10450 Science Center Drive
San Diego, CA 92121
(858) 625 2424
5 Sylvan Way
Parsippany, NJ 07054
(973) 254 3560
Novel Local Analgesic Results in Sustained Plasma Concentrations Significantly Reducing Postoperative Pain
Parsippany, NJ, Dec. 14, 2008 -- A Phase II trial of a single intraoperative administration of EXPAREL (DepoBupivacaine) resulted in significantly reduced pain with activity in the first 8 to 24 hours following surgery, when pain is generally greatest, compared to conventional treatment. The results of the multicenter, randomized, double-blind study were presented in a poster at the Annual Postgraduate Assembly in Anesthesiology in New York City today, by lead investigator Richard Langford, MD, FRCA, Pain and Anaesthesia Research Centre, St. Bartholomew’s Hospital, London, UK.
Dr. Langford indicated that EXPAREL provided safe and well-tolerated analgesia with normal wound healing in all patients and noted that the study also showed:
In addition, the study demonstrated dose-proportional sustained plasma concentrations which support the prolonged local release of bupivacaine.
Presenting the results, Dr. Langford stated, “In addition to significantly lowering pain scores with activity during the 8 to 24 hours after administration, EXPAREL also showed trends of decrease in the number of patients using opioids and a decrease in total opioid consumption. This is an important finding as lowering opioid usage can spare patients from side effects, such as sedation, nausea, vomiting and respiratory depression, that can adversely affect their recovery.”
EXPAREL, a proprietary product of Pacira Pharmaceuticals, Inc., is a novel long-acting,sustained-release formulation of bupivacaine HCL, a local anesthetic widely used for treating postoperative pain. The dose-escalating study evaluated the efficacy, safety, and pharmacokinetics of EXPAREL compared to bupivacaine HCL in 76 adult male patients (age ranges 48 to 63) in 10 hospitals in the UK and Australia. Subjects were randomized into one of four cohorts and intraoperatively administered either 175mg, 225mg, 300mg or 325mg of EXPAREL or 100mg bupivacaine HCL around the surgical wound by infiltration immediately before closure.
Safety assessments reported in the poster found EXPAREL to be safe and well-tolerated. Wound healing was normal in all EXPAREL subjects with no significant differences between cohorts. Adverse events were generally mild to moderate with no significant differences between cohorts and no serious adverse events were attributed to the study drug.
Inguinal hernia repair is one of the most common operations in routine surgical practice. In the U.S., more than 600,000 procedures are performed annually with a majority performed on an out-patient basis, according to the National Center for Health Statistics.
The Potential of EXPAREL
“The anesthesiology and surgical community recognizes the need for new approaches to postoperative pain management and welcomes the potential advance EXPAREL presents in overcoming limitations of conventional bupivacaine formulations,” said Ronald Burch, M.D, PhD, Chief Medical Officer, Pacira. “EXPAREL, currently in late Phase III clinical development, is being studied in several different types of surgical procedures where postoperative pain management is especially problematic and where the need for prolonged analgesia via a single administration can provide a significant improvement in pain relief, especially during the first 72-hours following surgery when pain is the most intense.”
EXPAREL is the latest product to benefit from Pacira’s proprietary sustained-release DepoFoam® technology. DepoFoam technology is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. It achieves this by encapsulating the drug in multivesicular liposomal particles which then release the drug over a desired period of time without altering the drug molecule. DepoFoam is a proven technology that is already used in two commercially available products in the U.S. and Europe.
About Pacira
Pacira Pharmaceuticals, Inc. is an acute care specialty pharmaceutical company founded in March, 2007 through the acquisition of the former SkyePharma PLC injectable business, for which an experienced management team was assembled to address the needs of the acute care market. The company's most advanced product, EXPAREL™ (DepoBupivacaine), a bupivacaine-based product intended to deliver postoperative pain relief by infiltration, is in late Phase III clinical development. Pacira will also study EXPAREL for nerve block, non-surgical pain such as long bone fracture and for intraarticular injection. EXPAREL benefits from the proprietary DepoFoam Technology owned by Pacira. Two other DepoFoam-based products -- DepoDur® and DepoCyt/DepoCyte® -- are marketed by partners in several global territories. The DepoFoam technology also forms the basis of multiple development projects providing Pacira an opportunity to expand its pipeline. Pacira owns two cGMP production facilities which produce the two approved products, EXPAREL clinical development and all pipeline materials.
