Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

Pfiz­er and Bio­haven bring rimegepant to Eu­rope as mi­graine war with Ab­b­Vie heats up

Ab­b­Vie’s been crank­ing up the heat on Bio­haven’s oral mi­graine med Nurtec with its ri­val Qulip­ta. Bio­haven’s so­lu­tion? Take the com­pe­ti­tion over­seas.

Nurtec — or rimegepant, as it’s known chem­i­cal­ly — is now the first drug ap­proved in the EU for both acute and pro­phy­lac­tic treat­ment of mi­graines, where it will be mar­ket­ed as Vy­du­ra. That’s good news for Pfiz­er, which inked a $1.2 bil­lion deal with Bio­haven back in No­vem­ber to take the lead on ex-US sales. And ac­cord­ing to the phar­ma gi­ant, a UK ap­proval should come any time now.

“To­day’s ap­proval marks a huge step for­ward for pa­tients in Eu­rope who are liv­ing with mi­graine,” Pe­ter Goads­by, di­rec­tor of the UK’s Na­tion­al In­sti­tute for Health and Care Re­search (NIHR) Clin­i­cal Re­search Fa­cil­i­ty, said in a news re­lease.

Rimegepant is part of a class of med­i­cines called cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) re­cep­tor an­tag­o­nists and works by block­ing the ac­tion of a nat­ur­al sub­stance in the body re­spon­si­ble for mi­graine headaches. Bio­haven, a Yale spin­out, snagged its first ap­proval as an acute treat­ment back in Feb­ru­ary 2020. Since then, Bio­haven has ex­pand­ed the dis­solv­ing pill’s la­bel to in­clude the pre­ven­tion of episod­ic mi­graines.

The in­dus­try has come a long way since the first drugs were ap­proved to pre­vent mi­graines. Gal­canezum­ab (or Em­gal­i­ty), for ex­am­ple, re­quires pa­tients to self-in­ject one dose per month. But in­jectable drugs may soon be nee­dled out by oral can­di­dates like ato­gepant (Qulip­ta) and rimegepant. Both Ab­b­Vie and Bio­haven tout their oral drugs as first of a kind.

Vy­du­ra’s specif­i­cal­ly ap­proved for the acute treat­ment of mi­graine with or with­out au­ra, and the pro­phy­lax­is of episod­ic mi­graine in adults who have at least four mi­graine at­tacks per month. The news comes just a cou­ple of months af­ter the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) gave the drug a nod back in Feb­ru­ary.

Ab­b­Vie — which picked up Qulip­ta in its $63 bil­lion Al­ler­gan buy­out — scored an ap­proval for mi­graine pre­ven­tion in the US back in Sep­tem­ber, months be­hind Nurtec. Even so, Goads­by said the move sig­naled a “broad­er shift in the treat­ment and man­age­ment par­a­digm for the mi­graine com­mu­ni­ty.”

More than 1 bil­lion peo­ple in the world are bogged down by mi­graine headaches, ac­cord­ing to Ab­b­Vie, in­clud­ing 39 mil­lion in the US alone.

But Bio­haven’s not go­ing down with­out a fight. The com­pa­ny re­port­ed $463 mil­lion in Nurtec sales for 2021, with $190 mil­lion of that in the fourth quar­ter alone. Dri­ving that growth was mas­sive sell­ing, gen­er­al and ad­min­is­tra­tive (SG&A) spend­ing, to­tal­ing $189 mil­lion in the fourth quar­ter, an in­crease of 66% over the same pe­ri­od last year.

Matthew Buten

“The in­crease was pri­mar­i­ly due to in­creased pro­mo­tion­al ac­tiv­i­ty sup­port­ing Nurtec ODT com­mer­cial sales in 2021,” Bio­haven CFO Matthew Buten said ear­li­er this year.

The com­pa­ny has tapped a suite of celebri­ty spokes­peo­ple to ap­pear in Nurtec ad cam­paigns, in­clud­ing ac­tress and TV host Whoopi Gold­berg, re­al­i­ty star Khloé Kar­dashi­an and the NASCAR Rick Ware rac­ing team.

Mean­while, Ab­b­Vie re­cruit­ed ten­nis star and mi­graine suf­fer­er Ser­e­na Williams to its “Any­time, Any­where” cam­paign for Ubrelvy, its CGRP re­cep­tor an­tag­o­nist for the treat­ment of acute mi­graine.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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