Neurolixis Announces In-­licensing Of Two Clinical Compounds From Pierre Fabre Medicament

SAN DIEGO - Sept. 23, 2013 - PRLog -- San Diego, CA, September 23, 2013 -- Neurolixis, Inc. today announced that it has licensed the worldwide development and commercialization rights to two clinical compounds from Pierre Fabre Medicament. The two serotoninergic compounds, F15599 and befiradol, have been tested by Pierre Fabre in Phase 1 and 2 clinical studies, respectively. Neurolixis plans to study befiradol in Parkinson’s disease patients that exhibit dyskinesia, and F15599 will be evaluated for its ability to normalize irregular breathing in Rett syndrome patients.

"The Neurolixis team has significant experience in serotonin pharmacology, and these two compounds have unprecedented levels of selectivity and efficacy. We are excited to continue the clinical development of befiradol and F15599, potentially providing new therapies to patients suffering from debilitating central nervous system disorders," said Mark Varney, Neurolixis’ President and CEO.

“We are pleased by this agreement with Neurolixis concerning two compounds discovered by Pierre Fabre in the neuropsychiatry area. It matches with our strategy to develop international partnerships at every stage of the pharmaceutical value chain, including research, clinical development, contract manufacturing and licensing in or out, with a special emphasis on our growth franchises, namely onco-hematology, dermatology, women health and neuropsychiatry,” commented Frédéric Duchesne, President of Pierre Fabre Médicament.

Neurolixis obtained an exclusive, royalty-bearing license with regulatory and clinical development milestone payments. Neurolixis’ development and commercialization rights are worldwide, and exclusive in all fields for the licensed compounds.

"Our first objective is to run a Phase IIa clinical study with befiradol in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID). Levodopa remains the gold standard treatment for PD but, after a few years, it elicits dyskinesia in a majority of PD patients. A successful treatment for dyskinesia has the potential to significantly improve patients' quality of life,” stated Mark Varney.  “No drug is approved for dyskinesia and LID remains a significant unmet medical need.”  Neurolixis has previously received two grants from the Michael J. Fox Foundation supporting proof-of-principle animal studies to test befiradol’s anti-dyskinetic properties.

The Company will also evaluate F15599 for its ability to normalize irregular breathing patterns seen in patients suffering from Rett syndrome, a severe genetically-encoded neurodevelopmental disorder.  In preclinical studies, F15599 reversed breathing deficits in transgenic mice with the MeCP2 gene mutation that underlies Rett’s syndrome.  Neurolixis has applied to the FDA for orphan drug designation for the treatment of Rett syndrome and will explore orphan drug designations in Europe and in other parts of the world under its worldwide development and commercialization rights.

About Parkinson’s Disease

PD is a chronic, progressive neurological disorder that affects one in 100 people over the age 60. Approximately 6 million people worldwide are suffering from this neurodegenerative disorder. The most commonly administered drug to treat the symptoms of PD is levodopa (also called L-dopa), which helps restore levels of dopamine, a chemical messenger in the brain. However, following prolonged use, many patients treated with levodopa develop uncontrollable movements, i.e. dyskinesia, a major source of disability in their lives.

About Rett Syndrome

Rett syndrome is a rare neurodevelopmental disorder that affects brain development, and primarily affects girls.  Most babies with Rett syndrome seem to develop normally at first, but symptoms appear after 6 months of age. Children with Rett syndrome develop a wide range of symptoms that include abnormal and distressing breathing patterns, as well as loss of speech and poor movement coordination. There is no cure for Rett syndrome.  The incidence of Rett is estimated at 1 in 10,000 females; in the United States approximately 16,000 girls and women affected.  Rett Syndrome is therefore classified as a “rare disease” and compounds aimed at treating it qualify for orphan drug status.

About Neurolixis, Inc.

Neurolixis, located in San Diego, California, is a privately-held biotechnology company developing therapies for disorders of the nervous system. The Company is focused on developing small molecule drugs for the treatment of psychiatric disorders such as depression and schizophrenia, and neurological disorders such as Parkinson’s disease and Rett syndrome.  Additional information regarding Neurolixis is available at http://www.neurolixis.com.

About Pierre Fabre Medicament

Pierre Fabre Laboratories, of which Pierre Fabre Médicament is the pharmaceuticals division, is the second largest independent pharmaceutical group in France and achieved a turnover of 1.98 billion Euros in 2012, with international sales accounting for 54%. Pierre Fabre has branches in 42 countries and its products are distributed in over 130 countries.  In prescription drugs, Pierre Fabre focuses on four therapeutic areas: oncology, dermatology, neuropsychiatry and women’s health. In oncology, Pierre Fabre achieves about 90% of its turnover outside its home country.