Additional information about Pacira is available at www.pacira.com.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the preliminary results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Editor's Notes:
Pacira Contact:
Taunia Markvicka Vice President, Commercial Development
973-254-3565
New Sustained-Release Analgesic Significantly Reduces Postop Pain, Opioid Use, and Reduces Opioid Related Adverse Events Compared to Gold Standard Pain Medication
Parsippany, NJ, Dec. 6, 2008 - A Phase II dose escalation study of a single intraoperative administration of EXPAREL™ (DepoBupivacaine) in patients who underwent total knee arthroplasty, or TKA, showed that the novel, sustained-release analgesic effectively and safely controlled moderate-to-severe postoperative pain for over 72 hours, it was reported today in a poster at the Biennial World Congress of the International College of Surgeons in Vienna, Austria. Commenting on the results, Kenneth W. Bramlett, MD, Orthopedic Department, West Alabama Research in Birmingham, Alabama concluded EXPAREL significantly reduced postoperative pain, decreased the use of opioids (therefore lowering associated side effects), and allowed some patients to avoid the use of opioids altogether.
EXPAREL, a proprietary product from Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained-release formulation of bupivacaine, a local anesthetic widely used for treating postoperative pain.
Dr. Bramlett said, "EXPAREL effectively controlled moderate to severe pain for more than 72 hours, with better relief achieved with higher doses and a dose-dependent effect in both analgesia and reduction in opioid rescue." He pointed out the clinical importance of the study outcomes noting that EXPAREL efficacy was statistically significant against bupivacaine, the gold standard of local anesthetics, rather than simply placebo, concluding, "EXPAREL may provide safe and effective, prolonged pain relief and an opioid-sparing alternative to currently available local analgesics."
Findings as reported in the poster include:
The multi-center, double-blind, randomized Phase II study used a parallel-group, active-control format to evaluate the efficacy and safety of EXPAREL for prolonged postoperative analgesia. Either a single intraoperative administration of EXPAREL or active control was given via local infiltration to 103 adult patients undergoing TKA in 5 centers across the U.S. and Europe.
TKA is the leading orthopedic surgery in the U.S. with approximately 534,000 procedures performed annually according to the National Center for Health Statistics. It is expected that the number of total knee replacement procedures will increase as our population continues to age.
The Potential for EXPAREL
EXPAREL is a novel formulation of bupivacaine designed to provide effective, safe, prolonged (72 hours) postoperative pain relief in a single administration. Currently available local anesthetics typically have short (about 6 to 8 hours) duration of action resulting in limited pain relief in the first few days following surgery when pain is the most intense.
"The results of this study clearly demonstrate the potential of EXPAREL in fulfilling this unmet need," said Ronald Burch, M.D, PhD, Chief Medical Officer, Pacira. "EXPAREL represents an important advance in pain control that allows for extended delivery of bupivacaine, a well-characterized analgesic with a long-established efficacy and safety record. We look forward to sharing the results of multiple phase II and III clinical trials across a broad range of surgical procedures."
EXPAREL, currently in late Phase III clinical development, is being studied in several different types of surgical procedures where postoperative pain management is especially problematic. It is the latest product to benefit from Pacira Pharmaceutical's proprietary sustained-release DepoFoam® technology. DepoFoam technology is designed to address the limitations of widely known and used drugs by enhancing their dosing and/or administration profile. It achieves this by encapsulating the drug in multivesicular liposomal particles which then release the drug over a desired period of time without altering the drug molecule. DepoFoam is a proven technology that is already used in two commercially available products in the U.S. and Europe.
