FDA proposed rules to lower nicotine in cigarettes

FDA takes steps to reduce smoking rates by lowering nicotine in cigarettes

FDA proposed rules to lower nicotine in cigarettes. Stockwinners.com
FDA proposed rules to lower nicotine in cigarettes

FDA Commissioner Scott Gottlieb earlier today issued a statement on steps to “dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.”

The FDA issued an advance notice of proposed rulemaking, or ANPRM, to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels.

“This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country,” Gottlieb said.

The ANPRM provides a “wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard,” he added.

He went on, “We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort. Notably, new estimates included in the ANPRM that are being published in the New England Journal of Medicine evaluate one possible policy scenario for a nicotine product standard.

If this scenario were implemented, this analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation.”

Publicly traded companies in the space include Altria Group (MO), British American Tobacco (BTI) and Philip Morris (PM). A beneficiary could be 22nd Century Group (XXII). The latter has a patent on a modified tobacco plant with 95% less nicotine than ordinary tobacco plants.


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Alexion blood disorder drug succeeds, shares rise

Alexion higher after blood disorder drug succeeds in head-to-head trial

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Alexion blood disorder drug succeeds, shares rise

Shares of Alexion (ALXN) are higher in Thursday’s pre-market trading after the company said its rare blood disorder drug was successful in a late-stage study.

WHAT’S NEW

The drug, ALXN1210, was being tested against another drug, Soliris, in a Phase 3 study in patients with paroxysmal nocturnal hemoglobinuria, or PNH.

ALXN1210 was shown to be non-inferior to Soliris, achieving the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase, or LDH, levels, a direct marker of complement-mediated hemolysis in PNH. ALXN1210 also demonstrated non-inferiority to Soliris on all four key secondary endpoints.

Detailed results will be submitted for presentation at a future medical conference, the company said, adding that it is planning regulatory submissions in the U.S., EU and Japan in the second half of 2018.

EXECUTIVE COMMENTARY

“We are very pleased with these positive data for ALXN1210 in the first and only head-to-head study versus Soliris, and the results reinforce our ambition to establish ALXN1210 as the new standard of care for patients with PNH,” said John Orloff, EVP and Alexion’s head of research and development.

Orloff added, “The data are also consistent with our hypothesis that immediate, complete, and sustained C5 inhibition is critical for patients with this potentially life-threatening disease… Soliris has established a high bar for efficacy.

Achieving non-inferiority on both co-primary and all key secondary endpoints, as well as seeing numeric results in favor of ALXN1210, in such a rigorous study met a very high hurdle.”

PRICE ACTION

Alexion is up nearly 8% to $132.50 per share in pre-market trading.


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