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Aratana Therapeutics (PETX) And Advaxis, Inc. Enter Exclusive Global Licensing Agreement


3/20/2014 10:34:27 AM

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KANSAS CITY, Kan.
, and PRINCETON, N.J., March 19, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for cats, dogs and other companion animals, and Advaxis, Inc. (NASDAQ: ADXS), a biotechnology company developing the next generation of cancer immunotherapies, today announced a global licensing agreement for Advaxis' ADXS-cHER2 for the treatment of osteosarcoma in dogs and three additional cancer immunotherapy products for the treatment of three other types of cancer. Each of the four licensed products is based on Advaxis' platform immunotherapy technology, which Advaxis is developing for the treatment of human cancers on a global basis. Under the agreement, Aratana will have exclusive rights to develop and commercialize the licensed immunotherapies for pet health applications, and will focus initially on developing ADXS-cHER2 for osteosarcoma.

Under the agreement, Aratana made a one-time upfront payment to Advaxis of $1 million and an additional $1.5 million equity investment in Advaxis common stock and warrants. Aratana agreed to pay up to an additional $6 million in clinical and regulatory milestones for each of the four products, assuming approvals in both cats and dogs in both United States and the European Union. In addition, Aratana agreed to pay up to $28.5 million in commercial milestones. Upon regulatory approval and commercialization of the immunotherapies, Aratana agreed to pay Advaxis a tiered royalty ranging from mid-single digit to 10% on net sales.

ADXS-cHER2 was validated in an ongoing clinical study in 13 client-owned dogs with osteosarcoma, conducted by Dr. Nicola Mason at the University of Pennsylvania School of Veterinary Medicine and sponsored by Advaxis. In the study, dogs treated with ADXS-cHER2 immunotherapy after the standard of care (amputation and follow up chemotherapy), had a statistically significant prolonged overall survival benefit (p=0.032) compared with dogs that received standard of care without ADXS-cHER2. The median survival time for dogs that did not receive ADXS-cHER2 immunotherapy was eight months, whereas the median survival time for those dogs treated with ADXS-cHER2 has not yet been reached. The first four dogs treated with ADXS-cHER2 are alive, with each dog surviving over 21 months. The majority of treated dogs are tumor-free. There were no short- or long-term complications associated with the immunotherapy and only low-grade, transient toxicities were reported in the study.

Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "We strive to accelerate the most innovative and promising new therapies for pets, and we are very encouraged by the results Advaxis has generated for ADXS-cHER2 in osteosarcoma, as well as the overall potential of their platform. Immuno-oncology is one of the most exciting advances in treating human cancers, so expanding our oncology portfolio of first in class, species specific antibodies to include Advaxis' immuno-oncology products is a natural fit. We are also particularly excited to work with the people at Advaxis and at The University of Pennsylvania, where many of our team have had long-standing relationships."

Daniel J. O'Connor, President and Chief Executive Officer of Advaxis, commented, "We admire Aratana's dedication to elevating cutting-edge drugs like ADXS-cHER2 to become potentially market-leading immunotherapies in this growing space. Given the Aratana team's combined decades of veterinary drug development experience and their leadership position in pet therapeutics, they are the ideal partner for maximizing the value of our cancer immunotherapies for pets. With upfront and potential near term multimillion dollar milestones from 16 potential approvals, this collaboration strengthens our financial ability to further advance our proprietary immunotherapies for the treatment of human cancers."

Conference Call and Webcast
Both Aratana Therapeutics and Advaxis will host a joint conference call tomorrow, Thursday, March 20, 2014, beginning at 8:00 a.m. Eastern Time. Please see below for details.

Conference call numbers:

Domestic/Canada:

1 (877) 870-4263

International:

1 (412) 317-0790

Webcast:

Accessible via the Investor Relations section of the Companies' websites at aratana.investorroom.com or ir.advaxis.com.

A replay of the conference call and webcast will be available beginning approximately one hour after the completion of the call. Access numbers for this replay are 1 (877) 344-7529 (U.S./Canada) and 1 (412) 317-0088 (international); conference ID: 10043084.

About ADXS-cHER2
Advaxis' ADXS-cHER2 is an Lm-LLO immunotherapy being developed by Advaxis for HER2-overexpressing cancers (such as breast, gastric, and other cancers in humans and for osteosarcoma in canines). ADXS-cHER2 secretes the cHER2 antigen, fused to LLO, directly inside the APC that are capable of driving a cellular immune response to HER2-overexpressing cells. In preclinical analysis, localized effect is the inhibition of the Treg and MDSC cells that Advaxis believes may promote immunologic tolerance of the HER2-overexpressing cancer cells of the tumor.

About Canine Osteosarcoma
Osteosarcoma is the most common primary bone tumor in dogs, accounting for roughly 85% of tumors on the canine skeleton. Approximately 8,000-20,000 dogs a year (predominantly middle to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States. This cancer initially presents as lameness and, oftentimes, visible swelling on the leg. Current standard of care treatment is amputation immediately after diagnosis, followed by chemotherapy and sometimes radiation. Invariably, the cancer metastasizes to the lungs, eventually leading to death.

