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Re: DewDiligence post# 367

Thursday, 11/10/2016 10:49:39 AM

Thursday, November 10, 2016 10:49:39 AM

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Bristol-Myers hands over $100M in cash for a new fibrosis drug, beefing up NASH focus

by john carroll
November 10, 2016 06:59 AM EST
Updated: 08:20 AM

It’s not all check­points all the time at Bris­tol-Myers Squibb. The big biotech has been ramp­ing up an am­bi­tious ef­fort in fi­bro­sis and NASH and this morn­ing it’s tak­ing the wraps off an­other deal in the field, pay­ing $100 mil­lion to Japan’s Nitto Denko for an early-stage drug can­di­date that now be­comes part of their port­fo­lio.

The key drug in this pack­age deal is ND-L02-s0201, a siRNA that is de­signed to in­hibit heat shock pro­tein 47. By hit­ting HSP47, their in­ves­ti­ga­tors be­lieve that they can cut the pro­duc­tion of col­la­gen that plays a role in fi­bro­sis and NASH, while help­ing cor­rect at least some of the dam­age that has al­ready been done to pa­tients.

The drug is un­der­go­ing a 5-week Phase Ib study now to give them a bet­ter idea of how the drug works for fi­bro­sis caused by NASH, an epi­demic fatty liver dis­ease, and he­pati­tis C. And Bris­tol-Myers gets the rights to Nitto Denko’s port­fo­lio in the field, bag­ging ex­clu­sive rights for fi­bro­sis in a va­ri­ety of dis­eases.

The deal in­cludes mile­stones, which weren’t dis­cussed in their state­ment.

Nitto Denko is a cen­tury-old di­ver­si­fied ma­te­ri­als man­u­fac­turer based in Osaka with a new­found in­ter­est in di­ver­si­fy­ing into biotech. Early this year the com­pany es­tab­lished a biotech sub­sidiary called Nitto Bio­Pharma, with fa­cil­i­ties in San Diego and plans to con­tinue to pur­sue R&D in IPF and other dis­eases.

Bris­tol-Myers execs have been putting a brave face on their re­cent de­ba­cle in front­line non-small cell lung can­cer for their PD-1 pi­o­neer Op­divo. The late-stage fail­ure left a bad scar, but the com­pany points to its R&D work in fi­bro­sis/NASH and heart fail­ure as ex­am­ples of a more di­ver­si­fied pipeline.

Back in Au­gust, 2015, the am­bi­tious R&D group struck a $1.25 bil­lion deal — $150 mil­lion up front — to gain an op­tion to ac­quire Prome­dior if its mid-stage fi­bro­sis pro­gram comes through.

Bris­tol-Myers has its sights set on PRM-151, a re­com­bi­nant form of human pen­traxin-2 pro­tein in de­vel­op­ment for id­io­pathic pul­monary fi­bro­sis and myelofi­bro­sis. The com­pany scored an­other pro­vi­sional buy­out agree­ment for Den­mark’s Galecto in 2014, agree­ing to pay up to $444 mil­lion for the com­pany. That deal cen­tered on TD139, an in­hibitor of galectin-3, which binds to car­bo­hy­drate struc­tures, play­ing a role in IPF that can be de­railed by this new drug. TD139 joined BMS-986020, a lysophos­pha­tidic acid 1 (LPA1) re­cep­tor an­tag­o­nist also in stud­ies for fi­bro­sis. Bris­tol-Myers also struck re­search deals with the Cal­i­for­nia In­sti­tute for Bio­med­ical Re­search (Cal­ibr) and The Med­ical Uni­ver­sity of South Car­olina.
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