Look out Gilead, Ab­b­Vie’s hep C com­bo comes with stel­lar da­ta, 8-week reg­i­men and a killer price

The FDA hand­ed Ab­b­Vie an OK and a help­ful la­bel on Thurs­day for its new com­bo ther­a­py for he­pati­tis C. And now they’re rolling it in­to an in­tense­ly com­pet­i­tive mar­ket with a low­ball price for the first 8-week reg­i­men that cov­ers all the ma­jor geno­types of the dis­ease.

In oth­er words, look out Gilead.

The drug’s com­mer­cial name is Mavyret, a com­bi­na­tion of pi­brentasvir com­bined with Enan­ta’s gle­capre­vir. Start­ing with the stan­dard 8-week course and then jump­ing to 12 and 16 weeks if nec­es­sary, re­searchers have tracked cure rates start­ing at 92% and ris­ing to 100%.

But it’s that short­er 8-week sched­ule that gives Ab­b­Vie an edge over the block­buster slate of drugs from Gilead, which demon­strat­ed in Q2 that there’s still some po­ten­tial to in­crease sales in the field.

Now Ab­b­Vie wants to re­al­ly slice in­to that mar­ket share of Gilead’s, and the an­a­lysts have been work­ing over­time to try and es­ti­mate the im­pact this drug can have as the 8th new ther­a­py for doc­tors and pa­tients to pick from. Ever­cor­eISI’s Umer Raf­fat diced the num­bers to com­pare whole­sale costs for a set 4-week sched­ule to see how they look in com­par­i­son. And pay­ers will have no prob­lem cheer­ing the price war that Ab­b­Vie clear­ly wants to start.

Look­ing over the peak sales es­ti­mates for this drug, Eval­u­atePhar­ma pegged 2022 sales at $1.3 bil­lion, mak­ing it a top 20 pipeline drug this year, though that’s no sure thing. Gilead is one of the most ag­gres­sive drug mar­keters on the plan­et, and they have come to dom­i­nate this dis­ease cat­e­go­ry for a rea­son.

Still, Leerink’s Ge­of­frey Porges be­lieves Ab­b­Vie can be a play­er with this drug and price, it just won’t make a huge splash on the bot­tom line.

Pa­tients, physi­cians and pay­ers are like­ly to em­brace Mavyret giv­en the drug’s pro­file and ex­cel­lent clin­i­cal da­ta, and this ap­proval and the sub­se­quent mar­ket share en­croach­ment are a key part of our cau­tious stance to­wards Gilead’s stock. Con­verse­ly, for Ab­b­Vie, this pric­ing means that the rev­enue con­tri­bu­tion from Mavyret is like­ly to be lim­it­ed, and large­ly con­sis­tent with our ex­ist­ing fore­cast.

Enan­ta is grab­bing a $40 mil­lion mile­stone on the ap­proval.

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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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.

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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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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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.

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.