Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Insmed Incorporated (INSM - Snapshot Report) recently announced about two important patent allowances in the U.S. and Europe for its lead candidate, Arikace.

The U.S. Patent and Trademark Office (USPTO) is looking to grant Arikace U.S. Patent Application No. 13/666,420 (titled lipid-based compositions of anti-infectives for treating pulmonary infections and methods of use thereof), which will expire on Dec 5, 2026.

The European Patent Office is looking to grant EU Patent Application No. 03816990 (titled sustained release of anti-infectives) for Arikace, which will expire on Oct 29, 2023. The patent will be valid in any European Patent Office member state where the company chooses to validate the patent.

Both patents will cover an aerosol composition for the treatment of pulmonary infections, including pseudomonas aeruginosa and mycobacterial infections, along with other indications, based on Insmed’s novel, once-daily inhalation formulation comprising amikacin and liposomal delivery technology.

These new patents will further boost the existing global patent portfolio of Arikace.

We note that in Apr 2013, the U.S. Food and Drug Administration granted orphan drug status to Arikace for the treatment of infections caused by non-tuberculous mycobacteria (NTM).

Insmed is currently conducting a phase II study on Arikace in the U.S. and Canada in patients suffering from NTM lung infection. Insmed expects to report top-line results from the study by the end of the first quarter of 2014. The company also plans to initiate a limited compassionate use program on the candidate in the second half of 2013.

If cleared by the regulatory bodies, Arikace would be the first approved inhaled antibiotic treatment for NTM lung infections.

Furthermore, Arikace is under phase III development for the treatment of pseudomonas aeruginosa (Pa) lung infections in patients suffering from cystic fibrosis (CF).

In Jul 2013, Insmed reported encouraging results from a phase III study on Arikace for the treatment of Pa in CF patients, when compared to Novartis’ (NVS - Snapshot Report) TOBI (tobramycin inhalation solution).

Insmed expects additional results from the study in the second half of this year. Arikace enjoys orphan drug status for this indication both in the U.S. and the EU. The company is currently enrolling patients for a two-year open-label extension study on Arikace for the same indication. The extension study is expected to be completed by mid 2015.

Insmed currently carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Gilead Sciences Inc. (GILD - Analyst Report) and Jazz Pharmaceuticals (JAZZ - Analyst Report) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy), respectively.  

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GRP IN DXYN 15.84 +7.90%
BOFI HLDG IN BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%