Back to top

Analyst Blog

Astellas Pharma Inc. (ALPMY) announced that it has reached an agreement with the U.S. Department of Justice to resolve civil claims regarding the marketing of Mycamine for injection. Astellas is liable to pay $7.3 million to the settling parties.

We note that the Department of Justice had launched an investigation on Astellas for alleged off-label promotion of Mycamine for pediatric use. 

In Mar 2005, the U.S. Food and Drug Administration (FDA) had approved Mycamine for the prevention of candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT) and the treatment of esophageal candidiasis. In Jun 2013, Mycamine gained U.S. approval for the expanded use of Mycamine injection in pediatric patients four months and older. In fiscal year 2012 (ended Jun 2013), Mycamine sales in the US were $108.1 million.

In Apr 2008, EU approval was received for the treatment of patients with invasive candidiasis and prevention of candida infection in patients undergoing allogeneic HSCT. For patients >=16 years of age the drug was cleared in the EU for oesophageal candidiasis, in addition to the above indications.

Besides the news of legal settlement, Astellas Pharmaalso announced the launch of the selective Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitor, Suglat tablets (25mg and 50mg) in Japan for the treatment of type II diabetes. Suglat was jointly developed by Astellas and Kotobuki Pharmaceutical Co., Ltd.

Astellas Pharma carries a Zacks Rank #3 (Hold). Some better stocks in the pharma sector include Salix Pharmaceuticals Ltd. (SLXP - Analyst Report), Impax Laboratories Inc. (IPXL - Snapshot Report) and Enanta Pharmaceuticals, Inc. (ENTA - Snapshot Report). Salix Pharma and Enanta carry a Zacks Rank #1 (Strong Buy) while Impax Labs holds a Zacks Rank #2.

Read the Full Research Report on ALPMY
Read the Full Research Report on IPXL
Read the Full Research Report on SLXP
Read the Full Research Report on ENTA

Zacks Investment Research

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

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 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
TRIQUINT SE… TQNT 20.67 +6.52%
RF MICRO DE… RFMD 12.47 +6.04%
VASCO DATA… VDSI 14.77 +4.68%
STRATTEC SE… STRT 80.24 +3.00%
PATTERSON-U… PTEN 34.54 +2.98%