Aratana Therapeutics Provides Product Updates
KANSAS CITY, Kan., Sept. 24, 2015 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today provided several product updates. The Company continues to advance its deep pipeline of novel therapeutics, including four products at pivotal stage (AT-001, AT-002, AT-003 and AT-014), while concluding that post-licensure marketing studies of canine lymphoma products AT-004 and AT-005 will not fully capture the market opportunity. Aratana is pursuing second-generation monoclonal antibodies and other solutions to canine lymphoma.
AT-001 (grapiprant for osteoarthritis pain in dogs)
On September 8, 2015, Aratana received from the FDA's Center for Veterinary Medicine (CVM) the technical section complete letter for effectiveness, which in addition to safety and CMC, constitutes the third and final major technical section complete letter.
Aratana expects to finalize label negotiations, complete the other minor sections and intends to submit an administrative New Animal Drug Application (NADA) in the first quarter of 2016. Approval is anticipated in the second quarter of 2016 and is expected to enable Aratana to commence commercialization of the product in the fall of 2016.
AT-002 (capromorelin for inappetence in dogs)
On August 26, 2015, Aratana submitted the technical section for effectiveness, which included the results of the positive pivotal field effectiveness study conducted under protocol concurrence with the CVM. Aratana anticipates a response from the CVM by February 22, 2016.
Aratana anticipates receiving its technical section complete for CMC in late 2015 or shortly thereafter. Accordingly, Aratana anticipates submitting a NADA in early 2016, which if approved, is expected to enable Aratana to commence commercialization of the product in mid-2016 or shortly thereafter.
AT-003 (bupivacaine liposome injectable suspension in dogs)
On August 23, 2015, Aratana submitted the technical section for effectiveness, which included the results of the positive pivotal field effectiveness study for post-operative pain management in dogs undergoing knee surgery conducted under protocol concurrence. Aratana anticipates a response from the CVM by February 20, 2016.
Aratana has received a response to its first CMC technical section submission and Aratana anticipates re-submitting the CMC section in late 2015. Accordingly, Aratana anticipates submitting a NADA, which if approved, is expected to enable Aratana to commence commercialization in late 2016.
AT-004 and AT-005 (monoclonal antibodies for canine lymphoma)
Aratana has enrolled approximately 50 dogs in its Mini B-CHOMP study, investigating the use of AT-004 in combination with abbreviated chemotherapy in canine B-cell lymphoma. The results are anticipated in mid-2016. Previously, the Company had received encouraging results from three independent studies looking at using AT-004 in combination with chemotherapy.
Aratana has been conducting two randomized, placebo-controlled studies (T-CHOMP and T-LAB) looking at the potential benefit of AT-005 in combination with two specific chemotherapy protocols and conducting a clinical experience program (T-CEP), where oncologists use the product at their discretion and share the data with Aratana. Although dogs are still being followed in those studies and final results are expected by mid-2016, Aratana completed an analysis of the results thus far and AT-005 does not seem to be adding significant progression free survival in canine T-cell lymphoma. Recent scientific studies suggest that AT-004 and AT-005 are not as specific to the targets as expected.
Given the mixed clinical and scientific results, Aratana does not believe AT-004 or AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. Therefore, Aratana is pursuing second-generation monoclonal antibodies and other efforts in lymphoma which are intended to deliver breakthrough benefits.
Both first-generation products, AT-004 and AT-005, are expected to continue to be available to oncologists as they are USDA licensed and Aratana is manufacturing these products today. Aratana believes the revenue and gross margin opportunity for the first-generation monoclonal antibodies will be modest, but given that there are not alternative monoclonal antibodies available to veterinarians, Aratana intends to maintain product availability.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, commented "Aratana has been aggressive in its pursuit of truly innovative therapies for pets and we have been remarkably successful from a regulatory perspective. From a commercial perspective, we only prioritize products that truly hit the mark with respect to addressing unmet medical needs. We will go back into development when we believe we need to optimize a product to capture a significant opportunity. The ability to take such a disciplined approach is an attractive attribute of the pet therapeutics opportunity."
Aratana will host an investor call to discuss these updates at 8:30 am EST on Friday, September 25, 2015.
Conference Call Information:
Interested participants and investors may access the conference call by dialing:
- 1 (866) 364-3820 (U.S.)
- 1 (855) 669-9657 (Canada)
- 1 (412) 902-4210 (international)
A replay of the call will be available beginning at approximately 10:30 a.m. EST on September 25, 2015. Access numbers for this replay are:
- 1 (877) 344-7529 (U.S.)
- 1 (855) 669-9658 (Canada)
- 1 (412) 317-0088 (international)
- Conference ID: 10073245
An audio webcast will be accessible via the Investor Relations section of the Aratana Therapeutics website aratana.investorroom.com.
About Aratana Therapeutics
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 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.
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 the timing for the submission of a NADA for AT-001, the timing for any product approvals, the timing of the commencement of commercialization of any product, the timing of any response from CVM, the timing for any technical section complete letter and the timing for results from any study and statements with respect to the continued availability of any products.
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 history of operating losses and expectations of losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; our substantial dependence on the success of certain of our product candidates; our dependence on novel technologies and compliance with complex regulatory requirements; 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; our inability to realize all of the anticipated benefits of our acquisitions and difficulty integrating acquired businesses; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our inability to identify, license, develop and commercialize additional product candidates; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, and partners; regulatory restrictions on the marketing of our product candidates; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing; our small commercial organization; difficulties managing the growth of our organization; our significant costs of operating as a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013 and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; limitations on our ability to use our net operating carryforwards; impact 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; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process; our failure to comply with regulatory requirements or obtain foreign regulatory approvals; 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 influence of significant stockholders over our business; and effects of anti-takeover provisions in our charter documents and under Delaware law. 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 16, 2015, 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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Aratana Therapeutics, Inc.
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