De­mo­c­rat Mar­cy Kap­tur of Ohio joined with Re­pub­li­can Andy Har­ris of Mary­land in pen­ning a new let­ter to At­tor­ney Gen­er­al Mer­rick Gar­land rais­ing fresh con­cerns about the most re­cent opi­oid set­tle­ments that re­quire Te­va Phar­ma­ceu­ti­cals to pro­vide more than $200 mil­lion worth of nalox­one sup­plies to just three states over 10 years, and which might cre­ate short­ages else­where.

Mar­cy Kap­tur

The let­ter, first ob­tained by End­points News, ques­tions what Gar­land’s plans are mov­ing for­ward, es­pe­cial­ly con­sid­er­ing Con­gress pre­vi­ous­ly raised warn­ings in Au­gust 2020 that man­u­fac­tur­ers sup­ply­ing MAT drugs to states at no cost in lieu of pay­ing out their set­tle­ments could cre­ate bot­tle­necks in sup­plies.

“At that time, con­cerns cen­tered on the im­pact of glob­al opi­oid set­tle­ment and FDA re­spond­ed that this would be bet­ter posed to the De­part­ment of Jus­tice (DOJ). These same con­cerns have es­ca­lat­ed in light of re­cent an­nounce­ments that mul­ti­ple states — Flori­da, Rhode Is­land and Texas — are al­low­ing the drug man­u­fac­tur­er to not on­ly pro­vide MAT treat­ment drugs but al­so opi­oid re­ver­sal agents, like nalox­one,” Kap­tur and Har­ris wrote.

Most re­cent­ly, Te­va agreed to pay part of its set­tle­ment with the state of Flori­da by pro­vid­ing gener­ic Nar­can (nalox­one hy­drochlo­ride nasal spray) val­ued at $84 mil­lion (whole­sale ac­qui­si­tion cost) over 10 years. Rhode Is­land’s AG sim­i­lar­ly agreed to a deal where Te­va will sup­ply 50,000 kits of Nalox­one (100,000 nasal sprays) per year for 10 years, val­ued at $62.5 mil­lion, as well as opi­oid treat­ment Sub­ox­one val­ued at $16 mil­lion over 10 years.  And in Texas, the state will get $75 mil­lion worth of Nar­can from Te­va over 10 years.

Andy Har­ris

“The un­in­tend­ed con­se­quences that could re­sult from these mis­guid­ed set­tle­ments are even more con­cern­ing,” the rep­re­sen­ta­tives wrote. “Al­low­ing one com­pa­ny to pro­vide free drugs to en­tire pa­tient pop­u­la­tions is tak­ing a vi­tal­ly im­por­tant choice away from physi­cians and pa­tients. These set­tle­ments span 10 or 15 years, de­pend­ing on the agree­ment, fun­da­men­tal­ly al­ter­ing the mar­ket and sti­fling in­no­va­tion in that space.”

And Kap­tur and Har­ris are ask­ing whether the DOJ has the au­thor­i­ty it needs to as­sess the im­pact that these set­tle­ments will have on the MAT and nalox­one mar­kets.

Mean­while, the FDA may need more con­gres­sion­al au­thor­i­ty to en­sure that opi­oids com­ing to mar­ket are bet­ter than what’s cur­rent­ly avail­able, com­mis­sion­er Rob Califf said at a hear­ing last week.

Sen. Mike Braun (R-IN) agreed that the FDA could use this ad­di­tion­al au­thor­i­ty to rein in opi­oid ap­provals as the cri­sis led to more than 100,000 over­dose deaths in 2021, ac­cord­ing to the CDC.

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

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.