This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

FDA: Amylin Pharma Concealed Heart Safety Risks of Key Diabetes Drug

Bradbury responds: "So, that's a great question. The tQT study wasn't required through the initial approval in the United States of Byetta. It was requested by another agency for us to complete and we did that for them. It is now, I believe, a requirement. This is part of the evolution of the increase in focus on cardiovascular safety for all medicines, particularly those in diabetes. It is now a requirement for all medicines in diabetes to have a tQT study, as far as I'm aware."

Bradbury alludes to the Canadian heart-safety study of Byetta, but he fails to mention that Amylin tried to keep the data out of FDA's hands during the Bydureon review. Had FDA been aware of the study at the beginning, it would have almost certainly been raised as an issue by U.S. regulators. Bradbury also ignores the fact that FDA very much wanted to see the Byetta tQT study in order to fully assess the safety of Bydureon.

"We responded appropriately to requests for additional data, and followed processes outlined by FDA for our submission," said Amylin's Izzo on Friday, disputing the FDA's charge that Amylin and its executives concealed important safety data related to Byetta and Bydureon from the agency.

In early November 2010, two weeks after the FDA rejected Bydureon, Amylin held its regular third-quarter conference call. According to a transcript, one analyst on the call prefaced his questions to Amylin executives with a note of thanks to how they handled the Bydureon setback. "Hey guys. Thanks for all the disclosure. I think I speak for everybody, you guys handled this well. We appreciate it."

"I appreciate your kind remarks with regards to disclosure," Bradbury says, in response. "We do try very hard to be as transparent as possible with everybody about what we know about the business."

The FDA has a problem with Bradbury's definition of "transparent" -- so, too, may investors and potential Amylin suitors now that the company's version of events leading to the second rejection of Bydureon have been revised.

--Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

>To submit a news tip, send an email to: tips@thestreet.com.

Follow TheStreet on Twitter and become a fan on Facebook.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
4 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,960.57 -123.23 -0.72%
S&P 500 1,978.34 -9.64 -0.48%
NASDAQ 4,449.5640 -22.5440 -0.50%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs