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    Default PCRX - Pacira Pharmaceuticals



    Pacira Pharmaceuticals, Inc. (Pacira), formerly Pacira, Inc., is the holding company for the Company’s California operating subsidiary of the same name, which it refers to as PPI-California. The Company is a specialty pharmaceutical company focused on the development, commercialization and manufacture of pharmaceutical products, based on its DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. Its product candidate EXPAREL is a long-acting bupivacaine (anesthetic/analgesic) product for postsurgical pain management. EXPAREL provides analgesia for up to 72 hours post-surgery. EXPAREL consists of bupivacaine encapsulated in DepoFoam. DepoFoam, its extended release drug delivery technology, is the basis for its commercial products: DepoCyt(e) and DepoDur, which it manufactures for its commercial partners. Its product portfolio and product candidate pipeline include EXPAREL, DepoCyt, DepoDur, DepoNSAID and DepoMethotrexate.

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    Default Re: PCRX - Pacira Pharmaceuticals


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    Default Re: PCRX - Pacira Pharmaceuticals


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    Default Re: PCRX - Pacira Pharmaceuticals

    IMO, this one is a no brainer... float 5.2M... Bupivacaine encapsulated in DepoFoam. Read the DD blog.

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    Default Re: PCRX - Pacira Pharmaceuticals

    That chart is funny... am i the only one enjoying the ride?

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    Super Moderator Adam's Avatar
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    Default Re: PCRX - Pacira Pharmaceuticals

    Quote Originally Posted by PhaseIII View Post
    That chart is funny... am i the only one enjoying the ride?
    A little lonely in here mate! Up 50% odd in a week. Not bad at all. Looks a little toppy at the moment but what a ride it certainly has been. Congrats!

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    Default Re: PCRX - Pacira Pharmaceuticals

    Quote Originally Posted by Adam View Post
    A little lonely in here mate! Up 50% odd in a week. Not bad at all. Looks a little toppy at the moment but what a ride it certainly has been. Congrats!
    Nope, not the only one. I saw this tip on your FDA calendar Adam and bought at $8 and sold everything at 11. Your website is very informative Adam, thanks.

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    Greed is Good! Snake Champion, Asteroids Champion Superfly's Avatar
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    Default Re: PCRX - Pacira Pharmaceuticals

    May 17, 2011--PACIRA PHARMACEUTICALS, INC. ANNOUNCES PHASE 3 EXPAREL™ DATA PRESENTATION

    Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that positive results from its Phase 3 study evaluating EXPAREL™ in patients following hemorrhoidectomy will be presented at the 2011 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Vancouver, British Columbia. Results from this multicenter, randomized, double-blind, parallel-group, placebo-controlled study demonstrated that patients experienced less pain and a reduction in opioid use for 72 hours following a single injection of EXPAREL at the end of the surgical procedure. This is the first time this study data has been presented at a major North American medical meeting.

    The poster presentation, titled "Extended-Release Multivesicular Liposome Bupivacaine (EXPAREL™) Is Superior to Placebo for Post-Hemorrhoidectomy Pain Reduction," will be presented by Dr. Stephen R. Gorfine, clinical professor of surgery in the Division of Colorectal Surgery at The Mount Sinai Medical Center, on Tuesday, May 17, 2011 at 11:30 a.m. EDT.

    "These Phase 3 data demonstrate that the median time to first opioid rescue for patients treated with EXPAREL following hemorrhoidectomy was significantly longer than those treated with placebo," said David Stack, president and CEO of Pacira Pharmaceuticals. "Patients in this study underwent excisional hemorrhoidectomy using the Milligan-Morgan technique, a painful soft tissue surgery. We believe that these data coupled with our positive Phase 3 data from our bunionectomy trial will help support the potential utility of EXPAREL in a clinical setting and build important mindshare among key opinion leaders. This is the first time that these Phase 3 data are being presented at a North American medical meeting and we believe this is another important milestone as we execute on our clinical and pre-commercial strategies."

    Key findings from this study include:

    The study met its primary endpoint with a statistically significant reduction in cumulative pain score in patients receiving EXPAREL compared to placebo (p<0.0001).
    A total of 189 patients were treated at 12 clinical sites in Europe.
    The percentage of patients who were entirely opioid free was higher (p<0.0008) with EXPAREL than with placebo.
    The median time to first opioid rescue was 14 hours and 20 minutes in the EXPAREL group, more than 10 times longer than the placebo group (1 hour and 10 minutes) (p<0.0001).
    EXPAREL patients consumed statistically significantly less opioid rescue medication through 72 hours compared to the placebo group (p=0.0006).

