News Article | October 31, 2016
EWING, N.J., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced the appointment of Fred M. Powell to the position of Senior Vice President, Chief Financial Officer effective October 31, 2016. Mr. Powell has a diversified corporate background including more than 20 years of financial experience within the biotech and pharmaceutical industry. Most recently, Mr. Powell served as Vice President and Chief Financial Officer for Celator Pharmaceuticals, which was a publicly-held biopharmaceutical company engaged in the development of a portfolio of cancer therapies. At Celator, he was responsible for the Company’s accounting, corporate finance and financial planning functions and played an integral role in the sale of Celator to Jazz Pharmaceuticals for over $1.5 billion. Prior to joining Celator, Mr. Powell was the chief financial officer of OraPharma, Inc. where he helped develop and grow the specialty healthcare company with annual sales of approximately $100 million until its acquisition by Valeant Pharmaceuticals in June, 2012. Mr. Powell was also chief financial officer of BMP Sunstone Corporation, a publicly traded U.S. specialty pharmaceutical company with annual sales in excess of $150 million, where he helped guide rapid double-digit growth and its eventual sale to Sanofi-Aventis for $520 million. He also held senior finance and administration positions at Eximias Pharmaceutical Corporation, Innaphase Corporation and ERT. Mr. Powell began his career with KPMG Peat Marwick and is a graduate of Penn State University. Robert F. Apple, President and Chief Executive Officer of the Company, stated, “We are very pleased to have Fred join the executive leadership team at Antares Pharma, bringing with him over 25 years of extensive financial experience, including more than two decades of experience in the healthcare industry. I believe Fred’s arrival will have a positive impact on our future growth, given his track record of successful business transactions in the areas of license agreements, joint ventures and acquisitions.” “I’m very excited to be joining Antares Pharma, and I look forward to making an immediate contribution to the organization.” Mr. Powell continued, “I believe that my background in finance and corporate development will complement the exciting business growth at Antares. With novel technology that has produced three approved drug device combination products and three first-to-file partnered products under active review for marketing approval at the Food and Drug Administration, I believe Antares Pharma is well-positioned for continued growth.” Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently announced the U.S. commercial launch of VIBEX® Sumatriptan Injection USP for the acute treatment of migraine and cluster headache. Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy. The Company's technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product deal with Teva that includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen. Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth. For more information, visit www.antarespharma.com. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the future growth of Antares and the impact of Fred M. Powell, the timing and results of the phase 3 studies for QuickShot® Testosterone (QST) and acceptance of the data by the U.S. Food and Drug Administration (“FDA”); the timing and Company’s ability to successfully complete a New Drug Application (“NDA”) for QST, acceptance of the NDA for QST by the FDA and approval of the same by the FDA; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP™; FDA action with respect to Teva’s Abbreviated New Drug Application (“ANDA”) filed for the Exenatide pen (generic version of Byetta) and future revenue from the same; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any future purchase orders and revenue pre or post FDA approval; the outcome of the pending patent litigation between Teva and Eli Lilly and Company regarding the Teriparatide multi-dose pen (generic version of Forteo); the timing and approval by the FDA of Teva’s ANDA for the Teriparatide multi-dose pen and any future revenue resulting therefrom; the timing and results of the development project with AMAG Pharmaceuticals for an auto injector for Makena; the timing and results of research projects, clinical trials and product candidates in development; actions by the FDA or other regulatory agencies with the respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2015, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
News Article | December 15, 2016