About Pacira
Pacira Pharmaceuticals, Inc. is an acute care specialty pharmaceutical company founded in March, 2007 through the acquisition of the former SkyePharma PLC injectable business, for which an experienced management team was assembled to address the needs of the acute care market. The company's most advanced product, EXPAREL™ (DepoBupivacaine), a bupivacaine-based product intended to deliver postoperative pain relief by infiltration, is in late Phase III clinical development. Pacira will also study EXPAREL for nerve block, non-surgical pain such as long bone fracture and for intraarticular injection. EXPAREL benefits from the proprietary DepoFoam Technology owned by Pacira. Two other DepoFoam-based products -- DepoDur® and DepoCyt/DepoCyte® -- are marketed by partners in several global territories. The DepoFoam technology also forms the basis of multiple development projects providing Pacira an opportunity to expand its pipeline. Pacira owns two cGMP production facilities which produce the two approved products, EXPAREL clinical development and all pipeline materials.
Additional information about Pacira is available at www.pacira.com.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the preliminary results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Editor's Notes:
Pacira Contact:
Taunia Markvicka Vice President, Commercial Development
973-254-3565
Parsippany, NJ, October 2, 2008 – Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, today announced the addition of a key senior executive to the company’s management team. David St. Peter, M.D. joins Pacira as Vice President of Medical Education and Scientific Affairs. Dr. St. Peter was previously with inVentiv Health where he held several senior management positions since 2001, most recently serving on their Executive Team as president of The Selva Group, LLC, a medical education and event management company. In addition to industry positions at Marion Merrell Dow and Merck, Sharp & Dohme, he is in private practice and continues to see patients in the acute care setting as a Hospitalist.
“Dr. St. Peter brings a clear understanding of the critical elements required for successful late-phase market development in the institutional setting. In addition to working closely with our R&D, clinical and commercial teams as we prepare for a successful launch of DepoBupivacaine, we expect his contributions to be broad-based throughout Pacira’s overall commercial program,” commented chief executive officer Dave Stack.
Dr. St. Peter holds an M.D. from Kansas University Medical Center and a B.S. from the University of Kansas. He completed an internship in surgery at the University of Missouri and St. Lukes Hospital and a residency in medicine at Baptist Medical Center. He is an active member of the AMA, Society of Hospital Medicine, ACRP, APPI, AAFP, Alpha Omega Alpha, Global Alliance for Medical Education (GAME) and the American Medical Writers Association. St. Peter holds active medical licenses in two states and is board certified.
About Pacira
Pacira is an acute care specialty pharmaceutical company with a primary focus on developing products which satisfy the needs of our customers in the institutional marketplace. The Company utilizes DepoFoam® delivery technology to cost-effectively improve patient care through enhanced dosing and administration profiles. Currently, the Company is developing DepoBupivacaine™ in phase III clinical studies for postsurgical pain. Revenues are generated from two approved products which are marketed by partners: DepoCyt® for lymphomatous meningitis and DepoDur® for post-surgical pain. Additional information about Pacira is available at www.pacira.com.
This press release contains forward looking statements, which involve risks and uncertainties within the meaning of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ materially from the forward looking statements discussed in this press release. These forward looking statements include risks and uncertainties that current or future collaboration will prove to be commercially successful.
Parsippany, NJ, August 6 2008 - Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, today announced the addition of a key senior executive to the company's management team. James S. Scibetta, joins Pacira as the Chief Financial Officer. Mr. Scibetta brings more than 20 years of financial leadership experience in private and public companies as well as investment banking to Pacira. Most recently he has been consulting to Genzyme Corporation (NASDAQ: GENZ) following his instrumental role as CFO of Bioenvision Inc. (NASDAQ: BIVN) in its 2007 sale to Genzyme for $345 million. Prior to his tenure at Bioenvision Mr. Scibetta was EVP and CFO of Merrimack Pharmaceuticals, Inc. where he aided the company in raising over $140 million of equity and debt capital. Mr. Scibetta is a Member of the Board of Directors and Chairman of the Audit Committee of both Labopharm Inc. (NASDAQ: DDSS) and Nephros Inc. (Amex: NEP). Prior to his life science company executive tenures, Jim held senior investment banking positions at PaineWebber and Shattuck Hammond Partners where he was responsible for sourcing and executing capital raising, strategic advisory and mergers & acquisitions transactions for a broad base of public and private technology-based healthcare companies encompassing businesses of biotechnology, pharmacy benefits management, CRO, health and wellness benefits management, disease management, evidenced-based medicine and others.
