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

Paladin And Somaxon Announce Filing Of New Drug Submission For Silenor®

Paladin Labs Inc. (TSX:PLB) and Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that Paladin has filed a New Drug Submission (NDS) that has been accepted for review by Health Canada for Silenor ® (doxepin) for the treatment and symptomatic relief of insomnia.

“We are pleased that Health Canada has accepted to review our submission for Canadian regulatory approval for Silenor ®,” said Mark Beaudet, interim President and Chief Executive Officer of Paladin Labs Inc. “We believe that Silenor ® can fill a significant unmet need in the Canadian insomnia market. To date, the Canadian prescription sleep aid market has consisted mainly of zopiclone, an older medication that, despite its limitations, has driven the market to exceed $87 million in 2011 1, an increase of 10% vs. 2010.”

If approved, Silenor ® could be the first and only prescription product approved for the treatment of insomnia in Canada that is not a controlled substance.

Paladin received rights to commercialize Silenor ® in Canada, South America and Africa from Somaxon in June 2011. Under the collaboration agreements, there is no payment due to Somaxon from Paladin as a result of the NDS filing. Once Silenor ® is commercialized in the licensed territories, Somaxon will be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales.

About Silenor ®

Silenor ® is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin. If approved, Silenor ® is expected to be the first and only non-controlled prescription sleep medication in Canada indicated for the treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakening and/or early morning awakenings.

About Paladin Labs Inc.

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. With this strategy, a focused Canadian national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at

About Somaxon Pharmaceuticals, Inc.

Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company that sells Silenor ® in the United States. For more information, please visit the company's web site at


1 of 3

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
AAPL $93.64 -0.11%
FB $118.57 0.84%
GOOG $698.21 0.75%
TSLA $241.80 0.43%
YHOO $36.53 -0.19%


Chart of I:DJI
DOW 17,891.16 +117.52 0.66%
S&P 500 2,081.43 +16.13 0.78%
NASDAQ 4,817.5940 +42.2360 0.88%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs