Un­fazed by dis­rup­tions, Cowen's in­vest­ment arm backs AM-Phar­ma's $176M piv­otal plan around lethal con­di­tion

It may not be the best time to start up a late-stage study un­re­lat­ed to Covid-19, but AM-Phar­ma isn’t let­ting a slight de­lay de­rail its over­all plan.

Erik van den Berg

The Dutch biotech has been sin­gu­lar­ly fo­cused on re­cAP, an an­ti-in­flam­ma­to­ry re­com­bi­nant hu­man form of an en­zyme orig­i­nal­ly found in cows called al­ka­line phos­phatase.

The one Phase III it be­lieves it needs for ap­proval was sched­uled for this sum­mer, fund­ed by a $133 mil­lion round last Ju­ly. Hav­ing pushed study ini­ti­a­tion to af­ter the sum­mer, AM-Phar­ma is adding $52 mil­lion for the reg­u­la­to­ry work need­ed to pre­pare for launch, in­clud­ing CMC val­i­da­tion and com­mer­cial sup­ply.

When the pan­dem­ic will peak is im­pos­si­ble to pre­dict, said CEO Erik van den Berg, but giv­en the sever­i­ty of the dis­ease that AM-Phar­ma is tack­ling — sep­sis-as­so­ci­at­ed acute kid­ney in­jury — they want­ed to start as soon as pos­si­ble and broad­ly stick to the orig­i­nal time­line. Da­ta from the Phase III tri­al are ex­pect­ed in 2023.

The new €23 mil­lion eq­ui­ty in­vest­ment by Cowen Health­care In­vest­ments, its first US-based in­vestor in the syn­di­cate, along­side the €24 mil­lion loan from the Eu­ro­pean In­vest­ment Bank, has boost­ed his con­vic­tion.

Right now, with all of AM-Phar­ma’s 23 staffers work­ing from home in Utrecht, the Nether­lands, crit­i­cal ac­tiv­i­ties are still on­go­ing. Doc­u­ments still need to be pre­pared for re­view be­fore sites can be ini­ti­at­ed — a siz­able project when you are plan­ning a tri­al in­volv­ing 1,400 pa­tients in 12 coun­tries.

“Our work is most­ly project man­age­ment and co­or­di­na­tion,” van den Berg said. “We don’t have any labs to close in this pe­ri­od. All of our sup­pli­ers are still on­line and al­so moved as much as pos­si­ble to home-based work­ing.”

There will be chal­lenges when the tri­al ac­tu­al­ly be­gins, as the pa­tients that will be re­cruit­ed tend to be treat­ed in in­ten­sive care units, many of which could be over­whelmed by se­vere coro­n­avirus pa­tients. While he is plan­ning for dif­fer­ent pos­si­bil­i­ties, van den Berg is hope­ful hu­man cre­ativ­i­ty will save them from the worst-case sce­nario.

In a sense it’s char­ac­ter­is­tic of a team that has built a busi­ness around of­fer­ing hope where there is lit­tle, re­duc­ing the mor­tal­i­ty rate by 40% ver­sus place­bo in Phase II. And it wouldn’t be the first time it has had to con­tend with un­fore­seen cir­cum­stances: van den Berg hadn’t been plan­ning on tak­ing the piv­otal pro­gram and com­mer­cial ef­forts un­til Pfiz­er pulled out of a deal to ac­quire the com­pa­ny, leav­ing it to go it alone.

“Worst case sce­nario is we’re sit­ting in our home of­fices for years,” he said. ”But I don’t think that’s re­al­is­tic. I don’t see it that bleak.”

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

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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Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

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.