Pacira President and CEO Dave Stack stated, "Jim brings outstanding experience and financial leadership with a strategic perspective focused on value creation to Pacira. We expect his contributions to enhance our organizational management, growth, and capital markets strategic initiatives."
About Pacira
Pacira is an acute care specialty pharmaceutical company with a primary focus on developing products which satisfy the needs of our customers in the institutional marketplace. The Company utilizes DepoFoam® delivery technology to cost-effectively improve patient care through enhanced dosing and administration profiles. Currently, the Company is developing DepoBupivacaine™ in phase III clinical studies for postsurgical pain. Revenues are generated from two approved products which are marketed by partners: DepoCyt® for lymphomatous meningitis and DepoDur® for post-surgical pain. Additional information about Pacira is available at www.pacira.com.
This press release contains forward looking statements, which involve risks and uncertainties within the meaning of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ materially from the forward looking statements discussed in this press release. These forward looking statements include risks and uncertainties that current or future collaboration will prove to be commercially successful.
Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, today announced the appointment of a new Board member and the addition of a key senior executive to the company’s management team. Gary Pace, Ph.D, joins the Board of Directors as a seasoned biopharmaceutical executive with more than 30 years of experience. Dr. Pace brings his development and commercial experience to Pacira as the founder and past Chairman and CEO of QRx Pharma Ltd (ASX: QRX), as well as holding director and chairman positions for several specialty pharmaceutical companies. Bill Kirkpatrick, Ph.D. joins Pacira as Vice President, Compliance. Dr. Kirkpatrick brings 30 years of medical regulatory and quality assurance experience to Pacira. He has been instrumental in leading several product approvals through the FDA for both specialty pharmaceutical and medical device companies including; Artes Medical, Baxter, Chiron Ophthalmics, and ICN Pharmaceucticals. Dr. Pace joins Pacira’s six existing Board members, including Chairman Fred Middleton, Sanderling Ventures; Luke Evnin, Ph.D., MPM Capital; Carl Gordon, Ph.D., Orbimed; John P. Longenecker, Ph.D., Favrille; Dave Stack, Pacira President and CEO; and Andreas Wicki, HBM Partners.
Pacira President and CEO Dave Stack stated, “Bill and Gary bring outstanding experience and leadership to Pacira. We expect their contributions to enhance the development and commercialization of DepoBupivacaine™ for post-surgical pain as well as advance our clinical pipeline of DepoFoam® technology-based products. With the expertise resident in our Board and our management team, we are well positioned to grow our proprietary product portfolio and our company, and thereby build significant value for patients, partners and all our stakeholders.”
About Pacira
Pacira is an acute care specialty pharmaceutical company with a primary focus on developing products which satisfy the needs of our customers in the institutional marketplace. The Company utilizes DepoFoam® delivery technology to cost-effectively improve patient care through enhanced dosing and administration profiles. Currently, the Company is developing DepoBupivacaine™ in phase III clinical studies for postsurgical pain. Revenues are generated from two approved products which are marketed by partners: DepoCyt® for lymphomatous meningitis and DepoDur® for post-surgical pain. Additional information about Pacira is available at www.pacira.com.
This press release contains forward looking statements, which involve risks and uncertainties within the meaning of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ materially from the forward looking statements discussed in this press release. These forward looking statements include risks and uncertainties that current or future collaboration will prove to be commercially successful.
