Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad tim­ing for In­tec.

Just when a key tri­al test­ing the com­pa­ny’s Ac­cor­dion drug de­liv­ery tech im­plod­ed in Parkin­son’s dis­ease, they hand­ed No­var­tis da­ta from a suc­cess­ful PK study of a cus­tom Ac­cor­dion pill en­gi­neered to de­liv­er a No­var­tis com­pound to en­tice the Swiss drug­mak­er in­to sign­ing a li­cens­ing agree­ment.

No­var­tis said thanks, but no thanks.

Jef­frey Meck­ler

For the cash-strapped Is­raeli drug de­vel­op­er, the fail­ure to clinch the deal marks a big blow. As of the third quar­ter, the com­pa­ny has $15.7 mil­lion in cash and equiv­a­lents, which HC Wain­wright an­a­lysts es­ti­mate will keep the lights on in­to mid-2020.

In re­sponse to the an­nounce­ment, the com­pa­ny’s stock tum­bled near­ly 11% to 53 cents in ear­ly trad­ing. On Ju­ly 19th, the last trad­ing day be­fore In­tec re­vealed the late-stage fail­ure, its stock closed at $2.29.

No­var­tis en­tered a ‘fea­si­bil­i­ty and op­tion’ agree­ment with In­tec last Jan­u­ary, but no fi­nan­cial de­tails were dis­closed at the time. How­ev­er, In­tec chief Jef­frey Meck­ler has since sug­gest­ed that a No­var­tis li­cens­ing deal could bring in be­tween $30 mil­lion to $80 mil­lion up­front, in ad­di­tion to mile­stone pay­ments.

The pro­gram no longer meets No­var­tis’ mid- to long-term strate­gic goals — de­spite the PK study hav­ing met tech­ni­cal ex­pec­ta­tions — and the drug­mak­er will pay In­tec $1.5 mil­lion to call it quits, the Jerusalem-based drug de­vel­op­er said on Wednes­day. 

“(W)e are now look­ing to iden­ti­fy ad­di­tion­al com­pounds in the No­var­tis port­fo­lio that can ben­e­fit from the unique char­ac­ter­is­tics the AP (Ac­cor­dion pill) plat­form,” Meck­ler said in a state­ment.

The com­pa­ny’s AP tech­nol­o­gy con­verts ac­tive in­gre­di­ents in­to a biodegrad­able poly­mer­ic film, which is fold­ed and then en­cap­su­lat­ed in a pill. The idea is to im­prove the ef­fi­ca­cy and safe­ty of ex­ist­ing drugs and drugs-in-de­vel­op­ment by re­leas­ing the ac­tive in­gre­di­ent slow­ly in the stom­ach over hours, al­low­ing the body to ab­sorb it more steadi­ly. Once the drug runs out, the pill is de­signed to sim­ply dis­solve in the gas­troin­testi­nal tract.

In Ju­ly, In­tec’s AP ver­sion of car­bidopa/lev­odopa failed to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment over Mer­ck’s car­bidopa/lev­odopa treat­ment Sinemet in a key late-stage Parkin­son’s dis­ease tri­al. Adding in­sult to in­jury, days ahead of the read­out Mer­ck an­nounced its de­ci­sion to cease man­u­fac­tur­ing of Sinemet in re­sponse to the mo­nop­oly of cheap gener­ics in the US mar­ket.

In­tec does, how­ev­er, have a high-pro­file part­ner in the form of Mer­ck. The large US drug­mak­er signed a re­search deal in May, in which In­tec is tasked with de­vel­op­ing a cus­tom AP for a Mer­ck com­pound. In­tec is al­so de­vel­op­ing Ac­cor­dion pills filled with cannabis-de­rived com­pounds for use in var­i­ous pain in­di­ca­tions.

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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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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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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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.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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