After investing in their Series B, Lilly bags a license for a batch of metabolic candidates

Xiayang Qiu, Regor Therapeutics CEO

Eli Lil­ly will li­cense in Re­gor Ther­a­peu­tics ther­a­pies for meta­bol­ic dis­or­ders, as a part of an agree­ment an­nounced Fri­day that will give the Chi­nese biotech an up­front pay­ment of up to $50 mil­lion, part of which is an eq­ui­ty in­vest­ment.

In a vague­ly word­ed re­lease, Lil­ly said it has a li­cense for cer­tain Re­gor ‘in­tel­lec­tu­al prop­er­ty’ and will have an op­tion to ex­tend that li­cense. In ex­change, Lil­ly will over­see glob­al clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion for any ther­a­pies, with the ex­cep­tion of Chi­na, Macau, Hong Kong and Tai­wan. Re­gor, a Shang­hai-based com­pa­ny, will re­serve the rights to these re­gions.

The com­pa­ny is el­i­gi­ble for up to $1.5 bil­lion in po­ten­tial pay­ments based on pre­clin­i­cal, clin­i­cal and com­mer­cial mile­stones, as well as tiered roy­al­ties from sales.

Re­gor CEO Xi­ayang Qiu said that the col­lab­o­ra­tion is, in part, a recog­ni­tion of Re­gor’s core tech­nol­o­gy, the Com­put­er Ac­cel­er­at­ed Ra­tio­nal Dis­cov­ery plat­form. CARD, an­oth­er in a long line of fan­ci­ly named biotech com­pu­ta­tion­al plat­forms, is de­signed to cre­ate a more ef­fi­cient process for the dis­cov­ery of new drugs. Through CARD, the team has ad­vanced a num­ber of prod­ucts in its pipeline in just two years, in­clud­ing RGT-587 for on­col­o­gy, which is set to en­ter Phase I tri­als, and and RGT-075 to tar­get a glucagon-like pep­tide 1 re­cep­tor hor­mone, which stim­u­lates glu­cose-in­duced in­sulin se­cre­tion. That can­di­date is en­ter­ing Phase II/III tri­als. The com­pa­ny was found­ed in 2018 by a team that in­cludes two Pfiz­er vet­er­ans and three — Qiu and Min Zhong, and CTO Wenge Zhong — who used to work for Am­gen’s Chi­nese R&D op­er­a­tions. Re­gor’s fo­cus so far has been on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases.

‘Re­gor’s tech­nol­o­gy will al­so al­low Lil­ly to fur­ther ac­cel­er­ate in­no­va­tion and de­liv­er break­through ther­a­pies in obe­si­ty and di­a­betes,’ Ruth Gi­meno, the VP of di­a­betes re­search at Lil­ly, said in a state­ment. In Feb­ru­ary, Lil­ly Asia Ven­tures led the Se­ries B fundrais­ing round, in which the com­pa­ny raised $90 mil­lion to back their clin­i­cal de­vel­op­ment. It al­so land­ed an in­vest­ment from Loy­al Val­ley Cap­i­tal, a com­pa­ny that played a role in fi­nanc­ing the so­cial me­dia video app Tik­Tok, and was list­ed as a top-10 in­flu­en­tial pri­vate eq­ui­ty firm in Chi­na.

‘To­geth­er we are work­ing hard for a bet­ter world by in­no­v­a­tive and trans­for­ma­tive med­i­cines which make mean­ing­ful im­pacts to pa­tients glob­al­ly,’ Loy­al Val­ley founder Andy Lin said in a state­ment at the time.

House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images)

Back in January 2019, the late House Oversight Committee chair Elijah Cummings kicked off a nearly 3-year-long drug pricing investigation that culminated today in a major new report detailing how prices for vital drugs have risen substantially since their launch, while calling on the Senate to pass a bill that will allow Medicare to negotiate some prices.

The committee’s investigation focused on 12 of the most expensive drugs for Medicare, showing massive price spikes that have accumulated over the years and made some drugs, like insulin, entirely unaffordable for some, to the point where some diabetics have had to ration their life-saving insulin, and some have died.

Andreas and Thomas Strüngmann (via Agreus Group)

While the ultimate fate of Novartis’ big generics arm Sandoz may still be up in the air, there’s no doubt it’s in play as a potential buyout target.

