IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
more than 1,400 pa tients showed that vildagliptin is well tol er ated in pa tients with type II di a be tes with
mild-to-mod er ate re nal im pair ment. Pa tients with mild re nal im pair ment and pa tients with normal renal
function reported similar efficacy of vildagliptin.
Com pe ti tion: Novartis lost the race to be come first on the mar ket with a DDP-IV in hib i tor. Merck & Co’s
Januvia (sitagliptin) was launched in the USA in Oc to ber 2006. Merck filed Januvia in Feb ru ary 2006,
just ahead of Galvus fil ing in March. Januvia does not cause weight gain, an ad van tage over some older
di a be tes treat ments. In March 2007 it was also ap proved in the EU. Januvia has been ex tremely suc cess -
ful and is now a lead ing oral antidiabetic.
There are sev eral other DPP-IV in hib i tors close to mar ket. Takeda’s alogliptin was sub mit ted for ap -
proval with the US FDA in Jan u ary 2008 and in Ja pan in Sep tem ber 2008. In Oc to ber 2008, it was re -
ported that Takeda had re ceived no ti fi ca tion that the FDA will not be able to com plete its re view of the
alogliptin NDA by the PDUFA date of Oc to ber 27 2008, due to “in ter nal re source con straints”. In Jan u ary
2009 Takeda stated that the re view would be com plete in June 2009. Bris tol Myers-Squibb’s Onglyza
(saxagliptin) was sub mit ted for ap proval in the USA and Eu rope in July 2008. Slightly fur ther back in de -
vel op ment is Phenomix/For est (both USA)’s dutogliptin in phase III tri als and Boehringer Ingelheim’s
BI 1356 which be gan phase III tri als in Au gust 2008. There are sev eral DPP-IV in hib i tors in phase II tri -
als, in clud ing Mitsubishi Tanabe Pharma’s TA 6666 (li censed to GlaxoSmithKline), Glenmark’s (In dia)
melogliptin, Roche’s carmegliptin, and ActivX (USA)/Kyorin (Ja pan)’s KRP 104.
In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Januvia was the world’s num ber
two prod uct in the A10B class (Oral Antidiabetics), with an 8.7% mar ket share and 178% fixed rate dol lar
growth. A com bi na tion of sitagliptin and metformin, Janumet, was the num ber 12 prod uct in the class
dur ing the same pe riod, with a 1.9% mar ket share and 599% growth. The lead ing prod uct in this class
was Takeda’s Actos (pioglitazone), with a 28.1% mar ket share and 9% fixed rate dol lar growth. Num ber
three was GSK’s Avandia (rosiglitazone), with a 8.1% mar ket share, but sales down 52% in fixed rate
dol lar terms. Sales of Avandia have been ad versely af fected by the pub li ca tion of a study in 2007 link ing it
to car dio vas cu lar prob lems. Galvus did not fig ure among the top 15 prod ucts in the class during this
period.
Sales/An a lyst Com ment: Novartis and an a lysts had high lighted Galvus as a po ten tial $1 bil lion plus
prod uct. How ever, in No vem ber 2007, fol low ing the an nounce ment of new liver safety prob lems with
high doses of the drug, Mor gan Stan ley an a lysts cut their Galvus sales fore cast. In Jan u ary 2009, they
fore cast Galvus sales of $80 mil lion in 2009 ($473 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008)
put 2007 sales at $8 mil lion. They fore cast sales of $35 mil lion in 2008 ($120 million by 2013).
NAVOBAN/NOVOBAN (tropisetron), a 5HT-3 an tag o nist anti-emetic/antinauseant, launched in Eu -
rope in 1992, and now avail able in around 50 mar kets world wide. It was launched in Ja pan in 1998. Clin i -
cal tri als were car ried out in the USA, but it has not been launched there.
STARLIX (nateglinide), an in su lin secretagogue, was launched in its first mar ket, Ja pan, in 1999 by
Yamanouchi (now Astellas, Ja pan) as Starsis, and Aventis (now sanofi-aventis, France) as Fastic. It is
in di cated for non-in su lin de pend ent di a be tes mellitus (Type 2 di a be tes) as a monotherapy or in com bi na -
tion with other oral antidiabetics such as Merck KGaA’s Glucophage (metformin) in pa tients whose
blood glu cose level is not con trolled by diet and ex er cise alone. Ad di tional FDA ap proval in com bi na tion
with a thiazolidinedione was given in 2003 in pa tients who are not ad e quately con trolled af ter a ther a peu -
tic re sponse to a TZD. Novartis has launched Starlix across Eu rope, as well as in South Af rica, the United
Arab Emirates, Latin Amer ica, the USA (2001) and Can ada (2002). Nateglinide is an amino acid de riv a -
tive. It stim u lates early in su lin se cre tion, with a rapid on set and short du ra tion of ac tion. It has a faster
onset of action than other oral antidiabetic drugs.
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