In five studies being presented today during the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, researchers are applying advanced biomedical engineering methods to improve the delivery of life-saving treatments to patients with a variety of medical conditions. These new methods are designed to carry therapies directly to the sites in the body where they are needed most, which could provide a substantial advantage over traditional, systemic methods. The studies highlight the benefits of emerging technological tools such as nanotechnology and engineered drug delivery vehicles. “All of these studies represent substantial advances resulting from biomedical engineering. They build upon established science with bioengineering strategies that could make therapies significantly more effective if they are pursued and refined,” said Armand Keating, M.D., press briefing moderator, professor of medicine and biomedical engineering, and director of the Cell Therapy Program, University Health Network in Toronto, Canada. “I believe each of these has the potential to change practice.” Researchers have developed the first artificial red blood cells designed to emulate vital functions of natural red blood cells. If confirmed safe for use in humans, the nanotechnology-based product could represent an innovative alternative to blood transfusions that would be especially valuable on the battlefield and in other situations where donated blood is difficult to obtain or store. The artificial cells, called ErythroMer, are designed to be freeze-dried, stored at ambient temperatures, and simply reconstituted with water when needed. “One key goal is to advance field resuscitation of civilian trauma victims in remote settings and soldiers who are wounded in austere environments without access to timely evacuation,” said lead study author Allan Doctor, MD, of Washington University in Saint Louis. “ErythroMer would be a blood substitute that a medic can carry in his or her pack and literally take it out, add water, and inject it. There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals. Delays in resuscitation significantly impact outcomes; it is our goal to push timely, effective care to field settings.” Proof-of-concept studies in mice, conducted in partnership with Greg Hare M.D., Ph.D., at the University of Toronto, demonstrate that the artificial cells capture oxygen in the lungs and release it to tissues — the main functions of red blood cells — in a pattern that is indistinguishable from that seen in a control group of mice injected with their own blood. In rats, ErythroMer effectively resuscitated animals in shock following acute loss of 40 percent of their blood volume. The donut-shaped artificial cells are formulated with nanotechnology, in partnership with Dipanjan Pan, Ph.D., at the University of Illinois at Urbana-Champaign, and are about one-fiftieth the size of human red blood cells. A special lining encodes a control system that links ErythroMer oxygen binding to changes in blood pH, thus enhancing oxygen acquisition in the lungs and then dispensing oxygen in tissues with the greatest need. Tests show ErythroMer matches this vital oxygen binding feature of human red blood cells within 10 percent, a level the researchers say should be sufficient to stabilize a bleeding patient until a blood transfusion can be obtained. So far, tests suggest ErythroMer has overcome key barriers that halted development of previous blood substitutes, including efficacy and blood vessel narrowing. The team’s next steps are testing in larger animals, ongoing safety assessment, optimizing pharmacokinetics, and ultimately conducting in-human clinical trials. The researchers are also pursuing methods for scaling up production. If further testing goes well, they estimate ErythroMer could be ready for use by field medics and emergency responders within 10-12 years. ErythroMer development has been supported by the Children’s Discovery Institute at Washington University and St. Louis Children’s Hospital, the Skandalaris Center at Washington University and the BioSTL Fundamentals Program. Gene Therapy Could Potentially Improve Quality of Life for Hemophilia Patients Preliminary data from an ongoing Phase I/II trial suggest that patients with hemophilia B, who are born unable to produce the blood-clotting protein factor IX (FIX), began producing FIX at sufficient levels after receiving a single infusion of an investigational gene therapy product called SPK-9001. The results show the highest and most consistent levels of FIX production of any gene therapy tested to date, according to the researchers. FIX is crucial to the formation of blood clots and prevention of life-threatening uncontrolled bleeding. This ongoing trial involves nine previously treated adult patients with a baseline FIX of less than 2 percent, which is considered extremely deficient. As of the November 30, 2016, data cut off, seven of the nine patients who have progressed to at least 12 weeks post-vector administration showed FIX levels in the range of 12-46 percent with a mean steady-state level greater than 28 percent, a range the researchers say is close enough to normal (at least 50% in healthy adults). Maintaining a minimum level of 12 percent is considered necessary to prevent minor, chronic bleeding in the joints, a common cause of disability in patients with hemophilia. SPK-9001 uses an inactive virus to deliver into a patient’s cells a small section of DNA that, when stabilized in the patient’s own liver cells, allows the body to produce FIX. Current standard of care for hemophilia B requires patients to self-administer intravenous infusions of laboratory-produced FIX at regular intervals, typically one to two times a week. A key downside of this standard regimen is that it causes FIX levels to fluctuate widely, and patients may need to limit their activities to avoid breakthrough bleeding when their FIX levels are low. The FIX levels achieved with SPK-9001 to date in this