If approved, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies. In development studies, Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body's own immune system to attack cancer cells. Dendreon plans to market Provenge in the U.S. on its own and is seeking partners for ex-U.S territories.
 
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer globally as per data from the American Cancer Society. The disease affects more than one million men in the United States .
 
We believe that approval of Provenge is critical for the financial performance of the company because the product has blockbuster potential and its successful commercialization could drive a company of Dendreon’s size to strong profitability.
 
The company plans to manufacture Provenge in its New Jersey facility. Furthermore, additional manufacturing facilities in Los Angeles and Atlanta will begin producing the drug in the second half of 2011.
 
Currently, we have an Outperform rating on Dendreon.

As per the agreement, Nabi will get an upfront payment of $40 million and is eligible to receive more than $500 million (together with upfront payment) as option fees and milestones for the vaccine, NicVAX, and follow-on nicotine vaccines. Nabi has the potential to receive double-digit royalties from sales if the product is commercialized. GlaxoSmithKline will have an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-generation nicotine vaccines using Nabi's intellectual property together with GSK's own technology.

NicVAX is currently being studied in the first of two phase III clinical trials with results expected at the end of 2010. While Nabi will be responsible for the development of this vaccine, GlaxoSmithKline on exercising its option will take responsibility for further development and commercialization of NicVAX.

Company estimates put the worldwide number of smokers at about 1.2 billion and smoking causes approximately 5.4 million deaths per year. In view of the huge increase in the number of smokers, Datamonitor expects the global market for smoking cessation to reach $4.6 billion by 2016 and vaccines could account for $2 billion in sales.

Currently available smoking cessation therapies have relapse rates which can be as high as 90% in the first year after a smoker quits. Although the vaccine holds immense potential, we however remain concerned about its successful development. In October, an anti-smoking vaccine developed by Cytos Biotechnology and Novartis (NVS) missed its main goal in a mid-stage study.

Chicago, IL – November 16, 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: GlaxoSmithKline plc (GSK), Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).

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Here are highlights from Friday’s Analyst Blog:

Glaxo H1N1 Vaccine Approved

GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.

The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is a part of the US Government’s intention to secure about 250 million doses to help fight the swine flu pandemic.

The current outbreak of swine flu pandemic can prove to be a big opportunity for vaccine manufacturers. In addition to Glaxo, other major players in this field include Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).

In fact, several companies including Sanofi Pasteur, the vaccine division of Sanofi-Aventis, Novartis Vaccines and Diagnostics Limited, the vaccine and diagnostics arm of Novartis, MedImmune LLC, a subsidiary of AstraZeneca and CSL Limited of Australia, have already received approval from the FDA for their swine flu vaccines.

Glaxo intends to start shipping its vaccine in December and expects to provide all the doses by year-end. We expect the company’s vaccine segment to post strong revenues in the fourth quarter of 2009. In addition to strong influenza product sales, the company has made significant progress in expanding its vaccine product portfolio. The approval of cervical cancer vaccine Cervarix in the US and Japan, H1N1 vaccine Pandemrix in Europe, and the H1N1 vaccine in the US should all help drive vaccine segment revenue.

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Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

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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=5518.

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SAFC Pharma's Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics − including a full menu of support services − from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. The expansion will enable both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors and is Biosafety Level 2 compliant, allowing manipulation of human pathogens.

SAFC has announced worldwide investments totaling $90 million to expand capacity for active pharmaceutical ingredients production and biologic drug products. With respect to this, SAFC’s Pharmorphix Solid State Research Laboratories in Cambridge, UK have recently installed a new single crystal X-ray diffraction system. The Oxford Diffraction SuperNova™ system, which can determine the crystal structures from the most challenging crystal samples, is the first industrial installation in the world.

Equipped with a powerful high flux dual wavelength microsource X-ray generator, the SuperNova instrument is capable of performing single crystal X-ray analyses on small microcrystalline fragments with dimensions of 30 to 50 microns. The dual wavelength capability will allow the rigorous determination of absolute stereochemistry of chemical entities, which contain first row elements only. Solid-form characterization and research is an essential part of the drug development process.

