CHMP scolds AB Sci­ence (again) for ma­sitinib short­com­ings, trig­ger­ing a new rout on stock price

AB Sci­ence has just stum­bled in­to an­oth­er set­back with its all-pur­pose an­ti-in­flam­ma­to­ry drug ma­sitinib. 

Alain Moussy

The Paris-based biotech run by founder Alain Moussy says that the CHMP has adopt­ed a neg­a­tive stance on ap­prov­ing the drug for ALS. And once again re­searchers drew some poor grades on tri­al de­sign and ex­e­cu­tion.

In a re­lease the biotech said that the CHMP not­ed that “the re­li­a­bil­i­ty of the da­ta was not ro­bust enough to sup­port a reg­is­tra­tion.” They were al­so con­cerned about the pos­si­bil­i­ty of bias be­ing in­tro­duced in­to their analy­sis.

Now AB Sci­ence will do some more analy­sis for a re-ex­am­i­na­tion and a sec­ond opin­ion in Ju­ly.

That’s not what in­vestors want­ed to hear. The com­pa­ny stock (EPA: $AB) plunged 29% on the news in the lat­est turn of a long-run­ning roller coast­er ride.

The com­pa­ny has been in hot wa­ter with reg­u­la­tors be­fore. 

Less than a year ago French reg­u­la­tors or­dered a tri­al halt on ma­sitinib to make sure the biotech was op­er­at­ing in ac­cor­dance with the rules on tri­al con­duct. AB Sci­ence said at the time that the ANSM ze­roed in on a trou­bled study —AB06006 — in­volv­ing ma­sitinib in treat­ing mas­to­cy­to­sis. But those prob­lems, the biotech kicked back, all oc­curred be­tween 2009 and 2015, be­fore they put a new qual­i­ty con­trol sys­tem in place.

They shrugged off the ac­tion, say­ing their ALS study would be un­hin­dered as it was be­ing con­duct­ed out­side of France.

Over the years AB Sci­ence has been known to put out cheery re­leas­es on da­ta and prospects on­ly to be forced to walk it all back. The EMA re­ject­ed its mar­ket­ing ap­pli­ca­tions on ma­sitinib for ad­vanced in­op­er­a­ble pan­cre­at­ic can­cer and gas­troin­testi­nal stro­mal tu­mors in 2014 and 2013, ham­mer­ing the com­pa­ny on poor tri­al de­sign, safe­ty as well as man­u­fac­tur­ing short­com­ings.

The big idea at AB Sci­ence is that the drug’s im­pact on mi­croglia damps down in­flam­ma­to­ry process­es linked to a va­ri­ety of dis­eases. But they’ve been hav­ing a hard time prov­ing that.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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