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DARMSTADT, Germany, and NEW YORK, May 10, 2017 /PRNewswire/ -- Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.[1] BAVENCIO will be co-commercialized by EMD Serono, the biopharmaceutical business of Merck in the US and Canada, and Pfizer. "This approval for BAVENCIO in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at biopharma business of Merck. "Coming just a few weeks after the approval for metastatic Merkel cell carcinoma, we continue to demonstrate our ability to accelerate access to innovative medicines for patients in need." "This approval builds on the ongoing clinical development program for BAVENCIO in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers," said Liz Barrett, Global President, Pfizer Oncology. "By drawing on the strength of the alliance, as well as Pfizer's deep experience in genitourinary cancers, we believe BAVENCIO will be an important treatment option, and we hope it will help to improve outcomes for these patients." Bladder cancer makes up approximately 90% of urothelial carcinomas and is the sixth most common cancer in the US.[2],[3] When the disease has metastasized, the five-year survival rate is approximately 5%.[4] Despite advances in the treatment of locally advanced or metastatic urothelial carcinoma, the prognosis for patients remains poor and more treatment options are needed.[2] "Once urothelial carcinoma progresses after treatment with chemotherapy, the five-year survival rate is alarmingly low," said Dr. Andrea Apolo, National Cancer Institute, Bethesda, MD. "Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease." The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts (N=242) of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study of BAVENCIO in the treatment of various solid tumors. The urothelial carcinoma cohorts enrolled patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. These data will be presented at an upcoming medical congress. The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity. The most common adverse reactions (reported in at least 20% of patients) in patients with locally advanced or metastatic urothelial carcinoma were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%).[1] For more information, please see Important Safety Information for BAVENCIO below. BAVENCIO is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, BAVENCIO is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses.[1] BAVENCIO has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[1] The alliance is committed to providing industry-leading patient access and reimbursement support through its CoverOne™ program in the United States. This program provides a spectrum of patient access and reimbursement support services intended to help patients receive appropriate access to BAVENCIO in the United States. The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study that included 242 patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen who were treated with BAVENCIO. Patients with active or a history of central nervous system metastasis; other malignancies within the last five years; an organ transplant; conditions requiring therapeutic immune suppression; or active infection with HIV, hepatitis B or C were excluded. Patients with autoimmune disease, other than type 1 diabetes, vitiligo, psoriasis, or thyroid disease that did not require immunosuppressive treatment, were excluded. Patients were included regardless of their PD-L1 status. Patients received BAVENCIO at a dose of 10 mg/kg intravenously over 60 minutes every two weeks until disease progression or unacceptable toxicity. Tumor response assessments were performed every six weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Efficacy outcome measures included confirmed overall response rate (ORR) and duration of response (DOR). Efficacy measures were evaluated in patients who were followed for a minimum of both 13 weeks and 6 months at the time of data cut-off. Out of the total 226 patients evaluable for efficacy, 44% had non-bladder urothelial carcinoma, including 23% of patients with upper tract disease; 83% of patients had visceral metastases; 34% of patients had liver metastases. Nine patients (4%) had disease progression following prior platinum-containing neoadjuvant or adjuvant therapy only. Forty-seven percent of patients only received prior cisplatin-based regimens, 32% received only prior carboplatin-based regimens, and 20% received both cisplatin and carboplatin-based regimens. The international clinical development program for avelumab, known as JAVELIN, involves more than 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types. In December 2015, Merck and Pfizer announced the initiation of a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. This trial is currently enrolling patients. BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3. BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5 and 11 (0.6%) with Grade 3. BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis and permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3. Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life- threatening (Grade 4) thyroid disorders. Thyroid disorders including hypothyroidism, hyperthyroidism, and thyroiditis were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3. Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer anti-hyperglycemics or insulin in patients with severe or life-threatening (Grade ≥ 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia. BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% (1/1738) of patients. BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response. BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3. BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants. The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%). The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial cancer (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%). Selected laboratory abnormalities (grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC  were hyponatremia (16%), gamma-glutamyltransferase increased (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%). BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for any indication in any market outside of the US. As announced on October 31, 2016, the European Medicines Agency (EMA) has validated for review Merck's Marketing Authorization Application for avelumab, for the proposed indication of metastatic Merkel cell carcinoma. BAVENCIO is a human programmed death ligand-1 (PD-L1) blocking antibody indicated in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, as well as for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.[1] These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory trials. BAVENCIO is not approved for any indication in any market outside the US. Immuno-oncology is a top priority for Merck and Pfizer Inc. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer. EMD Serono is the biopharmaceutical business of Merck - a leading science and technology company - in the US and Canada focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has 1,200 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. For further details and press materials about Merck in oncology please visit Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the "Merck" name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. About Pfizer Inc.: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. The information contained in this release is as of May 9, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about BAVENCIO (avelumab), Merck-Pfizer's Alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any other jurisdictions for the Indication or in any jurisdictions for any other potential indications for BAVENCIO, combination therapies or other product candidates; whether and when any such applications (including the pending application for BAVENCIO for metastatic Merkel cell carcinoma in the EU) may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of BAVENCIO, combination therapies or other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.


