Lawmakers are also facing a potential government shutdown that could prolong the economic pain. Nine drugmakers are pledging to thoroughly vet any coronavirus vaccine.
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Covid-19 news: Live updates
Author: Michelle Dryden
FOX News: Antifa violence is backed by “powerful political entities” who need to be exposed to stop it, Fox Nation host Lara Logan told “Fox & Friends First” on Tuesday.
— Talia Kaplan
FOX News: Bill Belichick is only focused on one thing at the start of the 2020 season – the Miami Dolphins.
— Ryan Gaydos
Video testimony from two soldiers supports widespread accusations that Myanmar’s military tried to eradicate the ethnic minority in a genocidal campaign.
— Hannah Beech, Saw Nang and Marlise Simons
FOX News: Naked except for “spit hoods” in a reference to the killing of Daniel Prude, several protesters sat outside Rochester’s police headquarters Monday morning to push for police accountability, local news outlets reported.
FOX News: Democrats do not have the “moral courage” to call out Black Lives Matter (BLM) protesters harassing diners, Turning Point USA spokesperson Rob Smith said on Tuesday.
— Joshua Nelson
Tuesday: Over the holiday weekend, another record-shattering heat wave slammed the West Coast and new fires erupted across California.
— Jill Cowan
HAMILTON, N.J.–(BUSINESS WIRE)–The Dodge Momentum Index increased 1.8% in August to 126.5 (2000=1000) from the revised July reading of 124.2. The Momentum Index, issued by Dodge Data & Analytics, is a monthly measure of the first (or initial) report for nonresidential building projects in planning, which have been shown to lead construction spending for nonresidential buildings by a full year. In August, the commercial component rose 3.3%, while the institutional component moved 1.2% lower.
The August increase in the overall Momentum Index is the second consecutive rise and a further sign that the construction sector continues to post a modest recovery following the large declines in April and June. This recovery, though, is uneven. The commercial component has risen 9% from its June low and is just 13% below its 2018 peak fueled by increased planning activity for warehouse and office projects. The institutional component, however, has declined for five consecutive months and has yet to hit bottom. The institutional component is now 34% below its recent peak. The public side of the building market is suffering as state and local government revenues have declined, creating budget cuts across the country. This has led to a significant pullback in education projects entering planning, placing substantial downward pressure on the institutional component of the Momentum Index.
In August, 11 projects each with a value of $100 million or more entered planning. The leading commercial projects were a $262 million UPS distribution facility in Mebane NC and a $200 million Amazon distribution center (Project Star) in San Antonio TX. The leading institutional projects were the $150 million BayCare South Florida Baptist Hospital in Plant City FL and the $125 million second phase of the Veterans Memorial Arena in Binghamton NY.
About Dodge Data & Analytics: Dodge Data & Analytics is North America’s leading provider of commercial construction project data, market forecasting & analytics services and workflow integration solutions for the construction industry. Building product manufacturers, architects, engineers, contractors, and service providers leverage Dodge to identify and pursue unseen growth opportunities that help them grow their business. On a local, regional or national level, Dodge empowers its customers to better understand their markets, uncover key relationships, size growth opportunities, and pursue specific sales opportunities with success. The company’s construction project information is the most comprehensive and verified in the industry. Dodge is leveraging its more than 125-year-old legacy of continuous innovation to help the industry meet the building challenges of the future. Learn more at www.construction.com.
Contacts
Media Contact: Nicole Sullivan | AFFECT Public Relations & Social Media | +1-212-398-9680,
- Companies will partner to develop novel antibody-drug conjugates using Catalent’s SMARTag bioconjugation platform and monoclonal antibodies from Exelixis’ growing preclinical pipeline
- Agreement includes exclusive options on multiple targets over three-year term, with potential to extend time and scope of the collaboration
- Deal is the fifth pipeline-enhancing agreement signed by Exelixis since 2018
ALAMEDA, Calif. & SOMERSET, N.J.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) and Catalent today announced a partnership under which Catalent’s Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag® site-specific bioconjugation technology.
