Replies to post #25621 on $heff's $tation of $tocks & $olid DD

[The_Free_Nebula]

With all the buzz about this stock it could easily be in the low teens by Friday

[Profe$$or]

Great post Sheff!!!!

[momentum74]

POZN market. WSJ article from a yahoo board poster pasted.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_P/threadview?m=tm&bn=14505&tid=28567&mid=28567&tof=2&frt=2


Below is an article from yesterday's WSJ that summarizes recent drug sales in the U.S.

PAY VERY CLOSE ATTENTION TO THE VERY LAST LAST LINE where it states that PPI (proton-pump inhibitors) were 2nd in overall U.S. drug sales in 2009 at a whopping 13.6 Billion!

How about a COX-2 selective NSAID pill that incorporates a PPI?

This drug is called VIMOVO and will absolutely DOMINATE a HUGE market after approval at the end of this month. AstraZeneca is already on board to launch this drug in the U.S. and European markets upon approval.

Read the short article below and HOLD ON TO YOUR SEATBELTS come April 30th cause if you thought SOMX was explosive, well..... You haven't seen ANYTHING yet!

Go SOMX & POZN

›APRIL 2, 2010
By JONATHAN D. ROCKOFF

Spending on prescription drugs topped $300 billion in the U.S. last year, rising 5.1% despite the economic downturn, according to IMS Health. But the rate of growth was at the low end of historical levels, reinforcing the difficulties brand-name drug makers face relying on the U.S. market to increase revenue.

The number of prescriptions dispensed in the U.S. also edged higher last year, increasing 2.1% to 3.9 billion, IMS Health reported Thursday. IMS Health collects data from drug makers, pharmacies and other sources and advises companies on health-care trends.

The results underscore the "resilience" of prescription-drug demand in the face of a down economy, said Murray Aitken, a senior vice president at IMS Health. In 2008, the spending rose just 1.8%, only the third time since 1957 the rate of growth was below 5%.

Investors
have traditionally viewed pharmaceutical stocks as good options during down economies, although some companies, such as Merck & Co., said the recent recession was damping sales.

Still, the data pointed to concerns for branded drug makers. The number of prescriptions dispensed for generic drugs rose 5.9% last year, but those for branded drugs declined 7.6%. Of all prescriptions that were dispensed, 75% were for generics last year, up from 57% five years earlier.

Partly because of the rising use of those generic drugs, prescription-drug spending managed to increase overall for the year to $300.3 billion, Mr. Aitken noted.

Drug makers and retailers also encouraged prescription-drug use by offering patients discounts on co-pays and other incentives. Slightly higher prices for certain brand-name treatments also contributed to higher revenue.

IMS Health said that it couldn't specify how much the prices for brand-name drugs increased.

Sales of brand-name drugs are expected to keep rising at relatively low rates in the mid-single digits, Mr. Aitken said. Making matters difficult for brand-name drug makers, several of their top-selling medicines, including Pfizer Inc.'s popular Lipitor, are scheduled to lose patent protection over the next few years.

One sign of the problems ahead for branded drug companies was in the results for cholesterol-fighting drugs. They continued to be the largest class of prescription medicines by prescription volume. But they dropped to third place from second in terms of overall sales, due to rising use of generic versions.

Antipsychotic medicines were the top-selling class of drugs in the U.S. last year, with sales of $14.6 billion. Proton-pump inhibitors were second with sales of $13.6 billion, according to IMS Health.

[$heff]

POZN ($9.74) will definitely be coiled like a rocket close to the April 30th PDUFA date. This is the short position from shortsqueeze.com and it is definitely telling on this play. SOMX bounced hard from $3.70 to over $10.00 on second day after approval. POZN keeps moving higher everyday on low volume. Selling is drying as April 30th approaches. The potential approval of Vimovo is much greater than what Silenor approval chances were because of the negative history of sleep drugs w/the FDA. Here is the "shorts" tale of the tape b/w POZN and SOMX. One drug waiting approval (Vimovo)& the other drug (Silenor) already approved. POZN has almost 50% in institutional holdings so that makes shares tougher to get IMO as institutions are much more likely to hold on and have to file and S-8 once they decide to sell.$heff

[$heff]

Stealth DD w/POZN #2 ($10.89)…How has the SPA has helped POZN in their chance for approval of Vimovo? The SPA allowed Pozen to address the FDA concern in early 2009!
Pozen has already had their setback with the FDA back in 2008. The PDUFA date almost did not happen after the FDA informed POZN of questions they had regarding the clinical endpoints in their study.
Once they and Pozen reached an agreement (via SPA) on the correct clinical endpoints the Phase III study moved forward to where it is today. The FDA has not had any questions from Pozen since late 2008. Below is an article written in 2008 about the Vimovo setback.



Having the SPA (Special Protocol Assessment) has allowed POZN to have access to the FDA more often than most companies do so that concerns the FDA had could be addressed by POZN before the decision date of April 30th. POZN has met with the FDA several times regarding Vimovo which does not often occur unless your product really fills a void (SPA) and the FDA wants to help you “get it approved.” The meetings with the FDA occurred in:

-2005 regarding their development plans for studies to pursue FDA approval of PN 100 and PN 200.
-In early 2006, POZN submitted an SPA to the FDA for their pivotal Phase 3 clinical trials for PN 200 so that was another opportunity
-In April 2006, POZN announced that they reached an agreement with the FDA on the Phase 3 pivotal clinical trials for PN 200. They had also reached an agreement w/ the FDA on their development program & study design.
-Dec 2008 the FDA informed POZN that it “isn't so sure that "endoscopically confirmed gastric ulcers" are the right endpoint. Back in October the FDA notified Pozen that it's trying to decide if the endpoint is clinically relevant. Showing that a drug changes something in the body isn't good enough for the agency; the FDA wants to know that the change results in a real benefit for patients.”
- In late January 2009, the FDA informed us that it had completed its internal discussions and that there was no change to the previous agreements that gastric ulcer incidence was an acceptable primary endpoint for our clinical programs.

POZN had the SPA with the FDA and that was critical to the point they are at now. They were able address the concern of the FDA by communicating the issue in 2008 and Pozen addressing it in 2009.

”In late January 2009, the FDA informed us that it had completed its internal discussions and that there was no change to the previous agreements that gastric ulcer incidence was an acceptable primary endpoint for our clinical programs. “ (from Pozen 10Q)

I believe that the issues that the FDA had with the approval of PN 200 & 400 were addressed in 2009. Most companies have to wait to hear from the FDA on approval day and oftentimes have not communicated with the FDA at all prior to the decision. This has not been the case with POZN with whom the FDA has been in regular contact with regarding their study enpts & other pertinent data. POZN believes that unless new information about Naproxen becomes available, long-term cardiovascular safety studies will not be required for FDA approval of Vimovo (which contains naproxen).
There have been no issues since and the company presented their breakthrough data at the ACR mtng in late 2009 that was very well received. I believe that there are no further issues that would keep Vimovo from getting approved IMO and that they addressed the FDA concerns in Jan 2009.

[$heff]

POZN (10.21) DD Post.. Analyst thoughts on POZN and its potential for Vimovo approval in two weeks! I am locked & loaded here folks and believe the market has seriously undervalued this company. That won't be the case when Vimovo is approved IMO.
http://finance.yahoo.com/news/Arthritis-Drug-Vimovo-twst-3473823072.html?x=0&.v=1
Dr. Jonathan Aschoff, Ph.D., is a Senior Equity Analyst at Brean Murray, Carret & Co., LLC