News Article | May 11, 2017
Site: www.businesswire.com

HALIFAX, Nova Scotia--(BUSINESS WIRE)--Emera (TSX: EMA) today reported higher net income of $312 million, compared with net income of $44 million in Q1 2016. Adjusted net income was $152 million in the first quarter of 2017, a 27 percent increase compared with Q1 2016. Despite the increase in adjusted net income in Q1 2017, earnings per share declined due to the new shares issued in August 2016 in conjunction with the TECO acquisition and the December 2016 equity issue. “Our higher adjusted first quarter net income primarily reflects the contribution from the TECO companies and improved results across our regulated utilities. This increase was partially offset by lower contributions from Emera Energy resulting from weak market conditions in the quarter. In addition, we delivered an increase in our cash flow,” said Chris Huskilson, President and CEO of Emera Inc. “The results demonstrate the strength and sustainability of our businesses, and the growth opportunities we have that will continue to support our targeted 8 percent dividend growth through to the end of the decade.” Financial Highlights (in millions of $CAD) except per share amounts; (1) See “Non-GAAP Measures” noted below. (2) Adjusted net income (1) and Adjusted earnings per common share (1) exclude the effect of mark-to-market adjustments. After-tax mark-to-market gains increased $236 million to $160 million in Q1 2017, compared with a $76 million loss in Q1 2016. The increase is due to a $121 million loss in the 2016 period resulting from the reversal of 2015 gains on USD-denominated currency and forward contracts related to the financing for the TECO Energy acquisition, changes in existing positions on long-term contracts at Emera Energy, and the reversal of 2016 mark-to-market losses at Emera Energy. The following table highlights significant changes in adjusted net income from 2016 to 2017 in the first quarter. Emera reports its results in six operating segments: Emera Florida and New Mexico, Nova Scotia Power Inc., Emera Maine, Emera Caribbean, Emera Energy, and Corporate & Other. Quarterly Segmented Results (in millions of $CAD, except per share amounts) (1) See “Non-GAAP Measures” noted below. (2) Adjusted net income (1) excludes after-tax mark-to-market loss in Emera Energy, and Corporate and Other Emera Florida and New Mexico’s net income was $79 million in Q1 2017 compared with $102 million in Q1 2016. Results were driven by lower electricity sales resulting from one of the mildest winters on record in Florida and New Mexico and higher OM&G at Tampa Electric for transmission and distribution system maintenance, partially offset by strong customer growth. Results in 2016 included an $8 million after-tax benefit related to a change in accounting for stock based compensation. The Florida utilities expect to earn within their allowed ROE ranges in 2017. Comparison information for Q1 2016 is presented for information only as Emera did not own the Emera Florida and New Mexico operations in Q1 2016. Net of the $45 million of permanent financing cost, Emera Florida and New Mexico contributed $34 million in Q1 2017. Nova Scotia Power Inc.’s net income was $70 million in Q1 2017, an increase of $17 million from $53 million in Q1 2016. The increase was primarily due to lower OM&G expense including lower storm costs in the Q1 2017 period, higher electricity sales due to more favorable winter weather compared to the very mild 2016 winter, and load growth; as well as decreased income tax expense. These lower costs were partially offset by increased depreciation due to increased property plant and equipment. The strong Q1 performance will be largely offset over the balance of the year, and NSPI’s expects 2017 net earnings to be consistent with 2016. Emera Maine’s net income was $13 million in Q1 2017, compared to Q1 2016 net income of $9 million. Results in Q1 2017 were driven by lower OM&G due to lower storm costs in 2017 and increased revenues due to transmission and distribution rate changes. Emera Caribbean’s net income of $7 million in Q1 2017 represents a decrease of $3 million compared to Q1 2016 net income of $10 million. The decrease was primarily due to lower energy sales at GBPC due to the effects of Hurricane Matthew. Emera Energy’s net income, adjusted to exclude mark-to-market changes, was $10 million in Q1 2017 compared to net income of $48 million in the same quarter last year. The decrease was primarily due to decreased Marketing and Trading margin due to warmer winter weather, increased natural gas pipeline infrastructure in the northeast U.S.; and lower electricity sales and margin at the New England generating facilities due to unfavorable market conditions, compared with Q1 2016 when more favorable short-term economic hedges were in place. Corporate & Other’s net loss was $27 million in Q1 2017 compared to nil in Q1 2016. The increased loss was primarily due to higher interest expense as a result of interest on the permanent financing of the TECO Energy acquisition. The Maritime Link project is on schedule and on budget, with the laying of the first submarine cable between Newfoundland and Nova Scotia underway. AFUDC earnings on the investment in the Maritime Link project were $7 million in Q1 2017 compared with $4 million in Q1 2016. AFUDC earnings on the investment in the Labrador Island Link project were $9 million in Q1 2017, compared with $5 million in Q1 2016. Emera uses financial measures that do not have