Hospira said it was confident that its cost cutting and restructuring initiative, Project Fuel, would improve profitability through 2011. The company’s restructuring plan consists of a 10% reduction in workforce and realignment of its product portfolio including the sale of non-core businesses. It has already identified about 3700 products - 50% of its portfolio - which can be eliminated in due course.

Hospira’s revised guidance was primarily the result of stronger sales of injectable generic drugs. The company derived about half of its total sales from the Specialty Injectable Pharmaceuticals (SIP). This segment is now expected to grow by 8% to 10%, up from its earlier projection of 4% to 6%.

Although the SIP outlook is promising, Hospira’s medical devices business is still suffering from the global liquidity crisis. Major capital investment for expensive equipments, such as hospital beds and MRIs, are likely to remain subdued for another 18 months.

Hospira is currently eyeing the H1N1 flu market and is in discussions with major players, like Baxter International (BAX), Novartis (NVS) and GlaxoSmithKline (GSK), which are developing vaccines. Given the huge potential of this segment, Hospira is looking for an opportunity where it can package bulk vaccines into syringes. If the company succeeds in grabbing a share of the H1N1 flu market, its SIP segment will get a further boost. We have a Neutral recommendation on the stock.

Shantha Biotech has been a prominent player in the vaccine segment for quite some time. It works with several international agencies like the UNICEF in the Asia Pacific, Africa and Latin America. The company is expected to post sales of $90 million in 2009. The deal should be beneficial to both the companies. While Shantha Biotechnics has the resources to produce quality vaccines at cheap rates, being the largest company entirely dedicated to vaccines, Sanofi has the financial strength and rich experience.

Shantha Biotech has a strong pipeline for vaccines, including a rotavirus vaccine (expected to be launched in 2012), a conjugated typhoid vaccine and an HPV vaccine. These vaccines could become major revenue earners for the company on approval.

Sanofi-Aventis possesses one of the world’s leading vaccine operations, with total sales of 2.86 billion Euros in 2008, an increase of 3% over the previous year. Sales in the second quarter were 712 million Euros, representing about 9.5% of the company's total revenue. In addition to existing products, Shantha Biotech’s developmental-stage vaccines would complement Sanofi Pasteur's current portfolio.

The current outbreak of the swine flu pandemic can prove to be a major opportunity for vaccine manufacturers. All major players in the vaccine segment are busy conducting human tests for H1N1 vaccines. Companies like Sanofi Pasteur, GlaxoSmithKline (GSK), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN) are all vying to get their vaccines to the market at the earliest.

Sanofi-Aventis is the biggest producer of flu medicines. The approval of H1N1 vaccine would enable the company to post strong revenue growth.

Although these vaccines do not safeguard against the deadly H1N1 flu, these are essential to protect families against seasonal flu and are recommended by Centers for Disease Control and Prevention. Local, state and federal health authorities are currently administering the production and distribution of H1N1 vaccine.

More than 200,000 people suffer from seasonal flu in the U.S. every year. The target group falls within the age bracket of 6 months to 19 years and 50 years or above, pregnant women, people with chronic diseases, individuals admitted to nursing homes, workers in health care departments and caretakers of children less than six months old.

Target operates general merchandise and food discount stores in the United States. Currently, the company operates 1,719 stores in 49 states.

Kroger Co. (KR) had earlier made seasonal flu vaccines available at its 1,900 stores, effective September. The company operates supermarkets stores in the U.S. under four models – combo store (including both food and drug), multi-department stores, marketplace stores, and price impact warehouses. The company currently operates 2,475 supermarkets and multi-department stores in 31 states.

Chicago, IL – September 3, 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: Novavax (NVAX), AstraZeneca (AZN), GlaxoSmithKline (GSK), Novartis (NVS) and Sanofi-Aventis (SNY).

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Here are highlights from Wednesday’s Analyst Blog:

Good News for Novavax

We are pleased to hear that the vaccine developer Novavax (NVAX) has made a major breakthrough in a phase II clinical trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate. While the trial carried out on 221 people (aged 18 to 49 years) showed strong immune system responses against three flu strains (H3N2, H1N1, and B), no major adverse events were reported.

Given the success of the mid-stage trial, Novavax now plans to initiate a study in elderly adults by the fourth quarter and a phase III study next year. Although the progress made by Novavax is positive news, the vaccine is not likely to hit the market in the next few years. Hence, the vaccine will not be of much use in the current pandemic.

