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.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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