IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Hormonal Agents
MIACALCIC/MIACALCIN (salcatonin), a syn thetic salmon calcitonin prep a ra tion for Paget’s dis ease,
os teo po ro sis, and hypercalcemia, was first launched in 1976. Now avail able in many mar kets, it has
proved par tic u larly pop u lar in It aly (calcitonin has tra di tion ally been widely used in South ern Eu rope). In
1987, a na sal spray for mu la tion was launched.
In April 2005, Miacalcic in di ca tions were up dated. Am poules and multidose vi als are now only in di cated
for pre ven tion of acute bone loss due to sud den im mo bi li za tion such as in pa tients with re cent
osteoporotic frac tures, Paget’s dis ease and hypercalcemia of ma lig nancy. Miacalcic na sal spray is in di -
cated for the treat ment of es tab lished post-meno pausal os teo po ro sis in or der to re duce the risk of ver te -
bral frac tures. Both for mu la tions are now con tra in di cated in patients with hypocalcaemia.
Li cens ing: In 1999, Noven’s (USA) women’s health joint ven ture with Novartis, Novogyne
Pharmaceuticals (pre vi ously known as Vivelle Ven tures LLC), agreed to co-pro mote Miacalcin na sal spray
in the USA.
Lifecycle Man age ment: In 2008, Novartis was de vel op ing an oral form of Miacalcic, with the labcode
SMC 021, in phase III tri als for osteoarthritis and os teo po ro sis. It uses Emisphere’s (USA) Eligen drug
de liv ery tech nol ogy. Novartis an tic i pates a fil ing for SMC 021 for the lead in di ca tion of osteoarthritis in
2011. Novartis ac quired ex clu sive world wide rights from Emisphere to de velop and com mer cial ize oral
calcitonin, us ing Emisphere’s pro pri etary Eligen drug de liv ery tech nol ogy in 2000. Novartis made a $10
mil lion in vest ment in Emisphere, which is el i gi ble for mile stone pay ments up to $30 million and royalties
on any sales.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Miacalcic was
the num ber one prod uct in the ‘Cal ci tonins’ class (H4A), with a 40.5% mar ket share, but sales were down
18% in fixed rate dol lar terms. Its clos est com pet i tor was Asahi Chem i cal’s Elcitonin (elcatonin), with a
23.2% mar ket share but 0% fixed rate dol lar growth. Num ber three was Upsher Smith’s Fortical
(salcatonin), with a 10.5% mar ket share and 23% growth in fixed rate dollar terms.
Sales/An a lyst Com ment: Miacalcic sales were $281 mil lion in 2007, down 17%. Mor gan Stan ley an a -
lysts (Jan u ary 2009) put sales at $253 mil lion in 2008 and fore cast sales of $232 mil lion in 2009 ($180
mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales for the oral SMC 021 prod uct of
$25 mil lion in 2012 ($50 million by 2013).
OMNITROPE (somatropin), man u fac tured by re com bi nant DNA tech nol ogy, is a biogeneric/biosimilar
prod uct to the hu man growth hor mone prod uct somatropin. It is pro duced in a 3.3mg/ml so lu tion for in -
jec tion. It re ceived its first world wide ap proval in 2004 in Aus tra lia, and was launched in Aus tra lia in 2005.
The in di ca tion is to treat growth dis tur bance in chil dren over three years of age and ad o les cents due to in -
suf fi cient se cre tion of growth hor mone and growth dis tur bance as so ci ated with Turner syn drome or
chronic re nal in suf fi ciency. It is also in di cated as a re place ment ther apy in adults with pro nounced growth
hor mone de fi ciency. Omnitrope was the first biosimilar product to be approved in the EU and the USA.
Omnitrope was ap proved in Eu rope and in the USA in 2006, af ter a lengthy cam paign in volv ing a le gal ac -
tion against the FDA. In Eu rope, Novartis’ Sandoz di vi sion aimed to be first onto the mar ket in 2004 and
had hoped to gain EU ap proval for Omnitrope be fore the end of 2003, fol low ing rec om men da tion by the
CPMP in June 2003. How ever, in April 2004 it be came ap par ent that the Eu ro pean Com mis sion was, in a
highly un usual step, re fus ing ap proval as it was un happy with the le gal path way of ‘well es tab lished use’
taken by Sandoz. Sandoz sub mit ted a sec ond ap pli ca tion in July 2004, based on a rec om men da tion from
the EMEA and the Com mis sion. In Jan u ary 2005, the CHMP fi nally is sued a pos i tive opin ion re gard ing
Omnitrope, pav ing the way for the launch of the first ge neric ri val to biotech med i cines in Eu rope.
Omnitrope was fi nally ap proved in Jan u ary 2006 and was launched in Ger many in May 2006. In 2007, it
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