HARRISBURG, Pa.--(BUSINESS WIRE)--Cortendo AB [ticker: CORT on NOTC-A], a global biopharmaceutical company focused on developing new solutions for rare diseases that is based in Radnor, Penn., is pleased to participate in the Rare Disease Day® event at the Pennsylvania State Capitol Building on Tuesday, February 24. Matthew Pauls, President and CEO of Cortendo, joins patients and their families, physicians and legislators to help raise awareness for the 30 million Americans currently living with a rare disease.
The event is Tuesday, February 24, 11:30 a.m. to 1:30 p.m., at the State Capitol Building, East Wing Rotunda.
“I am honored to join patients and their families, physicians, and leaders of the Commonwealth of Pennsylvania at this important event, and I look forward to hearing about their perspectives and insights in dealing with rare diseases,” said Pauls, who will be speaking about the role of industry in rare disease drug development. “Their stories of challenge, triumph and hope are both motivating and inspiring to Cortendo employees and undoubtedly to others working hard to find new and better solutions.”
Cortendo’s lead investigational drug is COR-003 (levoketoconazole), which is being studied in the global Phase 3 SONICS trial for the treatment of Cushing’s syndrome. COR-003 (levoketoconazole) has received orphan designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
According to the National Institutes of Health (NIH), a disease is rare if it affects fewer than 200,000 Americans. One in 10 Americans live with a rare disease—affecting 30 million people—and two thirds of these patients are children. There are more than 7,000 rare diseases but only approximately 450 FDA-approved medical treatments. Many rare diseases are not being studied by medical researchers.
Rare Disease Day is an annual awareness day celebrated around the world and dedicated to elevating public understanding of rare diseases and calling attention to the special challenges faced by these patients. Rare Disease Day takes place every year on the last day of February (February 28, or February 29 in a leap year)—the rarest date on the calendar—to underscore the nature of rare diseases and what patients face. Rare Disease Day was established in Europe in 2008 by EURORDIS, the organization representing patients with rare diseases in Europe, and is now observed in more than 80 nations.
Rare Disease Day is sponsored by the National Organization for Rare Disorders (NORD®), a leading independent, nonprofit organization committed to the identification, treatment, and cure of rare diseases. The Pennsylvania event on Tuesday is co-sponsored by NORD and the Connexion Healthcare Rare Disease Center of Excellence. Connexion Healthcare is an award-winning, full-spectrum healthcare communications company founded in 1999, and its Rare Disease Center of Excellence specializes in effectively communicating the science behind rare diseases and orphan drugs, and members have a personal connection with, and passion for, assisting patients and caregivers affected by rare diseases.
For more information about Rare Disease Day in Harrisburg and registration, go to http://bit.ly/PArareDay. For information about global activities, visit www.rarediseaseday.org. To search for information about rare diseases, visit the NORD Web site at www.rarediseases.org.
About Cortendo AB
Cortendo AB is a global biopharmaceutical company incorporated in Sweden and based in the United States. The Company’s strategic focus is to be the global leader in commercializing innovative medicines for orphan endocrine disorders. Cortendo is leading the way in the field of cortisol inhibition through the investigational drug, COR-003 (levoketoconazole), currently being studied in the global Phase 3 SONICS trial for the treatment of Cushing’s syndrome. COR-003 (levoketoconazole) has received orphan designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The Company’s intent is to independently commercialize its Orphan/Endocrine assets in key global markets and partner non-strategic product opportunities, such as diabetes, at relevant development stages.
Risk and Uncertainty
The development of pharmaceuticals carries significant risk. Failure may occur at any stage during development and commercialization due to safety or clinical efficacy issues. Delays may occur due to requirements from regulatory authorities, difficulties in recruiting patients into clinical trials due to physician or patient preferences or competing products, not anticipated by the Company. There is no assurance that Cortendo will receive marketing and regulatory approvals necessary to commercialize or produce COR-003 (levoketoconazole) or other products. Regulatory approvals may be denied, delayed, limited or revoked.
The commercial success of COR-003 (levoketoconazole), if approved in a territory, cannot be predicted with certainty. In addition, Cortendo may face the risk of interrupted supply of COR-003 for clinical or commercial use from the subcontractors Cortendo has contracted.
Cortendo Forward-Looking Statements
This press release contains forward-looking statements concerning Cortendo that involve a number of risks and uncertainties. All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding the Company's future financial position, strategy, anticipated investments, costs and results, plans, projects to enhance efficiency, outcomes of products development, future capital expenditures, liquidity requirements and objectives of management for future operations, may be deemed to be forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements or industry results to be materially different from those contemplated, projected, forecasted, estimated or budgeted, whether expressed or implied, by these forward-looking statements. Given these risks and uncertainties, investors should not place any undue reliance on forward-looking statements as a prediction of actual results. None of these forward-looking statements constitutes a guarantee of the future occurrence of such facts and data or of actual results. These statements are based on data, assumptions and estimates that the Company believes are reasonable. The forward-looking statements contained in this document are made only as of the date hereof. The Company expressly disclaims any obligation or undertaking to release publicly any updates of any forward-looking statements contained in this press release to reflect any change in its actual results, assumptions, expectations or any change in events, factors, conditions or circumstances on which any forward-looking statement contained in this press release is based.