Hepatitis A Outbreak: L.A. City’s Homeless Policies a Threat
Beyond bleaching sidewalks, the City of Los Angeles should immediately deploy portable toilets and hand-washing stations and put a halt to rousting homeless encampments.“Concentrate instead on improving overall sanitary conditions,” said Michael Weinstein.September 20, 2017 08:32 PM Eastern Daylight Time LOS ANGELES--(EON: Enhanced Online News)--AIDS Healthcare Foundation (AHF) today warned that an emerging outbreak of Hepatitis A in Los Angeles that follows a larger statewide outbreak may be both the result of, and further fueled by deplorable living conditions of homeless populations here in Los Angeles. The statewide outbreak, which began in San Diego County, where it has killed at least 16 people and infected almost 450, also spread to Santa Cruz, where it is thought that nearly 70 people became infected, according to reporter Soumya Karlamangla, reporting in the Los Angeles Times.On Tuesday, Los Angeles County health officials declared a formal outbreak of Hepatitis A after the number of those infected in Los Angeles County rose to 10 individuals—including two who appear to have no connection or link to the outbreaks in San Diego or Santa Cruz.“We acknowledge County officials for quickly declaring a formal outbreak of Hepatitis A while the actual numbers of cases are still relatively low here; however, this declaration must be followed with immediate and forceful actions: Portable toilets and hand-washing stations should be deployed immediately and the City of Los Angeles should put an immediate halt to rousting homeless encampments and concentrate instead on improving overall sanitary conditions,” said Michael Weinstein, president of AHF. This outbreak is a result of, and is likely to be further fueled by the deplorable living conditions of homeless populations in Los Angeles. L.A.’s homeless population vastly outnumbers those of any other city, county or region in the state, so the potential for an epidemic is very real. Swift, comprehensive action to halt the spread of infection and care for those infected in Los Angeles must be taken immediately.”According to a news report earlier this summer in the Los Angeles Times, the homeless population in Los Angeles County as of May 2017 is now nearly 58,000—a jump of 23% since 2016—a development which Los Angeles County Supervisor Janice Hahn called at the time, “staggering.”AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 821,000 individuals in 39 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us @aidshealthcare.ContactsAIDS Healthcare Foundation LA: Ged Kenslea Senior Director, Communications work: +1.323.308.1833 cell: +1.323.791.5526 firstname.lastname@example.org
Ricoh Joins Fight against Alzheimer’s Disease
LONDON--(EON: Enhanced Online News)--The partnership will see Ricoh and Alzheimer’s Research co-produce a number of awareness campaigns, leveraging Ricoh’s printing technologies and digital capabilities.Ricoh will also take part in generating much-needed research funding through a series of volunteering activities. The funds raised will support world-class researchers as they work to grow the body of science behind the complex diseases that cause dementia, most commonly Alzheimer’s disease.Participating Ricoh companies in Europe will also host a range of employee engagement and fundraising activities. The sessions will educate staff on the symptoms, causes and impact of dementia, as well as the current progress of research.Javier Diez-Aguirre, Vice President, Corporate Marketing, CSR & Environment, Ricoh Europe, says, “Ricoh shares the mission of Alzheimer’s Research to help bring about the first life-changing dementia treatment by 2025. We are now committing our people, technologies and expertise to contribute to achieving this mission. We are proud of our partnership with Alzheimer’s Research. We can’t wait to put our collective thinking, energy and passion into practice to help defeat dementia.”Timothy Parry, Director of Communications and Partnerships at Alzheimer’s Research, says, “We are proud to unveil our partnership with Ricoh Europe on World Alzheimer’s Day. This is a hugely influential company that leads its field in technical innovation, and through the partnership, Ricoh Europe is demonstrating that corporations of all types can play a meaningful role in overcoming our great medical challenge. We are grateful for the support of Ricoh Europe’s leadership and staff, and through our collaboration we are determined to help enable research breakthroughs that bring hope to individuals and families affected by dementia around the world”.For more information visit www.ricoh-europe.com.For more information about Alzheimer’s Research, visit www.alzheimersresearchuk.org
Alligator Bioscience to present ADC-1013 intratumoral clinical phase I study results at SITC in November 2017
Lund, Sweden, September 21, 2017 – Alligator Bioscience (Nasdaq Stockholm: ATORX) , a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, announced today that results from a clinical phase I study of the drug candidate ADC-1013 (JNJ-64457107) will be presented at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting, held from 8-12 November 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, US.Alligator Bioscience will give both an oral and poster presentation at the SITC conference with the title: “ First-in-human study with intratumoral administration of a CD40 agonistic antibody: preliminary results with ADC-1013/JNJ-64457107 in advanced solid malignancies ”. The oral presentation will be held at Session Clinical Trials: New Agents, starting at 1:45 p.m. ET (7:45 p.m. CET) on November 10, 2017.For further information about the program, please visit the conference web site: www.sitcancer.org/2017/home .For further information: Cecilia Hofvander, Director Investor Relations & Communications Phone +46 46 286 44 95 E-mail: email@example.com .This release contains information that Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:30 a.m. CEST on 21 September 2017.About ADC-1013ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Pre-clinical data have shown that the ADC-1013 antibody effectively activates T-cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T cell activation enables the immune system to attack the cancer. In addition, since some cancer cells express CD40 on the surface, ADC-1013 may act also through a secondary mechanism of action killing cancer cells directly.In August 2015, Alligator licensed global development rights for ADC-1013 to Janssen Biotech Inc. In October 2016, Janssen Biotech, Inc. started a second phase I clinical study (ClinicalTrials: NCT02829099). That study is an intravenous dose escalation study with ADC-1013 (JNJ-64457107).About the ADC-1013 clinical Phase I studyThe study to be presented is a multicenter, open-label phase I study in patients with advanced solid tumors evaluating safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response. The study is a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five hospitals in Sweden, Denmark and the UK. The study was performed by Alligator and includes 24 patients and ten different tumor types. For further information, please visit www.clinicaltrials.gov; NCT02379741.About Alligator BioscienceAlligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s growing pipeline includes lead clinical and pre-clinical drug candidates (ADC-1013, ATOR-1015, ATOR-1017, and ALG.APV-527) and novel research candidates. ADC-1013 (JNJ-64457107) is licensed to Janssen Biotech, Inc., part of J&J, for global development and commercialization. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 45 employees. For more information, please visit www.alligatorbioscience.com .
