IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Central Nervous System Agents
agomelatine AGO 178 N6A, N5B III
antipsychotic AQW 051 N5A9, N7D9 II
cannabinoid receptor agonist SAB 378 N7X II
mGlu5 receptor antagonist AFQ 056 N4A, N7X, A3F II
vaccine, nicotine withdrawal NIC 002, CYT002-NicQb N7B, J7A9 II
Alzheimer’s disease therapy CAD 106 N7X, N7D9, J7C I
antiepileptic BGG 492 N3A I
multiple sclerosis therapy BAF 312 N7X I
spinal cord injury therapy ATI 355 N7X I
VALDOXAN (agomelatine) is a melatonin M1 and M2 ag o nist, with po ten tial as a ther apy for de pres sion
and other pa thol o gies as so ci ated with dis tur bances in cir ca dian rhythms, such as jet lag and shift work.
In 2005, li cen sor Servier (France) sub mit ted a fil ing to the EMEA seek ing ap proval of agomelatine in the
treat ment of ma jor de pres sive dis or der. In July 2006, the EMEA’s Com mit tee for Me dic i nal Prod ucts for
Hu man Use (CHMP) adopted a neg a tive opin ion re gard ing the ap proval of agomelatine in ma jor de pres -
sive dis or der. Novartis said this was due to in suf fi cient data and the de ci sion is not ex pected to have any
ef fect on the de vel op ment strat egy and reg u la tory pro cess in the US, with sub mis sion planned for 2009.
Servier has sub se quently re-filed the European application with further clinical data.
Novartis is de vel op ing agomelatine to be come a new once-daily treat ment for pa tients with ma jor de -
pres sion. It be gan phase III tri als in the US at the end of 2006. Agomelatine has shown ef fi cacy com pa ra -
ble to cur rent stan dard ther a pies such as SSRIs (se lec tive se ro to nin reuptake in hib i tors) and SNRIs
(se ro to nin and norepinephrine reuptake in hib i tors) while of fer ing im proved tolerability, in clud ing a low
pro pen sity to cause sex ual dys func tion and weight gain as well as an improvement in the quality of sleep.
In March 2007 Novartis ini ti ated a US eight-week, multicenter, ran dom ized, dou ble-blind, ac tive-and
pla cebo-con trolled phase III trial of agomelatine for the treat ment of ma jor de pres sive dis or der (MDD).
The study aims to en roll 490 pa tients to eval u ate the ef fi cacy, safety and tolerability of daily 25mg or
50mg agomelatine and will com pare agomelatine and paroxetine tolerability. One week af ter com ple tion
of treat ment a sin gle fol low-up visit will be conducted.
Li cens ing: In 2006, Servier granted Novartis ex clu sive rights to de velop and mar ket agomelatine in the
USA and sev eral other coun tries. Servier re tains rights in the rest of the world.
Pat ents: In 1990, a pri or ity prod uct pat ent ap pli ca tion was filed in France by Adir (part of Servier). Ac -
cord ing to IMS Pat ent Fo cus, pat ents cov er ing the agomelatine prod uct fam ily run to 2011 in Eu rope, Ja -
pan and the USA. How ever, pro vided that agomelatine is ap proved, the com pa nies can ap ply for up to
five years ex tra pat ent pro tec tion in Europe, the USA and Japan.
AQW 051 is a com pound with po ten tial for the treat ment of schizo phre nia, Alz hei mer’s dis ease and cog -
ni tive de fects. In 2007, Novartis ini ti ated a phase II trial in 125 pa tients with mild Alz hei mer’s dis ease or
amnestic mild cog ni tive im pair ment. Pri mary out come mea sures will in clude val i dated com put er ized
cog ni tive as sess ment scores and sec ond ary out come mea sures will in clude qual ity of life and dis abil ity
as sess ments. Phase I trials have completed in the UK and Japan.
SAB 378, a cannabinoid (CB1) re cep tor ag o nist, is in phase II tri als for the treat ment of neu ro log i cal in di -
ca tions. Proof of ef fi cacy stud ies in osteoarthritis and di a betic neu rop a thy have been completed.
AFQ 056 is a glu ta mate (mGlu5) re cep tor an tag o nist. Novartis be gan a phase II trial in pa tients with Par -
kin son’s dis ease in 2007. Novartis has also com pleted a phase I trial in GERD.
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