http://www.straightstocks.com Leading Stock Market News, Opinions and Commentary Sat, 20 Mar 2010 18:23:35 +0000 http://wordpress.org/?v=2.9.2 en hourly 1 http://www.straightstocks.com/stock-watch/pozen-brings-good-data-earnings-analyst-blog/ http://www.straightstocks.com/stock-watch/pozen-brings-good-data-earnings-analyst-blog/#comments Wed, 28 Oct 2009 14:01:23 +0000 Zacks Market Commentaries http://www.zacks.com/stock/news/26537/Pozen+Brings+Good+Data+%26+Earnings+-+Analyst+Blog 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 ECN. Rates of erosive gastritis were also far lower in the Vimovo group at 18-21% vs. 38-39% for ECN.

Early in October, at the American College of Rheumatology meeting, Pozen presented data showing a significant reduction in the risk of gastric ulcers (GU), the primary endpoint of the phase III program, vs. ECN at a rate of 4-7% for Vimovo vs. 23-24% for ECN.

Vimovo is a fixed-dose combination of enteric-coated naproxen with an immediate release esomeprazole. Given the high risk for gastrointestinal side-effects for patients with OA and RA that take naproxen, roughly 60%, and the lingering concern on the cardiovascular safety of Cox-II inhibitors such as Celebrex post the withdrawal of Vioxx and Bextra, we believe that Vimovo has significant sales potential. Our financial model assumes Vimovo peaks at over $500 million worldwide.  Pozen has partnered with AstraZeneca (AZN) for the commercialization of Vimovo.

Vimovo is currently under U.S. FDA review with an action date set for late April 2010.  In mid-October, AstraZeneca filed for approval in the European Union via the decentralized procedure. Approval in the U.S. entitles Pozen to a $20 million milestone payment from AstraZeneca. The first approval outside the U.S. entitles Pozen to another $25 million.

The strong clinical data on Vimovo give us confidence in the phase III program for Pozen’s second pipeline candidate, PA-325/20, a fixed-dose combination of enteric-coated aspirin and immediate-release omeprazole. Similar to Vimovo, patients taking daily aspirin for cardiovascular protection or the potential reduction in the development of colorectal adenomas, are at risk for significant gastrointestinal side-effects. Phase II data on PA-325/20 demonstrated a significant reduction in gastric ulcers, 0% vs. 20%, after a 28-day concept study.

Third Quarter Performance

This morning, Pozen released financial results for the third quarter 2009. Total revenues for the quarter were $14.3 million, and consisted of $13.1 million in licensing and development revenues and $1.2 million in royalties on U.S. sales of Treximet at GlaxoSmithKline (GSK).

During the third quarter Pozen received a $10 million milestone for the filing of the U.S. NDA for Vimovo. The company earned $6.7 million, or $0.22 during the third quarter, 5 cents above our forecast. Pozen also has $51.3 million in cash and investments. We continue to be very positive on the stock and recommend purchase at this level -- Pozen currently has a Zacks Recommendation of Outperform.
Read the full analyst report on "POZN"
Read the full analyst report on "AZN"
Read the full analyst report on "GSK"
Zacks Investment Research
]]> http://www.straightstocks.com/stock-watch/pozen-brings-good-data-earnings-analyst-blog/feed/ 0 http://www.straightstocks.com/stock-watch/arenas-lorcaserin-has-safety-edge-analyst-blog/ http://www.straightstocks.com/stock-watch/arenas-lorcaserin-has-safety-edge-analyst-blog/#comments Mon, 21 Sep 2009 15:06:39 +0000 Zacks Market Commentaries http://www.zacks.com/stock/news/25042/Arena%27s+Lorcaserin+Has+Safety+Edge+-+Analyst+Blog Results from Arena’s (ARNA) phase III BLOSSOM study are strikingly similar to the BLOOM study, with mean total weight loss for the 10mg lorcaserin BID group coming in at 17.0 lbs in BLOSSOM vs. 17.9 lbs in BLOOM. These equated to 7.9% and 8.2% mean absolute weight loss. The placebo was 3.9% and 3.4% in each trial, respectively, putting the mean placebo-adjusted weight loss for each trial at 4.0% and 4.8%. Total categorical weight loss for the completer analysis was 63.2% in BLOSSOM and 66.4% in BLOOM, vs. 34.9% and 32.1% for the placebo.

Per the FDA draft guidance: “A product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.

Data from the BLOSSOM and BLOOM confirms that lorcaserin successfully meets the second criteria for approvability. However, perhaps even more important than efficacy, the safety and tolerability profile of lorcaserin in the completed phase III program was outstanding.

The biggest concern going into the phase III development with lorcaserin was the potential for increased rates of valvulopathy (what took down Phen-Fen). Completed 52-week data demonstrates no apparent affect on heart value function for lorcaserin patients.

Plus, a significant benefit of lorcaserin over both Vivus’ (VVUS) Qnexa and Orexigen’s (OREX) Contrave is that lorcaserin requires no four-week titration. This is because of the uniquely benign side-effect profile of the drug.

Adverse events (AEs) were surprisingly low for the combined program, with no specific event exceeding the placebo by > 4%. Both Qnexa and Contrave have a significant number of AEs that exceed 5% placebo adjusted, including dry mouth, tingling, constipation and altered taste for Qnexa and nausea, headache, constipation, vomiting and insomnia for Contrave. Serious adverse events in the lorcaserin phase III program were infrequent and did not differ statistically from placebo. Neuropsychiatric events, depression, mood alteration and suicidal ideation were all also similar to placebo.

Although the efficacy of lorcaserin is shy of Qnexa and Contrave, we believe the unique safety and tolerability profile make the drug a very attractive partnering asset for a large-cap pharmaceutical company. We expect that Arena will see to file the U.S. NDA (new drug application) alone by the end of the year and then partner prior to approval in 2010.

Expect Combination Use with Phentermine

According to data from Arena, Phentermine held approximately 80% of the prescription market share for obesity scripts in 2008. Other molecules including orlistat, sibutramine, topiramate and bupropion round-out the top-5.

Vivus’ Qnexa, a combination of phentermine and topiramate, clearly looks like the most efficacious drug. However, we believe that head-to-head, lorcaserin offers greater efficacy and far better tolerability than topiramate.  Therefore, we believe the number one treatment option for obesity scripts post approval of lorcaserin will be a combination lorcaserin-phentermine product.

Our biggest concern is that Arena does not intend to conduct a safety analysis of lorcaserin and phentermine together, choosing to keep lorcaserin as a single agent and defer any additional studies to its commercial partner.

Whether or not the U.S. FDA will request additional safety data on lorcaserin or on a potential “Phen-Lor" product remains to be seen. This could be a stumbling block for Arena next year when the FDA reviews the drug. More information and a detailed head-to-head presentation of all three post-phase III obesity drugs can be found in our full research report.
Read the full analyst report on "ARNA"
Read the full analyst report on "VVUS"
Read the full analyst report on "OREX"
Zacks Investment Research
]]> http://www.straightstocks.com/stock-watch/arenas-lorcaserin-has-safety-edge-analyst-blog/feed/ 0