Hot Watch List (comments).
PCRX (buy after short)
Pacira Pharmaceuticals Inc is formerly known as Blue Acquisition Corp.
We were incorporated in Delaware under the name Blue Acquisition Corp. in December 2006 and changed our name to Pacira, Inc. in June 2007. In October 2010, we changed our name to Pacira Pharmaceuticals, Inc.
Pacira Pharmaceuticals, Inc. is the holding company for our California operating subsidiary of the same name, which we refer to as PPI-California. On March 24, 2007, MPM Capital, Sanderling Ventures, OrbiMed Advisors, HBM BioVentures, the Foundation for Research and their co-investors, through Pacira Pharmaceuticals, Inc., acquired PPI-California, from SkyePharma Holding, Inc., which we refer to as the Acquisition. PPI-California was known as SkyePharma, Inc. prior to the Acquisition. In this prospectus, the term Predecessor refers to SkyePharma, Inc. prior to March 24, 2007, or the Acquisition Date, and the term Successor refers to Pacira Pharmaceuticals, Inc. and its consolidated subsidiaries.
2/3/2011 6:49:39 AM
Wall Street Journal -- Pacira Pharmaceuticals Inc. generated little interest among investors on its first day of trading Thursday, even after it cut its offering price in half.The company's stock opened at $7 a share on the Nasdaq, flat with its initial public offering price. It sold six million shares, nearly two million more than expected, but at a greatly reduced price. The company had originally set out to sell its stock within a $14 to $16 range.
October 02, 2011 by BiotechInvest
EXPAREL™
EXPAREL™ (bupivacaine extended-release liposome injection) is Pacira’s proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam, both of which are currently used 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.
EXPAREL is designed to extend the duration of analgesia provided by the commonly used local analgesic, bupivacaine. Based on clinical trial data, EXPAREL provides continuous and extended postsurgical analgesia for up to 72 hours*, compared with bupivacaine’s analgesic timeline of 7 hours or less**. Pacira believes EXPAREL will address a significant unmet medical need for a long-acting non-opioid postsurgical analgesic. Pacira believes that the utilization of EXPAREL in the armamentarium of post operative analgesics may reduce the dependence on opioid use in the post operative setting and delay the time to first opioid use so that oral rather than parenteral opioids can be used. This may:
Result in improved patient satisfaction and outcomes;
Minimize breakthrough episodes of pain and significantly reduce the consumption of supplemental opioid medications and;
Simplify postsurgical pain management and reduce hospital cost and staff time on non-patient care, monitoring of infusion pumps, catheters, leading to improved hospital economics
Status
In September 2010, Pacira filed a New Drug Application (NDA), for its lead product candidate, EXPAREL, a long-acting bupivacaine (anesthetic/ analgesic) product for postsurgical pain management. In December 2010, the FDA accepted the NDA for review and notified Pacira that its Prescription Drug User Fee Act (PDUFA) goal date (the date the FDA expects to complete its review of the EXPAREL NDA) is October 28, 2011.
Overall, EXPAREL has demonstrated safety in more than 1,300 subjects, across 21 studies. Most recently, EXPAREL has demonstrated efficacy and safety in two multicenter, randomized, double-blinded, placebo-controlled, pivotal Phase 3 clinical trials in patients undergoing soft tissue surgery (hemorrhoidectomy) and orthopedic surgery (bunionectomy). For more information regarding EXPAREL clinical studies and safety profile, please visit Pacira’s press release archives.
Several Phase 2 studies of EXPAREL™ have been completed and have shown effective pain control in soft tissue and bone surgery, in four different surgical models.
Additional clinical work in nerve block and epidural administration of EXPAREL is planned.
EXPAREL Development Program
EXPAREL has demonstrated efficacy and safety in two multicenter, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trials in patients undergoing soft tissue surgery (hemorrhoidectomy) and orthopedic surgery (bunionectomy). At a pre-NDA meeting in February 2010, the FDA acknowledged that the two pivotal Phase 3 clinical trials conducted by us, in patients undergoing hemorrhoidectomy and bunionectomy surgeries, appeared to be appropriately designed to evaluate the safety and efficacy of EXPAREL. Both trials met their primary efficacy endpoints in demonstrating statistically significant analgesia through 72 hours for the hemorrhoidectomy trial and 24 hours for the bunionectomy trial. Both trials also met multiple secondary endpoints, including decreased opioid use and delayed time to first opioid use. These two pivotal Phase 3 clinical trials formed the basis of the evidence for efficacy in the NDA for EXPAREL.
