Nu­clear scare to fu­el an­ti-ra­di­a­tion drug sales? PTx buys ex-Sanofi drug just in case

Part­ner Ther­a­peu­tics (PTx), a Boston start­up formed last week by a pair of Mer­ri­mack and Ser­agon ex­ec­u­tives, has made its first move: it’s ac­quired an ex-Sanofi can­cer drug with hopes that the FDA will OK it for ra­di­a­tion poi­son­ing. Like… the kind from an atom­ic bomb or a nu­clear plant dis­as­ter.

Bob Mul­roy

Seems like a rare and un­com­mon event to tar­get, but founder and CEO Bob Mul­roy says it’s best to be pre­pared.

“You would hope you’d nev­er need a drug like this for this kind of in­ci­dent,” Mul­roy told The Boston Globe. “But I think that, should an in­ci­dent like that oc­cur, be­ing pre­pared for it is a very im­por­tant thing.”

The Globe and oth­ers are posit­ing that in­sults slung be­tween Pres­i­dent Trump and North Ko­re­an leader Kim Jong Un are fu­el­ing fears of nu­clear war, lead­ing to de­mand from peo­ple and gov­ern­ments to stock­pile ra­di­a­tion sick­ness drugs.

The med­i­cine is called Leukine, and it’s cur­rent­ly ap­proved to treat acute myeloid leukemia pa­tients fight­ing in­fec­tions af­ter un­der­go­ing bone mar­row trans­plants. But da­ta pre­sent­ed at the 2016 Amer­i­can So­ci­ety of Hema­tol­ogy meet­ing showed Leukine’s abil­i­ty to boost sur­vival in mon­keys ex­posed to ra­di­a­tion if in­ject­ed 48 hours af­ter ex­po­sure. That’s in­ter­est­ing, con­sid­er­ing Am­gen’s ra­di­a­tion sick­ness drugs Ne­u­pogen and Neu­las­ta must be in­ject­ed al­most im­me­di­ate­ly af­ter ex­po­sure to ra­di­a­tion for it to work.

De­ba­sish Roy­chowd­hury

As part of the as­set ac­qui­si­tion deal, PTx al­so got a ded­i­cat­ed bi­o­log­ics man­u­fac­tur­ing fa­cil­i­ty in Lyn­nwood, Wash­ing­ton. The lo­ca­tion will serve as the core man­u­fac­tur­ing and sup­ply chain cen­ter for PTx’s op­er­a­tions, the com­pa­ny said in a state­ment.

An sBLA for the drug was filed in Sep­tem­ber 2017. The ap­pli­ca­tion WAS grant­ed pri­or­i­ty re­view and has a PDU­FA da­ta of March 29, 2018.

While ra­di­a­tion poi­son­ing in the con­text of nu­clear war is cer­tain­ly the most eye-pop­ping ap­pli­ca­tion, PTx has plen­ty of oth­er plans for Leukine’s de­vel­op­ment.

Leukine has shown promise in com­bo stud­ies with Yer­voy (ip­il­i­mum­ab) against melanoma. A 250-pa­tient, ran­dom­ized Phase II study in re­frac­to­ry melanoma in com­bi­na­tion with Yer­voy demon­strat­ed an im­prove­ment in sur­vival over Yer­voy alone, Part­ner says. Leukine is cur­rent­ly in a Phase III tri­al in front-line melanoma in com­bi­na­tion with Yer­voy and Op­di­vo (nivolum­ab).

Leukine is even a hope­ful for Alzheimer’s dis­ease.

“In con­trast to oth­er ap­proved growth fac­tors that stim­u­late one cell type, Leukine’s abil­i­ty to stim­u­late a broad­er va­ri­ety of cells, en­dows it with unique clin­i­cal po­ten­tial to ad­dress se­ri­ous med­ical needs across hema­to­log­ic dis­eases and can­cer as well as in­fec­tious, neu­ro­log­i­cal and pul­monary dis­or­ders,” said De­ba­sish Roy­chowd­hury, CMO at PTx and for­mer Ser­agon CMO, in a state­ment.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Donald Trump, AP

Trump reach­es for his pen as long-await­ed ex­ec­u­tive or­der on drug man­u­fac­tur­ing on-shoring fi­nal­ly ar­rives — re­ports

President Trump will sign a long-rumored executive order later today that is designed to spur more made-in-the-USA therapies, according to a slate of new reports out Thursday morning.

Drug manufacturing circles have been buzzing about this EO for months now, wondering how Trump plans to require the on-shoring of certain therapies.

According to the Bloomberg report, White House trade adviser Peter Navarro told reporters that the administration will come up with a list of essential medicines Trump wants to have made inside the US. The order will direct government purchasers to buy these essential meds from US suppliers. The reports add that the order relaxes drug safety and environmental regulations to make it happen.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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