IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
in for ma tion needs to be col lected to ver ify that the biomarker can iden tify those with a pre dis po si tion to
liver toxicity caused by the drug.
Sales/An a lyst Com ment: Prexige sales in 2007 were $91 mil lion. Mor gan Stan ley an a lysts (Jan u ary
2009) fore cast a fall to $26 mil lion in 2008, re main ing at that level un til 2014. Cowen & Co an a lysts (Au -
gust 2008) fore cast sales of $45 mil lion in 2008 ($40 mil lion in 2009-13).
VOLTAREN (diclofenac so dium), an NSAID, was first launched in 1973, and later in the USA in 1988. It is
now a ma ture prod uct and avail able world wide (as Voltarene, in French-speak ing coun tries, and as
Voltarol, in the UK and Ire land). Prod ucts in the Voltaren range in clude: an eyedrop form, Voltaren
Optha/Voltaren Colirio; a sol u ble tab let, Voltarol Dispersible; Voltaren Drops; a top i cal form as
Voltaren Emulgel; Voltaren En teric Coated Tab lets; Voltaren In jec tion; an oral,
once-/twice-daily sus tained-re lease form, Voltaren Re tard; Voltaren Rapide; an oral, once-daily sus -
tained re lease form, Voltaren SR/Voltaren XR; Voltaren Sup pos i to ries; and Voltaren Emulgel, a
top i cal gel for mu la tion. Voltaren Emulgel is available OTC in some markets.
Li cens ing: In March 2008, Endo li censed the US rights to Voltaren Gel (1% diclofenac top i cal gel) from
Novartis. Un der the terms of a five-year deal, Novartis will re ceive an upfront pay ment of $85 mil lion.
Novartis will also be el i gi ble for a one-time mile stone pay ment of $25 mil lion if an nual sales ex ceed $300
mil lion. Novartis will also be el i gi ble for roy al ties on net sales of Voltaren Gel in the USA. Novartis will sup -
ply the prod uct to Endo. Voltaren Gel was ap proved in the USA in Oc to ber 2007 for the treat ment of pain
as so ci ated with osteoarthritis in joints ame na ble to top i cal treat ment. Endo stated that it will launch
Voltaren Gel immediately.
Pat ents: Pat ent ex piry oc curred in Ger many in 1984, in the UK in 1986 and in the USA in 1995.
Sales/An a lyst Com ment: The Voltaren group (ex clud ing OTC sales) was Novartis’ num ber nine phar -
ma ceu ti cal prod uct in 2008 with sales of $814 mil lion, up 3% in lo cal cur rency terms. Mor gan Stan ley an -
a lysts (Jan u ary 2009) fore cast sales of $755 mil lion in 2009 ($584 mil lion by 2014). Cowen & Co an a lysts
(Au gust 2008) fore cast sales of $875 mil lion in 2008 ($970 mil lion by 2013). Ac cord ing to IMS data, in
the 12-month pe riod to the end of Sep tem ber 2008, Voltaren was Novartis’ num ber five in ter na tional
phar ma ceu ti cal prod uct, ac count ing for a 3.4% of au dited cor po rate phar ma ceu ti cal sales, with 4% fixed
rate dollar growth.
ZOMETA/ACLASTA/RECLAST (zoledronic acid), a po tent bisphosphonate bone-re sorp tion in hib i tor,
was launched in Can ada, its first world mar ket, in 2000 for the treat ment of tu mor-in duced
hypercalcemia (TIH). It has also been de vel oped for the treat ment of bone metastases in can cer, Paget’s
dis ease, and os teo po ro sis. For the hypercalcemia in di ca tion, Novartis gained ap proval in the US and Eu -
rope in 2001 and has since launched the prod uct as Zometa in over 70 mar kets. In 2005, it was launched
in Japan.
For the Paget’s dis ease and the os teo po ro sis in di ca tions, zoledronic acid is known as Aclasta (in Eu rope)
and Reclast (in the USA). Aclasta was ap proved in Eu rope and Can ada for these in di ca tions in 2005. Ap -
proval for these in di ca tions was granted in April 2007 in the USA.
Aclasta/Reclast has also been de vel oped as a 15-min iv in fu sion, once-yearly treat ment for
postmenopausal os teo po ro sis and other met a bolic bone dis eases. Reclast re ceived ap proval for this in di -
ca tion in the USA and launched there in 2007. The reg u la tory sub mis sion was based on ef fi cacy and
safety data from a three-year Piv otal Frac ture Trial in more than 7,700 women. Aclasta was also ap -
proved for this in di ca tion in the EU and Canada in 2007.
In 2008, Novartis sub mit ted zoledronic acid for ap proval in the USA and the EU for the treat ment of clin i -
cal frac ture pre ven tion af ter hip frac ture. In June 2008, the US FDA broad ened the US in di ca tion for
once-yearly zoledronic acid (Reclast) to in clude the pre ven tion of new clin i cal frac tures in pa tients fol low -
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