With Resta­sis in its crosshairs, My­lan adds a Botox biosim with Re­vance; Ver­tex starts sec­ond PhI­II triple com­bo CF study

With My­lan $MYL al­ready mov­ing in for the kill with a gener­ic ver­sion of Al­ler­gan’s Resta­sis, the big gener­ics com­pa­ny has set up a new pro­gram that can al­so go af­ter Al­ler­gan’s multi­bil­lion-dol­lar fran­chise for Botox. My­lan to­day an­nounced a deal to part­ner with Re­vance Ther­a­peu­tics $RVNC on a short-act­ing knock­off of Botox, which pro­vid­ed Al­ler­gan with chart-top­ping rev­enue of $3.4 bil­lion last year. Re­vance is al­ready an­gling to grab a share of the Botox mar­ket with a late-stage long-act­ing ri­val, along with com­pe­ti­tion from Evo­lus and Hugel. And there have been mixed re­views of just how suc­cess­ful that might be.

→ Ver­tex $VRTX is start­ing yet an­oth­er Phase III study of VX-659 (a sec­ond-gen­er­a­tion cor­rec­tor can­di­date), along with teza­caftor and iva­caftor as an in­ves­ti­ga­tion­al triple com­bo reg­i­men for peo­ple with cys­tic fi­bro­sis. Specif­i­cal­ly, the com­pa­ny is look­ing at CF pa­tients with two copies of the F508del mu­ta­tion, the most com­mon form of the dis­ease. The study will en­roll 100 pa­tients. This is the sec­ond triple com­bo study in­clud­ing these same ther­a­pies, with Ver­tex an­nounc­ing the first in Feb­ru­ary. That tri­al was en­rolling 360 pa­tients. “The first Phase III study…is de­signed to sup­port ap­proval of the VX-659 triple com­bi­na­tion in pa­tients with one F508del mu­ta­tion and one min­i­mal func­tion mu­ta­tion who cur­rent­ly have no treat­ment that ad­dress­es the un­der­ly­ing cause of dis­ease,” said Jef­frey Chodake­witz, Ver­tex’s ex­ec­u­tive vice pres­i­dent and CMO, in a state­ment. “This sec­ond study is de­signed to en­able us to broad­en the po­ten­tial la­bel for this reg­i­men to in­clude those with the most com­mon ge­net­ic form of cys­tic fi­bro­sis.”

Al­ler­gan’s $AGN has run in­to a speed bump along the reg­u­la­to­ry road for a uter­ine fi­broids drug. In a very brief note, the Dublin-based phar­ma ac­knowl­edged that the FDA has ex­tend­ed the re­view of its NDA for ulipristal ac­etate, set­ting a PDU­FA tar­get ac­tion date in Au­gust. The com­pa­ny is fair­ly op­ti­mistic about the drug — which is al­ready avail­able in Eu­rope and Cana­da and aced both PhI­II tri­als — fore­cast­ing $500 mil­lion to $1 bil­lion in sales.

→ In the clos­ing chap­ter to an em­bar­rass­ing sto­ry about a failed gov­ern­ment re­search sub­sidy pro­gram, San­ford Burn­ham Pre­bys Med­ical Dis­cov­ery In­sti­tute has agreed to re­turn $12.3 mil­lion to the state of Flori­da for fail­ing to ful­fill re­quire­ments made in an in­cen­tive agree­ment. The state first hand­ed SBP $155 mil­lion in in­cen­tives in 2006 — un­der then-gov­er­nor Jeb Bush — amount­ing to one of the largest in­cen­tive pack­ages in the state’s re­cent his­to­ry, ac­cord­ing to the Or­lan­do Sen­tinel. By 2016, how­ev­er, the in­sti­tute had de­cid­ed to re­lo­cate to Cal­i­for­nia for fi­nan­cial rea­sons, with­out reach­ing the goal of cre­at­ing 303 jobs. SBP is still ne­go­ti­at­ing with lo­cal stake­hold­ers re­gard­ing tran­si­tion of its op­er­a­tions to an­oth­er en­ti­ty, but its of­fi­cials in­sist that the in­sti­tute had con­tributed sig­nif­i­cant­ly to Flori­da’s life sci­ences in­dus­try dur­ing its 10-year pres­ence.

With con­tri­bu­tion by John Car­roll and Brit­tany Meil­ing.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Boehringer In­gel­heim ties the knot with Num­ab on new an­ti­bod­ies; Ca­balet­ta inks pact with Ar­ti­san

→ Switzerland’s Numab Therapeutics has added Boehringer Ingelheim to its roster of collaborators. And they will start with two projects aiming at developing new drugs for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy. “Numab’s technology platform fits well with our internal antibody discovery and engineering capabilities and will enhance our efforts to deliver transformative antibody-based therapeutics to patients,” said Paige Mahaney, an SVP at Boehringer Ingelheim.

Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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David Hallal

AlloVir tests how much an an­tivi­ral biotech can reap in a pan­dem­ic stock mar­ket

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.

Take­da’s post-merg­er deals con­tin­ue as OTC sub­sidiary is pre­pared for sale

Takeda has been burdened under mountains of debt since acquiring Shire for $62 billion 18 months ago, but one of the company’s biggest moves yet to relieve the stress could be on the horizon.

The Japanese pharma is preparing a bidding war for its $3.7 billion over-the-counter subsidiary, a sale that would dwarf previous spinoffs. Any transaction would be the latest in what’s been a long string of sell-offs, as Takeda marches unflinchingly toward its ultimate goal of shedding $10 billion in assets.

In­vestors give ail­ing Unum a lease on life and a whole new suite of ex­per­i­men­tal can­cer drugs

Investors, it seems, are willing to give Unum Therapeutics one last shot — or at least one last shot to a company of that name.

The ailing cancer biotech, beset by a series of clinical holds and multiple failed lead programs, announced today that they’ve acquired Kiq LLC and that investors are putting in $104 million to advance Kiq’s pipeline of kinase inhibitors. Unum shareholders will now own only 16.2% of the company and CEO Chuck Wilson indicated that the cell therapies the biotech has worked on since its founding may be on their way out, saying Unum will “explore strategic options” for those products.

RA Cap­i­tal dou­bles down on Sid­dhartha Mukher­jee's vi­sion for a new cell en­gi­neer­ing ap­proach, lead­ing Vor's $110M Se­ries B

Vor Biopharma is muscling up.

CEO Robert Ang, who was reluctant to divulge the headcount when discussing his move from Neon Therapeutics to Vor last August, readily offered that the team has grown from 6 to 50 in less than a year. The biotech is moving to a larger office on Cambridge Parkway Drive in weeks, giving it more space to complete the IND-enabling work and manufacturing scale-up — conducted by a CDMO partner — in preparation for clinical trials planned for the first half of 2021.