Two months ago, Or­p­hazyme en­list­ed the help of the Dan­ish courts to help over­see a re­struc­tur­ing in the wake of tri­al fail­ures, C-suite shake­ups and reg­u­la­to­ry re­jec­tions. The move was ex­pect­ed to help the com­pa­ny find a way to ei­ther sell it­self or its as­sets, at­tempt­ing to keep the re­search go­ing on what it once called its “pipeline-in-a-prod­uct.”

On Sun­day, the res­o­lu­tion of the court-run ef­forts came in­to view.

Kem­Pharm has agreed to ac­quire Or­p­hazyme and all as­sets and op­er­a­tions, the com­pa­nies an­nounced Sun­day evening, in­clud­ing the once-hyped drug can­di­date ari­mo­clo­mol. Kem­Pharm will pay $12.8 mil­lion in cash for the trans­ac­tion and as­sume li­a­bil­i­ties equal to about $5.2 mil­lion. The deal is ex­pect­ed to close be­fore June 1.

In ad­di­tion, the Flori­da-based biotech in­tends to keep on the “ma­jor­i­ty” of Or­p­hazyme’s re­main­ing em­ploy­ees, though the ex­act num­ber is not clear. End­points News has reached out for com­ment and will up­date this sto­ry ac­cord­ing­ly.

In­vestor re­ac­tion to the news was mut­ed, with Kem­Pharm shares $KMPH down rough­ly 3% in ear­ly Mon­day trad­ing.

The ac­qui­si­tion ef­fec­tive­ly marks the end of Or­p­hazyme’s sto­ry, which be­gan with high hopes for its sole drug as it pitched ari­mo­clo­mol as a po­ten­tial treat­ment for a wide range of CNS dis­eases. Though the biotech had sub­mit­ted its NDA for Nie­mann-Pick dis­ease type C, Or­p­hazyme had al­so test­ed it — or planned to test it — in ALS, Gauch­er dis­ease and in­clu­sion body myosi­tis.

Or­p­hazyme’s June 2021 CRL ap­par­ent­ly proved too tough to over­come on its own, how­ev­er. The re­jec­tion had been just one set­back in a string of bad news and fol­lowed mul­ti­ple piv­otal tri­al miss­es and its CEO’s abrupt res­ig­na­tion in late 2020. The chief ex­ec­u­tive’s re­place­ment al­so de­part­ed in Feb­ru­ary for Leo Phar­ma.

As the drug heads over to Kem­Pharm, it’s ev­i­dent from the com­pa­ny’s an­nounce­ment it be­lieves it can change ari­mo­clo­mol’s for­tunes. CEO Travis Mick­le said in a state­ment that it has “care­ful­ly eval­u­at­ed” the CRL and oth­er FDA cor­re­spon­dence and in­tends to re­sub­mit the NDA in Nie­mann-Pick dis­ease type C “as ear­ly as” the first quar­ter of 2023.

“We be­lieve the ef­fi­ca­cy sig­nal for ari­mo­clo­mol in NPC is con­vinc­ing and that there is a vi­able reg­u­la­to­ry path that could en­able a suc­cess­ful NDA re­sub­mis­sion,” Mick­le added.

Kem­Pharm is keep­ing de­tails on that po­ten­tial path­way close to the vest for now, but may have more an­swers in a Mon­day morn­ing in­vestor event. The biotech cit­ed its past ex­pe­ri­ence work­ing through CRLs as a rea­son it feels it can get ari­mo­clo­mol across the fin­ish line, al­lud­ing to strug­gles with an abuse-de­ter­rent opi­oid for acute pain.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.