Ambiorix1
09 Jan 2016
Zackx Invesxtment Research rank #1 Pacira Pharmaeuticals gets a Rank #1 (Strong Buy) from Zackx Investment Research. Ambiorix.
Ambiorix1
07 Jan 2016
Almost 250 million ! Jan. 07, 2016 (GLOBE NEWSWIRE article) -- Pacira Pharmaceuticals, Inc. today announced estimated EXPAREL® (bupivacaine liposome injectable suspension) and total revenues for the fourth quarter and full-year 2015. These estimates, which are unaudited, are based on management's preliminary financial analysis."We are pleased with the strong finish to 2015 and the preliminary revenues that benefited from a solid fourth quartera??seasonally the strongest period of the year for procedure volumes," said Dave Stack, chief executive officer and chairman of Pacira. "We are excited to have achieved a resolution with the FDA at the end of the quarter. In 2016, we will refocus our efforts to bolster the Pacira brand through targeted clinical studies, strategic commercial initiatives, and healthcare provider and patient-focused programs that seek to support the EXPAREL and DepoFoam® pipelines, and additional expansion opportunities."Fourth Quarter 2015EXPAREL revenues were an estimated $67.2 million, compared to $59.0 million in the fourth quarter of 2014.Total revenues were an estimated $69.4 million, compared to $61.8 million in the fourth quarter of 2014.Full-Year 2015EXPAREL revenues were an estimated $239.9 million, compared to $188.5 million in 2014.Total revenues were an estimated $249.0 million, compared to $197.7 million in 2014.Pacira will provide final financial results and additional information on the fourth quarter and year-end 2015 performance in the earnings press release and conference call expected in late February.
Ambiorix1
06 Jan 2016
...and in the US 1. JMP Securities initiated coverage on Pacira Pharmaceuticals Inc (provides a lot of royalties to SKP) with a Market Outperform rating. The target price for Pacira is set to $92. Pacira Pharmaceuticals shares closed at $75.63 on Monday.2; …and some Guru investors in the US seem to share the same faith. Mariko Gordon increased her stakes in Pacira during the third quarter. Gordon is the founder of Daruma Capital Management. She started the firm in 1995 with zero assets and now her portfolio is composed of 48 stocks with a total value of $1.6 billion. Clearly not Mrs. Nobody. The fund increased its holding in Pacira by 56.02% with an impact of 0.94% on its total assets. Reason for this is obviously the fact that during the third quarter, EXPAREL revenues grew 19% over the same period last year and the company ended the third quarter of 2015 with cash and cash equivalents, short-term investments and long-term investments of $164.4 million. Gordon is the largest guru shareholder followed by Jim Simons with 0.3% of shares outstanding, Paul Tudor Jones with 0.02% and Ron Baron with 0.02%. All this attention seems to bode well for SKP.Ambiorix.
MetalMuppet
23 Dec 2015
Re: RNS today Excellent rise in SP today
Chicken Lips
23 Dec 2015
Re: RNS today Agreed. Been in and out of SKP and classically when the SP dropped my nerves got the better of me. Still in but a smaller amount. Has been some great news over last few weeks. Looking great.
dave297
23 Dec 2015
RNS today Great news today which bodes well for our future & SP.Perhaps our dismal pas will be put to rest completely & we will be valued for our true potential & thereby avoiding the possibility of a low ball bid.
Ambiorix1
15 Dec 2015
US Nasdaq reaction on this news.. Pacira is up 14.99% so far this morning (in the US) after this good news was announced. A big hurdle is taken away for the extended use of Exparel... so we can expect (with little doubt) a very positive effect on the amount of royalties paid to SKP next year and the years ahead.IMO the SKP share price does not reflect this potential yet. Remember Pacira is also working on an extended use of Exparel. This paves the way for even more royalties. I wonder how long it will take before the SKP rating is revised upwards by the brokers and other institutional investors.... IMO it should be done.Ambiorix.