Under the terms of the agreement, Catalent will use its SMARTag® bioconjugation platform to build ADCs using monoclonal antibodies (mAbs) from Exelixis’ growing preclinical pipeline. In exchange for an upfront payment to Catalent of $10 million, Exelixis received an exclusive option to nominate up to a fixed number of targets using the SMARTag® ADC platform over a three-year period. The companies plan to advance the ADCs into preclinical development, and, prior to filing an Investigational New Drug application, Exelixis may exercise its exclusive option to a worldwide license of the related ADC program and continue clinical development and commercialization. Exelixis will provide research & development funding, and Catalent will be eligible for development and commercial milestones and royalties on net sales of any product commercialized as part of the collaboration.
Developed by Catalent’s Redwood Bioscience subsidiary, the SMARTag® technology platform provides optimized site-specific protein-modification and linker technologies for ADCs and other bioconjugates. The SMARTag® platform overcomes the limitations associated with traditional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity, and stability and enables the development of ADCs with a wider therapeutic window and improved manufacturability.
“With our lead product CABOMETYX now a global oncology franchise, over the past several years Exelixis has moved beyond our small molecule medicinal chemistry roots to build out a pipeline that encompasses a variety of promising therapeutic modalities,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. “Our collaboration with Catalent – the fifth pipeline-enhancing agreement we’ve signed since 2018 – provides an attractive framework for identifying and advancing differentiated ADC product candidates with the potential to improve upon current ADC therapies. We are looking forward to working with Catalent as we rapidly advance our mission to help cancer patients recover stronger and live longer.”
“The SMARTag® platform has recently demonstrated promising results in the clinic, highlighting the potential to create ADCs with significantly expanded therapeutic indices,” commented Mike Riley, Region President, Catalent Biologics, North America. “We are excited to partner with Exelixis, a leading oncology biotechnology company, and leverage our experienced team, unique SMARTag® technology platform, and deep analytical expertise to develop ADCs targeting various oncology indications.”
About Catalent Biologics
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.
About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,900 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
About Exelixis
Founded in 1994, Exelixis, Inc. is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ immediate and potential future financial and other obligations under the collaboration, option and exclusive license agreement with Catalent; the potential for the collaboration with Catalent to result in the advancement of differentiated ADC product candidates with the potential to improve upon current ADC therapies and advance Exelixis’ mission to help cancer patients recover stronger and live longer; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationship with Catalent, including Catalent’s adherence to its obligations under the collaboration, option and exclusive license agreement and the level of Catalent’s assistance to Exelixis in completing clinical trials, pursuing regulatory approvals or successfully commercializing partnered compounds in the territories where they may be approved; the continuing COVID-19 pandemic and its impact on Exelixis’ research and development and commercial activities; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; Exelixis’ and Catalent’s ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2020, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.
MINNEBRO is a Japanese trademark.
Catalent and SMARTag are registered trademarks of Catalent Pharma Solutions, Inc. or its affiliates or subsidiaries in the United States and other countries.
Contacts
Exelixis
Investors Contact:
Susan Hubbard
Executive Vice President,
Public Affairs & Investor Relations
(650) 837-8194
Media Contact:
Hal Mackins
For Exelixis, Inc.
