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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Cubist Receives CUBICIN Paragraph IV Notice Letter

Stocks in this article: CBST

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has received a Paragraph IV Notice Letter from Hospira, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of CUBICIN® (daptomycin for injection).

CUBICIN is currently protected by five FDA Orange Book-listed patents, which expire between 2016 and 2028. Hospira’s Notice Letter is directed to all of the patents listed in the Orange Book.

Cubist intends to vigorously enforce its extensive intellectual property rights for CUBICIN and plans to file a complaint alleging infringement within the required 45-day response period of the Hatch-Waxman Act. Once a suit is filed, a 30-month stay of approval will be imposed by the FDA on Hospira's ANDA.

In April 2011, Cubist announced it had settled its CUBICIN patent litigation with Teva Pharmaceuticals. As part of that settlement, Cubist granted Teva a license to sell generic daptomycin in the U.S. either as of June 24, 2018, if CUBICIN is granted pediatric exclusivity extension, or as of December 24, 2017. In addition, as part of this settlement, Teva will purchase its U.S. requirements of daptomycin exclusively from Cubist.

Since the settlement with Teva, Cubist has been granted two additional patents that are listed in the Orange Book: US Patent No. 8,003,673, which expires on September 4, 2028, and US Patent No. 8,058,238, which expires on November 28, 2020.

About CUBICIN

CUBICIN® (daptomycin for injection) is approved in the U.S. and many other non-US markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis, caused by methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, including important safety information, please visit www.cubicin.com.

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.

Forward Looking Statements

This press release contains forward-looking statements related to our plans to file a patent infringement lawsuit and enforce our intellectual property rights for CUBICIN. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include, but are not limited to: our ability to timely file a patent infringement lawsuit; adverse results of any litigation that we file to defend and/or assert our patents; and other risks common to our industry, including risks common to intellectual property and patent protection and maintenance in general and with respect to intellectual property and patents in our industry. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in our most recent 10-Q filing with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filing, which are incorporated into this press release by this reference. Forward-looking statements speak only as of the date of this release, and Cubist undertakes no obligation to update or revise these statements, except as may be required by law.

1 of 2

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!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

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