Dy­navax caps a long-run­ning reg­u­la­to­ry saga with an FDA OK for hep B vac­cine Hep­lisav

Reg­u­la­tors have been fret­ting for the last 5 years about Dy­navax’s Hep­lisav, a he­pati­tis B vac­cine linked to a long-run­ning string of un­ex­plained safe­ty is­sues, in­clud­ing an im­bal­ance in the rate of car­dio events that sug­gest­ed an un­der­ly­ing is­sue no one could clear­ly de­fine. But Thurs­day night came for­mal word that Dy­navax’s long reg­u­la­to­ry odyssey in search of an ap­proval — af­ter two ear­li­er re­jec­tions — was over. The FDA sanc­tioned the vac­cine for a com­mer­cial launch.

Ed­die Gray, Dy­navax CEO

The FDA nev­er has com­plete­ly let go of its safe­ty con­cerns, pro­duc­ing a la­bel that pro­vides the clin­i­cal da­ta Dy­navax $DVAX had gath­ered along the way. But the da­ta al­so in­cludes an ef­fi­ca­cy pro­file that’s clear­ly su­pe­ri­or to GSK’s En­ger­ix-B. And now the biotech — which has failed to pro­duce a part­ner for this prod­uct af­ter promis­ing last year to give it a try — will go up against the phar­ma gi­ant with a sales force of about 50 in the US.

RBC’s Matthew Eck­ler looked it all over and gave Dy­navax a thumbs up in the David-vs-Go­liath strug­gle to come:

Giv­en Hep­lisav’s su­pe­ri­or ef­fi­ca­cy and con­ve­nience pro­file, we con­tin­ue to see po­ten­tial to grow the cur­rent hep B vac­cine mar­ket (~$270M) through in­creased com­pli­ance, pre­mi­um pric­ing, and the cap­ture of adult di­a­bet­ic pop­u­la­tion, re­sult­ing in $300M pro­ject­ed peak rev­enue.

Dy­navax shares surged 15% on the news, though it wasn’t un­ex­pect­ed af­ter a pan­el vote in its fa­vor.

The biotech’s vac­cine — a com­bo of a he­pati­tis B sur­face anti­gen and a TLR9 ag­o­nist — pro­vid­ed a pro­tec­tion rate of 95% com­pared with 81% for En­ger­ix-B. In a sub­group analy­sis of Type 2 di­a­betes pa­tients, the range was 90% to 65%.

The vac­cine in­dus­try is a big field dom­i­nat­ed by glob­al play­ers like Sanofi and Glax­o­SmithK­line. That’s one rea­son why the biotech has been the sub­ject of con­sid­er­able spec­u­la­tion that it was a po­ten­tial buy­out tar­get, in­clud­ing a re­cent piece from Reuters claim­ing that some po­ten­tial buy­ers had been in to kick the tires. Noth­ing has come of that, so far. And Dy­navax CEO Ed­die Gray has in­sist­ed that the plan all along has been to com­mer­cial­ize the vac­cine, with help from a part­ner.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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.

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.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.