IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
ALBUFERON (albinterferon alfa-2b) is a pro tein com pris ing in ter feron alfa-2b fused with al bu min, which
is pro duced from the fused genes for these in di vid ual pro teins. It was orig i nated by Hu man Ge nome Sci -
ences (USA) and is be ing de vel oped pri mar ily for the treat ment of chronic hep a ti tis C. It en tered phase III
tri als with Novartis in 2006. The fu sion pro tein is ex pected to have pro longed ther a peu tic ac tiv ity and an
im proved side ef fect pro file com pared with re com bi nant hu man in ter feron alfa. Other in di ca tions for
which this fu sion pro tein has po ten tial in clude hep a ti tis B vi rus in fec tion, hairy cell leu ke mia, ma lig nant
mel a noma, non-Hodgkin’s lymphoma and chronic myelogenous leukemia.
In terim re sults from phase II tri als, in which treat ment-na ive pa tients re ceived Albuferon in com bi na tion
with ribavirin, showed it has the po ten tial for an im proved ef fi cacy and tolerability pro file with the need for
fewer in jec tions com pared to pegylated in ter feron, the cur rent stan dard of care. A first reg u la tory sub -
mis sion is planned for 2009.
In Jan u ary 2009, Novartis ini ti ated a ran dom ized, open-la bel, multicenter, ac tive-con trolled, adap -
tive-de sign, dose-rang ing phase IIb trial of albinterferon alfa-2b in treat ment-na ive pa tients with ge no -
types 2 and 3 chronic hep a ti tis C vi rus (HCV) in fec tion. The trial is ex pected to re cruit ap prox i mately 375
pa tients in four treat ment arms; three arms will re ceive albinterferon alfa-2b at doses of 900, 1200 or
1500 mcg once ev ery four weeks for 24 weeks, and the ac tive con trol group will re ceive 180 mcg
peginterferon alfa-2a once weekly for 24 weeks. All pa tients will also re ceive daily oral ribavirin (800 mg).
Sus tained virologic re sponse at week 48 will be the pri mary efficacy endpoint of the trial.
Li cens ing: In 2006, li cen sor and pat ent holder Hu man Ge nome Sci ences and Novartis agreed to
co-mar ket Albuferon in the USA; Novartis will com mer cial ize Albuferon in ter ri to ries out side the USA.
Clin i cal de vel op ment costs will be shared. HGS will re ceive an upfront pay ment of $45 mil lion, plus clin i cal
de vel op ment, com mer cial mile stone and other pay ments of up to $507.5 million.
Clin i cal Data: In De cem ber 2008, re sults of the phase III ACHIEVE 2/3 trial were re ported and Albuferon
was found to have met its pri mary end point of non-in fe ri or ity to Pegasys. Both drugs were given in com -
bi na tion with ribavirin in the trial of 933 treat ment-na ive pa tients with ge no type 2 and 3 HCV. In Jan u ary
2008, HGS low ered the dose of Albuferon in this trial be cause of lung-re lated safety con cerns. Pa tients
who were re ceiv ing the 1,200mcg dose ev ery two weeks, were changed to re ceive the 900mcg in jec tions
ev ery two weeks af ter the stud ies’ data mon i tor ing com mit tees ob served higher rates of lung-re lated
com pli ca tions. There was no safety concerns associated with the lower dose.
Com pe ti tion: Ver tex Pharmaceuticals’ (USA) ri val new hep a ti tis C drug, telaprevir, is in phase III tri -
als. It has been li censed-out to J&J and to Mitsubishi Tanabe.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2010 ($125 mil lion by 2013).
MENB (vac cine, Neisseria meningitidis group B, Novartis) is a re com bi nant vac cine against in fec tion with
Neisseria meningitidis group B. Novartis is con duct ing the de vel op ment of this prod uct in col lab o ra tion
with Ox ford Uni ver sity (UK). This new vac cine is be ing de vel oped to pro tect against a ma jor ity of global
strains for the men in gi tis B serogroup, for which no vac cine is cur rently avail able. The ge nome of N.
meningitidis, the or gan ism re spon si ble for the dis ease, was se quenced and cell sur face an ti gens iden ti -
fied; re verse vaccinology was used to iden tify a set of an ti gens that are con served across known B
serotypes of N meningitidis, and a vac cine de vel oped from a limited set of the identified antigens.
In 2006, Novartis ini ti ated a phase II trial of MenB in healthy in fants of two months of age. The open-la -
bel, con trolled, ran dom ized, multicenter trial will eval u ate the safety, tolerability, and immunogenicity of
two for mu la tions of the vac cine in 150 sub jects in the UK. Re sults from pre vi ously con ducted phase I tri -
als of MenB showed broad cov er age against most prev a lent strains of N meningitidis.
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