(415) 994-0040
Catalent
Media Contact:
Chris Halling
+44 (0)7580 041073
Richard Kerns
+44 (0) 161 728 5880
- Data presented as a late-breaker during a virtual ALERT session at the annual meeting of the European Respiratory Society
- Outcomes from the randomized, controlled, open-label REPLACE study included results from 226 patients with pulmonary arterial hypertension (PAH)
WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced results from the Phase IV REPLACE (Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy) study, in which intermediate-risk adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1) transitioned to Adempas® (riociguat) after an insufficient response to phosphodiesterase-5 inhibitor (PDE5i) therapy. Specifically, 41 percent of patients transitioning to Adempas therapy achieved the composite primary endpoint of clinical improvement in the absence of clinical worsening, compared with 20 percent in the PDE5i group (odds ratio [OR]=2.78, 95 percent confidence interval (CI) [1.53-5.06]; p=0.0007). The most common adverse events (AEs) were generally consistent with those seen in the pivotal PATENT study. These data, which are part of a collaboration between Bayer and Merck (known as MSD outside the United States and Canada), were presented today (Abstract # 3802) as part of an ALERT (Abstracts Leading to Evolution in Respiratory Medicine Trials) session at the virtual annual meeting of the European Respiratory Society (ERS) on September 7-9, 2020.
The pivotal PATENT-1 trial, a 12-week, multicenter, double-blind, randomized, placebo-controlled study, investigated the efficacy and safety of riociguat for the treatment of adult patients (n=443) with PAH (WHO Group1) who were treatment-naïve or were pretreated with endothelin receptor antagonists (ERA) or prostanoids (oral, inhaled or subcutaneous [SC]). Improvements were demonstrated in clinically relevant endpoints, including 6-minute walk distance (6MWD) 36 meters (m) (95 percent CI: 20m – 52m; p<0.0001), WHO functional class (FC) (p=0.0033; majority of patients had a WHO FC II or III at baseline), time to clinical worsening (TTCW) (p=0.0046) and pulmonary vascular resistance (–226 dyn·s·cm–5 [95 percent CI: -281 to -170], p<0.001), N-terminal pro b-type natriuretic peptide [NT-proBNP]; –432 ng/mL [95 percent CI: –782 to –82], p<0.001).
In the PATENT study, the most common AEs occurring more frequently (in more than or equal to 3 percent of patients) on Adempas than placebo were headache (27 percent versus 18 percent), dyspepsia/gastritis (21 percent versus 8 percent), dizziness (20 percent versus 13 percent), nausea (14 percent versus 11 percent), diarrhea (12 percent versus 8 percent), hypotension (10 percent versus 4 percent), vomiting (10 percent versus 7 percent), anemia (7 percent versus 2 percent), gastroesophageal reflux disease (5 percent versus 2 percent) and constipation (5 percent versus 1 percent). Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema.
“In clinical practice, a considerable proportion of intermediate-risk patients with pulmonary arterial hypertension do not reach or maintain specific treatment goals when treated with a PDE5i-based regimen,” said Sameer Bansilal, M.D., M.S., Senior Medical Director, U.S. Medical Affairs at Bayer. “It is therefore gratifying to see that forty-one percent of REPLACE study participants attained the clinical improvement endpoint when transitioning from PDE5 inhibitor therapy to Adempas. In addition to supporting the rationale for therapy modification, the REPLACE results add to the findings from the PATENT study, which found patients can be well-managed on Adempas-based mono or combination therapy.”
