FDA accepts new drug application from Pozen for arthritis drug

Shares in pharmaceutical firm Pozen (Nasdaq: POZN) climbed 7 percent Monday after the company disclosed that the U.S. Food and Drug Administration had accepted its new drug application for Vimovo.

The drug targets arthritis and includes the heartburn product “purple pill” Nexium from AstraZeneca. AstraZeneca is partnering with Pozen in development of Vimovo.

Shares traded at $6.93, up 46 cents, in late-morning trading. By early afternoon, the rally cooled to a 4.5 percent gain of 29 cents. Pozen closed at $6.73, up 4 percent for the day or 26 cents.

The FDA acceptance of the application triggered a $10 million milestone payment from AstraZeneca. Pozen filed the application in June.

Tthe drug formerly known as PN 400 combines Nexium with the anti-inflammatory drug naproxen. It is designed to help patients who face the risk of developing ulcers related to pain relievers.

Vimovo has been tested in clinical trials as a treatment for osteoarthritis, rheumatoid arthritis and a condition known as ankylosing spondylitis.

In September 2007, Pozen and AstraZeneca announced the launch of a Phase III clinical trial. Under a revised partnership agreement. Pozen could earn as much as $345 million from AstraZeneca.

Pozen has proprietary technology that enables the combination of drugs into one compound. It brought a migraine headache pain reliever to market in partnership with GlaxoSmithKline.

"Millions of people worldwide suffer from arthritis and we are excited about the prospect of developing and bringing an important new therapy to these patients," said Tony Zook, president and chief executive officer at AstraZeneca, at the time of the PN 400 partnership announcement.

Source : localtechwire.com

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TNF blockers raise cancer risk in kids

Blockbuster prescription drugs used to treat rheumatoid arthritis and other conditions can increase the risk of potentially deadly cancer in children and teenagers, U.S. health regulators said Tuesday in ordering stronger warnings on such medications.

The Food and Drug Administration, which urged greater caution with so-called TNF blockers last September, said an analysis of 48 reported cancer cases in children using the drugs "showed an increased risk of cancer, occurring after 30 months of treatment on average."

Eleven of the reported cases were fatal, the FDA said.

Anti-TNF drugs include Johnson & Johnson's Simponi or golimumab and its Remicade or infliximab; Abbott Laboratories ' Humira or adalimumab; UCB SA's Cimzia or certolizumab pegol; and Amgen Inc and Wyeth's Enbrel or etanercept.

Rheumatoid arthritis is an autoimmune disease that can strike young people, causing pain, stiffness and swelling.

It affects about 20 million people worldwide.

The drugs are used to treat other inflammatory conditions, including the bowel disorder known as Crohn's disease.

TNF (tumor necrosis factor) blockers make billions of dollars for manufacturers, but it is unclear how much they earn specifically from sales for children and teens. Not all of the drugs are approved for use in children for all related conditions.

Last year, Abbott's Humira earned $4.5 billion worldwide, while Amgen and Wyeth's Ebrel earned $1.2 billion. J&J's Remicade had 2008 sales of $3.7 billion. Its newer drug, Simponi, was approved earlier this year. UCB's Cimzia, launched in 2008, had about $14.4 million in global sales.

The drugs already carry the strongest warnings possible about the risk of possible serious infections. A new caution about cancer in younger patients will be added to the so-called "black box", the FDA said.


EVALUATING THE CANCER RISK

The FDA said in a statement on its website that its year-long analysis of the increased cancer risk in children showed about half the 48 cases involved lymphoma, which targets the immune system.

Rates for cancer cases with J&J's Remicade "were consistently higher compared to expected background rates for lymphomas and all malignancies," the FDA said. Cancer rates for lymphoma were also higher for Amgen and Wyeth's Enbrel, but rates for all cancers were similar to background rates, the FDA said.

The FDA did not calculate cancer rates for Abbott's Humira and UCB's Cimzia "because of minimal use in pediatric patients." J&J's Simponi was not approved at the time of the time of the analysis.

The FDA said it had "identified new safety information related to the occurrence of leukemia and new-onset psoriasis" that would also be included on the drugs' labeling.

An Abbott spokeswoman said the company would follow the regulator's new warning guidance.

"We will comply with FDA's guidance regarding labeling changes for the anti-TNF class and will continue to monitor the data to ensure patients and physicians have the information they need to make decisions about treatment," Abbott spokeswoman Raquel Powers said.

The FDA said it had reviewed 147 reports of leukemia in adults and children using TNF blockers, including 30 deaths.

While rheumatoid arthritis patients may already be at greater risk for the white blood cell cancer, "there is a possible association between treatment with TNF blockers and the development of leukemia in all patients treated with these drugs," the FDA said.

The FDA also reviewed 69 cases of psoriasis and said it found a possible link between the skin disorder and use of TNF blockers.

Brian Kenney, a spokesman for Johnson & Johnson's Centocor Ortho Biotech Inc unit, which makes Remicade and Simponi, said the company would work with the FDA to adopt the new warnings.

Amgen and Wyeth also said in a statement that they would revise their product warnings and continue evaluating risks and benefits of Enbrel.

