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News Article | May 8, 2017
Site: globenewswire.com

MIAMI, May 08, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), a multinational biopharmaceutical and diagnostics company, will announce operating and financial results for the three months ended March 31, 2017, after the close of the U.S. financial markets on Tuesday, May 9, 2017. OPKO’s senior management will provide a business update and discuss its financial results in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time on Tuesday, May 9, 2017. For those unable to participate in the live conference call or webcast, a replay will be available beginning May 9, 2017 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 17226044. The replay can be accessed for a period of time on OPKO’s website at http://investor.opko.com/events.cfm. About OPKO Health, Inc. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications. Our biologics business includes hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting oxyntomodulin for diabetes and obesity (in Phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.


News Article | May 4, 2017
Site: www.prlog.org

-- WOW Women Network (www.wwntwk.com), a place where great women gather informally to ignite relationships and build connections, held the monthly Coffee & Connections Networking event earlier this week at PTC in Needham.  The event was attended by over 60 women connected either through PTC's Women of PTC ERG or WWN, and was hosted by Super Connectors Kathy Cullen-Cote and Colleen Simonelli, both of PTC.Nettie Nitzberg, a recognized expert in helping global companies maximize their people investments and founder and principal of West5 Consulting (www.west5consulting.com), as well as founder of the WOW Women Network, facilitated the networking event, which featured an innovative networking style program that ditches the typical business networking protocols and instead delivers a truly unique connection-building experience.  Informal networking opportunities were also offered before the orchestrated program began.Attendees enjoyed the Ripple exercises and left the event with helpful strategies for future networking events.  Karen Gobler, principal at Vital Link, said, "The Ripple questions not only helped me think introspectively, but also connect with others at a deeper level. …You've empowered me with vital tools for navigating future events."  Cindy Loughran of Cindy Loughran Coaching, added, "[The] WOW networking event was great!...I appreciate you doing them and attracting such a great collection of women….I loved today's questions…It is such a great exercise.""We loved being joined by so many PTC women, and again express our gratitude to Kathy Cullen-Cote and Colleen Simonelli at PTC for stepping up and hosting this event!" said Nitzberg.  "And we're looking forward to meeting more fabulous women at additional upcoming events, currently planned for June, September, October and November," added Nitzberg.Nettie Nitzberg founded WOW Women in 2015 as a result of combining her love of connecting with her passion for supporting the success of women in business.  Now known as WOW Women Network, the organization's mission is to offer fun and creative ways to build connections and for women to get to know each other at a deeper level.  WWN events include Coffee & Connections (frequent morning events), Cocktails & Connections (casual, after-work morning events) and Community & Connections (opportunities to come together to offer service to a local organization providing help and support to women in crisis; usually once or twice a year).In addition, the WOW Women Network holds special events periodically, as well as quarterly Ripple Events, which feature an innovative networking style that ditches the typical business networking protocols and instead delivers a truly unique connection-building experience.Information about all of these events, as well as additional background on the organization and how to join, is available on the website, www.wwntwk.com West5 Consulting is a people and organization development company that is dedicated to solving people problems that impact business success.  Principal Nettie Nitzberg help clients optimize their processes for selecting, integrating and developing their most important resource – people, by creating work environments that attract, grow and retain top talent. West5 Consulting understands that the process starts, rather than ends, with a new hire. Their services include management and leadership development, onboarding, team building, culture, and more. Clients include PerkinElmer, PTC, JPMorgan Chase, TESARO, Babson College,McGraw-Hill Education, and Biogen, among others. Industries of interest include pharmaceutical, biomedical/biotechnology, higher education, finance, professional services, technology and non-profit organizations.  For additional information, please visit www.west5consulting.com or call 678-438-4803.


CARY, N.C.--(BUSINESS WIRE)--Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by TESARO, Inc. to be a specialty pharmacy provider in the distribution network for ZEJULA.


