Novartis Submits Bexsero to FDA for Marketing Approval - Analyst Blog

By
A A A

Novartis ( NVS ) announced the submission of its Biologic License Application (BLA) for meningitis B vaccine candidate Bexsero to the FDA for marketing approval among adolescents and young adults within the age group of 10-25 years.

The FDA granted Breakthrough Therapy designation to Bexsero in Apr 2014. We note that Bexsero is already approved in Europe for invasive meningococcal disease caused by serogroup B.

The Vaccines Division generated $1.4 billion in sales in 2013. Earlier, Novartis entered into an agreement with GlaxoSmithKline ( GSK ) in Apr 2014 for the exchange of certain assets.

Under the agreement, Novartis would divest its Vaccines business (excluding flu) to GlaxoSmithKline for $7.1 billion ($5.25 billion is upfront and up to $1.8 billion in milestone payments) along with royalties.

On the other hand, Novartis would acquire GlaxoSmithKline's oncology products for $14.5 billion and up to $1.5 billion as milestone payments.  The agreement also provides Novartis with opt-in rights to GlaxoSmithKline's current and future oncology R&D pipeline.

Novartis expects to close the deal with GlaxoSmithKline by the first half of 2015. Novartis also divested its blood transfusion diagnostics unit to Grifols S.A. for approximately $1.7 billion in cash in Jan 2014.

The acquisition of GlaxoSmithKline's oncology products and divestment of Vaccines business is a step in the right direction for Novartis. It will broaden Novartis' portfolio and enable it to focus better on its core capabilities besides contributing immensely to the top line. Margins are also expected to get a significant boost.

Novartis currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks may consider companies like Gilead Sciences ( GILD ) and Allergan ( AGN ). Both stocks carry a Zacks Rank #1 (Strong Buy).


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

ALLERGAN INC (AGN): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

NOVARTIS AG-ADR (NVS): Free Stock Analysis Report

GLAXOSMITHKLINE (GSK): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: AGN , GILD , NVS , GSK

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Stocks

Referenced

Most Active by Volume

64,789,752
  • $117.60 ▼ 0.86%
53,107,118
  • $10.39 ▼ 1.05%
42,600,857
  • $17.10 ▼ 0.47%
36,917,582
  • $11.02 ▼ 0.36%
34,902,121
  • $40.75 ▼ 0.10%
31,489,742
  • $15.68 ▲ 0.06%
31,037,743
  • $75.63 ▲ 2.19%
29,605,187
  • $10.11 ▼ 0.69%
As of 11/25/2014, 04:15 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com