No­var­tis eye drug fran­chise hit by failed Fo­vista stud­ies

Kuwait Times - - HEALTH & SCIENCE -

No­var­tis’s bid to bol­ster its eye drug port­fo­lio suf­fered a set­back yes­ter­day when it an­nounced com­bin­ing Lu­cen­tis with Fo­vista in pa­tients with neo­vas­cu­lar age-re­lated mac­u­lar de­gen­er­a­tion (nAMD) did not pro­duce bet­ter out­comes than treat­ment with Lu­cen­tis alone.

Two phase III stud­ies that com­bined Oph­thotech’s Fo­vista with Lu­cen­tis “did not meet the pri­mary end­point of su­pe­ri­or­ity”, No­var­tis said in a state­ment.

Two years ago, the Swiss drug­maker signed a po­ten­tial $1 bil­lion li­cens­ing deal with Oph­thotech to mar­ket Fo­vista out­side the United States.

It had hoped a suc­cess­ful com­bi­na­tion with Lu­cen­tis could help it counter wan­ing sales of Lu­cen­tis, which has been hurt by com­pe­ti­tion from other drugs. With the tri­als’ fail­ure, how­ever, No­var­tis said it still hoped anal­y­sis of un­der­ly­ing data would pro­vide fur­ther un­der­stand­ing and guid­ance on help­ing nAMD pa­tients. “The proven ef­fi­cacy of Lu­cen­tis monother­apy was not im­proved by the ad­di­tion of” Fo­vista, said Vas­ant Narasimhan, No­var­tis’s chief drug de­vel­op­ment of­fi­cer. “To­gether with Oph­thotech we con­tinue to an­a­lyze the data.”

No­var­tis shares slipped 0.3 per­cent in early trad­ing.

Age-re­lated mac­u­lar de­gen­er­a­tion af­fects up to 25 mil­lion peo­ple world­wide and is the lead­ing cause of early blind­ness in the in­dus­trial world.

In the first nine months of 2016, Lu­cen­tis’s sales for No­var­tis out­side the United States fell 11 per­cent, on top of a pre­vi­ous de­cline in 2015, due to com­pe­ti­tion from drugs in­clud­ing Re­gen­eron’s Eylea.

“A pos­i­tive re­sult of the study would have been wel­come to add a lit­tle pep to wan­ing Lu­cen­tis sales,” wrote Michael Nawrath, a Zuercher Kan­tonal Bank an­a­lyst, in a note. “For the small com­pany Oph­thotech this will be much worse than for No­var­tis, but it’s still a neg­a­tive re­sult.”

The fail­ure leaves No­var­tis hop­ing for more-fa­vor­able re­sults from a sep­a­rate phase III trial of its in­ves­ti­ga­tional med­i­ca­tion RTH258 against nAMD, due to be pub­lished early next year.

The fail­ure also im­pacts Roche, which has mar­ket­ing rights for Lu­cen­tis in the United States and had a deal with No­var­tis for a share of rev­enue from Fo­vista out­side the United States. —Reuters

BASEL, Switzer­land: The logo of Swiss drug­maker No­var­tis is seen at its head­quar­ters on Oc­to­ber 22, 2013. —AFP

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