Franz-Werner Haas, CureVac CEO (Thomas Kienzle/AFP via Getty Images)

Ger­many deal with Cure­Vac and GSK primed for 80M mR­NA vac­cines a year

If there’s an­oth­er pan­dem­ic, the Ger­man gov­ern­ment is de­ter­mined not to be caught off-guard when it comes to man­u­fac­tur­ing vac­cines.

Cure­Vac and GSK have signed a deal to sup­ply Ger­many with mR­NA vac­cines for pan­dem­ic pre­pared­ness go­ing for­ward. Af­ter a set­up pe­ri­od that will last no longer than two years, the con­tract gives Ger­many’s gov­ern­ment ac­cess to the Cure­Vac man­u­fac­tur­ing ca­pac­i­ty un­til 2029.

That en­ables the fed­er­al gov­ern­ment to have the rapid de­liv­ery of 80 mil­lion vac­cine dos­es for the re­main­der of the Covid-19 pan­dem­ic, or for any fu­ture in­fec­tious dis­ease out­breaks. The move is in an­tic­i­pa­tion of fu­ture sup­ply chain bot­tle­necks, sim­i­lar to what hap­pened at the start of the cur­rent pan­dem­ic.

Cure­Vac and GSK will get an an­nu­al stand­by fee from the gov­ern­ment, just to en­sure that man­u­fac­tur­ing ca­pac­i­ty is at a con­stant readi­ness. The deal is for the ex­act same amount of dos­es as a pre­vi­ous­ly an­nounced deal with BioN­Tech.

“Over the last two years, our so­cial and eco­nom­ic lives as well as glob­al health­care sys­tems and med­ical sup­ply in­fra­struc­tures were se­vere­ly chal­lenged by the COVID-19 pan­dem­ic,” Cure­Vac CEO Franz-Wern­er Haas said in a state­ment. “This un­der­scored the im­por­tance of hav­ing ac­cess to in­no­v­a­tive tech­nol­o­gy plat­forms, such as mR­NA tech­nol­o­gy, as well as cor­re­spond­ing ro­bust man­u­fac­tur­ing ca­pac­i­ties to rapid­ly de­vel­op and de­liv­er life-sav­ing vac­cines – par­tic­u­lar­ly as a pro­tec­tive mea­sure in case of fu­ture in­fec­tious dis­ease emer­gen­cies.

“Con­sid­er­ing the un­pre­dictable and vari­ant-dri­ven course of the COVID-19 pan­dem­ic, we are ful­ly com­mit­ted to safe­guard­ing pub­lic health to­day and in­to the fu­ture.”

The an­nounce­ment comes just days af­ter BioN­Tech inked a deal with the Ger­man gov­ern­ment to man­u­fac­ture and sup­ply mR­NA vac­cines for emer­gency sit­u­a­tions in pan­dem­ic pre­pared­ness. In that deal, which will be­gin as a five-year con­tract, BioN­Tech will re­serve and main­tain man­u­fac­tur­ing ca­pa­bil­i­ties for 80 mil­lion mR­NA vac­cine dos­es a year.

The two deals are a part of the March au­tho­riza­tion of more than $3 bil­lion to make sure com­pa­nies had enough pro­duc­tion ca­pac­i­ty to sup­ply the coun­try with enough dos­es for fu­ture out­breaks.

The deal was an­nounced rough­ly at the same time that BioN­Tech an­nounced re­search sur­round­ing the oral de­liv­ery of mR­NA vac­cines, as the com­pa­ny bought ex­clu­sive ac­cess to New Jer­sey-based Mati­nas Bio­Phar­ma’s lipid nanocrys­tal drug de­liv­ery plat­form.

Co­in­ci­den­tal­ly, both BioN­Tech and Cure­Vac have de­vel­oped portable man­u­fac­tur­ing op­tions, aimed at ramp­ing up vac­cine pro­duc­tion in times and places that call for it. Cure­Vac an­nounced in March that it has es­tab­lished a sep­a­rate com­pa­ny for its RNA print­er, a portable mi­cro­fac­to­ry for man­u­fac­tur­ing that can be scaled up or down when need­ed. That project is still in the pro­to­type stages, but last month, gen­er­al man­ag­er Markus Bergmann said that the end of the project was in sight.

Mean­while, BioN­Tech re­vealed its “BioN­Tain­er” a month ear­li­er. The fa­cil­i­ties are made of stacked ship­ping con­tain­ers, and are meant to be used as the first mod­u­lar mR­NA man­u­fac­tur­ing sites. The site al­lows for bulk mR­NA man­u­fac­tur­ing and for­mu­la­tion, while fill-and-fin­ish op­er­a­tions will be hand­ed over to com­pa­nies else­where.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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