standardized meaning under USGAAP and may not be comparable to similar measures presented by other entities. Emera calculates the non-GAAP measures by adjusting certain GAAP and non-GAAP measures for specific items the Company believes are significant, but not reflective of underlying operations in the period. Refer to the Non-GAAP Financial Measures section of our Management's Discussion and Analysis ("MD&A") for further discussion of these items. This news release contains forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information requires Emera to make assumptions and is subject to inherent risks and uncertainties. These statements reflect Emera management’s current beliefs and are based on information currently available to Emera management. There is a risk that predictions, forecasts, conclusions and projections that constitute forward-looking information will not prove to be accurate, that Emera’s assumptions may not be correct and that actual results may differ materially from such forward-looking information. Additional detailed information about these assumptions, risks and uncertainties is included in Emera’s securities regulatory filings, including under the heading “Business Risks and Risk Management” in Emera’s annual Management’s Discussion and Analysis, and under the heading “Principal Risks and Uncertainties” in the notes to Emera’s annual and interim financial statements, which can be found on SEDAR at www.sedar.com. The company will be hosting a teleconference Thursday, May 11, 2017 at 4:00pm Atlantic time (3:00pm Toronto/Montreal/New York; 2:00pm Winnipeg; 1:00pm Calgary; 12:00pm Vancouver) to discuss the Q1 2017 financial results. Analysts and other interested parties in North America may participate in the call by dialing 1-866-521-4909 at least 10 minutes prior to the start of the call. International participants should dial (647) 427-2311. No passcode is required. The teleconference will be recorded. For those unable to join live, playback can be accessed by dialing toll-free at 1-800-585-8367. The Conference ID is 4767504 (available until midnight, May 31, 2017). The teleconference will also be web cast live at emera.com and available for playback for one year. Emera’s Annual General Meeting is scheduled to be held May 12, 2017 at 2:00pm Atlantic time at Ondaatje Hall, Marion McCain Arts and Social Sciences Building, Dalhousie University, 6135 University Avenue, Halifax, NS. Emera Inc. is a geographically diverse energy and services company headquartered in Halifax, Nova Scotia with approximately $29 billion in assets and 2016 revenues of more than $4 billion. The company invests in electricity generation, transmission and distribution, gas transmission and distribution, and utility energy services with a strategic focus on transformation from high carbon to low carbon energy sources. Emera has investments throughout North America, and in four Caribbean countries. Emera continues to target having 75-85% of its adjusted earnings come from rate-regulated businesses. Emera’s common and preferred shares are listed on the Toronto Stock Exchange and trade respectively under the symbol EMA, EMA.PR.A, EMA.PR.B, EMA.PR.C, EMA.PR.E, and EMA.PR.F. Depositary receipts representing common shares of Emera are listed on the Barbados Stock Exchange under the symbol EMABDR. Additional Information can be accessed at http://www.emera.com or at www.sedar.com


Dr Kwon, medisch directeur bij Celltrion Healthcare, verklaarde: “ De publicatie van de NOR-SWITCH-gegevens in The Lancet markeert opnieuw een belangrijke mijlpaal voor het vergroten van het vertrouwen van artsen om biosimilar infliximab te gebruiken als overwogen wordt om hun patiënten over te schakelen.” Na presentaties tijdens zowel de 2016 United European Gastroenterology (UEG) Week als de jaarlijkse bijeenkomst van het American College of Rheumatology (ACR) bleek uit de bevindingen van de studie dat van de 50% van de patiënten die overgeschakeld waren naar CT-P13, het percentage patiënten met verslechtering van de ziekte vergelijkbaar was met die patiënten die referentie infliximab bleven gebruiken (respectievelijk 29,6 en 26,2%). De datadiscontinueringspercentages door een gebrek aan werkzaamheid voor referentie infliximab en biosimilar infliximab waren respectievelijk acht en drie. De tijd om de stopzetting van de medicijnen te onderzoeken was bijna identiek tussen de twee groepen, waarbij ook vergelijkbare totale remissiecijfers en frequenties van bijwerkingen waargenomen werden. 1 CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ The Lancet is een van 's werelds grootste onafhankelijke algemene medische tijdschriften. Het intercollegiaal getoetste tijdschrift publiceert medisch nieuws en origineel onderzoek en biedt evaluaties over alle aspecten van klinische geneeskunde en internationale gezondheid. The Lancet heeft een impactfactor van 44,002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, beschikbaar op: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [geraadpleegd in mei 2017]. