Failed NewLink goes dark in a reverse merger, as Lumos jumps on board for a ride to Wall Street

October 1, 2019 05:15 AM EDT

John Carroll

Failed NewLink goes dark in a reverse merger, as Lumos jumps on board for a ride to Wall Street

Three years ago shares of NewLink Genetics traveled at a lofty altitude above $50 a share, with some high hopes riding on IDO. Now those hopes have been thoroughly quashed, along with the shares, with a miniaturized market cap of $59 million and a stock price of $1.59. The company founder, Charles Link, left a couple of months ago.

And that makes it a fit vehicle for a reverse merger.

Charles Link

That’s what Lumos Pharma thinks. This morning the company said that they would merge into the public biotech, with a 50/50 share going to investors at each. When it’s over early next year, they’ll rename the company Lumos and trade as $LUMO.

The company plans to keep operations in Austin and Ames, Iowa, where NewLink has done its work. But it will focus primarily on LUM-201, which it hopes to make into “the world’s first oral therapeutic for pediatric growth hormone deficiency.” A Phase IIb is due to open up in the middle of next year, with two other indications in the pipeline. And that’s it, for now.

Stine Seed Farm, the biggest investor in NewLink, signed off on the deal, along with Lumos investors: Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Enterprise Associates (NEA), and Santé Ventures.

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Patrik Jonsson, the president of Lilly Bio-Medicines

January 26, 2020 10:57 AM EST

John Carroll

Deals

Who knew? Dermira’s board kept watch as its stock price tracked Eli Lilly’s secret bidding on a $1.1B buyout

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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2019 Trinity Drug Index Evaluates Actual Commercial Performance of Novel Drugs Approved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to capitalise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

ENDPOINTS CAREERS

Executive Director - Alexandria LaunchLabs

Alexandria Real Estate Equities

San Francisco, CA

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Samantha Truex (file photo)

January 27, 2020 04:54 AM EST

Jason Mast

Startups

Venture

Bruce Booth and Samantha Truex's latest venture aims just above Humira

In 2000, about a year after the first trial data on Humira came out, a Japanese team identified a new gene that appeared to prevent GI cancer in mice: gasdermin, they called it, after the particular proteins it expressed.

Over the next decade-and-a-half, scientists found five more genes in the same family – often identified as gasdermin A, B, C, D, E and F – and yet their purpose baffled scientists. Mutations in A appeared to make mice bald (alopecia), but deleting it had no effect. Mutations in F and A were linked to deafness. Mutant E caused human cells to self-destruct.

January 22, 2020 06:04 AM ESTUpdated 11:06 AM

John Carroll

Regulatory

FDA’s golodirsen CRL: Sarepta’s Duchenne drugs are dangerous to patients, offering only a small benefit. And where's that confirmatory trial?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Aymeric Le Chatelier, Ipsen

January 24, 2020 08:30 AM ESTUpdated 55 minutes ago

John Carroll

R&D

A $1B-plus drug stumbles into another big PhIII setback — this time flunking futility test — as FDA hold remains in effect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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January 24, 2020 06:17 AM ESTUpdated 06:42 AM

Natalie Grover

R&D

Roche's checkpoint player Tecentriq flops in another bladder cancer subset

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Recursion Pharmaceuticals

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Stephen Hahn, AP

January 23, 2020 08:56 AM EST

John Carroll

Bioregnum

Regulatory

The FDA has devalued the gold standard on R&D. And that threatens everyone in drug development

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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January 23, 2020 07:05 AM ESTUpdated 10:44 AM

John Carroll

R&D

UPDATED: New players are jumping into the scramble to develop a vaccine as pandemic panic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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