Cns | Date: 2015-08-21
Remote collaboration systems and methods may involve a server in communication with a network and a plurality of remote computers in communication with the network. The server may connect to the plurality of remote computers via the network. The server may generate a collaboration environment for each of the remote computers. The server may assign an access level from a plurality of access levels to each of the remote computers, the plurality of access levels including a view only access level and an edit access level. The server may provide secure access to a file to each of the remote computers at the access level assigned to each of the remote computers via the collaboration environment. The file can be remotely viewed by any of the remote computers having a view only access level and remotely viewed and remotely edited by any of the remote computers having an edit access level via the collaboration environment.
News Article | April 28, 2017
Scientific experiments, especially those that are meant to be used in the medical field, usually raise ethical concerns. However, one experiment published in the CNS Neuroscience and Therapeutics took the adage "two heads are better than one" quite literally. Tech Times reported in August 2016 that a Russian man volunteered to become the donor for a head transplant. Now it seems that it is possible after scientists successfully grafted a small rat head onto a bigger one. It is already a bizarre but remarkable event when the rare polycephaly condition appears, but it is rather unsettling when scientists force the condition by experimenting on animals, regardless of success rate, with the intention of expanding the procedure to humans. Researchers from China, along with Harbin Medical University researcher Xiaoping Ren, and Italian neurosurgeon Sergio Canavero, however, claim to have successfully transplanted a small rat's head onto a recipient rat without it suffering from blood loss or hypothermia. The key, apparently, is to use a third rat as a blood source during the procedure. By connecting the donor rat to the third rat using a silicone tube that is connected to a pump, blood flow to the brain tissue was guaranteed. The silicone tube also regulated the temperature to ensure that the donor rat's brain tissue is protected from hypothermia. Using the new bicephalic model the scientists developed, they concluded that there were no brain-damaging blood loss that occurred throughout the entire operation. They also found that the temperature-regulated silicone tube effectively protected brain tissue from hypothermia, allowing for a successful head transplant. The scientists noted, however, that the donor rat — the small rat whose head was cut off to be attached to another rat — showed signs that it was in pain. "Postoperative donor has pain reflex and corneal reflex," the study notes. The rats only survived for a short period after the experiment. Of course, the scientists are aiming to achieve long-term survival for both host and donor but it must be noted that the experiment was done to test the effectiveness of the transplant model they developed. While that seems cruel and unethical, the scientists were satisfied with the positive result of the model they developed. Satisfied enough, in fact, that Canavero already plans to test the procedures on humans in December 2017 — which could be either an exciting or extremely painful time for its volunteer, Valery Spiridonov. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.
News Article | April 20, 2017
VIDEO: New research shows children may struggle when crossing a busy road. Two reasons are perceptual judgment and motor skills, which were identified in a series of tests in which children... view more For adults, crossing the street by foot seems easy. You take stock of the traffic and calculate the time it will take to get from one side to the other without being hit. Yet it's anything but simple for a child. New research from the University of Iowa shows children under certain ages lack the perceptual judgment and motor skills to cross a busy road consistently without putting themselves in danger. The researchers placed children from 6 to 14 years old in a realistic simulated environment (see video) and asked them to cross one lane of a busy road multiple times. The results: Children up to their early teenage years had difficulty consistently crossing the street safely, with accident rates as high as 8 percent with 6-year-olds. Only by age 14 did children navigate street crossing without incident, while 12-year-olds mostly compensated for inferior road-crossing motor skills by choosing bigger gaps in traffic. "Some people think younger children may be able to perform like adults when crossing the street," says Jodie Plumert, professor in the UI's Department of Psychological and Brain Sciences. "Our study shows that's not necessarily the case on busy roads where traffic doesn't stop." For parents, that means taking extra precautions. Be aware that your child may struggle with identifying gaps in traffic large enough to cross safely. Young children also may not have developed the fine motor skills to step into the street the moment a car has passed, like adults have mastered. And, your child may allow eagerness to outweigh reason when judging the best time to cross a busy street. "They get the pressure of not wanting to wait combined with these less-mature abilities," says Plumert, corresponding author on the study, which appears in the Journal of Experimental Psychology: Human Perception and Performance, published by the American Psychological Association. "And that's what makes it a risky situation." The National Center for Statistics and Analysis reported 8,000 injuries and 207 fatalities involving motor vehicles and pedestrians age 14 and younger in 2014. Plumert and her team wanted to understand the reasons behind the accident rates. For the study, they recruited children who were 6, 8, 10, 12, and 14 years old, as well as a control group of adults. Each participant faced a string of approaching virtual vehicles travelling 25 mph (considered a benchmark speed for a residential neighborhood) and then crossed a single lane of traffic (about nine feet wide). The time between vehicles ranged from two to five seconds. Each participant negotiated a road crossing 20 times, for about 2,000 total trips involving the age groups. The crossings took place in an immersive, 3-D interactive space at the Hank Virtual Environments Lab on the UI campus. The simulated environment is "very compelling," says Elizabeth O'Neal, a graduate student in psychological and brain sciences and the study's first author. "We often had kids reach out and try to touch the cars." The researchers found 6-year-olds were struck by vehicles 8 percent of the time; 8-year-olds were struck 6 percent; 10-year-olds were struck 5 percent; and 12-year-olds were struck 2 percent. Those age 14 and older had no accidents. Children contend with two main variables when deciding whether it's safe to cross a street, according to the research. The first involves their perceptual ability, or how they judge the gap between a passing car and an oncoming vehicle, taking into account the oncoming car's speed and distance from the crossing. Younger children, the study found, had more difficulty making consistently accurate perceptual decisions. The second variable was their motor skills: How quickly do children time their step from the curb into the street after a car just passed? Younger children were incapable of timing that first step as precisely as adults, which in effect gave them less time to cross the street before the next car arrived. "Most kids choose similar size gaps (between the passing car and oncoming vehicle) as adults," O'Neal says, "but they're not able to time their movement into traffic as well as adults can." The researchers found children as young as 6 crossed the street as quickly as adults, eliminating crossing speed as a possible cause for pedestrian-vehicle collisions. So what's a child to do? One recommendation is for parents to teach their children to be patient and to encourage younger ones to choose gaps that are even larger than the gaps adults would choose for themselves, O'Neal says. Also, civic planners can help by identifying places where children are likely to cross streets and make sure those intersections have a pedestrian-crossing aid. "If there are places where kids are highly likely to cross the road, because it's the most efficient route to school, for example, and traffic doesn't stop there, it would be wise to have crosswalks," Plumert says. Yuanyuan Jiang, Luke Franzen, Pooya Rahimian, all graduate students in the UI's Department of Computer Science, and Joseph Kearney, computer science professor, are contributing authors. Paul Yon, who earned a master's degree at the UI, also contributed to the study. The U.S. National Science Foundation funded the work through grant awards BCS-1251694 and CNS-1305131.
