IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Li cens ing: In 2003, Novartis paid $255 mil lion for ap prox i mately 54% of pri vately-owned Idenix’s out -
stand ing cap i tal stock, gain ing rights to de velop and com mer cial ize telbivudine and other drug can di -
dates dis cov ered by Idenix. Novartis was re ported to hold a 56% stake in Idenix in 2008.
In Feb ru ary 2009, GlaxoSmithKline ac quired ex clu sive global rights to Idenix’s IDX 899. All de vel op ment
of IDX 899 and as so ci ated costs will be as sumed by GSK. In re turn, Idenix will re ceive an upfront pay -
ment of $34 mil lion and up to $416 mil lion in de vel op ment, reg u la tory and sales mile stones. Upon suc -
cess ful com mer cial iza tion, Idenix will re ceive dou ble digit, tiered roy al ties on world wide sales. IDX 899 is
a non-nucleoside re verse tran scrip tion in hib i tor, in phase II tri als as a potential therapy for HIV infection.
Clin i cal Data: In Sep tem ber 2008, Idenix re ported re sults from a phase I/II study of IDX 899 in treat -
ment-na ive pa tients with HIV-1 in fec tions. Sub jects were en rolled onto four co horts to re ceive ei ther
800, 400, 200 or 100 mg IDX 899 or pla cebo once-daily for seven days. Af ter seven days of treat ment
pa tients re ceiv ing 100, 200, 400 and 800 mg/day IDX 899 achieved mean re duc tions in plasma vi ral load
of 1.87, 1.84, 1.78 and 1.78 log10, re spec tively. For pla cebo-treated pa tients a mean in crease in vi ral
load of 0.10 log10 was ob served. No pa tients in any dose co hort ex pe ri enced se ri ous ad verse events and
no pa tients dis con tin ued the study. The most com monly re ported ad verse events were dys pep sia, head -
ache and nau sea; these events oc curred at a sim i lar rate in the placebo and IDX 899 treated cohorts.
In Feb ru ary 2008, Idenix re ported data from a phase I/II trial to eval u ate the safety, tolerability and an ti -
vi ral ac tiv ity of IDX 899. In the first co hort, eight and two HIV-1-in fected, treat ment-na ive pa tients were
given a seven-day course of 800 mg IDX 899 and pla cebo, re spec tively. Pa tients given IDX 899 achieved
a mean and me dian plasma vi ral load de crease of 2.01 log10 and 2.11 log10, re spec tively, af ter the
seven-day treat ment. Six of eight pa tients achieved a 2 log10 or greater de crease in vi ral load with one
pa tient achiev ing un de tect able vi rus lev els (less than 50 cop ies/mL). No se ri ous ad verse events were re -
ported and no pa tients dis con tin ued the study. A co hort of 400 mg IDX 899 once-daily fol lowed by a co -
hort of 200 mg IDX 899 once-daily will be evaluated.
RSV 604/A 60444 is an oral small mol e cule, in phase II tri als for the po ten tial treat ment of re spi ra tory
syncytial vi rus (RSV) in fec tion in 2008, in Aus tra lia, Eu rope and the USA.
Li cens ing: In 2005, Novartis and orig i na tor Ar row (UK) signed a li cens ing deal, un der which Novartis will
de velop, com mer cial ize and fund all fu ture work re lated to RSV 604. Ar row will re ceive an upfront pay -
ment of $10 mil lion, de vel op ment-re lated mile stone pay ments of up to $217 mil lion and roy al ties on
sales. Rights to back-up com pounds to RSV 604 are in cluded in the deal, plus a right of first ne go ti a tion on
fol low-up com pounds with dif fer ent chem is try, in de vel op ment with Ar row. Ar row was acquired by
AstraZeneca in March 2007.
Clin i cal Data: In 2005, Ar row re ported re sults from a dou ble-blind, pla cebo-con trolled, seven-day, oral
dose-es ca la tion study of A 60444 in healthy vol un teers. In the trial, 24 sub jects were ran dom ized to the
fol low ing treat ment groups: 150mg daily for seven days; 300mg once daily for seven days; or a load ing
dose of 600mg on day 1 fol lowed by 450mg on days two to seven. Re sults showed that A 60444 was well
tol er ated in all dos ing reg i mens; no se ri ous ad verse event was re ported. A to tal of 17, 13 and six ad verse
events were re ported in the 150, 300 and 600/450mg reg i mens, re spec tively; all events re solved. A
60444 plasma con cen tra tions above the in vi tro IC90 value were achieved in all three treatment groups.
Sales/An a lyst Com ment: In dus try an a lysts have es ti mated that the mar ket for RSV treat ments could
grow up to $2.5 billion.
TRANSVAX HCV (vac cine, HCV epitope-based, Intercell) is a vac cine for the treat ment of hep a ti tis C vi -
rus (HCV) in fec tion de vel oped us ing Intercell’s (Aus tria) pro pri etary Transvax tech nol ogy, and com prises
five T-cell epitopes of HCV cou pled with an immunostimulatory com pound. Intercell has ini ti ated a phase
© 2009 IMS Health In cor po rated or its af fil i ates Page 103