All entries for: Oncology

November 1, 2022

Eli Lilly & Company

Negative Outlook

Indianapolis, IN
10,001-50,000 employees

• Potential Significant Impact if Drugs Selected: “It is too soon to tell how the U.S. government will set these prices as the law specifies a ceiling price, but not a minimum or floor price. One or more significant Lilly products may be selected, which would have the effect of accelerating revenue erosion prior to patent expiry. The effect of reducing prices and reimbursement for certain of our products could significantly impact our business and consolidated results of operations” • Small Molecule Investment Strategy: “The IRA may meaningfully influence our and pharmaceutical industry business strategies. In particular it may reduce the attractiveness of investment in small molecule innovation” • Potential Legal Uncertainty: “Provisions of the IRA may be subject to legal challenges or other reformation, and the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. Additional policies, regulations, legislation, or enforcement, including those proposed and/or pursued by the U.S. Congress and executive branch of the U.S. administration and other regulatory authorities worldwide, could adversely impact our business and consolidated results of operations”

Disease Area: Multiple, Oncology
Drug Type: Biologic
November 1, 2022

Pfizer

Neutral Outlook

New York, NY
50,001+ employees

General Impact: “Governmental laws and regulations affecting our operations, including, without limitation, the recently enacted Inflation Reduction Act of 2022, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S”

Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 1, 2022

Eli Lilly & Company

Negative Outlook

Indianapolis, IN
10,001-50,000 employees

“The law “may reduce the attractiveness of investment in small molecule innovation,” Lilly wrote in its quarterly earnings filing, referring to drugs that are made as pills or tablets.”

Disease Area: Oncology
Drug Type: Small Molecule
November 1, 2022

Exelixis

Negative Outlook

Alameda, CA
1,001-5,000 employees

• General Impact: “Although public rulemaking and related agency guidance for the Inflation Reduction Act has yet to be issued and it is uncertain what impact the Inflation Reduction Act will ultimately have upon our business, over time the Inflation Reduction Act could reduce the revenues we are able to collect from sales of our products and increase our government discount and rebate liabilities” • Uncertainty: “In addition, we cannot know the final form or timing of any other legislative, regulatory and/or administrative measures, and some of these pending and enacted legislative proposals or executive rulemaking, if implemented without successful legal challenges, would likely have a significant and far-reaching impact on the biopharmaceutical industry and therefore also likely have a material adverse impact on our business, financial condition and results of operations”

Disease Area: Oncology
Drug Type: Small Molecule
November 1, 2022

Eli Lilly & Company

Discontinued Drug, Discontinued Research

Indianapolis, IN
10,001-50,000 employees

Eli Lilly laid blame Tuesday afternoon on President Joe Biden’s Inflation Reduction Act as the reason it scrapped a $40 million cancer drug.

As part of its third quarter update earlier Tuesday morning, the Big Pharma revealed it had removed a Phase I drug licensed from Fosun Pharma, a BCL2 inhibitor that had been undergoing studies for a variety of blood cancers. Though the reasoning had been initially unclear, an Eli Lilly spokesperson told Endpoints News in an email that “in light of the Inflation Reduction Act, this program no longer met our threshold for continued investment.”

Asked to explain how the IRA impacted this specific drug, the spokesperson highlighted the law’s impact on small molecule R&D.

“The IRA changes many dynamics for small molecules in oncology and when we integrated those changes with this program and its competitive landscape, the program’s future investment no longer met our threshold,” the spokesperson told Endpoints in a follow-up email.

1 Discontinued Drug: LOXO-338 (small molecule)
1 Discontinued Research Program

Disease Area: Oncology
Drug Type: Small Molecule
October 28, 2022

Sanofi

Neutral Outlook

Paris, France
50,001+ employees

SA CO Paul Hudson stated that the IRA “…will likely create significant uncertainties across our industry,” highlighting investments into future R&D. However, Mr. Hudson noted that SA is “well positioned in the short term” to navigate IRA challenges. 1. And that the orphan drug exemption to price setting is only applicable to drugs with only one indication, which disincentivizes pursuing additional indications 2. The discrepancy between the eligibility dates of biologics and small-molecule drugs for price setting

Disease Area: Neurological Diseases, Oncology
Drug Type: Biologic, Small Molecule
October 28, 2022

AbbVie 

Negative Outlook

Chicago, IL
50,001+ employees

Andrew Baum of Citigroup asked how ABBV anticipates pricing pressure assuming CMS selects Imbruvica for the Drug Price Negotiation Program and whether they expect it before 2026 due to expected contracting on formulary placement.

Disease Area: Oncology
Drug Type: Biologic