David Enloe, Recro Pharma CEO

Re­cro takes on big broth­er role with opi­oid ad­dic­tion drug mak­er, han­dling man­u­fac­tur­ing du­ties and ad­vis­ing on FDA work

Just three weeks ago, CD­MO Re­cro Phar­ma ex­pand­ed its foot­print to the West Coast, as it ac­quired San Diego-based Irisys for $50 mil­lion cash. The deal helped the com­pa­ny branch out in­to a broad­er set of dosage forms — and now that buy­out is al­ready bear­ing fruit.

Re­cro will serve as both an ad­vi­sor to Bio­Cor­Rx in its small mol­e­cule de­vel­op­ment for its opi­ate ad­dic­tion treat­ment drug, dubbed Bicx104, in ad­di­tion to man­u­fac­tur­ing it. The sub­cu­ta­neous pel­let of nal­trex­one has been giv­en the OK by the FDA to start in-per­son tri­als, large­ly fund­ed by the Na­tion­al In­sti­tute on Drug Abuse and the NIH.

It isn’t the com­pa­ny’s first for­ay in­to the opi­oid cri­sis — in April, Re­cro an­nounced an agree­ment with San Diego-based En­sysce — but it will al­low the CD­MO to use its ex­pe­ri­ence with man­u­fac­tur­ing and FDA fil­ings to guide the small­er com­pa­ny.

“This is a per­fect ex­am­ple of why Re­cro sought to ac­quire and did ac­quire Irisys, be­cause it al­lows us to en­gage in dif­fer­ent de­liv­ery modal­i­ties and thus, widens the mar­ket that we can work in,” CEO David En­loe said in a call with End­points News. “These are four reg­is­tra­tion batch­es with the FDA, it be­comes as much about the reg­u­la­to­ry and qual­i­ty find­ings as it does about the man­u­fac­tur­ing, and that’s a place where Re­cro will bring a lot of re­source and a lot of ex­pe­ri­ence there.”

Part of what Re­cro brings to the ta­ble is the heavy lift­ing to get FDA fil­ings over the goal line. With the Irisys ac­qui­si­tion, the com­pa­ny want­ed to ex­pand in­to dif­fer­ent dosage forms. Bicx104 was a way to do just that.

“For us, it was a mat­ter of in­still­ing con­fi­dence that the com­pa­ny wasn’t go­ing to be chang­ing di­rec­tion or ad­just­ing our fo­cus,” En­loe said. “This is a per­fect tar­get client for us, it’s a small­er com­pa­ny with a need for a lot of hands-on re­la­tion­ship and trust with us.”

More than 81,000 drug over­dose deaths took place be­tween June 2019 and May 2020 in the US alone, ac­cord­ing to the CDC, an all-time high. The in­crease is par­tial­ly at­trib­uted to the Covid-19 pan­dem­ic. Bicx104 is an ex­tend­ed-re­lease pel­let that de­liv­ers nal­trex­one plas­ma lev­els for about three months. It ful­ly biode­grades, which elim­i­nates the need to re­move and re­place it over time, and has the po­ten­tial to ad­dress al­co­hol abuse as well. Bio­Cor­Rx com­pares the drug to a Russ­ian prod­uct named Prodex­tox­one on its web­site.

In a state­ment, Bio­Cor­Rx CEO Brady Granier said:

The ex­cep­tion­al ser­vice and sup­port pro­vid­ed through our on­go­ing CD­MO re­la­tion­ship have been crit­i­cal to Bio­Cor­Rx’s suc­cess­ful ad­vance­ment of our im­plantable nal­trex­one pro­gram. Re­cro’s re­cent ac­qui­si­tion of IriSys fur­ther bol­sters our con­fi­dence in our CD­MO part­ner­ship as we move BICX104 in­to the clin­i­cal stage and a step clos­er to mar­ket for pa­tients bat­tling opi­oid use dis­or­der, as well as al­co­hol use dis­or­der.

Now that it has a coast-to-coast pres­ence, Re­cro is just get­ting start­ed an­nounc­ing these types of part­ner­ships, En­loe said.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”