Kevin Ali, Organon CEO

Organon inks $103M deal for per­tuzum­ab and deno­sum­ab biosim­i­lars

Organon is look­ing to boost its biosim­i­lar port­fo­lio with two well-known brand copies in de­vel­op­ment by Shang­hai-based Hen­lius Biotech.

The women’s health phar­ma is pay­ing $73 mil­lion up­front, plus up to $30 mil­lion in 2022 mile­stone pay­ments, for the per­tuzum­ab biosim­i­lar to Roche’s Genen­tech’s breast can­cer drug Per­je­ta and the deno­sum­ab biosim­i­lar to Am­gen’s Pro­lia for os­teo­poro­sis and Xge­va for bone prob­lem pre­ven­tion in can­cer.

The deal al­so in­cludes an op­tion to ne­go­ti­ate for ex­clu­sive Yer­voy biosim­i­lar rights. Yer­voy, or ip­il­i­mum­ab, is Bris­tol My­ers Squibb’s CT­LA-4 tar­get­ed can­cer med which it most of­ten mar­kets as an ad­ju­vant in com­bi­na­tion with its PD-1 in­hibitor Op­di­vo and chemother­a­py. The Op­di­vo plus Yer­voy com­bi­na­tion is ap­proved in sev­er­al dif­fer­ent ther­a­py ar­eas in­clud­ing cer­tain types of non-small cell lung and col­orec­tal can­cers.

Organon CEO Kevin Ali said in a state­ment, “Biosim­i­lars are a key growth pil­lar for Organon, and this col­lab­o­ra­tion rep­re­sents the suc­cess­ful ex­e­cu­tion of our strat­e­gy to ex­pand our biosim­i­lars port­fo­lio lever­ag­ing our strong glob­al foot­print and deep com­mer­cial ex­per­tise.”

Still, it may be some time away be­fore that hap­pens — both Hen­lius biosim­i­lars are still in ear­ly-stage de­vel­op­ment. Per­tuzum­ab is fur­ther along with Phase I suc­cess­ful end­points and re­cent­ly be­gun Phase III and the first sub­ject was dosed in April, ac­cord­ing to Hen­lius’ press re­lease. Hen­lius is test­ing deno­sum­ab with a clin­i­cal tri­al list­ed, which be­gan in April with re­sults ex­pect­ed in 2024.

Organon said in an email to End­points News that the plan is aim­ing for ap­proval in sev­en mar­kets — US, Cana­da, UK, Ger­many, France, Italy and Spain — with “mid-2020s” mar­ket launch­es ex­pect­ed for both biosim­i­lars.

A 2022 Car­di­nal Health re­port on biosim­i­lars es­ti­mates a first Pro­lia/Xge­va biosim­i­lar on the mar­ket in 2025 the same year its patent ex­clu­siv­i­ty ends in the US. Sev­er­al oth­ers in­clud­ing Sam­sung Bioepis are pur­su­ing the po­ten­tial­ly lu­cra­tive bone treat­ment. Am­gen re­port­ed $873 mil­lion in glob­al sales for Pro­lia and $545 mil­lion for Xge­va in 2021.

Per­je­ta is set to lose mar­ket ex­clu­siv­i­ty in the US in 2024. Roche re­port­ed sales of 4 bil­lion francs ($4 bil­lion) for 2021.

Organon, which spun out of Mer­ck last year, re­peat­ed its first-quar­ter change in re­gards to the Hen­lius deal that it “will no longer ex­clude ex­pens­es for up­front and mile­stone pay­ments re­lat­ed to col­lab­o­ra­tions and li­cens­ing agree­ments.” This means the po­ten­tial $103 mil­lion deal is not in­clud­ed in its 2022 guid­ance.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

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.

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

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.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

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.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.