Inflammatory bowel disease in childhood associated with increased risk of cancer
Children who develop inflammatory bowel disease (ulcerative colitis or Crohn’s disease) run a higher risk of cancer, both in childhood and later in life, a study from Karolinska Institutet published in The BMJ reports.Adulthood onset inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease have been associated with an increased risk of bowel cancer. However, there have been no studies showing how the cancer risk is affected by childhood onset of the disease and whether it changes over time.Using data from the Swedish National Patient Register, researchers at Karolinska Institutet have now compared the incidence of cancer in 9,405 individuals who were diagnosed with inflammatory bowel disease as children, with 92,870 individuals from the general population.Their results show that individuals who developed inflammatory bowel disease before the age of 18 had twice the cancer risk during childhood and adolescence as well as adulthood, compared with people who did not have such a diagnosis. The largest increase in risk was observed for bowel cancer, but there was also an increase in risk for other forms of cancer, such as blood and skin cancers.“We believe that the main cause is the chronic inflammation, which we know to be a driving factor for many different cancer types,” says principal investigator Ola Olén at Karolinska Institutet’s Clinical Epidemiology Unit at the Department of Medicine, Solna. “Early onset means that the body is exposed to inflammation for a longer time.”The study participants were diagnosed with inflammatory bowel disease between 1964 and 2014.“The treatment for inflammatory bowel disease improved considerably over these years, thanks in part to the introduction of new immunomodulating drugs, but unfortunately we can’t see that the relative incidence of cancer simultaneously declined,” says Dr Olén.Adult patients with inflammatory bowel disease are regularly invited to colonoscopy screenings, which can detect the presence of any cancer in the gut. The researchers believe that the knowledge of the cancer risk associated with the early onset of inflammatory bowel disease has to be factored into decisions on colonoscopy screening for children and adolescents, from both a healthcare and a patient perspective.”“Don’t forget that even if relative risks are high, the absolute risks are much more modest, and during childhood absolute risks are extremely small. Most young people don’t get cancer, and some of these forms of tumours are extremely rare,” explains Dr Olén. “But it’s probably important for individuals who develop inflammatory bowel disease in childhood to make sure to attend the examinations they’re invited to, especially those who have other strong risk factors for cancer, such as a family history of early cancer.”The research was financed by the Swedish Society of Medicine, Mag-tarmfonden, the Jane and Dan Olsson foundation, the Mjolkdroppen foundation, The Bengt Ihre research fellowship in gastroenterology, Karolinska Institutet foundations, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet (ALF), the Swedish Cancer Society, the Swedish Research Council, and the Swedish Foundation for Strategic Research.Publication: “Childhood-onset inflammatory bowel disease and risk of cancer – a Swedish nationwide cohort study 1964-2014” . Ola Olén, Johan Askling, Michael Sachs, Paolo Frumento, Martin Neovius, Karin Ekström Smedby, Anders Ekbom, Petter Malmborg and Jonas F Ludvigsson . The BMJ , online 21 September 2017, doi: 10.1136/bmj.j3951 .For more information, please contact: Ola Olén, researcher Department of Medicine, Solna, Karolinska Institutet Phone: +46 70 327 09 74 Email: Ola.Olen@ki.seJonas Ludvigsson, professor Department of Medical Epidemiology and Biostatistics, Karolinska Institutet Phone: +46 73 029 63 18 Email: Jonas.Ludvigsson@ki.se
• First approved immunotherapy for rare and aggressive skin cancer in the European Union, with initial launches planned in Germany and the UK • Builds on Bavencio’s previous accelerated approvals in the US and recent approval in Switzerland • Approval is based on data from the Javelin Merkel 200 study including durable tumor response rate and duration of responseDarmstadt, Germany, and New York, US, September 21, 2017 – Merck and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. (1) BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.
PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, responds to deceptive short seller articles published earlier today.Earlier today, two short seller articles, one by Viceroy Research and the other by Aurelius Value, were published on MiMedx. Parker H. "Pete" Petit, CEO, said, "The articles include several items that have virtually no basis in fact, are littered with innuendo and contain many statements that are simply not correct. This has all the markings of a concerted short seller attack by numerous entities attempting to short our stock and profit from fictitious information and innuendos. We believe that Viceroy Research and Aurelius Value are relying on misinformation from former MiMedx employees terminated for cause. Unfortunately, neither organization appears to have done adequate due diligence and fact-finding before publishing their so-called 'research reports.' We have scheduled a shareholder call tomorrow, Thursday, September 21st, at 10:30 am Eastern Time to discuss various topics on the Company's extremely positive performance and trajectory for future growth. We will also address this orchestrated short seller activity and the remedies the Company is seeking to have this unlawful practice of pushing fabricated information to shareholders in concert with coordinated short selling activity cease."In the meantime, the Company encourages all shareholders to review the detailed and factual press releases the Company has issued and other reports on the Company's website www.mimedx.com.
BONESUPPORT™ DATA PRESENTED AT EORS HIGHLIGHTS CERAMENT® BONE VOID FILLER’S ABILITY TO ELUTE DRUGS WITH POTENTIAL TO ENHANCE BONE GROWTH
Lund, Sweden, 08.00 CEST, 20 September 2017 – BONESUPPORT an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT platform announces that a pre-clinical study evaluating the in-vivo release kinetics of radio-labelled bone morphogenic protein (rhBMP-2) and zoledronic acid (ZA) from CERAMENT BONE VOID FILLER (BVF) was presented at the European Orthopaedic Research Society (EORS) in Munich on 15th September. The presentation was given by Mr Deepak Raina, Department of Orthopaedics, Medical Faculty, Lund University, Sweden.In his presentation, Mr Raina, outlined data showing that CERAMENT BVF achieved co-delivery of both rhBMP-2 and ZA in-vivo measured over a period of four weeks. After 4 weeks, CERAMENT BVF had eluted 57% of rhBMP-2 and 23% of ZA. This is an important finding since the constant availability of rhBMP-2 over a long period could give osteo-inductive properties to CERAMENT BVF while at the same time the presence of ZA locally prevents bone resorption.These data suggest that by using CERAMENT BVF to elute BMPs it could be possible to overcome the problems of local delivery of BMPs using currently available approaches.Another pre-clinical study, which demonstrated in vivo that CERAMENT loaded with a combination of rhBMP-2 and ZA in very low doses was able to quantitatively and qualitatively generate a high amount of mineralized bone volume was covered in a paper published in Nature Scientific Reports (Raina, D et al, reference below). The study showed that the mineralized volume was significantly higher when CERAMENT was combined with rhBMP-2 and ZA compared to CERAMENT in combination with just rhBMP-2.Mr Deepak Raina, commenting on his presentation said: “The important findings that we presented at EORS suggest that by capitalizing on CERAMENT BVF’s elution characteristics it could be possible to overcome the current problems associated with the local delivery of BMP to promote bone growth. The growing body of data that our research group is generating with CERAMENT BVF provides greater confidence that this novel approach could lead to a commercially available product able to enhance bone growth.”Richard Davies, CEO of BONESUPPORT, commented: “We are pleased that these in vivo data on CERAMENT BVF combined with bone morphogenic protein and zoledronic acid have been presented at this prestigious scientific conference. These data provide further support to our product pipeline strategy which is focused on developing new CERAMENT products that are able to enhance bone growth.”Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports http://bit.ly/22xgU84For more information contact:Richard Davies, CEOTel: +46 (0) 46 286 53 71Björn Westberg, CFOTel: +46 (0) 46 286 53 60Email: firstname.lastname@example.org
Alnylam and Sanofi Report Positive Topline Results from APOLLO Phase 3 Study of Patisiran in Hereditary ATTR (hATTR) Amyloidosis Patients with Polyneuropathy
– Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo –– Alnylam Intends to File New Drug Application (NDA) in Late 2017 and Marketing Authorisation Application (MAA) in Early 2018 –– Full Results to be Presented at 1st European ATTR Amyloidosis Meeting in November –– Alnylam to Host Conference Call Today at 8:30 a.m. ET –September 20, 2017 07:00 AM Eastern Daylight Time CAMBRIDGE, Mass. & PARIS--(EON: Enhanced Online News)--Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at 18 months. The key secondary endpoint was improvement in quality of life assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN).“Patients living with hATTR amyloidosis face an inevitable and painful advancement of their debilitating disease” “We are very proud to report the first ever positive Phase 3 results for an RNAi therapeutic, marking the potential arrival of an entirely new class of medicines. This moment is the culmination of a 15-year journey of tireless work by countless contributors who have overcome enormous scientific and business challenges to make RNAi therapeutics a reality,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “This is an incredibly exciting milestone for Alnylam and RNAi, and most importantly for patients and their treating physicians and families. We extend our deepest gratitude to all the patients, investigators and study staff who participated in the APOLLO study – they made this important scientific progress possible.”The APOLLO trial enrolled 225 hATTR amyloidosis patients with polyneuropathy, representing 39 genotypes, at 44 study sites in 19 countries around the world. Patients were randomized 2:1 to patisiran or placebo, with patisiran administered intravenously at 0.3 mg/kg once every three weeks for 18 months. For both the mNIS+7 and Norfolk QOL-DN endpoint measures provided below, a lower score indicates a better clinical result.At 18 months, the mean