Source : www.forbes.com

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New drug increases options for arthritis patients

Drugs that suppress the immune system have been a major breakthrough in the treatment of rheumatoid arthritis. Unfortunately, these drugs don't work for everyone, and not all patients can put up with the side effects. A new drug, called golimumab, has now been shown by researchers to help people who haven't benefited from other medicines.

What do we know already?

Rheumatoid arthritis is a painful condition that affects your joints. It happens when your immune system malfunctions and attacks healthy tissue in your joints, making them swollen and painful.

There are lots of treatments for people with rheumatoid arthritis, but often a drug that helps one person won't work for someone else. Doctors often suggest ibuprofen and similar drugs to help with pain and swelling. However, these drugs don't prevent further damage to the joints.

Drugs that do protect the joints are called disease-modifying drugs. A common one is called methotrexate. Steroids can also be used to reduce pain and protect your joints.

Several new arthritis drugs have been launched in recent years, increasing the options for people who haven't found a combination of treatments that suits them. The newest drugs alter the way someone's immune system works, making it less able to damage the joints. Drugs that do this are called biologics.

A new biologic, called golimumab, was launched in the United States in April this year. Last week, the committee that checks the safety of drugs in Europe recommended that golimumab be made available on the European market, although it's too soon to say when it will be launched in Britain.

Golimumab is given as a monthly injection, and intended for use alongside methotrexate. It belongs to a class of drugs called TNF inhibitors. A new study has looked at how effective golimumab is when other drugs have failed.

What does the new study say?

The study looked at 461 people, all of whom had given up on a previous TNF inhibitor, either because it hadn't worked or caused side effects. People were given a high or low dose of golimumab, or an inactive placebo. All patients continued with their other medicines, which usually meant methotrexate.

Everyone's symptoms were given a score. After 14 weeks, the researchers looked at whether people's scores had improved by at least 20 percent. Thirty-eight percent of people who took the higher dose of golimumab had improved, compared with 35 percent of people who took the lower dose, and only 18 percent of people who took a placebo.

The study didn't find many side effects, but golimumab works by suppressing your immune system, so it can potentially cause serious problems. The US drug regulator says possible side effects include dangerous infections, heart failure and a type of cancer called lymphoma, although these are likely to be rare. The most common side effects are cold and flu symptoms, and irritation at the spot where you have the injection.

How reliable are the findings?

The study was carefully done, but only lasted 24 weeks. So, we don't know how well golimumab works over the long term, or whether it has long-term side effects. That's an important issue, as we already know that similar drugs carry serious risks.

Another weakness is that the study compared golimumab to a placebo, and not another TNF inhibitor. There are several drugs in this class now, so it would be useful for doctors to know how they compare to each other. It can also be unfair to patients in the study if they're given a placebo when we already know there are already effective drugs available. In this case, patients in the placebo group were given "rescue" medication after the study ended.

Where does the study come from?

The study was done by researchers from several countries, including Austria, the Netherlands, and the United States. It appeared in The Lancet, a medical journal published by a company called Elsevier.

The study was funded by Centocor and Schering-Plough, the companies that market golimumab.
What does this mean for me?

Golimumab isn't available in the UK yet. The committee that advises the European drug regulator has recommended that the drug be licensed throughout Europe, which would allow it to be used in the UK. Assuming the drug gets a licence, it would also need approval from NICE before it became a standard NHS treatment.

Several other TNF inhibitors are already in use in the UK. They're called etanercept (brand name Enbrel) infliximab (Remicade) and adalimumab (Humira). They only tend to be used if other drugs haven't helped.

What should I do now?

If you have rheumatoid arthritis and your treatment isn't helping, make an appointment to see your doctor. He or she can help you find a drug or combination of drugs that works for you.

Source : www.guardian.co.uk

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New Drug May Help Patients With Psoriatic Arthritis

The drug golimumab shows promise in treating psoriatic arthritis, according to a new study. Psoriatic arthritis affects about 11 percent of people with psoriasis.

The University of California, San Diego-led study included 405 patients who still had active psoriatic arthritis after taking anti-rheumatic drugs or nonsteroidal anti-inflammatory drugs. The patients were randomly selected to receive injections of either 50 or 100 milligrams of golimumab or placebo every four weeks for 24 weeks.

The phase 3 study found that 51 percent of patients in the 50-mg group, 45 percent of those in the 100-mg group, and 9 percent of those in the placebo group achieved the American College of Rheumatology 20 percent improvement criteria (ACR20) by week 14. The improvements were in areas such as swollen and tender joints, pain, disease activity, physical function, and levels of C-reactive protein.

In addition, more patients in the 50-mg or 100-mg golimumab groups achieved ACR50 and ACR70 responses than those in the placebo group. Golimumab also improved psoriasis symptoms. Only 3 percent of patients in the placebo group achieved at least a 75 percent improvement in psoriasis symptoms, compared with 40 percent of those in the 50-mg golimumab group and 58 percent of those in the 100-mg golimumab group.

A small number of patients who received the drug experienced injection site reactions, and most of them were mild, the researchers said.

The study appears in the April issue of the journal Arthritis & Rheumatism.

Golimumab is a human monoclonal antibody designed to block signaling molecules that induce inflammation. A study released last year found that golimumab eased rheumatoid arthritis symptoms and even put some patients into remission.

More information

The National Psoriasis Foundation has more about psoriatic arthritis.

Source : http://www.forbes.com/

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