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IMS COM PANY PRO FILES NOVARTIS
ing a re cent low-trauma hip frac ture, and this de ci sion was based on safety and ef fi cacy data from the
Recurrent Fracture Trial.
In Sep tem ber 2008, Novartis re ported that once-yearly zoledronic acid 5 mg had been ap proved in the
EU for the treat ment of os teo po ro sis in men who are at in creased risk of frac tures. The ap proval will ap ply
in all 27 EU coun tries plus Ice land and Nor way. The la bel has also been broad ened to in clude re duc tion of
new frac tures in osteoporotic men and postmenopausal osteoporotic women who re cently ex pe ri enced a
hip frac ture. Ad di tion ally, the la bel also now in cludes re sults from the land mark Re cur rent Frac ture Trial
in more than 2100 pa tients, which shows that new frac tures were de creased by 35% with zoledronic acid
treat ment in men and postmenopausal women with a re cent low-trauma hip frac ture. Re sults which
showed that all-cause mor tal ity was re duced by 28% in zoledronic acid-treated pa tients com pared to
those re ceiv ing placebo are also included on the label.
In 2004, Novartis up dated the US la bels for Zometa, warn ing of side ef fect of osteonecrosis of the jaw, al -
though says a causal link can not be es tab lished. There were con cerns over an as so ci a tion be tween
zoledronic acid and alendronic acid and se ri ous atrial fi bril la tion in older women, but in No vem ber 2008
the FDA com pleted a re view of the tri als and stated that there was “no clear association.”
Novartis could ben e fit from re cent safety con cerns sur round ing HRT, tra di tion ally the main way of treat -
ing post-meno pausal risk of os teo po ro sis. As such, the mar ket for drugs aimed spe cif i cally at brit tle bone
dis ease is ex pected to grow. Con tro versy sur round ing the safety of HRT was fu elled by re sults of a study
in one mil lion women in 2003, con firm ing that the ther apy sig nif i cantly in creases (dou bles) the risk of
breast cancer.
Clin i cal Data: At ASCO in May 2008, Zometa dem on strated for the first time a sig nif i cant ben e fit for
premenopausal women with hor mone-sen si tive, early-stage breast can cer. A study (ABCSG-12) pre -
sented at ASCO showed that the ad di tion of Zometa to hor mone ther apy af ter sur gery sig nif i cantly re -
duced the risk of re cur rence or death by 36% be yond ben e fits achieved with hor mone ther apy alone.
Many stud ies are un der way ex am in ing the po ten tial anticancer ben e fits of Zometa. Two stud ies, AZ URE
(pre-and post-meno pausal breast can cer) and ZEUS (pros tate can cer), have com pleted pa tient re cruit -
ment, and re sults are expected in the next two to three years.
Pat ent: In De cem ber, the FDA granted Zometa an ad di tional six months of mar ket ing ex clu siv ity un til
2013 fol low ing the com ple tion of pe di at ric studies.
Lifecycle Man age ment: In 2008 Zometa was in phase III tri als as an adjuvant ther apy in breast can -
cer, with a first fil ing for this in di ca tion pro jected for 2010.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Procter & Gam -
ble’s Actonel (risedronic acid), was the num ber one prod uct in the ‘Bone Cal cium Reg u la tors’ class
(M5B), with an 18.4% mar ket share and 1% fixed rate dol lar growth. Zometa was num ber two with a
16.1% mar ket share and 2% fixed rate dol lar growth. Merck & Co’s Fosamax (alendronic acid) fell to
num ber three with sales down 47% in fixed dol lar terms, due to ge neric com pe ti tion, to re sult in a mar ket
share of 15.2%. Num ber four was Roche’s Bonviva (ibandronic acid), with an 11.5% mar ket share and
50% fixed rate dollar growth.
In April 2008, Novartis stated that a new study has shown that a once-a-year in fu sion of its bone drug
Reclast was better than Actonel at in creas ing bone mass in pa tients with os teo po ro sis caused by ste roids.
Actonel was taken as a daily pill in the trial, which in cluded 833 men and women.
As far as new prod ucts are con cerned, Amgen is de vel op ing denosumab, a fully hu man monoclonal an -
ti body, in phase III tri als that will eval u ate it in postmenopausal os teo po ro sis and can cer treat ment-in -
duced bone loss (TIBL) in met a static bone dis ease. Pos i tive re sults in phase II and III tri als have been
re ported. An a lysts ex pect a 2009 launch. A dis ad van tage of denosumab is its high pro duc tion cost. It is
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