Phar­ma groups de­cry Covid-19 vac­cine IP waiv­er ahead of Gene­va con­fer­ence

If the World Trade Or­ga­ni­za­tion gets its way, an IP waiv­er deal for Covid-19 vac­cines may be reached as soon as next week. But the crit­ics keep pil­ing up.

A hand­ful of phar­ma ad­vo­ca­cy and lob­by­ing groups — in­clud­ing the In­ter­na­tion­al Fed­er­a­tion of Phar­ma­ceu­ti­cal Man­u­fac­tur­ers and As­so­ci­a­tions and the Wash­ing­ton Coun­cil on In­ter­na­tion­al Trade — de­cried an IP waiv­er deal on Thurs­day, ar­gu­ing that it’s un­nec­es­sary and threat­ens to quash in­no­va­tion.

“An IP waiv­er does not ad­dress in­equitable ac­cess to Covid-19 vac­cines and will put glob­al health se­cu­ri­ty at risk. It will un­der­mine in­no­va­tion and in­dus­try’s abil­i­ty to part­ner, in­vest at risk, and re­spond quick­ly to fu­ture pan­demics,” the IF­P­MA said in a state­ment.

TRIPS Coun­cil chair, am­bas­sador Lansana Gberie of Sier­ra Leone, said yes­ter­day that del­e­ga­tions around the waiv­er “have en­tered in­to re­al ne­go­ti­a­tion mode in the last 24 hours,” and that the WTO is aim­ing to get a ver­sion ready for adop­tion next week by min­is­ters ar­riv­ing in Gene­va for the 12th Min­is­te­r­i­al Con­fer­ence.

Both In­dia and South Africa called for an IP waiv­er back in 2020. Just 32% of peo­ple in South Africa are ful­ly vac­ci­nat­ed, ac­cord­ing to the New York Times, com­pared to 67% in the US. Un­der the TRIPS agree­ment, de­vel­op­ing coun­tries would be able to re­pro­duce Covid vac­cines by us­ing the for­mu­la and tech­nol­o­gy cre­at­ed by orig­i­nal man­u­fac­tur­ers.

How­ev­er, the WC­IT ar­gues that such a deal “de­tracts from more ef­fec­tive so­lu­tions and pos­es a threat to IP rights which are crit­i­cal in al­le­vi­at­ing the scourge of in­equal­i­ty and glob­al pover­ty.” The group ar­gued that the re­al prob­lems are in clear­ance at points of en­try, in­fra­struc­ture gaps, and sup­ply chain gaps such as a lack of re­frig­er­a­tion equip­ment in lo­cal dis­tri­b­u­tion cen­ters.

“Led by the Unit­ed States, the de­vel­oped world has closed the sup­ply gap through vac­cine do­na­tions — and in­deed, there is now a glob­al sur­plus of dos­es,” WC­IT said.

In May, Switzer­land an­nounced they were de­stroy­ing 600,000 ex­pired dos­es of Mod­er­na’s shot. Eng­land and Den­mark have al­so tossed more than 6.6 mil­lion dos­es.

“By May 2021, less than six months af­ter the first vac­cine au­tho­riza­tion, month­ly pro­duc­tion out­put was close to a bil­lion vac­cine dos­es; enough to vac­ci­nate the world if coun­tries were will­ing and able to share,” the IF­P­MA said in a state­ment.

PhRMA al­so chimed in on Thurs­day, adding that world lead­ers “should fo­cus on the re­al chal­lenges of get­ting Covid-19 vac­cines and treat­ments to peo­ple around the world, such as last-mile dis­tri­b­u­tion, sup­ply chain is­sues and vac­cine hes­i­tan­cy.”

Mean­while, oth­ers ar­gue that the pro­posed deal is too lit­tle too late.

“It does not do much that you can’t al­ready do,” KEI founder and IP waiv­er and com­pul­so­ry li­cense ad­vo­cate Jamie Love told End­points News back in March, up­on see­ing a leaked draft of the wa­tered-down deal. Non­prof­it ad­vo­ca­cy org Pub­lic Cit­i­zen al­so said in a state­ment that the pro­pos­al would help no one “but the floun­der­ing WTO and should be re­ject­ed.”

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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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.

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.

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.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

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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