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IMS COM PANY PRO FILES NOVARTIS
multicenter phase III pro gram to as sess the immunogenicity and safety of IC51 in more than 4,900
subjects.
MENVEO (vac cine, meningococcal ACWY, Novartis) is a con ju gate quad ri va lent ACWY vac cine against
the A, C, W135 and Y serogroups of Neisseria meningitides, im por tant causes of bac te rial men in gi tis.
Phase III tri als in volv ing 13,000 peo ple be gan in 2006, tar get ing reg u la tory sub mis sion for use in in fants,
ad o les cents, and adults. Novartis has filed it for ap proval in the USA (Au gust 2008) and the EU (Oc to ber
2008): both sub mis sions are for ages 11-55. US approval is anticipated in 2009.
In April 2007, Novartis ini ti ated a phase III trial of Menveo in Co lom bia and Ar gen tina. This trial will eval u -
ate the safety and im mune re sponse of the vac cine in adults and ad o les cents in com par i son with a li -
censed con ju gate meningococcal ACWY vac cine and with a li censed polysaccharide vac cine in 3,000
sub jects. A safety/ef fi cacy phase III trial was also ini ti ated in the USA in March 2007. This study will eval -
u ate the safety of the vac cine and im mune re sponse in 3,000 adults and ad o les cents. An other phase III
trial ini ti ated in March 2007 in 4,500 healthy in fants in Ar gen tina, to eval u ate the safety and
immunogenicity of Menveo when ad min is tered with rou tine vac ci na tions. Reg u la tory sub mis sions for use
in chil dren from two years to 10 years were planned for 2009, but fol low ing dis cus sions with the FDA in
late 2008, the phase III pro gram in chil dren aged two to ten years was ex panded by 1,500 in fants and
this will mean a sub mis sion in the US for this age group is not expected until 2011.
Novartis de scribes Menveo as a new vac cine pro tect ing against four com mon types of meningococcal
men in gi tis known as A, C, W-135 and Y. This bac te rial dis ease is a rare, but po ten tially fa tal, in fec tion that
causes in fec tion of the mem branes around the brain and spi nal cord. Novartis states that the lat est phase
III data sug gests that Menveo has the po ten tial to be come the first vac cine to pro tect from in fancy to
adult hood against these four common serogroups.
Clin i cal Data: In Jan u ary 2008, Novartis re ported data from a phase II trial of Menveo con ducted in 421
in fants in the UK and Can ada. In the study, some pa tients re ceived three doses of the vac cine at two,
three and four months and oth ers at two, four and six months. At month 12, some par tic i pants re ceived
an ad di tional dose of MenACWY or a plain meningococcal polysaccharide. Re sults showed that Menveo
was well tol er ated, and one month af ter the last pri mary im mu ni za tion it pro duced high lev els of
immunogenicity against meningococcal serogroups A, C, W-135 and Y, with 93% of in fants achiev ing
hSBA titers of greater than or equal to 1:4 in the two, three, four-month group. Ad di tion ally, the dose at
month 12 gen er ated a strong im mune response in all four serogroups.
In May 2008, Novartis an nounced first phase III head-to-head data com par ing its multivalent con ju gate
vac cine against Neisseria meningitidis serogroups A, C, W and Y (Menveo/MenACWY) with the li censed
vac cine Menactra. In this US trial, more than 2,100 ad o les cents aged 11-18 years re ceived a sin gle vac -
ci na tion with Menveo or Menactra, and im mune re sponses against meningococcal serogroups A, C,
W-135 and Y were higher with Menveo.
Com pe ti tion: In 2000, Wyeth launched Prevnar (vac cine, pneumococcal 7-valent con ju gate), the first
vac cine aimed at pre vent ing in va sive pneumococcal dis ease in in fants and tod dlers (up to two years old),
such as otitis me dia (mid dle-ear in fec tions), pneu mo nia, bacteremia, and bac te rial men in gi tis. It is now
de vel op ing an im proved ver sion, known as Prevnar 13 (vac cine, 13-valent pneumococcal con ju gate).
In De cem ber 2008, Wyeth re ported that it has sub mit ted an MAA to the EMEA for ap proval to mar ket
Prevnar 13 for the pre ven tion of pneumococcal dis ease in in fants and young chil dren. The re view of the
MAA will be co or di nated by the EMEA for all EU coun tries, plus Nor way, Ice land and Liech ten stein. Wyeth
ex pects to file for pe di at ric ap proval in the USA in Q1 2009. Phase III eval u a tion of the vac cine in adults is
on go ing, and fil ings for use in adults are an tic i pated in 2010. In the 12-month pe riod to the end of Sep -
tem ber 2008, Prevnar was the num ber two prod uct in the J7A class (Pure Vaccines), with sales of $1,437
million, according to IMS.
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