News Article | May 18, 2017
Site: www.prnewswire.com

Abbott Laboratories, AbbVie, Amgen Incorporated, Aptar Pharma, AstraZeneca, Aurobindo Pharma USA Inc., BCM Group LLC, Biogen Incorporated, Centurion Medical Products, Daicel Corporation, Eli Lilly, Ermo, FDA, Forest Laboratories, Janssen, McArdle & Associates, LLC, Merck Research Laboratories, MITSUBISHI GAS CHEMICAL, Nemera, Nipro, Nipro Europe NV, Novo Nordisk A/S, Nye Lubricants, Pfizer Global Pharmaceuticals, Philips – Medisize, Plastibell DTP Holding, Regeneron Pharmaceuitcals Inc, Robert Bosch Packaging Technology Inc, Sandoz Pharmaceuticals, SCHOTT Pharmaceutical Packaging, Schreiner MediPharm, Shire, Smithers Rapra, Takeda, Terumo Pharmaceutical Solutions, TESARO, West Pharmaceuticals Services Inc, Zeon Chemicals L.P. and more. The preliminary attendee list and a series of interviews with key speakers such as SCHOTT, Eli Lilly and Shire are also available to read in the event website's download centre. Pre-Filled Syringes West Coast takes place on June 5th and 6th, 2017 at the Hyatt Regency, San Diego, CA. Further information including a detailed agenda and full speaker line-up is available at www.prefilled-syringes-westcoast.com. For all media inquiries, contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: tarri@smi-online.co.uk. Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/attendee-list-released-for-pre-filled-syringes-san-diego-summit-300460177.html


