Pub­lic Cit­i­zen ac­cus­es Pfiz­er of build­ing 'patent wal­l' for Covid treat­ment, set­ting up in­equities again

Pub­lic Cit­i­zen has called out Pfiz­er. Again.

The con­sumer ad­vo­ca­cy non­prof­it is­sued a state­ment Fri­day claim­ing the Big Phar­ma is build­ing a patent wall by fil­ing or in­tend­ing to file patent ap­pli­ca­tions in 61 coun­tries, as well as four re­gion­al patent of­fices, for nir­ma­trelvir, a key com­po­nent in Pfiz­er’s Covid-19 treat­ment Paxlovid.

Bur­cu Kil­ic

The Med­i­cines Patent Pool and Pfiz­er struck an agree­ment to qual­i­fy gener­ic man­u­fac­tur­ers in 95 coun­tries, many of which are clas­si­fied as low- or low­er-mid­dle-in­come, to pro­duce gener­ic ver­sions of Pfiz­er’s Covid-19 an­tivi­ral. But Pub­lic Cit­i­zen said the deal left out much of the world. Di­rec­tor Bur­cu Kil­ic said, in a call with End­points News Fri­day, that the agree­ment was large­ly a pub­lic re­la­tions move by the Big Phar­ma. The scope of the deal, while in the­o­ry pro­vides eq­ui­table ac­cess, is ac­tu­al­ly a “chick­en or the egg” sce­nario, he said, be­cause many of the coun­tries do not have ease of ac­cess to man­u­fac­ture the drug.

“Pfiz­er did re­al­ly great PR work at that time,” Kil­ic said. “It was on the head­lines of every pub­li­ca­tion, but the re­al­i­ty is much dif­fer­ent.”

Pe­ter May­bar­duk

“Many coun­tries, in­clud­ing most of Latin Amer­i­ca, may en­dure sup­ply short­ages and un­af­ford­able prices,” Pub­lic Cit­i­zen said in the let­ter. “Now, health ad­vo­cates will work to­geth­er to take down Pfiz­er’s patent wall brick by brick to en­sure that every­one, every­where has ac­cess to COVID treat­ments.”

Pe­ter May­bar­duk, the non­prof­it’s di­rec­tor of pub­lic med­i­cine pro­grams, said that the world is look­ing at a re­peat of the vac­cine in­equity that has grabbed a hold of the world fol­low­ing the rush to get Covid-19 vac­cines, but with ther­a­peu­tics in­stead.

“To not have any com­mit­ment from Pfiz­er so far is con­cern­ing,” he said. “We could eas­i­ly wind up in a sce­nario where 2/3 of the pop­u­la­tion is left be­hind. It won’t be (drug) hoard­ing, but it will be deeply in­equitable.”

Pfiz­er has al­ready filed ap­pli­ca­tions in a num­ber of coun­tries, in­clud­ing Mon­go­lia, New Zealand, and Nige­ria. It has in­di­cat­ed that it will file ap­pli­ca­tions in 23 more coun­tries – in­clud­ing Qatar, South Africa, Sri Lan­ka and Thai­land. It re­leased this state­ment when asked about Pub­lic Cit­i­zen’s open let­ter:

Pfiz­er be­lieves that the grant­i­ng of patent rights should be fo­cused on claims that le­git­i­mate­ly re­flect in­no­va­tion by the ap­pli­cant. We do not file patents that lack gen­uine in­no­va­tion, or for the pur­pose of lim­it­ing com­pe­ti­tion.

Car­o­line Roan

A let­ter dat­ed Jan. 31 sent from Car­o­line Roan, Pfiz­er’s se­nior VP of glob­al health and so­cial im­pact, re­in­forced that Pfiz­er will of­fer a tiered-pric­ing ap­proach for Paxlovid, with the cost de­pend­ing on each coun­try’s in­come lev­el. Low­er-in­come coun­tries will pay for the dos­es at cost through­out the pan­dem­ic, and Pfiz­er won’t re­ceive roy­al­ties on low­er-in­come coun­tries’ sales.

Roan’s let­ter al­so fo­cused on the idea that vac­cines are still the best first line of de­fense against the virus.

“It is im­por­tant to first ac­knowl­edge that while Paxlovid is an­oth­er tool in the ar­se­nal against COVID-19, vac­ci­na­tions re­main the first line of de­fense,” the let­ter said. “Since the start of the pan­dem­ic, Pfiz­er and BioN­Tech’s para­mount con­sid­er­a­tion has been eq­ui­table and af­ford­able ac­cess to COVID-19 vac­cines for all peo­ple around the world.”

But for Pub­lic Cit­i­zen, that wasn’t enough.

“We ap­pre­ci­ate that they an­swered the let­ter, but we wish that they had an­swered our ques­tions,” said May­bar­duk to whom Pfiz­er’s re­sponse was ad­dressed.

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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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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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 clinicaltrials.gov. 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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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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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.

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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

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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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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.