How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Bi­ol­yse, an On­tario-based man­u­fac­tur­er of ster­ile in­jecta­bles, forged a deal with Bo­livia last week to man­u­fac­ture up to 50 mil­lion J&J Covid-19 vac­cine dos­es, the agree­ment kicked off what will prove to be a test case for how dif­fi­cult the sys­tem of com­pul­so­ry li­cens­es is to nav­i­gate.

The first prob­lem: When Bi­ol­yse asked J&J, via a March let­ter, to li­cense its Covid-19 vac­cine, man­u­fac­ture it in Cana­da and pay 5% roy­al­ties on ship­ments to needy, low-in­come coun­tries, J&J re­ject­ed the of­fer, re­fus­ing to ne­go­ti­ate. J&J al­so did not re­spond to a re­quest for com­ment.

With an un­will­ing J&J, Bi­ol­yse then turned to the Cana­di­an gov­ern­ment to li­cense the patents un­der a pro­gram called the Cana­di­an Ac­cess to Med­i­cines Regime, which al­lows the ex­port of drugs and vac­cines to low-in­come coun­tries like Bo­livia, with the hopes of bet­ter­ing their re­spons­es to pub­lic health crises like HIV/AIDS, tu­ber­cu­lo­sis and oth­ers.

But for those drugs or vac­cines to be ex­port­ed from Cana­da, they need to be in­clud­ed in a list cre­at­ed by the Cana­di­an gov­ern­ment, known as Sched­ule 1, which is part of the coun­try’s Patent Act.

James Love

So far, Cana­da has not added Covid-19 drugs or vac­cines to that list.

“Block­ing the list­ing on Sched­ule 1 is re­al­ly bull­shit,” James Love, di­rec­tor of the NGO Knowl­edge Ecol­o­gy In­ter­na­tion­al, who’s been push­ing to in­crease ac­cess to Covid-re­lat­ed vac­cines and ther­a­peu­tics, told End­points News. “It’s bizarre that Covid-19 is not con­sid­ered a glob­al health is­sue in Cana­da.”

A spokesper­son for the Cana­di­an gov­ern­ment’s In­no­va­tion, Sci­ence and Eco­nom­ic De­vel­op­ment pro­gram ex­plained to End­points that it’s al­so not just about adding Covid-19 vac­cines to Sched­ule 1.

“It’s im­por­tant to note that adding a COVID vac­cine to Sched­ule 1 would not al­low a com­pul­so­ry li­cense for the pro­duc­tion and ex­port of these vac­cines. A com­pa­ny seek­ing au­tho­riza­tion un­der Cana­da’s Ac­cess to Med­i­cines Regime must be able to man­u­fac­ture the drug and con­duct nec­es­sary tri­als to es­tab­lish that the drug meets Cana­di­an safe­ty and ef­fi­ca­cy re­quire­ments be­fore au­tho­riza­tion would be grant­ed,” she said.

John Ful­ton

Bi­ol­yse’s EVP John Ful­ton told End­points that his com­pa­ny could re­verse en­gi­neer the J&J vac­cine from a cou­ple drops from a vial, but the com­pa­ny would need J&J’s co­op­er­a­tion to run a tri­al and it will need ad­di­tion­al gov­ern­ment funds to scale up.

And while the gov­ern­ment spokesper­son said she’s “close­ly fol­low­ing the sit­u­a­tion” be­tween Bi­ol­yse and Bo­livia, Ful­ton said the gov­ern­ment has not been straight­for­ward in ex­plain­ing how to add Covid-19 vac­cines to Sched­ule 1.

“I start­ed in­quir­ing in late Feb­ru­ary 2021 and still they won’t give me an an­swer on how to start the process,” Ful­ton said via text mes­sage. “I’ve had meet­ings with close to 30 dif­fer­ent high-lev­el of­fi­cials and no straight an­swer on how to trig­ger the ad­di­tion.”

Bi­ol­yse said in its agree­ment with Bo­livia that it should be able to pro­duce 200,000 dos­es per week, if it ob­tains the com­pul­so­ry li­cense.

But the odds of that oc­cur­ring are low, be­cause, as Ful­ton ex­plained, it will re­quire Cana­di­an gov­ern­ment of­fi­cials to go out on a limb, and “spend the po­lit­i­cal cap­i­tal and have the courage to wade in­to the geopo­lit­i­cal storm that will en­sue when they sig­nal they sup­port the loos­en­ing of IP to vac­ci­nate LMIC [low-to-mid­dle in­come coun­tries].”

Adding Covid-19 vac­cines to Sched­ule 1 al­so would open the door for Bi­ol­yse and oth­ers to make not just J&J’s vac­cine, but Pfiz­er and Mod­er­na’s mR­NA vac­cines too, which fur­ther com­pli­cates the sit­u­a­tion.

“150 dif­fer­ent things need to hap­pen for a CL [com­pul­so­ry li­cense] to be is­sued in Cana­da just on the ex­port side,” Ful­ton added. “The TRIPS waiv­er stream­lines this process on the im­porter side.”

Pfiz­er and Mod­er­na have both made clear in re­cent weeks that they are not go­ing to help any com­pa­nies try­ing to make copy­cat ver­sions of their prod­ucts, es­pe­cial­ly as they would be vy­ing for the same raw ma­te­ri­als and nec­es­sary equip­ment.

And the Cana­di­an gov­ern­ment does not seem ready to budge, at least for now.

In­stead, the spokesper­son said the coun­try will in­vest about $2.2 bil­lion over sev­en years to­wards grow­ing a vi­brant do­mes­tic bio­man­u­fac­tur­ing and life sci­ences sec­tor, while al­so pro­vid­ing $940 mil­lion in sup­port for low- and mid­dle-in­come coun­tries to ac­cess COVID-19 vac­cines, tests, and treat­ments through the WHO’s ACT-Ac­cel­er­a­tor.

So will Bi­ol­yse raise funds and move their op­er­a­tions to an­oth­er coun­try where ob­tain­ing a com­pul­so­ry li­cense and reg­u­la­to­ry clear­ance might be eas­i­er?

No, ac­cord­ing to Ful­ton, ex­plain­ing that Bi­ol­yse has the req­ui­site fa­cil­i­ty now, and adding a fill line to a new site would add be­tween 18 months and two years to the en­tire process. But he al­so thinks that ob­tain­ing a com­pul­so­ry li­cense is about more than deal­ing with Covid-19 in the short term

“I think Covid will be with us for a long time, and I hate to say it, but we have the time. What’s hap­pen­ing in In­dia could hap­pen to us in Cana­da,” Ful­ton added. “If a com­pul­so­ry li­cense sys­tem can’t work now, dur­ing a world­wide pan­dem­ic, what’s it for? What’s the use?”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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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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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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