IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Sales/An a lyst Com ment: Sales are de clin ing due to ge neric com pe ti tion. Mor gan Stan ley an a lysts
(Jan u ary 2009) put 2007 sales at $236 mil lion and pre dict $100 mil lion in 2008 and $94 mil lion in 2009
($81 million by 2014).
FLUVIRIN (in flu enza vac cine): Novartis ob tained rights to Fluvirin via the 2006 pur chase of Chiron. It is
ap proved for sale in 30 coun tries, in clud ing sev eral Eu ro pean mar kets, the US, Aus tra lia and Argentina.
OPTAFLU (vac cine, sea sonal in flu enza, Novartis) is a sea sonal in flu enza vac cine based on novel cell cul -
ture tech nol ogy in stead of tra di tional egg-based pro duc tion. Novartis ob tained the prod uct via the ac qui -
si tion of Chiron. OptaFlu re ceived EU ap proval in all 27 states, as well as Ice land and Nor way in June 2007
and was launched in Ger many and Aus tria in Sep tem ber 2007. It was launched in the UK in March 2008.
In early 2009 it was in phase III tri als in the USA. OptaFlu showed in piv otal phase III data that it was
highly ca pa ble of pro duc ing an im mune re sponse, at least as strong as the egg-based vac cine Agrippal
for each of the three in flu enza strains stud ied. It was also well tol er ated, show ing no mean ing ful dif fer -
ences in the safety pro file compared to traditional egg-based vaccines.
QUINVAXEM (vac cine, diph the ria, tet a nus, per tus sis, hep a ti tis B, H influenzae type B, Novartis/Crucell)
is a fully-liq uid, pentavalent vac cine for the pre ven tion of diph the ria, tet a nus, per tus sis, hep a ti tis B and
Haemophilus influenzae type b in fec tion in chil dren. It was de vel oped by Novartis and Crucell (Neth er -
lands). In 2006, it was granted Prequalification by the WHO, per mit ting it to be made avail able to su pra -
na tional or ga ni za tions (ma jor cus tom ers for com bi na tion vac cines which are used in mass vac ci na tion
pro grams in de vel op ing coun tries). Quinvaxem was launched in South Korea in 2006.
TOBI (tobramycin) is mar keted for the treat ment of chronic Pseu do mo nas aeruginosa in fec tions in cys tic
fi bro sis pa tients. By the age of 17, nearly 70% of peo ple with CF are in fected. TOBI is ad min is tered by
nebulizer twice daily, for 15 min utes each time, for 28 days, fol lowed by a 28-day drug-free pe riod.
Novartis ob tained rights to Tobi via the ac qui si tion of Chiron, in 2005.
Lifecycle Man age ment: Novartis is de vel op ing a dry pow der prod uct, In haled TOBI, with the
tobramycin ad min is tered via a hand-held breathe-ac ti vated de vice. It is un der go ing a mul ti na tional
phase III trial, eval u at ing its safety and ef fi cacy in the treat ment of Pseu do mo nas aeruginosa lung in fec -
tions in cys tic fi bro sis pa tients. In 2001, Chiron (now Novartis) and Nektar (USA) signed an agree ment
un der which Chiron would be re spon si ble for the clin i cal de vel op ment and world wide com mer cial iza tion
of tobramycin in haled pow der, which was granted Orphan Drug designation by the EU in 2003.
In De cem ber 2008, Novartis ac quired the pul mo nary drug de liv ery unit of Nektar. It has ac quired spe cific
pul mo nary de liv ery as sets, tech nol ogy, and in tel lec tual prop erty from Nektar for $115 mil lion in cash.
Cer tain dry pow der and liq uid pul mo nary for mu la tion and man u fac tur ing as sets (in clud ing cap i tal equip -
ment and man u fac tur ing cap i tal lease ob li ga tions) will be ac quired by Novartis. Novartis will also take on
140 Nektar per son nel, as well as cer tain in tel lec tual prop erty and man u fac tur ing meth ods. Man u fac tur -
ing and roy alty rights to tobramycin inhaled powder (Inhaled Tobi) will be transferred to Novartis.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Tobi was the
lead ing prod uct in the J1K class (Aminoglycosides), with a 33.0% mar ket share and 5% fixed rate dol lar
growth. Its near est ri vals are Bris tol-Myers Squibb’s Amikin (amikacin), with a 4.3% mar ket share and
sales down 6%, and Schering-Plough’s Garamycin (gentamicin), with a 4.1% mar ket share and sales
also down 6% in fixed rate dollar terms
Pat ents: In 2002, an ANDA for in haled tobramycin from Roxane, a sub sid iary of Boehringer Ingelheim
(Ger many), re ceived ten ta tive FDA ap proval for sale fol low ing the ex pi ra tion of TOBI’s or phan drug ex -
clu siv ity pe riod in De cem ber 2004. It was later with drawn, how ever, and in Oc to ber 2003, Chiron
reached a set tle ment with Roxane, which will now not launch a ge neric com pet i tor to TOBI un til Chiron’s
US for mu la tion patent expires in 2014.
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