Un­sealed doc­u­ments de­tail Bio­gen's fight against San­doz Tysabri biosim­i­lar

San­doz is hop­ing to cel­e­brate its re­cent­ly an­nounced spin­off from No­var­tis with swift ap­provals for its Tysabri biosim­i­lar in both the US and Eu­rope — but not if Bio­gen can help it.

Bio­gen filed suit against San­doz ear­li­er this month, ac­cus­ing the com­pa­ny of at­tempt­ing to “reap the ben­e­fits of Bio­gen’s hard work and suc­cess” by al­leged­ly in­fring­ing on Tysabri’s patent rights.

“Bio­gen has ap­plied for and ob­tained a wide va­ri­ety of is­sued patents cov­er­ing its in­ven­tions re­lat­ing to Tysabri, in­clud­ing re­gard­ing ther­a­peu­tic us­es of Tysabri, ways of mak­ing treat­ment with Tysabri safer for pa­tients and Bio­gen’s in­no­v­a­tive meth­ods of man­u­fac­tur­ing an­ti­bod­ies, such as Tysabri,” the com­pa­ny said in a 107-page redact­ed com­plaint, un­sealed on Mon­day.

No­var­tis an­nounced back in Ju­ly that its gener­ics arm had filed ap­pli­ca­tions for a Tysabri biosim­i­lar de­vel­oped by Pol­phar­ma Bi­o­log­ics. Tysabri, known gener­i­cal­ly as na­tal­izum­ab, was first ap­proved in 2004 as a mul­ti­ple scle­ro­sis treat­ment, but won a la­bel ex­pan­sion in 2008 for the treat­ment of mod­er­ate to se­vere Crohn’s dis­ease.

San­doz is seek­ing ap­pli­ca­tions in both con­di­tions, which af­fect rough­ly 400,000 and 500,000 peo­ple in the US, re­spec­tive­ly, ac­cord­ing to the com­plaint.

“The sub­mit­ted biosim­i­lar was de­vel­oped to have the same in­tra­venous (iv) dosage form, route of ad­min­is­tra­tion, dos­ing reg­i­men and pre­sen­ta­tion as the ref­er­ence med­i­cine,” San­doz said in Ju­ly, adding that the biosim­i­lar matched Tysabri in both ef­fi­ca­cy and safe­ty for pa­tients with re­laps­ing-re­mit­ting MS.

Bio­gen is as­sert­ing more than 25 patents against San­doz, some of which ex­tend to meth­ods of safe­ly ad­min­is­ter­ing Tysabri and man­ag­ing the risk of a brain in­fec­tion called pro­gres­sive mul­ti­fo­cal leukoen­cephalopa­thy, or PML, ac­cord­ing to the com­plaint.

Bio­gen vol­un­tar­i­ly pulled Tysabri from the mar­ket back in 2005, af­ter learn­ing that three pa­tients de­vel­oped PML in clin­i­cal tri­als. Reg­u­la­tors cleared the drug for re-en­try in 2006, with a new warn­ing la­bel and a risk-man­age­ment plan in­clud­ing a strat­e­gy for de­ter­min­ing pa­tients’ risk for de­vel­op­ing PML.

“Bio­gen’s in­no­v­a­tive ap­proach­es to safe­ly ad­min­is­ter­ing Tysabri and man­ag­ing PML risk were rec­og­nized by the U.S. Patent Of­fice, which re­ward­ed Bio­gen with grant­ed patents cov­er­ing safer ways to treat MS and CD us­ing Tysabri,” Bio­gen states in its com­plaint.

If Bio­gen pre­vails, the drug may be pro­tect­ed through the end of the decade, po­ten­tial­ly push­ing US sales up to $1.3 bil­lion, RBC Cap­i­tal Mar­kets an­a­lyst Bri­an Abra­hams wrote in a note to in­vestors. If not:

We cur­rent­ly see the fran­chise erod­ing to $700M by the end of the decade (46% biosim­i­lar ero­sion, risk-ad­just­ed) and be­lieve con­sen­sus num­bers now re­flect this as well. Un­like with small mol­e­cule patent cas­es, there would be no au­to­mat­ic 30-month stay to keep San­doz’s biosim­i­lar off the mar­ket un­less the court or­ders an in­junc­tion against San­doz, which we be­lieve is hard to as­sign a PoS to.

The news comes as gener­ic com­pe­ti­tion guts sales for Bio­gen’s MS treat­ment Tec­fidera, which raked in just un­der $398 mil­lion last quar­ter, down from $487.6 mil­lion in Q2 2021. Tysabri earned $516.2 mil­lion last quar­ter, slight­ly down from $524.2 mil­lion in 2021. In March, a court re­ject­ed Bio­gen’s at­tempt to re­vive a key patent for Tec­fidera.

Last month, No­var­tis chief Vas Narasimhan an­nounced plans to sep­a­rate from San­doz in the sec­ond half of next year, spin­ning off the gener­ics gi­ant with a pipeline of 15 biosim­i­lars.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

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Benjamine Liu, TrialSpark CEO

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Bob Duggan (Duggan Investments)

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

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Dave Marek, Myovant CEO

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