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.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.