Abbott Labs (ABT) recently signed a definitive agreement with PanGenetics BV for a pain candidate, PG110. Under the terms of the agreement, Abbott will acquire global rights to PG110 which is a novel biologic that targets Nerve Growth Factor (NGF) for the treatment of chronic pain. PanGenetics will receive an upfront payment of $170 million and $20 million in milestone payments. This agreement should allow Abbott to expand its pain product portfolio and leverage its expertise in biologics. The commercial opportunity in the pain market is significant. There is major demand for the development of a treatment that would provide relief from pain without the potential of addiction and abuse. It is estimated that there are about 72 million diagnosed chronic pain patients in the U.S. and EU, and up to 30% of chronic pain patients get inadequate relief. Current treatments include non-steroidal anti-inflammatory drugs (NSAIDs), ...

Vimovo Demonstrates Benefit Over Naproxen Yesterday, at the American College of Gastroenterology meeting in San Diego, Pozen (POZN) released data from two phase III trials comparing Vimovo (formerly PN400) to enteric-coasted naproxen (ECN) in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) who are at risk of developing NSAID-associated gastric ulcers. The data demonstrated that patients taking Vimovo experienced significantly greater reduction in severity of dyspepsia (SODA) and overall treatment evaluation for dyspepsia (OTE-DP) compared to patients taking ECN. The OTE-DP results showed 43-46% of the patients on Vimovo reporting positive change at month six vs. only 28-34% on ECN. The results were highly statistically significant. Plus, patients taking Vimovo also had discontinuation rates far below ECN, at 3-5% vs. 11-12%, respectively. The safety of Vimovo was also superior to ECN, with only 2% of the patients experiencing erosive duodenitis as compared to 10-14% for ...

Following the recent merger of Pfizer (PFE) and Wyeth, a U.S. court imposed a huge fine on the company’s subsidiary Pharmacia & Upjohn for fraudulent marketing of its painkiller Bextra (valdecoxib). The penalty of $1.195 billion was the largest criminal fine ever imposed in the U.S. In addition, a criminal forfeiture of $105 million was enforced on the company.   In September, Pfizer had agreed to pay an additional $1 billion along with interest to settle civil allegations related to fraudulent promotion of four drugs – Bextra, the anti-psychotic drug Geodon, the antibiotic Zyvox and the anti-epileptic drug Lyrica – as well as claims that the company paid kickbacks to physicians to prescribe these and nine other drugs.   In addition to the huge penalty, Pfizer had to agree to comply with the terms of a new and significantly expanded corporate compliance program. It seeks to ensure that ...

The world’s largest drugmaker Pfizer (PFE) now leads the list of largest healthcare fraud settlement payers. The company yesterday announced that it finalized with the U.S. Department of Justice (DoJ) to pay a total of $2.3 billion in penalty. The penalty is related to its off-label promotional practices for Bextra, and other fraudulent marketing practices for the promotion of four drugs. Pfizer also entered into an integrity agreement with the Health and Human Services Department under which it has agreed to ensure proper checks for a period of five years in order to avoid such issues.

In 2005, Bextra was voluntarily withdrawn from the market as it was illegally promoted for several unapproved indications and dosages. In order to resolve the matter, Pfizer agreed to pay a criminal fine of $1.3 billion, which is the largest criminal fine ever imposed in the U.S. In addition, the company agreed to pay

...

For Immediate Release

Chicago, IL - July 1, 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: Pozen (POZN), Kimberly-Clark Corporation (KMB), Enterprise Products Partners (EPD), Teppco Partners (TPP) and Chevron Corporation (CVX).

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 Tuesday's Analyst Blog:

Pozen Files For Approval of Vimovo

Today, Pozen (POZN) announced the submission of the new drug application (NDA) to the U.S. FDA, seeking marketing approval for Vimovo (proposed trade name for PN-400) for the treatment of signs and symptoms of osteoarthritis, rheumatoid arthritis and

...

Today Pozen (POZN) announced the submission of the new drug application (NDA) to the U.S. FDA, seeking marketing approval for Vimovo (proposed trade name for PN-400) for the treatment of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers.

Vimovo is a combination of 500mg enteric coated naproxen and 20mg immediate release esomeprazole. In early December 2008, Pozen released positive top-line data from its 400-301/-302 phase III program testing PN-400 (20mg esomeprazole / 500mg naproxen) vs. 500mg enteric coated naproxen alone. Results show that 400 patients total in both trials taking PN-400 experienced statistically significant fewer number of confirmed gastric ulcers by endoscopy compared to 400 subjects receiving enteric coated naproxen during the six-month period.

Pozen expects to receive a milestone payment of $10 million when the NDA is formally accepted for review by the FDA. We

...

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/4/09, Abbott Labs [ABT: 45.42, +0.86 (+1.93%)] and AstraZeneca [AZN: 43.34, +1.70 (+4.08%)] announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two

...

Emisphere [EMIS: 0.00, N/A (N/A)] is an emerging bio-pharma company specializing in the development of a drug delivery technology platform for the oral administration of therapeutic compounds which are either poorly absorbed or must be given through alternative routes such as injections.

On 6/1/09, EMIS announced that Novartis [NVS: 41.95, +1.66 (+4.12%)] and Nordic Bioscience have completed recruitment for the planned second multi-center Phase 3 study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere’s proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which is intended to be used to support a FDA regulatory approval filing in the U.S., includes more than 900 patients between the ages of 51-80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is

...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Genzyme [GENZ: 59.12, +0.75 (+1.28%)] and Isis Pharma [ISIS: 13.66, +0.53 (+4.04%)] announced on 5/20/09 that the Phase 3 clinical trial of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25% reduction in LDL

...

One of the only markets that still offer massive upside is that of health care.  One company recently received FDA approval to test two breakthrough drugs. This company has already soared 50% in a week’s time. But the fundamentals say this company is primed for a long-term climb up the charts.

This Small-Cap Biotech Just Hit its Stride

One of the most recession-proof industries is health care. No matter what happens to the economy people will always need medical attention - and new developments will always be in the works.

On Thursday, a small-cap pharmaceutical company, Pozen, Inc. (Nasdaq: POZN), soared after the Food and Drug Administration agreed to allow testing of two of its experimental drugs.

The stock is up over 50% in a week. Yesterday (Thursday), it was one of the top-five percentage gainers on the Nasdaq.

Pozen Inc. - Helping Those With Chronic Pain

Pozen is a

...