Overnight, Reuters picked up on a report out of Germany that EQT and the billionaire Strüngmann brothers — enjoying a huge windfall from the overnight success of BioNTech’s mRNA Covid vaccine — are kicking the tires at Sandoz. And Novartis CEO Vas Narasimhan confirmed they’ve seen some M&A interest, even if no hard offers are on the table.

Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients. The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers. A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Bristol Myers Squibb brought in more than $9 billion in sales from its anticoagulant Eliquis in 2020, and it continues to see growth with more than $8 billion in sales in the first nine months of 2021 (and another nearly $4.5 billion for Pfizer in 2021).

But in 2022, one of the largest PBMs in the US, CVS Caremark, has recently decided to no longer cover the megablockbuster, and instead will only offer coverage for warfarin and Janssen’s Xarelto.

Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.

Roche’s Genentech got a leg up in the packed anti-TIGIT race earlier this year when the FDA granted it the first breakthrough designation in the field based on some upbeat mid-stage data in non-small cell lung cancer. Now, looking to keep its lead, the pharma giant is offering a two-and-a-half-year look at the same patient group — but will two deaths crush its chances?

A combination of Genentech’s anti-TIGIT cancer tiragolumab plus PD-L1 inhibitor Tecentriq reduced patients’ risk of disease progression or death by 38% compared to those who received Tecentriq alone at a median follow-up of 2.5 years, the company said on Friday. In a pre-specified exploratory analysis of participants with high levels of PD-L1, the combo reduced the risk of disease worsening or death by 71% compared to the Tecentriq group.

Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.

Vlad Coric, Biohaven chariman and CEO

Days after reporting positive Phase III results for intranasal migraine med zavegepant, Biohaven chairman and CEO Vlad Coric is talking about marketing plans. It’s a month or more before Biohaven will file for FDA approval and likely a year before launch, but Coric is already thinking about messaging and commercialization.

His plan? A dual strategy to attract potential patients around speed to relief – zavegepant study results show the spray can provide relief in as fast as 15 minutes and a return to normal in 30 minutes – along with a secondary anti-nausea benefit in using an intranasal versus a pill.

Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.

Mathai Mammen, J&J EVP of pharmaceuticals, R&D (Rob Tannenbaum)

The new J&J has a fresh corporate face to show the public — several in fact.

As the healthcare conglomerate follows a now familiar pharma path in separating itself into an innovation-focused R&D-based group from its less appealing consumer side, it’s promoting some key individuals to the executive committee that steers the company.

Those fresh faces include Mathai Mammen, the global head of R&D who joins the inner circle as executive vice president of pharmaceuticals, R&D. External innovation chief Bill Hait becomes executive vice president, chief external innovation, medical safety and global public health officer. Jim Swanson, until today simply the chief information officer, adds the EVP part to his title in moving onto the committee. And Vanessa Broadhurst, company group chairman, global commercial strategy organization, has been appointed EVP, global corporate affairs.

Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.

Each year, we aim to highlight 20 extraordinary women who are leaving their mark on drug R&D — and this year’s group was no exception.

Our list, while by no means exhaustive, includes scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies worldwide. Our team of writers spent time with each honoree (with a few exceptions), learning their stories and sketching profiles, which you’ll find in our special report.

For the second time, we brought the celebration to a live virtual audience, featuring an award presentation followed by a panel on what it takes to break the glass ceiling in biopharma with Kojin Therapeutics CEO Luba Greenwood, AskBio CEO Sheila Mikhail, and Silverback Therapeutics CEO Laura Shawver. Our panelists had a lively discussion on how the industry’s culture has changed, how to handle sexual harassment, the progress we’ve made and the challenges that still hold women back today.

We applaud each of our honorees for scaling the heights of biopharma R&D. You got to meet most of them via brief recordings we played during our live event. Below, you’ll find bonus videos offering a longer glimpse into those interviews. And if you didn’t get a chance to tune in to our main event live, you can replay the entire show.

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

The newest building at Fujifilm Irvine Scientific’s Netherlands campus is open for business.

The company, amidst a massive amount of expansion that has placed it in the top-five companies by manufacturing capacity, announced the Tilburg site is fully operational as of Wednesday. It will allow for an increase in efficiency and affordability in shipping, thanks to its central Europe location, as well as put some flexibility into the supply chain.

Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.
https://endpts.com/after-investing-in-their-series-b-lilly-bags-a-license-for-a-batch-of-metabolic-candidates/