Emer­gent inks $225M cash small­pox deal as Chimerix im­plodes on re­org, FDA trou­ble

Emer­gent BioSo­lu­tions has made a name for it­self ever since the late 1990s by mak­ing drugs that are need­ed by the US gov­ern­ment. Mon­day, it took that a step fur­ther, as it en­tered a deal with Chimerix to ac­quire the ex­clu­sive rights to Tem­bexa, a small­pox treat­ment for all ages that was ap­proved in 2021, with a $225 mil­lion cash pay­ment.

The pick­up comes just as Chimerix re­leased its Q1 earn­ings re­port, in which CEO Mike Sher­man said that the com­pa­ny is drop­ping in­vest­ment in an­oth­er pro­gram while cir­cling its wag­ons around the lead drug af­ter hopes for an ac­cel­er­at­ed ap­proval were dam­aged by reg­u­la­tors. And that will set up a piv­otal tri­al in ad­vance of any ex­pect­ed ap­proval — news that sent in­vestors run­ning for the hills as its stock $CM­RX plunged 60%.

Emer­gent’s SVP of gov­ern­ment busi­ness Paul Williams said that the deal for the small mol­e­cule drug ex­pands its work in the gov­ern­ment’s small­pox pre­pared­ness strat­e­gy. The deal will come to­geth­er with an an­tic­i­pat­ed BAR­DA con­tract in the next three to six months fol­low­ing the clos­ing of this deal. The clos­ing of the deal is con­tin­gent on se­cur­ing that con­tract. Emer­gent will pay Chimerix a $225 mil­lion one-time up­front pay­ment up­on clos­ing, and a to­tal of $100 mil­lion in mile­stone pay­ments. The terms al­so in­clude sales-based roy­al­ty pay­ments.

Tem­bexa, which is an oral an­tivi­ral for­mu­lat­ed as 100 mg tablets, is in­di­cat­ed to treat small­pox in adults, chil­dren and new­borns. When the FDA an­nounced the ap­proval, it not­ed that though the virus that caus­es small­pox was erad­i­cat­ed in 1980, it is be­lieved that it could be used as a bioweapon in the fu­ture.

“The ad­di­tion of Tem­bexa to Emer­gent’s port­fo­lio of med­ical coun­ter­mea­sures builds up­on our core ca­pa­bil­i­ties and lever­ages our long and suc­cess­ful his­to­ry part­ner­ing with the US gov­ern­ment to ad­dress dan­ger­ous pub­lic health threats,” CEO Bob Kramer said. “It ex­em­pli­fies our thought­ful M&A strat­e­gy as part of our 2024 growth plan and po­si­tions us bet­ter to de­liv­er val­ue for our share­hold­ers.”

The ef­fec­tive­ness of Tem­bexa had to be stud­ied in an­i­mals with virus­es that are close­ly re­lat­ed to the var­i­ous virus, be­cause the var­i­ous virus no longer ex­ists.

The pick­up is a win for Emer­gent, right when the com­pa­ny was in need of some­thing pos­i­tive. At the end of April, the long­time CEO and co-founder of the CD­MO died of can­cer, less than a month af­ter re­tir­ing from his role as chair­man of the board of di­rec­tors.

Then, a re­port from the US House se­lect sub­com­mit­tee on the coro­n­avirus cri­sis re­port­ed that the num­ber of Covid-19 vac­cine dos­es tossed due to cross con­t­a­m­i­na­tion prob­lems at its Bal­ti­more plant was more like 400 mil­lion, as op­posed to the much small­er amount orig­i­nal­ly re­port­ed. The re­port al­so al­leged that Emer­gent ex­ec­u­tives tried to sweep the prob­lems un­der the rug, and ig­nored re­ports from qual­i­ty con­trol di­rec­tors say­ing that the site wasn’t fit for the task it was about to take on. Emer­gent has adamant­ly de­nied the re­port’s find­ings.

“To equate these qual­i­ty con­trol ac­tions with a ‘dis­card­ed dose’ fig­ure dis­plays a lack of un­der­stand­ing re­gard­ing the bio­man­u­fac­tur­ing process,” a state­ment said.

Emer­gent has made gov­ern­ment con­tracts its bread and but­ter ever since it land­ed a deal with the US for its an­thrax vac­cine around the time of the Sept. 11, 2001 at­tacks. That was its on­ly drug then, and short­ly af­ter, it re­vamped its man­u­fac­tur­ing sites and ramped up its im­mu­niza­tion pro­gram. Emer­gent land­ed a big $400 mil­lion con­tract with BAR­DA for its an­thrax vac­cine again in Oc­to­ber 2021. It was award­ed a $628 mil­lion con­tract from Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion to man­u­fac­ture Covid-19 vac­cines with no com­pet­i­tive bid­ding back in 2020, which even­tu­al­ly led to the Bal­ti­more mishap.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

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We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Can­cer as­so­ci­a­tion says na­tion­al bud­get deal threat­ens re­search fund­ing

As the US House of Representatives is expected to vote this evening on a deal that would raise the nation’s debt ceiling, some biopharma industry advocates worry about how proposed budget restrictions could affect drug research.

The proposed budget deal includes relatively flat funding for non-defense spending over the next fiscal year, and a 1% increase in fiscal year 2025, which the Association for Clinical Oncology said on Wednesday would “considerably restrict potential resources for the National Institutes of Health (NIH) and National Cancer Institute (NCI) at a time when scientists are on the cusp of so many promising cancer discoveries.”

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Ky­owa Kirin re­news sup­port for foun­da­tion that ful­fills wish­es for ter­mi­nal­ly ill adults

Although not as well-known as the pediatric-focused Make-A-Wish organization, the Dream Foundation has been making wishes come true for adults diagnosed with a terminal illness for decades. Kyowa Kirin began supporting the group six years ago, and now is doubling down on its commitment and extending its pledge through next year.

The financial support of Kyowa Kirin and on-the-ground work by its employees have directly led to 100 final dreams for people across the US and Puerto Rico. The Dream Foundation overall grants 2,500 requests each year to people who have a prognosis of 12 months or less to live. The wishes fulfilled range from family trips to places such as Disneyland or beach destinations to professional sports games to meet a sports hero.

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