Back to top

Analyst Blog

Zacks Equity Research

Canada Approves Vertex's Kalydeco

VRTX JNJ

 ZacksTrade Now

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.

Vertex Pharmaceuticals Incorporated (VRTX - Snapshot Report) recently announced the approval of its cystic fibrosis (CF) treatment, Kalydeco, in Canada. Kalydeco gained approval for the treatment of cystic fibrosis in patients aged 6 years and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Kalydeco is already approved in the US and the EU. While US approval came in January, EU approval was granted in July. Vertex Pharma reported Kalydeco sales of $49.2 million in the recently reported third quarter of 2012. Vertex Pharma is currently working on the EU launch of Kalydeco. The company expects reimbursement coverage in each of the four major European countries that account for 80% of the G551D patients in Europe in 2013.

Vertex Pharma reported that it is now treating most of the eligible G551D patients in the US. The company is working on expanding Kalydeco’s label and is conducting monotherapy studies which could expand the target population from the current 4% to approximately 15% of CF patients. Vertex Pharma also remains on track to commence pivotal studies in early 2013 with Kalydeco plus VX-809 in delta 508 homozygous patients.

Currently, Vertex Pharma has another marketed product in its portfolio: Incivek, which is approved for the treatment of hepatitis C virus (HCV). Vertex Pharma has an agreement with Johnson & Johnson (JNJ - Analyst Report) to commercialize Incivek outside the US.

Neutral on Vertex Pharma

We currently have a Neutral recommendation on Vertex Pharma, which carries a Zacks #4 Rank (Sell). Vertex Pharma’s third quarter results were disappointing with both earnings and revenues missing expectations. We expect Incivek sales to continue being affected by warehousing and a slowdown in new patient additions. Meanwhile, Kalydeco sales should pick up from 2013 when additional launches take place in the EU. With the company working on expanding Kalydeco’s label and strengthening its HCV portfolio, we expect investor focus to remain on pipeline progress.

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 GROUP DXYN 15.84 +7.90%
BOFL HOLDING 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%