Rosuvastatin cuts risk of catching pneumonia, study finds

Patients taking AstraZeneca Plc’s cholesterol-lowering medicine Crestor (Rosuvastatin) in a study were less likely to develop pneumonia, a finding that potentially will broaden use of such drugs.

The result supports earlier research suggesting drugs in this class, called statins, prevent deaths from pneumonia. The latest study, an analysis of a 17,000-person clinical trial that ended in 2008, was presented today, in Boston, at the Interscience Conference on Antimicrobial Agents & Chemotherapy.

Cholesterol drugs, led by Pfizer Inc.’s Lipitor, were the world’s second-best-selling category of medicines last year, with $35.3 billion in sales, according to IMS Health Inc., a health research company in Norwalk, Connecticut. Only cancer drugs exceeded that tally. The latest Crestor finding justifies further research into giving statins to patients with lung disease, scientists said.

“These data are consistent with the hypotheses that statin therapy may reduce incident pneumonia,” supporting further study of the drugs to treat pulmonary disease, the researchers wrote.

Statins work by blocking an enzyme involved in cholesterol production in the liver. Results from a separate study in 2008 showed that people hospitalized with pneumonia were less likely to die if they took a statin. There is also evidence the drugs may help reduce inflammation, the formation of blood clots, and the immune system’s inappropriate attacks on healthy tissue.

Side-Effect Reports

The results released today come from an analysis of a study called Jupiter designed to show whether Crestor was more effective than a placebo at reducing cholesterol levels. Since the original study didn’t set out to measure the effect on pneumonia, researchers went back and examined reports collected during the trial to compare rates of pneumonia and other infections among those getting Crestor and those on a placebo.

The analysis found that 257 patients taking a placebo developed pneumonia compared with 214 patients taking Crestor, researchers said. Patients taking Crestor were also less likely to develop fungal, soft tissue or gynecological infections.

Crestor generated $4.5 billion in revenue last year for London-based AstraZeneca; Lipitor had sales of $11.4 billion.

Pneumonia kills about 52,000 people a year in the U.S., with the elderly and infants being most at risk, according to the Centers for Disease Control and Prevention, based in Atlanta.

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FDA aprroves a new pain drug

Shares of Pozen Inc. surged more than 21% in the after hours trading session Friday after the U.S. Food and Drug Administration or FDA approved VIMOVO delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

VIMOVO, co-developed by Pozen and UK-based drug maker AstraZeneca Plc is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug or NSAID, and immediate-release esomeprazole, a proton pump inhibitor or PPI.

The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.

Nearly 27 million US residents and 140 million people worldwide suffer from osteoarthritis, which is the most common form of arthritis. According to the company, half of osteoarthritis patients on chronic non-steroidal anti-inflammatory drugs therapy are at the risk of developing gastric ulcers associated with it.

Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca, said, “In a single pill, VIMOVO provides a proven pain reliever with a built-in PPI for arthritis patients at-risk for NSAID-associated gastric ulcers.”

In the PN400-301 and 302 studies, the primary end point was the cumulative incidence of gastric ulcers through six months. Patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, in each of the trial, over a six-month treatment period.

Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO, compared to 23.1% among patients taking enteric-coated naproxen. Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO, compared to 24.3% with enteric-coated naproxen.

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Good news for a new AstraZeneca drug

There is good news surfacing for pharmaceutical firm AstraZeneca this morning. Turns out a new drug produced by AZN helps reduce heart patients' chances of dying by more than 20% when compared to the standard treatment. The drug is designed to prevent blood clots in heart patients.

The study followed 18,624 patients from 2006 to 2008, with roughly half taking rival medicine Plavix and the other half taking AZN's Brilinta. The results show that patients taking Brilinta had a 4.5% chance of dying, compared to a 5.9% chance for patients on Plavix.

The results also showed that AZN's offering was safer for patients, as it was less likely to trigger bleeding problems, which is one of Plavix's side effects. Yes, Brilinta has its own side effects, including breathing and heart-rhythm abnormalities, but some will be willing to take these chances based on the drug's efficacy. Some experts believe Brilinta will be a best-selling drug if it receives regulatory approval, which could take "years".