Pacira Pharmaceuticals, Inc. today announced a collaboration with Amylin Pharmaceuticals, Inc. for the development of sustained release injectable products based on the DepoFoam® technology platform from Pacira. The companies will work together to enhance the dosing profile for compounds within Amylin’s early research and development pipeline. The goal of the collaboration is to develop multiple products based on sustained release, subcutaneous injection.
Dave Stack, President and CEO of Pacira stated, “In addition to our own lead development candidate, DepoBupivacaine™, we believe that delivery of Amylin’s compounds using the DepoFoam® technology would create significant value for patient care, our partners, and Pacira”.
“Pacira’s DepoFoam® technology is an attractive delivery system and Amylin is excited to apply this technology to our peptide and protein therapeutics platform,” said Christopher Rhodes, Ph.D., Executive Director, Pharmaceutical Sciences of Amylin. “This collaboration fits well with Amylin’s research and development activities, which leverage our expertise in metabolism to develop potential therapies for diabetes and obesity.”
Terms of the agreement are not disclosed at this time.
About Pacira
Pacira is an acute care specialty pharmaceutical company with a primary focus on developing Products which satisfy the needs of our customers in the institutional marketplace. The Company utilizes DepoFoam® delivery technology to cost-effectively improve patient care through enhanced dosing and administration profiles. Currently, the Company is developing DepoBupivacaine™ in phase III clinical studies for postsurgical pain. Revenues are generated from two approved products which are marketed by partners: DepoCyt® for lymphomatous meningitis and DepoDur® for post-surgical pain. Additional information about Pacira is available at www.pacira.com.
This press release contains forward looking statements, which involve risks and uncertainties within the meaning of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ materially from the forward looking statements discussed in this press release. These forward looking statements include risks and uncertainties that current or future collaboration will prove to be commercially successful.
Pacira Pharmaceuticals, Inc., a leader in sustained release injectable technologies, today announced that David M. Stack has been selected as President, Chief Executive Office, and member of the Board of Directors.
Mr. Stack is currently the CEO and founding partner of Stack Pharmaceuticals, Inc., a commercialization, marketing and strategy firm serving emerging healthcare companies. He also is an Executive Partner at MPM Capital.
“David Stack is a proven, successful pharmaceutical executive with an exceptional blend of leadership and business skills”, said Fred Middleton, Chairman of the Board. “We are confident that he is the ideal person to lead Pacira by enhancing the revenue opportunities of our existing commercial products, DepoDur and DepoCyt, optimizing the development and launch of our key asset, DepoBupivacaine, while further exploring the untapped promise of our proprietary drug delivery technologies.”
Commenting on his appointment, Mr. Stack said, “I look forward to joining Pacira at this exciting time in its history. With strong financial backing by a pharmaceutical experienced syndicate, Pacira now has the opportunity to realize its potential by growing into a fully integrated, successful commercial company.”
From September 2001 until August 2004, Mr. Stack was President, Chief Executive Officer and Director of The Medicines Company (NASDAQ:MDCO). Prior to The Medicines Company he was the CEO of Stack Pharmaceuticals, Inc. where MDCO was one of the primary customers.
From May 1995 to December 1999, Mr. Stack served as the President and General Manager of Innovex, Inc. and was responsible for the Americas. Innovex, Inc. is a commercial solutions company offering a full range of marketing, sales and clinical development capabilities to pharmaceutical and biotechnology customers.
Mr. Stack’s prior experience also includes serving as the Vice President of Business Development and Marketing for Immunomedics, Inc. (NASDAQ:IMMU), as well as multiple senior business management positions at Roche Labs. Before he entered the commercial pharmaceutical sector, Mr. Stack was a retail and hospital pharmacist for three years after graduating from Albany College of Pharmacy.
He also holds a BS in Biology from Siena College. Dave was recognized as the Ernst and Young Entrepreneur of the Year in 2003 (New Jersey Healthcare). He is a Director of Bio-Imaging Technologies, Inc. (NASDAQ:BITI), Medsite, Inc., PepTx, Inc. and QRxPharma Pty Ltd.
