FDA OKs a new triple hep C drug from Gilead -- plus the top 10 an­ti-vi­ral com­pa­nies in the world

Gilead’s world­wide hep C mar­ket may be shriv­el­ing at a fast pace, but the com­pa­ny con­tin­ues to field new com­bos that are wip­ing out re­main­ing pock­ets of dis­ease.

To­day came news that Gilead’s three-drug com­bi­na­tion of so­fos­bu­vir, vel­patasvir and a new drug called vox­i­lapre­vir has been ap­proved for the hep C phar­ma­copeia. It will now be sold as Vo­se­vi.

Nor­bert Bischof­berg­er

“Di­rect-act­ing an­tivi­ral drugs pre­vent the virus from mul­ti­ply­ing and of­ten cure HCV. Vo­se­vi pro­vides a treat­ment op­tion for some pa­tients who were not suc­cess­ful­ly treat­ed with oth­er HCV drugs in the past,” said Ed­ward Cox, di­rec­tor of the Of­fice of An­timi­cro­bial Prod­ucts in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search.

Eval­u­atePhar­ma pegged the triple as a top-5 R&D prod­uct in the pipeline last May, an­tic­i­pat­ing glob­al sales of $1.14 bil­lion in 5 years. Hep C mar­kets have be­gun to shrink this year as a new wave of cock­tails prove ef­fec­tive in cur­ing the dis­ease as it is be­ing di­ag­nosed. Gilead rev­o­lu­tion­ized this mar­ket and re­mains ag­gres­sive about launch­ing new prod­ucts that can com­plete the task.

Nor­bert Bischof­berg­er, the head of R&D at Gilead, had this to say about the triple when it was sub­mit­ted to the FDA late last year:

The re­main­ing clin­i­cal need to treat HCV pa­tients is a safe and ef­fec­tive cure for pa­tients who have failed pre­vi­ous ther­a­py with DAA reg­i­mens, in­clud­ing those with NS5A in­hibitors. SOF/VEL/VOX has the po­ten­tial to fill that need by of­fer­ing sin­gle tablet dos­ing and high cure rates across all HCV geno­types for pa­tients with and with­out cir­rho­sis, who have failed pri­or treat­ment with oth­er high­ly ef­fec­tive reg­i­mens.

There’s no im­me­di­ate word on pric­ing.

To put this all in­to per­spec­tive, you can see be­low Eval­u­atePhar­ma’s re­cent list of the top 10 an­ti-vi­ral com­pa­nies in the world. With hep C shrink­ing, Gilead is ex­pect­ed to lose big over the next 5 years. But it will re­main the dom­i­nant gi­ant in the field. GSK is catch­ing up with its HIV drugs, though, and this re­mains a high­ly com­pet­i­tive field. The top 5 prod­ucts on the mar­ket and in the pipeline are out­lined be­low.

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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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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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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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.

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.