennsylvanie (ots/PRNewswire) -
- First Combination Vaccine Candidate in the U.S. Designed toProtect Infants and Young Children against Diphtheria, Tetanus,Pertussis, Polio, and Hib
Sanofi pasteur, the vaccines business of the sanofi-aventis Group(EURONEXT: SAN), (NYSE: SNY), announced today the acceptance of aBiologics Licensing Application (BLA) by the U.S. Food and DrugAdministration (FDA) for PENTACEL(TM) vaccine[i], a pediatriccombination vaccine candidate that targets diphtheria, tetanus,pertussis, polio, and Haemophilus influenzae type b (Hib).
PENTACEL vaccine is the first DTaP-based combination vaccinecandidate for use in infants in the U.S. that includes both polio andHib vaccine components. The diphtheria, tetanus, and pertussiscomponents in PENTACEL vaccine are based on the formulation inDAPTACEL(R)-- Diphtheria and Tetanus Toxoids and Acellular PertussisVaccine Adsorbed (DTaP vaccine) -- which was introduced by sanofipasteur in the U.S. in 2002. In clinical trials, PENTACEL vaccine wasadministered as a four-dose series -- at 2, 4, 6 and 15-18 months ofage -- concomitantly with other recommended childhood vaccines.
According to the current Recommended Childhood and AdolescentImmunization Schedule from the Advisory Committee on ImmunizationPractices (ACIP) of the U.S. Centers for Disease Control andPrevention (CDC), up to five separate vaccine injections may berequired during well-child visits. If licensed, PENTACEL vaccinecould reduce that number by two.
"PENTACEL vaccine could be easily integrated into the recommendedchildhood vaccination schedule," said Steven Black, MD, co-director,Kaiser Permanente Pediatric Vaccine Study Center. "In addition, thiscombination vaccine has the potential to protect against fivediseases in a single injection."
The regulatory submission of PENTACEL vaccine is based on resultsof clinical studies involving more than 5,000 children inmulti-center trials[ii] conducted in the U.S. and Canada. PENTACELvaccine is licensed for pediatric use in nine countries, includingCanada, where it has been used universally in infants and youngchildren since 1998.
Sanofi pasteur has been committed to pediatric immunization sinceit first introduced a diphtheria, tetanus and pertussis vaccine in1941. In 1996, sanofi pasteur was also the first company to license adiphtheria, tetanus, and acellular pertussis vaccine for use ininfants, TRIPEDIA(R) (Diphtheria and Tetanus Toxoids and AcellularPertussis Vaccine Adsorbed). In 2005, sanofi pasteur continued itstradition of innovation by introducing MENACTRA(R) (Meningococcal[Groups A, C, Y and W-135] Polysaccharide Diphtheria ToxoidConjugate) vaccine to protect against meningococcal disease inadolescents and adults, 11-55 years of age, and ADACEL(TM) (TetanusToxoid, Reduced Diphtheria Toxoid and Acellular Pertussis VaccineAdsorbed) as a booster dose for protection against tetanus,diphtheria and pertussis in adolescents and adults 11-64 years ofage.
Diphtheria is a disease caused by a bacterium, Corynebacteriumdiphtheriae that usually affects the tonsils, throat, nose and/orskin. It is passed from person to person by droplet transmission,usually by breathing in diphtheria bacteria after an infected personhas coughed or sneezed. Although diphtheria disease is rare in theU.S., it appears that C diphtheriae continues to circulate in areasof the country with previously endemic diphtheria. Diphtheria alsooccurs in many other parts of the world.
Tetanus is a severe, frequently fatal disease caused by anexotoxin produced by Clostridium tetani, a bacterium that is found inthe 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 toxincauses neuromuscular dysfunction, with rigidity and spasms ofskeletal muscles. The muscle spasms usually start in the jaw (whichis why the disease is sometimes called "lockjaw") and neck and mayspread to many other muscles, leading to generalized paralysis.
Pertussis, a highly contagious disease of the respiratory tract,is caused by exposure to bacteria (Bordetella pertussis) found in themouth, nose and throat of an infected person. Pertussis is primarilyspread by direct contact with discharge from the nose or throat ofinfected individuals. Classic--or severe pertussis--as defined by theWorld Health Organization, consists of at least 21 days of coughillness (with the cough coming in spasms or paroxysms), associatedwhoops or post-cough vomiting, and laboratory confirmation. Despitewidespread vaccination, reports of pertussis continue to rise in theU.S. At particular risk are newborns and babies who have not yet beenfully vaccinated against pertussis[iii],who are more likely to havesevere pertussis, and who face the possibility of seriouscomplications and death. Over the last decade, 80% of pertussisdeaths have occurred in infants under 6 months of age[iii].
