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.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Just in time to as­sure a de­ci­sion be­fore CVR dead­line, Bris­tol My­ers Squibb files NDA for Cel­gene/blue­bird CAR-T

A new CAR-T therapy may be coming. And maybe $9 per share for Celgene investors, too.

Bristol Myers Squibb announced they submitted an NDA for the multiple myeloma “ide-cel” CAR-T therapy Celgene developed in partnership with bluebird. The therapy is one of the three that has to be approved to unlock the BMS-Celgene contingent value agreement that would give shareholders of the absorbed NJ company $9 per share. The first, ozanimod, was approved last week. The second, a CAR-T treatment for non-Hodgkin’s lymphoma called liso-cel, was submitted to the FDA in December.

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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