Ambiorix1
15 Dec 2015
very good news !!!!!!!!! ARSIPPANY, N.J., Dec. 15, 2015 Pacira Pharmaceuticals, Inc today announced that it has achieved an amicable resolution with the United States in its lawsuit filed on September 8, 2015, Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al, 15-cv-07055 (SDNY Sept. 8, 2015)(LAK). The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia. “We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate,” stated Dave Stack, chief executive officer and chairman of Pacira. “This is especially important given the burgeoning U.S. opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting.”The key features of the resolution are as follows:The U.S. Food and Drug Administration (FDA) confirms that EXPAREL has, since its approval on October 28, 2011, been approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.The FDA approved a labeling supplement which amends the EXPAREL Package Insert (PI) to clarify and reinforce that:The use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site;The proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, with the two surgical models utilized in the pivotal trials provided as examples for the purpose of providing general guidance;There was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy study;The description of that duration of effect now includes a graphical representation of the mean pain intensity scores over time for the EXPAREL and placebo groups for the full 72-hour efficacy period, as well as information about median time to first opioid use and percentage of opioid-free patients in each treatment groupEXPAREL may be admixed with bupivacaine—including co-administered in the same syringe—provided certain medication ratios are observed.The September 2014 Warning Letter is formally withdrawn via a “Rescission Letter” from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) to Dave Stack.At the request of Pacira, the Rescission Letter includes FDA guidance related to two key procedures:Infiltration into the transversus abdominis plane (TAP), which is a field block technique covered by the approved indication for EXPARELInfiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions, which is also covered by the approved indication for EXPARELThe United States acknowledges that the rescission of the Warning Letter and approval of the Labeling Supplement reflect the scope of the indication in the NDA that FDA approved on October 28, 2011.
raptor66
09 Dec 2015
Is there a good news around the corner? Time 10:30.Volume 1.2m or mms up to their old tricks?
bamboozled
02 Dec 2015
Re: Flutiform-USA r66: "I wonder if Fluti is kept out of USA as it would directly compete with the GSK products???And in turn GSK provides SKP other business."I don't think this conspiracy theory applies. It is very costly and notoriously difficult to get FDA approval (as d297 mentioned) which is always a massive hurdle ,even if the individual components of fluti are widely known,tried and tested and used in patients for years. Remember GSK contested the patent expiry with Advair/Seretide under the assumption that although the drug is the same, it is the delivery/device that can vary the dosing to the lungs.However,FDA approval would of course be a massive coup for the company and no doubt the SP.
raptor66
02 Dec 2015
Re: Flutiform-USA I wonder if Fluti is kept out of USA as it would directly compete with the GSK products???And in turn GSK provides SKP other business.
dave297
02 Dec 2015
Flutiform-USA I know I have raised this issue before & I appreciate that the US Regulator is a very tough hurdle but surely approval in most countries of the world,growing sales & presumably recognition that Fluti helps sufferers must count for something & 1 of our several "partners" ( eg GSK) may be tempted to acquire our substantial files & research ( for a licence fee) & try & crack the US nut.That said I appreciate that if GSK considered that Fluti could achieve substantial sales in the US they would just buy us,thereby saving £9mill in royalties + all other products , some of which could be sold off) as an old fashioned asset strip.Either way I believe that our SP remains too low,despite the recent positive update
Ambiorix1
26 Nov 2015
expected to be ahead of previous expectations.... Year-end cash is expected to be ahead of the Board's previous expectations....Glad I am I ordered some more a few days ago... the (just to small) little dip could have been the last time we were able to get some SKP shares at this bargain price.Ambiorix.
dave297
26 Nov 2015
Trading Update Looks good to me ,with the exception of the shelving of our sleep product which is not material.Perhaps our SP will be able to recover its momentum with view to our continuing substantial potential & increasing attractiveness to a predator.
Ambiorix1
11 Nov 2015
More on Exparel November 06, 2015 Pacira Pharmaceuticals announces positive data on the use of EXPAREL as a post surgical analgesic following total knee replacement surgery. The study, which compared the use of EXPAREL infiltration to the standard of care in 1,110 patients, found that EXPAREL was associated with significant improvements in a variety of patient and health economic outcomes, including Opioid use, hospital stay and readmission rate. The poster, titled Liposomal Bupivacaine versus Femoral Nerve Block for Post-operative Pain Control following Total Knee Arthroplasty, was presented at the annual meeting of the American Association of Hip and Knee Surgeons being held in Dallas on Nov. 6-8, 2015.In the study, patients who underwent total knee arthroplasty received identical pre-, intra- and postoperative pain management protocols, with the exception of 527 patients who received EXPAREL infiltration in place of a femoral nerve block. The poster's authors compared several patient and cost-related outcomes. Opioid use during hospitalization was significantly reduced in the EXPAREL group. Other key findings included shorter hospital length of stay, lower 30-day all-cause readmission rate, reduced inpatient fall rate and an increased rate of discharge to home."Based on analysis of incorporating liposomal bupivacaine into the postsurgical analgesic protocol following total knee arthroplasty has significant and quantifiable benefits to both the patient and the institution," said Richard Iorio, M.D., professor of orthopaedic surgery at NYU School of Medicine. "The measurable opioid-sparing effect of this new regimen has enabled us to virtually eliminate intravenous patient-controlled analgesia, or PCA, devices from the standard of care in total joint arthroplasty patients, without compromising patient comfort. In addition, we found that the incremental cost of adding this new modality was offset by meaningful savings from shorter anesthesia induction time in the operating room, shorter hospital stays and lower rates of 30-day readmission."(reworked article)Ambiorix
