Man­u­fac­tur­ing roundup: Gen­Bio­Pro looks to counter Mis­sis­sip­pi trig­ger law; Pis­gah Labs to in­vest $55M in NC ex­pan­sion  

As the is­sues from the Roe V. Wade de­ci­sion con­tin­ue to cas­cade in var­i­ous cir­cles, in­clud­ing the biotech world, one man­u­fac­tur­er is look­ing to push back against state law.

Ac­cord­ing to a re­port from Bloomberg BNN, mifepri­s­tone man­u­fac­tur­er Gen­Bio­Pro is look­ing to chal­lenge a Mis­sis­sip­pi an­ti-abor­tion law set in­to mo­tion by the US Supreme Court’s re­ver­sal of Roe v. Wade, stat­ing that the move is keep­ing its prod­uct off the shelves.

While Mis­sis­sip­pi’s trig­ger law com­mit­ted to ban­ning most abor­tions, it in­cludes abor­tions re­ly­ing on pills ap­proved by the FDA such as mifepri­s­tone.

Gen­Bio­Pro is now amend­ing its com­plaint it filed in 2020 in Mis­sis­sip­pi to the state to ad­dress the trig­ger law. The case is at­tempt­ing to push back Mis­sis­sip­pi’s mifepri­s­tone re­stric­tions, which were in ef­fect be­fore the Roe V. Wade de­ci­sion, coun­ters FDA reg­u­la­tions over the pill.

The com­pa­ny is ar­gu­ing that FDA dis­pens­ing and pre­scrib­ing reg­u­la­tions for the pill pre­empt state re­quire­ments, in­clud­ing hav­ing a li­censed physi­cian pre­scribe the drug in per­son.

North Car­oli­na-based API man­u­fac­tur­er to ex­pand its ca­pa­bil­i­ties

Pis­gah Lab­o­ra­to­ries a phar­ma­ceu­ti­cal man­u­fac­tur­er and sub­sidiary of In­dia-based Ip­ca labs, will in­vest $55 mil­lion to ex­pand its man­u­fac­tur­ing prod­uct line and add 57 new jobs in east­ern North Car­oli­na.

Ac­cord­ing to the North Car­oli­na gov­er­nor’s of­fice, the site orig­i­nal­ly start­ed pro­duc­ing x-ray film dye and agro­chem­i­cals. The com­pa­ny re­ceived FDA ap­proval to man­u­fac­ture APIs in 2002 be­fore ex­clu­sive­ly de­vel­op­ing phar­ma­ceu­ti­cals in 2005. Pis­gah man­u­fac­tures the ac­tive in­gre­di­ents for pain med­i­cines and the treat­ment of dis­or­ders and dis­eases, such as Alzheimer’s and fi­bromyal­gia.

The ex­pan­sion will al­so add ster­ile in­jecta­bles, liq­uid fill­ing op­er­a­tions and a qual­i­ty con­trol lab­o­ra­to­ry, ware­hous­ing and mi­cro­bi­o­log­i­cal lab­o­ra­to­ries.

“Our par­ent com­pa­ny, Ip­ca Lab­o­ra­to­ries Lim­it­ed, is mak­ing a large in­vest­ment in Pis­gah’s fu­ture. Carv­ing a space in the high­ly com­pet­i­tive phar­ma­ceu­ti­cal mar­ket is not an easy task, but we wel­come the chal­lenge and in­tend to see many years of com­pa­ny growth, job cre­ation and ed­u­ca­tion op­por­tu­ni­ties for Pis­gah Labs and west­ern North Car­oli­na,” said site man­ag­er Dani Bai­ley.

The site al­so re­ceived a per­for­mance-based grant of $50,000 from the One North Car­oli­na Fund, which pro­vides fi­nan­cial as­sis­tance to lo­cal gov­ern­ments to help at­tract eco­nom­ic in­vest­ment and cre­ate jobs. Com­pa­nies re­ceive no mon­ey up­front and must meet job cre­ation and cap­i­tal in­vest­ment tar­gets to qual­i­fy for pay­ment.

In­di­an phar­ma com­pa­nies re­call­ing prod­ucts in the US over man­u­fac­tur­ing is­sues

Sun Phar­ma and Glen­mark, two man­u­fac­tur­ers of gener­ic drugs, is­sued a re­call over man­u­fac­tur­ing is­sues.

Ac­cord­ing to a re­port from Fierce Phar­ma, On June 21, Sun Phar­ma ini­ti­at­ed a vol­un­tary re­call of 50,680 vials of testos­terone cy­p­i­onate in­jec­tion be­cause of “wa­ter leak­age” at a plant in Gu­jarat, In­dia.

Glen­mark re­called over 98,307 packs of mometa­sone furoate top­i­cal so­lu­tion, a lo­tion that treats skin con­di­tions such as eczema, pso­ri­a­sis, al­ler­gies and rash. Glen­mark start­ed the re­call on June 16.

The is­sue for Glen­mark was over de­fec­tive pack­ag­ing at its plant in Hi­machal Pradesh, In­dia.

Pre­ci­sion NanoSys­tems and Repli­cate Bio­science en­ter in­to li­cens­ing deal to scale up ge­nom­ic med­i­cine man­u­fac­tur­ing

Pre­ci­sion NanoSys­tems (PNI) and Repli­cate Bio­science are look­ing to en­ter in­to a li­cens­ing agree­ment to ac­cel­er­ate the cre­ation, scale-up and de­liv­ery of self-repli­cat­ing RNA (sr­RNA) ther­a­pies.

Andy Geall

The agree­ment will see PNI pro­vide lipid nanopar­ti­cle so­lu­tions for scale-up and man­u­fac­tur­ing of up to 15 Repli­cate sr­RNA ther­a­peu­tics. The terms in­clude ag­gre­gat­ed mile­stone fees, roy­al­ties, and sub­li­cens­ing for in­come shar­ing, but the com­pa­ny re­mained mum on the wider de­tails.

“I’m con­fi­dent in PNI’s de­liv­ery tech­nol­o­gy and our work­ing re­la­tion­ship. With this agree­ment, Repli­cate aims to sig­nif­i­cant­ly ex­pand our port­fo­lio of sr­RNA ther­a­peu­tics be­yond our lead can­di­dates slat­ed to en­ter hu­man tri­als next year,” said Andy Geall, chief de­vel­op­ment of­fi­cer of Repli­cate.

The deal will al­so al­low Repli­cate to ex­plore more drug can­di­dates in ar­eas be­yond the com­pa­ny’s lead pro­grams, which ad­dress en­docrine ther­a­py re­sis­tance in breast can­cers, im­munother­a­py re­sis­tance in sol­id tu­mors and pos­si­bly fu­ture pan­demics.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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