Melin­ta Ther­a­peu­tics nabs FDA nod for more con­ve­nient re­work of an­tibi­ot­ic Or­bac­tiv, a for­mer Eli Lil­ly can­di­date

As pres­sure ris­es to ad­dress the su­per­bug cri­sis, Melin­ta Ther­a­peu­tics says it now has a more con­ve­nient op­tion to treat those with an­tibi­ot­ic-re­sis­tant skin in­fec­tions.

Chris­tine Ann Miller

Melin­ta got the OK for a new-and-im­proved for­mu­la­tion of its an­tibi­ot­ic ori­ta­vancin in acute bac­te­r­i­al skin and skin struc­ture in­fec­tions (AB­SS­SI) caused by sus­cep­ti­ble iso­lates of Gram-pos­i­tive mi­croor­gan­isms, in­clud­ing MR­SA, the com­pa­ny an­nounced on Mon­day. The drug, mar­ket­ed as Kimyr­sa, can be ad­min­is­tered over one hour as op­posed to Melin­ta’s ear­li­er Or­bac­tiv, which takes three.

“We have re­spond­ed to the re­quests of the med­ical com­mu­ni­ty to pro­vide an ori­ta­vancin prod­uct with a short­er in­fu­sion time,” CEO Chris­tine Ann Miller said in a state­ment. “We be­lieve that with the ap­proval of KIMYR­SA and prod­uct avail­abil­i­ty this sum­mer, physi­cians and pa­tients will now have a com­pelling new one-dose al­ter­na­tive to the cur­rent stan­dard of mul­ti-dose reg­i­mens for AB­SS­SI.”

Ori­ta­vancin’s long jour­ney to ap­proval, be­gin­ning in Eli Lil­ly’s pipeline, is rep­re­sen­ta­tive of the state of af­fairs in an­tibi­otics, a high-risk field from which Big Phar­ma re­treat­ed years ago. Many an­tibi­otics fail in de­vel­op­ment, while oth­ers with­er on the vine due to a lack of avail­able fund­ing. And for the ones that do make it to mar­ket, it’s an up­hill bat­tle against cur­rent­ly ex­ist­ing op­tions and cheap gener­ics.

Lil­ly sold the world­wide rights to ori­ta­vancin to In­ter­Mune in 2001. Four years lat­er, In­ter­Mune sold the drug to Tar­gan­ta Ther­a­peu­tics, which was on the hunt for “crit­i­cal­ly need­ed” an­tibi­otics to treat an­tibi­ot­ic-re­sis­tant in­fec­tions. In 2008, though, the FDA sent Tar­gan­ta back to the clin­ic, is­su­ing it a CRL for ori­ta­vancin in com­pli­cat­ed skin and skin struc­ture in­fec­tions.

The fol­low­ing year, The Med­i­cines Com­pa­ny lined up a $42 mil­lion deal to buy out Tar­gan­ta and the Phase III drug.

“We be­lieve that ori­ta­vancin can be­come an im­por­tant an­ti-in­fec­tive for se­ri­ous in­fec­tions in­volv­ing dif­fi­cult-to-treat bac­te­ria in dif­fi­cult-to-treat hos­pi­tal­ized pa­tients,” the com­pa­ny an­nounced. “Many of those crit­i­cal­ly ill pa­tients are the same pa­tients treat­ed with our ex­ist­ing prod­ucts.”

The FDA ap­proved ori­ta­vancin in 2014 for AB­SS­SIs caused by sus­cep­ti­ble Gram-pos­i­tive bac­te­ria, based on two tri­als dubbed SO­LO I and SO­LO II. The SO­LO tri­als com­pared ori­ta­vancin to van­comycin, an­oth­er Lil­ly orig­i­nal that’s now in the hands of ANI Phar­ma­ceu­ti­cals. The stud­ies showed that one 1,200 mg dose of ori­ta­vancin worked just as well as sev­en to 10 days of twice-dai­ly van­comycin treat­ments, ac­cord­ing to Melin­ta.

In 2017, Melin­ta ex­e­cut­ed a $270 mil­lion deal to buy out The Med­i­cines Com­pa­ny’s in­fec­tious dis­ease unit — in­clud­ing ori­ta­vancin.

In ad­di­tion to the SO­LO tri­als, the FDA based its lat­est ap­proval for ori­ta­vancin on an open-la­bel phar­ma­co­ki­net­ics study, which com­pared a one-hour Kimyr­sa treat­ment to a three-hour Or­bac­tiv treat­ment.

“Sin­gle-dose, long-act­ing an­tibi­otics, such as KIMYR­SA, may be es­pe­cial­ly ben­e­fi­cial for pa­tients who lack the sup­port or re­sources to ad­here to mul­ti­ple in­tra­venous ad­min­is­tra­tions,” An­drew Dold, an in­fec­tious dis­ease doc­tor in the Greater At­lanta re­gion, said in a state­ment.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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