Apricus Biosciences Announces NexACT Partner Has Completed pre-IND Meeting
Apricus Biosciences, Inc. recently announced its NexACT out-licensing partner, Exodos Life Science Limited Partnership, has completed a successful pre-IND meeting with the US FDA regarding its plan to conduct clinical trials to establish the safety and effectiveness of its patented, topical painkilling drug, ELS115, containing NexACT technology licensed from Apricus Bio.
Specifically, the meeting was a successful milestone in Exodos’ effort to file an
Exodos licensed Apricus Bio’s NexACT technology for the topical delivery of drugs to treat pain and inflammation. “We are very encouraged by the progress achieved thus far by Exodos, for its topical NSAID product, which the company currently expects to be ready for IND filing by mid-2012,” said Bassam Damaj, PhD, President and Chief Executive Officer of Apricus Bio. “The out-licensing of our NexACT technology has allowed Exodos to move more quickly toward its clinical goals for its first product in this important disease area.”
Apricus Bio noted that Exodos is expected to be the first NexACT technology out-licensing partner to file for approval to initiate a human clinical program.
NSAIDs, such as ibuprofen and ketoprofen, have been in use for decades, successfully reducing pain and inflammation for millions of patients. However, while these drugs work well in pill form, there are many conditions for which the ability to target the drug in a localized manner, such as for treatment of arthritis in the hands, may be advantageous. To date, the challenge has been that these drugs exhibit poor skin penetration, making such efforts to deliver them locally, unsuccessful.
This challenge may be solved by Apricus Bio’s NexACT technology, which is intended to open up the tight junctions between skin cells. As a result, certain drugs attached to proprietary NexACT chemicals may pass through the skin to reach their targets. Exodos’ drug, ELS115, a combination of NexACT technology and ketoprofen, may provide an effective and safe treatment of mild-to-moderate peripheral pain.
If the clinical studies establish that the drug is safe and can be delivered through the skin right where it is needed, the product may be an important alternative for patients with localized pain and who may also have a history of gastrointestinal, kidney or liver problems that may be exacerbated by drugs taken in pill form, be geriatric or pediatric patients, and/or patients at risk for drug interactions, if the levels of circulating ketoprofen are very low to non-existent. Exodos selected ketoprofen as the active ingredient for its drug because ketoprofen has a decades-long record of safe clinical use.
Exodos Life Sciences is a privately held pharmaceutical development company that focuses on advancing new product concepts through the 505(b)(2) process to early clinical proof-of-principle, followed by asset (project) sale. Exodos has adopted a semi-virtual model to control costs and advance projects by utilizing its experienced team and on-call external pharmaceutical experts and partners.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically validated NexACT drug delivery technology to enable multi-route administration of new and existing compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide.
In addition, the company is seeking to monetize its existing Rx Division product pipeline, including its first product, Vitaros, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from preclinical through Phase III, currently focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes, and cosmeceuticals among others.
The company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the company’s NexACT technology to comply with the FDA’s OTC requirements, can be cleared as 510(k) topical creams that are considered to be medical devices, or approved as 505(b)(2) NDAs or ANDAs as generic drugs. The company will also seek to market such drugs through these similar procedures in foreign countries.
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