IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Li cens ing: In Feb ru ary 2009, Novartis gained the ex clu sive world wide rights to elinogrel from Portola
Pharmaceuticals (USA). Novartis will have re spon si bil ity for phase III tri als, man u fac tur ing and com mer -
cial iza tion of elinogrel. Dr Trevor Mundel, Global Head of De vel op ment at Novartis noted that “Elinogrel is
a novel com pound with at trib utes that have the po ten tial to of fer clin i cal ben e fits over cur rently ap proved
antiplatelet ther a pies. Elinogrel will fur ther di ver sify our car dio vas cu lar pipe line and we hope it will prove
to be a strong ad di tion to our port fo lio.” Novartis will make an upfront pay ment of $75 mil lion to Portola
and will share with Portola the costs of the on go ing phase II tri als. Portola will also be el i gi ble for ad di tional
pay ments based on achiev ing de fined de vel op ment and com mer cial iza tion mile stones and would also re -
ceive roy al ties on fu ture sales. In ad di tion, Portola has an op tion to co-pro mote elinogrel in the US in the
hos pi tal and spe cialty mar kets and an op tion to co-fund phase III clin i cal trials and other development
activities in return for additional royalties.
Com pe ti tion: The gold-stan dard treat ment in this area is Bris tol-Myers Squibb’s Plavix (clopidogrel)
which is in di cated to pre vent atherosclerotic events in pa tients with a his tory of ischemic stroke, throm -
bo sis, myo car dial in farc tion (MI) or es tab lished pe riph eral ar te rial dis ease (PAD) and the treat ment of
acute cor o nary syn drome (ACS) in com bi na tion with as pi rin. Ma jor com pet i tors in de vel op ment are
Schering-Plough’s SCH 530348, an orally-ac tive, once-daily thrombin re cep tor an tag o nist, and Lilly’s
Effient (prasugrel), an oral platelet ag gre ga tion in hib i tor. SCH 530348 was in a large global phase III tri -
als pro gram in 2008 for the pre ven tion of ischemic com pli ca tions in pa tients with acute cor o nary syn -
dromes (i.e., un sta ble an gina, acute myo car dial in farc tion), as well as in pa tients with ex ist ing pe riph eral
ar te rial dis ease. SP ex pect a launch in 2010. Effient was filed for ap proval in the USA in De cem ber 2007
and in the EU in Feb ru ary 2008 for the treat ment of acute cor o nary syn drome (ACS) in pa tients who are
man aged with percutaneous cor o nary in ter ven tion (PCI). Effient was rec om mended for ap proval in the
EU in De cem ber 2008. The filings were despite mixed results and safety problems reported for prasugrel
in late 2007.
AstraZeneca was con duct ing phase III tri als with ticagrelor, an oral platelet purinoceptor 2T (P2T) an -
tag o nist, for the treat ment of ar te rial throm bo sis in acute cor o nary syn drome (ACS) in 2008. AZ an tic i -
pates fil ing in the USA and Eu rope in H2 2009.
In Jan u ary 2008 Cogentus be gan phase III tri als with its unique once-daily pill, CGT 2168, that com bines
clopidogrel with a gastroprotectant, omeprazole. The prod uct is de signed to sig nif i cantly re duce the GI
side ef fects com monly as so ci ated with antiplatelet ther apy. There are sev eral pro jects in phase II tri als
Eisai’s (Ja pan) E 5555, an oral thrombin re cep tor an tag o nist. The lat ter be gan a phase II trial in Oc to ber
2007 eval u at ing the agent in 240 pa tients with coronary artery disease.
Cardiovascular System Agents
aliskiren + valsartan — C9X, C9D9 Filed
valsartan + amlodipine + HCTZ — C9D3 Filed
aliskiren + amlodipine — C9X, C8A III
aliskiren + amlodipine + HCTZ — C9X, C8A, C3A III
ARB/NEP blocker LCZ 696 C2A, C9C II
pegmusirudin SPP 200 C6A, B1E II
renin inhibitor SPP 635 C9X II
atherosclerosis therapy APP 018, APL 180 C6A I
hypertension therapy LCI 699 C2A I
hypertension therapy VNP 489 C2A I
renin inhibitor SPP 1148 C9X I
renin inhibitor SPP 676 C9X I
renin inhibitor SPP 800 C9X Preclinical
ALISKIREN + VALSARTAN: Novartis is de vel op ing a fixed dose com bi na tion of valsartan (Diovan)
and aliskiren (Tekturna/Rasilez) for the treat ment of hy per ten sion and car dio vas cu lar dis eases. Phase
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