Adempas has a warning for embryo-fetal toxicity. Adempas cannot be used in pregnant women because it may cause fetal harm. In females of reproductive potential, pregnancy must be excluded before the start of treatment, monthly during treatment and one month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
About the REPLACE Study
REPLACE (Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy) was a prospective global, multicenter, double-arm, randomized, controlled, open-label Phase IV study.1 Conducted in 81 sites in 22 countries, the 24-week study assessed the clinical effects of transitioning to Adempas from PDE5i therapy in 226 patients with PAH who demonstrated an insufficient clinical response to stable treatment with PDE5i (sildenafil or tadalafil) either as monotherapy or in combination with an endothelin receptor antagonist (ERA). The 24-week study involved patients with PAH at intermediate risk despite treatment with PDE-5 inhibitors (sildenafil or tadalafil) with or without ERA combination.2 Intermediate risk was defined as World Health Organization functional class (WHO FC) III, with a 6-minute walking distance (6MWD) of 165-440m, despite receiving stable doses of PDE5i, an endothelin receptor antagonist (ERA) based on the European Society of Cardiology/European Respiratory Society (ESC/ERS) treatment guidelines.2
The blinded, centrally adjudicated composite primary endpoint was clinical improvement at week 24 (defined as two of the following: ≥10 percent/≥30 meter increase in 6MWD from baseline, WHO FC I/II, or ≥30 percent reduction in NT-proBNP from baseline) in the absence of clinical worsening (death from any cause, hospitalization for worsening PAH or disease progression).3 6-minute walking distance and WHO FC were assessed blind and clinical worsening events were independently adjudicated. Response rates were consistent with the overall results across the different types of PAH and pre-treatment therapies. The safety results are consistent with the known safety profile of riociguat.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is defined by elevated pressure in the arteries going from the right side of the heart to the lungs.4 Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope.5 PAH is caused by abnormalities in the walls of the pulmonary arteries.2,6
About Adempas® (riociguat)
Riociguat, licensed in the U.S. as Adempas, is a stimulator of soluble guanylate cyclase (sGC) and is the only treatment approved in the U.S. for use in two types of pulmonary hypertension (WHO Groups 1 and 4).
In October 2013, the U.S. Food and Drug Administration (FDA) approved riociguat under the name Adempas® for use in patients with PAH, as well as inoperable CTEPH or persistent/recurrent CTEPH after surgery. In March 2014, the European Medicines Agency approved riociguat under the name Adempas® for use in patients with PAH and inoperable CTEPH or persistent/recurrent CTEPH after surgical treatment. Riociguat has been granted orphan drug designation (ODD) in both the European Union and the U.S. In Japan, riociguat has been granted ODD for use in patients with inoperable CTEPH or persistent/recurrent CTEPH after surgical treatment; it was approved in Japan for this indication in January 2014, and for use in patients with PAH in February 2015.
Bayer and Merck (known as MSD outside the United States and Canada) are in a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. ADEMPAS®, the first sGC stimulator of this collaboration, is developed by Bayer and MSD. It has received marketing authorization in the U.S., Canada, EU, Japan and several other countries around the world.
INDICATIONS
Adempas (riociguat) tablets is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.
Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening.*
Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominantly patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).
*Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD, and persistent worsening of WHO functional class.
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Adempas (riociguat) tablets to a pregnant female because it may cause fetal harm.
Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and one month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.
For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
Contraindications
Adempas is contraindicated in:
• Pregnancy. Based on data from animal reproduction studies, Adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
• Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form.
• Concomitant administration with specific phosphodiesterase (PDE)-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.
• Patients with Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonias (PH-IIP).
Warnings and Precautions
Embryo-Fetal Toxicity. Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment. Advise females of reproductive potential to use effective contraception during treatment with Adempas and for at least one month after the last dose.
For females, Adempas is only available through a restricted program under the Adempas REMS Program.
Adempas REMS Program. Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program.
Important requirements of the Adempas REMS Program include the following:
• Prescribers must be certified with the program by enrolling and completing training.
• All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program.
• Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements.
• Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.
Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS.
Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension.
Bleeding. In the placebo-controlled clinical trials, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter-site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage.
Pulmonary Veno-Occlusive Disease. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas.
Most Common Adverse Reactions
The most common adverse reactions occurring more frequently (≥3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%).
Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension, and peripheral edema.
For important risk and use information, please see the full Prescribing Information, including Boxed Warning.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
References:
- ClinicalTrials.gov. Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy (REPLACE). Accessed on September 2, 2020. https://clinicaltrials.gov/ct2/show/NCT02891850
- Bayer. Data on File.
- Bayer. Data on File.
- Rosenkranz S. Pulmonary hypertension: current diagnosis and treatment. Clin Res Cardiol. 2007;96(8):527-541.
- McKenna SP et al. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res 2006;15(1):103-115.
- Galiè, N et al. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J 2009;30:394-403.
Contacts
Media:
David Patti, +1-973-452-6793
Bayer, U.S. Corporate Communications