The safety of EXPAREL has been demonstrated in 21 clinical trials consisting of nine Phase 1 trials, seven Phase 2 trials and five Phase 3 trials. EXPAREL was administered to over 1,300 human patients at doses ranging from 10 mg to 750 mg administered by local infiltration into the surgical wound, and by subcutaneous, perineural, epidural and intraarticular administration. In all 21 clinical trials, EXPAREL was well tolerated. The most common treatment emergent adverse events in the EXPAREL and placebo groups were nausea and vomiting and occurred with similar frequency across the EXPAREL and placebo groups. No signal of any of the central nervous system or cardiovascular system adverse events typically observed with high doses of bupivacaine has been observed with EXPAREL. We conducted two thorough QTc studies that demonstrated that EXPAREL did not cause significant QTc prolongation (a measure of cardiac safety mandated by the FDA for all new products) even at the highest dose evaluated. No events of destruction of articular cartilage, or chondrolysis, have been reported in any of the EXPAREL trials. EXPAREL did not require dose adjustment in patients with mild to moderate liver impairment.
Pivotal Phase 3 Clinical Trials
Hemorrhoidectomy. Our pivotal Phase 3 hemorrhoidectomy clinical trial was a multicenter, randomized, double-blind, placebo-controlled trial conducted in 189 patients at 14 sites in Europe. The study enrolled patients 18 years of age or older undergoing a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique, a commonly used method for surgically removing hemorrhoids. We studied a 300 mg dose of EXPAREL with a primary endpoint of pain control for up to 72 hours with morphine rescue medication available to both trial groups. Additional endpoints included the proportion of pain-free patients, proportion of patients requiring opioid rescue medication, total opioid usage, time to first use of opioid rescue medication and patient satisfaction.
The 300 mg dose of EXPAREL provided a statistically significant 30% reduction in pain (p<0.0001), as measured by the area under the curve, or AUC, of the NRS-R pain scores at 72 hours and all additional time points measured up to 72 hours. The numeric rating scale at rest score, or the NRS-R, is a commonly used patient reported measurement of pain. Under the NRS-R, severity of pain is measured on a scale from 0 to 10, with 10 representing the worst possible pain. The AUC of the NRS-R pain score represents a sum of the patient’s pain measured at several time points using the NRS-R, from time of surgery to the specified endpoint. A lower number indicates less cumulative pain. The p-value is a measure of probability that the difference between the placebo group and the EXPAREL group is due to chance (e.g., p = 0.01 means that there is a 1% (0.01 = 1.0%) chance that the difference between the placebo group and EXPAREL group is the result of random chance as opposed to the EXPAREL treatment). A p-value less than or equal to 0.05 (0.05 = 5%) is commonly used as a criterion for statistical significance.
PCRX already has approved drugs based on DepoFoam® technology:
DepoDur®
DepoDur® (morphine sulfate extended-release liposome injection) is an extended-release, injectable formulation of morphine utilizing Pacira’s DepoFoam® technology. DepoDur is indicated for epidural administration for the treatment of pain following major surgery. DepoDur is designed to provide effective pain relief for up to 48 hours following one epidural injection and has demonstrated improved patient mobility and freedom from indwelling catheters. DepoDur was approved by the FDA in 2004. For more information, please visit www.depodur.com.
In clinical trials, the majority of adverse events reported were typical opioid-related side effects, expected in the surgical populations studied. As with all opioids, the most serious side effect of morphine sulfate is respiratory depression, especially in elderly and debilitated patients, and in those with compromised respiratory function. The most common adverse events (greater than 10%) were decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache, and dizziness.
UK-based drug delivery specialist SkyePharma and US partner Endo Pharmaceuticals say that the US Food and Drug Administration has approved the former's New Drug Application for DepoDur (formerly DepoMorphine), a sustained-release injectable formulation of morphine. The product is indicated for the treatment of pain following major surgery and could be available by the end of 2004, noted Endo.
At the end of last year, SkyePharma submitted an application to the UK Medicines and Healthcare products Regulatory Agency for approval of DepoDur as a treatment for moderate-to-severe post-operative pain (Marketletter December 1, 2003). The company said that, after clearance in the UK, it would seek registration in other European Union countries under the Mutual Recognition Procedure. DepoDur utilizes SkyePharma's proprietary DepoFoam technology (Marketletters passim).