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today reported business highlights and financial results for the first quarter ended March 31, 2017. “We continue to make good progress in building Sage into a leading CNS company with the potential to deliver differentiated medicines for a variety of central nervous system disorders. We are focused on closing the innovation gap in areas of brain disorders where more breakthroughs for patients are needed,” said Jeff Jonas, M.D., Chief Executive Officer of Sage. “We are now nearing completion of enrollment in our lead Phase 3 program in super-refractory status epilepticus (SRSE), and remain focused on completing Phase 3 clinical development of brexanolone in both SRSE and postpartum depression (PPD) in 2017. Further, we continue to advance our growing pipeline of novel product candidates, including our lead oral compound, SAGE-217, in four clinical programs in both mood and movement disorders.” Sage is nearing completion of enrollment in the Phase 3 STATUS Trial, the first ever global, randomized, double-blind, placebo-controlled trial in SRSE. The Company expects to report top-line results from the STATUS Trial in the third quarter of 2017 after enrollment of an anticipated 126 evaluable patients and completion of all study follow-up periods and data analysis. Sage expects top-line results to include the primary endpoint, safety and tolerability, and select secondary endpoints, including open-label retreatment arm response and the Clinical Global Impression scale. Top-Line Results from Part A of SAGE-217 Phase 2 in Parkinson’s Disease Sage today announced top-line results from the Part A open-label portion of a Phase 2 clinical trial of SAGE-217 in Parkinson's disease: Sage is advancing a portfolio of novel central nervous system (CNS) product candidates targeting the GABA and NMDA receptor systems. Dysfunction in these systems is known to be at the core of numerous psychiatric and neurological disorders. Sage is pursuing a data-driven approach to CNS drug development by employing efficient human proof-of-concept studies both to uncover activity signals and to help understand future trial methodology, before investing in larger clinical programs. Financial Results for the First Quarter of 2017 Sage will host a conference call and webcast today at 4:30 PM ET to discuss its first quarter financial results and recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. The conference call can be accessed by dialing 1-866-450-8683 (toll-free domestic) or 1-281-542-4847 (international) and using the conference ID 12287678. A replay of the webcast will be available on Sage’s website approximately two hours after the completion of the event and will be archived for up to 30 days. Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage's lead program, brexanolone (SAGE-547), is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder, and for postpartum depression. Sage is developing its next generation modulators, including SAGE-217 and SAGE-718, in various CNS disorders. For more information, please visit www.sagerx.com. Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding development of our product candidates and their potential in the treatment of various CNS disorders; the expected timing of initiation and completion of clinical trials; the anticipated availability and announcement of data and results from clinical trials of our product candidates; our plans for evaluation of new indications and new compounds; our expectations regarding the regulatory pathway for brexanolone (SAGE-547) in the treatment of SRSE in the EU, and our belief that the results of the current development program for brexanolone in SRSE, if successful, will be sufficient for an MAA filing in the EU; our expectations regarding a potential future new drug application and MAA filing and commercial launch of brexanolone, if successfully developed and approved; and our expectations with respect to future cash use and cash needs. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may continue to experience slower than expected enrollment and randomization of evaluable patients in the STATUS trial or slower than expected clinical site initiation and enrollment in our other clinical trials, or the potential need for additional analysis or data or the need to enroll additional patients, leading to possible delays in completion of trials or in the availability of data; we may not be able to generate supportive non-clinical data or to successfully demonstrate the efficacy and safety of our product candidates at each stage of clinical development; success in our non-clinical studies or in earlier stage clinical trials may not be repeated or observed in ongoing or future studies involving the same compound or other product candidates, and ongoing and future pre-clinical and clinical results may not support further development of product candidates or be sufficient to gain regulatory approval to launch and commercialize any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and our ability to proceed with further clinical studies of a product candidate or to obtain marketing approval or may result in restrictions in an approved indication or the need for additional clinical trials, including the risk that the EMA may, despite scientific advice, decide that the data from our Phase 3 trial in SRSE are not sufficient to support approval; the internal and external costs required for our activities, and to build our organization in connection with such activities, and the resulting use of cash, may be higher than expected, or we may conduct additional clinical trials or pre-clinical studies, or engage in new activities, requiring additional expenditures and using cash more quickly than anticipated; and we may encounter technical and other unexpected hurdles in the development and manufacture of our products which may delay our timing or increase our expenses and use of cash, as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.


