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Posted On: 02/02/2022 4:06:14 PM
Post# of 148899
Gilead has had a recent major drug trial failure of a $5B cancer drug. While reading about this problem, I also saw that they had a trial problem in 2020 with a Rheumatoid Arthritis drug estimated to have peak sales of $2B. Basis a quick search, Gilead did not pursue FDA approval of the RA drug but it is approved by the EMA. Could Gilead be on the prowl for a drug like Leronlimab?
February 2,2022
Gilead’s trouble with its $5 billion drug magrolimab is considerably worse than it disclosed in a press release last week.
Originally, the big biotech alerted investors that they had to slam the brakes on enrolling patients in a slate of clinical trials that combined the CD47 drug magrolimab with azacitidine (Vidaza). That came after the agency flagged an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms.
Then in their Q4 update Tuesday night, some small print in their presentation noted that the FDA had expanded the hold.
FDA placed partial clinical holds on trials evaluating magrolimab in combination with azacitidine as well as the fully enrolled DLBCL and MM study.
“A subsequent partial clinical hold has been placed on the Phase II multiple myeloma study and the fully enrolled Phase II DLBCL study,” explained Merdad Parsey in their Q4 call with analysts. He continued:
Importantly, patients currently enrolled in our magrolimab studies can continue treatment, and our compassionate use programs remain open. We are working with FDA to take a comprehensive look at the safety data, and we’ll share the outcome as quickly as we can. In the meantime, we remain committed to the magrolimab development program and believe that it has the potential to address an important unmet medical need in these seriously ill patients. As you know, the patients in our ENHANCE Phase III trial have a very high unmet need, with a median overall survival of only 1 to 3 years on the current standard of care.
Separate from and prior to the partial clinical hold, our Phase Ib single arm study in higher risk MDS no longer has a viable path to submission based on regulatory feedback.
Magrolimab was the jewel in the crown of Forty Seven’s pipeline, which Gilead bought out for $4.9 billion close to 2 years ago as it shifted its pipeline focus more toward oncology. In the fall of 2020, the leading anti-CD47 monoclonal antibody won breakthrough status at the FDA, burnishing Gilead’s blockbuster prospects, which had already been high after the first cut of human data.
This isn’t the first time the executive crew at Gilead have grappled with opposing views at the FDA. The agency effectively killed filgotinib for the company, wiping out a major alliance that aimed at expanding the biotech’s franchise list.
https://endpts.com/that-partial-hold-on-gilea...ally-told/
August 18,2020
In a surprise twist, the FDA has rejected Gilead’s marketing application for filgotinib, dealing a body blow to Daniel O’Day’s hopes for a rapid improvement in the big biotech’s drug portfolio with a blockbuster addition.
Late on Tuesday, Gilead $GILD put out word that the agency had turned thumbs-down on their application for rheumatoid arthritis, saying that regulators wanted to see more data from two ongoing safety studies of the drug.
Ominously, though, Gilead also noted that the “FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.” And that could ultimately force Gilead to scrap one of the biggest development efforts in the industry.
There’s no sugarcoating the news. The best case scenario for Gilead now is a major delay as AbbVie pushes ahead with the recently approved rival Rinvoq. In calls with analysts the company outlined the agency’s frets about safety that could kill any chances of the high dose, leaving Gilead with the prospect of a weak commercial launch of a drug with limited efficacy, more similar to the aging Humira, in a packed field.
That was not supposed to happen.
Gilead had run the full suite of late-stage clinical trials — with more in the works — to prove that filgotinib lives up to its promise of being a boon to a wide range of patients. At every stage of development, the company had touted efficacy and safety data, underscoring their high expectations.
As is customary in these situations, a top-level R&D exec — in this case, CMO Merdad Parsey — expressed he was “disappointed in this outcome” and promised to carefully evaluate the response.
All the evaluating in the world, though, won’t prevent at least a major delay as Gilead waits for data from the MANTA and MANTA-RAy studies, due in H1 2021.
