Dy­navax takes a big step to­ward an OK for hep B vac­cine, but nag­ging safe­ty is­sues re­main

Ed­die Gray, Dy­navax CEO

Will the third time prove the charm for Dy­navax?

More than a few an­a­lysts are still ask­ing that ques­tion af­ter a pan­el of out­side ex­perts formed by the FDA of­fered a lop­sided vote in fa­vor of an ap­proval — with three ab­sten­tions for its hep B vac­cine Hep­lisav and on­ly one op­posed for safe­ty rea­sons.

Ef­fi­ca­cy was nev­er re­al­ly in doubt. The da­ta are sol­id. But there was plen­ty of fret­ting about Hep­lisav’s safe­ty pro­file, af­ter reg­u­la­tors spot­light­ed an im­bal­ance of deaths and car­diac events which has nev­er been ex­plained. The in­ter­nal FDA re­view last Wednes­day forced the stock $DVAX down 10%, but it rock­et­ed up 80% Fri­day evening af­ter the ex­perts weighed in on ways that the biotech could keep a care­ful eye on the health of the peo­ple tak­ing their vac­cine.

Whether the FDA signs off on that and green-lights the vac­cine, af­ter post­ing a sol­id set of da­ta in com­par­i­son with Glax­o­SmithK­line’s En­ger­ix-B, is now the big ques­tion. The agency on­ly rarely bucks its out­side ex­perts, and the man­date at the agency now is def­i­nite­ly in fa­vor of ap­provals over de­lay.

This pro­gram has al­ready been stiff-armed twice at the FDA, fol­low­ing a clin­i­cal hold ear­ly on in 2008.

RBC’s Matt Eck­ler is bet­ting that the com­pa­ny and the FDA can square away a plan for phar­ma­covig­i­lance, al­low­ing an ap­proval by Au­gust 10 and a launch next year — whether or not the biotech can land a part­ner. But there are plen­ty of un­re­solved ques­tions re­gard­ing the de­tails and how they may in­flu­ence the com­mer­cial re­cep­tion. He wrote:

Pri­or to the pos­i­tive vote, pan­el mem­bers ex­pressed lin­ger­ing con­cerns over the MI (my­ocar­dial in­farc­tion) sig­nal seen in HBV-23, as well as the suf­fi­cien­cy of the pro­posed de­sign of the post mar­ket­ing sur­veil­lance pro­gram. The cur­rent pro­pos­al from DVAX is to con­duct ob­ser­va­tion­al elec­tron­ic med­ical record re­view at Kaiser Per­ma­nente North­ern Cal­i­for­nia to com­pare 3-point MACE, and pre-spec­i­fied im­mune-me­di­at­ed events, in 20,000 Hep­lisav-B re­cip­i­ents vs 20,000 per­sons who re­ceive an­oth­er he­pati­tis B vac­cine. Based on this de­sign, the first in­ter­im analy­sis is es­ti­mat­ed with­in 12 months fol­low­ing ini­ti­a­tion. No­table pan­el mem­ber con­cerns with the de­sign in­clud­ed the po­ten­tial for se­lec­tion against high-risk pa­tients, which would lim­it the abil­i­ty to de­tect a safe­ty sig­nal, as well as the ca­pac­i­ty to pro­vide de­fin­i­tive an­swers with­in a rea­son­able time frame. Ad­di­tion­al­ly, pan­el mem­bers ex­pressed the view that full safe­ty da­ta should be in Hep­lisav’s la­bel, but that such a la­bel may cause physi­cians to se­lect against us­ing in high-risk pa­tients for whom the un­met med­ical need is great­est.

Dy­navax is bet­ting that the eas­i­er dos­ing reg­i­men will give them an edge in the mar­ket over the GSK ri­val, but there are no sure things in this mar­ket.

“The two-dose reg­i­men of­fers the po­ten­tial to in­crease pa­tient com­pli­ance, which physi­cians and ad­vo­cates agree is es­sen­tial to pre­vent­ing more cas­es of he­pati­tis B and achiev­ing the pub­lic health goal of erad­i­ca­tion,” said CEO Ed­die Gray in a state­ment. “We look for­ward to com­plet­ing our on­go­ing dis­cus­sions with the FDA re­gard­ing an ap­pro­pri­ate post-mar­ket­ing com­mit­ment as it fi­nal­izes its re­view.”

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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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.

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.

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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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.

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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