Any development on the influenza vaccine front is welcome news as a second wave of swine flu is expected to hit with the onset of winter in the northern hemisphere. It is estimated that globally about 5% to 20% of the population are infected from seasonal flu, killing as many as 250,000-500,000 people each year. According to the World Health Organization (WHO), up to a third of the world's population may be infected with swine flu this year, with about 15% of them requiring hospital care.

In another development, Chinese vaccine makers Sinovac Biotech and Hualan Biological Engineering expect their swine flu vaccines to be approved by the Chinese authorities this week. The most interesting aspect of this vaccine is that contrary to the earlier expectation that two doses of vaccine would be necessary; both companies have proved the effectiveness of the vaccine in single doses. While Sinovac expects to produce 30 million doses of the vaccine in a year, Hualan plans to produce up to 160 million doses.

According to the Centers for Disease Control, swine flu has become the world’s fastest-moving influenza pandemic, sweeping across 177 countries in the four months since it was first identified. Currently, AstraZeneca (AZN), GlaxoSmithKline (GSK), Novartis (NVS) and Sanofi-Aventis (SNY), supply seasonal flu vaccine in the US market. Many of these have started clinical testing of their swine flu vaccines recently.

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Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

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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=5518.

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Chicago, IL – September 2, 2009 – Zacks Equity Research highlights Amdocs (DOX) as the Bull of the Day and GameStop (GME) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Merck (MRK), Schering-Plough (SGP) and Citigroup Inc. (C).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676

Here is a synopsis of all five stocks:

Bull of the Day:

We maintain our Outperform recommendation for Amdocs (DOX) following its strong results for the fiscal third quarter of fiscal 2009. The company has industry-leading technology integration products for large transformational projects and managed services.

Long-term fundamentals for Amdocs remain firm due to the transition of telecom service providers to converged and consolidated solutions. Amdocs maintains a very strong financial position with healthy order backlog.

Recently, the company has won a series of large managed services contracts in various parts of the world. Except North America, operations in other regions have started gaining momentum.

Bear of the Day:

The video game industry, which surged ahead for a number of years, is now grappling with the recession. Heavy job losses and reduced access to credit markets have led to lower discretionary spending

This has resulted in lower demand for video game consoles and new software. This unfavorable backdrop was evident from GameStop’s (GME) dismal recent results. Despite the weak environment, management expects the release of popular titles in the second half of 2009 to stimulate sales.

We maintain an Underperform rating on the stock until we see an upturn in the company's growth trajectory.

Latest Posts on the Zacks Analyst Blog:

Merck Lays Merger Groundwork

With the merger of Merck (MRK) and Schering-Plough (SGP) scheduled to be completed by the fourth quarter this year, Merck is busy with the necessary groundwork.

Yesterday, the company announced the new management structure post merger. The current chairman, president and CEO of Merck, Richard T. Clark, will continue to head the combined company. The merged entity will comprise five main divisions -- Global Human Health, Animal Health, Consumer Healthcare, Research and Manufacturing.

Global Human Health, the combined company’s largest segment, will be headed by Kenneth Frazier, who is currently heading that division of Merck. This division will include prescription drugs, biologics and vaccines along with an emerging-markets group. Both the Research and Manufacturing segments will be headed by the respective current heads at Merck.

Citi Sells Credit Card Portfolio

Citigroup Inc. (C) announced on Monday the sale of ownership of three North American partnered credit card portfolios, representing approximately $1.3 billion in managed assets.

The sale constitutes the divesture initiatives taken by Citigroup to offload weak businesses and troubled assets that have caused huge losses in the past quarters. The portfolios were part of Citi Holdings, one of the company's segments resulting from the split earlier in the year. Citi Holdings holds the company's riskier assets and tougher-to-manage ventures, while Citicorp comprises the core franchise focusing on traditional banking around the world to generate long-term profitability.

Terms of the deals and the acquirer were not disclosed. Citigroup will continue to service the card portfolios through the first half of 2010 when the acquirer takes on those responsibilities.

Get the full analysis of all these stocks by going to http://at.zacks.com/?id=5507.

