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Does it scare anyone to think that the short interest has went from 200k to 600k shares in one week. That's a 200% increase!
while we wait a recap
Federal regulators are set to rule today whether an extended-release version of a government-approval local anesthetic can be sold by Pacira Pharmaceuticals, which has its main operations in La Jolla.
Exparel, a post-surgical injection administered at the surgical site, is designed to delay and shorten the need for pain relief from opioids such as morphine, which can cause costly and potentially life-threatening side effects, according to the company and its researchers.
The drug combines the anesthetic bupivacaine, which is sold by AstraZeneca, and DepoFoam, a fatty product developed by Pacira for holding medicine inside microscopic chambers for extended release.
If approved, Exparel could generate peak annual sales of $362 million in the United States and $576 million worldwide, according to reported estimates by the Los Angeles investment firm Wedbush Securities.
The Food and Drug Administration originally was scheduled to decide on Pacira's new drug application for Exparel by July 28, but the agency postponed the deadline three months after requesting additional information about the drug from its maker.
A new analysis of data from five clinical trials of Exparel showed that patients receiving the drug went without an opioid 3-1/2 times longer than those who received bupivacaine alone (9.9 hours versus 2.7 hours).
The Exparel patients also received 50 percent less opioids than the others, and they reported less pain over 72 hours.
While Pacira is headquartered in Parsippany, N.J., most of its employees work at its manufacturing and research and development center near the University of California San Diego campus.
Good luck to those who chose to hold through this bad boy.
think we are close to finding out...per AH shifting
GL
I am way up now. And going to be way upper soon. TY
PCRX uting AH 10.70x10.76
I know the feeling. I barely survived XNPT, SPPI and ACUR.
OPTR was not even halted when approved somewhere around 3PM on a Friday I think
@Investor666 Brian
A few Form "T'' s are going through on PCRX
and didn't move the needle, so large order accumulated over days
I made my money already on this one. I could not resist the $9.45 pps so I loaded back up. I could have sold again today and made more but this is why I like stocks like this. Monday we could open at $15 or $5. No guts no glory. I never cross my fingers that does not help. LOL. GLTA
u see the 300K trade @ EOD? , i think shorty covered slowly this week and it hit the tape,imo
@ 15:54 someone bought 350,000 shares
http://www.nasdaq.com/symbol/pcrx/time-sales
They will be a massive dilution if this is not approved.
You better keep your fingers crossed.
XNPT, SPPI, ACUR all approved late night. SPPI just about 9 PM. Hang in there. It's not over till the FDA sings!
I am in and holding. I flipped once but reloaded and I am going through win or lose.
The short interest has increased this past week.
no reason at all to think that, look at AVNR almost exactly a year ago, also DEPO in january, both approved, both PR's released after hours on a friday
Something tells me it's a no go. If they said it was the 28th then PCRX would have posted it already.
so, we may only hear over the weekend?
PCRX PDUFA
Fri, October 28, 12am – Sat, October 29, 12am
Calendar
FDA Calendar
Got some crazy cheap shares today on that drop. Should be fun seeing what happens.
PCRX approval tomorrow may get the stock price to $15, a no from the FDA could send it to $5, the risk/reward was too great for me, sold out. I usually always sell prior to an FDA meeting, if the stock had a nice run into the event.
another 9500 shares
big buys r coming in
someone just bought 10 000 shares at 10.60
someone has alot of faith!!
signs do look good for sure!!
Good Luck guys. I sent an early email out to the FDA. As soon as I get a response I will post it here. They probably won't answer till tomorrow. All signs look good to me.
I got in this after Sheff alerted and boy am I happy. WEEEEEEE
$heff's DD Post: Nice and detailed.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68206822
Oct. 19 PR link: http://finance.yahoo.com/news/Pacira-Pharmaceuticals-Inc-prnews-1887103512.html?x=0&.v=1
Pacira Pharmaceuticals, Inc. Announces New Data Demonstrating Longer Time to First Opioid Use and Reduction in Opioid-Related Adverse Events With EXPAREL™ Compared to Bupivacaine HCl
Pooled Analysis Findings Presented at American College of Clinical Pharmacy Annual Meeting; Data Demonstrating Sustained-Release Properties of EXPAREL also Presented
Companies:Pacira Pharmaceuticals, Inc.
