Emer­gent lands an­oth­er big mon­ey con­tract from BAR­DA for an­thrax

Af­ter neg­a­tive feed­back from the FDA, the loss of busi­ness with As­traZeneca and the dis­rup­tion to the Covid-19 sup­ply chain, the US gov­ern­ment has not lost faith in Emer­gent BioSo­lu­tions.

Emer­gent has land­ed a con­tract worth near­ly $400 mil­lion from BAR­DA to man­u­fac­ture its an­thrax vac­cine for the na­tion­al stock­pile for the next 18 months.

The news was re­vealed as a part of the com­pa­ny’s Form 8-K fil­ing with the SEC.

AV7909 is a com­bi­na­tion of Bio­Thrax and CPG 7909, a syn­thet­ic short DNA se­quence that has been proven to be an ef­fec­tive vac­cine ad­ju­vant that in­creas­es the speed of im­mune re­sponse. Emer­gent bought the li­cense for the vac­cine in 1998 from the state of Michi­gan, and over time, in­creased the price per dose six­fold.

“Our com­mit­ment to help­ing pro­vide so­lu­tions to pub­lic health threats, both nat­u­ral­ly oc­cur­ring and man­made, has nev­er been stronger,” the com­pa­ny said in a state­ment emailed to End­points News Fri­day. “We con­tin­ue to sup­port the gov­ern­ment’s strate­gies to pro­tect Amer­i­cans from un­think­able dis­eases and re­main fo­cused on ful­fill­ing our role in the re­sponse to the Covid-19 pan­dem­ic.”

The com­pa­ny has long played a role in the na­tion­al vac­cine stock­pile. It’s been the gov­ern­ment’s sole provider of an­thrax vac­cines, and over the last 10 years, ac­quired biode­fense com­peti­tors, small­pox treat­ments and oth­er drugs with seem­ing­ly the sole pur­pose of gear­ing up to pro­vide for gov­ern­ment con­tracts.

In 2020, the US gov­ern­ment paid Emer­gent $626 mil­lion for dos­es of an an­thrax vac­cine and small­pox vac­cine, among oth­er prod­ucts, help­ing de­prive the gov­ern­ment of mon­ey to buy the sup­plies the US need­ed for the pan­dem­ic. A New York Times in­ves­ti­ga­tion re­vealed that the gov­ern­ment in­creased the or­der of Bio­Thrax by $100 mil­lion when the com­pa­ny said it need­ed more sales to stay in busi­ness in 2016.

The com­pa­ny’s re­la­tion­ship with the US gov­ern­ment helped land it a $628 mil­lion con­tract to man­u­fac­ture Covid-19 vac­cines with no com­pet­i­tive bid­ding. Emer­gent has been un­der a BAR­DA con­tract since 2012 and was giv­en about $542.7 mil­lion for pro­duc­tion of Covid-19 vac­cine can­di­dates through 2021, and $85.5 mil­lion to ex­pand its vi­ral and non-vi­ral drug prod­uct fill/fin­ish ca­pac­i­ty in Bal­ti­more Cam­den and Rockville.

That deal came un­der im­mense scruti­ny when qual­i­ty con­trol of­fi­cials for J&J dis­cov­ered that drug sub­stance from As­traZeneca’s vac­cine had con­t­a­m­i­nat­ed J&J batch­es, lead­ing the com­pa­ny’s Bal­ti­more plant to cease op­er­a­tions while it was in­ves­ti­gat­ed and quar­an­tine mil­lions of dos­es, many of which had to be thrown out.

Ear­li­er this week, the FDA cleared an­oth­er batch of the J&J jab to be dis­trib­uted for use. That marks the 12th quar­an­tined batch giv­en the OK, though Emer­gent has since lost its busi­ness with As­traZeneca.

The deal comes just days af­ter the PRE­PARE Act of 2021 was in­tro­duced in the US House, which would cre­ate a na­tion­al stock­pile of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents in an at­tempt at pre­vent­ing sup­ply chain short­ages.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.