KANSAS CITY, Kan., Aug. 6, 2015 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals, announced today its second quarter 2015 financial results and product updates. For the quarter ended June 30, 2015, Aratana reported a net loss of $(8.0) million, or $(0.23) basic loss per share and $83.6 million in cash, cash equivalents and short-term investments.
“We continue to be on-track with our objective of having six products on the market in 2016 with a deep pipeline of additional therapeutics potentially coming to market behind those,” stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. “We are very excited about the outcomes we have achieved in our development programs.”
Recent Development Highlights:
- Positive results from the pivotal field study of AT-002 (capromorelin) in dogs with reduced appetite from a variety of causes. Clinical success rates were approximately 70% for the once-daily dose of AT-002 group vs. approximately 45% for the placebo group which represents a statistically significant difference (p<0.05), thereby achieving the study’s primary endpoint as agreed under protocol concurrence with the FDA’s Center for Veterinary Medicine (“CVM”). Secondary endpoints including an alternative owner appetite assessment questionnaire and body weight were also achieved. AT-002 appeared to be palatable and well accepted, and none of the serious adverse events were considered to be related to AT-002 treatment. Aratana anticipates submitting an administrative New Animal Drug Application (“NADA”) for AT-002 in dogs in 2016, which if approved, would allow the Company to commence commercialization of the product in mid-2016.
- Positive results from the pivotal field study of AT-003 (extended-release bupivacaine liposome injectable suspension) in dogs with post-operative pain. Dogs receiving AT-003 by infiltration during knee surgery demonstrated statistically significant improvements in pain evaluation compared to placebo (p<0.05), which was the primary endpoint as agreed under protocol concurrence with the CVM. Success criteria were based on pain evaluations at 24-hour intervals up to 72 hours after surgery, and AT-003 showed statistically significant higher success rates than placebo at each interval (p<0.05). Aratana anticipates submitting a NADA for AT-003 in dogs in 2016, which if approved, would allow the Company to commence commercialization of the product in 2016.
- Submission of all major technical sections for AT-001 (grapiprant) in dogs with osteoarthritis pain. Aratana continues its interactions with the CVM on its effectiveness technical section, the drug master file and Chemistry, Manufacturing and Controls (“CMC”) technical section. After successful completion of all technical sections Aratana will submit a NADA, which if approved, would allow the Company to commence commercialization of the product in 2016.
- Submission of product license application for AT-014 as a therapeutic vaccine to treat canine osteosarcoma. During the second quarter of 2015, the USDA waived the requirement to perform a study that demonstrates that the vaccine organism remains stable in dogs. Aratana is preparing to initiate a pivotal AT-014 field safety study in late 2015 or early 2016 and continues to anticipate conditional licensure for AT-014 in 2016.
- Positive results from a multi-site pilot field study of AT-002 in cats with weight loss. The study measured increases in body weight in cats with chronic kidney disease. Capromorelin-treated cats had statistically significant increases in body weight compared to placebo after 90 days (p<0.01) with differences beginning on day 30. AT-002 was well tolerated. Aratana believes that the results of this study sufficiently inform the Company in designing and proceeding with the pivotal field effectiveness study.
- Positive results from a multi-site pilot field study of AT-003 in cats with post-surgical pain. The placebo-controlled study demonstrated improvements in pain evaluations compared to placebo that approached statistical significance. Success rates were 60%-70% for cats treated with AT-003 and 30-40% for cats treated with placebo. Aratana believes that the results of this study sufficiently inform the Company in designing and proceeding with the pivotal field effectiveness study.
- Positive results from a multi-site field pilot study of AT-016. Aratana and its strategic partner VetStem Biopharma, Inc. shared positive results from a dose confirmation study of AT-016, an adipose-derived allogeneic stem cell product exclusively licensed to Aratana for the treatment of osteoarthritis pain in dogs. The double-blinded, multi-site, placebo-controlled field efficacy trial enrolled 90 dogs with osteoarthritis. The dogs who received a single intra-articular injection of AT-016 demonstrated a statistically significant improvement in treatment versus placebo (p<0.05). The primary endpoint was treatment success based on the Client Specific Outcome Measurement (CSOM) on day 60. The final study report is being prepared for CVM submission and agreement on the pivotal field effectiveness study design. If approved by the CVM, AT-016 could be commercially available in late-2017 or 2018.
