David Veitch, Basilea CEO

Swiss phar­ma Basilea sheds yet an­oth­er on­col­o­gy pro­gram as an­ti-in­fec­tives piv­ot plows for­ward

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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