With an FDA de­ci­sion loom­ing, Dy­navax is shop­ping a deal on Hep­lisav — re­port

Late Fri­day Reuters re­port­ed that Dy­navax Tech­nolo­gies $DVAX was shop­ping its he­pati­tis B vac­cine Hep­lisav in the wake of a pos­i­tive FDA pan­el re­view and a shot at a near-term FDA ap­proval.

Ed­die Gray, Dy­navax CEO

Quot­ing sources, the wire ser­vice re­port­ed that Dy­navax is en­gaged in a strate­gic re­view, with a chance of bag­ging a sale or li­cens­ing pact that could bring in a sub­stan­tial amount of cash. Reuters added that there is no guar­an­tee of a deal, as Dy­navax re­it­er­at­ed that it’s plan­ning a mar­ket launch for 2018. A com­pa­ny spokesper­son added: “We con­tin­ue to eval­u­ate any in­ter­est from po­ten­tial part­ners as part of our long-term strate­gic plan­ning.”

RBC’s Matthew Eck­ler took a look at the sto­ry and not­ed:

The Reuters ar­ti­cle mir­rors pri­or man­age­ment com­men­tary from when we saw them two weeks ago (link to pri­or note), in which they high­light­ed on­go­ing ef­forts to pre­pare for a 1Q18 US launch, while al­so re­main­ing open to part­ner­ship or di­vesti­ture. No­tably, man­age­ment high­light­ed the con­sol­i­dat­ed na­ture of the US vac­cine mar­ket, in which on­ly a hand­ful of com­pa­nies (GSK, JNJ, MRK, PFE, SNY, etc.) have ex­ist­ing ca­pa­bil­i­ties to com­mer­cial­ize Hep­lisav. So al­though we think that man­age­ment is amenable to part­ner­ing/sell­ing Hep­lisav (as­sum­ing agree­ment on price of course), we al­so think it’s im­por­tant to re­main cog­nizant of the unique dy­nam­ics of the vac­cine mar­ket rel­a­tive to oth­er ar­eas such as on­col­o­gy.

Dy­navax’s in­vestors have been on a slow-mo­tion roller coast­er ride that’s last­ed for years, with two ear­li­er re­jec­tions from the FDA.

Ef­fi­ca­cy was nev­er re­al­ly in doubt this last time around. The da­ta are sol­id. But there was plen­ty of fret­ting about Hep­lisav’s safe­ty pro­file, af­ter reg­u­la­tors spot­light­ed an im­bal­ance of deaths and car­diac events which has nev­er been ex­plained. The in­ter­nal FDA re­view forced the stock $DVAX down 10%, but it rock­et­ed up 80% af­ter the ex­perts weighed in on ways that the biotech could keep a care­ful eye on the health of the peo­ple tak­ing their vac­cine.

Whether the FDA signs off on that and green-lights the vac­cine, af­ter post­ing a sol­id set of da­ta in com­par­i­son with Glax­o­SmithK­line’s En­ger­ix-B, is now the big ques­tion. The agency on­ly rarely bucks its out­side ex­perts, and the man­date at the agency now is def­i­nite­ly in fa­vor of ap­provals over de­lay.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

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