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.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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