Poliomyelitis (polio) is a highly infectious disease caused by avirus that invades the nervous system and can cause severe paralysis.The virus enters the body through the mouth and multiplies in theintestine. Initial symptoms are fever, fatigue, headache, vomiting,stiffness in the neck, and pain in the limbs. One in 200 infectionsleads to irreversible paralysis (usually in the legs). Among thoseparalyzed, 5-10% die when their breathing muscles become immobilized.Polio mainly affects children under five years of age. Naturallyoccurring polio was eliminated in the U.S. in 1979 and in the WesternHemisphere by 1991; however, worldwide efforts are continuing towardseradication of this contagious and devastating disease.
Haemophilus influenzae type b disease, also called invasive Hibdisease, is caused by a bacterium, Haemophilus influenzae type b. Hibenters the body through the nose or throat and then can spread tocause meningitis (an infection of the coverings of the brain andspinal cord), blood stream infection, pneumonia, infection of theepiglottis, and other serious infections. Hib disease can causemental retardation in young children and be a life-threateninginfection. The Hib bacterium is still circulating in the U.S.today,[iv] and ongoing vaccination is critical in preventing aresurgence of invasive Hib disease, which was the leading cause ofbacterial meningitis in children under five years of age beforevaccines were introduced.
The sanofi-aventis Group is the world's third-largestpharmaceutical company, ranking number one in Europe. Backed by aworld-class R&D organization, sanofi-aventis is developing leadingpositions in seven major therapeutic areas: cardiovascular disease,thrombosis, oncology, metabolic diseases, central nervous system,internal medicine, and vaccines. The sanofi-aventis Group is listedin Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,sold nearly a billion doses of vaccine in 2004, making it possible toprotect more than 500 million people across the globe, which is about1.4 million per day. The company offers the broadest range ofvaccines, providing protection against 20 bacterial and viraldiseases. For more information, please visit: www.sanofipasteur.com
Forward Looking Statement
This press release contains forward-looking statements as definedin the Private Securities Litigation Reform Act of 1995.Forward-looking statements are statements that are not historicalfacts. These statements include financial projections and estimatesand their underlying assumptions, statements regarding plans,objectives and expectations with respect to future 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 believesthat the expectations reflected in such forward-looking statementsare reasonable, investors are cautioned that forward-lookinginformation and statements are subject to various risks anduncertainties, many of which are difficult to predict and generallybeyond the control of sanofi-aventis, that could cause actual resultsand developments to differ materially from those expressed in, orimplied or projected by, the forward-looking information andstatements. These risks and uncertainties include those discussed oridentified in the public filings with the SEC and the AMF made bysanofi-aventis, including those listed under "Risk Factors" and"Cautionary Statement Regarding Forward-Looking Statements" insanofi-aventis' annual report on Form 20-F for the year endedDecember 31, 2004. Other than as required by applicable law,sanofi-aventis does not undertake any obligation to update or reviseany forward-looking information or statements.
Sanofi-aventis Group subsidiaries in the United States includeSanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and SanofiPasteur Inc.
[i] The full chemical name for PENTACEL(TM) vaccine is:(Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate] - ActHIBÒReconstituted with Diphtheria and Tetanus Toxoids and AcellularPertussis Vaccine Adsorbed Combined with Poliovirus VaccineInactivated)
[ii] Herz A, Black S, Shinefield H, Noriega F, Greenberg, D.Safety of DTaP-IPV//PRP-T (PENTACEL) administered at 2, 4, 6, and 15to 18 months of age. Annual meeting of the Pediatric AcademicSocieties 2005
[iii] Vitek CR, Pascual FR, Baugham, AL, Murphy TV. Increase indeaths from pertussis from young infants in the United States in the1990s. Pediar Infect Dis J. 2003:22:628:634.6.
[iv] Donnelly, M.J, Herold, B.C., Jenkins, S.G., Daum, R.S.Obstacles to the elimination of Haemophilus influenzae type bdisease: Three illustrative cases. Pediatrics. Vol. 112, No. 6,December 2003, pp. 1465-1466
sanofi pasteur sanofi pasteur Alain BERNAL Len LAVENDA Vice-President Corporate Communications U.S. Media Relations Tel: +33-(0)4-37-37-78-97 Tel: +1-570-839-4446 Fax: +33-(0)4-37-37-77 89 Len.Lavenda@sanofipasteur.com
ots Originaltext: sanofi-aventis GroupIm Internet recherchierbar: http://www.presseportal.de
Contact:sanofi Pasteur, Alain BERNAL, Vice-President Corporate Communications, Tel: +33-(0)4-37-37-78-97, Fax: +33-(0)4-37-37-77-89;sanofi pasteur, Len LAVENDA, U.S. Media Relations, Tel: +1-570-839-4446, Len.Lavenda@sanofipasteur.com
In Zusammenarbeit mit Medizinfuchs
FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, PENTACEL(TM)