News Article | May 11, 2017
Site: www.businesswire.com

WASHINGTON--(BUSINESS WIRE)--DIA, (founded as the Drug Information Association), announced today keynote speaker Alexander Tsiaras, 11 tracks, more than 160 sessions, and a featured career fair at the DIA 2017 Global Annual Meeting, June 18 to 22 in Chicago, IL. Appropriately themed “Driving Insights to Action”, the DIA 2017 Global Annual Meeting is designed to foster the international exchange of actionable insights to improve health globally through the advancement of lifesaving medicines and technologies. An integral part of the health and life sciences community, this the platform on which all global stakeholders in the drug product development life cycle have an opportunity to converse, debate, and raise questions about the evolution of novel therapies, the pharmaceutical research and development (R&D) landscape, and regulatory challenges to drive action throughout health care product development. With traditional educational sessions and innovative learning experiences, the program includes themed tracks with scientific sessions focused on today’s hottest topics ranging from big data, medical affairs, and clinical operations to patient engagement, clinical trial safety, and value and access. In the keynote address, Interactive Storytelling and Personal Health Data Drives Unprecedented Patient Empowerment, Alexander Tsiaras will share how the fusion of personal stories of disease, powerful patient data, and visceral interactive experiences can drive greater patient engagement and outcomes. “With the changes in governance around the world, the continuing economic uncertainties, the ever-increasing consumer involvement, the regulatory challenges, plus the continuing pressure for even higher quality and innovative products, the life sciences industry is facing myriad challenges,” said Barbara Lopez Kunz, Global Chief Executive, DIA. “It’s important for all stakeholders in this arena to openly discuss these challenges, find ways to overcome them and take action to help move our ecosystem forward. Our global annual meeting provides the essential platform by which to do just that. Insights and outcomes garnered at this meeting will advance innovation to deliver safe, effective, and accessible healthcare products to patients.” DIA 2017 will host over 7,000 professionals from the pharmaceutical, biotechnology and medical device communities from over 50 countries for the five-day conference, which also features a three-day expo with more than 450 exhibiting companies. In addition to health care and life sciences industry professionals, academia, and students, representatives from global regulatory bodies such as: Food and Drug Administration (FDA), European Medicines Agency (EMA), International Coalition of Medicines Regulatory Authorities (ICMRA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, The Brazilian Health Regulatory Agency (Anvisa), National Center for Advancing Translational Sciences (NCATS) and Agency for Healthcare Research and Quality (AHRQ) will be in attendance. More importantly, these same groups of people will serve as session chairs and speakers, igniting questions, inspiring thought, and driving action. To learn more and register for DIA 2017, visit www.DIAglobal.org/DIA2017. For live updates, attendees and the public should follow and join the conversation on Twitter, @DrugInfoAssn using the hashtag #DIA2017. DIA (founded as the Drug Information Association) is an international, nonprofit, multidisciplinary member association that provides health care product development professionals a neutral and transparent forum for collaboration and the exchange of insights to improve health globally through the advancement of lifesaving medicines and technologies. DIA builds knowledge through, learning solutions (digital and in person training), conferences and insights in the areas of Regulatory Science, Translational Medicine, Patient Engagement and Value and Access for professionals in the pharmaceutical, biotechnology, and medical device communities. DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan). For more information, visit www.DIAglobal.org or connect with us on Twitter, LinkedIn, Facebook, and Instagram.


SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) today reported financial results and provided a corporate update for the quarter ended March 31, 2017. “During the first quarter of 2017 we continued to focus on regulatory activities for betrixaban and AndexXa™. Our goal is to gain approval for both products this year in the United States and in 2018 in the European Union,” said Bill Lis, chief executive officer of Portola. “Both are highly anticipated by the medical community because they are potentially life-saving medicines in indications where currently there are no approved therapies.” First Quarter 2017 Financial Results Collaboration and license revenue earned under Portola's collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals and Daiichi Sankyo was $5.1 million for the first quarter of 2017 compared with $8.3 million for the first quarter of 2016. Total operating expenses for the first quarter of 2017 were $45.7 million, compared with $73.6 million for the same period in 2016. Total operating expenses for the first quarter of 2017 included $9.0 million in stock-based compensation expense, compared with $7.1 million for the same period in 2016. Research and development expenses were $30.6 million for the first quarter of 2017, compared with $58.8 million for the first quarter of 2016. The decrease in R&D expenses was largely attributable to the termination of manufacturing activities on the 6x2000 liter, or Line C, manufacturing process in the third quarter of 2016, and decreased program costs related to betrixaban and cerdulatinib. Selling, general and administrative expenses for the first quarter of 2017 were $15.0 million, compared with $14.8 million for the same period in 2016. For the first quarter of 2017, Portola reported a net loss of $41.7 million, or $0.74 net loss per share, compared with a net loss of $65.0 million, or $1.15 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were 56.7 million for the first quarter of 2017, compared with 56.4 million for the same period in 2016. Cash, cash equivalents and investments at March 31, 2017 totaled $318.2 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. Conference Call Details The live conference call today, Monday, May 8, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 8594347. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call. About Portola Pharmaceuticals, Inc.     Portola Pharmaceuticals is a biopharmaceutical company developing products that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three investigational programs, including: betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and, cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola also is co-developing Syk-selective inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the timing of our regulatory events, the potential of our product candidates to advance the field of thrombosis and benefit patients and statements regarding the timing and ability to achieve other milestones and events. Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, regulatory developments in the United States and foreign countries; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


"We hebben een positieve start van het jaar gekend. De indiening van de aanvraag voor regelgevende goedkeuring voor caplacizumab in Europa om aTTP te behandelen was een zeer belangrijke mijlpaal voor de Vennootschap, evenals de voltooiing van de patiëntenrecrutering in de Fase III HERCULES studie. We zijn nu een commerciële infrastructuur aan het opzetten om caplacizumab naar de markt te brengen en we zijn toegewijd om het zo snel mogelijk toegankelijk te maken voor patiënten. Initiële recrutering voor de Fase IIb studie met ons anti-RSV Nanobody in baby's loopt volgens plan en we gaan verder met de voorbereidingen voor een studie met dit Nanobody in patiënten die een stamceltransplantatie hebben ondergaan en die een RSV infectie hebben. Gesprekken met regelgevende instanties over onze Fase IIb data in RA met vobarilizumab en over een potentieel Fase III studieprogramma waren informatief in onze evaluatie rond het verderzetten van de molecule in deze indicatie. We verwachten nog steeds om data over onze SLE studie met vobarilizumab in 300 patiënten te rapporteren in H1 2018. Onze partners hebben ook goede vooruitgang geboekt in de ontwikkeling van Nanobodies die we samen hebben ontdekt. In het bijzonder in deze periode, waren Merck KGaA's resultaten van een Fase Ib studie in psoriasis met ons anti-IL-17A/F bispecifiek Nanobody uiterst boeiend. Met vandaag meer dan 45 O&O programma's in eigen ontwikkeling en met partners, waarvan 8 in klinische ontwikkeling, kijken we uit naar belangrijke vooruitgang in 2017." De inkomsten daalden tot €9,1 miljoen (2016: €27,4 miljoen), hoofdzakelijk door lagere erkende inkomsten van vooruitbetalingen uit de lopende samenwerkingsovereenkomst met AbbVie en door mijlpaalbetalingen ontvangen in het eerste kwartaal van 2016. Gezien de productportefeuille nu meer producten bevat die zich in een later stadium van ontwikkeling bevinden, stegen de operationele kosten tot €29,3 miljoen (2016: €28,1 miljoen), hoofdzakelijk door hogere externe O&O kosten. Het netto financiële resultaat was -€1,9 miljoen (2016: €17,5 miljoen), hoofdzakelijk als gevolg van het effect van de berekening van de reële waarde van de Converteerbare Obligatie. Als gevolg van het voorgaande, sloot de Vennootschap de periode af met een netto verlies van €22,1 miljoen (2016: netto winst van €16,8 miljoen). Per 31 maart 2017 had de Vennootschap €209,2 miljoen aan liquide middelen, kasequivalenten, in pand