News Article | April 25, 2017
FRAMINGHAM, Mass.--(BUSINESS WIRE)--Alzheon announced publication of a newly elucidated molecular mechanism of action for tramiprosate, the active agent in the company’s lead clinical drug candidate ALZ-801, in the journal CNS Drugs.
News Article | April 27, 2017
SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced a comprehensive program update on entrectinib - an investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions - currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2. “Today’s update is the result of our team’s diligent efforts to advance entrectinib through the clinic for the benefit of patients with TRK and ROS1 fusion-positive cancers,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We are proud to announce substantial progress towards dual entrectinib NDA submissions for both TRK and ROS1, and are excited by the opportunity to serve two distinct groups of patients with cancer.” A conference call and webcast is being held on April 27, 2017 at 4:30 p.m. Eastern/1:30 p.m. Pacific to discuss the entrectinib program update. To participate in the conference call, please dial (877) 548-7906 (U.S.) or (719) 325-4765 (International) and provide Conference ID 2028635. To access the live webcast, go to https://www.ignyta.com/investors/. A replay of the presentation will be available shortly after the conclusion of the live call in the Investors section of the company's website at https://www.ignyta.com/investors/, and will be archived and available at that site for 14 days. Blazing a New Future for Patients with Cancer™ At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with the rarest cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class or best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations. For more information, please visit: www.ignyta.com. This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the development of entrectinib and our other product candidates, including the ability to reduce the size of certain CNS tumors; the clinical and/or non-clinical data or plans underlying entrectinib or any of our other development programs, and the timelines associated with such programs; our ability to design and conduct development activities for entrectinib and our other development programs; our ability to develop or access companion diagnostics for our product candidates; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to adequately fund our development programs; our ability to obtain regulatory approvals in order to market any of our product candidates or companion diagnostic tests; references to the potential market size for our products; and our ability to successfully commercialize any approved products. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta's plans to develop and commercialize its product candidates; the ability of our contract manufacturers to produce the active pharmaceutical ingredient and/or drug product necessary for clinical trials or commercialization of entrectinib or our other product candidates; the potential for final results of the ongoing clinical trials of entrectinib or other product candidates, or any future clinical trials of entrectinib or other product candidates, to differ from preliminary or expected results; Ignyta's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta's ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the potential for the company to fail to maintain the CAP accreditation and CLIA certification of its diagnostic laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent Quarterly Reports on Form 10-Q.
News Article | April 28, 2017
Group’s audited profit for the year 2016 compared to the preliminary results reported on February 28 for Q4 2016 has been improved by 1,500 thousand euros. The main reason of the profit increase is accrued selling expense reversal. Consequently this also affected retained earnings and accrued expenses captions in the statement of financial position. Sales of the Parent company in 2016 reached 91.1 million euros, which represents an increase by 8% compared to 2015, when Parent Company’s sales were 84.7 million euros. In 2016 the Parent company made a net profit of 9.6 million euros, which is a reduction by 34% compared to 2015, when the net profit of the Parent company was 14.6 million euros. The most rapid sales increase of the Group in 2016 was achieved in Uzbekistan, where sales grew by 65%. In 2016 Lithuania became one of the ten biggest markets of the Group, replacing Tajikistan. The biggest sales markets of the Group on 2016 were Russia, Latvia, Ukraine and Belarus. The most rapid sales increase of the Parent company in 2016 was achieved in Uzbekistan, where sales grew by 65%. Sales to Lithuania grew by 34% and sales to Belarus and the UK, each grew by 17%. The biggest sales reduction took place in The Netherlands, where sales shrunk by 56%. In 2016 Lithuania became one of the ten biggest markets also for the Parent company, as it replaced Turkmenistan. The biggest sales markets of the Parent company in 2016 were Russia, Ukraine Latvia and Belarus. The best sold products of the Parent company in 2016 were CNS medicines Neiromidin, Noofen and Adaptol, antibacterial preparations of Furamag and Furasol, antiarrhythmic medicine Etacizin, antituberculosis products PASA Sodium salt and antiallergic medicine Fenkarol. Share of company’s bestselling product Neiromidin in total sales of the Parent company increased from 18% to 20% in 2016. During the reporting period, registration processes of Parent company’s products continued in Turkey, Armenia, Russia, Kazakhstan, Lithuania, Moldova, Bosnia and Herzegovina, Myanmar, Cameroon and Vietnam. Registration of several products has been successfully completed in Estonia, Kyrgyzstan, Azerbaijan, Turkmenistan, Ukraine, Mongolia, Armenia, Turkmenistan and Bosnia and Herzegovina. Registration processes of several other products were launched in Turkey. Annual meeting of shareholders of JSC Olainfarm held on June 7, 2016 approved operating plan of the Group for 2016. According to it, sales of the Group in 2016 were planned to be 100 million euros, but the net profit was expected reach 10 million euros. According to this audited report for 2015, during this period 111% of annual sales target is met and annual profit target is exceeded by 16%. At the same meeting targets for Parent company’s operations were approved, stating that Parent company’s sales target is 86 million euros, but the profit target is 9 million euros. According to these accounts, Parent company met 106% of sales target and exceeded its profit target by 7%. JSC Olainfarm is one of the biggest pharmaceutical companies in Latvia with 45 years of experience in production of medication and chemical and pharmaceutical products. A basic principle of company's operations is to produce reliable and effective top quality products for Latvia and the rest of the world. Products made by the Group are being exported to more than 35 countries of the world, including the Baltics, Russia, other CIS, Europe, Asia, North America and Australia.
