Emer­gent gets a chance to re­deem it­self in mR­NA vac­cine deal with Prov­i­dence Ther­a­peu­tics

One of the most no­to­ri­ous names in Amer­i­can drug man­u­fac­tur­ing has land­ed a con­tract with a Cana­di­an drug­mak­er look­ing to make waves in the mR­NA Covid-19 vac­cine game and fill in the gaps the two big mR­NA com­pa­nies have strug­gled to fill.

In a five-year deal worth about $90 mil­lion, Emer­gent BioSo­lu­tions agreed to pro­vide CD­MO ser­vices to Prov­i­dence Ther­a­peu­tics, in­clud­ing drug de­vel­op­ment, bulk drug sub­stance for­mu­la­tion and fi­nal prod­uct man­u­fac­tur­ing to help the drug’s de­vel­op­ment. Pro­duc­tion is set to com­mence in 2022, if all goes ac­cord­ing to plan.

“The Cana­di­an gov­ern­ment has been per­pet­u­at­ing this false­hood that Cana­da can’t make these vac­cines,” Prov­i­dence CEO Brad Soren­son said in a phone call with End­points News on Wednes­day. “We can. We’ve made our vac­cines in Cana­da, we’re go­ing to make our vac­cines with ex­ist­ing in­fra­struc­ture in Cana­da with Emer­gent, you know, and we didn’t need hun­dreds of mil­lions of dol­lars of tax­pay­er dol­lars to do that.”

Prov­i­dence’s Covid-19 vac­cine can­di­date — dubbed PTX-COVID19-B — is cur­rent­ly in Phase II tri­als.

The deal is the lat­est in a flur­ry of moves from Prov­i­dence. The com­pa­ny just an­nounced that Ever­est will re­ceive rights to Prov­i­dence’s Covid-19 vac­cine in Asian mar­kets such as Chi­na, Tai­wan, Sin­ga­pore, Thai­land and In­done­sia in ex­change for $100 mil­lion up­front in cash, com­bined with an ad­di­tion­al up to $400 mil­lion in prof­it-shar­ing on the Covid-19 vac­cines and mile­stone pay­ments on col­lab­o­ra­tive and ad­di­tion­al prod­ucts.

The Prov­i­dence deal serves as a bit of a po­ten­tial re­demp­tion for Emer­gent. The com­pa­ny land­ed a con­tract with US Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion to man­u­fac­ture drug sub­stance for Covid-19 vac­cines for both J&J and As­traZeneca, but short­ly af­ter, the con­t­a­m­i­na­tion of batch­es — dis­cov­ered at a J&J site by a qual­i­ty con­trol work­er — led to the pro­duc­tion of all batch­es be­ing halt­ed, and an in­ves­ti­ga­tion by the FDA. A Form 483 brought to light un­san­i­tary con­di­tions that in­clud­ed mold on the walls, and lack­lus­ter pro­ce­dures, which in­clud­ed em­ploy­ees drag­ging bags of tox­ic waste through the fa­cil­i­ty.

Prov­i­dence’s con­ver­sa­tions with Emer­gent be­gan long be­fore the in­ci­dent in Bal­ti­more shed light on the com­pa­ny’s short­com­ings.

“Our di­a­logue con­tin­ued through­out that process,” Soren­son said. “It is two dif­fer­ent sites …We’ve had thor­ough dis­cus­sions with Ever­est in the Win­nipeg site, we’ve had mul­ti­ple trips back and forth with the var­i­ous teams, and we’re com­fort­able that they’re go­ing to be able to take the process that we’ve got and we’ve got the prop­er pro­to­cols in place to build and man­u­fac­ture.”

Emer­gent was per­mit­ted to re­sume pro­duc­tion in late Ju­ly, the com­pa­ny con­firmed to End­points in an email, but on­ly got the chance to make J&J drug sub­stance as As­traZeneca pulled out of its con­tract and sent its ser­vices to near­by CD­MO Catal­ent.

Be­fore those screw-ups, Emer­gent tout­ed its abil­i­ty to man­u­fac­ture more than 1 bil­lion dos­es a year, and CEO Bob Kramer went on CN­BC’s “Mad Mon­ey” in March to say just that fol­low­ing a $480 mil­lion, two-year deal with the US gov­ern­ment.

Mean­while, the team at Prov­i­dence has been frus­trat­ed at the lack of help it’s got­ten from the Cana­di­an gov­ern­ment.

A week ago, Bob Nelsen’s lat­est project Re­silience an­nounced that it will start mak­ing mR­NA for Mod­er­na’s Covid-19 vac­cine at its new site in Cana­da, with the help of a $163 mil­lion con­tract from the gov­ern­ment, while Mod­er­na al­so struck a deal for its own plant in Au­gust, and Ab­Cellera got $125.6 mil­lion to help build its 130,000-square-foot fa­cil­i­ty to de­vel­op an­ti­bod­ies.

That’s been frus­trat­ing for Soren­son to watch as his com­pa­ny seem­ing­ly was left in the dust. In an in­ter­view with Bloomberg, he said that last year, his com­pa­ny was op­er­at­ing at a sim­i­lar pace as Mod­er­na. Now, they’re play­ing catchup.

“In March of 2020, we were one month be­hind Mod­er­na,” he said. “Mod­er­na re­ceived a bil­lion dol­lars in sup­port from Warp Speed and you can see where they’re at now. Prov­i­dence re­ceived no sup­port from the Cana­di­an gov­ern­ment un­til al­most a year lat­er and even then, we re­ceived $10 mil­lion, which is nom­i­nal at best,” he said.

“We could’ve been sup­ply­ing vac­cines to the world and we could’ve been adding to the so­lu­tion as op­posed to dri­ving up prices and adding to the prob­lem.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

The House of Representatives this week passed two bills to strengthen America’s national stockpile of medical supplies and to allow the FDA to designate colleges and universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

The stockpile bill, known as HR 3635, passed by a vote of 397-22. Introduced by Rep. Elissa Slotkin (D-MI) and 15 other cosponsors, the bill would improve America’s ability to respond to future pandemics, as well as handle the ongoing Covid-19 pandemic too.

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Martine Rothblatt (AP Photo/Jack Plunkett)

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

United Therapeutics said Monday that it received a complete response letter for its potential pulmonary arterial hypertension drug Tyvaso DPI, due to an issue with a third-party facility that performs drug substance testing. The company said it expects an approval will come by next summer.

The inspection issue appears to be the only problem the FDA took notice of, according to United. There were no issues with packaging, manufacturing or testing Tyvaso DPI at the MannKind Corporation facility, the company said.

Re­call re­port: Glass found in Mer­ck an­tibi­ot­ic threat­ens 22,000 vials

A Merck antibiotic has been recalled after reports of the presence of glass particulate matter, the company announced Tuesday.

One lot of Cubicin will be recalled, which includes about 22,000 vials of the 500mg dose of the intravenously administered drug.

The recall comes after a piece of glass was found in a vial, raising safety concerns.

“Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines,” said Richard Haupt, the VP of vaccines & infectious diseases. “We sincerely regret any inconvenience caused by this recall.”