change from baseline in mNIS+7 was significantly lower in the patisiran group as compared with placebo (p less than 0.00001). The mean and median changes in mNIS+7 impairment scores for patisiran both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline. Patients in the patisiran group experienced improvement in quality of life compared to placebo, as assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) (p less than 0.00001). The mean and median changes in QOL scores for patisiran also both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline. All 5 other secondary endpoints also demonstrated statistically significant favorable differences in the patisiran arm compared to placebo (p less than 0.001). These were: NIS-W, the subdomain of mNIS+7 assessing muscle strength; Rasch-built Overall Disability Scale (R-ODS), a patient reported outcome measure of daily living and disability; 10-meter walk test, assessing gait speed; Modified body mass index (mBMI), assessing nutritional status; and COMPASS-31, a questionnaire to assess autonomic symptoms. The overall safety profile of patisiran was encouraging. The patisiran and placebo arms had similar frequencies of adverse events (AEs) (96.6 percent and 97.4 percent, respectively) and serious adverse events (SAEs) (36.5 percent and 40.3 percent, respectively). The frequency of deaths in the study was similar in the patisiran (4.7 percent) and placebo (7.8 percent) arms. Patisiran treatment was associated with fewer discontinuations from treatment compared with placebo (7.4 percent and 37.7 percent, respectively) and discontinuations from treatment due to AEs (4.7 percent and 14.3 percent, respectively). AEs reported in greater than 10 percent of patients and seen more frequently with patisiran compared with placebo were peripheral edema (29.7 percent vs. 22.1 percent, respectively) and infusion-related reactions (18.9 percent vs. 9.1 percent, respectively), both of which were generally mild-to-moderate in severity. “Patients living with hATTR amyloidosis face an inevitable and painful advancement of their debilitating disease,” said Akshay Vaishnaw, M.D., Ph.D., Executive Vice President, R&D of Alnylam. “We believe the very encouraging APOLLO data demonstrate the potential for investigational patisiran to help improve the lives of hereditary ATTR amyloidosis polyneuropathy patients. Our immediate objective is now to submit these data to global health authorities.”Based on these positive results, Alnylam expects to file its first New Drug Application in late 2017 and first Marketing Authorisation Application shortly thereafter. Sanofi Genzyme is currently preparing for regulatory filings for patisiran in Japan, Brazil and other countries, to begin in the first half of 2018. Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world.“This is a significant milestone that supports our belief that RNAi therapeutics have the potential to become an innovative new class of medicines for patients with rare genetic diseases,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “The APOLLO data suggest that patisiran could help improve the lives of people living with hATTR amyloidosis with polyneuropathy, a patient population in urgent need of additional treatment options. We look forward to working with Alnylam to make patisiran available around the globe as quickly as possible.”Full results, including data from an exploratory analysis of the subgroup of patients with cardiac involvement, will be presented at the 1st European ATTR Amyloidosis Meeting for Patients and Doctors, on November 2, 2017 in Paris, France.APOLLO is the largest randomized study ever completed in this disease. Nearly all eligible patients who completed APOLLO have rolled over to the APOLLO-Open Label Extension (OLE) study and continue to receive patisiran.Conference Call DetailsAlnylam management will discuss these results via conference call on September 20, 2017 at 8:30 a.m. ET. A slide presentation will also be available on the Investors page of the Company's website, www.alnylam.com, to accompany the conference call. To access the call, please dial (877) 312-7507 (domestic) or (631) 813-4828 (international) five minutes prior to the start time and refer to conference ID 88881001. A replay of the call will be available beginning at 11:30 a.m. ET on September 20, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and refer to conference ID 88881001.About the APOLLO Phase 3 StudyThe APOLLO Phase 3 study is a randomized, double blind, placebo-controlled, global study designed to evaluate the efficacy and safety of patisiran in hATTR amyloidosis patients with polyneuropathy. The primary efficacy endpoint was change from baseline in the mNIS+7 composite neuropathy impairment score at 18 months. Modified NIS+7 is a composite measure of neurologic impairment that evaluates sensorimotor capabilities, nerve conduction, reflexes, and autonomic function. Secondary endpoints included the Norfolk QOL-DN quality of life score as well as measures of motor strength (NIS-W), disability (R-ODS), gait speed (10-meter walk test), nutritional status (mBMI) and autonomic symptoms (COMPASS-31). Exploratory endpoints included cardiac measures in patients with evidence of cardiac involvement at baseline as well as measures of dermal amyloid burden and nerve fiber density in skin biopsies.About PatisiranPatisiran is an investigational medicine that uses the body’s natural processes to lower the levels of the TTR protein that causes TTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of TTR protein before it is made. This may help to enable the clearance of TTR amyloid deposits in peripheral tissues and potentially restore function to these tissues. The safety and efficacy of patisiran have not been evaluated by the U.S. Food and Drug Administration or any other health authority.About hATTR amyloidosisHereditary transthyretin (TTR)-mediated (hATTR) amyloidosis is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier of vitamin A. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. hATTR amyloidosis represents a major unmet medical need with significant morbidity and mortality, affecting approximately 50,000 people worldwide. hATTR amyloidosis patients have a life expectancy of 2.5 to 15 years from symptom onset, and the only approved treatment options are liver transplantation for early stage disease and tafamidis (approved in Europe, Japan and certain countries in Latin America, specific indication varies by region). There is a significant need for novel therapeutics to help treat patients with hATTR amyloidosis.About LNP TechnologyAlnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology.Alnylam - Sanofi Genzyme AllianceIn January 2014, Alnylam and Sanofi Genzyme, the specialty care global business unit of Sanofi, formed an alliance to accelerate the advancement of RNAi therapeutics as a potential new class of innovative medicines for patients around the world with rare genetic diseases. The alliance enables Sanofi Genzyme to expand its rare disease pipeline with Alnylam's novel RNAi technology and provides access to Alnylam's R&D engine, while Alnylam benefits from Sanofi Genzyme's proven global capabilities to advance late-stage development and, upon commercialization, accelerate market access for these promising genetic medicine products. In the case of patisiran, Alnylam will advance the product in the United States, Canada and Western Europe, while Sanofi Genzyme will advance the product in the rest of the world.About RNAiRNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding protein synthesis in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, with the goal of preventing disease-causing proteins from being made.About Alnylam PharmaceuticalsAlnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including three product candidates that are in late-stage development or will be in 2017. Looking forward, Alnylam will continue to execute on its "Alnylam 2020" strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam.About SanofiSanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.com.Alnylam Forward Looking StatementsVarious statements in this release concerning Alnylam's future expectations, plans and prospects, including, without limitation, Alnylam's views with respect to the topline results from its APOLLO Phase 3 clinical trial for patisiran, its plans for and the expected timing of regulatory filings seeking approval for patisiran from regulatory authorities in the United States, Europe and ROW countries, its expectations regarding the potential for patisiran to improve the lives of hATTR amyloidosis patients with polyneuropathy and their families, its plans for the commercialization of patisiran if approved by regulatory authorities, and expectations regarding its "Alnylam 2020" guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam's ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing, delays, interruptions or failures in the manufacture and supply of its product candidates, obtaining, maintaining and protecting intellectual property, Alnylam's ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, progress in establishing a commercial and ex-United States infrastructure, competition from others using technology similar to Alnylam's and others developing products for similar uses, Alnylam's ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam's dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.Patisiran has not been approved by the U.S. Food and Drug Administration, European Medicines Agency, or any other regulatory authority and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.Sanofi Forward Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the clinical development of and potential marketing approvals for the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “would be” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development of the product, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve the product or biological application that may be filed for the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.ContactsAlnylam Pharmaceuticals, Inc. Investors and Media Christine Regan Lindenboom, 617-682-4340 or Investors Josh Brodsky, 617-551-8276
GSK and Innoviva Report Positive Headline Results from IMPACT Study Showing Single Inhaler Triple Therapy Trelegy Ellipta Reduced COPD Exacerbations
Trelegy Ellipta met study primary endpoint demonstrating reduction in exacerbations compared with the dual therapies Anoro Ellipta and Relvar/Breo Ellipta in patients with COPDSeptember 20, 2017 02:00 AM Eastern Daylight Time LONDON--(EON: Enhanced Online News)--GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive headline results from the landmark phase III IMPACT study of Trelegy Ellipta, the first and only FDA approved once-daily single inhaler triple therapy comprising an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA).Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) is approved for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/ VI) and require additional bronchodilation or who are receiving Breo and Incruse (umeclidinium, UMEC).The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily dual COPD therapies from GSK’s existing portfolio. The study showed a:15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta (FF/VI,100/25mcg); 0.91 vs 1.07 per year; p<0.001 25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI, 62.5/25mcg); 0.91 vs 1.21 per year; p<0.001 In addition, statistically significant improvements were observed across all pre-specified key secondary endpoints and associated treatment comparisons:Change from baseline trough FEV1 at week 52 for FF/UMEC/VI compared with FF/VI was 97mL; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was 54mL; p<0.001 Change from baseline St George’s Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with FF/VI was -1.8 units; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was -1.8 units; p<0.001 Analysis of time to first on-treatment moderate/severe COPD exacerbation demonstrated a 14.8% reduction in risk for FF/UMEC/VI compared with FF/VI; p<0.001, and a 16.0% reduction in risk for FF/UMEC/VI compared with UMEC/VI; p<0.001 Based on review of the headline data, the safety profile of once-daily FF/UMEC/VI was consistent with the known profile of the individual medicines and their dual combinations. The most common adverse events across the treatment groups were viral upper respiratory tract infection, worsening of COPD, upper respiratory tract infection, pneumonia and headache. The incidences of common serious adverse events were worsening of COPD 11%, 11% and 13% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively; for pneumonia was 4%, 4% and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.Patrick Vallance, President R&D, GSK, said: “We are delighted with the positive results achieved in the