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.

→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

While gene ther­a­py com­pa­nies re­joice as the sec­tor gains trac­tion with ap­provals and a flur­ry of M&A ac­tiv­i­ty, one play­er is feel­ing the heat.

Back in 2015, Voy­ager Ther­a­peu­tics joined forces with Sanofi Gen­zyme in a deal worth up to $845 mil­lion ($100 mil­lion up­front + a po­ten­tial $745 mil­lion in mile­stones) to co-de­vel­op gene ther­a­pies for se­vere cen­tral ner­vous sys­tem dis­or­ders. But two years lat­er, the French drug­mak­er re­treat­ed, elect­ing to not pick up the op­tion to work on Voy­ager’s Parkin­son’s dis­ease pro­gram. (Last year, the FDA dis­ap­point­ed Voy­ager, telling the com­pa­ny that it was not open to an ac­cel­er­at­ed fil­ing on the Parkin­son’s drug on the ba­sis of Phase II da­ta — in­stead of re­quir­ing an ad­di­tion­al piv­otal study.)

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

In a boost to Philadel­phia’s thriv­ing life sci­ences scene, a for­mer Glax­o­SmithK­line cam­pus and a near­by site has been turned in­to what its de­vel­op­er calls “the largest cowork­ing ecosys­tem” for health­care com­pa­nies in the coun­try.

The Dis­cov­ery Labs, a com­pa­ny spawned by MLP Ven­tures, has se­lect­ed two lo­ca­tions in the King of Prus­sia area as the $500 mil­lion test case for its strat­e­gy of ac­quir­ing and con­vert­ing old phar­ma­ceu­ti­cal R&D fa­cil­i­ties world­wide. The sites add up to 1.64 mil­lion square feet.