Pacira Pharmaceuticals, Inc. today announced that Orphan Australia Pty Ltd, an Australian owned pharmaceutical company dedicated to providing novel, highly specialized pharmaceuticals, has been granted registration approval by the Therapeutic Goods Administration for DepoDur® in Australia. DepoDur, which was developed by and licensed from Pacira Pharmaceutical, Inc. and utilizes Pacira’s DepoFoam® technology, is a novel, single dose modified–release formulation of morphine.
The approved indication in Australia is “for the relief of post-operative pain, following major orthopedic, abdominal or pelvic surgery via the lumbar epidural route, at a maximum recommended dose of 10mg. Appropriate monitoring must be maintained for 48 hours.”
A single injection of DepoDur into the lumbar epidural space may provide pain relief for up to 48 hours, following major orthopaedic, abdominal or pelvic surgery without the restrictions and potential complications associated with an indwelling epidural catheter.
“We are pleased to add an innovative product like DepoDur to our growing hospital product portfolio” said John Michailidis, the Chief Executive Officer of Orphan Australia. “It fits well with our philosophy of providing specialists with novel, highly specialized products which otherwise would not be available to the Australian market. We believe DepoDur will play an important role in managing post-operative pain in selected types of surgery”.
DepoDur will be available in Australia from February 2008.
Flynn Pharma Limited, a specialty pharmaceutical company focused on acquiring and commercializing proprietary products in secondary healthcare and related markets, today announced it has acquired exclusive marketing and distribution rights to DepoDur® (morphine sulphate extended release liposome injection) for Europe and a number of other markets from San Diego-based Pacira Pharmaceuticals.
Pacira Pharmaceuticals, a former business unit of SkyePharma, PLC, is an independent private company focused on developing and manufacturing controlled-release injectable products based on their DepoFoam® and Biosphere® drug delivery platforms.
DepoDur, which utilizes the DepoFoam technology, is a novel, single dose extended-release formulation of morphine. A single injection of DepoDur into the lumbar epidural space may provide pain relief for up to 48 hours following major surgery without the restrictions and potential complications associated with an indwelling epidural catheter. DepoDur is the only opioid approved in Europe (UK, MHRA, 2006) for epidural use. In the US, DepoDur is marketed by EKR Therapeutics, Inc.
“We are pleased to add an innovative product like DepoDur to our growing hospital product portfolio.” said David Walters, Director of Flynn. “DepoDur is consistent with, and complementary to, our model of adding products for the secondary healthcare markets.”
Fred Middleton, Pacira’s Chairman of the Board commented, “In DepoDur, Flynn Pharma will have a new foundation on which to continue building their hospital franchise. Through the use of Pacira’s extended-release injectable technology, DepoFoam, DepoDur supports the sustained release of epidural morphine to provide up to 48 hours of post-surgery pain relief, when most pain can then be satisfactorily controlled with oral analgesics. In addition, there are an estimated 5 million surgical procedures in Europe where DepoDur can be used to manage post-operative pain in hospitalised patients. With a proven technology, a large market opportunity, and Flynn’s strong presence in hospitals, we look forward to having Flynn as our commercial marketing partner expanding DepoDur’s use into Europe.”
David Walters further noted, “Flynn is starting the launch process, including meetings with key opinion leaders, and we expect to have our UK sales force fully supporting DepoDur early in 2008.” He concluded, “We are very optimistic about Flynn’s growth prospects in 2008 and beyond as we plan DepoDur’s market penetration in Europe. We are actively planning to take the product beyond the UK through the mutual recognition procedure and have initiated the search and selection of marketing partners in Europe. This is the second new product Flynn will have launched into the hospital market following the successful launch of Medikinet® XL in March 2007.”
EKR Therapeutics, Inc., a specialty pharmaceutical company focused on acquiring, developing, and commercializing proprietary products to enhance patient quality-of-life in the acute care setting, today announced it has acquired exclusive marketing and distribution rights to DepoDur® (morphine sulfate extended release liposome injection) for the Americas from San Diego-based Pacira Pharmaceuticals who will continue to manufacture the product.