study have been sufficient to allow patients to engage in normal daily activities without the need for FIX infusions. Eight of the infused patients have required no factor IX concentrates to prevent or control bleeding events since the day after vector administration. One participant with severe joint disease self-administrated a precautionary infusion two days after administration of SPK-9001 for a suspected ankle bleed and again at week 35 post the data cut-off date and despite a factor IX activity level of 36, for a suspected knee bleed. In addition, six patients reported increased physical activity and improved quality of life. “One of the potential innovations with a gene therapy for hemophilia B, compared to factor IX infusions, is that once an individual establishes a stable factor activity level, then they may remain at that level for an extended time,” said Katherine A. High, MD, of Spark Therapeutics, Inc. in Philadelphia. “At the factor IX levels seen in this study, most normal activities of daily living should be open to people with hemophilia. It could be a potential paradigm shift in the treatment of hemophilia.” Two participants recently suffered an autoimmune response and were put on corticosteroids. Despite the immune response and decline in FIX activity level, these two participants have not had any bleeds or required replacement FIX. The researchers will continue to track patient outcomes for at least five years. Funding for the study was provided by Spark Therapeutics and Pfizer, Inc. Microcapsules Could Be Game-Changer for Hemophilia Patients Prone to Immune Response A new drug delivery technology uses the body’s natural processes to supply the blood-clotting protein factor VIII (FVIII) directly to the site of a developing clot to stop bleeding in patients with hemophilia A. The approach, in which small amounts of FVIII are encased within microscopic capsules that are injected into the bloodstream, could significantly improve outcomes for the approximately 30 percent of patients with severe hemophilia A in which direct infusion of FVIII triggers an immune response. People with hemophilia A do not produce FVIII, a protein necessary for forming blood clots, putting them at risk of dangerous uncontrolled bleeding. The standard treatment for these patients is intravenous infusion of FVIII; however, if the patient’s immune system attacks the infused FVIII, the drug’s effectiveness is greatly reduced. These patients often require several infusions a day to control a single bleeding event. In vitro experiments show the new microcapsules act as a shield that allows the FVIII payload to fly under the immune system’s radar and potentially stem bleeding with only one or two injections. In addition, the microcapsules are designed to go directly to the site where FVIII is needed by hitchhiking on platelets, cell fragments present in blood that play a key role in clot formation. “This is a completely new way to target delivery of a biologic drug, capitalizing on the natural functions of cells that are already in your body,” said Caroline E. Hansen, a graduate student in the laboratory of bioengineer and pediatric hematologist Wilbur A. Lam, MD, PhD, of the Georgia Institute of Technology and Emory University in Atlanta. “We’re utilizing platelets’ natural behavior to accomplish targeting and delivery. Because platelets are so heavily relied upon in the clot formation process, they could actually carry these microcapsules to the forming clot or the site of injury.” After binding to platelets and traveling to a forming clot, the microcapsules are designed to burst open, releasing FVIII. This bursting occurs when platelets join a clot and contract. The FVIII then stimulates the formation of fibrin at the site, creating a mesh network that holds the blood clot together. The researchers recently tested their microcapsules in laboratory experiments that model sites of blood vessel injuries, comparing the amount of fibrin formed when FVIII was delivered via microcapsules versus traditional systemic infusions. They found that the microcapsules resulted in 2.7 times as much fibrin formation compared to a systemic FVIII infusion when immune antibodies were present, a test that mimicked what happens when FVIII infusions trigger an immune response in a person with hemophilia A. After further examination of how the microcapsules influence the formation of fibrin, the team plans to test the microcapsules in mouse models. Funding for the study was provided by the NIH and the NSF. New Chemotherapy Delivery Method Improves Survival After Bone Marrow Transplant in Older Acute Myeloid Leukemia Patients A new analysis shows older patients with acute myeloid leukemia (AML) survived longer after receiving an allogeneic stem cell transplant if they were first treated with the experimental chemotherapy delivery method known as CPX-351 instead of the standard “7+3” administration of chemotherapy drugs cytarabine and daunorubicin. Researchers say the findings are encouraging for improving survival among high-risk AML patients who currently have limited treatment options and poor survival rates. The new study is a subgroup analysis of a large Phase III randomized controlled trial completed earlier this year that found CPX-351 nearly doubled overall