- Advancing studies to assess adding AT-005 and AT-004 to a multi-agent chemotherapy. Aratana has completed enrollment in its second multi-center, blinded, placebo-controlled, randomized study designed to assess adding AT-005 to a multi-agent chemotherapy protocol for dogs with T-cell lymphoma (T-LAB); a prior study, T-CHOMP, was fully-enrolled in January 2015. Aratana has initiated an approximately 60-client-owned dog study to compare the effectiveness of two cycles of CHOP plus AT-004 against historical benchmarks for a standard of care CHOP protocol (mini B-CHOMP). Study results from both T-LAB, T-CHOMP and mini B-CHOMP are expected by mid-2016.
- Initiated multi-site pilot field study of AT-018. Aratana initiated a multi-center, masked, placebo-controlled, randomized field study in client owned dogs with atopic dermatitis. The study targets to enroll over 50 dogs into multiple treatment groups. Results from this study are expected in early 2016.
Other Highlights:
- Clinical Experience Programs expanded in canine lymphoma. AT-005 continues to be commercially available through a T-cell Clinical Experience Program or T-CEP. At the end of June 2015, there were approximately 70 active sites in T-CEP, which allowed Aratana to record $230 thousand in net revenue from product sales. After mini B-CHOMP is fully-enrolled, we intend to make AT-004 available on a rolling regional basis as part of a B-cell Clinical Experience Program or B-CEP. Similar to the T-CEP program, the B-CEP program will allow a discount on AT-004 in exchange for data associated with lymphoma treatments and outcomes. We continue to expand the manufacturing capacity needed to supply the broader canine lymphoma market while we complete the scientific and post-marketing studies for AT-004 and AT-005. However, due to current manufacturing constraints, we do not intend to expand the number of T-CEP sites until late 2016 and expect a limited commercialization through the T-CEP and B-CEP programs until late 2016 at which time a commercial launch is anticipated.
- Continued expansion of commercial operations. Aratana’s sales strategy includes a small specialty sales force and a somewhat larger primary care sales force. The Company anticipates hiring our sales management starting in 2015, and sales representatives beginning in 2016. Over the course of 2016, Aratana anticipates staffing approximately two dozen sales territories, and it intends to work with veterinary distributors to expand the sales and marketing reach.
- Initiation of partnering efforts outside the U.S. While Aratana intends to commercialize its products inside the U.S., its strategy is to seek sales, marketing and distribution partnerships outside the U.S. As Aratana nears its final U.S. regulatory submissions for initial products in dogs and has generated pilot efficacy data in cats, it will commence efforts to secure appropriate partnerships for its attractive product portfolio.
Financial Results:
Aratana had $230 thousand in net revenue for the quarter ended June 30, 2015 related to its T-cell lymphoma product (AT-005). For the six months ended June 30, 2015, the Company reported $386 thousand in AT-005 net revenue. Aratana received conditional approval for AT-005 in January 2014 and started making the product commercially available in November 2014 to a select group of veterinary oncologists as part of the Company’s T-CEP program. The Company also received full approval from the USDA for its AT-004 product as an aid in the treatment of B-cell lymphoma in January 2015. As a result of this approval, the Company received and recorded a $3.0 million milestone payment from its former license partner Elanco Animal Health in the first quarter of 2015, which was offset by the amount recognized as a result of the mutual termination of the AT-004 agreement with Elanco in February 2015 of $2.5 million and another $0.5 million milestone payment at the time of first commercial sale, expected in the second half of 2015. In the six months ended June 30, 2014, Aratana reported license and collaboration revenue of $476 thousand mainly related to the reimbursement of R&D services for its out-licensed product, AT-006.
Research and development expenses totaled $6.1 million for the quarter ended June 30, 2015 compared to $4.3 million for the quarter ended June 30, 2014. For the first six months of 2015, research and development expenses totaled $12.3 million, as compared to the first six months of 2014 of $7.9 million. The increase in research and development expense is due primarily to increased costs associated with the advancement of the Company’s ongoing development programs, as well as the increase in the number of product candidates in development as a result of acquisitions, licensing and option programs.
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