Sev­er­al CEOs and 17 years lat­er, Melin­ta scores an FDA OK for its an­tibi­ot­ic

 

Eu­gene Sun, CEO, Melin­ta

It’s tak­en 17 years and a long chain of CEOs, but pri­vate­ly held Melin­ta Ther­a­peu­tics has nabbed an FDA ap­proval for its an­tibi­ot­ic de­lafloxacin, which can now be sold as Baxdela.

Melin­ta an­nounced a lit­tle more than a year ago that the an­tibi­ot­ic had proven non-in­fe­ri­or to van­comycin for acute bac­te­r­i­al skin and skin struc­ture in­fec­tions (AB­SS­SI). The last switch up in the ex­ec­u­tive suite at Melin­ta, once called Rib-X, was when Mary Szela— now CEO of Nov­e­l­ion — was re­placed by R&D chief Eu­gene Sun in 2015.

Baxdela is a flu­o­ro­quinolone that ex­hibits ac­tiv­i­ty against both gram-pos­i­tive and gram-neg­a­tive pathogens, in­clud­ing MR­SA, in both oral and IV forms.

Melin­ta is one of a few late-stage de­vel­op­ers in this space, look­ing to ad­dress the grow­ing de­mand for new an­tibi­otics in a world of grow­ing drug re­sis­tance. Za­vante tout­ed its own win in April, prep­ping an FDA ap­pli­ca­tion. Paratek hit a few days ahead of that biotech. But Cem­pra has had a ma­jor set­back to deal with.

The field has its at­trac­tions, but it’s not easy, which ex­plains an ab­sence of many large phar­ma play­ers on the R&D side. There are a num­ber of cheap, gener­ic an­tibi­otics avail­able for front­line use. And any new an­tibi­ot­ic is go­ing to face an up­hill bat­tle gain­ing trac­tion in this mar­ket.

“The ap­prox­i­mate­ly 3 mil­lion pa­tients hos­pi­tal­ized each year in the U.S. with AB­SS­SI of­ten present treat­ment chal­lenges ow­ing to their un­der­ly­ing med­ical con­di­tions, mak­ing op­ti­mal an­tibi­ot­ic se­lec­tion dif­fi­cult. Baxdela pro­vides a treat­ment op­tion for adult pa­tients with AB­SS­SI based on its cov­er­age spec­trum, IV and oral dos­ing flex­i­bil­i­ty, ef­fi­ca­cy and safe­ty pro­file,” said Sun in a pre­pared state­ment. “The ap­proval of Baxdela demon­strates FDA’s com­mit­ment to mak­ing new and ef­fec­tive an­tibi­otics avail­able to ad­dress un­met needs for hos­pi­tal­ized AB­SS­SI pa­tients.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

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Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

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One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

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Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

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The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

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Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

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