Tom Loewald, Cambrex CEO

Af­ter Chi­nese CD­MO fails, Cam­brex ac­quires in­gre­di­ent man­u­fac­tur­er Snap­drag­on Chem­istry

While CD­MO Cam­brex has been ex­pand­ing steadi­ly through­out the year, its lat­est ac­qui­si­tion sees a deep­er dive in­to the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent game.

The New Jer­sey-based CD­MO has agreed to ac­quire Snap­drag­on Chem­istry, a pro­duc­er of chem­i­cal ser­vices and API man­u­fac­tur­ing for bio­phar­ma cus­tomers. The deal will see Cam­brex ac­quire Snap­drag­on’s two fa­cil­i­ties in Waltham, MA. Cam­brex did not dis­close the deal amount to End­points News.

CEO Tom Loe­wald emailed End­points about the rea­son­ing be­hind the deal:

Cam­brex views Snap­drag­on Chem­istry as an ex­cel­lent strate­gic fit; the ac­qui­si­tion will en­hance each com­pa­ny’s re­spec­tive of­fer­ings, de­liv­er­ing a com­pre­hen­sive so­lu­tion for drug sub­stance de­vel­op­ment and man­u­fac­tur­ing chal­lenges. We be­lieve of­fer­ing a seam­less scale-up op­tion from Snap­drag­on to one of Cam­brex’s larg­er-scale drug sub­stance fa­cil­i­ties will be a dis­tinct ad­van­tage for Snap­drag­on cus­tomers, com­pared to the cost and time­line of trans­fer­ring their prod­uct(s) to a 3rd par­ty CD­MO for scale-up.

Snap­drag­on opened a 51,000-square-foot fa­cil­i­ty in May de­signed to boost the com­pa­ny’s GMP man­u­fac­tur­ing and process de­vel­op­ment ca­pa­bil­i­ties. How­ev­er, Snap­drag­on was ex­pect­ed to be picked up by an­oth­er com­pa­ny a few months ago.

Chi­nese CD­MO Asym­chem had ini­tial­ly agreed to ac­quire Snap­drag­on in a $58 mil­lion deal, ac­cord­ing to a re­port from Chem­i­cal & En­gi­neer­ing News. How­ev­er, in Sep­tem­ber, Snap­drag­on an­nounced that the Asym­chem deal was no longer go­ing to pro­ceed as the two com­pa­nies were un­able to agree to “mit­i­ga­tion terms” that would be sat­is­fac­to­ry for the US Trea­sury’s Com­mit­tee on For­eign In­vest­ment in the Unit­ed States.

For Cam­brex, this is its sec­ond ac­qui­si­tion of the year, buy­ing the Wa­ter­ford, Ire­land-based Q1 Sci­en­tif­ic — a provider of en­vi­ron­men­tal­ly con­trolled cGMP sta­bil­i­ty stor­age ser­vices — in June.

How­ev­er, Cam­brex is al­so mak­ing sev­er­al do­mes­tic moves as well.

In Sep­tem­ber, Cam­brex com­plet­ed the first phase of a $30 mil­lion ex­pan­sion at its API man­u­fac­tur­ing fa­cil­i­ty in High Point, NC, in the state’s Tri­ad re­gion. The new ex­pan­sion will add 30,000 square feet of an­a­lyt­i­cal and chem­i­cal de­vel­op­ment lab­o­ra­to­ries, with the abil­i­ty to ex­pand the head­count by 85 em­ploy­ees.

In the Mid­west, Cam­brex an­nounced in Oc­to­ber that it will in­vest $16.5 mil­lion in two projects in Iowa and Min­neso­ta. First, the com­pa­ny is plan­ning to cre­ate a 21,000-square-foot R&D fa­cil­i­ty in Min­neapo­lis, which is ex­pect­ed to add around 40 jobs over the next two to three years. At the same time in Charles City, IA, Cam­brex is launch­ing a 9,000-square-foot ex­pan­sion and a 21,000-square-foot ren­o­va­tion project at the API man­u­fac­tur­ing site, al­so adding 40 jobs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

Man­u­fac­tur­ing roundup: Touch­light nets $2M grant from the Gates Foun­da­tion; Ex­per­ic clos­es $14M Se­ries B

The manufacturer of the “Doggybone DNA” synthetic vector has netted deals with big names, the latest of which is a grant from the Bill & Melinda Gates Foundation to help further Touchlight’s “preclinical development” of its vaccine platform.

The vaccine program aims to build on evidence that the synthetic DNA the company produces can produce strong antibodies and durable T cell responses following vaccine administration.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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