Amarin's Vascepa reigns supreme in fish oil battle, as AstraZeneca's rival fizzles
AstraZeneca’s competitive threat to Amarin’s mighty Vascepa in patients with cardiovascular risk has wilted.
On Monday, the British drugmaker said it was abandoning a large cardiovascular (CV) outcomes trial testing its fish oil pill Epanova after an independent data monitoring committee predicted the therapy had a low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia who carry a high risk of CV disease.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.
SPONSORED
January 21, 2020 07:00 AM EST
Trinity
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).
SPONSORED
January 20, 2020 07:00 AM EST
Blue Latitude Health
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.
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.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.
UPDATED: Eli Lilly’s $1.6B cancer drug failed to spark even the slightest positive gain for patients in its 1st PhIII
Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.
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.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.
Kura co-founder heads to Asian multi-national as biotech eyes the goal posts for lead drug
Six years after Kura Oncology snagged a farnesyl transferase inhibitor from J&J and leapt straight into clinical development, one of the biotech’s founders is leaving to start a new chapter in his career.
CMO and development chief Antonio Gualberto is exiting the company, and Kura — led by longtime biotech entrepreneur Troy Wilson — is on the hunt for a replacement. Wilson credited the CMO for some key biomarker work, including the discovery of the CXCL12 pathway as a target of their lead drug tipifarnib. Those biomarkers are being relied on to define the patient population most likely to benefit from the drug.
FDA waves Epizyme's $186K rare cancer drug through to market — now get ready for the second act
After winning the hearts of the expert panel convened by the FDA despite a bleak in-house review and a checkered development history, Robert Bazemore has steered Epizyme to its first-ever OK for a rare cancer drug.
The approval in epithelioid sarcoma sets tazemetostat, now Tazverik, up nicely for a quick expansion to follicular lymphoma — a much bigger indication for which the biotech has just submitted an NDA.
UPDATED: 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.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.
2019 a 'transformative year' for pharma M&A. Is that a good thing?
Big Pharma keeps getting bigger.
Fueled by the mega-mergers between Bristol-Myers Squibb and Celgene and between Allergan and AbbVie, the industry last year saw $350 billion worth of M&A, according to the new year-end report from the consultants at PwC. That’s a more than 50% increase on 2018.
“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.
