Daraprim and Vecamyl sales brings Turing $5.6 million in 3Q 2015, New Drug applications on the way

Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, reported net revenue $5.6 million  for the third quarter 2015.

According to the company’s quarterly report, this revenue represents Daraprim and Vecamyl sales. The company said that research and development spending of approximately $7 million reflects its progress advancing TUR-002 and TUR-004 with the FDA and multiple preclinical programs.

Investigational New Drug applications

The company said in its quarterly report on Thursday, Toxoplasmosis is on the Center for Disease Controls’ list of neglected parasitic infections (NPIs) as a priority for public health action. Turing also said it intended to file Investigational New Drug applications with the FDA for new candidate medications, currently in preclinical studies. The most advanced pipeline products are dihydrofolate reductase (DHFR) inhibitors with improved pharmacological profiles relative to pyrimethamine. Turing is also actively engaged in licensing opportunities for toxoplasmosis therapeutics.

Phase I clinical program for TUR-004

Epileptic encephalopathies are a diverse group of severe epilepsy disorders in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function. Beginning in November, the company is initiating the Phase I clinical program for TUR-004, its new candidate for this group of disorders.

TUR-002 development

The company further said it was developing, TUR-002, as it explains – an intranasal formulation of ketamine for the treatment of Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD).

Ketamine, which has been extensively used as an anesthetic, may also be used as rapid treatment for these disorders as suggested by experimental studies.The company said it had plans to initiate Phase I trials for TUR-002 by the first quarter of 2016.

TUR-007

Turing has initiated preclinical work in Q3 ’15 at an industry-leading CRO to aid in the development of TUR-007.

TUR-007 is a preclinical drug candidate targeting pathological mechanisms associated with Canavan Disease. Canavan is a neurological disorder that manifests in early infancy and is caused by an inherited genetic abnormality. This genetic aberration leads to a deterioration of myelin in the brain, thereby preventing proper transmission of nerve signals. Symptoms include intellectual disability and the inability to crawl, walk, sit or talk. Some patients suffer from paralysis, blindness and seizures with a life expectancy limited to early adolescence. There is currently no approved treatment, the company noted.

TUR-005 for Lafora Disease

TUR-005 is a preclinical drug candidate for Lafora Disease, a fatal autosomal recessive neurological disorder typically diagnosed in adolescents. Dysfunction of one or more key proteins involved in glycogen processing leads to the presence of hallmark Lafora bodies and is associated with neurodegenerative myoclonic epilepsy for which no disease-modifying treatments exist. Turing said it also initiated preclinical work in Q3 ’15 at an industry-leading CRO to aid in the development of TUR-005.

Cross reacting material 197 (CRM197) is a non-toxic variant of diphtheria toxin, for which Turing believes is an ideal platform technology capable of intracellular delivery of cargo proteins into cytosol and across the blood-brain-barrier. The company with offices in Switzerland and the U.S. said it was developing CRM197 fusion constructs with therapeutic proteins of up to 1,000 amino acids in length as a proof of concept before assessing even larger delivery systems.

Due to the high cost of pursuing these development objectives, Turing expects to spend at least 60% of its revenue on research and development for the foreseeable future.

Martin Shkreli, founder and CEO of Turing said,

“Our Research and Development organization, led by Dr.Eliseo Salinas, has surpassed my expectations in advancing TUR-004 for epileptic encephalopathies and TUR-002 for depression with the FDA.” Dr. Salinas remarked, “We are very excited about the potential for Turing’s pipeline of new drug candidates to help patients in need of better medications.”