This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
TheStreet Open House

Keryx CEO vs. a Short-Seller: Zerenex Patent Debate

Stocks in this article: KERX AMRN

Bentsur: Next, we have also heard about the possibility that older ferric citrate filings could impede on our ability to obtain Patent Term Extension. First, we don't know whether any of these older filings physically exist or whether they were actually 505(b) filings, meaning NDAs, or rather just nutraceutical filings. Even if they do exist and one or more of them were actually 505(b) filings, such filings occurred prior to the 1962 Kefauver Harris Act, which required efficacy studies of drugs from that point forward in order to be approved. All older filings received an eight-year grace period to conduct efficacy studies or appeal their case in order to remain on the market. The cutoff date for the Kefauver Harris Act grace period was July of 1970, and in fact, all four older ferric citrate filings show up as being pulled from the market on that date, meaning, none of them made the cut as an approved drug and no ferric citrate approval appears after that date. Incidentally, two ferric ammonium filings do appear after the July 1970 cutoff date, meaning ferric ammonium approvals deemed have been approved subsequent to the Kefauver Harris Act.

Keryx short-seller: There is no such thing as a nutraceutical filing. I don't think these very old ferric ammonium citrate filings are relevant because iron citrate itself was approved by the FDA in 1973! Though forty years have passed, the active ingredient remains the same -- iron. If you don't believe me about the tenuous thread upon which Zerenex's exclusivity hangs, look at Keryx's own 2011 10-K filing, which includes a statement that perifosine (in clinical development at that time) would qualify for NCE. Notably absent is a similar statement regarding NCE status for Zerenex.

Bentsur: So while we're very much engaged in dialogue with prospective partners, and there does seem to be significant interest, we were not at all apprehensive about launching the drug on our own, if the timing and or economics of the business development discussions do not coincide with our goals or expectations.

Keryx short-seller: While Big Pharma has done its share of ill-advised partnerships and acquisitions, one thing Big Pharma almost always does well is due diligence on intellectual property and market exclusivity. In this regard, I agree with Ron's comment above. Keryx will be launching Zerenex on its own. His warning Tuesday to that effect will be prove to be prescient in the days and months ahead.

-- Reported by Adam Feuerstein in Boston.

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

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!

Markets

DOW 17,387.21 -291.49 -1.65%
S&P 500 2,029.55 -27.54 -1.34%
NASDAQ 4,681.4970 -90.2660 -1.89%

Partners Compare Online Brokers

Free Reports

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