Aca­cia Phar­ma's twice spurned drug fi­nal­ly makes the FDA cut

Third time’s the charm for Aca­cia Phar­ma.

The Cam­bridge, UK-based com­pa­ny on Thurs­day fi­nal­ly se­cured FDA ap­proval for its treat­ment for pa­tients with post­op­er­a­tive nau­sea & vom­it­ing (PONV), who are symp­to­matic de­spite hav­ing re­ceived pro­phy­lac­tic treat­ment.

The drug, an in­tra­venous for­mu­la­tion of the se­lec­tive dopamine D2 and D3 an­tag­o­nist amisul­pride, was shown to help pa­tients in four pos­i­tive piv­otal clin­i­cal tri­als by 2017. But man­u­fac­tur­ing trou­bles re­peat­ed­ly hob­bled the com­pa­ny’s quest to get the ther­a­py — brand­ed Barhem­sys — on to the US mar­ket.

In late 2017, Aca­cia sub­mit­ted an FDA ap­pli­ca­tion to mar­ket the drug — de­signed to help the 30-40% of sur­gi­cal pa­tients who suf­fer from PONV de­spite pri­or pro­phy­lax­is, as well as for com­bi­na­tion pro­phy­lax­is in high-risk pa­tients — on­ly to re­ceive a re­jec­tion in Oc­to­ber 2018.

The US agency made its de­ci­sion based on a pre-ap­proval in­spec­tion of a fa­cil­i­ty run by the con­tract man­u­fac­tur­er of the drug’s main in­gre­di­ent — amisul­pride — and not on clin­i­cal or non-clin­i­cal da­ta in the ap­pli­ca­tion, as­sured Aca­cia in a press re­lease, adding that the FDA had asked for no ex­tra stud­ies or da­ta analy­ses re­lat­ed to the treat­ment.

Ju­lian Gilbert

With re­newed en­thu­si­asm lat­er that month, Aca­cia’s con­tract man­u­fac­tur­er had agreed to “in­sti­tute a cor­rec­tive and pre­ven­tive ac­tion plan that will rec­ti­fy the de­fi­cien­cy iden­ti­fied as quick­ly as pos­si­ble. We con­tin­ue to plan for a launch in the first half of 2019,” Aca­cia chief Ju­lian Gilbert said in a state­ment.

Aca­cia then re­sub­mit­ted its mar­ket­ing ap­pli­ca­tion in De­cem­ber, in­di­cat­ing that the FDA’s con­cerns out­lined in the com­plete re­sponse let­ter had been re­solved. But in May 2019, the com­pa­ny re­ceived an­oth­er re­jec­tion, with the FDA flag­ging the same con­cerns.

“We are on track to com­plete the qual­i­fi­ca­tion of an al­ter­na­tive sup­pli­er of amisul­pride and plan to en­gage with FDA as soon as pos­si­ble to de­ter­mine the most rapid route to ob­tain­ing ap­proval,” Gilbert said in a state­ment at the time.

Now with the ap­proval in tow, Aca­cia said it ex­pects to launch the ther­a­py in the sec­ond half of this year.

Aca­cia Phar­ma’s sec­ond prod­uct, remi­ma­zo­lam in­jec­tion, is cur­rent­ly un­der re­view by the FDA for use in pro­ce­dur­al se­da­tion.

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New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

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Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

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The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

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The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

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The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.