One fact that could skew the results a bit is that AZN paid for the research, but this is a common practice in the pharmaceutical world.

Currently, the stock is treading along support in the $46 region as it waits for its 10-week moving average to come into the picture and push the stock higher. The question is whether or not the shares will be able to garner enough momentum to top past resistance in the $49-50 region. The stock has turned away from this region three other times in the past, and it could do so again. Will the news about Brilinta be enough to help puncture this resistance? I'm not sure, but history certainly suggests that it won't happen.

Source : www.bloggingstocks.com

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AstraZeneca, Bristol-Myers diabetes drug wins U.S. OK

AstraZeneca PLC and Bristol-Myers Squibb Co won U.S. approval on Friday to sell a new pill for adults with diabetes.

Onglyza enters a field clouded in recent years by concerns about heart-related risks. U.S. regulators have pressed manufacturers to more closely evaluate cardiovascular safety of proposed new medicines.

The Food and Drug Administration said Onglyza was not linked to increased heart problems in low-risk patients but the agency was requiring future study cardiovascular safety for higher-risk diabetics.

Though there are numerous diabetes therapies on the market, some cause weight gain or other complications and many patients do not reach optimal blood sugar levels, creating an opportunity for new treatments.

The companies hope Onglyza will carve out substantial sales by competing against Merck & Co's blockbuster drug, Januvia, which had $1.4 billion worldwide sales in 2008.

BMO Capital Markets analyst Robert Hazlett forecast Onglyza sales of $60 million in 2009, rising to $450 million in 2011 with peak sales approaching $1 billion over time.

Onglyza, a once-a-day pill known generically as saxagliptin, is AstraZeneca's first new drug since cholesterol fighter Crestor went on sale in 2003.

Both Onglyza and Januvia enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

The drugs are cleared to treat Type 2 diabetes, which is linked with obesity, poor diet and lack of exercise. Nearly 24 million people in the United States, or nearly 8 percent of the population, have the condition, government statistics show.

FDA officials took a closer look at the cardiovascular safety of diabetes medicines after researchers linked GlaxoSmithKline PLC's pill Avandia to greater heart-related risks in 2007. A strong warning was added to the drug, although Glaxo says it is as safe as other approved diabetes medicines.

Onglyza's most common side effects include upper respiratory tract and urinary tract infections and headaches, the FDA said. Allergic-like reactions such as rashes and hives also were reported.
European regulators recommended approval of Onglyza in June, clearing the way for its launch there in the coming months.

Shares of Bristol-Myers gained 0.8 percent to close at $21.74 on the New York Stock Exchange. AstraZeneca shares gained 0.2 percent to close at $46.44, also on the NYSE.

Source : www.reuters.com

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Astrazeneca Development Partner, Pozen, Inc., Submits New Drug Application For Pn400

AstraZeneca today announced that its development partner, Pozen, Inc., has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO (PN400) (enteric coated naproxen /esomeprazole magnesium) tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers. PN400 is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole.

The proposed trade name is VIMOVO, pending regulatory approval. Upon the FDA’s notification of acceptance of the NDA filing for PN400, a $10 million milestone payment from AstraZeneca will be payable to POZEN.

If approved, PN400 would offer a new arthritis treatment option for patients at risk of gastric ulcers, associated with non-steroidal anti-inflammatory drugs (NSAID). Nearly 27 million US residents and 140 million people worldwide suffer from osteoarthritis. The risk factors for NSAID-associated gastric ulcers include age (>/= 50 years), a documented history of gastric ulcers, or concomitant use of low-dose aspirin.

The NDA submission is based on data from a comprehensive clinical trials programme. The PN400 301/302 studies fully met their primary objective, showing subjects taking PN400 experienced significantly fewer endoscopically confirmed gastric ulcers compared to subjects receiving enteric coated (EC) naproxen. The primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, approximately 400 subjects received either PN400 or EC naproxen 500mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months.

