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.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

Endpoints Premium

Premium subscription required

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

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.