News Article | May 1, 2017
NEW YORK, May 01, 2017 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced the appointment of Emmanuel O. Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24 years of regulatory experience within the U.S. Food and Drug Administration (FDA), having held leadership positions at the FDA’s Center for Drug Evaluation and Research (CDER). “Dr. Fadiran has an accomplished track record of working within the FDA,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “His depth of experience makes him an excellent choice to manage the considerable number of regulatory filings that Anavex has planned.” Prior to joining Anavex, Dr. Fadiran served as a Clinical Pharmacology Team Leader at the FDA’s CDER. During his 24-year (1993-2017) tenure at the FDA, Dr. Fadiran reviewed hundreds of New Drug Applications (NDAs), supplemental New Drug Applications (sNDAs), Biologics License Application (BLAs), Abbreviated New Drug Applications (ANDAs) and Investigational New Drug applications (INDs) for approval and made strategic recommendations for the development of several products across many therapeutic categories. He was on review teams for several novel therapies including first-in-class approvals. Dr. Fadiran also led a cross-disciplinary NDA review team and authored the first Cross-Discipline Team Leader (CDTL) review for the Division of the Pulmonary and Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and implementation of the U.S. FDA Guidance for Industry for population pharmacokinetics. “I am very pleased to be joining Anavex at this important and exciting time for the company,” stated Dr. Fadiran. “There are tremendous opportunities ahead, and I look forward to working with the Anavex team to deliver on the corporate objectives for 2017 and beyond.” Dr. Fadiran has been involved in the formulation of significant strategic FDA regulatory initiatives including serving as a member of the Senior Management Teams for the Data Standard (Janus) and Sentinel Initiatives. He was an active member of the FDA Senior Science Council working group for the creation and launching of the FDA’s Strategic Plan for Regulatory Science in 2012. Recently, he has played an active role in the development of the Comprehensive in vitro Proarrhythmia Assay (CiPA) for future replacement of the thorough QT studies. As a long-term member of the FDA Institutional Review Board (IRB), he actively contributed to the development of standard operating procedures (SOP) for the committee. Dr. Fadiran holds a BS (Pharmacy) and MS from Obafemi Awolowo University, Ile-Ife, Nigeria and a PhD in Pharmaceutical Sciences from the University of Strathclyde, Glasgow, UK. Dr. Fadiran is a recipient of the prestigious Fogarty International Fellowship of the National Institutes of Health (NIH) (1991-1993) as well as numerous awards from the FDA, among them the Commissioner’s Award of Excellence, in recognition of his outstanding contributions to regulatory review of applications and development of regulatory guidance and policies. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, recently successfully completed a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors and successfully completed Phase 1. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX 2-73 has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
News Article | April 27, 2017
One year after launching iOS version of PPD ACT in the U.S. and Australia, UNC School of Medicine launches Android version and Canada launches iOS app to increase participation. CHAPEL HILL, N.C. - The UNC School of Medicine today launched the Android version of PPD ACTTM, a mobile app-based study helping to further the understanding of why some women suffer from Postpartum Depression (PPD) and others do not - critical knowledge for researchers working to find more effective treatments. PPD ACTTM, previously available for iOS only, is now available in the U.S. and Australia for Android devices and the iOS version is now available in Canada. Additionally, all users in the U.S. may access a new module to help researchers understand the economic impact and burden that PPD has on society. The app surveys women to identify those who have had symptoms of PPD and invites certain women to provide DNA samples so that researchers can study the genes of those affected by PPD. During its first year, approximately 14,000 women enrolled in the study, far surpassing expectations. PPD ACT was initially launched as an iPhone-based ResearchKit app, an open-source framework developed by Apple that allows researchers to create app-based studies with global reach. However, since approximately half of the U.S. population uses Android phones, as do many women in Australia, this new version of the app will open the doors for many more women to participate. Additionally, a Canadian team led by Women's College Hospital in Ontario, Canada, has received funding to expand the iOS app into Canada, responding to the numerous requests from Canadian women wanting to participate in the study. "The participation from the first year of the study is astounding and, frankly, unprecedented in terms of using the social media platform of an app to recruit women for study participation involving the donation of genetic samples," said Samantha Meltzer-Brody, MD, MPH, director of the Perinatal Psychiatry Program at the UNC Center for Women's Mood Disorders and lead researcher for the study. "Launching the Android version in the U.S. and Australia and expanding into Canada allows for an even larger group of women the opportunity to share their experiences so that we can more effectively diagnose and treat PPD in the future." This study is the first of its kind and uniquely designed for rapid collection of a large number of DNA samples required for genetic analysis. The eventual goal is to gather 50,000 samples from around the globe through continued expansion to additional countries. PPD ACTTM has also had impact beyond research. Many women have sought care and treatment based on symptoms that became apparent after completing the screening module of the app. "As someone who experienced a variation of PPD symptoms after the births of both of my daughters, I would have welcomed an application, in the privacy of my home, at my fingertips, to potentially help target the 'what and why' of this temporary mental health challenge," said patient Jamie Belsito. "In addition to gathering valuable data, PPD ACT is also starting a much-needed dialogue to help eradicate the stigma often associated with PPD, and to encourage more providers to thoroughly screen for and treat PPD." The U.S. version of the app will also now feature a module which will help researchers better understand the burden that PPD has on patients' quality of life, maternal function, bonding and utilization of health care services. Currently, researchers have an inadequate understanding of the economic burden and the cost of PPD on society. This health outcomes research is being conducted in collaboration with Sage Therapeutics, Inc. "Until now, the impact of PPD on individuals, their families, and society has been poorly understood. This research, undertaken by UNC, Sage and our collaborators, helps to provide a new, real-world, data-driven understanding of the disease burden postpartum depression patients experience and of their healthcare utilization," said Steve Kanes, MD, PhD, Chief Medical Officer at Sage. "We are very excited to collaborate with UNC in helping to further study the functional and economic impact of this complication of pregnancy." Android users in the U.S. and Australia will be able to download PPD ACTTM from Google Play. The app continues to be available for iPhone users as a free download from the App Store in the U.S. and Australia, and it is now also available in Canada. International research partners include The University of Queensland in Australia and Women's College Hospital in Toronto, Canada. To help spread the message, UNC has partnered with Postpartum Support International, which is dedicated to increasing awareness among public and professional communities about the emotional changes that women experience during pregnancy and postpartum. "Postpartum Support International is thrilled to partner with UNC on this pioneering study, and to collaborate with researchers around the world," said Ann Smith, president of Postpartum Support International. "We will spread the message and opportunity to participate through our global network of volunteers and professional members. We are confident that findings from this study will prevent suffering and increase positive outcomes for future generations." The app is intended for women 18 years or older who have previously given birth and believe they may have experienced or are currently experiencing signs or symptoms of PPD such as anxiety, depression, guilt, irritability or extreme sadness. To download the app or learn more about the study or PPD, visit pactforthecure.com. Patrick Sullivan, MD, Yeargen Distinguished Professor of Psychiatry and Genetics at the UNC School of Medicine, is a co-investigator in this project. Development of the app and support for the study are provided by the Foundation of Hope for research and treatment of mental illness; Sage Therapeutics, a neuroscience-focused company discovering medicines to treat life-threatening, rare CNS disorders; the UNC Departments of Genetics and Psychiatry; and the UNC Center for Health Innovation. Little Green Software, a full-service app development firm, developed the app. The UNC Center for Women's Mood Disorders is internationally known in the evaluation and treatment of women with mood disorders that occur during periods of hormonal change. Reproductive mood disorders include depression and anxiety disorders associated with the reproductive life cycle. To learn more, click here. Established by the UNC Health Care System (UNC HCS) and the UNC School of Medicine (UNC SOM), the Center for Health Innovation initiates, evaluates and supports the adoption of disruptive, patient-centered innovations in the delivery and financing of health care. The Center strives to provide rapid assessment, coordinated facilitation, program management, partnership development and funding for innovation. To learn more, click here.
