Months af­ter earn­ing its first ap­proval, Idor­sia is back with a Phase III win for a dif­fer­ent, J&J-part­nered drug.

The Swiss biotech said aproci­ten­tan, its dual en­dothe­lin re­cep­tor an­tag­o­nist, has aced a late-stage tri­al in­volv­ing pa­tients with re­sis­tant hy­per­ten­sion, spurring sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in blood pres­sure on top of back­ground ther­a­py.

The topline re­sults con­firm Idor­sia’s hy­poth­e­sis that en­dothe­lin is the “miss­ing link” for pa­tients whose hy­per­ten­sion can’t be con­trolled by ex­ist­ing ther­a­pies, ac­cord­ing to CSO Mar­tine Clozel. By its es­ti­mate, by 2025 that group could to­tal 10 mil­lion in the US alone.

“I have long been con­vinced that re­sis­tant hy­per­ten­sion is on­ly re­sis­tant to treat­ment be­cause the en­dothe­lin sys­tem had not been tack­led,” she said in a state­ment. “The ob­ser­va­tion of high en­dothe­lin lev­els in pop­u­la­tions most at risk of de­vel­op­ing re­sis­tant hy­per­ten­sion, as well as the close as­so­ci­a­tion be­tween en­dothe­lin and the co­mor­bidi­ties of­ten seen in pa­tients with re­sis­tant hy­per­ten­sion, sug­gest­ed that en­dothe­lin is a key con­trib­u­tor to the prob­lem.”

J&J paid Idor­sia $230 mil­lion back in 2017 to snag com­mer­cial­iza­tion rights to the drug on the back of its $30 bil­lion buy­out of Acte­lion, which was run by the hus­band-and-wife team of CEO Jean-Paul Clozel and CSO Mar­tine Clozel. They spun out the R&D work in­to Idor­sia, and notched their first OK ear­li­er this year when the FDA ap­proved its treat­ment for in­som­nia. The EMA fol­lowed with its own en­dorse­ment days ago.

In the Phase III tri­al, which en­rolled 1,971 pa­tients, in­ves­ti­ga­tors first gave all par­tic­i­pants a fixed-dose com­bi­na­tion of a cal­ci­um chan­nel block­er (am­lodip­ine), an an­giotensin re­cep­tor block­er (val­sar­tan) and a di­uret­ic (hy­drochloroth­iazide) for at least four weeks be­fore en­ter­ing a four-week run-in pe­ri­od where place­bo was added to the back­ground ther­a­py. Pa­tients whose blood pres­sure re­mains con­sis­tent­ly high were then moved in­to the first treat­ment part of the study.

A to­tal of 730 pa­tients were ran­dom­ized to one of three groups: 12.5 mg aproci­ten­tan, 25 mg aproci­ten­tan or place­bo.

Af­ter 4 weeks of treat­ment, a sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful re­duc­tion in the pri­ma­ry end­point mea­sure of sys­tolic blood pres­sure – as­sessed by mea­sure­ment at trough of un­at­tend­ed au­to­mat­ed of­fice blood pres­sure (AOBP) – was ob­served in both the 12.5 mg (p<0.005) and 25 mg (p<0.005) aproci­ten­tan groups com­pared to place­bo.

In Part 2, all pa­tients got 25 mg aproci­ten­tan for 32 weeks, where the re­duc­tion in blood pres­sure was ob­served across groups.

Then mov­ing on­to Part 3, Idor­sia re-ran­dom­ized pa­tients so that half got place­bo again — and saw their sys­tolic blood pres­sure in­crease.

“This pro­vid­ed repli­ca­tion of the treat­ment ef­fect of aproci­ten­tan and con­firmed its durable an­ti­hy­per­ten­sive ef­fect,” the com­pa­ny wrote.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung — of Medivation fame — has run into its first setback.

San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.