Company Overview of ContraVir Pharmaceuticals, Inc.
ContraVir Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development of antiviral drugs with a primary emphasis on the treatment of Hepatitis B virus (HBV) infections. The company engages in the development of TXL, a lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate for the treatment of Hepatitis B; and CRV431, a novel drug candidate for the treatment of chronic HBV infection. It also develops Valnivudine, an orally available small molecule compound for the prevention of post-herpetic neuralgia, as well as for the treatment of herpes zoster infection and acute zoster-associated pain. Co...
399 Thornall Street
Edison, NJ 08837
Founded in 2013
Key Executives for ContraVir Pharmaceuticals, Inc.
CEO & Director
Total Annual Compensation: $410.0K
Chief Operating Officer
Total Annual Compensation: $275.0K
Part-Time Consultant & Member of Scientific Advisory Board
Total Annual Compensation: $332.8K
Compensation as of Fiscal Year 2017.
ContraVir Pharmaceuticals, Inc. Key Developments
ContraVir Pharmaceuticals, Inc. Announces Agreement by the U.S. Food and Drug Administration to Allow its Utilization of 505(b)(2) Regulatory Pathway for the Treatment of Chronic Hepatitis B
Feb 12 18
ContraVir Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has agreed to allow the company to utilize the 505(b)(2) Regulatory Pathway to streamline the development and registration of TXL for the treatment of Chronic Hepatitis B. The 505(b)(2) Regulatory Pathway allows a company to rely upon FDA's previous findings of safety and efficacy of an approved and marketed product to supplement its own safety and efficacy data, and may be considered in the review by the FDA of a future New Drug Application (NDA). On January 8, 2018, the ContraVir Executive Team met with the FDA's Division of Antiviral Products at the Center for Drug Evaluation and Research, to review and discuss the data generated for TXL to date, as well as the data package that would be required for the filing of an NDA and successful registration of TXL in the US leveraging the 505(b)2 Regulatory Pathway. On February 7, 2018, ContraVir received final written minutes from the FDA summarizing the outcome of the meeting and feedback received. Key highlights from the meeting outcome include: Agreement on an abbreviated non-clinical Development Program; Agreement on a Clinical Pharmacology Package; Agreement on the major elements of Phase 3 trial design in treatment-naive patients with chronic hepatitis B (both HBeAg and HeAg), including duration of treatment, clinical endpoints, comparator and; Agreement on number of patients for the safety database needed for NDA submission. The outcome of the meeting with FDA is a positive step towards the further execution of the streamlined development and registration of TXL in the US, which is expected to allow a faster and more cost-effective path to approval and commercialization in the US.
ContraVir Pharmaceuticals Completes Renal Impairment Study with TXL™
Feb 6 18
ContraVir Pharmaceuticals, Inc. announced the results of a Phase 1 study with TXL assessing the safety, pharmacokinetics and tolerability of TXL in patients with severe renal impairment. The study of 16 subjects included 8 healthy subjects with normal kidney function and 8 subjects with severely impaired kidney function. Results from the study confirmed that TXL was safe and well tolerated in both patient groups. Importantly, the data showed that the blood concentrations of tenofovir (TFV) in severely renally-impaired subjects receiving 50 mg of TXLâ„¢ were similar to the TFV exposure levels observed after dosing of Viread® 300 mg, the current standard of care. These findings indicate that dosing strength adjustments of TXL is not warranted in patients with compromised renal function.
ContraVir Pharmaceuticals, Inc., Annual General Meeting, Feb 21, 2018
Jan 24 18
ContraVir Pharmaceuticals, Inc., Annual General Meeting, Feb 21, 2018, at 09:00 US Eastern Standard Time. Location: 399 Thornall Street, First Floor New Jersey United States Agenda: To elect seven directors for a one-year term to expire at the 2018 annual meeting of stockholders; to ratify the appointment of BDO USA, LLP as independent registered public accounting firm for the fiscal year ending December 31, 2018; to approve an amendment to the company's 2013 equity incentive plan to increase the reservation of common stock for issuance there under to 10,700,000 shares from 7,700,000 shares; to authorize an amendment to certificate of incorporation to effect a reverse stock split of issued and outstanding common stock at a specific ratio, within a range of 1-for-5 and 1-for-20, to be determined by Board of Directors in its sole discretion and effected, if at all, on or before February 21, 2019; and to transact any other business that may properly come before annual meeting or any adjournment or postponement of the meeting.
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