NVS Amends sNDA; Completes Merger - Analyst Blog
11 Abril 2011 - 9:15AM
Zacks
Novartis (NVS) recently announced amendment to
its supplemental new drug application (sNDA) for Afinitor tablets.
Afinitor is currently marketed for the treatment of advanced renal
cell carcinoma (RCC; kidney cancer) after treatment with an
anti-VEGF therapy like Pfizer’s (PFE) Avastin,
Sutent or Onyx Pharmaceuticals/Bayer’s
(ONXX/BAYRY) Nexavar. Afinitor is also marketed for the treatment
of subependymal giant cell astrocytomas (SEGA), a benign brain
tumor associated with tuberous sclerosis (TS).
Novartis was seeking FDA approval for the treatment of patients
with advanced neuroendocrine tumors (NET) of gastrointestinal, lung
or pancreatic origin from the US Food and Drug Administration
(FDA). The amendment is now limited only to treat patients with
advanced NET of pancreatic origin. The amendment was based on a
feedback from the FDA.
The application is due to be reviewed by an advisory panel to
the FDA on April 12, 2011. The amendment by Novartis suggests that
Afinitor may not be approved for the treatment of patients with
advanced neuroendocrine tumors (NET) of gastrointestinal and lung
origin.
In another development, Novartis announced an agreement with
Meda to sell global rights to manufacture market and commercialize
Elidel (pimecrolimus) cream 1% for an upfront payment of $420
million in cash. Elidel is used to treat mild to moderate atopic
dermatitis. The objective behind the deal is to focus on
commercialization of new and core products.
The deal is expected to close in the second quarter of 2011,
following which Novartis will make the upfront payment. Within 3
years of closing the deal, Meda will take over the global
manufacturing of Elidel. Of the $406 million gain from the
transaction, $345 million will be recognized by the end of 2011.
The remainder will be recognized in 2012 and 2013.
Meanwhile, Novartis also announced that it has completed the
merger with Alcon Inc. (ACL). Per the terms of the
merger agreement, Alcon shareholders will receive a total
consideration of $168 per share in the form of 2.9228 Novartis
shares or American Depositary Shares (ADS) along with a cash
payment of $8.20 for each share.
Alcon will become the second largest division within Novartis
following the completion of the merger. Moreover, Novartis’ CIBA
Vision, select eye care medicines and an Alcon business wing will
be integrated into Alcon, forming an organization, which will
contribute more than $8.7 billion in sales (over 70%) to the eye
care segment.
The acquisition of Alcon is expected to help Novartis diversify
and make up for revenues, which is lost to generic competition.
Moreover, it will help the company strengthen its position in the
eye care market, which presents significant growth potential due to
the unmet needs of an ageing population.
Our Recommendation
Currently, we have a Neutral recommendation on Novartis, which
is supported by a Zacks #3 Rank (short term “Hold” rating). We are
pleased with Novartis’ wide range of products and its efforts to
diversify further as is evident by the acquisition of Alcon.
However, we prefer to remain on the sidelines due to the imminent
patent cliff faced by Novartis.
ALCON INC (ACL): Free Stock Analysis Report
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
ONYX PHARMA INC (ONXX): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
Zacks Investment Research
Alcon (NYSE:ACL)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Alcon (NYSE:ACL)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024