    In addition, the study showed that EXPAREL was well tolerated, with the incidence of adverse events (AEs) similar to placebo. GI side effects, commonly associated with opioid use, were reduced in the EXPAREL group compared to placebo, and there were no serious adverse events (SAEs) reported in patients receiving EXPAREL. Overall, 94.7% of patients treated with EXPAREL were "satisfied" or "extremely satisfied" with their postsurgical analgesia at 72 hours compared with 73.9% in the placebo group (p<0.0007).

    There were no deaths or withdrawals due to an AE in the study. There was one SAE (mild thrombophlebitis), which occurred in a patient who had received placebo, and was resolved the next day after treatment. The most common AEs experienced were gastrointestinal in nature, occurring in 8.4% of EXPAREL patients and 13.8% of placebo patients.

    For more information or to view the full poster, please visit the scientific presentations page located in the investors and media section on the Pacira website at Pacira Pharmaceuticals, Inc..

    PR-USA.net - Pacira Pharmaceuticals, Inc. Announces Phase 3 EXPAREL™ Data Presentation at the American Society of
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    Default Re: PCRX - Pacira Pharmaceuticals

    Nice data released today

    Key safety findings from these studies include:

    823 patients were exposed to EXPAREL at doses from 75 mg to 600 mg across ten wound infiltration studies and five surgical procedures
    Only 32.9% of patients who received EXPAREL at a dose of 300 mg experienced a treatment emergent adverse event (TEAE), 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
    The most common TEAEs experienced were gastrointestinal in nature, and occurred in approximately 43% of EXPAREL patients, compared to 49% of bupivacaine patients. The most common adverse events were nausea, vomiting and constipation
    TEAEs generally increased with an increasing dose of either bupivacaine or EXPAREL
    Key efficacy findings from these studies include:

    823 patients were exposed to EXPAREL at doses from 75 mg to 600 mg in both soft-tissue and orthopedic models across five surgical procedures: hemorrhoidectomy, bunionectomy, breast augmentations, total knee arthroplasty, and inguinal hernia repair
    EXPAREL demonstrated statistically significant lower pain intensity in the two pivotal trials, with p </=0.0005 compared to placebo at the primary endpoint
    EXPAREL demonstrated a statistically significant lower (p </=0.05) opioid usage in those trials, including a:
    Delay in the need for opioids
    Decrease in the amount of opioids required
    Increase in the number of patients able to avoid opioids entirely
    Investors & Media - RSS Content - Pacira Pharmaceuticals, Inc.

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    Default Re: PCRX - Pacira Pharmaceuticals

    Pacira Pharmaceuticals, Inc. Appoints Two Life Sciences Industry Veterans to Its Board of Directors

    Laura A. Brege and Paul J. Hastings bring more than 50 years of financial, operational and commercial expertise to the board



