KANSAS CITY, Kan. and OXFORD, United Kingdom, Oct. 13, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals, and Atopix Therapeutics Ltd., a clinical stage company focused on innovative oral therapeutics for allergic diseases, today announced the completion of a global licensing agreement for the development and commercialization of a novel oral CRTH2 antagonist for animal health indications. The decision to enter into this licensing agreement, which was previously announced, was based on favorable results from early de-risking studies performed under the now-completed option agreement between the two companies. Under the license agreement, Aratana agreed to develop and seek approval for the use of the product in atopic dermatitis, focusing initially on developing the product for dogs.
CRTH2 is a G protein-coupled receptor expressed selectively by key cells that mediate allergic responses that has been shown to play an important role in both allergic sensitization and effector responses to allergen. CRTH2 antagonists block mast cell-dependent activation of Th2 lymphocytes, basophils and eosinophils, interrupting an important immune pathway. Studies in models of allergic dermatitis have demonstrated that CRTH2 antagonists reduce accumulation of leukocytes, tissue swelling and production of cytokines, chemokines and IgE.
Atopix is currently evaluating its lead once-daily oral candidate (known as OC459) in a human Phase 2 study in moderate to severe atopic dermatitis, and is supporting a registration study of OC459 in patients with eosinophilic asthma in Russia. Aratana plans to conduct a dose-ranging pilot study in client-owned dogs in atopic dermatitis.
Steven St. Peter, M.D., chief executive officer of Aratana Therapeutics, stated, "We believe this product fits nicely into our portfolio of companion animal therapeutics. We continue to be committed to developing products that target the underlying cause of the disease rather than just the symptoms."
Tim Edwards, Executive Chairman of Atopix Therapeutics, stated, "Given the Aratana team's combined decades of veterinary drug development experience, we believe Aratana is the ideal partner for maximizing the value of this compound in the companion animal health market. We will continue to maximize the value of our CRTH2 antagonists in the field of human health through other collaborations."
In exchange for an exclusive, world-wide license to all non-human animal health applications, Aratana made a one-time payment to Atopix of $1 million at signing and agreed to pay additional milestone payments upon the achievement of certain regulatory milestones as well as royalties on sales, as previously announced.
About Aratana Therapeutics, Inc.
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The company's pipeline includes more than fifteen therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.
About Atopix Therapeutics Ltd
Atopix Therapeutics Limited is a privately held, clinical stage, biopharmaceutical company based in Oxford, UK, with an innovative approach to allergic disease. The company is developing a novel class of oral anti - allergic medicines, called CRTH2 antagonists, to treat atopic dermatitis, asthma and allergic rhinitis. Its lead candidate is currently being studied in a Phase II clinical trial for moderate - to-severe atopic dermatitis in several leading European dermatology centres. Atopix has a pipeline of highly potent back-up CRTH2 antagonists, including the Phase I ready oral candidate ATX2417, and topical candidates that can be formulated for treatment of a number of severe allergic conditions including eye disease. For more information, please visit http://www.atopixtherapeutics.co.uk.
Aratana Therapeutics Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements with respect to expectations regarding the timing of discussions with the FDA and approval of products; expectations regarding development programs, trials, studies and commercialization; expectations regarding in-licensing initiatives and collaborations; and expectations regarding the Company's plans and opportunities.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; market conditions and our ability to raise capital under the shelf registration statement from the sale of our securities; our substantial dependence on the success of certain of our lead product candidates, our inability to identify, license, develop and commercialize additional product candidates; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; uncertainties regarding the outcomes of studies regarding our products; our inability to realize all of the anticipated benefits of our acquisitions of Vet Therapeutics and Okapi Sciences; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, partners and other third parties which conduct our target animal studies and certain other development efforts; our lack of a sales organization; our significant costs of operating as a public company; our current exemption from the requirement to maintain internal control over financial reporting, and any failure to achieve or maintain effective internal control over financial reporting in the future; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; limitations on our ability to use our net operating carryforwards; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; our failure to comply with regulatory requirements; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an "emerging growth company," as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 26, 2014, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contacts:
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SOURCE Aratana Therapeutics, Inc.