Symbol Price Change
PCRX 9.43 +0.18
Press Release Source: Pacira Pharmaceuticals, Inc. On Wednesday October 19, 2011, 4:05 pm EDT
PARSIPPANY, N.J., Oct. 19, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX - News) today announced new data demonstrating a reduction in opioid burdens with EXPAREL™ (bupivacaine liposome extended-release injectable suspension) at doses up to and including 300 mg compared to bupivacaine HCl in a multimodal setting at the 2011 Annual Meeting of the American College of Clinical Pharmacy (ACCP) in Pittsburgh. These data are the result of a pooled analysis of five trials conducted for postsurgical pain management.
Currently under review with the U.S. Food and Drug Administration, EXPAREL is an innovative long-acting bupivacaine that has been evaluated in multiple Phase 2 and Phase 3 clinical studies to assess prolonged postsurgical analgesia for up to 72 hours with a single-dose local administration at the surgical site. The drug combines bupivacaine with DepoFoam®, a proven product delivery technology that encapsulates medications and delivers them over a desired time period.
Joseph F. Dasta, M.Sc., FCCM, FCCP, adjunct professor at the University of Texas, College of Pharmacy, presented the data, which evaluated the use of EXPAREL at doses up to and including 300 mg compared to bupivacaine HCl at doses up to and including 150 mg administered via wound infiltration across three surgical models including hemorrhoidectomy, total knee arthroplasty and herniorrhaphy. Data pooled from these five active-control, double-blind, randomized, multicenter, parallel-group trials of more than 700 patients demonstrated that across all surgical models, EXPAREL resulted in longer time to first opioid use (TTFO), a reduced overall consumption of opioids, fewer opioid-related adverse events (ORAEs) and better pain control compared to bupivacaine HCl. Each finding was statistically significant (P<0.0001).
Specific results include:
A median TTFO that was 3.5 times longer for patients receiving EXPAREL compared to patients receiving bupivacaine HCl (9.9 hours vs 2.7 hours, respectively).
A 50% reduction in the total amount of morphine-equivalent opioids consumed for patients receiving EXPAREL compared to patients receiving bupivacaine HCl (7.9 mg vs 15.8 mg, respectively).
A 46% reduction in the mean number of ORAEs for patients receiving EXPAREL compared to patients receiving bupivacaine HCl (0.25 vs 0.46, respectively).
Less pain over 72 hours was demonstrated for patients receiving EXPAREL compared to patients receiving bupivacaine HCl, as evidenced by an area under the curve analysis, a measure of pain over time (AUC0-72 315 vs 427, respectively).
"Postsurgical patients often require opioids, which along with pain relief, cause a plethora of costly and sometimes life-threatening side effects," said Dasta. "In this pooled analysis, patients receiving EXPAREL had less opioid consumption and fewer ORAEs over 72 hours. In my experience, patients who have no or few ORAEs are more likely to benefit from an improved recovery experience. Pharmacists should be particularly interested in this unique approach to postsurgical analgesia as it has not only clinical, but potentially economic implications."
Additionally, Deedee Hu, PharmD, clinical specialist in the Department of Critical Care and Cardiology at Memorial Hermann Memorial City Medical Center in Houston, Texas, also presented new data during a poster presentation at ACCP today demonstrating that EXPAREL exhibits pharmacokinetic properties consistent with bimodal and sustained-release formulations. These data were collected from a total of 446 individuals receiving 75 mg to 750 mg of EXPAREL or bupivacaine HCl across 11 studies. Various surgical models (hemorrhoidectomy, herniorrhaphy, bunionectomy or total knee arthroplasty) and routes of administration (wound infiltration, subcutaneous, epidural or nerve block) were studied.
The key findings include:
EXPAREL exhibited an initial peak in plasma concentration 0.25-2 hours after administration (likely due to the small amount of extraliposomal bupivacaine present in EXPAREL) followed by a second peak at 12-24 hours (due to the slow and prolonged release of bupivacaine from the DepoFoam). Bupivacaine HCl exhibited a single peak in plasma concentration at 0.25-2 hours followed by a rapid decline toward zero.
Even at doses up to 600 mg, the maximal plasma concentration of EXPAREL was 935 ng/mL, which is 2- to 4-fold below the minimal toxicity threshold for bupivacaine HCl (central nervous system effects are usually first seen at bupivacaine levels of >2000 ng/mL; cardiac system effects are usually first seen at levels of >4000 ng/mL).
