IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
be ing re corded as fail ures in some cases). A re view of data from over 3400 pa tients par tic i pat ing in tri als
of the fixed com bi na tion showed few deaths or se ri ous ad verse events; most se ri ous com pli ca tions were
likely to be dis ease-re lated. Most ad verse events were of mild or mod er ate in ten sity; the most com mon
ad verse events were head ache, dizziness and loss of strength, which were likely to be disease-related.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, the ma jor prod uct in the P1D class
(Anti-Malarials) was GlaxoSmithKline’s Malarone (atovaquone + proguanil), with a 43.6% mar ket
share and 7% fixed rate dol lar growth. Num ber two was Roche’s Lariam (mefloquine), with a 4.5% mar -
ket share, but sales down 15% in fixed rate dol lar terms. Coartem was the num ber 11 prod uct in this
class, with a 1.4% mar ket share and 17% fixed rate dollar growth.
In Oc to ber 2008, the Artemisinin En ter prise Con fer ence 2008 was held at the Uni ver sity of York (UK). It
was spon sored by the Bill and Melinda Gates Foun da tion and the Roll Back Ma laria Part ner ship. It was re -
ported at the con fer ence that, in the face of in creas ing par a site re sis tance to anti-ma lar ial drugs, there is
now a great deal of re li ance on artemisinin com bi na tion ther a pies to treat ma laria. How ever, ACTs are ex -
pen sive and de mand threat ens to out strip sup ply. It was re ported at the con fer ence that de mand for
ACTs will dou ble over the next four years, po ten tially grow ing to over 300 mil lion doses an nu ally. There is
ex pected to be a short age in 2010 be cause of a lack of the Ar te mi sia annua worm wood plant, which pro -
vides the raw ma te rial for artemisinin and its semi-syn thetic de riv a tives. The Cen tre for Novel Ag ri cul -
tural Prod ucts at the Uni ver sity of York is us ing plant breed ing tech nol o gies in or der to cre ate crops that
pro duce higher yields of artemisinin. The In sti tute for One World Health is us ing fer men ta tion com bined
with in no va tive syn thetic chem is try to pro duce a sta ble sec ond source of artemisinin (semi-syn thetic) to
sup ple ment ex ist ing nat u ral sources. Also, the non-profit Med i cines for Ma laria Ven ture is work ing to de -
velop syn thetic artemisinin-like drugs. These ex per i men tal drugs have been shown to cure malaria in
mice in just one dose and it is reported that clinical trials in humans will begin in 2009.
Respiratory System Agents
FORADIL (formoterol), a long-act ing, beta-2 ag o nist (LABA) in sin gle-dose dry-pow der form, in di cated
in the treat ment of asthma, was first launched un der li cense from Yamanouchi by Novartis in 1990. It is
now avail able in over 80 coun tries world wide (out side Ja pan) via Novartis. It is also used in COPD. Foradil
is for mu lated for use with the Aeroliser de vice, a sin gle-dose ad min is tra tion in haler which al lows pa -
tients to con firm that they have taken their medication.
In 2005, the FDA asked GSK, which mar kets the LABAs Advair (fluticasone + salmeterol) and Serevent
(salmeterol), and Novartis (Foradil) to add new warn ings to their la bels stat ing that the drugs could in -
crease the chances of se vere asthma ep i sodes that could re sult in death. La bels for these prod ucts were
up dated in 2006. In March 2008, US health of fi cials re quested more in for ma tion from Novartis and other
man u fac tur ers of prod ucts con tain ing LABAs to fur ther an a lyze the safety of their med i cines. The prod -
ucts in cluded Foradil, Advair, Serevent and AstraZeneca’s Symbicort (budesonide + formoterol). In Oc -
to ber 2008, it was re ported that the safety of these LABA-con tain ing prod ucts will be dis cussed at a
two-day joint meet ing of the FDA’s Pul mo nary-Al lergy Drugs, Drug Safety and Risk Man age ment, and
Pe di at ric Ad vi sory Com mit tees in De cem ber 2008. This will be the third com mit tee re view of the class,
con tin u ing the FDA’s en quiry into the ben e fits and risks of the LABA class for the treat ment of asthma in
chil dren and adults in light of an ob served in creased risk of asthma-re lated deaths. At the meet ing the
ad vi sory com mit tee rec om mended the with drawal of the asthma in di ca tion for Foradil and Serevent, due
to the risks of the drugs out weigh ing the benefits. The recommendation did not apply to Advair and
Symbicort.
Li cens ing: Foradil was li censed-in from Yamanouchi (now Astellas, Ja pan) in 1986 for all mar kets out -
side Ja pan. It was first launched in Ja pan in 1986 by orig i na tor Yamanouchi and Aventis (now
sanofi-aventis, France). Schering-Plough (USA) ac quired US mar ket ing & dis tri bu tion rights in 2002.
© 2009 IMS Health In cor po rated or its af fil i ates Page 61