DepoCyt(e)®
DepoCyt(e)® (cytarabine liposome injection) is a sustained-release liposomal formulation of the chemotherapeutic agent cytarabine utilizing Pacira’s DepoFoam® technology. Depocyt(e) is indicated for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma, a cancer of the immune system.
Lymphomatous meningitis can be controlled with conventional cytarabine, but because of the drug’s short half-life, a spinal injection is required twice per week in a hospital setting. Pacira’s DepoFoam formulation has extended the administration of cytarbine from twice weekly to once every two weeks in an outpatient setting. DepoCyt(e) was granted accelerated approval by the FDA in 1999 and full approval in 2007.
About DepoFoam(TM)
DepoFoam(TM) is SkyePharma's proprietary extended-release injectable delivery technology. This is fully commercialised and approved by regulatory agencies in both the USA and Europe. DepoFoam(TM) consists of lipid-based particles containing discrete water-filled chambers dispersed through the lipid matrix. The particles are 10-30 microns in diameter and are suspended in saline. The suspension resembles skimmed milk and can be injected through a fine needle. The water-filled chambers containing active drug account for most of the weight of the particles. The lipids are naturally occurring substances (or close analogues) such as phospholipids and triglycerides. The small amount of lipid is cleared rapidly in the body as the particles deliver their drug payload over a period that can be modified from 1 to 30 days.
Well, PCRX has a good pain drug and advanced technology (taken from other company) to converse an old drug to new one.
The science logic said me to buy PCRX before PDUFA. But "biotech dummy" logic is saying: sell it short at maximum and after CRL buy it at minimum.
There are some alarming signs:
1) FDA already postponed PDUFA for EXPAREL: The first PDUFA date was July 28, 2011
2) FDA didn't ask a panel to vote for EXPAREL
3) PCRX itself was never get any approvals from FDA, all approved drugs were originated from other pharmas
4) drugs based on liposomes usually are not stable (FDA may ask about stability/manufacturing)
5) some phase III clinical trials for EXPAREL failed to meet the primary efficacy endpoints
"Other Clinical Trials
In 2009, we completed two Phase 3 clinical trials comprising 223 patients who received EXPAREL, comparing them to patients who received bupivacaine in a multimodal setting where patients received additional concomitant analgesics. One of these Phase 3 clinical trials was for total knee arthroplasty and the other was for hemorrhoidectomy. Although EXPAREL performed as expected and continued to demonstrate its safety and tolerability, due to the unexpectedly positive results in the control arm, these trials did not meet their primary endpoint. The results of these studies influenced some of the inclusion and exclusion criteria and protocol specified measures used in our successful pivotal Phase 3 clinical trials described above.
Based on the outcome of these two trials, in 2009, we discontinued a Phase 3 clinical trial in breast augmentation early. At the time of discontinuation, we had only enrolled approximately half of the number of patients required to demonstrate statistical significance. EXPAREL demonstrated a positive trend and safety, but did not meet the primary efficacy endpoint. We have collected data on all patients for whom data was available and expect to publish this data in a peer reviewed medical journal."
Conclusions: it's a high risk to buy PCRX before PDUFA, may be it's better to short it because CRL will crash pps to $7 or even less.
PCRX financial situation is not good:
"Since inception, we have incurred significant operating losses. Our net loss was $27.1 million for the year ended December 31, 2010, including research and development expenses of $18.6 million. Our net loss was $31.7 million for the year ended December 31, 2009, including research and development expenses of $26.2 million. We do not expect our currently marketed products to generate revenue that is sufficient for us to achieve profitability because we expect to continue to incur significant expenses as we advance the development of EXPAREL and our other product candidates, seek FDA approval for our product candidates that successfully complete clinical trials and develop our sales force and marketing capabilities to prepare for their commercial launch. We also expect to incur additional expenses to add operational, financial and management information systems and personnel, including personnel to support our product development efforts and our obligations as a public reporting company. For us to become and remain profitable, we believe that we must succeed in commercializing EXPAREL or other product candidates with significant market potential."
Sales of approved drugs are also not impressive:
Disclosure: I don't have any PCRX positions now. May be I will short it before PDUFA.
October 31, 2011 by BiotechInvest
FDA approved PCRX drug and now this company is good for long. Sell off after approval was hard so we will see the the entry point not soon. May be next year and below $6-7 range. So, I sent PCRX to archive .
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