News Article | April 26, 2017
"Our net sales and operating profit were higher in January-March 2017 than in January-March of the previous year. The higher operating profit was due to growth in net sales, and in addition higher milestone payments than in the previous year. "The Easyhaler product family for treatment of asthma and chronic obstructive pulmonary disease continued to grow well, led by the Bufomix Easyhaler combined formulation. As regards our other key proprietary products, intensive care sedative Dexdor continued to grow strongly and sales of Simdax for treatment of acute decompensated heart failure, which has been in the markets for a long time, also continued to grow well. As expected, sales of Orion's branded Parkinson's drugs Stalevo, Comtess and Comtan continued to decline, but growing other products were able to compensate for the decline in sales of Parkinson's drugs and increase the total sales of the Proprietary Products business division. "Net sales of the Specialty Products business division were similar to the previous year. The halt to growth was due to changes in the market environment and ever-intensifying competition, for example in Finland, where changes were made to the pricing system for substitutable prescription drugs at the beginning of the year that narrowed the so-called price band. In addition, sales of Remsima, which delivered clear growth in previous years, were slightly lower in the first quarter than in the comparative period, mainly due to the timing of the national tendering competition in Norway. "Fermion's sales grew well in the first quarter. In recent years order cycles in the trade in pharmaceutical raw materials have become ever shorter, and this has led to clearly greater fluctuation in business volume than before within each year and between different years. Our other business divisions were able to increase their net sales in the first quarter of the year. "Orion's new Senior Vice President for Research and Development, Christer Nordstedt, became a member of Orion's Executive Management Board in February. During the review period we focused on taking forward our ongoing clinical development projects, which have progressed as planned. After the review period, in April we submitted a marketing authorisation application for the new salmeterol-fluticasone combined formulation in the Easyhaler product family in Europe. "We estimate that in 2017 net sales will be at similar level to 2016. We estimate that operating profit excluding material capital gains will be at least EUR 280 million. Our outlook estimate and the basis for it can be found in this report under 'Outlook for 2017' and 'Basis for outlook'." On 13 February Orion announced the appointment of Dr Christer Nordstedt, M.D., Ph.D., as Senior Vice President for Research and Development and member of the Executive Management Board of the Orion Group as of 21 February 2017. On 1 March Orion transferred altogether 107,965 Orion Corporation B shares held by the Company as share bonuses for the earning periods 2014-2016 and 2016 to the persons belonging to the Share-based Incentive Plan for key persons of the Group. On 22 March Orion Corporation's Annual General Meeting was held in Helsinki. On 6 April the amendments to Sections 5 and 9 (1) of Orion Corporation's Articles of Association were recorded in the Trade Register. A news conference and teleconference on the published results will be held on Wednesday 26 April 2017 at 13:30 EEST in Hotel Kämp, address: Pohjoisesplanadi 29, Helsinki. President and CEO Timo Lappalainen will give a brief presentation in English on the financial review. The event can be followed live as a webcast accessible at Orion's website at http://www.orion.fi/en/investors. After the presentation, questions can be asked by telephone in Finnish and English. The teleconference code is 8575853 and the telephone numbers to participate in the teleconference are: A recording of the webcast of the event in English and a recording of the presentation by the President and CEO in Finnish will be published on the Orion website during Wednesday 26 April 2017. Financial reports and related presentation material are available at http://www.orion.fi/en/investors promptly after publication. The website also has a form for subscribing to Orion's releases. For additional information about the financial review: The Orion Group's net sales in January-March 2017 were up by 7% at EUR 279 million (EUR 262 million in January-March 2016). The net effect of currency exchange rates was plus EUR 3 million. The Pharmaceuticals business's net sales were up by 6% at EUR 265 (249) million. Net sales of Orion's Stalevo® (carbidopa, levodopa and entacapone) and Comtess®/Comtan® (entacapone) Parkinson's drugs were down by 7% at EUR 30 (33) million, which was 11% (13%) of the Pharmaceuticals business's net sales. The Diagnostics business's net sales were up by 7% at EUR 14 (14) million. The Orion Group's operating profit was up by 14% at EUR 92 (80) million. Milestone payments accounted for EUR 7 (4) million of the operating profit. The Pharmaceuticals business's operating profit was up by 13% at EUR 90 (80) million. Milestone payments accounted for EUR 7 (4) million of the operating profit. The Diagnostics business's operating profit was up by 32% at EUR 3.5 (2.6) million. The Group's sales and marketing expenses were EUR 47 (44) million. R&D expenses were EUR 26 (25) million and accounted for 9% (10%) of the Group's net sales. Pharmaceutical R&D expenses amounted to EUR 24 (23) million. Research projects are reported in more detail under Pharmaceuticals in the Business Reviews. Other operating income and expenses were EUR 0 (0) million. The Group's profit before taxes was up by 11% at EUR 89 (80) million. Basic earnings per share were EUR 0.50 (0.45) and diluted earnings per share were EUR 0.50 (0.45). Equity per share was EUR 3.52 (3.37). The return on capital employed before taxes (ROCE) was 51% (46%) and the return on equity after taxes (ROE) 49% (47%). The Group's gearing was 12% (-20%) and the equity ratio 53% (44%). The change in gearing is due to payment of the dividend earlier than in the previous year, and consequently the Company's cash and cash equivalents were clearly lower than in the comparative period. The Group's total liabilities at 31 March 2017 were EUR 443 (613) million. The non-interest-bearing liabilities in the comparative period include the dividends (EUR 183 million) transferred from equity in March 2016 but not paid until the beginning of April 2016. At the end of the period, interest-bearing liabilities amounted to EUR 152 (186) million, including EUR 150 (176) million of long-term loans. The Group had EUR 92 (283) million of cash and cash equivalents and money market investments at the end of the period. The change is explained by the earlier payment of the dividend than in the previous year. Cash flow from operating activities was EUR 63 (52) million. The higher cash flow was mainly due to the increase in net sales. Cash flow from financing activities was EUR -186 (-2) million. The change is explained by the earlier payment of the dividend than in the previous year. The Group's capital expenditure totalled EUR 15 (9) million. This comprised EUR 13 (7) million on property, plant and equipment and EUR 3 (2) million on intangible assets. Fermion has an ongoing significant expansion investment at its Hanko manufacturing plant, and Orion has ongoing expansion of Easyhaler production capacity at its Espoo pharmaceuticals production plant. Net sales are estimated to be at similar level to 2016 (net sales were EUR 1,074 million in 2016). Operating profit excluding material capital gains is estimated to be at least EUR 280 million (operating profit excluding capital gains was EUR 293 million in 2016). Orion's branded Parkinson's drugs are Comtess®, Comtan® and Stalevo®. Generic competition to these products commenced in the United States in 2012 and has already extended to nearly all markets. As a result of the competition, Orion's sales of these products have decreased to low levels in the United States and some other markets, and competition is expected to extend gradually in all markets. However, in 2017 growth in sales of other products is expected to continue to compensate for the decline in sales of these products. Sales of the Easyhaler product family are forecast to continue to grow. A generic