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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

(Image: Shutterstock)

Suf­fer­ing in si­lence: COPD pa­tients face fre­quent symp­toms, dis­sat­is­fac­tion with meds, but don't talk to docs — sur­vey

Most COPD patients suffer symptoms daily, but contrary to the typical advice doled out in pharma TV commercials, they’re not talking to their doctors about it. A new Phreesia point-of-care survey finds that fewer than half (44%) of chronic obstructive pulmonary disease (COPD) patients have detailed discussions about symptoms with their doctors.

Meanwhile, two-thirds of patients said COPD has a “substantial impact” on their everyday lives.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.