Formerly a business unit of SkyePharma, PLC, Pacira Pharmaceuticals is an independent private company focused on developing and manufacturing controlled-release injectable products based on their DepoFoam® and Biosphere® drug delivery platforms.
DepoDur, which utilizes the DepoFoam technology, is the only extended-release opioid that is approved by the Food and Drug Administration (FDA) for epidural use. A single injection of DepoDur into the lumbar epidural space may provide pain relief for up to 48 hours following major surgery without the restrictions and potential complications associated with an indwelling epidural catheter.
“Pacira’s technology platform significantly enhances the value potential of DepoDur and the product’s characteristics fit exceptionally well with EKR’s acquisition model,” said Howard Weisman, EKR’s Chairman & CEO. “DepoDur is patent protected, addresses an important medical need in our market space, and has growth prospects that can be fully exploited through the application of EKR’s expertise and strengths in the acute care market.”
Fred Middleton, Pacira’s Chairman of the Board commented, “EKR Therapeutics has demonstrated in the past that they possess the strengths to successfully bring a focused marketing and clinician targeting approach to DepoDur to help it reach its full commercial potential. This product was clinically developed as a proprietary treatment by Pacira R&D and it received FDA approval in 2004 for long-acting post-surgical pain management. We welcome EKR’s validation of our technology platform and their promotional support of DepoDur. We look forward to working with EKR as our partner on the expanded commercial marketing of DepoDur.”
Mr. Weisman further noted, “EKR is commencing a number of pre-launch activities, including interacting with opinion leaders, and we expect to fully deploy our sales force in support of DepoDur early next year.” He concluded, “We are very optimistic about EKR’s growth prospects in 2008 as we foresee a ramp up in sales for both DepoDur and Gelclair® and anticipate favorable market synergies between these products.” Gelclair, which is marketed to acute care facilities and cancer centers, is indicated for the management of pain associated with oral lesions of various etiologies, including chemotherapy and radiation induced oral mucositis/stomatitis.
Tong Zhang, Ph.D., Director of Business Development for EKR, added, “Acquiring the rights to DepoDur exemplifies EKR’s strategy of focusing on building a portfolio of premier products in the acute care space.” He further noted, “Our strict acquisition criteria center on innovative products that offer value to healthcare providers and their patients, thus, representing excellent opportunities for EKR to realize strong returns on investment.”
SkyePharma Inc. announced today that the company has changed its name to Pacira Pharmaceuticals, Inc. The name change reflects Pacira’s transformation from a former business unit of SkyePharma PLC to an independent, private company with existing commercial products, a strong product in clinical development, and novel drug delivery technologies for the sustained-release of injectable pharmaceutical products.
Pacira, Inc. (formerly Blue Acquisition Corp.), which is now controlled and funded by a group of life science investment firms, acquired the company divested from its former parent, SkyePharma PLC, in March 2007. The new investor group made the investment in Pacira Pharmaceuticals based on the significant development opportunity of its technology and of DepoBupivacaine™, a sustained-release local analgesic now in clinical development for use in the $5.7 billion postoperative pain market.
Fred Middleton, Managing Director of Sanderling Ventures, and Chairman of Pacira, Inc. stated, “Pacira Pharmaceuticals now has the resources necessary to pursue the commercial potential for DepoBupivacaine™, as well as to deliver on the promise of our proprietary sustained-release technologies, which can be used with a broad range of proteins, peptides, and traditional pharmaceuticals. Our new name, Pacira, reflects strong local commitment of more than a decade as a San Diego based product research and development organization. In the future we plan to consider directly marketing our own products still in development, as well as in-licensing products in core therapeutic areas of interest, such as pain. Pacira will continue to develop new sustained-release injectable products with our two proprietary technologies, either alone or in collaboration with other biotech and pharmaceutical companies.”
Along with the new name, Pacira has developed a new corporate logo and website that can be found at www.pacira.com.
The name change is effective immediately.
EVENTS
PAST EVENTS