Aratana Therapeutics Expands Pain Franchise with Novel Regenerative Cell Therapy for Treating Osteoarthritis
Enters Exclusive License Agreement with Vet-Stem, Inc. for Allogeneic Stem Cell Technology
Conference Call June 13, 2014, at 8 a.m. Eastern Time
KANSAS CITY, Kan., June 12, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals, today announced it has entered into an exclusive license agreement with Vet-Stem, Inc., for its novel, allogeneic stem cell therapy technology. Under the agreement, Aratana obtains exclusive rights to commercialize Vet-Stem's allogeneic stem cells in the United States, which if approved, will be the first FDA-regulated, "off the shelf" regenerative cell therapy for the treatment of osteoarthritis in dogs.
Vet-Stem pioneered the use of adipose tissue as a source for stem cells in veterinary regenerative medicine, but to date has offered only autologous stem cell therapy as a service (adipose tissue, also known as fat tissue, is harvested from the patient from which stem cells are isolated then reintroduced into the same patient). The positive experience using adipose-derived stem cells in this way is strong, with thousands of veterinarians utilizing the service since its introduction in 2004. Although excess doses can be frozen and banked, they can be used only as a future therapy for the original donor patient.
Vet-Stem has now developed a technology platform for producing allogeneic stem cell therapies, where a single donor sample can be used to generate a large bank of doses that can be stored and used to treat multiple patients. Aratana has licensed this allogeneic therapy, which will be tested for safety and efficacy in randomized, placebo-controlled dogs with osteoarthritis and submitted to the FDA for approval.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "As we continue to build our pipeline, we have made a clear strategic investment in the high-need area of pain management for our pets. We therefore are pleased to expand our pain franchise further by adding an allogeneic, regenerative cell therapy product, which in addition to its aim of reducing the pain of osteoarthritis, has the potential to impact the progression of the disease, and to promote tissue regeneration. We will examine this phenomenon in planned studies, which could result in product labeling that specifies disease-modifying properties."
Robert J. Harman, D.V.M., M.P.V.M., Founder and Chief Executive Officer of Vet-Stem, stated, "Aratana is the ideal commercial partner for our regenerative cell therapy for osteoarthritis, based upon their deep expertise in pain and the overall quality of their pet heath organization. We look forward to accelerating development of what we believe to be an effective and potentially disease-modifying therapy, and to offering a more streamlined therapeutic option for veterinarians and their patients."
Aratana and Vet-Stem expect to initiate a blinded, multi-center, placebo-controlled, dose confirmation study later this month. Aratana does not expect U.S. FDA approval before 2016.
Dr. St. Peter concluded, "The advantages of a product-based stem cell therapy versus the current service-based model include the potential for lower overall treatment costs for osteoarthritis, higher market penetration, the benefit of scheduled campaign manufacturing, and for patients and their owners, no need for surgery to harvest tissue."
Under the terms of the agreement, Aratana will have an exclusive license to develop and commercialize products in the U.S., based upon Vet-Stem Technology for the treatment of pain and inflammation of canine osteoarthritis. Vet-Stem will continue to be responsible for the ongoing development of its allogeneic stem cell technology. Aratana will pay $500,000 upon signing of the license as a reimbursement to Vet-Stem for a portion of its past development expenses and will be responsible for funding future budgeted development. Aratana will also pay up to $4.5 million in success-based development and regulatory milestones, as well as tiered royalties upon potential commercialization of the stem cell therapy, based on potential sales. Aratana will also have the exclusive right to negotiate expansion of the agreement to include the European Union countries during the calendar year of 2014.
Conference Call and Webcast
Date: Friday, June 13, 2014
Time: 8:00 a.m. Eastern Time
Conference call numbers:
Webcast: Accessible via the Investor Relations section of the Company's website at aratana.investorroom.com
A replay of the conference call and webcast will be available beginning approximately one hour after the completion of the call through July 15, 2014. Access numbers for this replay are 1-877-344-7529 (U.S./Canada) and 1-412-317-0088 (international); conference ID: 10048060.
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other 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.
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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 statements regarding our expectations regarding the approval of products; expectations regarding development programs, trials, studies, approvals and commercialization; expectations regarding in-license 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; our substantial dependence on the success of certain of our lead product candidates, AT-001, AT-002, AT-003, AT-004, AT-005, AT-006 , AT-007, AT-008 and AT-014; 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; effects of competition; our failure to attract and keep senior management and key scientific personnel; our complete reliance on third-party manufacturers and third parties to conduct all 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 lack of effective internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; 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.
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