IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
calcitonin, us ing the Eligen drug de liv ery tech nol ogy. Novartis made a $10 mil lion in vest ment in
Emisphere. Emisphere is el i gi ble for mile stone pay ments up to $30 mil lion and royalties on any sales.
Clin i cal Data: In Oc to ber 2008, Emisphere re ported that a phase I study by Novartis and Nordic Bio sci -
ence dem on strated that oral salmon calcitonin us ing its Eligen tech nol ogy taken 30-60 min utes be fore
meals with 50ml of wa ter re sults in im proved ab sorp tion and im proved ef fi cacy mea sured by the
biomarker of re duced bone re sorp tion, com pared to the com monly-pre scribed nasal formulation.
Musculoskeletal System Agents
canakinumab ACZ 885 M1C, R3X, V3X, S1P Filed
drug delivery system, human
parathyroid hormone — M5B9, H4E, V7A I
osteoporosis therapy ATF 936 M5B9 I
RA therapy QAL 964 M1C I
CANAKINUMAB (ACZ 885), a hu man monoclonal an ti body to IL-1 beta, was filed for ap proval in the US
and EU in De cem ber 2008 for the treat ment of Cryopyrin-As so ci ated Pe ri odic Syn dromes (CAPS), which
in clude Muckle-Wells Syn drome (a rare in her ited in flam ma tory con di tion which is man i fested by rash,
joint aches, fe vers and mi graine head aches). In a trial in pa tients with Muckle-Wells syn drome, all symp -
toms were re lieved within days by a sin gle in jec tion of ACZ 885. It has an Or phan Drug des ig na tion in the
EU, Swit zer land and the US for treat ing CAPS. The com pany noted that the first sub mis sions were pre vi -
ously planned for 2009 but were moved for ward to De cem ber 2008 af ter data from two clin i cal stud ies
showed adults and chil dren achieved rapid and long lasting clinical remission of these diseases.
Canakinumab also has po ten tial in rheu ma toid ar thri tis (RA) with less fre quent dos ing than TNF-al pha
agents. It was in phase II tri als for RA and sys temic ju ve nile id io pathic ar thri tis (the most se vere form of
ar thri tis in chil dren) in 2008. It has Or phan Drug sta tus for SJIA in the USA and Eu rope. In No vem ber
2008, Novartis re ported that phase III tri als in SJIA are set to be gin in 2009. Phase III tri als in adult rheu -
ma toid ar thri tis are set to begin in 2010.
In No vem ber 2009, Novartis re ported that canakinumab was also in phase II tri als in gout and that it
plans to be gin phase II tri als in Type 2 di a be tes in 2009.
Canakinumab is also in phase I tri als for the treat ment of wet age-re lated macular de gen er a tion (AMD).
In Jan u ary 2007, Novartis ini ti ated a ran dom ized, dou ble-blind, pla cebo-con trolled, 26-week, phase I/II
study in the USA eval u at ing the safety and ef fi cacy of mul ti ple doses of canakinumab in 130 chronic ob -
struc tive pul mo nary dis ease (COPD) pa tients. Pri mary out come mea sures will in clude the im pact on pul -
mo nary func tion in COPD pa tients vs pla cebo and sec ond ary out come mea sures will in clude the im pact of
mul ti ple doses over a pe riod of 45 weeks, safety and tolerability. This trial is expected to complete in
March 2009.
Clin i cal Data: In April 2008, Novartis an nounced re sults from a phase II study of canakinumab in 20 pa -
tients (aged be tween six and 50 years) with cryopyrin-as so ci ated pe ri odic syn dromes (CAPS), in clud ing
Muckle Wells syn drome. Pa tients were treated with in jec tions of canakinumab ev ery two months at doses
of 150 mg in adults and 2 mg/kg in chil dren. Symp toms im proved within one day and all pa tients
achieved com plete clin i cal re mis sion within seven days. On av er age, clin i cal re mis sion lasted 115 days.
Canakinumab was well tol er ated, with only mild skin re ac tions at the in jec tion site. The most com mon ad -
verse events were upper respiratory tract infections.
In Sep tem ber 2008, Novartis an nounced re sults from a phase I/II trial of canakinumab in 19 pa tients
with sys temic ju ve nile id io pathic ar thri tis (SJIA) aged four to 19 years. Pa tients in the trial re ceived a sin -
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