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Lilly (LLY) Gets FDA Panel Advice for New Study on Sintilimab
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Eli Lilly (LLY - Free Report) and partner Innovent Biologics announced that FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted in favor of conducting an additional study to get approval for their lung cancer candidate, sintilimab, in the United States.
Lilly and Innovent market sintilimab with the trade name of Tyvyt only in China.
Lilly and Innovent submitted the biologics license application (“BLA”) for sintilimab in March 2021, seeking approval for the candidate in the first-line treatment of adult patients with advanced non-squamous non-small cell lung cancer (“NSCLC”) with no EGFR or ALK mutations. The BLA was supported by data from the study — ORIENT-11 — that was solely conducted in China.
The ODAC meeting was convened to discuss the concerns related to approval of the sintilimab BLA by the FDA based on single country foreign data. Although the ORIENT-11 study met its primary endpoint of progression free survival (“PFS”), the ODAC concluded that Lilly and Innovent’s Chinese study was not enough to support U.S. approval.
The new study will likely delay the approval of sintilimab in the United States by a couple of years or more. Shares of Lilly declined 1.5% on Feb 10, following the unfavorable outcome of the ODAC meeting. Lilly’s shares have gained 15.6% in the past year compared with the industry’s increase of 16%.
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The ODAC pointed out that multiregional clinical studies are the preferred international standard for drug development as these can represent a diverse patient population. Data from these studies can help effectively evaluate the consistency of a drug’s effectiveness across geographic regions. The ODAC also pointed out that Innovent had no discussion with the FDA while designing the ORIENT-11 study. The study’s primary endpoint was PFS. However, the FDA-preferred primary endpoint for a lung cancer study is overall survival. The ODAC concluded that the ORIENT-11 study does not effectively represent the diverse ethnic subgroups within the U.S. population.
The committee argued that the data from the study are not applicable to the U.S. population and U.S. medical practice. It is difficult to make a definitive conclusion if the pharmacokinetics (PK) data can be applied to the diverse U.S population. The committee thus recommended an additional study to demonstrate its applicability to the U.S. population before the BLA can be approved.
Following the ODAC vote, Lilly’s partner Innovent proposed to conduct an additional study across China, the United States and the European Union. The study will compare sintilimab directly to an approved immune checkpoint inhibitor for an improvement in objective response rate as the study’s primary endpoint.
In a separate press release, Lilly announced that it has signed an agreement with the U.S. government for the supply of its COVID-19 drug candidate, bebtelovimab. Per the agreement, the company will supply up to 600,000 doses of the candidate to the U.S. government for at least $720 million, following its potential authorization for emergency use. The company has already submitted a request for emergency use authorization for bebtelovimab as a treatment for mild-to-moderate COVID-19 in certain high-risk patients.
The delivery of up to 600,000 doses of bebtelovimab needs to be completed by the end of the first quarter. The U.S. government has an option to procure additional 500,000 doses of the candidate, which will need to be delivered by July-end, if exercised.
Lilly stated that the agreement will add at least $720 million to the top line and 20 cents to the bottom line in 2022.
In January, the FDA had revised the emergency use authorization for Lilly’s already approved antibody cocktail medicine for COVID-19, bamlanivimab plus etesevimab, limiting its use in patients who have been infected or exposed to a coronavirus variant that is susceptible to these treatments.
The FDA’s decision to limit the authorized use of bamlanivimab/etesevimab was based on data, which showed that these treatment options are highly unlikely to be effective against the Omicron variant in the United States. However, Lilly said that an authentic virus analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
Estimates for Pfizer have improved from earnings per share of $5.70 to $6.62 for 2022 and $4.77 to $4.84 for 2023 over the past 30 days.
Pfizer delivered an earnings surprise of 19.79%, on average, in the last four quarters. Shares of PFE have gained 45.7% so far this year.
Glaxo’s earnings estimates have increased from $3.22 to $3.29 per ADS for 2022 but declined from $3.39 to $3.34 per ADS for 2023 over the past 30 days.
Glaxo delivered an earnings beat of 20.52%, on average, in the last four quarters. Shares of GSK have gained 24.3% so far this year.
Vertex’s earnings estimates have increased from $13.39 to $14.33 per share for 2022 and $14.10 to $15.31 per share for 2023 over the past 30 days.
Vertex delivered an earnings beat of 10.01%, on average, in the last four quarters. Shares of VRTX have gained 10.3% so far this year.
