IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Li cens ing: Nateglinide was li censed-in from Aji no mo to (Ja pan) in 1994 by Novartis for mar ket ing world -
wide out side Ja pan, South Ko rea, Tai wan, China, the UK, and Ire land. In 2000, Merck KGaA ac quired
co-pro mo tion and co-mar ket ing rights from Novartis. Merck is com mer cial iz ing Starlix in Eu rope and cer -
tain coun tries in Af rica, South east Asia, and Latin Amer ica for the com plete term of nateglinide’s pat ent.
Sankyo (Ja pan) ob tained lo cal co-li censed mar ket ing rights in Ja pan in 2002 and took over co-mar ket ing
in Japan from sanofi-aventis.
Clin i cal Data: Novartis an nounced plans to con duct the larg est clin i cal trial to date on the pre ven tion of
Type 2 di a be tes and car dio vas cu lar dis ease in 2001. The NAV I GA TOR (Nateglinide And Valsartan in Im -
paired Glu cose Tol er ance Out comes Re search) trial will in ves ti gate whether Starlix or high blood pres sure
med i ca tion Diovan (valsartan) can pre vent di a be tes and/or car dio vas cu lar events in in di vid u als with im -
paired glu cose tol er ance that are at high risk for car dio vas cu lar events. NAV I GA TOR is a mul ti na tional
study that will involve about 7,500 individual in over 30 countries.
ZELMAC/ZELNORM (tegaserod), an aminoguanidine indole 5HT4 ag o nist for ir ri ta ble bowel syn drome
(IBS) was launched in Mex ico, its first world mar ket in 2001. It has since been launched in over 56 coun -
tries as a short-term treat ment for women with IBS with con sti pa tion as the pri mary symp tom. It is also
ap proved for use in chronic con sti pa tion in more than 20 mar kets. It was ap proved and launched in the
USA in 2002, as a short-term treat ment for women with con sti pa tion as the primary symptom of IBS.
In March 2007, the FDA re quested that Novartis sus pend sales and mar ket ing of Zelnorm in the USA. This
move was in re sponse to a ret ro spec tive anal y sis of clin i cal trial data from over 18,000 pa tients, show ing
a sta tis ti cally sig nif i cant im bal ance in the in ci dence of car dio vas cu lar ischemic events, in clud ing myo car -
dial in farc tion, stroke and un sta ble an gina pectoris, in pa tients tak ing tegaserod (in ci dence of 0.11%)
com pared to pla cebo (in ci dence of 0.01%). Sub se quently, Can ada (April 2007), Aus tra lia (April 2007),
Swit zer land (May 2007) and a num ber of other coun tries also requested the withdrawal of tegaserod.
In July 2007, Novartis an nounced that it has es tab lished with the FDA, a re stricted ac cess pro gram
(called a treat ment IND) for Zelnorm so that pa tients who need tegaserod can be con sid ered for treat -
ment. The pro gram al lows women in the USA un der 55 years of age who suf fer from IBS with con sti pa -
tion (IBS-C) or chronic id io pathic con sti pa tion (CIC) and for whom no other treat ment has pro vided
sat is fac tory re lief and/or pa tients who had sat is fac tory im prove ment of their symp toms with prior
tegaserod treat ment for IBS-C or CIC to have ac cess to tegaserod for re lief of the symp toms as so ci ated
with these con di tions. The pro gram pro to col en sures that pa tients and phy si cians are fully in formed of
the potential risks and benefits of the drug.
Even be fore the most re cent prob lems in the USA, Zelnorm had not had an easy time from the reg u la tory
au thor i ties. In Eu rope, Novartis with drew its ap pli ca tion in 2001 be cause of a dis pute over ef fec tive ness
with the Eu ro pean au thor i ties, but in 2004 it re-filed tegaserod, based on data from the ZENSAA trial. The
agency is sued a neg a tive opin ion in 2005. Novartis ap pealed and again the agency rec om mended
against the ap proval of tegaserod. In the USA, the FDA ini tially re jected tegaserod in 2001 on safety
grounds, par tic u larly the in ci dence of gall blad der re mov als in treated pa tients, but later re versed its de ci -
sion. Novartis says the in ci dence of gall blad der re mov als is con sis tent with that of the gen eral IBS pop u -
la tion (2-3 times higher than the general population).
In 2004, the FDA added a warn ing against se ri ous con se quences of di ar rhea as so ci ated with use of
Zelnorm, as well as pre cau tions about ischemic co li tis (re duced blood flow to the in tes tines, the same ad -
verse event that led to with drawal of GSK’s Lotronex in 2000). Novartis’ re sponse was that these side
ef fects are rare, how ever crit ics claim that the drug does not of fer enough im prove ment over pla cebo to
war rant the potential dangers.
Pat ents: Ac cord ing to IMS Pat ents In ter na tional, pat ents on Zelmac run un til 2012 in many mar kets (the
pat ent has been ex tended to 2016 in the USA).
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