IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Pat ents: Lamisil’s pat ent in the UK, Ger many and It aly ex pired in 2005. US mar ket ing ex clu siv ity ex -
pired in June 2007.
Lifecycle Man age ment: In 1998, the FDA ap proved Lamisil DermaGel for the treat ment of tinea
versicolor, tinea corporis and tinea pedis. It does not have an in di ca tion for tinea cruris like the cream for -
mu la tion. In 1998, a spray for mu la tion was launched in Puerto Rico. In 1999, it was launched as an OTC
treat ment, Lamisil AT Cream (1% terbinafine), for ath lete’s foot. Novartis said it was the first
Rx-to-OTC switch prod uct for the con di tion in nearly ten years. Novartis claims that Lamisil AT works
within one week, as op posed to four for ex ist ing treat ments. Lamisil AT was launched in the UK in 2001.
Lamisil Spray Pump and So lu tion Drop per OTC for mu la tions were launched in 2000.
In Sep tem ber 2007, the FDA granted mar ket ing ap proval for Novartis’ oral gran ule for mu la tion of Lamisil
in the treat ment of tinea capitis in chil dren aged four years and older. The prod uct is ap proved for a
once-daily, six-week reg i men. Novartis is also de vel op ing a nail lac quer for mu la tion in phase III tri als
(NM 100060).
Com pe ti tion: In 2007, var i ous com pa nies in clud ing Teva, Dr Reddy’s, Mylan and Barr launched ge neric
terbinafine prod ucts in the USA. Novartis also launched its own terbinafine ge neric. Lamisil has al ready
been ex posed to ge neric com pe ti tion in a large num ber of mar kets outside the USA.
Ac cord ing to IMS, Lamisil was the num ber six prod uct in the J2A class (‘Sys temic Agents for Fun gal In fec -
tions’) class in the 12-month pe riod to the end of Sep tem ber 2008, with a 6.1% mar ket share, but sales
down 71% in fixed rate dol lar terms. Pfizer’s Vfend (voriconazole) was num ber one, with a 16.6% mar -
ket share and sales up 11% in fixed rate dol lar terms. Merck & Co’s Cancidas (caspofungin) was num ber
two, with a 12.4% mar ket share, but sales down 1%. Pfizer’s Diflucan (fluconazole) was num ber three,
with an 8.4% mar ket share, but with sales down 21%.
Sales/An a lyst Com ment: Lamisil had sales in 2007 of $595 mil lion, ac cord ing to Mor gan Stan ley an a -
lysts (Jan u ary 2009), who put 2008 sales at around $266 mil lion. Sales are de clin ing due to ge neric com -
pe ti tion. Mor gan Stan ley an a lysts fore cast sales of $202 mil lion in 2009 ($79 million by 2014).
Genitourinary System/Sex Hormones
ENABLEX/EMSELEX (darifenacin), a once-daily, ex tended-re lease se lec tive muscarinic M3 re cep tor
an tag o nist for the treat ment of over ac tive blad der, was ap proved in the USA and in all 25 Eu ro pean
mem ber states, plus Nor way and Ice land in 2004. It was first launched in 2005 in the USA as Enablex by
Novartis. It was launched in Swe den, Den mark, Nor way and Swit zer land in 2005 by Novartis as Emselex
and in Ger many as Emselex by li censee Bayer. It was also launched in Uru guay as Enablex in 2005. It has
since been launched in a num ber of world mar kets. In Eu ro pean coun tries, it is mar keted as Emselex. In
North Amer ica, Uru guay, Brazil, Co lom bia, Ar gen tina, Aus tra lia and South Af rica, it is mar keted as
Enablex. In 2008, it was launched in Portugal and the Slovak Republic.
Li cens ing: Darifenacin was orig i nally de vel oped by Pfizer, which filed for US ap proval in 2002. It was ac -
quired by Novartis in 2003 for $225 mil lion. In 2004, Novartis granted Bayer ex clu sive Ger man com mer -
cial iza tion and dis tri bu tion rights. In 2005, Novartis and Procter & Gam ble en tered into an agree ment for
the co-pro mo tion and fur ther de vel op ment of Enablex in the USA. Novartis would con tinue to re cord rev -
e nues for Enablex and would pay roy al ties to P&G based on the prod uct’s per for mance. In 2006, Ardana
Bio sci ence (UK) gained rights to mar ket darifenacin in the UK. In 2007, Beijing Med-Pharm (China)
signed an ex clu sive deal with Novartis to reg is ter, market and distribute Enablex in China.
Clin i cal Data: In 2004, data was pre sented at the Amer i can Uro log i cal As so ci a tion meet ing from a
439-pa tient study. Ad min is tra tion of 7.5mg and 15mg of darifenacin re duced the num ber of noc tur nal
awak en ings by 22.1% and 22.7% re spec tively com pared with 3.6% in the pla cebo group af ter 12 weeks.
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