Af­ter ramp­ing up its vac­cine pro­duc­tion in South Africa, As­pen yet to re­ceive a sin­gle or­der

Stephen Saad

When As­pen Phar­ma­care made an agree­ment with J&J to make and sell its own gener­ic Covid-19 vac­cine much of the world re­joiced. As­pen CEO Stephen Saad said that it would help catch Africa up to speed with the rest of the world, and Pres­i­dent Joe Biden’s ad­min­is­tra­tion agreed and pledged $200 mil­lion to the plant in Gqe­ber­ha to ex­pand pro­duc­tion.

But now, de­spite be­ing the first fac­to­ry in Africa to make vac­cines for the con­ti­nent, the phar­ma has not re­ceived a sin­gle or­der, which could lead to the shut­ter­ing of the site, ac­cord­ing to a re­cent re­port from The New York Times.

A back­log in avail­able vac­cines has led to the slow dis­tri­b­u­tion in Africa. And health agen­cies now have no need for new dos­es un­til the old ones are ap­pro­pri­ate­ly ad­min­is­tered or ex­pired.

This may come as a sur­prise. Less than 20% of Africa is ful­ly vac­ci­nat­ed. That num­ber was ex­pect­ed to shrink when man­u­fac­tur­ing sites such as As­pen’s were up-and-run­ning. Saad said that his com­pa­ny would ramp up its Covid-19 vac­cine ca­pac­i­ty to 1.3 bil­lion dos­es a year by ear­ly 2024 and that the ex­pan­sion could gen­er­ate more than $542 mil­lion a year in ad­di­tion­al rev­enue.

Stavros Nico­laou

Mean­while, As­pen’s head of strate­gic trade de­vel­op­ment Stavros Nico­laou told the Times that As­pen will piv­ot to anes­thet­ic man­u­fac­tur­ing if there are still no or­ders from the phar­ma with­in the next six weeks. How­ev­er, not all 500 of the staffers will be suc­cess­ful in mak­ing the tran­si­tion, he said.

“CO­V­AX is still un­der con­tract with J&J and we would be very hap­py for any dos­es that we are still ex­pect­ing to be sup­plied by As­pen,” Gavi, the vac­cine al­liance said in a state­ment. “We have com­mu­ni­cat­ed this to J&J. How­ev­er, again this is sole­ly a de­ci­sion that rests with J&J.”

J&J’s in­tel­lec­tu­al prop­er­ty li­cense is good un­til the end of 2026 and in­cludes any new ver­sions of drug sub­stances as the threat of vari­ants looms. J&J’s vac­cine is ben­e­fi­cial in Africa, par­tic­u­lar­ly the rur­al parts, be­cause it is a sin­gle shot, mak­ing it eas­i­er for those who have to trav­el long dis­tances to be­come ful­ly in­oc­u­lat­ed.

It’s not the first bit of con­tro­ver­sy to come out of the plant. Re­ports came out in Au­gust that while the US poured mon­ey in­to the site in an ef­fort to pro­vide dos­es to the African con­ti­nent, the ma­jor­i­ty of dos­es made there were be­ing shipped over­seas to Eu­rope. That was hap­pen­ing at a time in which just 2% of Africans were vac­ci­nat­ed, and at least 800,000 had been shipped to Spain in June and Ju­ly.

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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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.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

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.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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