This Day On The Street
Continue to site
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

Keryx Falls On Questions About Zerenex Market Exclusivity

NEW YORK ( TheStreet) -- Move over Amarin (AMRN - Get Report), you have company on the "NCE worry" bus.

Keryx Pharmaceuticals (KERX - Get Report) shares fell 22% to $7.11 Friday after an independent research firm raised questions about the company's ability to convince FDA to grant New Chemical Entity status to its experimental iron-based phosphate binder Zerenex.

IPD Analytics, which conducts intellectual property healthcare research for Wall Street investors, issued its Keryx report on Friday. The IPD report also questioned the strength of Keryx's patents protecting Zerenex from potential generic competitors.

Keryx shares have more than doubled since Jan. 28 when positive results from a long-term safety study of Zerenex were released. Keryx intends to seek U.S. and European approval for Zerenex, which would be used to lower blood levels of phosphorous in patients undergoing kidney dialysis. Zerenex may have a commercial advantage over other so-called phosphate binders because its iron-based core appears to reduce the need for intravenous iron and expensive anemia-boosting drugs like Amgen's (AMGN - Get Report) Epogen.

The IPD report issued Friday speculates that the active ingredient in Zerenex may not be differentiated enough from Ferriseltz, developed by the Japanese drugmaker Otusuka and FDA approved in 1997 for use during MRI procedures. If FDA finds the active ingredients similar, Keryx could be denied NCE status and the five years of market exclusivity that goes with the designation. Without the protection of an NCE designation, generic filers could also file faster challenges to Zerenex.

"It is unclear whether Zerenex will qualify for New Chemical Entity (NCE) exclusivity or a Patent Term Extension on one patent that covers Zerenex," the IPD report states. "In October 1997, FDA approved Otsuka's NDA for Ferriseltz (ferric ammonium citrate). It is possible that ferric citrate (the active ingredient in Zerenex) may be a salt of ferric ammonium citrate (the active ingredient in Ferriseltz). If FDA determines that ferric citrate is a salt of ferric ammonium citrate, then FDA could determine that Zerenex is not eligible to receive NCE exclusivity or a Patent Term Extension."

Healthcare investors involved with Amarin and its lipid-lowering drug Vascepa have become well aware of the overhang created when questions are raised about a drug's NCE status. FDA approved Vascepa in July but the agency has yet to determine whether the drug deserves NCE status. The uncertainty over Vascepa's market exclusivity contributed to Amarin's inability to partner the drug and delayed its launch.

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
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!
SYM TRADE IT LAST %CHG
AMRN $2.15 0.00%
AMGN $162.38 0.00%
KERX $11.02 0.00%
AAPL $132.65 0.00%
FB $81.91 0.00%

Markets

DOW 18,037.97 -42.17 -0.23%
S&P 500 2,108.92 -8.77 -0.41%
NASDAQ 5,060.2460 -31.8390 -0.63%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs