Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Menveo; MenACWY-CRM
Status: U.S., EU and other filings expected in 2008/9
Organizations involved:
Novartis Vaccines and Diagnostics Ltd. – Manuf.; R&D; Tech.; Intl. mark.
Novartis Pharmaceutical Corp. – USA mark.
Novartis AG – Parent
Cross ref: See the entries above for Meningococcal Vaccines (#497); the established competing product, Menactra, from Sanofi Pasteur (entry below); and the conventional unconjugated polysaccharide vaccines (Menomune-A/C/Y/W-13; also from Sanofi Pasteur). See also another conjugate vaccine, Menjugate (#501), from Chiron/Novartis.
Description: Meningococcal (Groups A, C, Y and W-135) Poly-saccharide Diphtheria Toxoid Conjugate Vaccine or Menveo is a quadravalent vaccine containing a combination of individually cultured, inactivated, and purified Neisseria meningitidis strain types A, C, Y and W-135 capsular polysaccharides chemically conjugated to Corynebacterium diphtheriae CRM197 protein (CRM197), a nontoxic mutant diphtheria toxin (toxoid or inactivate toxin), combined prior to use with aluminum hydroxide adjuvant. Conjugation of the N. meningitidis polysaccharide antigens to diphtheria toxoid carrier substantially increases immune responses to the polysaccharides, particularly longer-term protection attributed to induction of T cell-dependent immune responses.
Note, this vaccine appears on track for use in infants, e.g., as young as 6 months, while Menactra (see related entry) is used in older children (i.e., is not effective in infants).
Companies.: The vaccine is being developed and will be manufactured and marketed by Novartis AG. Development was almost halted in late 2006/early 2007, but development was accelerated as Novartis established control over Chiron’s vaccines’ operations, with more than 10 000 subjects enrolled in clinical trials in 2007.
Status: Filings in the U.S., European Union and other territories are expected in 2008/9. Novartis expected to submit initial applications in later 2008 for use of Menveo in persons age 11-55. This did not happen. And in 2009, further filings are planned for use of the vaccine in infants and younger children, down to age 2 months, the group most needing the vaccine.
Trials: Results from Phase II trials show that Menveo may protect infants as young as two months old. Highest attack rate for this potentially fatal bacterial disease are usually seen in infants from three to 12 months of age. Existing vaccines, e.g., Menactra, have not worked in very young children.
If all goes well, the vaccine could reach the market by 2010.
Trials: In the Jan. 9, 2008 issue of the Journal of the American Medical Association, it was reported that Menveo boosted the immunity of infants as young as six months. in a trial in 421 healthy infants in Britain and Canada. The vaccine boosted immunity to all four strains in the three different dosing groups, but the less frequent dosing groups had less protection against serogroup A. At least 92 percent of infants who received the vaccine at two, three and four months developed antibodies to all four strains of meningitis. However, was not large enough to prove the vaccine safe, and the length of immunity in vaccinated infants remains unknown, with the need for booster vaccination before the vaccination currently given in adolescence remaining unknown.
Market: Novartis hopes to dominate the market for meningitis vaccines, with Menveo useful in younger children than Menactra, and with its MenB, recombinant meningitis type B vaccine, expected to also enter the market in 2010 (see related entry). [Menactra is approved for use in infants down to two years of age]. Novartis calculates a baseline U.S. annual demand for ACWY meningitis vaccine at 19 million doses for primary vaccination candidates with another potential 19 million doses for catch-up campaigns. Novartis also estimates that approval of Menveo for young infants would open up another 15 million annual dosage market. The company calculated that number of doses from three numbers: the 4 million annual birth cohort in the U.S.; a four-shot regimen for vaccination of infants; and a traditional 80-90% vaccination rate for vaccines for young infants. Menveo will have a commercial advantage by being available to the full range of patients visiting pediatricians: newborns through adolescents.
In the adolescent market and among college-aged students where Sanofi-Aventis has established Menactra Novartis believes it will have room to enter as a result of a Phase III head-to-head comparative trial versus Menactra. Novartis believes that it will come to the market with evidence of superiority to Menactra in several features including improved immune response to the Y sertotype in adolescents.
Superiority (or not) to Menactra will have al large impact on the market for Menveo, Menveo will compete with Menactra, but Menactra is already well-established in the marketplace. Some analysts have projected peak sales for Menveo of about $120 million a year..
Companies involvement:
Full monograph
502.5 Meningococcal Conjugates Vaccine/Novartis
Nomenclature:
Meningococcal Conjugates Vaccine/Novartis [BIIO]
menveo [TR]
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine [FDA]
MenACWY-CRM [SY]
FDA Class: Biologic BLA
Year of approval (FDA) = 2010
Date of 1st FDA approval = 20100219
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
conjugates
vaccines, bacterial
vaccines, combination
vaccines, subunit
bacterial culture <!-- bacterialculture -->
Corynebacterium diphtheriae
Neisseria catarrhalis
Bacillus anthracis prophylaxis
Corynebacterium diphtheriae CRM197 protein
diphtheria toxin
Diphtheria Toxoid
formaldehyde
polysaccharides
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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