gegeven geldmiddelen en beleggingen op korte termijn. De cash burn van €26,2 miljoen ligt hoger dan vorig jaar door een vertraging in een betaling van €5,5 miljoen, die pas in het begin van Q2 2017 werd ontvangen en ook als gevolg van het groter aantal mijlpaal- en vooruitbetalingen die in Q1 2016 werden ontvangen. Ablynx verwacht om topline resultaten van de Fase III HERCULES studie met caplacizumab in aTTP patiënten te rapporteren in de tweede helft van 2017. Deze data zullen naar verwachting de recent ingediende aanvraag tot markttoelating (MAA) bij het Europees Geneesmiddelenbureau (EMA) en de geplande indiening van de vergunningsaanvraag voor biologische middelen (Biologics License Application - BLA) in de Verenigde Staten in 2018 ondersteunen. Ablynx is een biofarmaceutische onderneming actief in de ontwikkeling van Nanobodies®, gepatenteerde therapeutische eiwitten gebaseerd op enkel-keten antilichaamfragmenten die de voordelen combineren van medicijnen gebaseerd op conventionele antilichamen en kleine chemische moleculen. Ablynx is toegewijd om nieuwe medicijnen te ontwikkelen die een duidelijk verschil kunnen maken voor de samenleving. De Vennootschap heeft vandaag meer dan 45 programma's in eigen ontwikkeling en met partners in diverse therapeutische indicaties zoals inflammatie, hematologie, immuno-oncologie, oncologie en ademhalingsziekten. Ablynx heeft overeenkomsten met verscheidene farmaceutische bedrijven waaronder AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk en Taisho Pharmaceutical. De onderneming is gevestigd in Gent, België. Meer informatie is te vinden op www.ablynx.com.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH): 2-Day Workshop by Dr. Huber" conference to their offering. This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course. - Learn about the regulatory background and requirements for validation of analytical methods and procedures - Learn how to plan, execute and document development and validation of methods developed in-house - Be able to explain the different requirements for validation, verification and transfer of analytical procedures - Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods - Be able to explain your company's strategy for method validation, verification, transfer and equivalency testing - Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks - Be able to justify and document decisions about revalidation after method changes - Be able to define and demonstrate FDA and EU compliance to auditors and inspectors - Be able to develop inspection ready documentation during on-going routine operation - Understanding what questions will be asked during audits and inspections and how to answer them For more information about this conference visit http://www.researchandmarkets.com/research/2rp8mk/validation


News Article | May 11, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Capnia, Inc. (NASDAQ:CAPN), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update following its recent annual meeting and announced financial results for the three months ended March 31, 2017. At Capnia’s annual meeting, held on May 8, 2017, shareholders approved all of the proposed proxy initiatives, including the Company’s name change to Soleno Therapeutics, Inc., the re-election of Ernest Mario, Anish Bhatnagar, Stuart Collinson, and William Harris as Class III directors and, at the discretion of the Board of Directors, approval to conduct a reverse stock split, if needed.  Separately, Capnia was recently granted a 180-day extension by NASDAQ to regain compliance with the exchange’s minimum bid price rule. The name change to Soleno Therapeutics, Inc. and the Company’s shares trading under the NASDAQ ticker symbol, “SLNO”, are both currently expected to become effective on May 12, 2017. “The recent merger between Capnia and Essentialis has refocused our business on the development and commercialization of novel therapeutics for the treatment of rare diseases, such as PWS, where our lead product candidate, DCCR, has demonstrated significant potential,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “Our name change to Soleno Therapeutics reflects this new focus.  We strengthened our balance sheet through the completion of a $10 million financing that closed concurrently with the merger, and are well-positioned to further advance the development program for DCCR.” “We are looking forward to our upcoming interactions with FDA and EMA to discuss our proposed development program for DCCR as a treatment for patients with PWS,” continued Dr. Bhatnagar.  “Following receipt of their guidance, we expect to initiate the subsequent clinical trial for PWS later in 2017.” Total revenue recognized in the three months ended March 31, 2017, was $0.3 million, compared to $0.4 million for the same period in 2016. Research and development expenses in the first quarter of 2017 were $1.0 million, compared to $1.8 million for the same period in 2016.  