Corcept Therapeutics Announces Partnership With Idis for Global Access to Korlym(R)

Posted on July 25, 2013 by MaryO

PRINCETON, NJ and MENLO PARK, CA, Jul 24, 2013 (Marketwired via COMTEX) — Corcept Therapeutics Incorporated CORT  announced today that Korlym(R) (mifepristone) 300 mg Tablets is available to patients outside of the United States through an Idis Access Program.

Idis Access Programs enable patients around the world to be prescribed investigational or approved drugs prior to their commercial launch in that country through a regulatory-compliant and ethical channel on a named-patient basis. Corcept, a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, has been offering Korlym in the United States since April 2012 as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

“We are pleased to partner with Idis so that physicians outside the United States can prescribe Korlym,” said Steven Lo, Corcept’s Vice President of Commercial Operations. “We are dedicated to meeting the needs of patients worldwide. Our partnership with Idis will help us make sure that every Cushing’s syndrome patient who could benefit from Korlym will have access to the medicine.”

Charles Simmons, President of Established Brands at Idis said of the partnership, “We are very excited to work with Corcept to provide patients around the world with access to this important treatment. Patients are at the heart of what we do at Idis and providing access to an important medicine like Korlym, creating a bridge to treatment irrespective of the number of patients involved, is one of the ways we do it”.

Licensed healthcare professionals outside the United States with patients who might benefit from Korlym should contact Idis directly:

Idis UK & Eire Enquiries Tel: +44 (0) 1932 824 100 Fax: +44 (0) 1932 824 300 Email: uk@idispharma.com

Idis Rest of the World Enquiries Tel: +44 (0) 1932 824 123 Fax: +44 (0) 1932 824 323 Email: internationalsales@idispharma.com

About Cushings Syndrome Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20 to 50. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be fatal if not treated effectively.

About Corcept Therapeutics Incorporated Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. Korlym, a first generation GR-II antagonist, is the company’s first FDA-approved medication. Corcept has a phase 3 trial underway for mifepristone for treatment of the psychotic features of psychotic depression and a portfolio of selective GR-II antagonists that block the effects of cortisol but not progesterone. It owns extensive intellectual property covering the use of GR-II antagonists, including mifepristone, in the treatment of a wide variety of metabolic and psychiatric disorders. It also holds composition of matter patents for its selective GR-II antagonists. For more information about Corcept please visit: http://www.corcept.com

About Idis Idis has 25 years experience partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs. Since 1987, Idis has developed and managed access to thousands of medicines from every therapeutic category, impacting the lives of hundreds of thousands of patients in countries around the world.

Idis leverages decades of experience, regulatory insight, and a thorough understanding of local and global requirements to create access to medicines at every stage of a product’s lifecycle from pre-approval to market exit, and in times of unexpected production shortages.

The company’s European headquarters are located in Weybridge, United Kingdom, and North American headquarters are located in Princeton, NJ.

For more information about Idis please visit http://www.idispharma.com.

From Marketwatch

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A cellular and molecular basis for the selective desmopressin-induced ACTH release in Cushing’s disease patients: key role of AVPR1b receptor and potential therapeutic implications

Posted on July 25, 2013 by MaryO

Journal of Clinical Endocrinology and Metabolism, 07/25/2013  Review Article

Luque RM et al. – The study aims to determine, for the first time, whether desmopressin acts directly and exclusively on pituitary corticotropinoma cells to stimulate ACTH expression/release, and to elucidate the cellular and molecular mechanisms involved in desmopressin–induced ACTH increase in Cushing’s disease (CD).

The present results provide a cellular and molecular basis to support the desmopressin stimulation test as a reliable, specific test for the diagnosis and post–surgery prognosis of CD.