IMPACT study. This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations. It is important to note that all treatments were comprised of different combinations of the same component molecules administered in the same Ellipta inhaler, in a single dose, once a day to allow direct treatment comparisons. We hope these results will inform global guidelines and look forward to sharing the results with regulatory authorities. We will continue to analyse the wealth of data generated to further the understanding of the treatment of COPD.”Mike Aguiar, CEO of Innoviva, Inc., commented: “The results of the IMPACT study have been long awaited by the medical community. We believe these data will significantly contribute to the body of evidence on the use of single inhaler triple therapy, as well as the ongoing role of ICS/LABA and LAMA/LABA treatments in appropriate patients with COPD.”Full results will be presented at upcoming scientific meetings and in peer-reviewed publications.On 14 September 2017 GSK and Innoviva, Inc. announced EU Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation for Trelegy Ellipta) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.On 18 September 2017 GSK and Innoviva, Inc. announced US Food and Drug Administration (FDA) approved Trelegy Ellipta for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.Global regulatory filings with the IMPACT study are expected to commence in the second quarter of 2018 for consideration of expansion of the indicated patient population.About IMPACT The InforMing the PAthway of COPD Treatment (IMPACT) study was a randomised, double-blind, 3-arm parallel group, multicentre study evaluating FF/UMEC/VI (100mcg/62.5mcg/25mcg) versus UMEC/VI (62.5mcg/25mcg) and FF/VI (100mcg/25mcg), all given once daily via the ELLIPTA dry powder inhaler. The total duration of the study was approximately 55 weeks consisting of a 2-week run-in period, 52-week treatment period and a 1-week safety follow-up period. Patients had moderate to very severe symptomatic COPD with a history of exacerbation in the prior 12 months. In the study, 10,355 patients were treated in over 1,035 study centres globally.The primary efficacy endpoint was the annual rate of on-treatment moderate and severe exacerbations. This was compared for FF/UMEC/VI versus UMEC/VI and, FF/UMEC/VI versus FF/VI. Other endpoints included lung function and patient reported outcomes, including health related quality of life measures.About COPD COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both and limits airflow to the lungs, interfering with normal breathing. It is thought to affect 384 million people worldwide. 1For people living with COPD the inability to breathe normally and worsening of their symptoms can consume their daily life and make simple activities, like walking upstairs, an everyday struggle.Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin. 2Every person with COPD is different, with different needs, different challenges and different goals. Understanding this, and providing support to help meet these needs is the foundation of our work.About Trelegy Ellipta Trelegy Ellipta is the first once-daily single inhaler triple therapy approved in the US for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.Trelegy contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, in a single inhaler, the Ellipta.Full US Prescribing Information, including BOXED WARNING and Medication Guide is available at: us.gsk.com.Important Safety Information (ISI) for Trelegy Ellipta The following ISI is based on the Highlights section of the US Prescribing Information for Trelegy Ellipta. Please consult the full Prescribing Information for all the labelled safety information for Trelegy Ellipta.Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths. This finding with salmeterol is considered a class effect of all LABA. The safety and efficacy of Trelegy Ellipta in patients with asthma have not been established. Trelegy Ellipta is not indicated for the treatment of asthma.Trelegy Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or any of the ingredients.Trelegy Ellipta should not be initiated in patients experiencing episodes of acutely deteriorating COPD. Do not use Trelegy Ellipta to treat acute symptoms.Trelegy Ellipta should not be used in combination with other medicines containing LABA because of risk of overdose.Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.There is an increased risk of pneumonia in patients with COPD taking Trelegy Ellipta. Monitor patients for signs and symptoms of pneumonia.Patients who use corticosteroids are at risk for potential worsening of infections (e.g. existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex). Use Trelegy Ellipta with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.There is a risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Trelegy Ellipta.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of Trelegy Ellipta in susceptible individuals. If such changes occur, consider appropriate therapy.If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta and institute alternative therapy.Use Trelegy Ellipta with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.Assess patents for decrease in bone mineral density initially and periodically thereafter after prescribing Trelegy Ellipta.Close monitoring for glaucoma and cataracts is warranted in patients taking Trelegy Ellipta. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.Worsening of urinary retention may occur in patients taking Trelegy Ellipta. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.Use Trelegy Ellipta with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.Be alert to hypokalemia and hyperglycemia in patients taking Trelegy Ellipta.The most common adverse reactions reported for Trelegy Ellipta (incidence ≥1%) are headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.Innoviva – Innoviva is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination therapy for COPD. For more information, please visit Innoviva's website at www.inva.com.GSK cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.Innoviva forward-looking statements This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events, including the development, regulatory and commercial plans for closed triple combination therapy and the potential benefits and mechanisms of action of closed triple combination therapy. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks, uncertainties and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" contained in Innoviva's Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which are on file with the U.S. Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Innoviva's other filings with the SEC, other unknown or unpredictable factors also could affect Innoviva's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. (INVA-G).Registered in England & Wales: No. 3888792Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GSReferencesGlobal Initiative for Chronic Obstructive Lung Disease Global Initiative for Chronic Obstructive Lung Disease. 2017. Pocket guide to COPD diagnosis, management, and prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf Diagnosis of COPD. World Health Organisation. Available at: http://www.who.int/respiratory/copd/diagnosis/en/]