The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. Sales and marketing expenses in the first quarter of 2017 were $0.1 million, compared to $0.5 million for the same period in 2016. The decrease was primarily due to a reduction in direct sales personnel. General and administrative expenses in the first quarter of 2017 were $1.2 million, compared to $1.9 million for the same period in 2016. The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. The change in fair value of warrants income for the three months ended March 31, 2017, was $0.1 million, which represents a decrease in the fair value of the Series A and Series C Warrants compared to the value of the warrants at December 31, 2016. The change in fair value of warrants income in the first quarter of 2016 was $1.2 million, which represented an increase in the fair value of the Series A, Series B and Series C Warrants compared to the value of the warrants at December 31, 2015. Net loss for the first quarter of 2017 was $2.9 million, or a loss of $0.11 per share, compared to a net loss of $3.2 million, or a loss of $0.22 per share, for the first quarter of 2016. Cash and cash equivalents at March 31, 2017, totaled $10.5 million, compared to $2.7 million at December 31, 2016. PWS is a rare and complex genetic neurobehavioral/metabolic disorder affecting appetite, growth, metabolism, cognitive function and behavior.  The committee on genetics of the American Academy of Pediatrics states PWS affects both genders equally and occurs in people from all geographic regions: its estimated incidence is one in 15,000 to 25,000 live births. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.  This disorder is typically characterized by hyperphagia, a chronic feeling of insatiable hunger, behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development.  Hyperphagia, in the absence of effective limitations to access to food, can lead to morbid obesity.  In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia, which is the unrelenting hunger that severely diminishes the quality of life for patients and their families, as the most important or a very important symptom to be relieved by a new medicine. DCCR has received Orphan Drug Designation from the US FDA for the treatment of PWS. Diazoxide choline controlled-release tablet is a novel, proprietary controlled-release, crystalline salt formulation of diazoxide, which is administered once-daily.  The parent molecule, diazoxide, as an oral suspension, has been used for decades in thousands of patients in a few rare diseases in neonates, children and/or adults, but not in PWS.  Essentialis conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS.  The DCCR development program is supported by positive data from two completed Phase II clinical studies and six completed Phase I clinical studies in various metabolic indications, as well as a pilot study in PWS patients.  In the PWS pilot study, DCCR showed promise in addressing the hallmark symptoms of PWS, most notably hyperphagia. Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.  The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase II/III clinical development program during 2017.  Soleno continues to market Capnia’s innovative medical devices, including the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns, Serenz® Nasal Relief, an over-the-counter nasal allergy relief wash available in the US, and the NeoForce portfolio of neonatal pulmonary resuscitation solutions. It is expected that these products will be monetized and will not be a focus for the company in the long term. For more information, please visit www.soleno.life. This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase II/III clinical development program of DCCR in PWS in the second half of 2017. We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on May 11, 2017, including under the caption titled "Risk Factors." Capnia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.


News Article | September 12, 2017
Site: www.prweb.com

Enterprise Management Associates (EMA), a leading IT and data management research and consulting firm, today announced it will host a research webinar titled “Optimizing Storage Architectures: An Objective Comparison of Leading Storage Intelligence Solutions,” featuring Steve Brasen, research director of systems and storage management at EMA. No IT infrastructure element is more impactful to service performance, reliability, and cost-effectiveness than storage. Processes for data access, distribution, and protection are directly impacted by the configurations of storage arrays, SAN fabrics, NAS systems, backup and disaster recover (BDR) devices, and hosted cloud storage solutions. Recognizing the importance of these resources but lacking visibility into their functional performance, most organizations overprovision storage solutions to ensure business requirements are continuously met. Storage Intelligence solutions provide key insights into the entire storage ecosystem, enabling informed decision making on improving service performance and reliability, the proactive identification of potential problems, and identifying opportunities for reducing the cost of operations. During this webinar, Brasen will provide insights from new research on storage intelligence, as well as a side-by-side comparison of the leading storage intelligence solution suites. Evaluated solutions include: The webinar is Tuesday, September 19 at 2:00 p.m. Eastern. Those who wish to attend can register at: http://research.enterprisemanagement.com/optimize-storage-architectures-webinar-pr.html About EMA Founded in 1996, EMA is a leading industry analyst firm that specializes in providing deep insight across the full spectrum of IT and data management technologies. EMA analysts leverage a unique combination of practical experience, insight into industry best practices, and in-depth knowledge of current and planned vendor solutions to help their clients achieve their goals. Learn more about EMA research, analysis, and consulting services for enterprise line of business users, IT professionals and IT vendors at http://www.enterprisemanagement.com or blogs.enterprisemanagement.com.

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