Chi­na green­lights home­grown pneu­mo­coc­cal, HPV vac­cines for the mar­ket — break­ing grips by Pfiz­er, Mer­ck

Pfiz­er’s dom­i­nat­ing pneu­mo­coc­cal vac­cine Pre­vnar 13 fi­nal­ly has a ri­val — and it’s nei­ther Mer­ck nor any of the small biotechs try­ing to top­ple the megablock­buster.

Chi­na has ap­proved a pneu­mo­coc­cal 13-va­lent con­ju­gate vac­cine de­vel­oped by a unit of Wal­vax Biotech­nol­o­gy, as an al­ter­na­tive op­tion main­ly for in­fants and chil­dren 6 weeks to 5 years old. On the same day, reg­u­la­tors al­so an­nounced they have OK’d Cecol­in, an HPV vac­cine for women aged 9 to 45 de­vel­oped by Xi­a­men In­no­vax.

With over 15 mil­lion new­borns in just 2018, and giv­en that pneu­mo­coc­cal dis­ease is the main cause of death for chil­dren un­der the age of 5, the coun­try “has a huge clin­i­cal need for the vac­cine,” ac­cord­ing to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

The home­grown vac­cine has scored a broad­er la­bel than Pre­vnar 13, which nabbed an OK in 2016 chiefly for ba­bies up to 15 months old.

Na­tion­al Busi­ness Dai­ly re­port­ed that Pre­vnar 13 can cost up to $430 (RMB$3,000) per treat­ment. Wal­vax spokes­peo­ple told the lo­cal pub­li­ca­tion that their new prod­uct will be priced at an ad­van­tage to Pfiz­er’s en­trenched ri­val but not too low.

It may be an­oth­er three months be­fore the first vac­cines could be ad­min­is­tered fol­low­ing man­u­fac­tur­ing clear­ance, Na­tion­al Busi­ness Dai­ly added.

Yuxi Wal­vax, the sub­sidiary in charge of Wal­vax’s vac­cine R&D busi­ness, is a rare bright spot in a trou­bled op­er­a­tion. The Shang­hai-list­ed com­pa­ny was em­broiled in a vac­cine scan­dal a few years back when a dif­fer­ent unit fo­cused on sell­ing over­seas prod­ucts was found to be hawk­ing prob­lem­at­ic batch­es. In 2019, Xin­hua not­ed oth­er than Yuxi Wal­vax, all of its oth­er branch­es (which make plas­ma prod­ucts and mon­o­clon­al an­ti­bod­ies) are reg­is­ter­ing loss­es.

The biotech is al­ready mar­ket­ing a 23-va­lent pneu­mo­coc­cal poly­sac­cha­ride vac­cine, a Diph­the­ria, Tetanus and Acel­lu­lar Per­tus­sis com­bined vac­cine, and sev­er­al menin­gi­tis vac­cines. It’s al­so re­ceived fund­ing from the Bill and Melin­da Gates Foun­da­tion to de­vel­op new HPV vac­cines tar­get­ing HPV-16 and -18.

That’s the same types of HPV cov­ered by In­no­vax’s Cecol­in, which would com­pete with GSK’s old­er Cer­var­ix and Mer­ck’s Gar­dasil (both tetrava­lent and 9-va­lent). GSK has part­nered with In­no­vax on oth­er HPV vac­cine can­di­dates.

As the first home­grown HPV vac­cine, Cecol­in will sell for $47 (RMB$329) per vial, EEO re­port­ed. Younger girls on­ly need two shots while women 15 or above re­quire 3. That com­pares to around $186, $114 and $86 for cur­rent 9-va­lent, tetrava­lent and 2-va­lent op­tions as ob­served in a Shang­hai hos­pi­tal, re­spec­tive­ly, the lo­cal out­let added.

Both Wal­vax’s and In­no­vax’s new of­fer­ings were ap­proved un­der the pri­or­i­ty re­view path­way.

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.

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.

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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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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