Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfiz­er and BioN­Tech said Fri­day that they’ve sub­mit­ted a bi­o­log­ics li­cense ap­pli­ca­tion to the FDA for full ap­proval of their mR­NA vac­cine for those over the age of 16.

Pe­ter Marks FDA

How long it will take the FDA to de­cide on the BLA will be set once it’s been for­mal­ly ac­cept­ed by the agency.

Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, pre­vi­ous­ly told End­points News that the re­view of the BLA should take be­tween three and four months, but it may be even faster than that.

“In this case, since they’re al­ready un­der emer­gency use au­tho­riza­tion and the large bulk of ad­di­tion­al in­for­ma­tion com­ing in will be safe­ty da­ta and in­for­ma­tion on man­u­fac­tur­ing, we’re in­tend­ing to speed that re­view,” he said.

Pfiz­er and BioN­Tech are al­so await­ing im­mi­nent ap­proval for an ap­pli­ca­tion to ex­pand the cur­rent EUA for their vac­cine to in­clude in­di­vid­u­als 12 to 15 years of age. The com­pa­nies said Fri­day that they in­tend to sub­mit a sup­ple­men­tal BLA to sup­port li­cen­sure of the vac­cine in this age group once the re­quired da­ta six months af­ter the sec­ond vac­cine dose are avail­able.

Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Ger­many’s leader An­gela Merkel on Thurs­day an­nounced her op­po­si­tion to the Biden ad­min­is­tra­tion’s sur­prise de­ci­sion to back a World Trade Or­ga­ni­za­tion waiv­er that would sus­pend in­tel­lec­tu­al prop­er­ty around the Covid-19 vac­cines.

Merkel, ac­cord­ing to the Fi­nan­cial Times, said the pro­pos­al has “se­ri­ous im­pli­ca­tions,” not­ing that what’s lim­it­ing vac­cine sup­plies is not IP, as Mod­er­na CEO Stéphane Ban­cel al­so said Thurs­day, but pro­duc­tion ca­pa­bil­i­ties with high-qual­i­ty stan­dards.

“The pro­tec­tion of in­tel­lec­tu­al prop­er­ty is a source of in­no­va­tion and it must re­main so in the fu­ture,” she said. Ger­many or any oth­er coun­try that’s a mem­ber of the WTO has the pow­er to ve­to the waiv­er.

Rus­sia, France and Spain of­fered sup­port for the US pro­pos­al, while oth­er diplo­mats from Brazil and Chi­na said they would dis­cuss it un­der the WTO frame­work.

UK calls for those un­der 40 to not re­ceive the As­traZeneca vac­cine

The UK’s Joint Com­mit­tee on Vac­ci­na­tion and Im­mu­ni­sa­tion on Fri­day called to re­strict the use of the As­traZeneca Covid-19 vac­cine to on­ly those who are over 40 years old be­cause of con­cerns re­lat­ed to rare but po­ten­tial­ly fa­tal cas­es of blood clots with low platelets.

As of April 28, the UK’s drug reg­u­la­tor re­ceived 242 re­ports of blood clot­ting cas­es in peo­ple who al­so had low lev­els of platelets in the UK, fol­low­ing the use of the As­traZeneca vac­cine.

“These num­bers are very small com­pared to the mil­lions of peo­ple who have re­ceived the vac­cine. The over­all in­ci­dence of case re­ports of throm­boem­bol­ic events with low platelets af­ter first or un­known dos­es was 10.5 per mil­lion dos­es,” the JCVI said.

The com­mit­tee al­so not­ed that the ma­jor­i­ty of these rare events oc­curred af­ter the first dose, so, “Every­body who has al­ready had a first dose of the Ox­ford/As­traZeneca vac­cine should re­ceive a sec­ond dose of the same jab, ir­re­spec­tive of age, ex­cept for the very small num­ber of peo­ple who ex­pe­ri­enced blood clots with low platelet counts from their first vac­ci­na­tion.”

EMA starts rolling re­view of GSK, Vir mon­o­clon­al an­ti­body

The Eu­ro­pean Med­i­cines Agency on Fri­day kicked off a rolling re­view of Glax­o­SmithK­line and Vir’s Covid-19 mon­o­clon­al an­ti­body sotro­vimab.

The com­pa­nies said the de­ci­sion to start the rolling re­view is based on the in­ter­im analy­sis of ef­fi­ca­cy and safe­ty da­ta from a Phase III tri­al, which eval­u­at­ed sotro­vimab as monother­a­py for the ear­ly treat­ment of COVID-19 in 583 adults at high-risk of hos­pi­tal­iza­tion.

Re­sults of the in­ter­im analy­sis demon­strat­ed an 85% (p=0.002) re­duc­tion in hos­pi­tal­iza­tions over 24 hours or deaths in those re­ceiv­ing sotro­vimab com­pared to place­bo, which was the pri­ma­ry end­point of the tri­al.

An emer­gency use ap­pli­ca­tion for sotro­vimab has al­so been sub­mit­ted to the US FDA and Health Cana­da.

Eu­ro­pean Com­mis­sion lays out strat­e­gy for de­vel­op­ing more ther­a­peu­tics

The Eu­ro­pean Com­mis­sion on Thurs­day said it would es­tab­lish a “ther­a­peu­tics in­no­va­tion boost­er” by Ju­ly to ush­er the most promis­ing Covid-19 ther­a­peu­tics from pre­clin­i­cal re­search to mar­ket au­tho­riza­tion.

By June, the com­mis­sion will cre­ate a port­fo­lio of 10 po­ten­tial Covid-19 drugs and win­now that port­fo­lio down to the best five.

“It will or­gan­ise match­mak­ing events for in­dus­tri­al ac­tors in­volved in ther­a­peu­tics to en­sure enough pro­duc­tion ca­pac­i­ty and swift man­u­fac­tur­ing. New au­tho­ri­sa­tions, rolling re­views and joint pro­cure­ment con­tracts will be up and run­ning be­fore the end of the year,” the com­mis­sion said.

By Oc­to­ber, the com­mis­sion said it hopes to have at least three new ther­a­peu­tics to mar­ket, and pos­si­bly two more by the end of 2021, with the de­vel­op­ment of flex­i­ble reg­u­la­to­ry ap­proach­es to speed­ing up the as­sess­ment of drugs that are promis­ing and safe.

CMS in­creas­es pay­ments for mon­o­clon­al an­ti­bod­ies to in­cen­tivize home in­fu­sions

The US Cen­ters for Medicare & Med­ic­aid Ser­vices are up­ping their pay­ments for the ad­min­is­tra­tion of Covid-19 mon­o­clon­al an­ti­bod­ies from $310 to $450 for most health care set­tings, or $750 when mon­o­clon­al an­ti­bod­ies are ad­min­is­tered in a ben­e­fi­cia­ry’s home, in­clud­ing tem­po­rary lodg­ings like ho­tels, cruise ships or home­less shel­ters.

“These high­er na­tion­al av­er­age pay­ment rates re­flect ad­di­tion­al in­for­ma­tion pro­vid­ed to CMS about the costs of pro­vid­ing these ser­vices in a safe and time­ly man­ner, such as clin­i­cal staff and per­son­al pro­tec­tive equip­ment,” the cen­ters said.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

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