IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
was launched in the UK, Den mark, the Neth er lands, It aly, France, Spain, Fin land and Austria. It was
launched in Bulgaria and Belgium in March 2008.
In Sep tem ber 2008, the US FDA ap proved Sandoz’s sNDA for a new strength car tridge (10mg/1.5ml) of
Omnitrope for use with a new re us able in jec tor pen, Omnitrope Pen 10.
In the USA, Pfizer, the maker of a branded somatropin prod uct, Genotropin, lob bied against the ap -
proval of Omnitrope and asked the FDA to de lay ap proval. The FDA in formed Novartis in 2004 that it has
been un able to reach a de ci sion be cause of un cer tainty re gard ing sci en tific and le gal is sues. In 2005,
Sandoz sued the FDA, seek ing to force it to make a de ci sion on its ap pli ca tion. The law suit, filed in a US
Dis trict Court in Wash ing ton, al leged that the FDA vi o lated fed eral law by fail ing to make a fi nal rul ing,
keep ing Omnitrope in “per pet ual limbo.” In May 2006, us ing a spe cial reg u la tion, the FDA au tho rized
Omnitrope and cleared the way for it to com pete with Pfizer’s Genotropin in the USA. The spe cial reg u la -
tion is known as 505(b)(2). The FDA ex pressly re jected the sug ges tion that the ap proval pro vided a
far-reach ing pre ce dent for au tho riz ing fol low-on versions of other types of currently marketed products.
Sandoz did not seek a ther a peu tic equiv a lence rat ing for Omnitrope. Con se quently, Omnitrope is not au -
to mat i cally substitutable for Genotropin at the phar macy, al though in dus try ex perts said that a pre scrip -
tion writ ten for somatropin could be filled with Omnitrope.
Com pe ti tion: In the 12 month pe riod to the end of Sep tem ber 2008 Omnitrope was num ber nine in the
‘To tal Growth Hor mones’ class, with a 1% mar ket share and 500% fixed rate dol lar growth, ac cord ing to
IMS. Genotropin was num ber one, with a 29.8% mar ket share and 3% fixed rate dol lar growth. In sec ond
place was Novo Nordisk’s Norditropin, with a 24.1% mar ket share and 9% fixed rate dol lar growth, fol -
lowed in third place by Lilly’s Humatrope (somatropin) with a 16.8% mar ket share and 18% growth.
SANDOSTATIN (octreotide), a somatostatin an a logue, first launched in 1988, is mainly used in the
treat ment of gas tro in tes ti nal tu mors and acromegaly and avail able in most ma jor mar kets in clud ing the
USA and Ja pan. Sandostatin LAR, a new long-act ing dos age form (once-monthly in jec tion for
acromegaly), was launched in Ger many in 1997 and in the UK in 1998. In 1998, the FDA ap proved
Sandostatin LAR, which is now sold in many mar kets world wide, including Japan.
Pat ents: Pat ents have now ex pired and Sandostatin is open to ge neric com pe ti tion.
Clin i cal Data: In Jan u ary 2009 Novartis re ported in terim data from a multicenter, pro spec tive, ran dom -
ized, pla cebo-con trolled, dou ble-blind phase IIIb trial of Sandostatin LAR. The Ger man trial in cluded 85
treat ment na ive pa tients with lo cally in op er a ble or met a static func tion ally ac tive neuroendocrine tu mors
(NETs), with the pri mary tu mor in the midgut, who were with out cu ra tive ther a peu tic op tions. Fol low -
ing six months of treat ment, Sandostatin LAR-treated pa tients had a 66% re duc tion in risk of dis ease
pro gres sion, com pared with the pla cebo group; tu mor growth was halted in 69% and 39% of pa tients re -
ceiv ing Sandostatin LAR and pla cebo, re spec tively. Sandostatin LAR-treated pa tients had no tu mor pro -
gres sion for a me dian of 14.3 months, compared with six months for placebo-treated patients.
Com pe ti tion: In 2005, Boehringer Ingelheim launched a ge neric ver sion of octreotide in the USA. In
2006, Teva and Novartis launched ge neric octreotide prod ucts in the US. In the 12-month pe riod to the
end of Sep tem ber 2008, Sandostatin was the lead ing prod uct in the H1C class (Hypothalmic Hor mones),
with a 62.4% mar ket share and 4% fixed rate dol lar growth. The num ber two prod uct was Ipsen’s
Somatuline (lanreotide), with an 8.8% mar ket share and 17% fixed rate dol lar growth. Num ber three
was Pfizer’s Somavert (pegvisomant), with a 6.6% mar ket share and sales up 26% in fixed rate dol lar
terms. Num ber four was Takeda’s Enantone (leuprorelin), with a 4.4% mar ket share and 1% fixed rate
dollar growth.
Ambrilia (Can ada) is car ry ing out phase III tri als with its pro pri etary pro longed-re lease for mu la tion of
octreotide, which it re fers to as octreotide C2L (drug de liv ery sys tem, octreotide, Ambrilia in IMS
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