FDA Approves NeurogesX's Qutenza After the market closed on November 16, 2009, NeurogesX (NGSX) announced that the U.S. FDA had approved Qutenza (capsaicin patch) for the management of neuropathic pain due to postherpetic neuralgia (PHN).  We expect management to spend the next several months preparing for the launch by facilitating reimbursement procedure, establishing distribution channels, hiring and training the specialty sales force, and conducting the manufacturing for commercial supply. Key to our bullish sales forecast for the drug will be establishing a permanent reimbursement code for both the product and application, as Qutenza requires administration by a physician or healthcare professional. Qutenza is a cutaneous (skin) patch designed to treat peripheral neuropathic pain conditions. The Qutenza patch provides a pure high concentration (8%) of a synthetic capsaicin, known as trans­-capsaicin, directly to the site of pain via a rapid-delivery cutaneous delivery system designed to provide ...

  On November 6, 2009, Inhibitex (INHX) reported financial results for the third quarter period ending September 30, 2009. Total revenues for the quarter were $0.29 million and consisted of $0.25 million in collaborative research and development payments and $0.04 million in licenses fees. Net loss for the third quarter totaled $4.5 million, or $0.10 per share. This was in-line with our forecast. The company exited the third quarter with $21.1 million in cash, equivalents and short-term investments. This amount does not include the approximately $23 million in gross procedures raised in late October through the private placement of common stock and warrants to new and existing shareholders. We forecast that Inhibitex will exit 2009 with approximately $37 million in cash and investments. This should be enough to fund operations, including completing the ongoing phase II FV-100 program and completing a phase Ia and phase Ib program on INX-189, through ...

Results from Arena’s (ARNA) phase III BLOSSOM study are strikingly similar to the BLOOM study, with mean total weight loss for the 10mg lorcaserin BID group coming in at 17.0 lbs in BLOSSOM vs. 17.9 lbs in BLOOM. These equated to 7.9% and 8.2% mean absolute weight loss. The placebo was 3.9% and 3.4% in each trial, respectively, putting the mean placebo-adjusted weight loss for each trial at 4.0% and 4.8%. Total categorical weight loss for the completer analysis was 63.2% in BLOSSOM and 66.4% in BLOOM, vs. 34.9% and 32.1% for the placebo. Per the FDA draft guidance: “A product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose ...

Javelin Pharmaceuticals Inc.

(Public, AMEX:JAV)

The follow article has been submitted to StocksHaven Investments by Nicholas DeCesare, a highly respected investor and journalist within the biopharma realm.

Take one look at a chart of Javelin Pharmaceuticals over the past six months and you will see a stock that has doubled in price but still sits only around $2.00 per share.  In fact, just two years ago, the stock was being recommended by analysts with its stock price hovering around $7.00.  In short, as detailed on their website, Javelin is a specialty pharmaceutical company that applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs that target current unmet and under-served medical need in the pain management market.  Javelin’s focus is different than other pharmaceutical companies’ pain management products: they develop new and proprietary administration routes for well-characterized molecules

...

For Immediate Release

Chicago, IL - June 8, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: MannKind (MNKD), Pfizer, Inc. (PFE), Novo Nordisk (NVO), Eli Lilly (LLY) and Alkermes Pharmaceuticals (ALKS).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Friday's Analyst Blog:

Raising MannKind to Hold

We believe that MannKind's (MNKD) Afresa offers distinct advantages over traditional needle-based insulin therapy. The key advantage is the convenience of an inhaled delivery. Diabetes patients using Afresa will no longer have to worry about a needle injection. Along with convenience,

...

MNKD: Upgraded to Hold from SellWe upgrade MannKind Corp. (MNKD) to Hold from Sell based on some positive developments during the last few months and potential catalysts in the coming months.Afresa is finally under the FDA review now After several years of extensive pre-clinical and clinical trials and spending millions of dollars, MannKind finally submitted its new drug application (NDA) for its lead drug candidate Afresa in March 2009. The FDA officially accepted the NDA filing in May 2009.This is positive news to the company. Although still facing rigorous review by the FDA, especially after the report of lung cancer in patients treated with Pfizer's (PFE) Exubera, Afresa will finally get a nod from the FDA, in our view.As a background, Afresa is inhaled insulin for the treatment of diabetes. It is dry-powder inhaled deep into the ...

This weekend, I’ll be speaking at the Mt. Vernon Research/Investor’s Daily Edge “Boom & Doom” conference in South Florida. During my presentations, I’ll offer the attendees my top five stocks that I believe will fare well, no matter whether we’re in a depression or expansion. Now, it wouldn’t be fair to the paying customers if I give you those top five stocks here. But what I can do is provide you with the stockpicking method to my (some say considerable) madness…

A Fat Pipeline… And An Even Fatter Dividend

Several of the stocks are in the healthcare sector - my specialized area of expertise.

Not only do I cover that sector for Mt. Vernon Research, I also believe that owning the right healthcare stocks is crucial for having a well-balanced portfolio.

While President Obama’s goal to make healthcare affordable for every American is noble, it’s difficult to execute

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We are moving our rating on Amgen, Inc. (AMGN) from Hold to Sell.We struggle to understand how the top-line might accelerate to a pace over the next three quarters that would allow management to deliver revenues within the current range of $14.4 to $14.8 billion. This would mean a significant pick-up in trends considering the first quarter delivered revenues of only $3.3 billion.We would not be surprised to see the top-line guidance revised down again after the second quarter. We are comfortable with our below-guidance estimate of $14.275 billion forecast.Based on our 2009 through 2013 model, Amgen's 5-year earnings CAGR [compound annual growth rate] is 5%. This is far below the biotechnology peer-group average of around 15% (13% for Gilead, 8% for Biogen, 17% for Celgene, 12% for Roche, 16% for Genzyme). In fact, Amgen's 5% earnings CAGR is even below several ...

Highlights include Biogen Idec, Inc. (BIIB), AstraZeneca plc (AZN), Bristol-Myers Squibb, Inc. (BMY) and Sanofi-Aventis SA (SNY).R&D Day Highlights the Best Pipeline In Biotech

Last week, Biogen Idec (BIIB) held an R&D Day, highlighting the broad depth of the company's pipeline. In total, Biogen Idec boasts 7 programs in phase III registration programs and 20 other programs in phase II "proof-of-concept" programs. Biogen's development programs span oncology, neurology and cardiovascular disease, and include both small molecules and biologics. In our opinion, it's the best pipeline in biotech.

Phase III / Registration programs include:   

BG-12: An anti-inflammatory second generation oral fumaric acid molecule that offers a more convenient and potentially neuroprotective treatment option for multiple sclerosis. BG-12 is currently in 2 phase III trials, DEFINE and CONFIRM, with data expected in 2010 and 2011.     ...

Amgen, Inc. (AMGN), a global biotechnology company, is focused on the development and commercialization of human therapeutics. The company's key products are Epogen/Aranesp (anemia), Neupogen/Neulasta (neutropenia), and Enbrel (inflammatory disease). Results over the past few quarters demonstrate the challenging, but stabilizing ESA market.Nevertheless, we still feel as though the pipeline is significantly undervalued, and we continue to recommend the name as a long-term Hold within the biotechnology sector. Recent positive news on phase III denosumab is a big reason we continue to be positive on Amgen. Our price target is $56.Based on our 2009 through 2013 model, the 5-year earnings CAGR [compound annual growth rate] of 7% is generally in-line with that of most large-cap pharmaceutical companies. Yet it is well below some of the larger biotechnology peers such as Genentech (DNA), Biogen (BIIB), Celgene  (CELG), Genzyme (GENZ) and Gilead ...