competitor to Dexdor® was approved in some European countries. However, the impact of these approvals is not included in the outlook estimate because at this stage it is still difficult to estimate the precise timing and significance of possible competition. The patent for the Simdax® molecule expired in September 2015 but this is still not expected to have a material impact on sales of the product in 2017. Sales of generic products account for a significant proportion of Orion's total sales, and price competition has continued in many markets. Competition in Finland, the most important generic market for Orion, will remain intense in 2017. In addition, at the beginning of the current year in Finland changes were made to the pricing system for substitutable prescription drugs by narrowing the so-called price band. The estimated negative impact of this change on Orion's sales has been taken into account in the outlook estimate. However, product launches continue to support Orion's position as market leader. In 2016 sales of Remsima® generated a significant portion of the growth in net sales of the Speciality Products business division. Sales of the product in the current year are expected to be similar to the previous year. Collaboration agreements with other pharmaceutical companies are an important component of Orion's business model. Often payments related to these agreements, which vary greatly from year to year, are recorded in net sales. Forecasting the timing and amount of payments is difficult. Possible future payments relating to agreements already made have in some cases been conditional on, for instance, the progress of research projects or results received, which are not known until studies have been completed. On the other hand, making new agreements is generally a process for which neither the schedule nor the outcome is known before the final signing of the agreement. The Group's total capital expenditure in 2017 is expected to be higher than in 2016, when it was EUR 51 million. The largest single ongoing projects are expansion of Fermion's Hanko manufacturing plant and increasing Easyhaler product family production capacity. Marketing expenditure will be higher than in the previous year due to additional promotion of sales from the Easyhaler product portfolio, for example. Because the registrations and launches of new products are projects that take more than a year, the increases in resources and other inputs required in 2017 were planned mainly during the previous year. Research and development costs will be similar to 2016. They are partly the Company's internal fixed cost items, such as salaries and maintenance of the operating infrastructure, and partly external variable costs. External costs arise from, among other things, long-term clinical trials, which are typically performed in clinics located in several countries. The most important clinical trials scheduled for 2017 are either ongoing from the previous year or at an advanced stage of planning, therefore their cost level can be estimated rather accurately. The accrued costs are materially affected by collaboration arrangements and how the costs arising are allocated between Orion and its collaboration partners. For instance, Bayer is paying the majority of the darolutamide (ODM-201) research costs. Sales of Orion's branded Parkinson's drugs will decrease in 2017 due to generic competition. The effects of the competition have been taken into account in the outlook estimate for the current year. However, the timing of the extension and intensity of generic competition to Stalevo in Europe and elsewhere still entails uncertainty that may materially affect the accuracy of the estimate made at this stage. The basic Simdax and Dexdor patents have expired. However, the products have other still valid product protection. Nevertheless, for these products there is a possibility that generic competition might commence before expiry of the respective product protection. Orion has become aware that marketing authorisation for a generic version of Dexdor has been granted in some European countries. Orion is continuing actions to defend its rights. Sales of individual products and also Orion's sales in individual markets may vary, for example depending on the extent to which the ever-tougher price and other competition prevailing in pharmaceutical markets in recent years will specifically affect Orion's products. Deliveries of Parkinson's drugs to Novartis, the most important collaboration partner, are based on timetables that are jointly agreed in advance. Nevertheless, they can change, for example as a consequence of decisions by Novartis concerning among others adjustments of stock levels. In addition, changes in market prices and exchange rates affect the value of deliveries to Novartis. The exchange rate risk due to the US dollar has decreased in recent years because the share of Orion's net sales invoiced in dollars has fallen to below ten per cent and at the same time the value of purchases in dollars has increased. The greatest exchange rate risk at present relates to European currencies such the Swedish crown and British pound. However, the overall effect of the risk due to currencies of European countries will be abated by the fact that Orion has organisations of its own in most of these countries, which means that in addition to sales income, there are also costs in these currencies. Changes in the Japanese yen exchange rate have become more important as sales of Parkinson's drugs in Japan have increased. The exchange rate effect related to the Russian rouble has increased due to the strong volatility of the currency. However, Russian sales are not a significant portion of Orion's entire net sales. Orion's broad product range may cause risks to the delivery reliability and make it challenging to maintain the high quality standard required in production. Authorities and key customers in different countries undertake regular and detailed inspections of development and manufacturing of drugs at Orion's production sites. Any remedial actions that may be required may at least temporarily have effects that decrease delivery reliability and increase costs. Orion's product range also includes products manufactured by other pharmaceutical companies. Possible problems related to the delivery reliability or quality of the products of those manufacturers may cause a risk to Orion's delivery reliability. Research projects always entail uncertainty factors that may either increase or decrease estimated costs. The projects may progress more slowly or faster than assumed, or they may be discontinued. Nonetheless, changes that may occur in ongoing clinical studies are reflected in costs relatively slowly, and they are not expected to have a material impact on earnings in the current year. Owing to the nature of the research process, the timetables and costs of new studies that are being started are known well in advance. They therefore typically do not lead to unexpected changes in the estimated cost structure. Orion generally undertakes the last, in other words Phase III, clinical trials in collaboration with other pharmaceutical companies. Commencement of these collaboration relationships and their structure also materially affect the schedule and cost level of research projects. Collaboration arrangements are an important component of Orion's business model. Possible collaboration and licensing agreements related to these arrangements also often include payments to be recorded in net sales that may materially affect Orion's financial results. In 2014-16 the annual payments varied from EUR 8 million to EUR 39 million. The payments may be subject to certain conditions relating to the development of research projects or sales, and whether these conditions are triggered and the timing of triggering always entail uncertainties. Orion's dividend distribution takes into account the distributable funds and the capital expenditure and other financial requirements in the medium and long term to achieve the financial objectives. On 31 March 2017 Orion had a total of 141,257,828 (141,257,828) shares, of which 38,100,273 (38,906,154) were A shares and 103,157,555 (102,351,674) B shares. The Group's share capital was EUR 92,238,541.46 (92,238,541.46). At the end of March 2017 Orion held 675,401 (283,366) B shares as treasury shares. On 31 March 2017 the aggregate