Consistent plasma curves were observed for all doses of EXPAREL, suggesting that dosing can safely be adapted to meet the specific needs of each surgical model.
"These data show that EXPAREL delivers bupivacaine over three days with the well-established DepoFoam carrier matrix, providing postsurgical pain relief while extending the traditional duration of action from seven hours to up to 72 hours," said Dr. Hu. "This bimodal release may be beneficial in the multimodal treatment of postsurgical pain."
"The body of clinical evidence that supports the utility of EXPAREL as a postsurgical pain management therapy continues to grow and we believe these data presented at ACCP further support its potential clinical and health economic utility," said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. "Based upon the positive feedback we have received from a variety of clinical key opinion leaders and hospital organizations, we believe that EXPAREL may become a valuable therapeutic option for physicians and their patients, should it be approved by the FDA at the end of October."
About Pacira
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, manufacture and commercialization of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL (bupivacaine liposome extended-release injectable suspension), the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive Phase 3 clinical development for postsurgical analgesia by infiltration. EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at www.pacira.com.
About EXPAREL™
EXPAREL (bupivacaine liposome extended-release injectable suspension) is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Market data indicate that there is an unmet medical need for a longer-acting anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL's potential, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the timing of, and our ability to obtain regulatory approval of EXPAREL; the timing of our anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2010, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contacts:
James S. Scibetta
Chief Financial Officer
Pacira Pharmaceuticals, Inc.
(973) 254-3570
Dan Budwick
Vice President, Media Relations
Pure Communications, Inc.
(973) 271-6085
October 18 Article 11 second(s) ago
http://finance.yahoo.com/news/Pacira-Pha...
Pacira Pharmaceuticals, Inc. Announces Key EXPAREL™ Data to be Presented at American College of Surgeons 97th Annual Clinical Congress
from the PR: "The schedule for Pacira podium presentations are as follows:
Presentation Title: Comparison of Immediate-Release Bupivacaine vs. EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) on Opioid Requirements and Related Adverse Events from Phase 2 and 3 Studies Utilizing Multimodal Analgesia Across Multiple Surgical Models
Presented by: Sonia Ramamoorthy, M.D., associate professor of surgery at the University of California, San Diego
Date & Time: Monday, October 24 from 9:45-11:15 a.m. PDT
Location: Moscone Convention Center, Moscone West, 3rd Floor, Room 3014/3016/3018
Presentation Title: EXPAREL™ (Bupivacaine Extended-Release Liposome Injection), an Investigational Multi-Vesicular Liposomal Bupivacaine Based Analgesic, Decreases Pain, Opioid Use, and Opioid-Related Adverse Events for Three Days Post Surgery
Presented by: Stephen R. Gorfine, M.D., clinical professor of surgery, Mount Sinai School of Medicine
Date & Time: Wednesday, October 26 from 4:15-5:45 p.m. PDT
Location: Moscone Convention Center, Moscone North, Exhibition Level, Room 134"
GLTA investors!
Sentiment : Strong Buy
Hey 67, tell me the scoop on this. How much debt? Why the super low volume? EPS -27 dollars? Chances of approval?
I'am DDing as I type
There are few shorts in PCRX, you need to recheck your data, shorts have little to no effect on the current PPS:
Avg Vol (3 month)3: 70,118
Avg Vol (10 day)3: 68,813
Shares Outstanding5: 17.23M
Float: 5.47M
% Held by Insiders1: N/A
% Held by Institutions1: N/A
Shares Short (as of Sep 15, 2011)3: 286.99K
Short Ratio (as of Sep 15, 2011)3: 3.70
Short % of Float (as of Sep 15, 2011)3: 5.30%
Shares Short (prior month)3: 269.37K
There is a massive futile attempt to short this before approval.
Just like Dendreon.
It's very obvious, this is being shorted by some entity. Most likely the company itself, through the MM's.
You're looking at at least $15.00 on approval.
Anytime the market is up, and a stock like this is down, it should tell you something.
Feuerstein gives Exparel a 75-80% chance of FDA Approval.
Not too shabby.
Check out the video:
http://www.thestreet.com/_yahoo/video/11270708/the-next-big-thing-in-biotech-pacira.html?cm_ven=YAHOOV&cm_cat=FREE&cm_ite=NA&s=1#1205438262001
GLTA!
