ZUG, Switzerland--(BUSINESS WIRE)--Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today announced financial results and operational highlights for the quarter ended September 30, 2015.
Research and Development
- Toxoplasmosis is on the Center for Disease Controls' list of neglected parasitic infections (NPIs) as a priority for public health action. We intend 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.
- 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, we are initiating the Phase I clinical program for TUR-004, our new candidate for this group of disorders. The first trial will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in healthy young adult subjects. TUR-004 has received Fast Tack Designation from the FDA.
- We are developing, TUR-002, 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. It is estimated that more than fifteen million adults in the United States suffer from MDD and more than seven million from PTSD over a given year, many of whom will experience suicidal ideation. In addition, a World Health Organization report indicates that by 2030 depression will be the leading cause of disease burden globally. We plan to initiate Phase I trials for TUR-002 by the first quarter of 2016.
- 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. Turing has initiated preclinical work in Q3 '15 at an industry-leading CRO to aid in the development of TUR-007.
- 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 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, which we believe is an ideal platform technology capable of intracellular delivery of cargo proteins into cytosol and across the blood-brain-barrier. We are 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. Our initial focus is on monogenic diseases with validated animal models and a firmly established connection between the defective protein and associated disorder. Turing entered a Sponsored Research Agreement in Q2 '15 with the Hospital for Sick Children in Toronto to discover and develop new treatments based on this technology.
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."
With respect to Daraprim®, after consulting with patient advocacy groups and infectious disease doctors, Turing understands that toxoplasmosis patients are primarily concerned with timely access and minimal out-of-pocket costs. We are committed to continuing the expansion of our distribution partnerships in order to facilitate optimal patient access. In addition to participation in federal and state programs with costs as low as 1 penny per pill, and patient savings programs under which patients' out-of-pocket expenses do not exceed $10 per prescription, Turing contributes to Patient Services, Inc. (PSI), a longstanding independent charity that provides support for financially needy patients' cost-sharing obligations for any toxoplasmosis therapies, consistent with PSI's advisory opinion from the HHS Office of Inspector General. In order to better address the needs of physicians and patients, Turing will be introducing a 30-count bottle to address the needs of hospitals as well as a sample package to ensure physicians have timely and affordable access to therapy in emergency situations.
Financial Update: Quarter Ended September 30, 2015
For the third quarter of 2015, net revenue was $5.6 million representing Daraprim® and Vecamyl®sales. Research and development spending of approximately $7 million reflects Turing's progress advancing TUR-002 and TUR-004 with the FDA and multiple preclinical programs.
The following represents expectations for selected financial figures in the quarter ended September 30, 2015.
|Turing Pharmaceuticals AG and Subsidiaries|
|(amounts in thousands, unaudited)|
Three Months Ended
Nine Months Ended
|Research and Development||6,969||11,467|
The September 30, 2015 financial information is subject to independent auditor review. Accordingly, the amounts set forth above are estimates based solely on currently available information, which is subject to change and has not been reviewed by our independent auditors. We have not finalized our review of financial statements for the quarter ended September 30, 2015 and during the course of our review we may identify items that would require us to make adjustment to our preliminary operating results described above. As a result, the discussion above constitutes forward-looking statements and, therefore, we caution you that these statements are subject to risks and uncertainties, including possible adjustments to our preliminary operating results. Unless otherwise noted, Turing is providing this information as of November 12, 2015 and disclaims any duty to update the information contained herein.
Turing Pharmaceuticals AG is a privately-held biopharmaceutical company with offices in Zug Switzerland and New York, New York. Turing focuses on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there are currently limited or no treatment options. Products being developed include intranasal ketamine for a variety of mood disorders and Syntocinon® (oxytocin nasal solution) for multiple indications. Daraprim®(pyrimethamine) for the treatment of Toxoplasmosis in combination with sulfonamide and Vecamyl® (mecamylamine HCl tablets) for hypertension are Turing's first commercial products.
For more, visit www.turingpharma.com.
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the initiation of product development activities, including but not necessarily limited to clinical trials. Forward-looking statements provide Turing Pharmaceuticals' current expectations and forecasts of future events. Turing Pharmaceuticals' performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Turing Pharmaceuticals undertakes no obligation to update publicly any forward-looking statements.