Bob Kramer, Emergent BioSolutions CEO

Emer­gent award­ed $379M+ to sup­ply the DOD with a skin de­con­t­a­m­i­na­tion lo­tion

Mary­land-based man­u­fac­tur­er Emer­gent BioSo­lu­tions is kick­ing off the new year with a mul­ti­mil­lion-dol­lar con­tract to sup­ply a lo­tion used in case of chem­i­cal at­tacks.

Emer­gent said on Thurs­day that it has inked an “in­def­i­nite-de­liv­ery” and “in­def­i­nite-quan­ti­ty” pro­cure­ment con­tract to sup­ply RS­DL kits, or re­ac­tive skin de­con­t­a­m­i­na­tion lo­tion, for use by all branch­es of the US mil­i­tary. The con­tract’s val­ue is worth up to $379.6 mil­lion, and Emer­gent’s Cana­di­an sub­sidiary will serve as the sub­con­trac­tor to sup­ply the lo­tion kits to the DOD. Emer­gent’s stock $EBS was up around 9% on Fri­day af­ter­noon.

The con­tract be­gan in De­cem­ber 2022 and has four, sin­gle-year op­tion re­newals. The RS­DL kits them­selves will be used to re­move or neu­tral­ize chem­i­cal war­fare agents from the skin. This can in­clude sarin or mus­tard gas and T-2 tox­in, among oth­er chem­i­cals.

Ac­cord­ing to an Emer­gent spokesper­son in an email to End­points News, the con­tract is es­ti­mat­ed to man­u­fac­ture over 13,000 cas­es of RS­DL ac­tive kits and over 1,300 cas­es of train­ing kits.

“This con­tract is an­oth­er ex­am­ple of our long­stand­ing part­ner­ship with the US gov­ern­ment and our unique ca­pa­bil­i­ty to help de­vel­op and de­liv­er med­ical coun­ter­mea­sures for a va­ri­ety of threats, in­clud­ing bi­o­log­i­cal and chem­i­cal at­tacks, for the US and al­lied gov­ern­ments. Spe­cif­ic to RS­DL, it builds up­on our 10-year re­la­tion­ship with DoD to help pro­tect Amer­i­can ser­vice mem­bers,” said Paul Williams, se­nior vice pres­i­dent, gov­ern­ment med­ical coun­ter­mea­sures at Emer­gent, in an emailed state­ment to End­points.

Emer­gent has been con­tract­ed by the US gov­ern­ment since the 1990s to man­u­fac­ture drugs and prod­ucts for the de­fense space.

Last year, the man­u­fac­tur­er nabbed the glob­al rights for Tem­bexa from the North Car­oli­na-based biotech Chimerix, along with its 10-year BAR­DA con­tract to pro­duce 1.7 mil­lion dos­es of the drug. The con­tract was val­ued at $680 mil­lion, as well as a “prod­uct pro­cure­ment” val­ued at $115 mil­lion. Ad­di­tion­al op­tions were val­ued at $551 mil­lion, which can be com­mit­ted at BAR­DA’s dis­cre­tion.

Emer­gent al­so an­nounced in No­vem­ber that it was hand­ed a $10 mil­lion re­search award from the DOD’s Con­gres­sion­al Di­rect­ed Med­ical Re­search Pro­grams to eval­u­ate the ef­fi­ca­cy of its sin­gle-dose chikun­gun­ya virus vac­cine can­di­date.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.