Za­vante CEO sells his late-stage an­tibi­ot­ic biotech to Nabri­va — grab­bing the helm in the deal

The last time I talked to Za­vante CEO Ted Schroed­er in the spring of 2017, he was steer­ing his an­tibi­ot­ic Zolyd (fos­fomycin for in­jec­tion, or ZTI-01), plan­ning to squeak past the goal lines at the FDA with­out a pen­ny to spare of his $45 mil­lion in in­vestor back­ing.

Ted Schroed­er

The an­tibi­ot­ic is an old one, out­side the US, and he had grabbed coun­try rights in ex­pec­ta­tions that it would work as ex­pect­ed.

Now, about 15 qui­et months lat­er, we heard Tues­day af­ter­noon that Nabri­va $NBRV is step­ping in to buy the an­tibi­ot­ic and hus­tle it to reg­u­la­tors — in­di­cat­ing that Schroed­er’s old time­line and bud­get may have gone a lit­tle south some­how.

Nabri­va is hand­ing over 8.2 mil­lion shares to com­plete the ac­qui­si­tion, with a lit­tle un­der $100 mil­lion more in mile­stones.

The an­tibi­ot­ic is now called Con­tepo, and Schroed­er is still in charge of get­ting it to the FDA. In fact, he’s tak­ing the CEO’s job in the deal, tak­ing the place of Col­in Broom.

Nabri­va had a $3.30 share price at the close, with a $134 mil­lion mi­cro cap val­u­a­tion.

De­vel­op­ing an­tibi­otics may be ur­gent­ly need­ed, but they are not go­ing af­ter block­buster mar­kets. Most an­tibi­otics in use are cheap gener­ics, mak­ing this one risky field with­out a ma­jor up­side. That’s one rea­son why drug re­sis­tance con­tin­ues to get worse. With­out bet­ter mar­ket in­cen­tives, we’ll con­tin­ue to see ma­jor play­ers bow out, as we saw re­cent­ly when No­var­tis shut down its an­tibi­otics re­search work and laid off 140 peo­ple.

Broom, now work­ing as a con­sul­tant to Schroed­er, said:

We ex­pect that Nabri­va’s ex­pert com­mer­cial, med­ical af­fairs and sup­ply chain in­fra­struc­ture will be able to ful­ly sup­port CON­TEPO, a nov­el, po­ten­tial first-in-class IV treat­ment in the Unit­ed States. We be­lieve CON­TEPO will be ben­e­fi­cial in the ear­ly, ap­pro­pri­ate treat­ment of com­pli­cat­ed uri­nary tract in­fec­tions caused or sus­pect­ed to be caused by mul­ti-drug re­sis­tant (MDR) bac­te­ria. Nabri­va ex­pects to file New Drug Ap­pli­ca­tions (NDAs) with the U.S. Food and Drug Ad­min­is­tra­tion for both lefa­mulin and CON­TEPO in the fourth quar­ter of 2018.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.