J&J joins block­buster HIV com­bo race with new­ly ap­proved 4-in-1 pill

Slid­ing in­to the HIV com­bo ri­val­ry be­tween Gilead and GSK, J&J has notched an ap­proval for a 4-in-1 pill based on its an­ti­retro­vi­ral med darunavir.

To be mar­ket­ed as Sym­tuza, the drug is a sin­gle dai­ly pill that com­bines J&J’s darunavir (800mg) with co­bici­s­tat (150 mg), emtric­itabine (200 mg) and teno­fovir alafe­namide (10 mg) from Gilead. The lat­ter two form the back­bone com­bi­na­tion for Gilead’s block­buster triplet Bik­tarvy — with 2022 pro­ject­ed sales at $3.71 bil­lion — while co­bici­s­tat is a phar­ma­co­ki­net­ic en­hancer.

Bri­an Wood­fall

While cock­tail ther­a­pies have proven high­ly ef­fec­tive at keep­ing HIV at bay, the big play­ers in the mar­ket have all been hus­tling along to prove that their com­bos can do the job while promis­ing to im­prove ad­her­ence to drug reg­i­mens and height­en their con­sis­ten­cy. Janssen, the J&J sub­sidiary be­hind the new treat­ment, be­lieves that darunavir’s “high bar­ri­er to re­sis­tance” will al­so be key for clin­i­cians.

Jef­feries has pegged peak sales at $1 bil­lion.

Sym­tuza was ap­proved for both treat­ment-naïve pa­tients and cer­tain sta­bly sup­pressed pa­tients on an­ti­retro­vi­ral ther­a­py, though it was not rec­om­mend­ed for pa­tients with he­pati­tis B — sim­i­lar to its sta­tus in Eu­rope and Cana­da, where it got the green light in 2017 and ear­li­er this year, re­spec­tive­ly.

In two Phase III tri­als, the drug demon­strat­ed non-in­fe­ri­or­i­ty against a con­trol reg­i­men, show­ing sim­i­lar vi­ral sup­pres­sion rates and low vi­ro­log­ic fail­ure rates.

“There is more to be done in our fight to make HIV his­to­ry, and we will not stop here,” said Bri­an Wood­fall, Janssen’s glob­al head of late de­vel­op­ment, in­fec­tious dis­ease. “We will con­tin­ue our ef­forts to ad­vance treat­ment and re­main stead­fast in our pur­suit of ful­fill­ing the dream of a pre­ven­tive HIV vac­cine.”

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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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

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.

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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A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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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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Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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