IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
may play a role in the long-term dis ease man age ment. Novartis de scribed pimecrolimus as the first
ascomycin macrolactam de riv a tive de vel oped for the treat ment of inflammatory skin diseases.
In 2005, the FDA added a “black box” la bel to Elidel and an other pre scrip tion ec zema prod uct Protopic,
warn ing that they might in crease the risk for cer tain can cers, es pe cially in chil dren. There is ev i dence that
the prod ucts can cause can cer in mice and mon keys and there have been 13 re ports of skin can cer and
lym phoma in chil dren and adults among us ers. How ever, Novartis has stated that there is no ev i dence
that Elidel causes lym phoma and noted that the num ber of lym pho mas in ques tion “is be low the num ber
typ i cally ob served in the gen eral pop u la tion.” The Amer i can Acad emy of Der ma tol ogy has also is sued a
state ment crit i ciz ing the FDA decision for the same reasons.
Li cens ing: In 2006, Conor Medsystems ob tained world wide, non-ex clu sive li cense to pimecrolimus for
use with its next-gen er a tion con trolled vas cu lar drug de liv ery technologies.
In 2004, Avantec Vas cu lar ob tained an op tion to li cense pimecrolimus for use in its drug-eluting stents.
Pre clin i cal stud ies of the pimecrolimus-eluting stent in a por cine cor o nary model showed that the prod uct
re duced intimal pro lif er a tion.
Clin i cal Data: Data pub lished in 2004 sug gested that Elidel was safe and ef fec tive for use in in fants.
Novartis has con ducted tri als in chil dren as young as three months and the orig i nal NDA re quested ap -
proval for use in chil dren over three months of age. How ever, in 2001 the FDA ap proved the prod uct for
use only in chil dren over two years of age.
Com pe ti tion: Elidel’s main com pet i tor is Astellas’ Protopic (tacrolimus), an other new non-steroidal
prod uct, first launched in Ja pan in 1999. Re sults of a head-to-head six-week study re vealed that Protopic
was more ef fec tive at treat ing mod er ate-to-se vere ec zema than pimecrolimus. The trial in volved 193
chil dren re ceiv ing ei ther tacrolimus 0.1% oint ment or pimecrolimus 1% cream and ex am ined at weeks
one and three and at the end of the study. But data from three stud ies pre sented at the Amer i can Acad -
emy of Der ma tol ogy meet ing in 2004, dem on strated that tacrolimus oint ment is more ef fec tive that
pimecrolimus cream in the treat ment of adult and pe di at ric atopic der ma ti tis. In the sec ond half of 2004,
Fujisawa pre sented a meta-anal y sis of re sults of three tri als in volv ing over 1,000 pa tients at the World
Con gress of Pe di at ric Der ma tol ogy claim ing that tacrolimus is better than pimecrolimus at all lev els of se -
ver ity of ec zema. Novartis has crit i cized these re sults as Protopic (0.1%), used in the study, is not ap -
proved for pe di at ric use or for mild dis ease (whereas Elidel is not ap proved for se vere and very se vere
pa tients); Astellas has not presented data for moderate patients where the two products overlap.
Ac cord ing to IMS, Elidel led the D5X class (‘Other Nonsteroidal Prod ucts for In flam ma tory Skin Dis or -
ders’) in the 12-month pe riod to the end of Sep tem ber 2008, with a 38.3% mar ket share, al though sales
were down 17% in fixed rate dol lar terms. Protopic was num ber two with a 37.7% mar ket share and 12%
fixed rate dol lar growth. Nycomed Pharma’s Solaraze (diclofenac) was num ber three, with a 13.8%
mar ket share and 19% fixed rate dollar growth.
Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast 2009 sales of $145 mil lion
($112 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $155 mil lion in 2008 ($100
mil lion by 2013).
LAMISIL (terbinafine), an antifungal agent, was first launched in 1991 in the UK. It is now avail able in -
ter na tion ally, in clud ing the USA and Ja pan. It is avail able in oral tab let and top i cal cream and spray for -
mu la tions in most mar kets. Lamisil com bines a high level of ef fi cacy with rapid ac tion and a low re lapse
rate. It is used in the treat ment of fun gal in fec tions of the skin and nails. It is highly ef fec tive in the treat -
ment of fun gal nail in fec tions, and can clear up nail in fec tions in only three months, as op posed to six
months with other drugs. It is also ef fec tive in the treat ment of ring worm, ath lete’s foot, jock itch, and
other fungal infections.
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