No sur­prise: Af­ter near unan­i­mous ad­comm, FDA re­jects Eli Lil­ly bid to bring Jar­diance to type 1 pa­tients

In an un­sur­pris­ing move, the FDA has re­buffed Eli Lil­ly and Boehringer In­gel­heim in their ef­forts to ex­pand the in­di­ca­tion for their best-sell­ing di­a­betes drug Jar­diance, is­su­ing a com­plete re­sponse let­ter.

The CRL came four months af­ter an FDA ad­vi­so­ry com­mit­tee vot­ed 14-2 against al­low­ing the two drug­mak­ers to mar­ket the drug for type 1 di­a­betes, say­ing the risks out­weighed the po­ten­tial ben­e­fits. The FDA does not pub­licly re­lease its re­jec­tion let­ters, but in a press re­lease, Eli Lil­ly ac­knowl­edged the rul­ing was “con­sis­tent with the out­come of the En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee in No­vem­ber.”

That com­mit­tee ruled Lil­ly and Boehringer would need to con­duct an­oth­er study to bet­ter as­sess safe­ty, open­ing the door for an even­tu­al re­sub­mis­sion. Nei­ther Lil­ly nor Boehringer, which orig­i­nal­ly de­vel­oped the com­pound, com­ment­ed in their joint re­lease on whether they would pur­sue.

Jar­diance be­longs to a class of drugs known as SGLT-2 in­hibitors. These drugs, first in­tro­duced in the US by J&J in 2013, in­hib­it a pro­tein in the kid­neys that con­trols how the or­gans re­ab­sorb glu­cose. If you in­hib­it the pro­tein, you can low­er glu­cose re­ab­sorp­tion and thus low­er blood sug­ar lev­els. Jar­diance was ap­proved in 2014 and in­di­cat­ed, like oth­er SGLT-2 in­hibitors, for type 2 di­a­betes.

With type 2 di­a­betes be­com­ing one of the most com­mon chron­ic ill­ness­es across much of the plan­et, the drugs have reaped bil­lions for J&J, As­traZeneca, Lil­ly and No­vo Nordisk, and pre­cip­i­tat­ed ef­forts by each drug­mak­er to ex­pand the list of po­ten­tial pa­tients. Lil­ly has come up short in the lat­est ef­forts; while As­traZeneca and No­vo Nordisk won spe­cial­ized ap­proval for low­er­ing the risk of car­dio­vas­cu­lar events such as heart at­tacks, Lil­ly’s da­ta for the same in­di­ca­tions un­der­whelmed.

The NJ-based lega­cy phar­ma is now the third com­pa­ny to try and fail to win US ap­proval for their SGLT-2 in­hibitor in type 1 pa­tients, join­ing As­traZeneca and Sanofi. The agency has been wary be­cause of da­ta sug­gest­ing the drug can cause di­a­bet­ic ke­toaci­do­sis, a life-threat­en­ing com­pli­ca­tion in which the body, short on in­sulin, switch­es to burn­ing fats, let­ting off po­ten­tial­ly tox­ic lev­els of acidic ke­tone bod­ies.

Type 2 pa­tients can get di­a­bet­ic ke­toaci­do­sis but it is far more preva­lent in type 1 pa­tients. Lil­ly’s pro­posed sub­mis­sion called for dos­es of 2.5mg and the drug would’ve been tak­en sole­ly as an ad­junct to in­sulin — a sharp dos­ing con­trast to type 2 pa­tients, who re­ceived 10 or 25 mg and take it with or with­out in­sulin. The FDA re­view in No­vem­ber not­ed Lil­ly showed Jar­diance im­proved blood sug­ar lev­els in Type 1 pa­tients but said their lone 26-week study didn’t ad­e­quate­ly dis­pel con­cerns about ad­verse ef­fects.

A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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Lil­ly Asia Ven­tures co-leads $100M+ round for Chi­nese biotech and its late-stage lu­pus drug

Can a Chinese biotech deliver the first new lupus drug in decades? A high-profile group of VCs are betting on it.

Lilly Asia Ventures and Lake Bleu Capital are the co-headliners for RemeGen’s latest raise, which brought in more than $100 million. Hudson Bay Capital and Vivo Capital — which, like LAV, also invested in a pre-IPO round for Legend Biotech unveiled today — chimed in, as did Janchor Partners and OrbiMed.

GSK's asth­ma bi­o­log­ic Nu­cala is one step clos­er to ap­proval in key chron­ic rhi­nos­i­nusi­tis pop­u­la­tion

Months after GSK’s Nucala cleared in a pivotal rare blood disorder study, the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps.

The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps.

Servi­er bags an an­ti­body spe­cial­ist in its lat­est on­col­o­gy M&A deal with plans to add the plat­form tech

Whatever Servier learned about Symphogen during their 2-year development alliance must have significantly whetted their appetite for an acquisition.

Paris-based Servier announced Friday that it has struck a deal to buy out the antibody expert. The acquisition comes 2 years after Servier acquired Shire’s cancer business for $2.4 billion. They’ve been working with Symphogen on a slate of programs, including some favs – PD-1, LAG3 and TIM3 — where they are looking to differentiate themselves from the more prominent drugs in these niches.

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GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

→ Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is joining the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and has led global vaccine R&D since 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research.  IAVI is led by Mark Feinberg, the former CSO of Merck Vaccines. 

Ahead of US IPO, Leg­end Biotech adds $150M, top-tier in­vestors to back CAR-T pipeline

Last month Nanjing Legend Biotech revealed that it sees, and was quietly planning for, a future as a public company in the US, separate but still tied to its former parent, Chinese CRO GenScript. It’s evidently a vision that enticed investors, drawing marquee names for a pre-IPO round.

The Series A fetched a whopping $150.5 million from Hudson Bay Capital Management, Lilly Asia Ventures, Vivo Capital, RA Capital Management and JJDC, the venture arm of J&J. The pharma giant has helped fund Legend’s CAR-T work with the $350 million upfront payment it handed over to partner on the lead BCMA program.

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In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.