survival compared to the 7+3 regimen. The researchers examined survival and other health outcomes among trial participants who received chemotherapy and then hematopoietic stem cell transplantation, a treatment that provides healthy replacement stem cells to the bone marrow to better equip patients to fight the disease on their own. Of 309 total trial participants, 91 received an allogeneic stem cell transplant, including 52 in patients who received CPX-351 compared with 39 in patients receiving 7+3. CPX-351-treated patients were also more likely to undergo transplantation while in a remission state (75 percent of CPX-351 vs. 62 percent of 7+3). In the first 100 days after transplantation there were 53 percent fewer deaths among patients receiving CPX-351 compared with those receiving 7+3 therapy. The active ingredients of CPX-351 are the same as those in the 7+3 regimen, but in contrast to 7+3 in which cytarabine and daunorubicin are delivered separately, CPX-351 encapsulates the drugs into a single delivery vehicle in a fixed synergistic molar ratio. “The two drugs together are delivered to the cell in the proper synergistic ratio that optimizes the cell-killing ability of these two drugs,” said lead study author Jeffrey E. Lancet, MD, of the Moffitt Cancer Center in Tampa, Fla. “We think that by doing this, we can improve delivery to the cancer cells at the proper ratio.” The trial focused on the group of AML patients considered at high risk; all participants were older than 60 and had AML related to prior chemotherapy, AML arising from MDS, or AML MDS-related cytogenetic abnormalities. The study was funded by Celator Pharmaceuticals, Inc., a subsidiary of Jazz Pharmaceuticals plc. New CAR-T Treatment Holds Promise for Children and Young Adults with Hard-to-Treat Leukemia Children and young adults with relapsed or refractory ALL who receive chimeric antigen receptor (CAR) T-cell therapy targeting CD22, a protein found on the surface of leukemic cells, appear to mount a clinical response and, in some cases, achieve remission. Researchers from the Pediatric Oncology Branch of the National Cancer Institute of the National Institutes of Health genetically altered patients’ own T cells to track down and kill cancer cells expressing CD22. The study — the first to evaluate CAR targeting CD22 in humans — also gives a first glimpse into how patients who already received CAR-T therapy directed at a different antigen, CD19, might fare when given a second immunotherapy. Data are presented for 16 patients who received the new anti-CD22 therapy. One of the six patients treated at a lower dose initially set by the U.S. Food and Drug Administration (FDA) and other agencies attained remission. The majority – eight of 10 – participants treated at a higher dose level (a dose comparable to that used by current CD19 CAR programs) attained a complete remission without evidence of residual disease after one month of their infusion. There have since been relapses among six out of nine patients who achieved remission, the majority of which are due to drops in CD22 expression on the cells, which has similarly been observed with CD19 CAR therapy. So far, one patient remains in remission beyond one year. “We’ve been able to show that you can give a second CAR therapy that is directed against a different antigen and have it be safe and effective,” said study author Terry J. Fry, MD, of the Center for Cancer Research, National Cancer Institute in Bethesda, MD. Dr. Fry said this adds to the notion that a single antigen-directed CAR immunotherapy probably won’t be sufficient for long-term durable remissions in many patients and points to the potential for targeting multiple cancer-related proteins (also called bispecific targeting). Participants in this Phase 1 trial had relapsed or treatment-resistant ALL and were either CAR naïve or previously treated with anti-CD19 CAR T cells and/or blinatumomab therapy and some who became resistant to CD19 CAR due to loss of CD19. The patients, ranging in age from 7– 22 years old, all had CD22+ ALL and had previously undergone at least one allogeneic stem cell transplant. A majority of participants (11 out of 16) had relapsed after receiving anti-CD19 CAR T cell before entering the trial. Researchers collected T cells from eligible patients and modified them to recognize and bind to CD22. Patients then received an infusion of their own modified cells and were evaluated for response and adverse effects after an average of 28 days. The primary adverse event was cytokine release syndrome, a common, potentially dangerous reaction to this type of infusion, which Dr. Fry reports was mild in all cases; fever and low blood pressure were the main symptoms. There was one death due to sepsis that occurred after resolution of cytokine release syndrome. While the trial is continuing to accrue patients, these early results raise new questions about how anti-CD22 CAR therapy might best be used; for example, if it is better to wait for relapse after initial CAR therapy or preempt it by co-treating it. Dr. Fry and his team plan to investigate the combined use of anti-CD19 and CD22 CAR targeting approaches with the hypothesis that this will increase the likelihood of sustained remission. This study was funded by the National Institutes of Health.