About VIMOVO (naproxen sodium/esomeprazole magnesium)

VIMOVO is an investigational product under co-development by AstraZeneca and POZEN, Inc. that combines the pain reliever naproxen (an NSAID) with esomeprazole, a proton pump inhibitor (PPI). VIMOVO is under investigation for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric ulcers.

About Osteoarthritis

Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 140 million individuals worldwide, and impacting approximately 18% of women and 9.6% of men aged 60 and above. A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness.Osteoarthritis commonly affects the hands, feet, spine or large weight-bearing joints, such as the hips and knees.

About Ankylosing spondylitis

Ankylosing spondylitis is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis (sacroiliac joints). Ankylosing spondylitis may also cause inflammation and pain in other parts of the body as well.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:www.astrazeneca.com

Source : www.pressreleasepoint.com

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AstraZeneca drug beats Plavix in test, shares leap

AstraZeneca Plc's experimental heart drug Brilinta has beaten Sanofi-Aventis SA and Bristol-Myers Squibb Co's blockbuster Plavix in a pivotal clinical trial, lifting its shares sharply.

Topline results from the head-to-head study of the two drugs -- one of the largest comparative trials ever undertaken before approval -- underpin hopes for a pipeline product that analysts see as a potential multibillion-dollar-a-year seller.

The new medicine is a chance for AstraZeneca to prove its ability to get major new drugs to market at a time when older ones face patent expiry, following a drought of new product launches in recent years.

If approved, it will compete for business against one of the world's most successful medicines, since Plavix rakes in annual sales of some $8 billion.

AstraZeneca said on Monday the trial showed Brilinta worked better than Plavix in protecting high-risk patients from heart attacks and strokes, and it remained on schedule to submit the drug for regulatory approval in the fourth quarter.

Its shares jumped 6.3 percent by 1115 GMT in a flat market for European drug stocks .SXDP.

Panmure Gordon analyst Savvas Neophytou said the clinical success should provide enough differentiation to make Brilinta a commercial hit. He currently predicts sales of $1.66 billion by 2014 but said this figure could rise once detailed results of the study are released.

Full results of the so-called Plato study -- a Phase III trial involving 18,624 patients with acute coronary syndrome given either Brilinta or Plavix -- will be presented at the European Society of Cardiology annual meeting in August.

Source : www.reuters.com

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Research sheds new light on inflammatory disease

Scientists at the University of Liverpool have found that understanding the precise timing of communication between cells that coordinate the body's response to disease could be key to new drug developments.

Researchers, in collaboration with AstraZeneca and the Universities of Manchester and Warwick, are investigating the NF-kappa-B signalling system, which governs the responses within cells to stimuli such as stress and infection. It plays a central role in conditions such as cancer, inflammatory bowel disease, rheumatoid arthritis and asthma.

It was thought that blocking NF-kappa-B signals with drugs might alleviate these conditions, but scientists have now found that the timing of these signals can change cell behaviour and cause disease. The research suggests that drugs would need to change the timings in order to treat disease more effectively.

Professor Mike White, from the University's School of Biological Sciences, explains: "We know that the NF-kappa-B signalling system is a vital component of all cells and acts to control cell death and growth. When this system goes wrong, however, it can cause diseases such as cancer and inflammatory bowel disease. Currently, drugs target signal pathways and block them in order to treat diseases, but the NF-kappa-B system is so complex that the outcome of treatment is unpredictable.

"Our new research shows that the amount of NF-kappa-B in the nucleus of a cell varies in a wave-like pattern over time. It is the timing of these waves that can change the cell's behaviour and affect the development of disease. This means that instead of blocking the signal pathway, drugs need to change the timing of the waves to treat disease successfully."

Professor Douglas Kell, Chief Executive of the Biotechnology and Biological Sciences Research Council (BBSRC) and co-author of the research, added: "The results both aid and challenge drug designers. It will not simply be a matter of using a drug to knock down one key biological player in inflammatory disease. A systems biology approach to this work will enable us to get a complete picture of the biology underpinning inflammation and thus pinpoint the potential axes of control that might be targeted with drugs."

Source : www.physorg.com

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