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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

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