Tetraphase has two suit­ors, de­spite strug­gling mar­ket for an­tibi­otics

The mar­ket for an­tibi­otics may be “bro­ken,” but one small an­tibi­ot­ic com­pa­ny is seem­ing­ly in de­mand: Tetraphase Phar­ma­ceu­ti­cals. In March, the com­pa­ny said it had agreed to be ac­quired by Acel­Rx in an all-stock deal val­ued at $14.4 mil­lion. But this week, an­oth­er drug­mak­er ap­pears to be court­ing Tetraphase — La Jol­la Phar­ma­ceu­ti­cals sub­mit­ted a non-bind­ing pro­pos­al to swal­low Tetraphase for $22 mil­lion.

At the heart of ei­ther deal is Tetraphase’s an­tibi­ot­ic er­ava­cy­cline (brand­ed as Xer­a­va), which was ap­proved in 2018 for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions, some four years af­ter the com­pa­ny re­port­ed its first batch of piv­otal tri­al da­ta. Last year, the drug gen­er­at­ed a mere $3.6 mil­lion in net sales.

Akin to Acel­Rx, La Jol­la is al­so of­fer­ing Tetraphase stock­hold­ers one con­tin­gent val­ue right (CVR), which would en­ti­tle the hold­ers to re­ceive ag­gre­gate pay­ments of up to $12.5 mil­lion for Xer­a­va in net sales mile­stones start­ing in 2021.

La Jol­la, which has an ap­proved drug for sep­tic or oth­er dis­trib­u­tive shock and an­oth­er ther­a­py un­der FDA re­view for malar­ia, has $77.2 mil­lion of cash which it plans to use to fund the trans­ac­tion, it said in a fil­ing.

Tetraphase in­vestors cheered the deal — shares of the Wa­ter­town, Mass­a­chu­setts-based com­pa­ny soared more than 56% to $2.12 in Thurs­day pre­mar­ket trad­ing.

The Acel­Rx deal was ap­proved by both sets of share­hold­ers and is ex­pect­ed to close in the sec­ond quar­ter. La Jol­la said its deal could be com­plet­ed by May 11, sub­ject to due dili­gence.

Tetraphase, like peers Achao­gen and Melin­ta, has seen its val­ue go up in smoke as fee­ble sales frus­trat­ed growth, as doc­tors who are con­fined by hos­pi­tal bud­gets are steered to use old­er, cheap­er an­tibi­otics in their first re­sponse, re­serv­ing fresh, more tar­get­ed al­ter­na­tives for acute cas­es.

The in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are fast dwin­dling, and the pipeline for new an­tibi­otics is em­bar­rass­ing­ly sparse, the WHO has warned. Drug­mak­ers are en­ticed by green­er pas­tures, com­pared to the long, ar­du­ous and ex­pen­sive path to an­tibi­ot­ic ap­proval that of­fers lit­tle fi­nan­cial gain as treat­ments are typ­i­cal­ly priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them.

As it stands, the an­tibi­ot­ic mar­ket is cursed — it har­bors the stink of mul­ti­ple bank­rupt­cies, a dearth of in­no­va­tion and is con­se­quent­ly bare­ly whet­ting the vo­ra­cious ap­petites of ma­jor phar­ma­ceu­ti­cal com­pa­nies and most ven­ture cap­i­tal­ists. The Tetraphase an­nounce­ment comes months af­ter bank­rupt an­tibi­ot­ic com­pa­ny Ar­a­digm turned to old part­ner/in­vestor Gri­fols for a fi­nal $3 mil­lion fire sale.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Trevor Martin (Mammoth)

Eye­ing in-vi­vo edit­ing, Mam­moth li­cens­es Jen­nifer Doud­na’s new CRISPR en­zyme

Last month, Jennifer Doudna revealed in Science a new, “hyper-compact” CRISPR enzyme that was half the size of traditional CRISPR enzymes and could, she suspected, offer a new, more versatile tool for gene editing.

Now, the University of California-Berkeley has licensed that enzyme, known as Casφ, exclusively to a biotech startup she and two former students set up three years ago: Mammoth Biosciences. It’s the second new CRISPR protein Mammoth has licensed from Doudna’s lab, after they licensed Cas14 in 2019.

Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).