Gilead Sciences, Inc (GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients [...]
Gilead Sciences, Inc (GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). Earlier, in September 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data.
In September 2009, the drug received conditional marketing approval in Canada and Europe under the trade name Cayston (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Gilead plans to make the product available in Germany and the UK in early 2010. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation, which has orphan drug status in the US and Europe . Applications for marketing approval of Cayston are pending in Australia , Switzerland and Turkey .
CF is a chronic, debilitating genetic disease that affects the respiratory and digestive systems of approximately 70,000 people worldwide, including 35,000 people in the European Union. Cayston was granted conditional marketing authorization to address the unmet medical need of the CF patients. A decision regarding full marketing authorization will be based on the completion of the ongoing phase III study examining the efficacy and safety of Cayston compared to Novartis’ (NVS) tobramycin inhalation solution (TOBI) in CF patients with pulmonary P. aeruginosa.
During the third quarter conference call, Gilead stated that it expects to complete enrollment by the year end and make the data available towards the middle of next year. We believe positive data from this study will help it to receive approval from the regulatory authorities in both US and Europe . We have a Neutral recommendation on the stock. Read the full analyst report on "GILD" Read the full analyst report on "NVS" Zacks Investment Research
Franklin Biotechnology Discovery A (MAPTX) seeks capital appreciation by primarily investing in securities of biotechnology companies and discovery research firms.
This non-diversified fund may invest a substantial portion of assets in equity securities of smaller capitalization companies with a market capitalization of less than $1.5 billion.
Gilead Sciences Inc. (GILD), Celgene Corp. (CELG) and Genzyme Corp. (GENZ) [...]
Franklin Biotechnology Discovery A (MAPTX) seeks capital appreciation by primarily investing in securities of biotechnology companies and discovery research firms.
This non-diversified fund may invest a substantial portion of assets in equity securities of smaller capitalization companies with a market capitalization of less than $1.5 billion.
Gilead Sciences Inc. (GILD), Celgene Corp. (CELG) and Genzyme Corp. (GENZ) are among the fund’s key holdings.
Templeton Developing Markets A (TEDMX) seeks long-term capital appreciation through investment in securities of emerging economies.
The fund may invest up to 20% of net assets in the securities of issuers in developed market countries. It may also invest in exchange-traded funds to gain exposure to certain segments of the equity markets while maintaining liquidity.
J. Mark Mobius has been lead manager at the fund since October 1991. The fund distributes dividends and capital gains, if any, annually.
Click here to see all the mutual funds offered by Matthews International.
Chicago, IL – November 10, 2009 – Zacks.com announces the latest Industry Outlook. Today, Zacks Equity Research discusses the Big Pharma & Biotech sector, including Alcon (ACL), Novartis (NVS), Gilead Sciences (GILD), Biogen Idec (BIIB) and Acorda Therapeutics (ACOR).
In the pharma space, we are positive on stocks like Alcon (ACL) and Novartis (NVS). We believe these companies will continue witnessing revenue growth based on continued international penetration, new product launches and market share expansion. Pipeline expansion through in-licensing deals and acquisitions should also add to growth.
Novartis should see strong vaccine sales this flu season. The company has received approval from the U.S. Food and Drug Administration for its swine flu vaccine, which should drive revenues.
Although we have Neutral ratings on names like Johnson & Johnson and Abbott Labs, we maintain a positive outlook on these stocks given their diversified revenue base, strong business segments, contributions from recent acquisitions and impressive late-stage pipelines. We also have a positive outlook on Bristol-Myers, which has a strong presence in attractive areas like biologics, cancer and cardiovascular drugs.
In the biotech space, we are positive on names like Gilead Sciences (GILD) and Biogen Idec (BIIB) even though we have Neutral recommendations on these stocks. Gilead’s HIV franchise has been helping the company post better-than-expected earnings over the past few quarters and we expect this trend to continue.
Biotech companies that could be acquisition targets provide opportunities for significant returns. Here, we would like to mention two companies that could be potential take-out targets -- Biogen Idec and Acorda Therapeutics (ACOR). In addition to holding a leading position in the multiple sclerosis market, we believe Biogen has the best pipeline in all of biotech and could be an attractive takeover candidate for pharma companies interested in biologics.
Meanwhile, Acorda is one of the more interesting biotechnology companies under our coverage. We have an Outperform rating on the stock. Acorda recently received a favorable recommendation from an FDA advisory panel on its key pipeline drug, Fampridine-SR, which could have blockbuster potential worldwide.
Want more from Zacks Equity Research? Subscribe to the free Profit from the Pros newsletter: http://at.zacks.com/?id=5510.
About Zacks
Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1978 by Leonard Zacks. As a PhD in mathematics Len knew he could find patterns in stock market data that would lead to superior investment results. Amongst his many accomplishments was the formation of his proprietary stock picking system; the Zacks Rank, which continues to outperform the market by nearly a 3 to 1 margin. The best way to unlock the profitable stock recommendations and market insights of Zacks Investment Research is through our free daily email newsletter; Profit from the Pros. In short, it's your steady flow of Profitable ideas GUARANTEED to be worth your time! Register for your free subscription to Profit from the Pros at http://at.zacks.com/?id=5511.
Disclaimer: Past performance does not guarantee future results. Investors should always research companies and securities before making any investments. Nothing herein should be construed as an offer or solicitation to buy or sell any security.
Contact:
Mark Vickery
Web Content Editor
312-265-9380
Visit: www.zacks.com
Gilead Sciences, Inc. (Public, NASDAQ:GILD) reported earnings yesterday, but the blow-out-quarter doesn't seem to be impressing investors today, as shares are down 3%.
Here is a summary of the call:
* Net profit 72 cents/share beats 67 cents/share estimate
* Revenue increases 31 pct to $1.8 billion
Gilead Sciences Inc said on Tuesday its quarterly profit rose 36 percent, due in part to royalties on sales of the flu drug, Tamiflu, but sales of its core HIV drugs failed to impress investors and its
out-quarter doesn't seem to be impressing investors today, as shares are down 3%.
All News |
Breaking News |
Featured Stories