Get 40% Off
🔥 This hedge fund gained 26.16% in the last month. Get their top stocks with our free stock ideas tool.See stock ideas

UPDATE 3-US FDA plays down cancer link with Sanofi's Lantus

Published 07/01/2009, 04:16 PM
C
-
SASY
-
NOVOb
-

* FDA says studies may be too short to assess risk

* Questions whether cancer risk "truly exists"

* Sanofi shares up 3.1 percent (Adds doctor comment in graphs 8-9)

By Lewis Krauskopf and Susan Heavey

NEW YORK/WASHINGTON, July 1 (Reuters) - The U.S. Food and Drug Administration on Wednesday cast doubt on recent studies that suggested possible cancer risk with Sanofi-Aventis' widely used Lantus diabetes drug, boosting investor confidence in the blockbuster product.

Shares of the French drugmaker, which have stumbled in the past week over Lantus concerns, rose 3.1 percent in Paris after the FDA also said patients should not stop taking their therapy without consulting a physician.

In a communication posted on its website, the agency questioned four recently published studies over the cancer link, saying they did not track patients long enough to properly evaluate any such risk from the drug.

Additionally, the FDA said, "inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of (Lantus) and cancer truly exists."

It added that there may be differences in the patients studied that could have contributed to the studies' findings.

Shares of the French drugmaker have plunged about 13 percent in the last week amid concerns that patients and doctors worried about Lantus' safety would stop using the product and turn to rival treatments such as Novo Nordisk's long-acting insulin Levemir.

Lantus is a top seller for Sanofi, and it is seen as particularly important as other key Sanofi products -- blood thinners Plavix and Lovenox -- face possible generic competition. Lantus tallied 2.45 billion euros ($3.5 billion) in 2008 sales, a figure analysts have expected to grow over the next five years.

3rd party Ad. Not an offer or recommendation by Investing.com. See disclosure here or remove ads .

Dr. Richard Bergenstal, president-elect of medicine and science with the American Diabetes Association, said it appears the FDA was taking the risk posed by the Lantus studies "seriously but cautiously."

"I do think they were saying when you get confusing data or conflicting data, don't make clinical decisions until we get more," Bergenstal said.

Sanofi has stood behind the safety of its diabetes drug, and a company spokesman in Paris said on Wednesday it was "committed to working with the FDA and other health authorities and scientific experts to clarify the situation."

The FDA said it would continue reviewing the safety data for Lantus, including the new studies, to better understand any possible cancer risk.

Earlier this week, the European Medicines Agency said it was asking its scientific experts to perform a detailed assessment of the European studies' results and any other relevant information, since a link between Lantus and cancer "cannot be confirmed nor excluded."

Mark Dainty, an analyst at Citigroup, said the stock's recent drop meant the market was already discounting a worst-case scenario.

But the actual decline in Lantus sales might not be as severe as the 60 percent drop seen in global sales of GlaxoSmithKline's Avandia, which was linked to heart attack risk in 2007, he said.

(Reporting by Lewis Krauskopf and Susan Heavey; Additional reporting by Ben Hirschler in London; Editing by Lisa Von Ahn, Derek Caney and Richard Chang)

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.