Zan­tac pulled off shelves due to can­cer scare; The end of the road for Mo­tif Bio

GSK is re­call­ing its heart­burn med­i­cine Zan­tac, sold gener­i­cal­ly as ran­i­ti­dine, from all mar­kets af­ter the FDA found it con­tains “‘un­ac­cept­able’ lev­els of prob­a­ble can­cer-caus­ing im­pu­ri­ty.” The drug is one of sev­er­al blood pres­sure and heart fail­ure med­ica­tions that have been pulled off the sheves since last year due to con­cerns about car­cino­genic ma­te­r­i­al in­tro­duced in the man­u­fac­tur­ing process. Four Zan­tac pre­scrip­tion-on­ly med­i­cines are in­volved: a syrup, an in­jec­tion and tablets of 150 and 300 mil­ligram (mg) dosages. But the over-the-counter ver­sions, which are pro­duced by a dif­fer­ent com­pa­ny, would not be af­fect­ed, ac­cord­ing to the UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­tion Agency.

→ 2019 has not been kind to Mo­tif Bio, who was plan­ning to launch and roll­out its drug iclaprim, but was halt­ed by a Feb­ru­ary com­plete re­sponse let­ter from the FDA that sent its stock crash­ing in­to pen­ny stock ter­ri­to­ry. The com­pa­ny is now wav­ing the white flag af­ter hear­ing back from a meet­ing with the FDA. The short an­swer: they will need years and loads of cash — that they don’t have — in or­der to com­plete a tri­al. CEO Gra­ham Lums­den had this to say: “We now have con­fir­ma­tion of what will be re­quired to progress iclaprim to­wards a po­ten­tial ap­proval. The Com­pa­ny is work­ing hard to find a part­ner or oth­er en­ti­ty to com­plete the HABP/VABP Phase III tri­al, com­mer­cialise iclaprim and en­sure the best out­come for share­hold­ers in Mo­tif Bio.”

→ While Themis, backed by its part­ner Mer­ck, was gear­ing up for a Phase III tri­al of its chikun­gun­ya vac­cine last month, Emer­gent BioSo­lu­tions leapfrogged ahead with the an­nounce­ment that its chikun­gun­ya virus (CHIKV) virus-like par­ti­cle (VLP) vac­cine can­di­date has been grant­ed EMA PRIME des­ig­na­tion. The vac­cine is in­tend­ed to pre­vent the dis­ease caused by the chikun­gun­ya virus in­fec­tion, an ill­ness that spreads through mos­qui­to bites.  No vac­cine or treat­ment is cur­rent­ly avail­able.

→ Cit­ing “ad­verse mar­ket con­di­tions,” ADC Ther­a­peu­tics took an un­ex­pect­ed U-turn at the NYSE last week, but that hasn’t stopped the com­pa­ny from ink­ing a col­lab­o­ra­tion with can­cer-fo­cused Avac­ta Group. Un­der the agree­ment, Avac­ta will pro­vide Af­firmer drug con­ju­gates to be used against three undis­closed can­cer tar­gets. It will al­so pro­vide these to ADC to aim its pro­pri­etary cy­to­tox­ic war­heads (PBDs) at the site of the tu­mor.

→ With larg­er phar­ma com­pa­nies turn­ing to more lu­cra­tive prospects, small­er com­pa­nies like MGB Bio­phar­ma have tak­en up most of the work in com­bat­ting the ever­grow­ing threat of an­tibi­ot­ic re­sis­tance. MGB re­vealed a Phase IIa clin­i­cal tri­al up­date of its bac­te­ri­ci­dal an­tibi­ot­ic, MGB-BP-3, for the treat­ment of clostrid­i­um dif­fi­cile-as­so­ci­at­ed dis­ease (CDAD) — an in­fec­tion of the large in­tes­tine that is the most fre­quent cause of di­ar­rhea in hos­pi­tals and care homes.

The com­pa­ny says that “the first co­hort of pa­tients has now com­plet­ed treat­ment with the low­est dose and re­sults in­di­cate high ef­fi­ca­cy and good tol­er­a­bil­i­ty of MGB-BP-3.” They’ve be­gun re­cruit­ment for the next co­hort, with topline re­sults from both Cana­da and the US an­tic­i­pat­ed in ear­ly 2020.

On­coSec, a late-stage in­tra­tu­moral im­muno-on­col­o­gy com­pa­ny, an­nounced an in­vest­ment and op­tion deal with Grand Decade, a sub­sidiary of Chi­na Grand Phar­ma­ceu­ti­cal (CGP). CGP and its af­fil­i­ate Sir­tex will in­vest $30 mil­lion in On­coSec. In ex­change, CGP and Sir­tex will re­ceive a con­trol­ling share in On­coSec. The deal gives GCP an ex­clu­sive li­cense to On­coSec’s cur­rent and fu­ture prod­ucts and sets a min­i­mum for price-per-share should CGP seek to ac­quire the rest of the com­pa­ny with­in the next year.

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

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

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.

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: 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.

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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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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.

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.