About the Bull and Bear of the Day

Every day, the analysts at Zacks Equity Research select two stocks that are likely to outperform (Bull) or underperform (Bear) the markets over the next 3-6 months.

About the Analyst Blog

Updated throughout every trading day, the Analyst Blog provides analysis from Zacks Equity Research about the latest news and events impacting stocks and the financial markets.

About Zacks Equity Research

Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.

Continuous analyst coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today by visiting http://at.zacks.com/?id=5508.

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=5509.

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Almost 25 pharmaceutical companies are racing against time to bring the vaccine to the market. Among these the top five which include, Sanofi-Pasteur of France (the vaccine arm of Sanofi-Aventis, SNY), AstraZeneca (AZN), GlaxoSmithKline (GSK), Baxter (BAX), and Novartis (NVS) are likely to contribute almost 80% of the total production.

Baxter and Novartis are seeking approval to market vaccines made from cell-based cultures, which have better yields than the traditional method of growing viruses in chicken eggs. In a major breakthrough, China-based Sinovac Biotech (SVA) announced that clinical trials have shown the effectiveness of its new vaccine in a single shot whereas earlier it was assumed that two doses per person would be required. This means more people can be vaccinated. The vaccine is expected to be available within a short time from Baxter as the company declared the completion of production of the first batch of the cell-based vaccine Celvapan. On receiving approval from the concerned health authorities, the company will be able to commence shipment. GlaxoSmithKline intends to begin its shipments in late September while Sanofi-Pasteur expects to begin production by year end.

The vaccine market has emerged as one of the most lucrative segments for pharmaceutical companies. It is expected to grow at a CAGR of over 13% during 2009-2012. The H1N1 pandemic should fuel further growth in this segment.

Hiberix was approved under the FDA's accelerated approval pathway, mainly due to a nationwide shortage of Hib vaccines since December 2007. Merck & Co., Inc. (MRK) voluntary recalled and subsequently suspended production of 2 Hib vaccines, PedvaxHIB and COMVAX, licensed in the United States.

Following the shortage in Hib vaccines, the U.S. Centers for Disease Control and Prevention temporarily postponed the Hib vaccine booster dose for children not at a high risk for infection. This deferral was effective from Dec. 18, 2007 through Jun 25, 2009.

The launch of Hiberix should allow Glaxo to take advantage of the shortage in supply of Hib vaccines. The availability of Hiberix will ensure that children are able to complete their vaccination schedule on time. Before the introduction of Hib vaccines, Hib disease was a leading cause of bacterial meningitis in children under 5 years of age in the U.S.

Hiberix is used in nearly 100 countries and should be available in the U.S. shortly. The approval of Hiberix is a boost for Glaxo's vaccine product portfolio. We are encouraged by the growth in the company's vaccine business, which posted sales of £2,539 million in 2008. The vaccine portfolio consists of products like Rotarix, Synflorix, and Relenza.

The most significant product in Glaxo's vaccine portfolio is Cervarix, a vaccine for human papillomavirus (HPV), which was approved in the E.U. in September 2007 and is currently under regulatory review in the U.S. Cervarix should contribute significantly to Glaxo's top-line over the next several years. Once launched in the U.S., Cervarix will compete directly with Merck's Gardasil.

During late July, as requested by the FDA, Wyeth submitted additional information regarding the vaccine. Though the FDA was initially expected to respond by Sept 30, 2009, the agency has now pushed back the approval date by 90 days. The agency stated that it will need the extra time to review the additional information, which it considers to be a major amendment.

Prevnar is one of the world’s best selling vaccines. It treats illness caused by 7 strains of pneumococcal bacteria.  The vaccine recorded sales of about $2.7 billion in 2008, and we expect $2.9 billion of sales in 2009. In an effort to build on the success of Prevnar, Wyeth has developed the PV13 for infants and toddlers. The new vaccine will block 13 strains including the original 7. Earlier in July, PV13 received its first marketing approval from the regulators of Chile. The company is currently seeking approval for PV13 in about 50 countries.

