Ad­di­tion­al ex­clu­siv­i­ty for a can­cer treat­ment could cost the pub­lic $3 bil­lion, an­a­lyst says

Last week, the FDA grant­ed ad­di­tion­al ex­clu­siv­i­ty to Ea­gle Phar­ma­ceu­ti­cals’ can­cer med­i­cine Tre­an­da (ben­damus­tine hy­drochlo­ride), a de­ci­sion that ef­fec­tive­ly halts the in­tro­duc­tion of gener­ic ver­sions of the in­jec­tion un­til 2022, which one an­a­lyst said could cost the pub­lic $3 bil­lion.

The de­ci­sion by the FDA comes as the com­pa­ny’s oth­er ben­damus­tine hy­drochlo­ride prod­uct, known as Ben­de­ka, won sev­en years of or­phan drug ex­clu­siv­i­ty last sum­mer be­cause of a US dis­trict court win for the com­pa­ny against the FDA.

The FDA said in its con­clu­sion last week that be­cause of the court’s de­ci­sion, “the scope of Ben­de­ka’s ex­clu­siv­i­ty ex­tends to all ap­pli­ca­tions con­tain­ing the same ac­tive moi­ety as Ben­de­ka, ben­damus­tine, and bars the ap­proval of any ap­pli­ca­tion con­tain­ing ben­damus­tine for any ex­clu­siv­i­ty-pro­tect­ed in­di­ca­tion start­ing on the date of Ben­de­ka’s ap­proval for sev­en years, i.e., from De­cem­ber 7, 2015 un­til De­cem­ber 7, 2022, un­less a spon­sor es­tab­lish­es clin­i­cal su­pe­ri­or­i­ty or an ex­cep­tion to ex­clu­siv­i­ty ap­plies.”

Ron­ny Gal

Both Ben­de­ka and Tre­an­da are ap­proved in the US for the treat­ment of pa­tients with chron­ic lym­pho­cyt­ic leukemia and pa­tients with in­do­lent B-cell non-Hodgkin’s lym­phoma that has pro­gressed dur­ing or with­in six months of treat­ment with rit­ux­imab or a rit­ux­imab-con­tain­ing reg­i­men.

Ac­cord­ing to an Ea­gle SEC fil­ing Fri­day, the FDA’s de­ci­sion in fa­vor of the com­pa­ny en­sures that no ben­damus­tine prod­uct (in­clud­ing gener­ic ver­sions of Ben­de­ka and Tre­an­da) may launch in the US un­til that date set by the FDA — 7 De­cem­ber 2022.

In mak­ing its de­ci­sion, the FDA ex­plained how its hands were tied by the court’s de­ci­sion. “If Ben­de­ka had been clin­i­cal­ly su­pe­ri­or to Tre­an­da, its ex­clu­siv­i­ty would not have blocked AN­DAs [ab­bre­vi­at­ed new drug ap­pli­ca­tions] ref­er­enc­ing Tre­an­da. Now that it has ob­tained ex­clu­siv­i­ty pur­suant to a court or­der with­out es­tab­lish­ing clin­i­cal su­pe­ri­or­i­ty to Tre­an­da, even though it is not a dif­fer­ent drug from the pre­vi­ous­ly ap­proved drug, Tre­an­da, its ex­clu­siv­i­ty ex­tends to block any drug for the same ac­tive moi­ety.”

Gener­ic ver­sions of Tre­an­da, mean­while, were poised to en­ter the mar­ket in No­vem­ber 2019, Ea­gle said.

Bern­stein an­a­lyst Ron­ny Gal took is­sue with the FDA’s de­ci­sion, not­ing to in­vestors: “This is poor per­for­mance by FDA which shows that even in the Got­tlieb era, the risk-averse bu­reau­cra­cy can get lost in its own maze of reg­u­la­tions. The il­log­i­cal de­ci­sion will cost the pub­lic some $3B in added costs.”

How­ev­er, one of the gener­ic com­pa­nies seek­ing to bring its own ben­damus­tine prod­uct to mar­ket may sue over the de­ci­sion, Gal not­ed.

Te­va Phar­ma­ceu­ti­cals, Ea­gle’s part­ner, al­so said the FDA has ap­pealed the dis­trict court’s de­ci­sion from last sum­mer. How­ev­er, bar­ring a re­ver­sal by the ap­pel­late court, drug ap­pli­ca­tions ref­er­enc­ing Ben­de­ka al­so will not be ap­proved by the FDA un­til the or­phan drug ex­clu­siv­i­ty ex­pires in De­cem­ber 2022.

Gal said that there are at least five gener­ic com­pa­nies pur­su­ing gener­ic ver­sions of Ben­de­ka and Tre­an­da.

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

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In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

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Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

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Jacob Van Naarden (Eli Lilly)

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

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