Princeton University and Celator Pharmaceuticals | Date: 2013-05-29
Particulate constructs stabilized by amphiphilic copolymers and comprising at least one active coupled to a hydrophobic moiety provide sustained release of the active in both in vitro and in vivo environments.
Princeton University and Celator Pharmaceuticals | Date: 2013-08-16
Particulate constructs stabilized by amphiphilic copolymers and comprising at least one active coupled to a hydrophobic moiety provide sustained release of the active in both in vitro and in vivo environments.
News Article | November 8, 2016
DUBLIN, Nov. 8, 2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter of 2016 and updated financial guidance for 2016. "We have made substantial progress towards achieving our corporate objectives for 2016, delivering solid top-line growth in our commercial business, investing in broadening our hematology/oncology portfolio with the completion of the Celator acquisition and increasing our investments in R&D," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "In the third quarter, we began a rolling NDA submission for Vyxeos for the treatment of acute myeloid leukemia, and we are pleased with the achievement of important clinical milestones, advancement of key R&D programs and expansion of our clinical development portfolio, all of which support our goal of developing and commercializing meaningful therapies for patients while building shareholder value." GAAP net income attributable to Jazz Pharmaceuticals plc for the third quarter of 2016 was $87.1 million, or $1.41 per diluted share, compared to $88.0 million, or $1.39 per diluted share, for the third quarter of 2015. Adjusted net income attributable to Jazz Pharmaceuticals plc for the third quarter of 2016 was $158.5 million, or $2.57 per diluted share, compared to $159.3 million, or $2.52 per diluted share, for the third quarter of 2015. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release. Net product sales increased 10% in the third quarter of 2016 compared to the same period in 2015 due to higher net product sales of Xyrem and Defitelio. Xyrem net product sales increased 18% in the third quarter of 2016 compared to the same period in 2015. Erwinaze/Erwinase net product sales decreased 24% in the third quarter of 2016 compared to the same period in 2015 due to an Erwinaze supply interruption in the U.S. late in the third quarter of 2016. The company expects that it will continue to experience Erwinaze inventory and supply challenges, which have resulted, and are expected to continue to result, in temporary disruptions in the company's ability to supply certain markets, including the U.S. Defitelio/defibrotide net product sales increased $8.5 million in the third quarter of 2016 compared to the same period in 2015 primarily due to net sales of $7.1 million in the U.S. Operating expenses changed over the prior year period primarily due to the following: As of September 30, 2016, cash, cash equivalents and investments were $426.0 million, and the outstanding principal balance of the company's long-term debt was $2.3 billion. Cash, cash equivalents and investments decreased from December 31, 2015 primarily due to the acquisition of Celator for approximately $1.5 billion, repurchases under the company's share repurchase program and a $150.0 million milestone payment triggered by FDA approval of Defitelio on March 30, 2016, partially offset by borrowings of $1.0 billion under the company's revolving credit facility and cash flows from operations of $409.8 million. During the nine months ended September 30, 2016, the company repurchased 2.1 million ordinary shares for $259.8 million, at an average cost of $125.65 per ordinary share, under a share repurchase program approved in November 2015. This share repurchase program was completed in September 2016. The company's board of directors has authorized a new share repurchase program under which the company is authorized to repurchase a number of ordinary shares having an aggregate purchase price of up to $300 million. Under the new program, which has no expiration date, the company may repurchase ordinary shares from time to time on the open market. The timing and amount of repurchases will depend on a variety of factors, including the price of the company's ordinary shares, alternative investment opportunities, restrictions under the company's credit agreement, corporate and regulatory requirements and market conditions. The new share repurchase program may be modified, suspended or discontinued at any time without prior notice. In September 2016, the company completed patient enrollment for its two Phase 3 studies evaluating JZP-110 in excessive sleepiness associated with obstructive sleep apnea. In September 2016, the company initiated the rolling NDA submission to the FDA for Vyxeos for the treatment of acute myeloid leukemia. Vyxeos has received FDA orphan drug designation for the treatment of AML and was granted breakthrough therapy designation for treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. During the third quarter of 2016, the company activated clinical sites in the Phase 3 study of defibrotide for the prevention of VOD in high-risk patients following hematopoietic stem cell transplantation. In November 2016, the company completed enrollment in the Phase 3 study of Xyrem in pediatric narcolepsy patients with cataplexy. Jazz Pharmaceuticals is updating its full year 2016 financial guidance as follows (in millions, except per share amounts and percentages): Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EST (9:30 p.m. GMT) to provide a business and financial update and discuss its 2016 third quarter results. The live webcast may be accessed from the Investors & Media section of the company's website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 95431988. A replay of the conference call will be available through November 15, 2016 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 95431988. An archived version of the webcast will be available for at least one week in the Investors & Media section of the company's website at www.jazzpharmaceuticals.com. Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com. To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the company presents non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc (and the related per share measure) and its line item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line item components exclude from reported GAAP net income (and the related per share measure) and its line item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the tax effect of non-GAAP adjustments and, for the comparable 2015 periods, adjust for the amount attributable to noncontrolling interests. In this regard, the components of non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc, including non-GAAP cost of product sales, non-GAAP selling, general and administrative expenses and non-GAAP research and development expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that each of these non-GAAP financial measures, when considered together with the company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the company's condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; and the company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. In this regard, the company modified the calculation of its non-GAAP income tax provision commencing in the second quarter of 2016 and accordingly, the income tax effect of the adjustments between GAAP reported and non-GAAP adjusted results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). For purposes of comparability, the non-GAAP income tax provision and the corresponding income tax adjustment to arrive at non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc (and the related per share measures) for the comparable 2015 periods are presented on the same basis. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' future financial and operating results, including 2016 financial guidance, the company's goal of developing and commercializing new therapies for patients and building shareholder value, the company's expectation for continuing Erwinaze manufacturing, inventory and supply challenges, potential share repurchases and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with maintaining or increasing sales of and revenue from Xyrem, such as the potential introduction of generic competition or other competitive products; regulatory restrictions and requirements applicable to Xyrem and ongoing patent litigation and related proceedings; effectively commercializing the company's other products and product candidates; protecting and enhancing the company's intellectual property rights; delays or problems in the supply or manufacture of the company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements; the difficulty and uncertainty of pharmaceutical product development and the uncertainty of clinical success; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired businesses such as Celator Pharmaceuticals, Inc.; potential restrictions on the company's ability and flexibility to pursue share repurchases and future strategic opportunities as a result of its substantial outstanding debt obligations; the ability to achieve expected future financial performance and results; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 and future filings and reports by the company, including the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Celator Pharmaceuticals | Date: 2012-10-15
Lyophilized liposomal formulations with two or more encapsulated drugs are disclosed. These formulations display superior drug retention profiles and also maintain size distribution following lyophilization and reconstitution.
Celator Pharmaceuticals | Date: 2015-11-03
Compositions which comprise liposomes having controlled release of a platinum agent are useful in achieving enhanced therapeutic effects particularly when these drugs are administered in combination with other therapeutic agents.
Celator Pharmaceuticals | Date: 2016-01-07
Compositions which comprise delivery vehicles having stably associated therewith non-antagonistic combinations of two or more agents, such as antineoplastic agents, are useful in achieving non-antagonistic effects when combinations of drugs are administered.
Celator Pharmaceuticals | Date: 2011-09-20
Compositions which comprise an anthracycline agent, and a cytidine analog are encapsulated in liposomal carriers. The preferred anthracycline agent is selected from the group of daunorubicin, doxorubicin, and idarubicin, while the preferred cytidine analog is selected from the group of cytarabine, gemcitabine, or 5-azacytidine. The combination of the anthracycline agent and cytidine analog encapsulated in said liposomal carriers are useful in achieving a drug retention and a sustained drug release for each therapeutic agent.
Celator Pharmaceuticals | Date: 2012-01-18
Provided is a composition suitable for parenteral administration to a subject, which composition comprises daunorubicin and cytarabine encapsulated in liposomes in a mole ratio of daunorubicin:cytarabine of about 1:5, wherein said liposomes have a mean diameter in the range of 4.5 nm to less than 250 nm; and wherein the pharmacokinetics of the composition are controlled by the liposomes, whereby the daunorubicin and cytarabine agents are to be delivered to a disease site in a coordinated fashion, thereby assuring that said ratio is maintained at the disease site.