Fol­low­ing its Eu­ro­pean ap­proval last Sep­tem­ber, Bris­tol My­ers Squibb has de­cid­ed not to launch Op­du­alag, an in­fu­sion of the phar­ma gi­ant’s Op­di­vo and new an­ti­body re­latlimab, in Ger­many due to pric­ing pres­sures. The drug won ap­proval to treat ad­vanced melanoma in adults and ado­les­cents aged 12 years and old­er.

Per a Bris­tol My­ers spokesper­son, Op­du­alag won’t be mar­ket­ed in Ger­many “for the fore­see­able fu­ture,” as the coun­try’s drug pric­ing law from 2010 makes it so that the phar­ma gi­ant “sees no pos­si­bil­i­ty to achieve a ben­e­fit rat­ing from the G-BA [Gemein­samer Bun­de­sauss­chuss] for Op­du­alag.”

Not in­clud­ing that ben­e­fit rat­ing from the G-BA means the price reg­u­la­tor does not think Op­du­alag has any ad­di­tion­al ben­e­fit over its ap­pro­pri­ate com­para­tor (“prefer­ably a ther­a­py for which end­point stud­ies are avail­able and which has proved ben­e­fi­cial in prac­ti­cal use,” the Ger­man reg­u­la­tor’s Eng­lish web­site says), so the drug’s year­ly treat­ment costs can­not be high­er than what it is be­ing com­pared to.

Part of the rea­son is due to BMS’ use of pro­gres­sion-free sur­vival (PFS) in mea­sur­ing Op­du­alag’s ef­fi­ca­cy. A BMS spokesper­son said that while the com­bo drug demon­strat­ed sta­tis­ti­cal­ly-sig­nif­i­cant PFS over an­ti-PD-1 monother­a­py in pa­tients with ad­vanced melanoma, the AMNOG law does not con­sid­er PFS a “pa­tient-rel­e­vant end­point.”

Bris­tol My­ers added:

Our goal is to make Op­du­alag avail­able to ap­pro­pri­ate adult and ado­les­cent ad­vanced melanoma pa­tients in coun­tries around the world where it is ap­proved for use. We are dis­ap­point­ed that this is not pos­si­ble in Ger­many at this time due to the cur­rent ben­e­fit as­sess­ment sys­tem and re­cent GKV-Fin­StG re­forms. We re­main open to re­con­sid­er­ing should that change in the fu­ture.

Ac­cord­ing to the Mu­nich-based lawyer Ga­bor Kiss, last No­vem­ber, the new GKV Fi­nan­cial Sta­bi­liza­tion Act (GKV-Fin­StG) law came in­to ef­fect, and one of its pro­vi­sions al­so set an ad­di­tion­al 20% re­bate for drugs that are used as a com­bi­na­tion reg­i­men and that ful­fill cer­tain cri­te­ria. BMS’ Op­du­alag could have po­ten­tial­ly ful­filled those cri­te­ria if the com­pa­ny had gone through the process.

BMS Ger­many’s gen­er­al man­ag­er Neil Archer said in an email, “Phar­ma­ceu­ti­cal in­no­va­tion needs long-term plan­ning hori­zons. And long-term plan­ning hori­zons need sta­ble frame­work con­di­tions.” Archer added that Ger­many is a lo­ca­tion where “phar­ma­ceu­ti­cal in­no­va­tion and in­vest­ment is rec­og­nized has de­te­ri­o­rat­ed sig­nif­i­cant­ly.”

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.