Pozen shares up on new drug application submission

NEW YORK -- Shares of Pozen Inc. got a boost Wednesday after the company said it submitted a new drug application to the U.S. Food and Drug Administration for the marketing approval of two potential cardiovascular drugs.

THE SPARK: The move is a major step toward commercializing the drugs and means that the company thinks it has proven that the drugs are safe and effective.

THE BIG PICTURE: Posen's PA32540 and PA8140 are both intended as alternatives to plain aspirin for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers.

Pozen's drugs contain aspirin and the omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.

Pozen is seeking approval for use in patients at risk of aspirin-induced ulcers.

Pozen CEO John Plachetka called the move "an important milestone for the drug" and said the company looks forward to completing a commercial deal with a partner "in the upcoming months."

THE SHARES: Up 15 cents, or 3 percent, to $5.39 in morning trading, after peaking at $5.50 earlier in the day. Over the past 52 weeks, the company's shares have traded between $4.81 and $8.12.

Pozen shares are down about 2 percent so far this year.

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BRIEF-Vanda expects to submit tasimelteon application by mid 2013

March 25 (Reuters) - Vanda Pharmaceuticals Inc :

* Reports successful completion of pre-NDA meeting with FDA on tasimelteon for

the treatment of non-24-hour disorder in the totally blind

* FDA confirmed that efficacy and safety data to be submitted in tasimelteon

NDA for non-24 is adequate to support filing

* Says is targeting an NDA submission for tasimelteon in mid-2013.

* Source text * Further company coverage

((Bangalore Newsroom; +1 646 223 8780))

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BRIEF-pSivida says Alimera to resubmit marketing approval application for Iluvien to FDA by end March

March 22 (Reuters) - pSivida Corp :

* Reports updates on Iluvien for planned resubmission to FDA and European

launch

* Says Alimera announced it intends to resubmit its NDA for Iluvien for DME to

FDA by end of March 2013 * Source text * Further company coverage

((Bangalore Newsroom; +1 646 223 8780))

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About That Updated Application...

Bob's post yesterday got me excited. Finally the government is going to simplify things and make my life easier to sign up for health insurance. So I anxiously waited for the document to be released this morning and as soon as it hit I saw this story on Yahoo. According to the story there are only 12 pages for the family to complete. Wahoo!!!

The original was 26 pages and included pages for six family members to enroll. With five in my family I was looking at having to complete 22 to 24 pages. I had to see it to believe it so I pulled it off the CCIIO website.

It was a 12 page application...that allowed for TWO people to enroll. What about my three kids? How do I add them to the application? Reading into the detail a little further on the bottom of page two was the kicker. It says:

"If you have more than 2 people in your family, you'll need to make a copy of the pages and attach them."

Let's recap. The original 26 page application was designed to enroll six family members. It is now extinct and has been replaced by a new and simplified 12 page application for two people. For me to add all three children (each additional family member requires two pages) increases the new simplified app to 18 pages.

Saving 8 pieces of paper might excite Al Gore, but for most people it's still going to be a long process.

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Watson gets FDA application approval

PARSIPPANY, N.J. -- Watson Pharmaceuticals Inc. said Thursday that a subsidiary has received regulatory approval for a generic drug designed for the treatment of heavy menstrual bleeding.

The company said that it intends to begin shipping the product immediately.

Watson said the tranexamic acid tablets are the generic equivalent to Ferring Pharmaceuticals' drug Lysteda. Ferring has filed patent infringement lawsuits against Watson, but the litigation is still pending.

Watson cited IMS Health data showing that Lysteda had U.S. sales of roughly $25 million in the 12 months that ended Nov. 30.

Watson, based in Parsippany, N.J., is the world's third-largest generics prescription drug manufacturer with more than 750 products marketed globally.

Shares gained $1.71, or 2 percent, to $85.92. Its stock is near the high end of its 52-week trading range of $55 to $91.47.

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