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Lilly (LLY) Gets FDA Panel Advice for New Study on Sintilimab
Eli Lilly (LLY - Free Report) and partner Innovent Biologics announced that FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted in favor of conducting an additional study to get approval for their lung cancer candidate, sintilimab, in the United States.
Lilly and Innovent market sintilimab with the trade name of Tyvyt only in China.
Lilly and Innovent submitted the biologics license application (“BLA”) for sintilimab in March 2021, seeking approval for the candidate in the first-line treatment of adult patients with advanced non-squamous non-small cell lung cancer (“NSCLC”) with no EGFR or ALK mutations. The BLA was supported by data from the study — ORIENT-11 — that was solely conducted in China.
The ODAC meeting was convened to discuss the concerns related to approval of the sintilimab BLA by the FDA based on single country foreign data. Although the ORIENT-11 study met its primary endpoint of progression free survival (“PFS”), the ODAC concluded that Lilly and Innovent’s Chinese study was not enough to support U.S. approval.
The new study will likely delay the approval of sintilimab in the United States by a couple of years or more. Shares of Lilly declined 1.5% on Feb 10, following the unfavorable outcome of the ODAC meeting. Lilly’s shares have gained 15.6% in the past year compared with the industry’s increase of 16%.
The ODAC pointed out that multiregional clinical studies are the preferred international standard for drug development as these can represent a diverse patient population. Data from these studies can help effectively evaluate the consistency of a drug’s effectiveness across geographic regions. The ODAC also pointed out that Innovent had no discussion with the FDA while designing the ORIENT-11 study. The study’s primary endpoint was PFS. However, the FDA-preferred primary endpoint for a lung cancer study is overall survival. The ODAC concluded that the ORIENT-11 study does not effectively represent the diverse ethnic subgroups within the U.S. population.
The committee argued that the data from the study are not applicable to the U.S. population and U.S. medical practice. It is difficult to make a definitive conclusion if the pharmacokinetics (PK) data can be applied to the diverse U.S population. The committee thus recommended an additional study to demonstrate its applicability to the U.S. population before the BLA can be approved.
Following the ODAC vote, Lilly’s partner Innovent proposed to conduct an additional study across China, the United States and the European Union. The study will compare sintilimab directly to an approved immune checkpoint inhibitor for an improvement in objective response rate as the study’s primary endpoint.
In a separate press release, Lilly announced that it has signed an agreement with the U.S. government for the supply of its COVID-19 drug candidate, bebtelovimab. Per the agreement, the company will supply up to 600,000 doses of the candidate to the U.S. government for at least $720 million, following its potential authorization for emergency use. The company has already submitted a request for emergency use authorization for bebtelovimab as a treatment for mild-to-moderate COVID-19 in certain high-risk patients.
The delivery of up to 600,000 doses of bebtelovimab needs to be completed by the end of the first quarter. The U.S. government has an option to procure additional 500,000 doses of the candidate, which will need to be delivered by July-end, if exercised.
Lilly stated that the agreement will add at least $720 million to the top line and 20 cents to the bottom line in 2022.
In January, the FDA had revised the emergency use authorization for Lilly’s already approved antibody cocktail medicine for COVID-19, bamlanivimab plus etesevimab, limiting its use in patients who have been infected or exposed to a coronavirus variant that is susceptible to these treatments.
The FDA’s decision to limit the authorized use of bamlanivimab/etesevimab was based on data, which showed that these treatment options are highly unlikely to be effective against the Omicron variant in the United States. However, Lilly said that an authentic virus analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank & Stocks to Consider
Lilly currently carries a Zacks Rank #3 (Hold). Some better-ranked pharma or large biotech companies include Glaxo (GSK - Free Report) , Pfizer (PFE - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Pfizer have improved from earnings per share of $5.70 to $6.62 for 2022 and $4.77 to $4.84 for 2023 over the past 30 days.
Pfizer delivered an earnings surprise of 19.79%, on average, in the last four quarters. Shares of PFE have gained 45.7% so far this year.
Glaxo’s earnings estimates have increased from $3.22 to $3.29 per ADS for 2022 but declined from $3.39 to $3.34 per ADS for 2023 over the past 30 days.
Glaxo delivered an earnings beat of 20.52%, on average, in the last four quarters. Shares of GSK have gained 24.3% so far this year.
Vertex’s earnings estimates have increased from $13.39 to $14.33 per share for 2022 and $14.10 to $15.31 per share for 2023 over the past 30 days.
Vertex delivered an earnings beat of 10.01%, on average, in the last four quarters. Shares of VRTX have gained 10.3% so far this year.