MiMedx Files With The FDA To Initiate The Company's Investigational New Drug Phase 2 Clinical Trial For Osteoarthritis Of The Knee
PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 2 clinical trial for osteoarthritis of the knee.The osteoarthritis clinical trial will study MiMedx's AmnioFix® Injectable in a Phase 2, prospective, double-blinded, randomized controlled trial of the micronized dehydrated human amnion/chorion membrane (dHACM) injection as compared to saline placebo injection in the treatment of knee osteoarthritis. The Company expects patient enrollment to commence by the end of the year.The trial will enroll approximately 318 study patients with a diagnosis of knee osteoarthritis defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. The IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of knee osteoarthritic pain.The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90, expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group. The Western Ontario and McMaster Universities (WOMAC) scores will be one of the study's secondary endpoints measured at 30, 60, 90 and 180 days.Osteoarthritis of the knee is an extremely common occurrence in older patients, where it represents the biggest cause of disability and reduction of activity in patients over the age of 50. There are 14 million individuals in the U.S. who have symptomatic knee osteoarthritis and there were 7.8 million knee joint pain injections in the U.S. in 2015. Common medical treatment options include injectable medications such as corticosteroid; other injections such as hyaluronic acid (HA) and platelet rich plasma (PRP); and surgery, such as knee arthroscopy and knee replacement. Randomized trials have shown that corticosteroid injections may present short-term relief to patients with the condition, but unfortunately, the condition tends to recur, and complications may occur, such as systemic hyperglycemia, septic arthritis, and joint degradation. Clinicians generally agree that a lifetime limit of 2-3 corticosteroid injections is appropriate in unresponsive patients.HA injections may provide temporary symptomatic relief and are widely used. However, their use is not without controversy and is currently not recommended by the American Academy of Orthopedic Surgeons in their treatment guidelines. PRP preparations have been popularly deployed in the treatment of knee osteoarthritis. However, concerns exist regarding this modality, since various methods of producing the material have differing bioactivity, and there is some debate in the literature about whether or not PRP is universally effective.Bill Taylor, President and COO, stated, "With the variability of efficacy, cost, and side effects of current treatments for osteoarthritis, other treatment options are needed. This is particularly true when chronicity begins to develop and surgery is becoming the only remaining option. We believe our PURION® Processed AmnioFix® Injectable would be an ideal treatment alternative for osteoarthritis of the knee. Studies have confirmed that the natural characteristics of amniotic membrane may provide clinical benefits in the areas of enhanced soft tissue healing and inflammation modulation."The osteoarthritis study will be the fourth IND trial for MiMedx AmnioFix Injectable. The other three IND trials include the Plantar Fasciitis Phase 2B, Plantar Fasciitis Phase 3, and Achilles Tendonitis Phase 3 trials. MiMedx also plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company's Plantar Fasciitis Phase 3 trial completes.Over 80 clinical studies documenting the efficacy and effectiveness of MiMedx allografts have been published to date. The Company's robust compendium of current clinical activity includes 28 ongoing clinical studies in various stages of development and execution, 123 clinical sites under management, and 175 physicians currently contracted for research activities. This vigorous agenda of clinical activities encompasses over 450 legal agreements and contracts for study involvement.Parker H. "Pete" Petit, CEO, said, "There should not be any further concerns about MiMedx becoming a biopharma focused organization in an expedited fashion. We have accomplished rapid asset development in these areas over the years, and in March we disclosed to shareholders that our new strategic focus would be new therapeutic areas as a biopharma company. At that point, I did not think our level of expertise and accomplishments to date were fully appreciated. However, having two ongoing phase 3 trials and one phase 2 trial at a large number of centers will be quite an accomplishment. We have been able to very efficiently and effectively conduct our trials to this point without the assistance of a Clinical Research Organization (CRO). We expect to continue to build our staff as our demands increase. Along those lines, we will shortly announce additional very experienced biopharma executives to our staff. They will help continue our rapid development of the opportunities we have with our placenta based technology.""We are anxious to commence the Phase 2 clinical trial and we expect the study results to be compelling. We look forward to reporting the results to the medical and investment communities," added Taylor.About MiMedx MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.Important Cautionary Statement This press release includes forward-looking statements, including statements regarding the Company's belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee and expectations that study results will be compelling. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
