Mer­ck com­pletes a clin­i­cal tri­al Odyssey, fi­nal­ly bag­ging an FDA OK for C diff an­ti­body

Nicholas Kart­so­nis, Mer­ck

Mer­ck had to en­dure de­lays and some scold­ing by ex­perts along the way, but the phar­ma gi­ant has picked up the FDA’s ap­proval to start mar­ket­ing be­zlo­tox­um­ab to pre­vent the re­cur­rence of Clostrid­i­um dif­fi­cile in­fec­tions. The drug will be sold as Zin­pla­va, with a launch planned for ear­ly 2017.

Picked up from Medarex just months be­fore the Bris­tol-My­ers’ buy­out, Mer­ck $MRK be­lieves that the IgG1/kap­pa an­ti­body can help pre­vent tens of thou­sands of new cas­es of C. diff each year among high-risk pa­tients.

Back in June, an FDA pan­el of out­side ex­perts vot­ed 10 to 5 to ap­prove the drug, with the 5 ‘no’ vot­ers rais­ing point­ed con­cerns that Mer­ck nev­er made the piv­otal study large enough to iden­ti­fy which pa­tients would be most like­ly to ben­e­fit from it. That may have helped per­suade the agency to hold back on an ap­proval, push­ing the PDU­FA date back to Oc­to­ber 23rd, when it fi­nal­ly flashed the green light af­ter re­quest­ing some more in­fo from Mer­ck.

One of the rea­sons for the de­lays and de­bate over this treat­ment may have had to do with the fact that Mer­ck had been de­vel­op­ing the pro­gram in tan­dem with ac­tox­um­ab. But the com­ple­men­tary ther­a­py failed to mea­sure up in a piv­otal test of its own as a com­bo with be­zlo­tox­um­ab, and the phar­ma gi­ant flushed that drug last fall as it sig­naled plans to push ahead for a so­lo ap­proval.

Mer­ck’s team has had plen­ty of time with this pro­gram. The com­pa­ny in-li­censed the treat­ment from Medarex and the Uni­ver­si­ty of Mass­a­chu­setts Med­ical School back in 2009. While Zin­pla­va is not an an­tibi­ot­ic, Mer­ck has been in­vest­ing heav­i­ly in the field, in­clud­ing its $9.5 bil­lion buy­out of Cu­bist.

“For gen­er­a­tions, Mer­ck has been stead­fast in its com­mit­ment to fight­ing in­fec­tious dis­eases – and that com­mit­ment con­tin­ues to­day. Zin­pla­va is a hu­man mon­o­clon­al an­ti­body that binds to C. dif­fi­cile tox­in B and neu­tral­izes its ef­fects,” said Dr. Nicholas Kart­so­nis, vice pres­i­dent of clin­i­cal de­vel­op­ment, in­fec­tious dis­eases, Mer­ck Re­search Lab­o­ra­to­ries.

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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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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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

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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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.

Mi­rati's KRAS drug looks like the ear­ly fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed numerically higher response rates than sotorasib solo and as part of a combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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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.