IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
re ported that it had come to a set tle ment agree ment with Novartis that will allow it to market 2.5mg
tablets.
Fifth placed Sandostatin, for the treat ment of acromegaly, has ex pe ri enced growth due to in creased use
of the once-monthly ver sion, Sandostatin LAR, which now ac counts for 85% of sales. Novartis re ports
that in 2008 new com pe ti tion to the Sandostatin LAR prod uct has had min i mal im pact on prod uct sales.
Pharmaceuticals
Alimentary Tract and Metabolism Agents
EUCREAS (vildagliptin + metformin) is a fixed com bi na tion oral tab let for mu la tion of vildagliptin, a
dipeptidyl peptidase IV in hib i tor, com bined with metformin for the treat ment of Type 2 di a be tes. It was
first launched in the UK in March 2008. It has since been launched in Fin land, Den mark, Brazil, Nor way,
Ger many, Spain, Aus tria and Hungary.
GALVUS (vildagliptin), an oral dipeptidyl peptidase IV (DPP-IV) in hib i tor, was first launched in June 2007
in Brazil and Mex ico. In Sep tem ber 2007, it was ap proved in all 27 EU mem ber states plus Nor way and
Ice land for the treat ment of Type 2 di a be tes. The ap proval al lows for once-daily oral vildagliptin to be ad -
min is tered with other oral antidiabetic med i ca tions, in clud ing metformin, sulfonylureas (SUs) or
thiazolidinediones. How ever, Novartis has found liver safety prob lems with high doses of the drug and
sought re vi sion of pre scrib ing rec om men da tions be fore in tro duc ing Galvus to the Eu ro pean mar ket. In
Feb ru ary 2008, Novartis re ported that the Eu ro pean Com mis sion had ap proved the pre scrib ing changes
for vildagliptin in all 27 EU coun tries, as well as Nor way and Ice land; the ap proval cov ers the use of 50 mg
once-daily vildagliptin in com bi na tion with a sulphonylurea, or 50 mg twice-daily vildagliptin in com bi na -
tion with metformin or a thiazolidinedione. The pre vi ously ap proved 100 mg once daily dose of
vildagliptin will not be avail able. In 2008, Galvus was launched in Sin ga pore, the UK, Nor way, It aly, Fin -
land and the Czech Republic. It was filed for approval in Japan in April 2008.
EU ap proval was granted in No vem ber 2007 for Eucreas, a sin gle-tab let com bi na tion of Galvus with the
oral antidiabetic med i cine metformin, and it was launched in Eu rope in 2008.
Skin tox ic ity wor ries have set back Galvus’ ap proval in the US. Filed with the FDA in early 2006, Galvus
first had its re view pe riod ex tended by the FDA by three months from No vem ber 2006 af ter clin i cal data
were sub mit ted to sup port the pro posed dos ing and in di ca tions as well as com ple ment ear lier data on the
risk/ben e fit pro file. Then in Feb ru ary 2007 the FDA is sued an ap prov able let ter for the prod uct and re -
quested ad di tional data, in clud ing a clin i cal study in pa tients with re nal im pair ment. This has de layed the
de vel op ment of Galvus in the US in at least two years. Novartis is now con duct ing safety stud ies but a
resubmission for US regulatory approval is not expected before 2010.
Li cens ing: In March 2008, Novartis Ko rea and HANDOK (South Ko rea) signed a co-pro mo tion agree -
ment for vildagliptin in South Ko rea.
Clin i cal Data: In Sep tem ber 2008, Novartis re ported re sults from the GALIANT trial of more than 2,400
pa tients with Type 2 di a be tes treated with vildagliptin 100 mg once-daily. Vildagliptin showed non-in fe -
rior ef fi cacy to thiazolidinediones (TZDs) (-0.68% ver sus -0.57% HbA1c re spec tively, p = 0.001) in pa -
tients with in ad e quately con trolled blood sugar lev els (HbA1c more than 7%) with metformin alone.
Weight loss was noted in pa tients treated with vildagliptin whereas those pa tients treated with TZDs put
on weight (-0.58 kg ver sus +0.33 kg, re spec tively). From a pooled anal y sis from ap prox i mately 6,000
pa tients, vildagliptin was shown to have a fa vor able car dio vas cu lar pro file, with fewer car dio vas cu lar and
cerebrovascular events e.g. heart at tacks and strokes, than pla cebo. An anal y sis of pooled re sults from
© 2009 IMS Health In cor po rated or its af fil i ates Page 24