ARK Animal Health, a Subsidiary of Sorrento Therapeutics, Announces Submission of Two Major Technical Sections of a New Animal Drug Application
SAN DIEGO, Sept. 27, 2016 /PRNewswire/ -- ARK Animal Health, Inc. (ARK), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), has filed the Effectiveness and Target Animal Safety major technical sections of the New Animal Drug Application (NADA) for the control of pain associated with bone cancer in dogs. ARK was granted a Minor Use/ Minor Species (MUMS) Drug Designation for ARK-001, a proprietary formulation containing the active ingredient Resiniferatoxin (also known as RTX) in June 2015. Under the MUMS designation, ARK seeks the conditional approval of RTX and plans to complete the balance of the NADA application in 2017.
RTX is a potent agonist of the TRPV1 receptor that is expressed on afferent nerves. A single injection of RTX can irreversibly ablate these nerves and represents a method of chemical surgery with extreme selectivity since the effect of a single treatment should endure for the lifetime of the animal. Afferent nerves are hyper-activated in many neurogenic inflammatory states which result in chronic pain and tissue damage in a variety of conditions including cancer pain, osteoarthritis, navicular syndrome and idiopathic cystitis.
"RTX has a unique mechanism of action that will be a completely new treatment option for veterinarians seeking to manage pain in dogs," said Dr. Bryan Jones, President of ARK. "In addition we are eager to expand the potential indications in dogs as well as targeting unique syndromes in cats and horses."
"This important milestone represents Sorrento's commitment to maximizing the value of each of the assets in the Sorrento portfolio," said Dr. Henry Ji, CEO and President of Sorrento.
About ARK Animal Health, Inc.
ARK Animal Health is a subsidiary of Sorrento Therapeutics operating under a shared services agreement with Sorrento in order to leverage the development expenses that overlap with the Human program activities, such as API manufacturing. In addition to developing ARK-001 for control of pain associated with bone cancer in dogs, ARK is developing several different modes of delivery for RTX. RTX can be used for treatment of osteoarthritis in several species, neuropathic pain in horses and idiopathic cystitis in cats.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, pain management, inflammation and autoimmune diseases. Sorrento's lead products are multiple late-stage biosimilar and biobetter antibodies, as well as clinical CAR-T therapies targeting solid tumors.
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc.and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2014 regarding ARK's Conditional New Animal Drug Application and Sorrento's and ARK's expectations regarding RTX; and expectations for Sorrento's and its subsidiaries technologies and collaborations. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries' technologies and prospects; risks related to RTX; risks related to seeking regulatory approvals and conducting clinical trials; and other risksmost recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's 2015, as amended, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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SOURCE Sorrento Therapeutics, Inc.