IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast sales of $25 mil lion in 2012
and $50 mil lion in 2013.
Dermatological Agents
drug delivery system, NexACT,
terbinafine, Novartis NM 100060 D1A, V7A III
psoriasis therapy AHT 956 D5B
Ipsoriasis therapy BCT 194 D5A I
NM 100060 (drug de liv ery sys tem, NexACT, terbinafine, Novartis) is a top i cal lac quer for mu la tion of
terbinafine, an antifungal, for the po ten tial treat ment of onychomycosis. The prod uct, which uti lizes
NexMed’s (USA) pro pri etary NexACT skin ab sorp tion enhancers, con tains less than 1% of the dose of li -
censed oral terbinafine. Terbinafine is sold by Novartis un der the trade name Lamisil.
In Jan u ary 2007, Novartis com menced phase III tri als for NM 100060. The pro gram con sists of two piv -
otal, ran dom ized, dou ble-blind, pla cebo-con trolled stud ies. The par al lel group stud ies are de signed to as -
sess the ef fi cacy, safety and tolerability of NM 100060 in pa tients with mild to mod er ate toe nail
onychomycosis. Ap prox i mately 1,000 pa tients will par tic i pate in the two stud ies, which will take place in
the US, Europe, Canada and Iceland.
In Au gust 2008, NexMed re ported that an NDA will not be filed with the US FDA at pres ent, based upon
first in ter pret able re sults from two phase III tri als. Re sults from a Eu ro pean com para tor study are ex -
pected mid-2009.
Li cens ing: Novartis ac quired ex clu sive world wide rights to de velop and com mer cial ize NM 100060 from
NexMed in 2005.
AHT 956 com pleted phase I tri als with Novartis for use in pso ri a sis in 2008.
BCT 194 was in phase I tri als with Novartis in 2007 for the treat ment of pso ri a sis. It is re ported to be a
top i cal antipsoriasis prod uct.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2012 ($75 mil lion in 2013).
Hormonal Agents
drug delivery system, oral
salmon calcitonin, Emisphere/Novartis SMC 021 H4A, V7A III
DRUG DE LIV ERY SYS TEM, ORAL SALMON CALCITONIN, EMISPHERE/NOVARTIS: Novartis, in
part ner ship with Nordic Bio sci ence (Den mark) is de vel op ing SMC 021, an oral ver sion of salmon
calcitonin, in phase III tri als. Novartis has stated that it an tic i pates fil ing for ap proval of SMC 021 for the
lead in di ca tion of osteoarthritis in 2011. In Oc to ber 2008, Emisphere re ported that Novartis and Nordic
Bio sci ence have ini ti ated a sec ond phase III trial of SMC 021 in osteoarthritis pa tients. The trial will eval u -
ate the safety and ef fi cacy of the agent in pa tients (aged 51-80 years) with pain ful symp toms of knee
osteoarthritis, and will be con ducted at mul ti ple sites, in clud ing in the USA. The study is de signed to meet
US FDA reg is tra tion re quire ments, and is expected to complete in H2 2011.
Li cens ing: SMC 021 uses Emisphere’s (USA) pro pri etary Eligen drug de liv ery tech nol ogy. In 2000,
Novartis ac quired ex clu sive world wide rights from Emisphere to de velop and com mer cial ize oral
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