Act­ing on its plans to dis­card its on­col­o­gy pipeline, Swiss com­pa­ny Basilea Phar­ma­ceu­ti­ca has de­cid­ed to sell its can­cer drug BAL0891 to Ko­re­an biotech Sil­la­Jen for $14 mil­lion up­front.

Basilea had an­nounced its de­ci­sion to ditch its on­col­o­gy pipeline in Feb­ru­ary, as a part of a re­or­ga­ni­za­tion of its R&D pipeline around an­ti-in­fec­tives, in­clud­ing its two ap­proved drugs in that space. Tues­day’s sale will al­so fetch Basilea ad­di­tion­al mile­stone pay­ments of up to $320 mil­lion and tiered roy­al­ties on net sales.

Adesh Kaul

“This trans­ac­tion marks an im­por­tant step on our path to be a fo­cused an­ti-in­fec­tives com­pa­ny,” said Basilea’s CFO Adesh Kaul in a press state­ment.

Basilea had ini­tial­ly in-li­censed the drug in 2018 from a Dutch com­pa­ny called NTRC Ther­a­peu­tics. Un­der this col­lab­o­ra­tion, NTRC was el­i­gi­ble to re­ceive mile­stones up to CHF 170 mil­lion ($175 mil­lion) and roy­al­ties.

Since then, Basilea hand­held the drug in­to get­ting an IND from the FDA in 2021, al­low­ing it to start a Phase I clin­i­cal tri­al. While Basilea had planned to ini­ti­ate the tri­al in the first quar­ter of 2022, it is un­clear how that will progress with the new Sil­la­Jen deal in place.

Mean­while, Basilea has al­so de­cid­ed to sell the in­tel­lec­tu­al prop­er­ty rights from the NTRC deal to Sil­la­Jen, ac­cord­ing to the press state­ment. Basilea, how­ev­er, will re­main re­spon­si­ble for mak­ing mile­stone and roy­al­ty pay­ments to NTRC.

BAL0891 is a mi­tot­ic check­point in­hibitor de­signed to push cells through mi­to­sis with­out ad­e­quate time for cor­rect chro­mo­some seg­re­ga­tion. This will, the biotech con­tends, re­sult in aber­rant tu­mor cell di­vi­sion lead­ing to tu­mor cell death. Pre­clin­i­cal stud­ies had shown po­ten­tial across mul­ti­ple can­cer types such as breast, gas­tric and col­orec­tal can­cer.

Basilea has been steadi­ly get­ting rid of its oth­er on­col­o­gy pro­grams as well. On Sept. 8, Basilea an­nounced it had sold its nov­el PARG in­hibitor dis­cov­ery pro­gram to the UK-based Nodus On­col­o­gy for CHF 242 mil­lion ($250 mil­lion). PARG is an en­zyme es­sen­tial in the re­pair of DNA dam­age, and its in­hi­bi­tion leads to an­ti-can­cer ef­fects.

The com­pa­ny al­so said it was not go­ing to ex­pand the stud­ies on its oth­er on­col­o­gy drug lisa­van­bu­lin. Along the same lines, Baselia al­so an­nounced it had de­cid­ed to scrap a li­cens­ing deal for one of its oth­er can­cer drugs, de­r­azan­ti­nib, and re­turn the rights to Mer­ck by the end of the year.

Basilea had said its re­struc­tur­ing plans would cut its op­er­at­ing ex­pens­es by rough­ly 30% in 2023, aim­ing to put the com­pa­ny on the path to prof­itabil­i­ty.

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.