Gilead is mount­ing its coun­ter­feit drug law­suit, nam­ing two “king­pins” and a com­plex net­work of con­spir­a­tors who al­leged­ly sold im­i­ta­tion bot­tles of its HIV meds, some of which end­ed up in US phar­ma­cies.

The phar­ma gi­ant on Wednes­day pro­vid­ed an up­date on what it called a “large-scale, so­phis­ti­cat­ed coun­ter­feit­ing con­spir­a­cy,” ac­cus­ing two new de­fen­dants of “lead­ing and or­ches­trat­ing” a scheme to sell hun­dreds of mil­lions of dol­lars in il­le­git­i­mate drugs pos­ing as meds such as Bik­tarvy and De­scovy.

Two Flori­da men, Lazaro Rober­to Her­nan­dez and Ar­man­do Her­rera, were named as “king­pin de­fen­dants” in re­cent­ly un­sealed court doc­u­ments and ac­cused of set­ting up and con­trol­ling a se­ries of “fly-by-night” whole­salers to sell the coun­ter­feit meds.

Ann Don­nel­ly

Back in Au­gust, US Dis­trict Judge Ann Don­nel­ly froze the as­sets of more than 50 new­ly named de­fen­dants, ac­cord­ing to the un­sealed doc­u­ments, in­clud­ing Her­nan­dez and Her­rera.

Gilead first filed suit back in Ju­ly 2021, and ear­li­er this year al­leged that de­fen­dants have sold more than 85,000 bot­tles of coun­ter­feit Gilead meds. The de­fen­dants al­leged­ly sold au­then­tic-look­ing bot­tles, pur­chased il­le­gal­ly from pa­tients, with coun­ter­feit doc­u­men­ta­tion, ac­cord­ing to a new com­plaint. In some cas­es, those bot­tles con­tained com­plete­ly dif­fer­ent drugs, ei­ther a gener­ic painkiller or high-dose tablets of the an­tipsy­chot­ic Sero­quel.

The an­tipsy­chot­ic can cause se­da­tion, drowsi­ness and oth­er se­ri­ous prob­lems when tak­en in com­bi­na­tion with oth­er drugs or at high dos­es. One pa­tient who un­know­ing­ly took the an­tipsy­chot­ic af­ter re­ceiv­ing a coun­ter­feit bot­tle of Bik­tarvy was un­able to speak or walk af­ter­ward, Gilead said in its first com­plaint.

While fed­er­al law re­quires pre­scrip­tion drugs to come with a pedi­gree, or a doc­u­ment track­ing every sale, de­fen­dants al­leged­ly dis­trib­uted bot­tles with fal­si­fied pedi­grees that claimed to trace the coun­ter­feits to an au­then­tic source.

“Gilead will con­tin­ue to work close­ly with the U.S. Food and Drug Ad­min­is­tra­tion (FDA), phar­ma­cies and the De­part­ment of Jus­tice to re­move coun­ter­feit and tam­pered med­ica­tion from cir­cu­la­tion and to pre­vent fu­ture dis­tri­b­u­tion of coun­ter­feit med­ica­tions,” the com­pa­ny said in a state­ment on Wednes­day.

Bik­tarvy was ap­proved for the treat­ment of HIV back in 2018, and Gilead spent a pri­or­i­ty re­view vouch­er a year lat­er to get De­scovy on the mar­ket for both treat­ment and pre­ven­tion. The drugs earned Gilead $2 bil­lion and $397 mil­lion in the US last quar­ter, re­spec­tive­ly.

“In­di­vid­u­als who be­lieve they have been dis­pensed a coun­ter­feit Gilead med­ica­tion should im­me­di­ate­ly re­port the med­i­cine to their health­care provider, phar­ma­cy and Gilead Prod­uct Qual­i­ty Com­plaints,” Gilead said Wednes­day.

Au­then­tic Bik­tarvy tablets are pur­plish-brown and cap­sule-shaped with the num­bers “9883” writ­ten on one side and “GSI” on the oth­er, ac­cord­ing to Gilead. De­scovy tablets are blue and rec­tan­gu­lar with “225” on one side and “GSI” on the oth­er.

Gilead has is­sued a list of trust­ed dis­trib­u­tors, in­clud­ing the big firms Car­di­nal Health, Amerisource­Ber­gen and McKesson.

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.