About Aratana Therapeutics, Inc.
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. 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 Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis' immunotherapies are based on a novel platform technology using live, attenuated bacteria to stimulate the immune system to selectively target cancer cells while reducing tumor defenses.

ADXS-HPV, Advaxis' lead immunotherapy for the treatment of HPV-associated cancers, has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neckcancer, and a Phase 1/2 in anal cancer. ADXS-HPV has orphan drug status for both anal and head and neck cancers. As part of its global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers, Advaxis has granted exclusive licenses for the development and commercialization of ADXS-HPV in Asia and India.

ADXS-cHER2 is an immunotherapy for the treatment of HER2-overexpressing cancers (such as breast, gastric, esophageal, and other cancers in humans and for osteosarcoma in canines). Advaxis' lead animal-health immunotherapy, ADXS-cHER2, has demonstrated encouraging survival data in a Phase 1 trial in canine osteosarcoma. These data provide the rationale to advance this same immunotherapy into a Phase 1 clinical trial in patients with HER2-overexpressing cancers such as breast, gastric esophageal and others. The Company is preparing an IND submission for ADXS-cHER2 in the treatment of overexpressing cancers in 2014.

Advaxis has created more than 20 distinct immunotherapies based on its platform, either directly or through strategic collaborations with recognized cancer centers of excellence. Advaxis has clinical research collaborations with the University of Pennsylvania, Brown University, the Georgia Regents University Cancer Center, the Icahn School of Medicine at Mount Sinai, and others.

For more information please visit www.advaxis.com or connect with Advaxis on

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 statements regarding Aratana's 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 Aratana'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 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: Aratana's limited operating history and expectations of losses for the foreseeable future; Aratana's lack of commercial sales; Aratana's failure to obtain any necessary additional financing; Aratana's substantial dependence on the success of certain of Aratana's lead product candidates, AT-001, AT-002, AT-003, AT-004, AT-005, AT-006 and AT-007; Aratana's inability to identify, license, develop and commercialize additional product candidates; Aratana's inability to obtain regulatory approval for Aratana's existing or future product candidates; the lack of commercial success of Aratana's current or future product candidates; uncertainties regarding the outcomes of studies regarding Aratana's products; Aratana's inability to realize all of the anticipated benefits of Aratana's acquisitions of Vet Therapeutics and Okapi Sciences; effects of competition; Aratana's failure to attract and keep senior management and key scientific personnel; Aratana's complete reliance on third-party manufacturers and third parties to conduct all Aratana's target animal studies and certain other development efforts; Aratana's lack of a sales organization; Aratana's significant costs of operating as a public company; Aratana's lack of effective internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of Aratana's customers; impacts of generic products; unanticipated safety or efficacy concerns; Aratana's limited patents and patent rights; Aratana's failure to comply with Aratana's intellectual property license obligations; Aratana's infringement of third party patents and challenges to Aratana's patents or rights; Aratana's failure to comply with regulatory requirements; Aratana's failure to report adverse medical events related to Aratana's products; legislative or regulatory changes; the volatility of Aratana's stock price; Aratana's status as an "emerging growth company," as defined in the JOBS Act; the potential for dilution if we sell shares of Aratana's common stock in future financings; the significant control over Aratana's business by Aratana's principal stockholders and management; the potential that a significant portion of Aratana's total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in Aratana's charter documents and under Delaware law; and Aratana's intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission, or SEC, on January 30, 2014, along with Aratana's 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 Aratana's views to change. These forward-looking statements should not be relied upon as representing Aratana's views as of any date subsequent to the date of this press release.

Advaxis Forward-Looking Statements Disclaimer

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis' ability to develop the next generation of cancer immunotherapies; Aratana's ability to develop and commercialize products for one or multiple pet cancer indications based on the technology licensed from Advaxis; the achievement under the license agreement between Advaxis and Aratana of the various milestones associated with the development and commercialization of products based on all four compounds; regulatory approval of any product developed by Aratana; commercialization of any product successfully developed by Aratana; the timing or amount of any payment by Aratana under the license agreement, including any payments based on net sales; the timing or outcome of any registration program for ADXS-HPV; Advaxis' evaluation of ADXS in other HPV-associated cancers including a Phase 2 study in advanced cervical cancer, a Phase 1/2 study in head and neck cancer and a Phase 1/2 study in anal cancer; the timing or outcome of Advaxis' planned IND submission for ADXS-cHER2 in breast cancer; the safety and efficacy of Advaxis' proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2013, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT:

Advaxis Investor Contact:
Lisa Caperelli
Senior Director of Investor Relations and Corporate Communications
caperelli@advaxis.com
215.206.1822

Aratana Therapeutics Investor Contact:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.
jdrumm@tiberend.com
212.375.2664

For all Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach / Amy Wheeler
amielach@tiberend.com / awheeler@tiberend.com
212.375.2694 / 646.362.5750

SOURCE Aratana Therapeutics, Inc.; Advaxis, Inc.



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