Fre­se­nius Kabi pays $50 mil­lion to set­tle crim­i­nal charges

An In­di­an drug man­u­fac­tur­er has agreed to pay $50 mil­lion in fines and for­fei­tures, the US De­part­ment of Jus­tice an­nounced Tues­day. Fre­se­nius Kabi On­col­o­gy Lim­it­ed (FKOL) plead guilty to con­ceal­ing and de­stroy­ing records; the charges came in the wake of a 2013 US FDA in­spec­tion of its plant in Kalyani, In­dia.

Bri­an Boyn­ton

“By hid­ing and delet­ing man­u­fac­tur­ing records, FKOL sought to ob­struct the FDA’s reg­u­la­to­ry au­thor­i­ty and pre­vent the FDA from do­ing its job of en­sur­ing the pu­ri­ty and po­ten­cy of drugs in­tend­ed for U.S. con­sumers,” said Act­ing As­sis­tant At­tor­ney Gen­er­al Bri­an Boyn­ton of the Jus­tice De­part­ment’s Civ­il Di­vi­sion in a press re­lease an­nounc­ing FKOL’s guilty plea. “FKOL’s con­duct put vul­ner­a­ble pa­tients at risk. The De­part­ment of Jus­tice will con­tin­ue to work with the FDA to pros­e­cute drug man­u­fac­tur­ers who ob­struct these in­spec­tions.”

The of­fens­es are fed­er­al mis­de­meanors. Ac­cord­ing to the De­part­ment of Jus­tice and the FDA, FKOL sys­tem­at­i­cal­ly re­moved records and equip­ment from Kalyani plant premis­es in ad­vance of a Jan­u­ary 2013 FDA in­spec­tion. “Kalyani plant em­ploy­ees re­moved com­put­ers, hard­copy doc­u­ments, and oth­er ma­te­ri­als from the premis­es and delet­ed spread­sheets that con­tained ev­i­dence of the plant’s vi­ola­tive prac­tices,” ac­cord­ing to the Jus­tice De­part­ment an­nounce­ment.

Af­ter that in­spec­tion, the firm re­ceived a Ju­ly 2013 warn­ing let­ter from the FDA de­tail­ing the many ir­reg­u­lar­i­ties ob­served by in­spec­tors on their Jan­u­ary vis­it to Kalyani. Among the prob­lems found by the FDA was FKOL’s prac­tice of blend­ing failed batch­es of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) with batch­es that had passed spec­i­fi­ca­tions, so that fi­nal tests for im­pu­ri­ties would meet spec­i­fi­ca­tion.

Al­so, FKOL staff used test and “de­mo” chro­matogram da­ta files that were ac­tu­al­ly in­ject­ed be­fore the sam­ple in­jec­tions, and “used to con­clude that batch­es were in con­for­mance with the spec­i­fi­ca­tion, said the FDA.

“Dur­ing the in­spec­tion your firm al­so re­peat­ed­ly de­layed, de­nied, lim­it­ed or re­fused to pro­vide in­for­ma­tion to the FDA in­ves­ti­ga­tors,” wrote the FDA, cit­ing sev­er­al ex­am­ples of these prac­tices in the let­ter.

As not­ed in the De­part­ment of Jus­tice fil­ings against FKOL, equip­ment was re­moved from the fa­cil­i­ty in ad­vance of the in­spec­tions, a find­ing al­so cit­ed by the FDA in its warn­ing let­ter: “You have al­so re­cent­ly in­formed us that High Pres­sure Liq­uid Chro­matog­ra­phy units and PCs were re­moved from the fa­cil­i­ty for the du­ra­tion of the in­spec­tion to con­ceal da­ta ma­nip­u­la­tions. This ac­tion, which ap­par­ent­ly al­so oc­curred in as­so­ci­a­tion with past in­spec­tions, is very wor­ri­some to us and should be ex­plained in your re­sponse to this let­ter.”

The Kalyani FKOL plant was cit­ed again in a De­cem­ber 2017 warn­ing let­ter for fail­ure to in­ves­ti­gate and doc­u­ment out-of-spec­i­fi­ca­tion re­sults; here, in­ves­ti­ga­tors found about 248 in­stances of abort­ed chro­mato­graph­ic se­quences not jus­ti­fied by ma­chine mal­func­tion or oth­er prob­lems. The 2017 let­ter al­so found in­ad­e­quate test pro­ce­dures.

Not­ing the de­fi­cien­cies iden­ti­fied in the 2013 warn­ing let­ter, the FDA said in 2017, “These re­peat­ed fail­ures demon­strate that your fa­cil­i­ty’s over­sight and con­trol over the man­u­fac­ture of drugs is in­ad­e­quate.”

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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