Ab­b­Vie nabs pe­di­atric OK for hep C drug Mavyret; Glen­mark launch­es cheap­er SGLT2 in­hibitor in In­dia

→ Build­ing off a sur­prise suc­cess with Mavyret in adults, Ab­b­Vie has nabbed an FDA ap­proval to mar­ket the he­pati­tis C drug for chil­dren ages 12 to 17. The drug — a com­bi­na­tion of gle­capre­vir and pi­brentasvir — racked up $3.438 bil­lion in net rev­enue for 2018, far ex­ceed­ing peak sales ex­pec­ta­tions. The OK was based on a tri­al of 47 HCV pa­tients with geno­types 1-4 sug­gest­ing a 100% cure rate, though it cov­ers all six geno­types.

→ In­dia’s Glen­mark on Tues­day launched a new SGLT2 in­hibitor called Re­mogliflozin. It is the first-ever launch of the di­a­betes drug, which was part­ly de­vel­oped by GSK, and it will be sold in In­dia. SGLT2 in­hibitors, such as Forx­i­ga, In­vokana and Jar­diance, work by pre­vent­ing the kid­neys from re­ab­sorb­ing glu­cose back in­to the blood. Re­mogliflozin, which has shown to be com­pa­ra­bly ef­fi­ca­cious and safe as Forx­i­ga in a late-stage head-to-head study, will be sold at a price of 25 ru­pees (36 cents) per day, a dis­count of more than 50% to ex­ist­ing SGLT2 in­hibitors on the In­di­an mar­ket, a com­pa­ny spokesper­son told End­points News.

→ A day af­ter the FDA added boxed warn­ings to zolpi­dem and oth­er in­som­nia med­i­cines for seem­ing to cause dan­ger­ous be­hav­iors, Ei­sai is go­ing all in on a sleep-wake reg­u­la­tion agent that it says com­pares fa­vor­ably to zolpi­dem. The Japan­ese com­pa­ny was col­lab­o­rat­ing with Pur­due Phar­ma on lem­borex­ant, but now says it will buy out all world­wide de­vel­op­ment and com­mer­cial­iza­tion rights. “Pur­due’s busi­ness pri­or­i­ties have shift­ed since this col­lab­o­ra­tion was ini­ti­at­ed,” CEO Craig Lan­dau said, adding they will now fo­cus on on­col­o­gy, non-opi­oid pain and oth­er CNS pro­grams. Oth­er po­ten­tial in­di­ca­tions in­clude ir­reg­u­lar sleep-wake rhythm dis­or­der in pa­tients with Alzheimer’s Dis­ease.

→ We fi­nal­ly know ex­act­ly how many jobs Mer­ri­mack Phar­ma’s $MACK lat­est pro­gram ter­mi­na­tion cost. In an SEC fil­ing, the com­pa­ny said 13 staffers now re­main, around half of the 27 who sur­vived the last round of lay­offs in No­vem­ber. A few weeks ago Mer­ri­mack an­nounced it was aban­don­ing its ex­per­i­men­tal drug, MM-310, af­ter an ear­ly-stage study in­volv­ing pa­tients with sol­id tu­mors showed that treat­ment with the drug was cu­mu­la­tive­ly tox­ic to pa­tients, de­spite tri­al pro­to­col amend­ments. Its pipeline now con­sists of two pre­clin­i­cal pro­grams.

→ As Mo­tif Bio works to re­solve the FDA’s con­cerns about the safe­ty of iclaprim, it’s dou­bling down on the an­tibi­ot­ic with a new com­bo pro­gram that broad­ens its ap­pli­ca­tion be­yond skin in­fec­tions. The UK biotech is part­ner­ing up with Scot­land’s Lamel­lar Bio­med­ical to test iclaprim along­side LMS-611 for cys­tic fi­bro­sis lung in­fec­tions. Mo­tif Bio says the two drugs have been grant­ed or­phan des­ig­na­tion for Staphy­lo­coc­cus au­reus pneu­mo­nia in pa­tients with CF in the US and Eu­rope, re­spec­tive­ly.


Na­tal­ie Grover con­tributed re­port­ing.

 

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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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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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

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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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.