Furthermore, the data indicates that AVPR1b is responsible of the direct/exclusive desmopressin–stimulatory pituitary effects observed in CD, thus opening the possibility of exploring AVPR1b–antagonists as potential therapeutic tools for CD treatment.

~~~~~~~~

Abstract

  1. RM Luque1,#,
  2. A Ibáñez-Costa1,#,
  3. LM López-Sánchez1,
  4. L Jiménez-Reina2,
  5. E Venegas-Moreno3,
  6. MA Gálvez4,
  7. A Villa-Osaba1,
  8. AM Madrazo-Atutxa3,
  9. MA Japón5,
  10. A de la Riva6,
  11. DA Cano3,
  12. P Benito-López4,
  13. A Soto-Moreno3,
  14. MD Gahete1,
  15. A Leal-Cerro3,*and
  16. JP Castaño1,*

–Author Affiliations


  1. 1Department of Cell Biology, Physiology and Immunology University of Córdoba, Reina Sofía University Hospital, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC); CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn); 14014, Córdoba, Spain.

  2. 2Department of Morphological Sciences, University of Córdoba. Córdoba, Spain.

  3. 3Instituto de Biomedicina de Sevilla (IBiS), University Hospital Virgen del Rocío/Consejo Superior de Investigaciones Científicas/University of Seville and Endocrinology, Metabolism and Nutrition Unit, Virgen del Rocío University Hospital, Seville, Spain.

  4. 4Service of Endocrinology and Nutrition, Reina Sofía University Hospital, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC). Córdoba, Spain.

  5. 5Department of Pathology, Virgen del Rocio University Hospital, Seville, Spain.

  6. 6Service of Neurosurgery, Reina Sofía University Hospital Córdoba, Spain.
  1. Address all correspondence and requests for reprints to: Raúl M. Luque and Justo P. Castaño.Department of Cell Biology, Physiology and Immunology; Campus Universitario de Rabanales, Edificio Severo Ochoa (C6), Planta 3; University of Córdoba, E-14014 Córdoba, Spain. Phone:(34)-957218594. Fax: (34)-957218634. E-mails: raul.luque@uco.es; justo@uco.es.

  1. ↵# These authors have codirected this study.

Abstract

Context: Desmopressin is a synthetic agonist of vasopressin-receptors (AVPRs). Desmopressin stimulation test is employed in the diagnosis and post-surgery prognosis of Cushing’s disease (CD). However, the cellular and molecular mechanisms underlying the desmopressin-induced ACTH increase in CD patients are poorly understood.

Objective: 1) To determine, for the first time, whether desmopressin acts directly and exclusively on pituitary corticotropinoma cells to stimulate ACTH expression/release, and 2) to elucidate the cellular and molecular mechanisms involved in desmopressin-induced ACTH increase in CD.

Design: 8 normal-pituitaries (NPs), 23 corticotropinomas, 14 nonfunctioning-pituitary adenomas (NFPA), 17 somatotropinomas and 3 prolactinomas were analyzed for AVPRs-expression by qrtPCR. Primary cultures derived from corticotropinomas, NFPAs, somatotropinomas, prolactinomas and NPs were treated with desmopressin and ACTH-secretion/expression, [Ca2+]i-kinetics, AVPRs-expression and/or proliferative-response were evaluated. The relationship between AVPRs-expression and plasma adrenocorticotropin/cortisol levels obtained from desmopressin-tests was assessed.

Results: Desmopressin affects all functional parameters evaluated in corticotropinoma-cells but not in NPs or other pituitary-adenomas cells. These effects might be due to the dramatic elevation of AVPR1b expression levels found in corticotropinomas. In line with this notion, the use of an AVPR1b-antagonist completely blocked desmopressin-stimulatory effects. Remarkably, only AVPR1b-expression was positively correlated with elevated plasma adrenocorticotropin levels in corticotropinomas.

The present results provide a cellular and molecular basis to support the desmopressin stimulation test as a reliable, specific test for the diagnosis and post-surgery prognosis of CD. Furthermore, our data indicates that AVPR1b is responsible of the direct/exclusive desmopressin-stimulatory pituitary effects observed in CD, thus opening the possibility of exploring AVPR1b-antagonists as potential therapeutic tools for CD treatment.

Footnotes

  • ↵* These authors have codirected this study.

Full Text (PDF)

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