Tetraphase plots Q4 launch for first an­tibi­ot­ic af­ter long-await­ed OK for er­ava­cy­cline

It took a few years more than ex­pect­ed, but Tetraphase fi­nal­ly has a prod­uct to sell.

Late Mon­day, the biotech an­nounced that the FDA has ap­proved their lead an­tibi­ot­ic, er­ava­cy­cline, for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions (cIAI). The com­pa­ny ex­pects to launch the in­tra­venous drug as Xer­a­va in the US by the end of the year.

Guy Mac­don­ald

The news comes four years af­ter Tetraphase first post­ed pos­i­tive Phase III da­ta for the drug in this in­di­ca­tion, back when the com­pa­ny thought the an­tibi­ot­ic could al­so treat com­pli­cat­ed uri­nary tract in­fec­tions (cU­TI). As er­ava­cy­cline flopped the late-stage study for cU­TI, reg­u­la­tors sent the com­pa­ny’s first NDA back de­mand­ing a sec­ond set of re­sults.

While the fol­low-up cU­TI study ul­ti­mate­ly proved to be equal­ly dis­ap­point­ing — ham­mer­ing the stock $TTPH and de­stroy­ing the pro­gram’s fu­ture — Tetraphase man­aged to build a new case around a promis­ing Phase III that, when com­bined with the first study, showed er­ava­cy­cline was non-in­fe­ri­or to the wide­ly used gener­ic an­tibi­otics er­tapen­em and meropen­em.

With a fi­nal de­ci­sion from Eu­ro­pean reg­u­la­tors com­ing up, com­mer­cial­iza­tion is now at the top of mind.

“We are thrilled to have re­ceived FDA ap­proval, and a pos­i­tive opin­ion from the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) in Eu­rope all with­in the same quar­ter,” said CEO Guy Mac­don­ald in a state­ment. “We will now turn our ef­forts to­wards de­liv­er­ing Xer­a­va to pa­tients suf­fer­ing from cIAI in the Unit­ed States, an im­por­tant goal we ex­pect to be­gin ex­e­cut­ing on in the fourth quar­ter of this year.”

While the list price will be fi­nal­ized over the next few weeks, Mac­don­ald tells me it will fall with­in the range of $175 to $250 per day — dis­tin­guish­ing the drug from some re­cent­ly ap­proved an­tibi­otics, like Achao­gen’s Zem­dri, which are in­tend­ed to be used “ba­si­cal­ly where noth­ing else works.”

“We clear­ly want to pen­e­trate the first and sec­ond line mar­ket and get the drug used much ear­li­er,” he said. “Our la­bel sup­ports that, and the pric­ing strat­e­gy we pick as well.”

The fo­cus on com­pli­cat­ed pa­tients in hos­pi­tals, he adds, means their sales team can be con­cen­trat­ed in their ef­forts. So far, Tetraphase has built out a team of about 50, with 35 of those be­ing re­gion­al sales reps.

With Big Phar­ma bow­ing out of the an­tibi­otics field one by one — No­var­tis be­ing the lat­est to join the ex­o­dus — the tall charge of de­vel­op­ing new weapons for the bat­tle against grow­ing an­tibi­ot­ic re­sis­tance has large­ly fall­en on small­er biotechs. Tetraphase’s tech­nol­o­gy, li­censed from Har­vard, promis­es to im­prove up­on the tetra­cy­cline class of an­tibi­otics, mak­ing them pow­er­ful enough to over­come mul­tidrug re­sis­tance.

Philip Barie, a pro­fes­sor of surgery and pub­lic health at Weill Cor­nell Med­i­cine, put it this way:

Com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions are the sec­ond-most preva­lent in­fec­tion site in in­ten­sive care units (ICUs), as well as the sec­ond lead­ing cause of in­fec­tion-re­lat­ed mor­tal­i­ty in ICUs. With the grow­ing cri­sis of an­tibi­ot­ic re­sis­tance, treat­ment op­tions for these polymi­cro­bial in­fec­tions are lim­it­ed fol­low­ing surgery or per­cu­ta­neous drainage, and the causative pathogens may be mul­ti-drug re­sis­tant. Cur­rent em­pir­ic treat­ments for cIAI have lim­i­ta­tions, and there is a need for new and nov­el treat­ments. Er­ava­cy­cline has a broad spec­trum of an­tibac­te­r­i­al ac­tiv­i­ty and a clin­i­cal pro­file that ad­dress­es this un­met med­ical need.

Tetraphase shares steadi­ly rose lead­ing up to the an­nounce­ment about the ap­proval, and has tak­en a 11% plunge since the news hit.

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