MIAMI, May 18, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), announces that data from a prospective study conducted at Veteran Affairs (VA) hospitals confirming the 4Kscore test’s ability to accurately predict aggressive prostate cancer were presented in a podium presentation on May 16, 2017 at the 112th American Urological Association (AUA) Annual Meeting in Boston.  The study entitled, “An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer,” was presented by Sanoj Punnen, M.D., Assistant Professor of Urologic Oncology at the Miller School of Medicine, Department of Urology at the University of Miami in Miami, Florida. The study is the second U.S. prospective clinical study to establish the clinical validity of the 4Kscore test to predict the presence of aggressive prostate cancer prior to performing a prostate biopsy. The VA study was conducted at eight VA hospitals across the United States. A total of 366 men were enrolled in the study, and 208 (56%) of the participants were African American. Of all cancers diagnosed among African American men, prostate cancer is the most common (31% of all cancers), and African American men have a twofold greater risk of prostate cancer mortality compared to non-Hispanic whites.1 Overall, the 4Kscore demonstrated a high degree of accuracy for predicting the presence of aggressive (Gleason score 7 and higher) prostate cancer with an area under the receiver operator curve (AUC) of 0.81, significantly better than PSA alone or a clinical model based on PSA. Importantly, there was an equally high ability of the 4Kscore to discern aggressive disease in the African American men compared with the non-African American men (AUC = 0.80 v. 0.84, p = 0.32). The calibration and decision curve analysis were also consistent with the performance shown in the first U.S. validation study. “The VA study confirms the 4Kscore’s accuracy in predicting a man’s risk of having aggressive prostate cancer and showed that it is an equally effective and vital clinical test for African American men, who have the highest rates of prostate cancer mortality,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health. “These positive results add to our growing body of clinical evidence that demonstrate 4Kscore’s utility to accurately identify the risk of aggressive prostate cancer. Moreover, these data validate the clinical value of the 4Kscore test in a VA setting and show it to be identical to the performance previously shown in community and academic sites across the U.S. and Europe.” According to the Prostate Cancer Foundation,2 “every 3.3 minutes a man is diagnosed with prostate cancer, and millions of men and their families are fighting the disease globally. In the United States, prostate cancer affects 1 in 8 men, making it the most common non-skin cancer in America. This means that a non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma, and kidney cancers combined. In 2017 alone, it is estimated that more than 161,000 men will be diagnosed with prostate cancer, and more than 27,000 will die from the disease. A man of African descent is 73% more likely to develop prostate cancer than a Caucasian man, and more than twice as likely to die from the disease.” The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient's age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines. OPKO Health is a diversified healthcare company that seeks to establish industry leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy) , OPK88002, a NK-1 antagonist to treat pruritus ( itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet Syndrome. In addition, the Company is advancing its CTP technology, which includes a long acting hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and a long acting Factor VIIa drug for hemophilia in phase 2a. OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the clinical utility for the 4Kscore test, its ability to accurately predict aggressive prostate cancer in men generally and in the African American population, the expected benefits of our 4Kscore test, whether clinical trial results are indicative of the 4Kscore test's ability to predict aggressive prostate cancer, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, today announced the appointment of David Brooks, M.D., Ph.D., to Senior Vice President, Clinical Development. Dr. Brooks will be responsible for the execution of Eleven’s ongoing and planned clinical trials. He will report to Arthur DeCillis, M.D., Chief Medical Officer. “Eleven is at a pivotal inflection point, as we progress our Phase 3 registration trial of Vicinium™ and prepare to advance our second program, Proxinium™, into a Phase 1/2a study in combination with a checkpoint inhibitor,” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “We are pleased to welcome David to the Eleven team as we continue to build out our clinical development organization. David brings a highly-relevant skillset, including experience overseeing the simultaneous development of multiple oncology programs as monotherapies and in combination with immuno-oncology agents. We look forward to his contributions as we continue to evaluate the potential of our locally- and systemically-administered TPTs and work to bring new medicines that improve upon existing therapeutic options to patients.” Dr. Brooks joins Eleven Biotherapeutics from Deciphera Pharmaceuticals, where he served as Vice President, Clinical Research and Translational Medicine. In this role, Dr. Brooks led the clinical development of four oncology product candidates, set clinical strategy for assets entering testing in direct anti-tumor and immune combination therapy, and planned clinical trials evaluating the combination of immunotherapies with novel myeloid cell checkpoint blockers. Prior to joining Deciphera, Dr. Brooks was Senior Director Physician, Oncology Early Clinical Development at AstraZeneca, where he led the clinical development of a dual specificity PI3K inhibitor across multiple oncology indications and managed a portfolio of external alliances and investigator-sponsored studies. Earlier in his career, Dr. Brooks served as Medical Head, Translational Medicine at TESARO Inc., as Chief Medical Officer and Senior Vice President at Generation Health, Inc., and as Medical Director, Global Clinical Medicine at Abraxis Bioscience, Inc. He also worked at Shire Human Genetic Therapies, Inc. and Merck & Co., Inc. Dr. Brooks holds a M.D. and Ph.D. in Molecular Biology from Cornell University. He completed his residency in Internal Medicine at the University of Pennsylvania and a fellowship in Medical Genetics at the Children’s Hospital of Philadelphia/Hospital of the University of Pennsylvania. He also served as an Instructor in Medicine in the Division of Medical Genetics at the University of Pennsylvania. “I am pleased to join the Eleven team at such an important time,” said Dr. Brooks. “The Company’s lead drug candidates have demonstrated promising anti-tumor activity and safety as single agents. I am eager to work with Eleven’s team to further demonstrate the potential of Vicinium in the clinic. I am particularly excited to progress the ongoing Phase 3 registration trial of Vicinium for patients with high-grade non-muscle invasive bladder cancer, a disease which has not seen meaningful advancements in approximately forty years.” Dr. Brooks is the third recent addition to Eleven’s clinical development group in recent months. In the first quarter, Eleven appointed Gary Conboy as Executive Director, Clinical Sciences and Mary Rohrer as Associate Director, Clinical Operations. Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based upon the Company's TPT platform. The Company's TPTs incorporate a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule in order to achieve focused tumor cell killing. The Company believes its TPT approach offers significant advantages in treating cancer over existing ADC technologies. The Company believes its TPTs provide effective tumor targeting with broader cancer cell-killing properties than are achievable with small molecule payloads that require tumor cell proliferation and face multi-drug resistance mechanisms. Additionally, the Company believes that its TPT's cancer cell-killing properties promote an anti-tumor immune response that will potentially combine well with immuno-oncology drugs such as checkpoint inhibitors. For more information please refer to the Company's website at www.elevenbio.com. Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement, the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of clinical trials, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company's product candidates and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.


