Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Con­tract re­searcher Charles Riv­er Lab­o­ra­to­ries has been on a roll re­cent­ly to flesh out its man­u­fac­tur­ing arm with a spe­cif­ic fo­cus on its ca­pa­bil­i­ties in gene ther­a­py. Now, the firm is putting its name to a big check for a Mary­land-based vi­ral vec­tor firm it thinks will add to its grow­ing ex­per­tise in the field.

Charles Riv­er will dole out $292.5 mil­lion for gene ther­a­py CD­MO Vi­gene Bio­sciences with the pos­si­bil­i­ty for an ad­di­tion­al $57.5 mil­lion in per­for­mance-based pay­ments, the com­pa­nies said Mon­day. The deal will close at the start of Q3, a Charles Riv­er spokesman said.

For Vi­gene, the sale comes right on the heels of a Feb­ru­ary an­nounce­ment that the com­pa­ny would add 52,000 feet of man­u­fac­tur­ing space at its Rockville head­quar­ters fol­low­ing a $1.225 mil­lion loan that Vi­gene se­cured from Mary­land’s com­merce de­part­ment. The ex­pan­sion was set to add 245 new jobs by 2025.

The CD­MO is ex­pect­ed to gen­er­ate be­tween $30 mil­lion and $35 mil­lion in 2021, and Charles Riv­er an­tic­i­pates year-over-year growth of 25% by 2026.

Vi­ral vec­tors are key com­po­nents used in many gene ther­a­pies and re­in­force Charles Riv­er’s grow­ing pres­ence in the field af­ter a spate of re­cent ac­qui­si­tions. In Feb­ru­ary, the com­pa­ny snatched Cog­nate and its 500 em­ploy­ees along with tech for cel­lu­lar im­munother­a­py, im­muno-on­col­o­gy, re­gen­er­a­tive med­i­cine and ad­vanced cell ther­a­py ther­a­peu­tics. Cog­nate had al­so re­cent­ly an­nounced an ex­pan­sion at the time of the buy, pledg­ing to dou­ble man­u­fac­tur­ing ca­pac­i­ty at its Mem­phis head­quar­ters and Eu­ro­pean sites.

James Fos­ter

With the ad­di­tion of Vi­gene, the Charles Riv­er cell and gene ther­a­py port­fo­lio will ex­pand each ma­jor CD­MO plat­form: cell ther­a­py, vi­ral vec­tor and plas­mid DNA pro­duc­tion, CEO James Fos­ter said in the press re­lease.

“In these emerg­ing, high-growth, val­ue-added seg­ments, we in­tend to con­tin­ue to dif­fer­en­ti­ate our­selves by bring­ing our high-sci­ence, cus­tomiz­able ap­proach to sup­port the com­plex needs of cell and gene ther­a­py de­vel­op­ers and in­no­va­tors world­wide,” he said. “Our goal is to be­come our clients’ sci­en­tif­ic part­ner of choice for ad­vanced drug modal­i­ties from dis­cov­ery and non-clin­i­cal de­vel­op­ment to CGMP man­u­fac­tur­ing.”

Vi­gene has a par­tic­u­lar ex­per­tise in AAV pro­duc­tion, as well as lentivirus. That range will com­ple­ment Charles Riv­er’s cur­rent end-to-end, gene-mod­i­fied cell ther­a­py so­lu­tion, the com­pa­ny said.

Mean­while, Charles Riv­er has kept adding on in oth­er ar­eas of its busi­ness amid a busy 2020. In April, the com­pa­ny teamed up with Va­lence Dis­cov­ery to ex­pand its AI plat­form for mol­e­c­u­lar prop­er­ty pre­dic­tion, gen­er­a­tive chem­istry and mul­ti­pa­ra­me­ter op­ti­miza­tion. Va­lence’s plat­form al­lows small mol­e­cule drugs in new re­gions of chem­i­cal space, al­low­ing for rapid op­ti­miza­tion against po­ten­cy, se­lec­tiv­i­ty, safe­ty and phar­ma­col­o­gy, the com­pa­ny says.

In Jan­u­ary, the com­pa­ny bought an­ti­body dis­cov­ery com­pa­ny Dis­trib­uted Bio for up to $104 mil­lion, with the goal of cut­ting down a year from clients’ ear­ly-stage de­vel­op­ment time­lines, the com­pa­ny said.

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.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

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 Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, 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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

David Mussafer, chairman of Advent International

Ad­vent to sell stake in man­u­fac­tur­er and drug de­vel­op­er in a deal worth over $1B — re­port

After almost three years of investment, private equity firm Advent International may look to sell its part in Bioduro-Sundia.

A Reuters report on Monday detailed that Advent International plans to sell a majority stake in the manufacturing and drug development company that could value the company at over $1 billion, three people with knowledge of the matter told the news site.

However, one of the sources said that a formal sale might not happen until next year.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

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.