It is estimated that PV13 would cover 92% of invasive pneumococcal disease, compared to 81% covered by Prevnar. Wyeth filed for EU approval of PV13 for pediatric use in December 2008. Meanwhile, GlaxoSmithKline (GSK) received European approval for its pediatric 10-valent vaccine, Synflorix (meant for children aged 6 weeks to 2 years), in March 2009, which will compete with Prevnar and PV13. However, GlaxoSmithKline does not have plans to launch the vaccine in the U.S.

Prevnar has witnessed solid sales growth over the past few quarters based on a number of reasons. Due to a recommendation from the Centers for Disease Control (CDC), compliance on a fourth dose for all healthy children under 24 months is over 80%.  Wyeth has been expanding Prevnar growth internationally through National Immunization Programs (NIP) with the governments of several countries.

We expect the list of countries to grow further as a result of the recommendations by the World Health Organization (WHO) to include Prevnar in these programs. We have a Neutral recommendation on the stock.

Chicago, IL – August 11, 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: Sanofi-Aventis (SNY), GlaxoSmithKline (GSK), Novartis (NVS), Merck (MRK) and Wyeth (WYE).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Monday’s Analyst Blog:

H1N1 Vaccine from Sanofi?

All countries are waiting eagerly for the H1N1 vaccine since the outbreak of the swine-flu pandemic, which has killed hundreds if not thousands of people worldwide. As the swine influenza A (H1N1) virus is comparatively new, no vaccine is available at present to prevent the infection. In this respect, French pharmaceutical giant Sanofi-Aventis (SNY) has some good news. The company announced that Sanofi Pasteur, the vaccines division of the group has started the human testing of its H1N1 swine flu vaccine and accordingly filed a supplemental license application with the US FDA.

Sanofi-Aventis is the biggest producer of flu medicines. On approval, the vaccine will have the potential to earn robust revenue for the company. Viewing this potential, many companies are already working on similar vaccines like GlaxoSmithKline (GSK) and Novartis (NVS).

The vaccine is expected to be available within a short time from Baxter as the company recently declared the completion of production of the first batch of the vaccine. Glaxo expects to manufacture the vaccine within the next two months. The company already has an order book of more than 290 million doses of the vaccine taking estimated value of the orders to about $1.5 billion. We believe if this momentum of orders from several governments continues, the order value can reach up to $ 3 billion.

The vaccine market has emerged as one of the most lucrative segments for a pharmaceutical company. It is expected to grow at a CAGR of over 13% during 2009-2012. The swine flu pandemic is expected to add further growth to this segment. For the last two years, Gardasil from Merck (MRK) for the treatment of cervical cancer and Wyeth’s (WYE) Prevnar (for illness caused by pneumococcal bacteria) were the top selling vaccines. Now, GSK should be able to corner a significant share of this segment with its H1N1 vaccine.

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About Zacks Equity Research

Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.

Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today: http://at.zacks.com/?id=5517

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=5518.

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Contact:
Mark Vickery
Web Content Editor
312-265-9380
Visit: www.zacks.com

Staph infections are caused by a drug-resistant strain of bacteria often found in hospitals. PentaStaph is being tested against three different strains of staph and two other antigens.

The deal is valued at $46 million, of which $20 million will be paid immediately. The remaining $26 million will be paid after achievement of four key milestones. The deal is scheduled to close by year-end and Nabi expects to achieve the four milestone payments within 18 months.

GlaxoSmithKline has a strong presence in the vaccine market. The company’s acquisition of ID Biomedical in 2005 helped Glaxo position itself as a major global force in both the injectable and nasally administered flu shot market. The company has several important vaccines in its portfolio including Relenza, Synflorix, and Rotarix.

Going forward, a major contributor to revenue could be Cervarix, a vaccine for HPV (human papillomavirus) which was approved in the E.U. in September 2007 and is currently under regulatory review in the U.S. Cervarix is approved in about 67 countries and has been submitted for approval in many more.

The product is approved for women between the ages of 10 to 45. This is a significant advantage over Merck’s (MRK) Gardasil which is currently approved for ages 11 to 26 (Merck filed for FDA approval in December 2007 to expand the age range through age 45, and recently got a second Complete Response Letter).

Although Merck beat Glaxo to the market, we expect Cervarix to have peak sales in the area of £2 billion. Glaxo has presented very encouraging data against genotypes that account for 70% of cervical cancer cases and management believes that Cervarix may offer protection against several other genotypes. That could increase this figure to 80% of cervical cancer cases. Approval could come later this year.

