Man­u­fac­tur­ing roundup: Lon­za col­lab­o­rates with a VC in Is­rael; Pi­ra­mal up­dates one fa­cil­i­ty while open­ing a new one

The Swiss CD­MO pow­er­house Lon­za is no stranger to Is­rael, but a re­cent col­lab­o­ra­tion has ce­ment­ed a new hold over biotech in the re­gion.

Ac­cord­ing to the com­pa­ny, Lon­za and the Is­rael Biotech Fund, a ven­ture fund in­vest­ing in Is­raeli and Is­raeli-re­lat­ed biotech com­pa­nies, an­nounced a two-year frame­work agree­ment.

The deal aims to pro­vide ac­cel­er­at­ed time­lines for the de­vel­op­ment and man­u­fac­ture of bi­o­log­ics and small mol­e­cules. Lon­za will add sup­port to the IBF by work­ing to de-risk and pro­vide de­vel­op­ment and man­u­fac­tur­ing ser­vices to the IBF’s port­fo­lio com­pa­nies. The fi­nan­cial terms of the deal were not dis­closed.

The IBF will in turn pro­vide Lon­za with ac­cess to IBF’s port­fo­lio com­pa­nies and broad net­work in the biotech in­dus­try in Is­rael.

The agree­ment will try to broad­en the scope of ser­vices pro­vid­ed by Lon­za to phar­ma­ceu­ti­cal com­pa­nies in the Is­raeli biotech ecosys­tem.

Pn­i­na Weitz, Lon­za’s glob­al head of ven­ture cap­i­tal busi­ness de­vel­op­ment and re­la­tion­ship man­age­ment, not­ed that de­spite Is­rael’s size, the coun­try had over 1,750 life sci­ence com­pa­nies ac­tive at the end of 2020, many of which are start-ups and small biotech com­pa­nies.

“If these com­pa­nies can re­tain in­vestor in­ter­est and bring their ther­a­peu­tics to lat­er stages, it can po­si­tion them for ac­qui­si­tion or even tak­ing their mol­e­cules to mar­ket them­selves – an op­tion more star­tups are choos­ing due to in­creased fund­ing,” Weitz said in an email to End­points News. 

Lon­za isn’t the on­ly big play­er to start work­ing with the IBF. In 2021, Mer­ck, Pfiz­er, As­traZeneca, Te­va and Ama­zon teamed up to launch a new in­cu­ba­tor with the IBF for star­tups walk­ing the line be­tween AI and drug de­vel­op­ment. Lon­za has been ac­tive in the re­gion pre­vi­ous­ly coun­try as, in 2018, the CD­MO opened a 10,000-square-foot in­no­va­tion cen­ter in Haifa that is des­gined to work with acad­e­mia and ear­ly stage com­pa­nies.

In­di­an drug man­u­fac­tur­er opens and up­dates sev­er­al fa­cil­i­ties across the globe

The In­di­an drug man­u­fac­tur­er Pi­ra­mal Phar­ma So­lu­tions has been busy for the past few days.

First, a new pro­duc­tion block came on­line at the com­pa­ny’s drug prod­uct site in Pi­tham­pur, In­dia, last Tues­day.

The new pro­duc­tion area can now han­dle batch sizes of 150 to 600 kilo­grams, al­low­ing the site’s ca­pac­i­ty to pro­duce OSD form drug prod­ucts. Ac­cord­ing to the com­pa­ny, the site was fund­ed as part of an $11 mil­lion cap­i­tal in­vest­ment by Pi­ra­mal.

The Pi­tham­pur site’s ca­pac­i­ty has now in­creased from 3 bil­lion dos­es to 4.5 bil­lion dos­es and will em­ploy ap­prox­i­mate­ly 600 work­ers. The site will aim to sup­ply drug prod­ucts to biotech and phar­ma com­pa­nies glob­al­ly, and the site has been in­spect­ed by a host of reg­u­la­to­ry agen­cies in­clud­ing the FDA.

Now the man­u­fac­tur­er has al­so opened a new API plant in Au­ro­ra, On­tario, Cana­da. The new plant was con­struct­ed as part of a CAD 30 mil­lion ($23 mil­lion) cap­i­tal in­vest­ment in its Au­ro­ra site. The site has more than 10,000 square-feet of new man­u­fac­tur­ing space and in­cludes two new re­ac­tor suites with ad­di­tion­al fil­tra­tion and dry­ing ca­pa­bil­i­ties.

The site has al­so been in­spect­ed by reg­u­la­tors in the US, UK and Japan.

Pi­ra­mal has al­ready been on a tear this year. In Jan­u­ary, the CD­MO an­nounced plans to in­vest mil­lions to cre­ate a high-through­put screen­ing fa­cil­i­ty to en­hance its in vit­ro bi­ol­o­gy ca­pa­bil­i­ties at its drug dis­cov­ery site in Ahmed­abad, In­dia. The new ex­pan­sion is sched­uled to go live in Q3 of this year.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Merck closes in on a potential $40 billion buyout of Seagen, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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