BioN­Tech part­ners with Bill and Melin­da Gates Foun­da­tion, scor­ing $55M eq­ui­ty in­vest­ment; BeiGene brush­es off short at­tack

→ Less than two months af­ter Ger­man biotech BioN­Tech raised a her­culean $325 mil­lion in an up­sized round of fi­nanc­ing — the Bill and Melin­da Gates Foun­da­tion have signed a pact with the com­pa­ny, mak­ing an ini­tial eq­ui­ty in­vest­ment of $55 mil­lion to de­vel­op vac­cine and im­munother­a­py can­di­dates to pre­vent HIV and tu­ber­cu­lo­sis. To­tal fund­ing un­der the deal could hit $100 mil­lion, via po­ten­tial grant fund­ing from the foun­da­tion, BioN­Tech said on Wednes­day.

→ BeiGene, a pi­o­neer and dar­ling of the grow­ing US-Chi­na biotech crowd, was the sub­ject of a fe­ro­cious short re­port pub­lished by J Cap­i­tal on Thurs­day. Shares fell rough­ly 9% on both the Nas­daq $BGNE and the Hong Kong stock ex­change (06160) on al­le­ga­tions that the com­pa­ny faked sales of the Cel­gene drugs it’s in charge of mar­ket­ing in Chi­na, in­vest­ed in bo­gus man­u­fac­tur­ing sites, and over­spent on wages for R&D staff. Tim Mur­ray, au­thor of the re­port, fur­ther ac­cused ex­ecs of “pump­ing and dump­ing,” talk­ing up BeiGene’s stand­ing with Chi­nese drug reg­u­la­tors and po­ten­tial for its drugs while covert­ly sell­ing off their own stock.

In a state­ment to the HKEX, BeiGene called the al­le­ga­tions “in­ac­cu­rate, un­found­ed and mis­lead­ing” as well as “bla­tant­ly false.”

“From its in­cep­tion, BeiGene has op­er­at­ed with an un­wa­ver­ing com­mit­ment to com­pli­ance, ethics, and in­tegri­ty,” it wrote. “BeiGene re­mains fo­cused on its mis­sion to build a bio­phar­ma­ceu­ti­cal com­pa­ny that will pro­vide the high­est qual­i­ty ther­a­pies to the great­est num­ber of pa­tients around the world.”

No­var­tis $NVS is palm­ing off a Chi­na-based unit for $790 mil­lion yuan (about $110.5 mil­lion), ac­cord­ing to a Wednes­day re­port by Dow Jones. The plant, which was opened a decade ago, was sold to Chi­na’s Zhe­jiang Ji­uzhou, ex­clud­ing the Swiss drug­mak­er’s tech­nol­o­gy and drug-de­vel­op­ment as­sets. The ac­qui­si­tion will help Zhe­jiang Ji­uzhou ce­ment its po­si­tion as a strate­gic sup­pli­er to No­var­tis, not­ed the re­port.

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.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.