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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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With plans to spend $360M, As­traZeneca will build its first-ever man­u­fac­tur­ing site in Ire­land

AstraZeneca is planning to spend a pretty penny for a new manufacturing facility in Dublin.

The Big Pharma will shell out $360 million to build an API plant for small molecules at its Alexion campus in College Park, Dublin, it announced Tuesday morning. AstraZeneca said the focus of the facility will be late-stage development and early commercial supply for small molecule therapies.

“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” AstraZeneca global ops chief Pam Cheng said in a statement. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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