MIAMI, May 18, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), announces that data from a prospective study conducted at Veteran Affairs (VA) hospitals confirming the 4Kscore test’s ability to accurately predict aggressive prostate cancer were presented in a podium presentation on May 16, 2017 at the 112th American Urological Association (AUA) Annual Meeting in Boston.  The study entitled, “An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer,” was presented by Sanoj Punnen, M.D., Assistant Professor of Urologic Oncology at the Miller School of Medicine, Department of Urology at the University of Miami in Miami, Florida. The study is the second U.S. prospective clinical study to establish the clinical validity of the 4Kscore test to predict the presence of aggressive prostate cancer prior to performing a prostate biopsy. The VA study was conducted at eight VA hospitals across the United States. A total of 366 men were enrolled in the study, and 208 (56%) of the participants were African American. Of all cancers diagnosed among African American men, prostate cancer is the most common (31% of all cancers), and African American men have a twofold greater risk of prostate cancer mortality compared to non-Hispanic whites.1 Overall, the 4Kscore demonstrated a high degree of accuracy for predicting the presence of aggressive (Gleason score 7 and higher) prostate cancer with an area under the receiver operator curve (AUC) of 0.81, significantly better than PSA alone or a clinical model based on PSA. Importantly, there was an equally high ability of the 4Kscore to discern aggressive disease in the African American men compared with the non-African American men (AUC = 0.80 v. 0.84, p = 0.32). The calibration and decision curve analysis were also consistent with the performance shown in the first U.S. validation study. “The VA study confirms the 4Kscore’s accuracy in predicting a man’s risk of having aggressive prostate cancer and showed that it is an equally effective and vital clinical test for African American men, who have the highest rates of prostate cancer mortality,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health. “These positive results add to our growing body of clinical evidence that demonstrate 4Kscore’s utility to accurately identify the risk of aggressive prostate cancer. Moreover, these data validate the clinical value of the 4Kscore test in a VA setting and show it to be identical to the performance previously shown in community and academic sites across the U.S. and Europe.” According to the Prostate Cancer Foundation,2 “every 3.3 minutes a man is diagnosed with prostate cancer, and millions of men and their families are fighting the disease globally. In the United States, prostate cancer affects 1 in 8 men, making it the most common non-skin cancer in America. This means that a non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma, and kidney cancers combined. In 2017 alone, it is estimated that more than 161,000 men will be diagnosed with prostate cancer, and more than 27,000 will die from the disease. A man of African descent is 73% more likely to develop prostate cancer than a Caucasian man, and more than twice as likely to die from the disease.” The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient's age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines. OPKO Health is a diversified healthcare company that seeks to establish industry leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy) , OPK88002, a NK-1 antagonist to treat pruritus ( itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet Syndrome. In addition, the Company is advancing its CTP technology, which includes a long acting hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and a long acting Factor VIIa drug for hemophilia in phase 2a. OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the clinical utility for the 4Kscore test, its ability to accurately predict aggressive prostate cancer in men generally and in the African American population, the expected benefits of our 4Kscore test, whether clinical trial results are indicative of the 4Kscore test's ability to predict aggressive prostate cancer, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


