Ar­ray wres­tles FDA OK for its MEK/BRAF melanoma com­bo, to hit the phar­ma­cy as Mek­tovi and Braftovi

Watch out No­var­tis.

Just a few weeks af­ter turn­ing up at AS­CO with pos­i­tive da­ta to show off, Ar­ray Bio­Phar­ma $AR­RY has nailed an FDA ap­proval for its MEK in­hibitor binime­tinib, which will be sold as Mek­tovi, as well as en­co­rafenib — a BRAF in­hibitor now dubbed Braftovi.

This is the first OK for its com­bo, which is slat­ed to go up pri­mar­i­ly against No­var­tis’ ri­val duo Tafin­lar+Mekin­ist in the ad­vanced BRAF mu­tant melanoma sec­tor.

Ron Squar­er, Ar­ray CEO

The news came out in bits and pieces. Ar­ray’s web­site had a pro­mo up for the com­bo and the FDA post­ed the la­bel and a note on the OK for Mek­tovi. But Ar­ray even­tu­al­ly post­ed its state­ment short­ly be­fore 2 pm ET.

The la­bel shows the drug com­bo is to be used among pa­tients with BRAF V600E or V600K mu­ta­tions.

“Near­ly half of pa­tients di­ag­nosed with metasta­t­ic melanoma test pos­i­tive for the BRAFmu­ta­tion,” said Va­lerie Guild, pres­i­dent of the AIM at Melanoma Foun­da­tion, adding the twin ap­proval is “wel­come news for the melanoma com­mu­ni­ty.”

Jef­feries has been weigh­ing in on be­half of the biotech, giv­ing them the edge in the head-to-head bat­tle to come with the phar­ma gi­ant. In a re­cent run­down on the com­bo for Ar­ray, an­a­lysts not­ed:

At AS­CO 2018, AR­RY pre­sent­ed ad­di­tion­al da­ta from COLUM­BUS tri­al; mOS of 33.6mo for bi­ni/en­co com­bo vs. 23.5mo for en­co alone vs. 16.9mo for ve­mu­rafenib, demon­strat­ing high­er po­ten­cy of en­co­rafenib vs. ve­mu­rafenib (mPFS of 14.9/9.6/7.3mo for com­bo/en­co/ve­mu­rafenib). On OS/PFS da­ta, AR­RY notes that aca­d­e­m­ic physi­cians/KOLs view bi­ni/en­co as the “best-in-class” al­though not a head-to-head study com­par­i­son on dou­blets. For safe­ty/tol­er­a­bil­i­ty, AR­RY notes physi­cians are com­fort­able with cross-study com­par­i­son; bi­ni/en­co’s low­er rates of pyrex­ia (any grade, 18% on bi­ni/en­co vs. 50-60% for Tafin­lar+Mekin­ist) & pho­to­sen­si­tiv­i­ty (vs. Zelb­o­raf+Cotel­lic) will be well po­si­tioned with com­mu­ni­ty-based physi­cians who are more con­cerned with safe­ty is­sues.

Jef­feries, for one, be­lieves that Ar­ray can do bet­ter than what No­var­tis has done in this part of the melanoma mar­ket, where the phar­ma gi­ant has been earn­ing about $400 mil­lion for its com­bi­na­tion.

That may be, but it was a sell-the-news kind of day on Wall Street. Ar­ray’s shares slid about 4% by the close.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.