IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Com pe ti tion: Ac cord ing to IMS, Zelmac was the sec ond lead ing gas tro in tes ti nal sensorimotor mod u la -
tor in the 12-month pe riod to the end of Sep tem ber 2008, with sales down 94% in fixed rate dol lar terms.
It made up 45.2% of the mar ket or $19 mil lion in sales. Its only ma jor com pet i tor in this class is
GlaxoSmithKline’s Lotronex (alosetron) which led the mar ket with a 51.7% mar ket share or $22 mil lion
in sales, up 43% in fixed rate dol lar terms. Also in cluded in the class are some ge neric ver sions of
tegaserod sold in In dia, Ban gla desh, Pa ki stan, Chile, Peru and Co lom bia, which have neg li gi ble sales.
Lotronex tar gets di ar rhea-pre dom i nant IBS (and is a 5HT3 an tag o nist), while Zelmac tar gets con sti pa -
tion-pre dom i nant IBS (and is a 5HT4 ag o nist). In 2007, Pro me theus Lab o ra to ries (USA) gained exclusive
rights to Lotronex in the USA.
A re cent new com pet i tor in this area is Takeda’s Amitza (lubiprostone) a se lec tive chlo ride chan nel ac ti -
va tor that works to in crease fluid se cre tion and mo til ity in the in tes tine speed ing up the pas sage of stool
and thus re duc ing symp toms of con sti pa tion. Amitza was ap proved by the US FDA in April 2008 in adults
(fe male) for con sti pa tion-pre dom i nant ir ri ta ble bowel syn drome (IBS-C) fol low ing the fil ing of a sNDA in
July 2007. Amitza is pend ing ap proval in Eu rope. Also pend ing ap proval in Eu rope is Movetis’
prucalopride, a se lec tive 5-HT4 re cep tor ag o nist, for the treat ment of gas tro in tes ti nal mo til ity dis or -
ders, es pe cially those af fect ing the lower bowel, in clud ing chronic con sti pa tion and irritable bowel
syndrome (IBS). It was filed for approval in May 2008.
Sales/An a lyst Com ment: Zelnorm/Zelmac fell from the list of top 20 Novartis prod ucts in 2007 fol low -
ing sus pen sion in the US and other mar kets. Ther a peu tic op tions for IBS are lim ited. Med i ca tions in the
past have usu ally been di rected at iso lated symp toms (e.g. di ar rhea/con sti pa tion). With the mar ket sus -
pen sion in the US and other mar kets in 2007, the pros pects for Zelnorm look gloomy al though the FDA
left the door opened for the pos si bil ity of the drug re turn ing to the US mar ket. In dus try an a lysts say that
even if the prod uct is re in tro duced, its sales will prob a bly be low be cause of the neg a tive pub lic ity and the
pos si bil ity of in creased risk for car dio vas cu lar events. Mor gan Stan ley an a lysts (Jan u ary 2009) have con -
sid er ably re duced fore casts for Zelnorm. They now ex pect only $13 mil lion in sales be tween 2009-2014.
Cowen & Co an a lysts (Au gust 2008) put 2007 sales at $88 mil lion and think sales will fall to $15 million in
2008 ($10 million by 2012/2013).
Antineoplastics/Immunomodulating Agents
CERTICAN (everolimus), an orally ac tive rapamycin an a logue with immunosuppressant ac tiv ity, was
ap proved for the pre ven tion of re jec tion in re nal and heart trans plan ta tion in Swe den in 2003. Swe den
acted as the ref er ence mem ber state for the EU’s Mu tual Rec og ni tion pro cess, which com pleted by the
end of 2003 in 15 coun tries. In 2004, Novartis launched everolimus in Ger many, its first world mar ket, for
the pre ven tion of re jec tion ep i sodes in pa tients with heart and kid ney trans plants in com bi na tion with low
dose ciclosporin. It has now been launched in sev eral world mar kets, most re cently in Rus sia in 2008. In
2007, Novartis re ported that phase III tri als in liver trans plan ta tion were also un der way. Everolimus is
now be ing de vel oped for the treat ment of cancer by Novartis under the brandname Afinitor.
Li cens ing: In 2002, Novartis li censed everolimus to Guidant (USA) on a co-ex clu sive ba sis for use in the
lat ter’s drug-eluting stents for the treat ment of cor o nary and pe riph eral vas cu lar dis eases. Novartis will
pro vide everolimus to Guidant, sup ply data to sup port reg u la tory fil ings, and re ceive mile stone pay ments
and roy al ties on sales of everolimus-eluting stents. This agree ment was later re vised to give Guidant ex -
clu siv ity, and the right to grant sub-licenses.
Pat ents: Wyeth had be gun le gal pro ceed ings against Novartis in cer tain EU coun tries, claim ing that
everolimus in fringes sirolimus pat ents. How ever, Novartis has been granted a dec la ra tion of non-in -
fringe ment in a num ber of coun tries. Both Wyeth and Novartis EU pat ents are due to ex pire around 2010.
In 2001, the Eu ro pean Pat ent Of fice up held Novartis’ European patent.
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