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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.

Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,600+ biopharma pros reading Endpoints daily — and it's free.