    PARSIPPANY, N.J. June 2, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX), an emerging specialty pharmaceutical company, today announced the appointments of Laura A. Brege and Paul J. Hastings to its board of directors. Together, Brege and Hastings bring more than five decades of biotechnology and pharmaceutical industry experience with both privately-held and publicly-traded companies. Pacira also announced today that Carl L. Gordon, Ph.D., a founding general partner of OrbiMed, will be stepping down from the board. With these appointments, the board membership has been expanded from seven to eight.
    "We are excited to welcome Laura and Paul to our board and believe that their unique perspectives and relevant experience will be immediately beneficial to our team," said David Stack, president and chief executive officer of Pacira Pharmaceuticals. "With more than 50 years of clinical development, commercial, financial and operational experience in the pharmaceutical and biotechnology industries, we believe their insights will prove particularly valuable as we continue to mature as a company. We are executing our pre-commercial strategy for EXPAREL™ in preparation for its potential approval by the U.S. FDA later this year and we believe Laura and Paul's contributions will strengthen our capabilities as we move forward on our roadmap toward success. At the same time, we wish to thank Carl Gordon for his dedicated service on the board over the years. His insights and guidance have been valuable and have played an important role in our ability to execute successfully on our strategic plan."
    Ms. Brege serves as executive vice president, corporate affairs for Onyx Pharmaceuticals, whose lead product, Nexavar® (sorafenib), has been approved in more than 100 countries for the treatment of liver cancer. In this role, Ms. Brege is responsible for the oversight of all external relationships including medical and scientific affairs, government affairs and public affairs. Previously, Ms. Brege held the roles of chief operating officer and executive vice president and chief business officer for Onyx. In these roles, she oversaw the expansion of key corporate capabilities and strengthened the company's financial position by significantly adding to its cash reserves. Prior to joining Onyx in 2006, Ms. Brege was a general partner at Red Rock Capital Management, a venture capital firm, and senior vice president and chief financial officer at COR Therapeutics. Ms. Brege earned her undergraduate degree from Ohio University and has an MBA from the University of Chicago.
    Mr. Hastings has served as president and chief executive officer of OncoMed Pharmaceuticals since January 2006. Prior to joining OncoMed, Mr. Hastings was president and chief executive officer of QLT, Inc. Before this role, Mr. Hastings served as president and chief executive officer of Axys Pharmaceuticals, which was acquired by Celera Corporation in 2001. Prior to Axys, Mr. Hastings was president of Chiron Biopharmaceuticals and also held a variety of management positions of increasing responsibility at Genzyme Corporation, including president of Genzyme Therapeutics Europe and president of Worldwide Therapeutics. Mr. Hastings currently serves as chairman of the board of the Bay Area Biosciences Association (Bay Bio) and serves on the executive committee of the board of directors of the Biotechnology Industry Association. He received a Bachelor of Science degree in pharmacy from the University of Rhode Island.
    "With our recent initial public offering and our new drug application submission to the Food and Drug Administration, we have entered a new phase of development as a company," said Fred Middleton, chairman of the board of Pacira Pharmaceuticals. "We are pleased to attract additional experienced talent to Pacira's board of directors. We believe that Laura and Paul will together bring important commercial leadership to the board as we approach our upcoming PDUFA (Prescription Drug User Fee Act) date and the potential launch of EXPAREL™ later this year. We look forward to incorporating Laura's and Paul's insights into the execution of the Company's strategy for our planned product launch and rapid growth in future periods."

    Pacira Pharmaceuticals, Inc. Appoints Two Life Sciences Industry Veterans to Its Board... -- PARSIPPANY, N.J. June 2, 2011 /PRNewswire/ --
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    Default Re: PCRX - Pacira Pharmaceuticals

    hmmm

    Pacira Pharmaceuticals, Inc. Announces FDA Extension of EXPAREL PDUFA Target Date by Three Months - Yahoo! Finance

    PARSIPPANY, N.J., June 14, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., (Nasdaq:PCRX - News), an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) by three months. The new PDUFA goal date is October 28, 2011.

    The FDA requested additional information from Pacira, which the company has submitted. The FDA determined that this information constituted a major amendment. The agency has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide the FDA time to complete the review.
    Sold all mine couple weeks ago at 14.25

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    Default Re: PCRX - Pacira Pharmaceuticals

    This is looking attractive right now in the high 8's lower 9's ....

    Pacira Pharmaceuticals, Inc. Reports Second Quarter 2011 Financial Results

    As of June 30, 2011, Pacira had unrestricted cash, cash equivalents and short term investments of $47.2 million

    Cash used in operating activities and for the purchase of fixed assets used in investing activities ("cash burn") was approximately $17 million for the six months ended June 30, 2011

    Pacira is updating its expectation for cash burn for the fourth quarter of 2011 to approximately $15 million from its previous expectation of $25 million. This fourth quarter 2011 cash burn expectation is based upon the assumption that Pacira will commence the launch of EXPAREL in the first quarter of 2012, and therefore does not include a $10 million milestone to Skye Pharmaceuticals which will be due upon the first commercial sale of EXPAREL.

    Upcoming Activities
    Pacira expects to present at the following investor conferences:
    Wedbush PacGrow Healthcare Biotech Conference, August 16 in New York
    UBS Global Life Sciences Conference, September 19-21, in New York

    Pacira expects to have a presence at the following medical meetings:
    American Society of Plastic Surgeons (ASPS), September 23-27, in Denver, Colo.
    American College of Clinical Pharmacy (ACCP), October 16-19, in Pittsburg, Pa.
    American College of Surgeons (ACS), October 23-27, in San Francisco, Calif.


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