Still to be determined, though, was what raised a red flag about the 200 mg dose — the high dose in the Humira comparison studies and whether it would kill any chances of an OK at that dosage. That’s a common practice in the rheumatoid arthritis/anti-inflammatory field, where regulators are keenly concerned about the impact of chronic dosing intended to run for years.
Evan Seigerman at Credit Suisse picked up on the threat the CRL poses to Gilead, noting:
Gilead management cited broad concerns from the agency around the high dose, including mortality, herpes zoster infection, increased risk for malignancy, and blood-clot issues. Bottom line there is no simple fix to these complex issues, putting the entire filgotinib program (RA and beyond) at risk.
Truist analyst Robyn Karnauskas talked it over with Gilead execs and also came away with a clear impression that the franchise is at risk of being swept away.
GILD had discussions with FDA on MANTA going into NDA filing, but more talks needed on what FDA wants from MANTA and what is needed on benefit/risk profile for 200mg dose. For a competitive label, filgotinib needs better safety. We believe there is clear risk if these 2 issues aren’t resolved from a competitive standpoint. If label is not competitive, GILD may not launch if it’s not in shareholders’ best interest, which we think is smart.
Earlier in the year analysts at Cortellis, a part of Clarivate Analytics, set the consensus on peak sales for filgotinib at $1.4 billion, a top 10 drug in the pipeline. Some analysts were even more bullish, setting the top line at about $2 billion.
Gilead had carefully gathered a battery of safety data in making their pitch, drawing on a range of studies. The FDA has been acutely concerned about the JAK class of anti-inflammatories, running from restrictions on Pfizer’s JAK1/JAK3 inhibitor Xeljanz’s use to an initial rejection for Eli Lilly’s Olumiant.
Gilead signed up for a $750 million upfront to gain licensing rights to filgotinib from Galapagos, after AbbVie walked away. Then they expanded the development deal, with billions on the table, after O’Day arrived.
If the CRL does end filgo’s chances, Gilead has plenty to lean back on. Its HIV franchise remains one of the most dominant and durable in the industry. And O’Day has been wheeling and dealing on the oncology side, where he’s looking to make a splash.
Gilead’s shares slid more than 5% after the news hit, a major turn for a company with an $86 billion market cap. At Galapagos on Wednesday, it was even worse. Their shares dropped 28%.
https://endpts.com/fda-hands-gilead-a-stunnin...r-setback/
February 2,2022
Gilead’s trouble with its $5 billion drug magrolimab is considerably worse than it disclosed in a press release last week.
Originally, the big biotech alerted investors that they had to slam the brakes on enrolling patients in a slate of clinical trials that combined the CD47 drug magrolimab with azacitidine (Vidaza). That came after the agency flagged an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms.
Then in their Q4 update Tuesday night, some small print in their presentation noted that the FDA had expanded the hold.
FDA placed partial clinical holds on trials evaluating magrolimab in combination with azacitidine as well as the fully enrolled DLBCL and MM study.
“A subsequent partial clinical hold has been placed on the Phase II multiple myeloma study and the fully enrolled Phase II DLBCL study,” explained Merdad Parsey in their Q4 call with analysts. He continued:
Importantly, patients currently enrolled in our magrolimab studies can continue treatment, and our compassionate use programs remain open. We are working with FDA to take a comprehensive look at the safety data, and we’ll share the outcome as quickly as we can. In the meantime, we remain committed to the magrolimab development program and believe that it has the potential to address an important unmet medical need in these seriously ill patients. As you know, the patients in our ENHANCE Phase III trial have a very high unmet need, with a median overall survival of only 1 to 3 years on the current standard of care.
Separate from and prior to the partial clinical hold, our Phase Ib single arm study in higher risk MDS no longer has a viable path to submission based on regulatory feedback.
Magrolimab was the jewel in the crown of Forty Seven’s pipeline, which Gilead bought out for $4.9 billion close to 2 years ago as it shifted its pipeline focus more toward oncology. In the fall of 2020, the leading anti-CD47 monoclonal antibody won breakthrough status at the FDA, burnishing Gilead’s blockbuster prospects, which had already been high after the first cut of human data.
