Seat­tle Ge­net­ics grabs Im­munomedics’ tu­mor drug in $2B deal, shoot­ing for a quick OK

Clay Sie­gall, Seat­tle Ge­net­ics

You can count Seat­tle Ge­net­ics as the new flag car­ri­er for Im­munomedics’ sol­id tu­mor drug IM­MU-132. The biotech is pay­ing $300 mil­lion to claim glob­al rights on the drug, com­mit­ting up to $1.7 bil­lion more in mile­stones.

That mile­stone mon­ey should get rolling soon. Seat­tle Ge­net­ics will now take the lead on a Phase III study for metasta­t­ic triple neg­a­tive breast can­cer. And once the BLA is filed, it’s ob­lig­at­ed to pay over the first of its mile­stone mon­ey as Seat­tle Ge­net­ics looks to vault to an ap­proval as ear­ly as late 2017.

“In just over three years, we have brought IM­MU-132 through clin­i­cal de­vel­op­ments in mul­ti­ple in­di­ca­tions, and have ad­vanced the TNBC in­di­ca­tion to a po­ten­tial ac­cel­er­at­ed ap­proval and launch by late 2017 or ear­ly 2018, which could make IM­MU-132 avail­able to pa­tients deal­ing with a high­ly ma­lig­nant form of breast can­cer,” not­ed Mor­ris Plains, NJ-based Im­munomedics CEO Cyn­thia L. Sul­li­van.

Seat­tle Ge­net­ics $SGEN in­vestors drove the stock down 6%, while Im­munomedics $IM­MU saw their shares rise on­ly 7%.

IM­MU-132 (sac­i­tuzum­ab govite­can) fits square­ly in Seat­tle Ge­net­ics’ com­fort zone. It is an armed an­ti­body that con­tains SN-38, the ac­tive metabo­lite of irinote­can, de­signed for pre­cise de­liv­ery to avoid off-tar­get tox­i­c­i­ty.

The deal — with a $250 mil­lion in an up­front and an ad­di­tion­al $50 mil­lion for ad­di­tion­al ex-US rights — falls just days af­ter Sul­li­van and her crew tout­ed the lat­est up­date on the drug and its plans to seek an ac­cel­er­at­ed ap­proval. At a re­cent re­view, the com­pa­ny said:

(P)atients ex­pe­ri­enced two com­plete and 23 par­tial re­spons­es, while an ad­di­tion­al three pa­tients with ini­tial par­tial re­spons­es are await­ing con­fir­ma­tion. Over­all, 81% of pa­tients treat­ed with IM­MU-132 showed tu­mor shrink­age from base­line mea­sure­ments. The clin­i­cal ben­e­fit rate (com­plete and par­tial re­mis­sions, and pa­tients with sta­ble dis­ease) at six months or lat­er com­put­ed to 44%. The me­di­an du­ra­tion of re­sponse for those with ob­jec­tive re­spons­es was al­most 11 months. It was em­pha­sized that these are in­ter­im re­sults, since 20 pa­tients are con­tin­u­ing treat­ment; a fi­nal out­come must await analy­sis of all pa­tients en­rolled.

An­a­lysts though, have fret­ted about this drug in the re­cent past, in­clud­ing wor­ries about the man­u­fac­tur­ing process, which Seat­tle Ge­net­ics is like­ly to tack­le quick­ly.

Af­ter TNBC, Seat­tle Ge­net­ics plans to go af­ter new in­di­ca­tions as it fol­lows up on Phase II stud­ies in urothe­lial can­cer, small-cell lung can­cer and non-small-cell lung can­cer. And Seat­tle Ge­net­ics CEO Clay Sie­gall says the late-stage tu­mor drug will fit neat­ly in its pipeline of an­ti­body drug con­ju­gates. He said:

This pro­gram would com­ple­ment our rich pipeline of late- and ear­ly-stage pro­grams, po­ten­tial­ly al­low­ing us to bring a new ther­a­py for triple-neg­a­tive breast can­cer to pa­tients in need. We have suc­cess­ful­ly demon­strat­ed our ex­per­tise in the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion of AD­Cs in on­col­o­gy, and we look for­ward to work­ing with Im­munomedics to ad­vance this pro­gram.

In ad­di­tion to the cash and mile­stones, Seat­tle Ge­net­ics is al­so buy­ing in­to Im­munomedics, pay­ing $14.7 mil­lion for shares at a slight pre­mi­um and re­serv­ing the right to buy more lat­er at the same price. Seat­tle Ge­net­ics has the right to make up to a $57 mil­lion eq­ui­ty in­vest­ment for up to a 9.9% stake in Im­munomedics.

Right af­ter the deal was an­nounced, Im­munomedics said it would post­pone its an­nu­al meet­ing as its in­vestors took time to ab­sorb the im­pli­ca­tions of the pact.

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