number of votes conferred by the A and B shares was 864,487,614 (880,191,388) excluding treasury shares. At the end of March 2017, Orion had 48,273 (49,370) registered shareholders. Each A share entitles its holder to twenty (20) votes at General Meetings of Shareholders and each B share one (1) vote. However, a shareholder cannot vote more than 1/20 of the aggregate number of votes from the different share classes represented at a General Meeting of Shareholders. The Company itself and Orion Pension Fund do not have the right to vote at an Orion Corporation General Meeting of Shareholders. Both share classes, A and B, confer equal rights to the Company's assets and dividends. The Articles of Association entitle shareholders to demand the conversion of their A shares to B shares within the limitation on the maximum number of shares of a class. In January-March 2017 in total 193,881 shares were converted. Orion's A shares and B shares are quoted on Nasdaq Helsinki in the Large Cap group under the Healthcare sector heading under the trading codes ORNAV and ORNBV. Trading in both of the Company's share classes commenced on 3 July 2006, and information on trading in the Company's shares has been available since this date. On 31 March 2017 the market capitalisation of the Company's shares, excluding treasury shares, was EUR 6,863 million. Orion shares are also traded on various alternative trading platforms in addition to Nasdaq Helsinki. Authorisations of the Board of Directors Orion's Board of Directors was authorised by the Annual General Meeting on 22 March 2016 to decide on acquisition of shares in the Company and on a share issue in which shares held by the Company can be conveyed. The authorisation to acquire shares was utilised during 2016. The terms and conditions of the authorisation were reported in more detail in a stock exchange release on 22 March 2016. The Board of Directors is not authorised to increase the share capital or to issue bonds with warrants or convertible bonds or stock options. Orion has two currently operating share-based incentive plans for key persons of the Group, which were announced in stock exchange releases published on 5 February 2013 and 2 February 2016. On 1 March 2017 Orion transferred altogether 107,965 Orion Corporation B shares held by the Company as share bonuses for the earning periods 2014-2016 and 2016 to the key persons belonging to the incentive plans of the Orion Group. The transfer was based on the authorisation by the Annual General Meeting on 22 March 2016. The price per share of the transferred shares was EUR 47.1011, which was the volume weighted average quotation of Orion Corporation B shares on 1 March 2017. The total transaction price of the transferred shares was therefore EUR 5,085,270.26. Orion's shares are in the book-entry system maintained by Euroclear Finland, and Euroclear Finland maintains Orion's official shareholder register. At the end of March 2017, Orion had a total of 48,273 (49,370) registered shareholders, of whom 96% (96%) were private individuals holding 39% (41%) of the entire share stock and 61% (62%) of the total votes. There were altogether 63 (58) million nominee-registered and foreign-owned shares, which was 44% (41%) of all shares, and they conferred entitlement to 10% (9%) of the total votes. At the end of March 2017 Orion held 675,401 (283,366) B shares as treasury shares, which is 0.5% (0.2%) of the Company's total share stock and 0.08% (0.03%) of the total votes. The Annual General Meeting of the Shareholders of Orion Corporation was held on 22 March 2017 in Messukeskus Helsinki, Expo and Convention Centre. The following matters among others were handled at the meeting. Adoption of the financial statements for financial year 1 January to 31 December 2016 The Annual General Meeting adopted the financial statements of the Company and Group as per 31 December 2016. Based on the adopted statement of financial position for the financial period ending 31 December 2016, a dividend of EUR 1.35 per share and in addition an extra EUR 0.20 special dividend per share to commemorate Orion's centenary year, in total EUR 1.55 per share, were approved in accordance with the Board's proposal. The record date for dividend distribution was 24 March 2017 and the payment date was 31 March 2017. The members of the Board of Directors and the President and CEO were discharged from liability for the financial year 1 January to 31 December 2016. Remuneration of the members of the Board of Directors The Annual General Meeting decided that as the annual fees for the term of office of the Board of Directors, the Chairman shall receive EUR 84,000, the Vice Chairman shall receive EUR 55,000 and the other Board members shall receive EUR 42,000 each. Furthermore, as a fee for each meeting attended, the Chairman shall receive EUR 1,200, the Vice Chairman shall receive EUR 900 and the other Board members shall receive EUR 600 each. The travel expenses of Board members shall continue to be paid in accordance with previous practice. The aforementioned meeting fees shall also be paid to the Chairmen and to the members of the committees established by the Board. Of the aforementioned annual fees, 60% was to be paid in cash and 40% in the Company's shares, so Orion Corporation B shares were to be acquired in the period 27 April to 4 May 2017 from the stock exchange in amounts corresponding to EUR 33,600 for the Chairman, EUR 22,000 for the Vice Chairman and EUR 16,800 for each of the other Board members. The part of the annual fee paid in cash, which corresponds to the approximate sum necessary for the payment of the income taxes on the fees, was to be paid no later than 31 May 2017. The annual fees encompass the full term of office of the Board of Directors. It was also decided that the Company shall pay the transfer tax related to the portion of the annual fees of the members of the Board of Directors to be paid in shares. Members and Chairman of the Board of Directors The number of members in the Board of Directors was confirmed to be seven. Sirpa Jalkanen, Timo Maasilta, Eija Ronkainen, Mikael Silvennoinen and Heikki Westerlund were re-elected as members of the Board of Directors for the following term of office, and Ari Lehtoranta and Hilpi Rautelin were elected as new members. Heikki Westerlund was elected as the Chairman of the Board of Directors. PricewaterhouseCoopers Oy, authorised public accountants, were elected as the auditor for the following term of office. The auditor's fee shall be paid against an invoice approved by the Company. Amendments to Sections 5 and 9 (1) of the Articles of Association The Annual General Meeting decided to amend Section 5 of the Articles of Association by deleting the last sentence of Section 5 concerning the maximum age (67 years) of a person elected as a member of the Board of Directors. Following the amendment, Section 5 of the Articles of Association is in its entirety as follows: "The Board of Directors shall comprise at least five (5) and at most eight (8) members. The term of the members of the Board of Directors shall end at the end of the Annual General Meeting of Shareholders following the election. The General Meeting of Shareholders shall elect the Chairman of the Board of Directors and the Board of Directors shall elect the Vice Chairman of the Board of Directors, both for the same term as the other members." In addition, the Annual General Meeting decided to amend the first paragraph of Section 9 of the Articles of Association to correspond to the amended wording of the Auditing Act. Following the amendment, the first paragraph of Section 9 of the Articles of Association is in its entirety as follows: "The company shall have one auditor, which shall be Authorised Public Accountants." Constitution of the Board of Directors At its constitutive meeting following the Annual General Meeting, the Board of Directors elected Timo Maasilta as its Vice Chairman. The average number of employees in the Orion Group in January-March 2017 was 3,475 (3,401). At the end of March 2017 the Group had a total of 3,483 (3,409) employees, of whom 2,812 (2,731) worked in Finland and 671 (678) outside Finland. Salaries and other personnel expenses in January-March 2017 totalled EUR 53 (53) million. Companies belonging to the Orion Group are parties to various legal disputes, which are not, however, considered to be significant legal