Vlad Coric (Photo Credit: Andrew Venditti)

Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Sev­en years af­ter spin­ning out of Yale, Bio­haven has en­tered the ranks of com­mer­cial-stage biotechs.

The FDA hand­ed down an OK for its CGRP drug, rimegepant, as an acute treat­ment. Dubbed Nurtec, the oral­ly dis­solv­ing pill will join Al­ler­gan’s (soon to be Ab­b­Vie’s) Ubrelvy and Lil­ly’s Reyvow on the mar­ket amid a new wave of mi­graine ther­a­pies re­shap­ing the dis­ease space.

In a piv­otal Phase III tri­al, Nurtec hit the co-pri­ma­ry end­points on pain free­dom and free­dom from most both­er­some symp­toms at two hours post dose, prov­ing su­pe­ri­or to place­bo.

On top of the new en­trants, Nurtec will al­so be com­pet­ing with en­trenched gener­ic med­i­cines such as trip­tans — avail­able at low cost but with a tran­sient ef­fect. CEO Vlad Coric said the com­pa­ny would be able to com­pete, cit­ing con­cerns around trip­tans’ ef­fi­ca­cy and the large num­ber of Amer­i­cans – 40 mil­lion – with mi­graines.

”A large por­tion of that num­ber are not sat­is­fied with trip­tans, are not re­spond­ing to trip­tans or can’t take trip­tans,” Coric told End­points News. “So very im­por­tant drug for pa­tients first and a very im­por­tant drug for the com­pa­ny giv­en the large mar­ket size.”

He al­so said pa­tients will pre­fer Nurtec pills to in­jec­tions, the de­liv­ery route for most of the new mi­graine drugs,  al­though that still leaves Lil­ly’s Reyvow as an oral com­peti­tor.

Bio­haven has yet to an­nounce the list price. Ubrelvy, a CGRP drug that’s tak­en once or twice a day, has a stick­er price of $4,896 per year — a price that drug-pric­ing watch­dog ICER has now con­clud­ed is cost-ef­fec­tive. Mean­while Reyvow, which binds to 5-HT1F re­cep­tors, is $640 for an eight-pill pack.

“The mar­ket­ing strat­e­gy for the prod­uct fo­cus­es on three lev­els of dif­fer­en­ti­a­tion: (a) fast on­set at ~60 min, (b) durable ef­fect of up to 48 hours post dose, and (c) eas­i­ly ad­min­is­tered ODT for­mu­la­tion,” SVB Leerink an­a­lyst Marc Good­man not­ed, based on dis­cus­sion with ex­ecs.

He added that the com­pa­ny has a full sales force ready, at a num­ber “sig­nif­i­cant­ly above 200 reps but not 1,000 reps.”

The roll­out ex­e­cu­tion would be cru­cial for Nurtec to reach the $1.03 bil­lion in sales that an­a­lysts at Cortel­lis have en­vi­sioned.

The drug is al­so be­ing test­ed for the pre­ven­tion of mi­graines with topline da­ta ex­pect­ed lat­er this quar­ter, al­though Bio­haven will face even tougher com­pe­ti­tion there with four of­fer­ings al­ready in place. Then there’s vazegepant, its in­tranasal take on CGRP, which al­so scored promis­ing Phase II/III re­sults.

With ad­di­tion­al re­port­ing by Ja­son Mast

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

(L-R) Dr. Robert Redfield, director of the Centers for Disease Control and Prevention; Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases; Adm. Brett P. Giroir, Assistant Secretary for Health; and Dr. Stephen M. Hahn, commissioner of the Food and Drugs Administration prepare to testify at a hearing of the House Committee on Energy and Commerce on Capitol Hill on June 23, 2020 in Washington, DC. The committee is investigating the Trump administration's response to the COVID-19 pandemic. (Photo by Kevin Dietsch-Pool/Getty Images)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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