The vaccine is expected to be available within a short time from Baxter as the company recently declared the completion of production of the first batch of the vaccine. Glaxo expects to manufacture the vaccine within the next two months. The company already has an order book of more than 290 million doses of the vaccine taking estimated value of the orders to about $1.5 billion. We believe if this momentum of orders from several governments continues, the order value can reach up to $ 3 billion.
 
The vaccine market has emerged as one of the most lucrative segments for a pharmaceutical company. It is expected to grow at a CAGR of over 13% during 2009-2012. The swine flu pandemic is expected to add further growth to this segment. For the last two years, Gardasil from Merck (MRK) for the treatment of cervical cancer and Wyeth’s (WYE) Prevnar (for illness caused by pneumococcal bacteria) were the top selling vaccines. Now, GSK should be able to corner a significant share of this segment with its H1N1 vaccine.

With this deal, Sanofi would be able to target not only the fast growing vaccine segment but also the sought-after emerging market region. Apart from Sanofi, it is reported that GlaxoSmithKline (GSK) and Novartis (NVS) were interested in acquiring a stake in Shantha Biotech.

Shantha Biotech, a player in the vaccine segment, works with several international agencies like the UNICEF in the regions of Asia-Pacific, Africa and Latin America. The company is expected to post revenues of $90 million in 2009.

The company’s vaccines are available at an affordable price -- for example, Shantha Biotech’s cholera vaccine costs around $2 a dose compared to up to $45 for those produced by others. New products under development by the company include a rotavirus vaccine (expected to be launched in 2012), a conjugated typhoid vaccine and HPV vaccine.

These vaccines, on approval, could be major revenue earners for the company. We are hopeful of the success of these programs as the Sanofi deal brings with it financial strength as well as the experience of Sanofi’s vaccine division, Sanofi Pasteur.

In order to accelerate revenue growth, Sanofi intends to grow through new partnership arrangements as well as through "disciplined" acquisitions.  In addition to the Shantha Biotech deal, Sanofi completed three acquisitions recently, two of which are in the emerging markets. These include the acquisition of Laboratorios Kendrick (manufactures generic painkillers and allergy pills) of Mexico in April 2009, the takeover of Brazil’s Medley SA (for $680 million) and the buyout deal of BiPar Sciences Inc. of California (for the development of new cancer treatments).

Sanofi-Aventis possesses one of the world’s leading vaccine operations, with total sales of €2.86 billion in 2008, an increase of 3% over the previous year. Sales in the first quarter increased 14% to €627 million, representing about 7% of the company's total revenue.

In addition to the existing products, Shantha Biotech’s vaccines in the developmental stage would complement Sanofi Pasteur's current portfolio. This would enable Sanofi to have a strong foothold in the emerging markets.

In order to tackle the high demand, GSK is increasing its existing capacity for the production of Relenza to about 190 million doses by the end of this year from the current level of 60 million. The company witnessed huge growth in Relenza sales which came in at £60m ($98.4 million) during the second quarter of 2009, compared with £3 million ($4.9 million) recorded in the year-ago period. GSK expects full year sales to touch $573 million.

GlaxoSmithKline expects to earn revenue of about $2.1 billion from the sale of a new H1N1 vaccine next year. According to the World Health Organization (WHO), about 2 billion people could be infected in the next two years. Last May, the U.S. Department of Health and Human Services placed orders for GSK’s H1N1 vaccine.

GSK expects the candidate “A" H1N1 vaccine to be available around the October - December 2009 timeframe. In the meantime, we expect Relenza to benefit from the outbreak as the vaccine has proved somewhat effective in combating H1N1.

In the U.S., swine flu has killed about 300 people and made more than 1 million sick. To make matters worse, according to the Centers for Disease Control and Prevention, these numbers could go up. As a result, the U.S. recently placed an order to buy more vaccines worth $1 billion and France ordered an extra 28 million vaccines from Sanofi-Aventis (<a href="http://(SNY)">SNY).

The swine flu pandemic has been a boon to GSK. This is a big opportunity for the company where new products can compensate the eroding margin caused by the genericization of key products.