WALTHAM, Mass., May 22, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the results of the Our Way Forward survey – a national survey of patients and healthcare providers developed to better understand the unmet education and support needs of the advanced ovarian cancer community. Created with input from leading ovarian cancer advocacy groups – National Ovarian Cancer Coalition (NOCC) and Ovarian Cancer Research Fund Alliance (OCRFA) – the results from the survey indicate that regardless of the stage of ovarian cancer, there is uncertainty among patients about what to expect after diagnosis – whether they are initially diagnosed or actively seeking greater resources and connections to lessen the burden of the disease. The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 2017 and May 2017 among 254 women living with ovarian cancer and 232 physicians who treat ovarian cancer patients. “Facing ovarian cancer can be extremely stressful and anxiety-provoking,” said Stephanie V. Blank, MD, Professor in the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai, and Director of Women's Health, Mount Sinai Downtown-Chelsea Center. “We can support survivors by better understanding their needs and perspectives, and how these evolve with time.” The survey reveals that around half (53 percent) of patients felt that ovarian cancer had a severe or very severe impact on their lives. For patients who are currently in treatment or who have been treated, about half (49 percent) admitted that they find not being sure of the path forward after diagnosis to be very or extremely challenging. According to the survey, more than two in five patients who are currently in treatment, or who have been treated, find not knowing what to expect during treatment (46 percent) or after treatment (47 percent) to be very or extremely challenging. These findings were significantly pronounced in women surveyed who experienced a recurrence of their disease. Women who experienced recurrence were more likely than those who have not experienced a recurrence to say they currently feel fear (32 percent vs. 15 percent), anxiety (36 percent vs. 22 percent) and uncertainty (31 percent vs. 18 percent). The overwhelming majority (87 percent) of women who have experienced recurrence report the thought of cancer returning can be overwhelming and more than half (58 percent) report the period of remission when they are no longer receiving therapy is sometimes worse than going through treatment. Understanding the gaps in perception among patients and healthcare providers, as well as anxiety and uncertainty that exists between the two, may help improve care and patient well-being throughout the ovarian cancer experience. More than seven in ten (71 percent) ovarian cancer patients reported getting very anxious before visits to their healthcare provider. More than a third (34 percent) of healthcare providers are unsure if, or do not feel that, they give their ovarian cancer patients all of the information they need about ovarian cancer. There are also differences in how often patients and healthcare providers perceive they are having discussions about treatment and expectations for managing ovarian cancer. Patients are craving information from their healthcare providers about expectations, treatment, recurrence and support. For example, 61 percent of patients said it would be very or extremely helpful to discuss with their healthcare provider how to cope with the unknown. “We are incredibly grateful for the community’s robust response to the survey,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “As an organization, TESARO is committed to being a trusted partner to the ovarian cancer community and we hope to continue to work with NOCC and OCRFA to find a way forward on behalf of this underserved community and strengthen the emotional and education support that patients and oncologists have as it relates to ovarian cancer, no matter the stage of their disease.” Resources for Ovarian Cancer Patients The survey was conducted as part of TESARO’s Our Way Forward initiative (www.ourwayforward-oc.com), a call-to-action that encourages patients, their loved ones and physicians to rethink how they talk about advanced ovarian cancer and ways to partner together to navigate the physical and emotional challenges that the disease brings. As part of Our Way Forward, TESARO is committed to offering a series of resources for patients living with ovarian cancer, directly informed by the survey insights, including a discussion guide available for download that provides suggested questions and topics for the stages of ovarian cancer experience, including disease recurrence. TESARO is also partnering with “The Moth” for a special storytelling event, “Stories that Illuminate the Ovarian Cancer Experience,” which will provide a forum for patients, advocates and physicians to share their stories and for everyone in attendance to learn more about how to strengthen conversations to facilitate patient care and well-being. The first Our Way Forward storytelling event will be hosted in Chicago in June. About the Our Way Forward Survey          The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 13 and May 2, 2017, among 254 women 18+ years of age living in the U.S. who have been diagnosed with ovarian cancer. Survey respondents were selected from individuals who had agreed to participate in surveys through the Harris Poll and their partners or were recruited to participate by patient advocacy organizations, NOCC and OCRFA. Results are representative of only those surveyed. A parallel survey was conducted between April 17 and May 5, 2017, among 232 physicians who treat ovarian cancer patients in the U.S. consisting of 201 medical oncologists and 31 gynecologic oncologists. Survey respondents were selected from physicians who had agreed to participate in surveys through the Harris Poll and their partners. More information about the campaign, full survey methods and survey findings, including important resources to enhance conversations about ovarian cancer, are available on the Our Way Forward website at www.ourwayforward-oc.com and via NOCC at ovarian.org and OCRFA at ocrfa.org. About Ovarian Cancer  Approximately 22,000 women are diagnosed with ovarian cancer each year in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth leading cause of cancer death among women. Despite high-response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85 percent of patients will experience recurrence within two years. Per NCCN guidelines, BRCA testing and genetic counseling remain important components of the medical workup for all patients upon a diagnosis with ovarian cancer. About National Ovarian Cancer Coalition (NOCC) Founded in 1991, the mission of the NOCC is to save lives by fighting tirelessly to prevent and cure ovarian cancer, and to improve the quality of life for Survivors. Through national programs and local NOCC chapter initiatives, the NOCC's goal is to educate communities and increase awareness about the symptoms of ovarian cancer. The NOCC also offers information to assist newly-diagnosed patients, hope to Survivors, and support to caregivers. The NOCC is also committed to the advancement of ovarian cancer research, specifically in funding the Ovarian Cancer Dream Team with Stand Up To Cancer®. About Ovarian Cancer Research Foundation Alliance (OCRFA) Ovarian Cancer Research Fund Alliance (OCRFA) is the largest global organization dedicated to fighting ovarian cancer.  OCRFA advances research to prevent, treat and defeat ovarian cancer, supports women and their families before, during and beyond diagnosis, and works with all levels of government to ensure ovarian cancer is a priority.  As the largest non-government funder of ovarian cancer research, OCRFA invests in innovative, promising research.  And OCRFA is the voice for the ovarian cancer community: fighting for more resources and policies on Capitol Hill, helping future health professionals recognize the disease through our Survivors Teaching Students® program, providing hope and insight by pairing newly diagnosed patients with our Woman to Woman program and connecting survivors at our Ovarian Cancer National Conference.  We are united to defeat ovarian cancer.  www.ocrfa.org About TESARO  TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. 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