On top of hun­dreds of law­suits waged by state and lo­cal gov­ern­ments, sev­er­al ma­jor drug­mak­ers and dis­trib­u­tors are now fac­ing a fed­er­al crim­i­nal probe for their role in per­pet­u­at­ing the opi­oid cri­sis.

Fed­er­al pros­e­cu­tors in Brook­lyn are in­ves­ti­gat­ing whether phar­ma com­pa­nies have vi­o­lat­ed the Con­trolled Sub­stance Act — a pro­vi­sion nor­mal­ly re­served for drug deal­ers ac­cord­ing to ex­perts — by in­ten­tion­al­ly al­low­ing their opi­oids to flood com­mu­ni­ties, the Wall Street Jour­nal first re­port­ed. As it turned out, at least six com­pa­nies in­clud­ing J&J, Te­va, Mallinck­rodt, Am­neal and the dis­trib­u­tors McKesson and Amerisource­Ber­gen have dis­closed in re­cent SEC fil­ings that they have re­ceived grand ju­ry sub­poe­nas from the US At­tor­ney’s Of­fice for the East­ern Dis­trict of New York.

John Kapoor In­sys

No­tably, John Kapoor — the founder and for­mer chair­man of In­sys — was con­vict­ed of vi­o­lat­ing the Con­trolled Sub­stances Act but a fed­er­al judge has over­turned that part of his con­vic­tion (leav­ing charges of con­spir­a­cy, wire and mail fraud, for­fei­ture and rack­e­teer­ing in­tact).

Be­tween April and Au­gust of this year, the afore­men­tioned six com­pa­nies were asked to turn over doc­u­ments re­lat­ed to their an­ti-di­ver­sion poli­cies and pro­ce­dures and dis­tri­b­u­tion of their opi­oid med­ica­tion.

J&J and Te­va wrote that they un­der­stand the sub­poe­nas to be “part of a broad­er in­ves­ti­ga­tion in­to man­u­fac­tur­ers’ and dis­trib­u­tors’ mon­i­tor­ing pro­grams and re­port­ing un­der the Con­trolled Sub­stances Act.” The Mallinck­rodt, Am­neal and McKesson fil­ings al­so con­tained ver­sions of the state­ment, while Amerisource­Ber­gen didn’t spec­i­fy the na­ture of the probe.

Crim­i­nal charges, if they were to re­sult from the in­ves­ti­ga­tion, would mark a sig­nif­i­cant es­ca­la­tion in the le­gal tac­tics de­ployed against high-pro­file play­ers ac­cused of fu­elling the opi­oid epi­dem­ic. Ac­cord­ing to the CDC, pre­scrip­tion opi­oids led to 218,000 deaths in the US from 1999 to 2017.

Ear­li­er this year the US At­tor­ney in Man­hat­tan charged Rochester Drug Co­op­er­a­tive, the sixth-largest drug whole­saler in the US, with dis­trib­ut­ing nar­cotics that it knew “were be­ing sold and used il­lic­it­ly” and fail­ing to re­port these im­prop­er us­es to au­thor­i­ties. Two for­mer ex­ecs were al­so in­dict­ed for crim­i­nal of­fens­es.

The of­fice called the case “the first of its kind” as it es­sen­tial­ly charged a phar­ma­ceu­ti­cal dis­trib­u­tor and its ex­ecs for drug traf­fick­ing.

It’s a sig­nif­i­cant de­par­ture from the types of lit­i­ga­tion that opi­oid mak­ers such as Pur­due Phar­ma have faced, in which their ag­gres­sive sales tac­tics were blamed for caus­ing phys­i­cal and fi­nan­cial harm to the plain­tiffs. Pur­due, whose mar­ket­ing strate­gies for Oxy­Con­tin were wide­ly con­sid­ered to have plant­ed mis­con­cep­tions about the ad­dic­tive na­ture of opi­oids across the med­ical com­mu­ni­ty, has filed for bank­rupt­cy as the first step of a $10 bil­lion set­tle­ment that’s still un­der dis­pute.

John Kapoor, the high­est-rank­ing phar­ma ex­ec to be con­vict­ed in an opi­oid-re­lat­ed case so far, was most in­fa­mous for cook­ing up an elab­o­rate scheme to bribe doc­tors — go­ing so far as of­fer­ing lap dances — in­to pre­scrib­ing their pow­er­ful drug for can­cer pain, Sub­sys, to pa­tients who didn’t even have can­cer.

But a ju­ry al­so found him guilty of vi­o­lat­ing the Con­trolled Sub­stances Act. US Dis­trict Court Judge Al­li­son Bur­roughs over­turned it on Tues­day, rul­ing that pros­e­cu­tors had failed to prove that they had the in­tent to dis­trib­ute the drug for non-le­git­i­mate us­es.

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.