6:31AM Pacira Pharma announces efficacy and safety of EXPAREL; Did not have any impact on normal healing in the presence of silicone breast implant material. (PCRX) 10.45 : Co announced that the company's lead investigational product for postsurgical pain management, EXPAREL was highlighted in the "Hot Topics in Plastic Surgery" panel at the annual scientific assembly of the American Society of Plastic Surgeons (ASPS) in Denver, Colo. Also at ASPS, new data from a two-year observational study of EXPAREL following breast augmentation were presented during an oral session on Saturday, September 24, 2011. There was no meaningful difference in impact on breast appearance or implant material in the bupivacaine versus EXPAREL groups. Neither EXPAREL nor bupivacaine were associated with any serious adverse events, deaths or withdrawals from the study
August 11, 2011 06:31 EDT PCRX
theflyonthewall.com: Pacira Pharma reports Q2 EPS (51c) vs. consensus (58c)
Reports Q2 revenue $3.6M vs. consensus $3.50M :theflyonthewall.com
First, Pacira Pharmaceuticals(PCRX_) is expecting an FDA approval decision on Oct. 28 for Exparel in post-surgical pain management. Exparel is a proprietary, long-acting formulation of the painkiller bupivacaine. FDA extended the Exparel review by three months because Pacira submitted additional information.
I met with Pacira executives a couple of weeks ago and walked out confident in Exparel's approval. The three-month delay sounded much more procedural than anything worrisome.
http://www.thestreet.com/_yahoo/story/11185692/1/biotech-stock-mailbag-adventrx-pharma.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
OB; Not that i know of. If i run into anything i will post.
GL
mlkr-
I'm doing some prelilminary DD on PCRX, got a quick question re the PDUFA extension:
Has PCRX said anything more specific about exactly what the "modification of research" is?
TIA.
PCRX's 3 months extension is a modification of research according to FDA it seems.. PPS down by $2.00. $11.00s stox now!
6:33AM Pacira Pharma receives FDA extension of EXPAREL PDUFA target date by three months (PCRX) 13.22 : Co announces the FDA has extended the Prescription Drug User Fee Act goal date for its review of the New Drug Application for EXPAREL by three months. The new PDUFA goal date is October 28, 2011. The FDA requested additional information from co, which the co has submitted.
Pacira Pharmaceuticals, Inc. Announces FDA Extension of EXPAREL PDUFA Target Date by Three Months
http://finance.yahoo.com/news/Pacira-Pharmaceuticals-Inc-prnews-1210291847.html?x=0&.v=1
Pacira Pharmaceuticals, Inc. to Present at UBS Global Specialty Pharmaceuticals Conference
http://www.prnewswire.com/news-releases/pacira-pharmaceuticals-inc-to-present-at-ubs-global-specialty-pharmaceuticals-conference-122493003.html
6:34AM Pacira Pharma provides data highlighting safety, efficacy for EXPAREL across multiple surgical models (PCRX) 10.97 : Co provides clinical data highlighting the safety profile of EXPAREL as well as comprehensive, program-wide efficacy data. Key safety findings from these studies include: Only 32.9% of patients who received EXPAREL at a dose of 300 mg experienced a treatment emergent adverse event, compared to 38.9% of patients who received a placebo. Approximately 62% of all EXPAREL patients experienced a TEAE, compared to 75% of bupivacaine patients. Key efficacy findings from these studies include: EXPAREL demonstrated statistically significant lower pain intensity in the two pivotal trials compared to placebo at the primary endpoint. EXPAREL demonstrated a statistically significant lower opioid usage in those trials, including a: Delay in the need for opioido; Decrease in the amount of opioids required; Increase in the number of patients able to avoid opioids entirely.
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http://www.pacira.com/index.php
http://finance.yahoo.com/q/h?s=PCRX+Headlines
Pacira Pharmaceuticals, Inc., a pharmaceutical company, engages in the development, commercialization, and manufacture of pharmaceutical products for hospitals and ambulatory surgery centers. It provides its pharmaceutical products based on DepoFoam drug delivery technology. The company's product portfolio consists of EXPAREL, a long-acting bupivacaine product for postsurgical pain management; DepoCyt for the treatment of lymphomatous meningitis; DepoDur for controlling post operative pain; DepoNSAID, which is in preclinical trials for the acute pain; and DepoMethotrexate that is in preclinical trials for the treatment of rheumatoid arthritis oncology. Pacira Pharmaceuticals, Inc. is based in Parsippany, New Jersey.
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