Thomas Lingelbach, Valneva CEO

Pfiz­er nabs $95M stake in Val­ne­va as Ly­me dis­ease vac­cine ap­proach­es piv­otal study

Pfiz­er is in­vest­ing some mon­ey in its Ly­me dis­ease part­ner biotech as the pair gears up for a Phase III study.

The Big Phar­ma chipped in $95 mil­lion in eq­ui­ty for Val­ne­va, good enough for an 8.1% stake in the French vac­cine mak­er. Mon­day’s deal comes af­ter the two com­pa­nies ini­tial­ly agreed to de­vel­op the can­di­date in April 2020 and a few months af­ter the pro­gram read out Phase II pe­di­atric re­sults.

Kathrin Jansen

“As the ge­o­graph­ic foot­print of Ly­me dis­ease widens, the med­ical need for vac­ci­na­tion be­comes even more im­per­a­tive,” Pfiz­er’s head of vac­cines R&D Kathrin Jansen said in a state­ment. “We are ex­cit­ed to con­tin­ue part­ner­ing with Val­ne­va on the de­vel­op­ment of VLA15 and look for­ward to work­ing to­geth­er to progress the pro­gram.”

The eq­ui­ty deal val­ued Val­ne­va’s stock price at $10.02 per share. In­vestors re­act­ed warm­ly to the news, with Val­ne­va shares $VALN jump­ing 83% while the mar­ket was closed for the June­teenth hol­i­day, af­ter drop­ping 13% in the fi­nal min­utes of last Fri­day’s trad­ing ses­sion.

On top of the eq­ui­ty fi­nanc­ing, Pfiz­er and Val­ne­va are al­so slight­ly amend­ing their orig­i­nal Ly­me dis­ease vac­cine deal. Val­ne­va will now take on 40% of the re­main­ing shared de­vel­op­ment costs in­stead of 30%, and Pfiz­er will pay roy­al­ties rang­ing from 14% to 22% in­stead of start­ing at 19%. Pfiz­er will add an­oth­er $100 mil­lion in po­ten­tial sales mile­stones as well.

Val­ne­va had made most of its head­lines in the last cou­ple years for its work in Covid-19 vac­cines, promis­ing to de­vel­op an al­ter­na­tive shot to the wide­ly used Pfiz­er, Mod­er­na and As­traZeneca jabs. Though Val­ne­va’s shot even­tu­al­ly got across the fin­ish line in the UK, the vac­cine like­ly will not be avail­able in Eu­rope much longer af­ter the EU de­cid­ed to ter­mi­nate its pur­chase agree­ment last month.

And last week, the com­pa­ny said chances of re­viv­ing the con­tract are slim, send­ing its shares plung­ing.

But the Ly­me dis­ease pro­gram has rolled right along, pass­ing a Phase II test for adults last Sep­tem­ber and achiev­ing its goals in an­oth­er Phase II study in April. Funds from Mon­day’s eq­ui­ty fi­nanc­ing are ex­pect­ed to go to­ward the piv­otal Phase III tri­al, which will like­ly launch in the third quar­ter, the com­pa­nies said.

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.

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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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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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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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.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.