IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
In the USA, the prod uct was in de vel op ment with TAP Pharmaceuticals, the Takeda Abbott jv which was
con cluded in May 2008 with Takeda re tain ing rights to this prod uct. TAP started mar ket ing the drug in the
USA in 2003.
Li cens ing: Apomorphine was li censed to TAP by Pentech. TAP holds ex clu sive world wide rights to
apomorphine for the treat ment of Par kin son’s Dis ease. An agree ment be tween TAP and Takeda giv ing
Takeda rights to the prod uct out side Eu rope and the USA was ter mi nated in 2001. Pharmacia (now Pfizer,
USA) has held rights to an intranasal for mu la tion for erec tile dys func tion and fe male sex ual dysfunction
since 2002.
Com pe ti tion: Abbott has stated that it has high hopes for Uprima and be lieves that it will of fer pa tients a
prom is ing new op tion. The ED mar ket is now dom i nated by a bat tle be tween the PDE-V in hib i tors Pfizer’s
Viagra (sildenafil), Bayer’s Levitra (vardenafil) and Lilly’s Cialis (tadalafil). In the year end ing Sep tem -
ber 2008, Viagra was still the world’s lead ing ED drug with 44.5% mar ket share, up 4% (fixed dol lar
growth) over the pre vi ous year, fol lowed by Cialis with 33.4% share (up 18%) and then Levitra with 13%
(up 10%).
� Musculoskeletal System Agents
BENET (risedronic acid), a bisphosphonate com pound, was launched in Ja pan in May 2002 by Takeda for
the treat ment of postmenopausal os teo po ro sis. Sanofi-aventis (France) is co-mar ket ing the prod uct in
Ja pan as Actonel. In June 2004, the Jap a nese side-ef fect warn ing state ments for risedronic acid were
re vised fol low ing lo cal re ports of ADRs. The list of se ri ous po ten tial side-ef fects for the prod uct, along with
Pfizer’s Cardenalin (doxazosin), has been ex panded to in clude hepatic dys func tion and jaun dice, as well
as hep a ti tis for Cardenalin. A once-a-week for mu la tion of risedronic acid is avail able in the USA, Can ada
and a num ber of other coun tries, now in clud ing Japan following approval in April 2007.
Li cens ing: Orig i na tor Procter & Gam ble (USA) li censed it out to Aji no mo to (Ja pan) for Ja pan in 1992,
where it was co-de vel oped with sublicensees Takeda and Aventis (now sanofi-aventis). Risedronic acid
pre vents bone cal cium from be ing re ab sorbed by the body. Risedronic acid was launched in the USA in
1998 as Actonel for the treat ment of Paget’s dis ease by P&G and Aventis. It is now widely avail able for
the treat ment of Paget’s dis ease and the pre ven tion and treat ment of os teo po ro sis. In 1997, P&G and
Aventis agreed to co-de velop and co-mar ket risedronic acid worldwide.
Clin i cal Data: In 2004, Aventis re ported re sults from a five-year pla cebo-con trolled paired bi opsy study
of risedronic acid in 86 postmenopausal women with os teo po ro sis. Pa tients were treated with risedronic
acid or pla cebo, and bone tis sue bi op sies taken from 21 and 27 pa tients in each treat ment group were
histologically ex am ined at base line and af ter five years of treat ment. Re sults showed a sig nif i cant mod er -
ate and sus tained de crease in bone turn over in pa tients treated with risedronic acid, with no sig nif i cant
de crease in pla cebo. New bone was nor mal and of good qual ity. Bi opsy data showed a mod er ate sup pres -
sion of bone re mod el ing, in line with es ti mated sup pres sion of bone turnover in patients treated with
risedronic acid.
Lifecycle Man age ment: The prod uct was filed for ap proval in Paget’s dis ease in Ja pan in July 2007 and
ap proval granted in July 2008.
Com pe ti tion: Benet was the world’s num ber 10 bone cal cium reg u la tor in the 12-month pe riod to the
end of Sep tem ber 2008, ac cord ing to IMS, with a mar ket share of 1.5% and 2% de cline in fixed rate dol -
lar growth. Procter & Gam ble’s risedronic acid prod uct Actonel led the class with a 18.4% mar ket share
but a sales de cline of 1% in fixed rate dol lar terms. Novartis’ Zometa (zoledronic acid) was num ber two
with 16.1% mar ket share and up 14% over the pre vi ous year. Num ber three was Merck & Co’s Fosamax
(alendronate), with a 15.2% down 47% over the previous year.
© 2009 IMS Health In cor po rated or its af fil i ates Page 49