This isn’t the first time the executive crew at Gilead have grappled with opposing views at the FDA. The agency effectively killed filgotinib for the company, wiping out a major alliance that aimed at expanding the biotech’s franchise list.
https://endpts.com/that-partial-hold-on-gilea...ally-told/
August 18,2020
In a surprise twist, the FDA has rejected Gilead’s marketing application for filgotinib, dealing a body blow to Daniel O’Day’s hopes for a rapid improvement in the big biotech’s drug portfolio with a blockbuster addition.
Late on Tuesday, Gilead $GILD put out word that the agency had turned thumbs-down on their application for rheumatoid arthritis, saying that regulators wanted to see more data from two ongoing safety studies of the drug.
Ominously, though, Gilead also noted that the “FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.” And that could ultimately force Gilead to scrap one of the biggest development efforts in the industry.
There’s no sugarcoating the news. The best case scenario for Gilead now is a major delay as AbbVie pushes ahead with the recently approved rival Rinvoq. In calls with analysts the company outlined the agency’s frets about safety that could kill any chances of the high dose, leaving Gilead with the prospect of a weak commercial launch of a drug with limited efficacy, more similar to the aging Humira, in a packed field.
That was not supposed to happen.
Gilead had run the full suite of late-stage clinical trials — with more in the works — to prove that filgotinib lives up to its promise of being a boon to a wide range of patients. At every stage of development, the company had touted efficacy and safety data, underscoring their high expectations.
As is customary in these situations, a top-level R&D exec — in this case, CMO Merdad Parsey — expressed he was “disappointed in this outcome” and promised to carefully evaluate the response.
All the evaluating in the world, though, won’t prevent at least a major delay as Gilead waits for data from the MANTA and MANTA-RAy studies, due in H1 2021.
Still to be determined, though, was what raised a red flag about the 200 mg dose — the high dose in the Humira comparison studies and whether it would kill any chances of an OK at that dosage. That’s a common practice in the rheumatoid arthritis/anti-inflammatory field, where regulators are keenly concerned about the impact of chronic dosing intended to run for years.
Evan Seigerman at Credit Suisse picked up on the threat the CRL poses to Gilead, noting:
Gilead management cited broad concerns from the agency around the high dose, including mortality, herpes zoster infection, increased risk for malignancy, and blood-clot issues. Bottom line there is no simple fix to these complex issues, putting the entire filgotinib program (RA and beyond) at risk.
Truist analyst Robyn Karnauskas talked it over with Gilead execs and also came away with a clear impression that the franchise is at risk of being swept away.
GILD had discussions with FDA on MANTA going into NDA filing, but more talks needed on what FDA wants from MANTA and what is needed on benefit/risk profile for 200mg dose. For a competitive label, filgotinib needs better safety. We believe there is clear risk if these 2 issues aren’t resolved from a competitive standpoint. If label is not competitive, GILD may not launch if it’s not in shareholders’ best interest, which we think is smart.
Earlier in the year analysts at Cortellis, a part of Clarivate Analytics, set the consensus on peak sales for filgotinib at $1.4 billion, a top 10 drug in the pipeline. Some analysts were even more bullish, setting the top line at about $2 billion.
Gilead had carefully gathered a battery of safety data in making their pitch, drawing on a range of studies. The FDA has been acutely concerned about the JAK class of anti-inflammatories, running from restrictions on Pfizer’s JAK1/JAK3 inhibitor Xeljanz’s use to an initial rejection for Eli Lilly’s Olumiant.
Gilead signed up for a $750 million upfront to gain licensing rights to filgotinib from Galapagos, after AbbVie walked away. Then they expanded the development deal, with billions on the table, after O’Day arrived.
If the CRL does end filgo’s chances, Gilead has plenty to lean back on. Its HIV franchise remains one of the most dominant and durable in the industry. And O’Day has been wheeling and dealing on the oncology side, where he’s looking to make a splash.
Gilead’s shares slid more than 5% after the news hit, a major turn for a company with an $86 billion market cap. At Galapagos on Wednesday, it was even worse. Their shares dropped 28%.
https://endpts.com/fda-hands-gilead-a-stunnin...r-setback/
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