proceedings for the Group. Finland is the most important individual market for Orion, generating about one-third of the total net sales. According to IMS Health statistics, Finnish wholesale of human pharmaceuticals in January-March 2017 was EUR 546 (538) million. Orion was able to increase its sales faster than market growth, and strengthened its position as leader in marketing pharmaceuticals in Finland. According to statistics collected by IMS Health, Orion's wholesale of human pharmaceuticals in Finland in January-March 2017 amounted to EUR 72 (69) million, up by 4% compared with the previous year. Orion's market share of Finnish pharmaceuticals markets was 13% (13%). The most important individual therapy area for Orion is still the treatment of Parkinson's disease. Orion's branded Parkinson's drugs containing entacapone (Stalevo®, Comtess® and Comtan®) account for slightly over 10% of the Group's net sales. Sales of Orion's branded Parkinson's drugs decreased in Europe due to commencement of generic competition. Sales increased in Japan, mainly due to growth in Stalevo, which was launched in that market in 2015. According to IMS Health pharmaceutical sales statistics, in Europe total sales of the most common intravenous anaesthetics and intensive care sedatives (propofol, midazolam, remifentanil and dexmedetomidine) in the 12-month period ending in December 2016 were EUR 523 (525) million. According to IMS Health pharmaceutical sales statistics, sales of Orion's Dexdor® intensive care sedative (dexmedetomidine) were up by 34% at EUR 48 (36) million in Europe. Net sales and operating profit of the Pharmaceuticals business In January-March 2017 the Pharmaceuticals business's net sales were EUR 265 (249) million and its operating profit was EUR 90 (80) million. Milestone payments accounted for EUR 7 (4) million of the net sales and operating profit, and they comprised payments related to marketing rights. The operating profit of the Pharmaceuticals business was 34% (32%) of the segment's net sales. Net sales of Orion's top ten pharmaceuticals in January-March 2017 were up by 8% at EUR 120 (111) million. They accounted for 45% (44%) of the total net sales of the Pharmaceuticals business. The product portfolio of Proprietary Products consists of patented prescription products in three therapy areas: central nervous system diseases, oncology and critical care, and Easyhaler® pulmonary drugs. Net sales of Proprietary Products in January-March 2017 were up by 12% at EUR 98 (88) million. Sales of Parkinson's drugs continued to decline, but sales of other products grew well. Orion's drugs for treatment of Parkinson's disease are Stalevo® (active ingredients carbidopa, levodopa and entacapone) and Comtess®/Comtan® (entacapone). Their total net sales in January-March 2017 were down by 7% at EUR 30 (33) million. In the United States Orion's Parkinson's drugs have several generic competitors, and competition is increasing in Europe and also other markets. In Japan the first marketing authorisations for generic Comtan products were granted, but generic competition has not yet commenced. Net sales of Simdax®, a drug for treatment of acute decompensated heart failure, in January-March 2017 were up by 12% at EUR 15 (14) million. Simdax is sold in altogether over fifty countries worldwide. Total net sales of the Easyhaler® product family for treatment of asthma and chronic obstructive pulmonary disease were up by 15% in January-March 2017 at EUR 18 (16) million. The increase was mainly due to sales of the Bufomix Easyhaler® combined formulation (budesonide-formoterol). Sales of Bufomix Easyhaler were up by 38% at EUR 8 (6) million in January-March 2017. In the last quarter of 2016, through the decentralised procedure the budesonide-formoterol Easyhaler combined formulation received marketing authorisation for Germany, the United Kingdom and France. The national approval process has been completed in Germany and is ongoing in the United Kingdom and France. Orion is expanding Easyhaler production at the Espoo pharmaceuticals production plant. Net sales of Orion's Dexdor® intensive care sedative (dexmedetomidine) in January-March 2017 were up by 18% at EUR 17 (14) million. Sales of the Precedex® intensive care sedative were up by 79% at EUR 7 (4) million, mainly due to greater deliveries of the pharmaceutical ingredient to the partner than in the comparative period. Net sales of the Specialty Products business division's off-patent, i.e. generic prescription drugs, self-care products and biosimilars in January-March 2017 were EUR 122 (123) million. Finland, Scandinavia, and Eastern Europe and Russia are the most important markets for Specialty Products. The business division's sales in Finland in January-March 2017 were up by 3% at EUR 72 (70) million due to good growth in sales of self-care products and Remsima®. Sales were down by 8% at EUR 20 (21) million in Scandinavia and up by 9% at EUR 13 (12) million in Eastern Europe and Russia. Net sales of the biosimilar Remsima® for treatment of rheumatoid arthritis among other things were down by 6% at EUR 11 (12) million due to the timing of the national tendering competition in Norway. In the Nordic countries and some Eastern European markets Orion itself sells veterinary drugs, and in other markets the Company operates through partners. In addition, in the Nordic countries Orion markets and sells veterinary drugs manufactured by several other companies. Orion's Animal Health business division has a strong market position in the Nordic countries, its home markets. Net sales of the Animal Health business division in January-March 2017 were up by 5% at EUR 19 (18) million. Sales of the animal sedative product family at EUR 7 (7) million accounted for 39% (37%) of the division's net sales. The product family comprises Orion's animal sedatives Dexdomitor® (dexmedetomidine), Domitor® (medetomidine) and Domosedan® (detomidine), and antagonist Antisedan® (atipamezole), which reverses the effects of the sedatives. Fermion manufactures active pharmaceutical ingredients for Orion and other pharmaceutical companies. Its product range comprises nearly 30 pharmaceutical ingredients. For other pharmaceutical companies Fermion manufactures generic pharmaceutical ingredients and offers contract manufacturing services for development and manufacturing of new active pharmaceutical ingredients. Fermion's sales grew well in the first quarter. In recent years order cycles in the trade in pharmaceutical raw materials have become ever shorter, and this has led to clearly greater fluctuation in business volume than before within each year and between different years. Fermion's net sales in January-March 2017 excluding pharmaceutical ingredients supplied for Orion's own use were up by 47% at EUR 16 (11) million and accounted for over one-half of Fermion's entire net sales. Fermion has an ongoing significant expansion investment at its Hanko manufacturing plant. The Group's R&D expenses in January-March 2017 were EUR 26 (25) million, of which the Pharmaceuticals business accounted for EUR 24 (23) million. The Group's R&D expenses accounted for 9% (10%) of the Group's net sales. R&D expenses also include expenses related to development of the current portfolio. In 2014 Orion commenced global collaboration with Bayer in the development and commercialisation of the novel oral androgen receptor antagonist darolutamide (ODM-201). The companies have an ongoing joint Phase III clinical trial (ARAMIS) for evaluation of the efficacy and safety of darolutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). In 2016 Orion and Bayer agreed to expand the darolutamide development programme and towards the end of the year commenced a new Phase III trial (ARASENS) that will evaluate the efficacy and safety of the drug candidate in combination with standard androgen deprivation therapy (ADT) and the chemotherapy drug docetaxel in patients having newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who are starting hormone therapy. In December 2016 Orion completed trials with a salmeterol-fluticasone combined formulation in the Easyhaler® product family. Based on the positive findings, in April 2017 Orion submitted a marketing authorisation application for the product in Europe. In this formulation fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Orion is continuing development of an alpha-2c adrenoceptor antagonist (ORM-12741) for treatment of symptoms of Alzheimer's disease in collaboration with Janssen Pharmaceuticals Inc. Orion has an ongoing Phase IIa clinical trial with a new drug formulation. In the initial Phase IIa clinical trial conducted by Orion, the efficacy and safety of the drug candidate in treatment of cognitive and behavioural symptoms related to Alzheimer's disease were investigated with positive results. Orion has completed the Phase II clinical trial with orally administered levosimendan (ODM-109) for treatment of patients with amyotrophic lateral sclerosis (ALS). Although the trial did not achieve its primary objective, the findings were, however, promising. Based on the findings, Orion is planning to continue the development programme. The US Food and Drug Administration (FDA) has granted ODM-109 Orphan Drug Designation. Orion has an ongoing Phase II clinical trial with a drug candidate for treatment of symptoms of Parkinson's disease in which the COMT inhibitor (ODM-104) developed by Orion is combined with the pharmaceutical ingredients carbidopa and long-acting levodopa used to treat Parkinson's disease. In the trial the efficacy of the drug candidate in treating symptoms of Parkinson's disease will be investigated and the product will be compared with a Stalevo product already in the markets in which the active ingredients are the COMT inhibitor entacapone, carbidopa and levodopa. Orion has an ongoing Phase II clinical trial with a new targeted FGFR+VEGFR inhibitor (ODM-203) for treatment of cancers. The trial will investigate the efficacy of the drug candidate in slowing the growth of solid cancerous tumours in patients in which FGFR changes in cancerous tumours have been detected. Orion has commenced a Phase I clinical trial with a BET protein inhibitor (ODM-207) which inhibits transcription of key oncogenes such as Myc in many cancers. In preclinical studies, ODM-207 has shown antiproliferative effects in several solid tumour cell lines. The trial will investigate the safety and the tolerability of the drug candidate and provisionally its efficacy in cancer patients. Orion's partner Tenax Therapeutics, Inc. will develop and commercialise levosimendan in US and Canadian markets for a new cardiovascular indication, prevention of low cardiac output syndrome (LCOS) in cardiac surgery patients. The company has completed the Phase III clinical trial for this indication. According to the preliminary findings, the trial did not achieve its primary objectives. Tenax has announced that it will continue analysing the findings and will discuss the trial results and possible continuance of development work with the US Food and Drug Administration (FDA). In addition, Orion has several projects in the early research phase investigating central nervous system diseases, cancer and neuropathic pain, among others. Orion Diagnostica manufactures convenient and quick in vitro diagnostic tests and testing systems suitable for point-of-care testing. Net sales of the Diagnostics business in January-March 2017 were up by 7% at EUR 14.4 (13.5) million. QuikRead® infection tests remained the main product, with sales continuing to increase. With the help of CRP tests from the QuikRead go® product family in infectious disease diagnostics, antibiotic treatment can be targeted at patients that need it and unnecessary use of antibiotics avoided in situations in which a patient would not benefit from them. Avoiding unnecessary antibiotic treatments helps in tackling the growing problem of antibiotic resistance. The operating profit of the Diagnostics business was up by 32% at EUR 3.5 (2.6) million thanks to growth in sales with good margins, among other things. The operating profit accounted for 24% (19%) of the segment's net sales. 1) The figure has been calculated from the profit attributable to the owners of the parent company. CONSOLIDATED STATEMENT OF CHANGES IN EQUITY CHANGES IN PROPERTY, PLANT AND EQUIPMENT FAIR VALUE MEASUREMENT AND HIERARCHY OF FINANCIAL INSTRUMENTS Orion Corporation is the parent company of the Orion Group. The Group consists of two business areas, or operating segments, and five business divisions. Orion reports on its operations segmentally. Contract manufacturing and other, i.e. manufacturing for other companies, is included in the Pharmaceuticals business segment, but it is not a separate business division, it is part of the Group's Supply Chain organisation. This report has been prepared in accordance with the IAS 34 Interim Financial Reporting standard. The same accounting policies as for the Financial Statements for 2016, supplemented by amendments to existing IFRS and IAS standards endorsed by the EU that have been adopted as of 1 January 2017, have been applied in preparing the report. The amendments to standards had no effect on the Consolidated Financial Statements. The policies and calculation methods applied during the period can be found on the Orion website at http://www.orion.fi/en/investors. The data in this financial review are not audited. The figures in parentheses are for the corresponding period of the previous year. All the figures in this report have been rounded, which is why the total sums of individual figures may differ from the total sums shown. Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2016 amounted to EUR 1,074 million and the Company had about 3,500 employees. Orion's A and B shares are listed on Nasdaq Helsinki. Orion, established in 1917, is celebrating its centenary in 2017.
News Article | April 24, 2017
Regenerative Medicine Market is estimated at $20.07 billion in 2015 and is projected to reach $101.3 billion by 2022 growing at a CAGR of 26.0% from 2015 to 2022Pune , India - April 24, 2017 /MarketersMedia/ — Regenerative Medicine Industry Description According to Stratistics MRC, the Regenerative Medicine Market is estimated at $20.07 billion in 2015 and is projected to reach $101.3 billion by 2022 growing at a CAGR of 26.0% from 2015 to 2022. Growing research applications, growing demand in tissue engineering, biomaterials and stem cell therapy systems are some of the factors driving the market growth. However, high cost associated with biomaterials will be a major factor to restrict the market growth. The stem cells application and advancements in nanotechnology will further drive the market over the forecast period. Gene therapies segment is expected to be the fastest emerging technology due to tremendous potential of gene therapy in minimizing immune rejections, which commonly occur after transplantations. Asia-Pacific would be the fastest growing region for regenerative medicine market. Europe and North America together accounted for over 3/4th of the market revenue and anticipated to be most profitable regional market. Some of the key players in the market include Shire Pharmaceuticals, Advanced Cell Technology, Inc, Genzyme, Athersys, Inc., Kinetic Concepts, Inc., NuVasive Inc., Stem cells, Inc., Cytori Therapeutics, Inc., Cytomedix Inc., Mesoblast Ltd. , Zimmer Holdings, Inc., Orthofix, DePuy Synthes Inc., Cell Medica and CryoLife. Request for Sample Report @ https://www.wiseguyreports.com/sample-request/456590-regenerative-medicine-global-market-outlook-2015-2022 Technologies Covered: • Small Molecules and Biologics • Gene Therapy • Cell Therapy Applications Covered: • Dermatology • Cardiovascular Disorders • Central Nervous System (CNS) • Orthopedic • Dental • Other applications o Autoimmune Diseases o Muscle Regeneration o Ocular Diseases o Internal organ regeneration Leave a Query @ https://www.wiseguyreports.com/enquiry/456590-regenerative-medicine-global-market-outlook-2015-2022 Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements Buy now @ https://www.wiseguyreports.com/checkout?currency=one_user-USD&report_id=456590 Continued... Contact Us: Sales@Wiseguyreports.Com Ph: +1-646-845-9349 (US) Ph: +44 208 133 9349 (UK) Contact Info:Name: NORAH TRENTEmail: email@example.comOrganization: WISE GUY RESEARCH CONSULTANTS PVT LTDAddress: Office No. 528, Amanora Chambers Magarpatta Road, Hadapsar Pune - 411028Phone: +91 841 198 5042Source URL: http://marketersmedia.com/regenerative-medicine-market-2017-global-share-trend-and-opportunities-forecast-to-2022/189453For more information, please visit https://www.wiseguyreports.com/sample-request/456590-regenerative-medicine-global-market-outlook-2015-2022Source: MarketersMediaRelease ID: 189453