Chicago, IL – July 22, 2009 – Zacks Equity Research highlights VimpelCom (VIP) as the Bull of the Day and Regis Corp. (RGS ) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Merck (MRK), GlaxoSmithKline (GSK) and Wyeth (WYE).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676

Here is a synopsis of all five stocks:

Bull of the Day:

VimpelCom (VIP) is the second largest cellular carrier in Russia with over 25% market share and continued expansion in regions of the Commonwealth of Independent States (CIS), operating GSMbased wireless services.

We are encouraged with VimpelCom's successful sales growth trend and the company's ability to retain subscribers on a recurring basis, even as overall economic factors remain weak.

Additionally, the ongoing expansion initiatives into emerging Asian markets are expected to boost opportunity in wireless. We reiterate our Buy rating while we account for global economic factors, ongoing geopolitical events in Russia (surrounding countries) and weaker local exchange rates against the U.S. dollar which may affect near-term earnings.

Bear of the Day:

We maintain our Sell rating on shares of Regis Corp. (RGS ).

The offerings of common stock and convertible notes will likely strengthen the company's balance sheet and provide management with additional flexibility to withstand the economic recession.

However, these capital raises also significantly dilute current shareholders, and we note that the company's operating environment remains weak. As such, we maintain our Sell rating on the shares at this time.

Latest Posts on the Zacks Analyst Blog:

Merck & Glaxo May See a Boost

Recently, the World Health Organization (WHO) recommended the inclusion of oral rotavirus vaccines in all national immunization programs. This recommendation is likely to boost the sales of Merck’s (MRK) RotaTeq and GlaxoSmithKline’s (GSK) Rotarix vaccines. RotaTeq (approved in US in 2006) and Rotarix (2008 approved) recorded sales of $665 million and $268 million, respectively, last year.

According to the WHO, the infection caused by rotavirus (diarrhea) kills an estimated 1,600 children under the age of 5 every day, mostly in Africa and Asia. International agencies like WHO, UNICEF and GAVI (the Global Alliance for Vaccines and Immunization, a WHO partner) are working towards fighting rotavirus diarrhea and pneumonia together. These two diseases account for more than 35% of child deaths every year, especially in the less developed countries. The effort to tackle pneumonia paves the way for higher sales of Wyeth’s (WYE) Prevnar.

Get the full analysis of all these stocks by going to http://at.zacks.com/?id=5507.

About the Bull and Bear of the Day

Every day, the analysts at Zacks Equity Research select two stocks that are likely to outperform (Bull) or underperform (Bear) the markets over the next 3-6 months.

About the Analyst Blog

Updated throughout every trading day, the Analyst Blog provides analysis from Zacks Equity Research about the latest news and events impacting stocks and the financial markets.

About Zacks Equity Research

Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.

Continuous analyst coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

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Provenge, a therapeutic vaccine candidate being developed by Dendreon for the treatment of prostate cancer is likely to receive FDA approval in the first half of 2010. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body's own immune system to attack cancer cells.

We remind investors that the company met with disappointment in 2007 when the FDA asked for further data before approving it. The disappointing news had caused the company to retrench 15% of its workforce and sent its shares on a downward journey.

However, in April 2009, Dendreon reported positive results from its IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) study of Provenge in men with advanced prostate cancer. Following the positive results, the company is once again gearing up to market Provenge once the FDA approval comes through.

Provenge has blockbuster potential; we estimate U.S. sales to be $120 million in 2010 and $200 million in 2011. If the drug is approved, we believe the company will be profitable in 2010. Dendreon will market Provenge in the U.S. on its own and we expect it to announce a partner for the drug in rest of the world soon.

Dendreon will market Provenge in the U.S. on its own. However, on a global basis, we anticipate a partner soon. Once sales start to flow, Dendreon can focus back on the development of its pipeline candidates once more.

Following the positive results announced in late April, Dendreon’s shares have been on the upswing and is trading above the $20 mark. The stock closed on July 2 at $23.48. We believe that the current share price represents an attractive entry point for long-term investors.

Dynavax Technologies Corp. (DVAX) is a biopharmaceutical company focused on drug development for the treatment and prevention of various infectious and inflammatory diseases.