Allergan Innovation Recognized With Three 2017 Allure Best of Beauty Breakthrough Awards
PRNewswire/ -- For over 17 years, the highly-coveted Allure Best of Beauty Breakthrough Awards have recognized hair, makeup and skin products, fragrances and devices for their innovative formulations, performance and technologies. Today Allergan plc (NYSE: AGN) is happy to announce that Allure has awarded the 2017 Best of Beauty Breakthrough Award to three of the company's products: JUVÉDERM VOLBELLA® XC, RHOFADE® (oxymetazoline HCl) cream 1%, and SkinMedica® Lytera 2.0 Pigment Correcting Serum. Allergan plc logo "As a company, Allergan is committed to innovation and developing products that meet evolving patient needs, which is why we continue to be a leader in the aesthetic and medical dermatology categories," said Bill Meury , Chief Commercial Officer at Allergan , "We are proud and grateful that Allure has recognized this commitment with their prestigious Beauty Breakthrough Award." JUVÉDERM VOLBELLA® XC was honored marking the second Allure Beauty Breakthrough award for the JUVÉDERM® collection of fillers (JUVÉDERM VOLUMA® XC won in 2014). Both products feature Allergans proprietary VYCROSS® technology.This second win for the collection emphasizes the brand's position as the dermal filler category leader and recognizes the technology's tailored gel properties and specialized filler product offerings for specific treatment areas. JUVÉDERM VOLBELLA® XC adds subtle volume to lips and softens the appearance of vertical lip lines in adults over the age of 21.1-4 A 2017 addition to Allergan's Medical Dermatology portfolio, RHOFADE® cream was also named an Allure Beauty Breakthrough Award winner. RHOFADE® cream is a prescription medicine used on the skin to treat ongoing facial redness due to rosacea in adults.5 Since FDA approval in January, the brand has made great strides in educating media and consumers about ongoing facial redness due to rosacea. Finally, Allure named SkinMedica® Lytera® 2.0 Pigment Correcting Serum a breakthrough product, which marks the fifth time SkinMedica® has won an Allure Beauty Award, and the second time the brand has earned the publication's breakthrough accolade. This is also the fourth editorial award for Lytera® 2.0 since launch, adding to the nine wins collected by the product's predecessor, Lytera® Skin Brightening Complex . SkinMedica® Lytera® 2.0 Pigment Correcting Serum is an advanced pigment-correcting serum with an innovative formula that is retinol and hydroquinone free that reduces the appearance of existing skin discoloration and supports the skin's ability to resist intrinsic and extrinsic factors that can cause reoccurring and future discoloration. The 2017 Beauty Breakthrough Award winners will be announced in the October issue of Allure. JUVÉDERM VOLUMA® XC and JUVÉDERM VOLBELLA® XC Important Information APPROVED USES JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over the age of 21. JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21. IMPORTANT SAFETY INFORMATION Are there any reasons why I should not receive JUVÉDERM VOLUMA® XC or JUVÉDERM VOLBELLA® XC injectable gels? Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins used in these products. What precautions should my doctor advise me about? Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied The safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, and the safety of JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in controlled clinical studies Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment Patients who experience skin injury near the site of injection with these products may be at higher risk for side effects Tell your doctor if you are on immunosuppressive therapy used to decrease the body's immune response, as use of these products may result in an increased risk of infection Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment What are possible side effects? The most common side effects included swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, and itching. With JUVÉDERM VOLUMA® XC, most side effects were moderate (uncomfortable) and lasted 2 to 4 weeks. For JUVÉDERM VOLBELLA® XC, most side effects were mild or moderate and lasted 30 days or less. One of the risks with using these products is unintentional injection into a blood vessel, and, while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring. As with all skin injection procedures, there is a risk of infection. To report a side effect with JUVÉDERM VOLUMA® XC or JUVÉDERM VOLBELLA® XC, or for product information, please call Allergan at 1-800-433-8871. Please also visit Juvederm.com for more information. Available by prescription only. RHOFADE® (oxymetazoline HCl) cream 1% Important Safety Information Indication RHOFADE® (oxymetazoline HCl) cream 1% is a prescription medicine used on the skin to treat ongoing facial redness due to rosacea in adults. Important Safety Information Before you use RHOFADE® cream, tell your doctor about all your medical conditions, including if you have: heart, blood vessel, or blood pressure problems, or narrow-angle glaucoma (get medical help if these conditions worsen); problems with blood circulation or have had a stroke; Sjögren's syndrome; scleroderma; Raynaud's phenomenon; thromboangiitis obliterans; or irritated skin or open sores on the face. Tell your doctor about your medications, as use with RHOFADE® cream may cause serious side effects. The most common side effects at the application site include: skin reactions, worsening of rosacea pimples, itching, redness, and pain. You may report side effects to the FDA at 1-800- FDA -1088. Please see full Product Information for RHOFADE® cream. SkinMedica® The SkinMedica® product described here is intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. This SkinMedica® product is not intended to be a drug product that diagnoses, treats, cures or prevents any disease or condition. This product has not been approved by the FDA and the statements on these pages have not been evaluated by the FDA . References: 1. Data on File, Allergan ; Proforma Sales JUVÉDERM VOLUMA® XC, 2015. 2. Bernardin A et al. VYCROSS®: An innovative dermal filler technology. Poster presented at: 1st Annual Anti-Aging Medicine European Congress (AMEC); October 11-12, 2013 ; Paris, France . 3. JUVÉDERM VOLBELLA® XC Patient Labeling, 2016. 4. JUVÉDERM VOLUMA® XC Patient Labeling, 2016. 5. RHOFADE® Prescribing Information, 2017.