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 ...

Gilead Sciences (GILD) reported financial results for the second quarter of 2009 on July 21, 2009. Total revenues increased 29% year over year to $1,647.2 million, beating our forecast by $35 million.  Revenues were driven by the company’s HIV franchise which posted sales of $1,410 million, up 26% year over year.  HIV franchise sales consisted of Viread at $159 million, Truvada at $608 million and Atripla at $569 million. Sales of Atripla, which is a combination of Truvada and Bristol-Myers Squibb’s (BMY) Sustiva, increased 60% year over year. However, there was some inventory stocking during the reported quarter.  Total product sales for the second quarter were $1,568 million, an increase of 27% year over year. Products like Hepsera ($67 million), AmBisome ($73 million), Letairis ($44 million), and Ranexa ($36 million) also contributed meaningfully to revenues. Royalties and other revenues totaled $78.8 million. ...

On Jul 16, Gilead Sciences Inc. (GILD) entered into a license and collaboration agreement with Tibotec Pharmaceuticals, a unit of Johnson & Johnson (JNJ), for the development of a once-daily antiretroviral HIV pill.

The companies are looking to develop a combination pill that will combine Gilead's Truvada with Tibotec's TMC-278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use in treatment-naïve HIV patients. If successfully developed and approved, the combination pill would be the second complete antiretroviral treatment for HIV to be available in a single pill. The use of single pills makes treatment simpler for patients.

Gilead's Atripla is the first once-daily pill to be available in the HIV market. Atripla is a combination of Truvada, itself a fixed-dose combination of two nucleoside reverse transcriptase inhibitors (NRTI): Viread and Emtriva, and Sustiva, an NNRTI manufactured by Bristol-Myers Squibb (BMY).

In addition to the treatment-naïve patient population, we believe the

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Gilead's Strong Fundamentals Should ContinueBusiness continues to look strong for Gilead Sciences (GILD). The company's tenofovir-based HIV products (Viread, Truvada and Atripla) are number one and widening their lead. The clinical data continues to support the switching of patients from older generation molecules such as abacavir and lamivudine to Gilead's franchise. Also driving impressive trends are revised HIV treatment guidelines from the U.S. Department of Health and Human Services recommending only Truvada (and Atripla) as the backbone of choice in naïve patients.These new guidelines, put into place in November 2008, downgraded Epzicom to an alternative medication based on cardiovascular risk and high rates of virologic failure. Finally, the new FDA chief, Margaret Hamburg, a former New York City Health Commissioner, has significant experience in combating infectious disease, such as HIV/AIDS, and we believe that this type of focused leadership only further adds to the ...

Gilead to Acquire CV Therapeutics for $1.4 BillionIn a surprise move this morning, Gilead Sciences (GILD) announced it has signed a definitive agreement to acquire CV Therapeutics, often referred to as "CVT" (CVTX) for $1.4 billion, or $20 per share. The news comes a month after CVT rejected an unsolicited bid from Astellas Pharmaceuticals for $1.0 billion, or $16 per share. Once the deal closes, CV Therapeutics will become a wholly-owned subsidiary of Gilead.We are surprised by the announcement this morning considering the move is outside Gilead's core focus of infectious diseases such as HIV and Hepatitis C. CV Therapeutics' leading product, Ranexa, is indicated for the treatment of chronic angina.The HIV/AIDS franchise drugs -- Viread, Truvada and Atripla -- accounted for 81% of Gilead's $5.3 billion in revenues in 2008. Gilead management is making a bold move to diversify its ...

Foster City, CA, based Gilead Sciences, Inc. (GILD) is perhaps the world's premier play on HIV/AIDS therapy.  Gilead's third quarter financial results were solid -- nothing new -- for the company, as management has posted upside surprise after upside surprise throughout the past several years. EPS of $0.55 in the quarter was $0.02 above our forecasts based on strong product sales and lower-than-expected SG&A [selling, general and administrative] costs.

Sales of key products, Truvada and Atripla, both exceeded expectations in the third quarter.  The Atripla uptake is going very well, and with the recent approval for Viread in HBV, Gilead remains well positioned to continue the strong top-line growth demonstrated over the past few years.   The pipeline is also progressing nicely.  Letairis should become the best-in-class ETRA for PAH, and given the lack of drug-drug interactions seen in the phase III trials, it should be used first-line with

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Caxton AssociateseCaxton Associates Hedge Fund HoldingsThis post is being written as part of HedgeFundBlogger.com's Investment Securities Tool which analyzes the holdings of hedge fund managers.Up next in the macro hedge fund tracking series we have Caxton Associates, ran by Bruce Kovner. Taken from Wikipedia, Kovner's bio is as follows: "Kovner's first trade was for $3,000, borrowed against his MasterCard, in soybean futures contracts. Realizing growth to $40,000, he then watched the contract drop to $23,000 before selling. He later claimed that this first, nerve-racking trade taught him the importance of hedge fund risk management. In his eventual role as a trader under the legendary Michael Marcus at Commodities Corporation (now part of Goldman Sachs), ...