The company was recently hit hard by a couple of major negative events: the clinical hold and the subsequent termination of the partnership with Merck (MRK) for Heplisav, a late stage candidate for Hepatitis B vaccine, and the discontinuation of the Tolamba program for allergy. Currently, Dynavax is in active discussions with regulatory agencies to resolve the FDA's clinical hold on Heplisav and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.

The deal with Glaxo is a big positive

In 4Q08, Dynavax and GlaxoSmithKline (GSK) signed a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.

The company believes that the alliance with GSK, which could be worth up to $800 million, provides an opportunity to develop an entirely new product franchise.

Flu vaccine program still in early stage

The universal flu vaccine which Dynavax is developing under a global supply and option agreement with Novartis (NVS) has the potential to be a prominent player in the market for seasonal influenza vaccines. Encouraging preclinical data have been presented at various medical conferences. However, since the candidate is in preclinical stage, it ceases to be a current option to deal with the global swine flu breakout.

No product on the horizon

Even though, we were pleased to hear about the company's agreement with Glaxo, we remain concerned that the company has no visible drug candidate under development. We don't think that DVAX can afford and/or has an immediate plan to acquire any late stage drug candidate under the current financial conditions. Therefore, we do not recommend the shares currently and have a Hold rating.

Chicago, IL - June 26, 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: Sanofi-Aventis (SNY), Biogen-Idec (BIIB), Marathon Oil Corporation (MRO), Shell (RDS.A) and StatoilHydro (STO).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Thursday's Analyst Blog:

Sanofi Doing Deals

Sanofi-Aventis (SNY) posted EPS of e5.36 in 2008, an increase of just 2% from 2007. Revenue fell 1% in 2008 as a number of products experienced significantly declining sales including Ambien, Tritace and Copaxone.

For 2009 we expect revenue growth to return, as generic erosion is more than offset by strong growth of Taxotere, Lantus, Avapro and the vaccines business. We expect revenue growth of 6% in 2009 and EPS of e5.93 ($4.10), up 11% from 2008. EPS should continue to benefit from strong contributions to royalty income from U.S. Plavix sales and operating margin improvement as a result of cost-cutting. We also expect foreign exchange to benefit both revenue and EPS in 2009 as the U.S. dollar strengthens against the Euro.

Generic competition will continue to be a concern, however. While we expect new product launches to make significant revenue contributions in the early part of the next decade, they will not be enough to compensate for increased generic erosion. Gross margins will likely contract now that Lovenox and Plavix (E.U.) sales are at or near peak levels, combined with softer pricing on current and soon-to-be off-patent drugs.

We expect Sanofi to continue look to contain operating costs in order to grow EPS in the face of weakening sales of some of its biggest products. This should help keep EPS at positive, albeit modest, growth over the next few years.

We also expect the company to look to grow revenue through additional partnering deals and acquisitions. We expect Sanofi to look for a small-to-mid sized deal in the high-growth biotech space in order to help plug revenue holes left by patent expirations. We believe Biogen-Idec (BIIB) makes the most sense as an acquisition candidate.

Marathon Leaving Irish Project

On Wednesday, June 24, 2009, Texas-based Marathon Oil Corporation (MRO) announced the sale of its interest in the Corrib offshore natural gas development project on Ireland's northwest coast, a joint-venture between Shell (RDS.A), StatoilHydro (STO) and Marathon. The company has reached an agreement in this regard with Alberta-based oil and gas company Vermilion Energy Trust.

Per the agreement, Marathon will sell its wholly owned Irish subsidiary, Marathon International Petroleum Hibernia Ltd. (having an 18.5% interest in the Corrib development) to Vermilion in a deal worth between $235 million and $400 million, subject to the timing of first commercial gas at Corrib.

Under the terms of the deal, Vermilion will pay Marathon an initial payment of $100 million at the closure of the transaction, expected during the second half of 2009, subject to government and regulatory approvals. The remaining portion will be due at the time of first production from the site, which is expected between late 2010 and late 2011. Additionally, Vermilion is slated to invest up to $300 million to complete the facilities needed to reach the gas.

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About Zacks Equity Research

Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.

Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today: http://at.zacks.com/?id=5517

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=5518.

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