Chi-Med cuts surufatinib PhIII short; FDA greenlights Herceptin copycat from Amgen, Allergan

June 14, 2019 10:28 AM EDT

Amber Tong

Chi-Med cuts surufatinib PhIII short; FDA greenlights Herceptin copycat from Amgen, Allergan

Christian Hogg Chi-Med

→ One of Chi-Med’s late-stage favorites is graduating early from its Phase III study, having met its primary endpoints at interim analysis. The Hong Kong-headquartered biotech left out the numbers in its brief statement, which noted that surufatinib hit a PFS goal among patients with extra-pancreatic neuroendocrine tumors. CEO Christian Hogg has tapped the drug, alongside savolitinib, for approvals over the next two years to follow up on the landmark OK for fruquintinib in China.

→ Amgen $AMGN and Allergan $AGN have nabbed an OK to market their Herceptin copycat — christened Kanjinti — in the US for all approved indications of the Roche blockbusters including HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma. “Kanjinti is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA,” David Nicholson, Allergan’s chief research and development officer, noted.

David Nicholson Allergan

→ Last year, Sun Pharmaceuticals entered the crowded market for plaque psoriasis with its IL-23 inhibitor Ilumya. On Friday, the Indian drugmaker said the monoclonal antibody — in-licensed from Merck $MRK back in 2014 for $80 million — cleared a mid-stage study in patients with psoriatic arthritis. The interim analysis revealed that over 71% of patients treated with the drug experienced a 20% improvement in joint and skin symptoms, meeting the primary endpoint of the study.

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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.

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Aymeric Le Chatelier, Ipsen

January 24, 2020 08:30 AM ESTUpdated 09:17 AM

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 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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January 24, 2020 04:10 PM EST

Zachary Brennan

Pharma

Gilead claims Truvada patents in HHS’ complaint are invalid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

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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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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