Axsome PPC to include three novel, non-opioid, Phase 3-stage product candidates for chronic pain
145 issued Axsome PPC patents, including 21 covering neridronate, provide protection as far as 2036
Indications include osteoarthritis, osteoporosis, and complex regional pain syndrome
NEW YORK, Oct. 11, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will focus on its growing core CNS portfolio. As a result, the Company has created Axsome Pain and Primary Care (Axsome PPC), a new business unit to house, manage, develop and enhance the value of Axsome’s non-CNS assets. The assets in Axsome PPC include the Company’s pain and primary care product candidates and related intellectual property.
“The new corporate structure allows us to maintain focus on Axsome’s growing core CNS portfolio, and to position the non-CNS assets for continued clinical development and enhanced value creation by placing them in a discrete business unit,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “The differentiated product candidates and technology in Axsome PPC have the potential to significantly benefit patients living with pain and other serious conditions including osteoporosis. The new structure provides for clearer communication of the potential of these assets and facilitates business development activities related to them.”
Core CNS Portfolio
Axsome’s core CNS portfolio currently includes three differentiated, clinical-stage product candidates:
Axsome PPC Portfolio
The assets in Axsome PPC include three Phase 3-stage product candidates. Two of the product candidates (AXS-06 and AXS-02) are being developed directly by Axsome, and one of the candidates (neridronate) is covered by Axsome’s intellectual property portfolio. These product candidates are being developed for five different indications including the signs and symptoms of osteoarthritis and rheumatoid arthritis, osteoporosis, the pain of knee osteoarthritis, chronic low back pain, and complex regional pain syndrome:
Axsome PPC Patent Portfolio
The intellectual property of Axsome PPC includes 145 issued and more than 90 pending patents which provide protection as far as 2036. These patents cover AXS-02, other bisphosphonates and related compounds, and AXS-06. Of the current portfolio, 21 issued or allowed patents cover the use of neridronate for pain, including 10 patents that specifically cover CRPS, providing patent protection out to 2033. Axsome PPC is currently a business unit and not a separate legal entity, and all of the assets are still held by Axsome Therapeutics.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s CNS product candidate portfolio includes three clinical-stage candidates, AXS-05, AXS-07, and AXS-09. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD), a Phase 2 trial in Major Depressive Disorder (MDD), and a Phase 2 trial in smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-05, AXS-07, and AXS-09 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the Company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials, futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
Senior Vice President, Operations
Axsome Therapeutics, Inc.
25 Broadway, 9th Floor
New York, NY 10004