Adamas wins its first FDA OK, set­ting up mar­ket launch for a re­for­mu­lat­ed Parkin­son’s drug

More than a year af­ter Adamas $ADMS post­ed pos­i­tive re­sults from a piv­otal Phase III study of ADS-5102 — an ex­tend­ed-re­lease ver­sion of the gener­ic Parkin­son’s treat­ment aman­ta­dine — the com­pa­ny got a green light from the FDA to sell the ther­a­py.

The drug will be sold as Go­cov­ri.

Gre­go­ry Went, CEO

Prob­a­bly not un­ex­pect­ed­ly, the drug was able to beat out a place­bo in sig­nif­i­cant­ly re­duc­ing the side ef­fects of Parkin­son’s. And the Emeryville, CA-based biotech boasts that this is the first and on­ly drug ap­proved for “dysk­i­ne­sia in pa­tients with Parkin­son’s dis­ease re­ceiv­ing lev­odopa-based ther­a­py” — an or­phan in­di­ca­tion. The ther­a­py is de­signed to help pa­tients who suf­fer from the sharp, in­vol­un­tary move­ment dis­or­der brought on by lev­odopa, com­mon­ly used to con­trol the dis­ease.

In­vestors em­braced the news, send­ing shares rock­et­ing up 57%.

The gener­ic drug, though, is al­ready used off la­bel for dysk­i­ne­sia, which may well in­ter­fere with the com­pa­ny’s sales ex­pec­ta­tions. Walid Gel­lad, an as­so­ciate pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, high­light­ed the off la­bel use in a Tweet.

The ap­proval marks a ma­jor shift for Adamas, which has been lin­ing up job of­fers for 59 sales ex­ecs they be­lieve can reach the vast ma­jor­i­ty of the physi­cians and spe­cial­ists who han­dle the bulk of the cas­es. And the team there has been lay­ing the ground­work with pay­ers to help roll out the drug.

What Adamas doesn’t have right now is a price. “We an­tic­i­pate a list price for Go­cov­ri around the range of the pre­vi­ous dis­clo­sure: $10K – $30K,” the com­pa­ny told me in an email. The fi­nal price, they say, will be heav­i­ly in­flu­enced by pa­tient ac­cess. In the US, whole­sale prices are typ­i­cal­ly heav­i­ly dis­count­ed for ma­jor pay­ers.

The gener­ic drug is sold by on­line phar­ma­cies, of­ten for the flu or Parkin­son’s, for a lit­tle more than $2 per 100 mg cap­sule.

Adamas ran two Phase III stud­ies for the drug, demon­strat­ing that it trig­gered a 37% re­duc­tion in Uni­fied Dysk­i­ne­sia Rat­ing Scale (UDysRS) to­tal score vs. 12 per­cent for place­bo at week 12. The re­sults were con­firmed in the sec­ond study, with Go­cov­ri achiev­ing a 46% re­duc­tion in UDysRS vs. 16% for place­bo.

The drug launch starts in Jan­u­ary, ac­cord­ing to Adamas, which can now wrap up its pre-launch ef­forts.

“To­day’s ap­proval is a tremen­dous mile­stone for Adamas and for the Parkin­son’s dis­ease com­mu­ni­ty,” said Adamas CEO Gre­go­ry T. Went. “Go­cov­ri has the po­ten­tial to help peo­ple with Parkin­son’s dis­ease suf­fer­ing from dysk­i­ne­sia by fi­nal­ly pro­vid­ing physi­cians with an ef­fec­tive tool to ad­dress this long-stand­ing un­met med­ical need.”

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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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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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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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.