This Day On The Street
Continue to site
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

The Deal: Onyx Trials Cloud Amgen Deal

NEW YORK ( The Deal) -- A Bloomberg article that ran Aug. 14 cited anonymous sources saying that Amgen's (AMGN - Get Report) $10 billion, $120 per share, acquisition of Onyx Pharmaceuticals (ONXX) was hanging on whether Amgen could see results of a clinical trial for Onyx's Kyprolis.

However, the reference to the study results was ambiguous and left parties tracking the deal trying to figure out which trial the sources were alluding to and whether access to the data could truly be a deal-breaker.

Kyprolis is a key element in Onyx's valuation. It's a next-generation proteasome inhibitor that received accelerated approval in the U.S. last year as a third-line treatment for multiple myeloma, a cancer of specific blood cells. The company needs approval in the U.S. and EU to meet its revenue guidance. The Food and Drug Administration offers urgently needed drugs accelerated approval based on preliminary data. However, the drug company must continue to pursue more proof of the drug's clinical effectiveness to attain permanent, or regular, approval.

To attain that approval, and market the drug in the EU, Onyx has two major ongoing Kyprolis clinical trials: Focus and Aspire. One of these two trials is very likely what the unnamed source was referencing in the Bloomberg article. "It's very unlikely that Amgen wanted results of a trial that's incomplete," ISI Group analyst Mark Schoenebaum said Aug. 16 in a research note.

During its second-quarter sales and earnings call, Onyx said Focus had recently undergone an interim analysis and that Kyprolis hadn't met its endpoint yet. That is not a bad signal. It's simply an early look at a trial and quite often at that point a trial hasn't met its outcome goal. Final analysis for Focus is expected next year.

These trials are "blinded," meaning nobody is supposed to know which patients are in the treatment arm and which are controls. They are coded so only an independent research committee can "unblind" the data to do an interim analysis. If the data are unblinded any other way, the trial could very well not be accepted by regulators and that could delay approval.
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ONXX $0.00 0.00%
AMGN $141.22 -1.79%
AAPL $111.97 1.10%
FB $93.35 -0.70%
GOOG $649.00 1.20%


Chart of I:DJI
DOW 16,790.19 +13.76 0.08%
S&P 500 1,979.92 -7.13 -0.36%
NASDAQ 4,748.3610 -32.9030 -0.69%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs