Panther closes acquisition of technology assets of Faulk Pharmaceuticals

The transaction provides Panther Biotechnology with a proprietary, multinational patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications.

"We are excited to have achieved this important milestone and are very much looking forward to working with the Faulk team to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer and other diseases," stated Evan Levine, Chief Executive Officer of Panther Biotechnology.

"The closing of this acquisition validates our ability to execute on our strategy of acquiring unique opportunities within the biomedical industry."

"We look forward to taking an active role in advancing our latest stage clinical asset, TRF-DOX, into phase 2 trials this year," stated Dr. Page Faulk of Faulk Pharmaceuticals.

"As well, we are very pleased to become part of a company that shares our commitment to advancing the other pipeline biotechnology assets developed under our platform."

The lead development program is a ligand-drug conjugate, TRF-DOX, a combination of transferrin glycoproteins with Doxorubicin for targeted delivery to tumors with the reduction of serious side effects.

Clinical results demonstrate significant improvement over Doxorubicin. In a randomized, double blind, controlled study of patients with advanced FIGO stage IV ovarian cancer, the addition of either TRF-DOX or Doxorubicin to conventional chemotherapy was compared. Treatment with TRF-DOX resulted in a statistically significant increase in survival over Doxorubicin in patients with drug resistant ovarian cancer.

In a non-blinded study in patients with acute leukemia, TRF-DOX was dosed at 10% of the usual dose and demonstrated an 87% decline in cancer cells circulating in the blood and no extension of the disease to bone marrow in 100% of the patients.

TRF-DOX also exhibited a complete response of both the primary tumor and metastatic lesions in a patient with angiosarcoma after having failed three months of standard chemotherapy. Panther plans to submit applications for a phase 2 study in ovarian cancer and a phase 1a / 1b study in lung cancer.

TRF-DOX leverages the targeting ability of the plasma protein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself.

Cytotoxicity studies demonstrate that a dose reduction of ten to one hundred-fold kills all cancer cells in multiple indications. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.

In exchange for substantially all of the assets of Faulk Pharmaceuticals, Panther has issued fifty thousand shares of common stock of Panther Biotechnology in addition to a tiered royalty payment agreement based on the achievement of specified revenue milestones for any commercialized products based on the acquired technology as follows: for each calendar year continuing until the date that is ten years after the expiration of the last patents, Panther will pay Faulk a royalty on net revenue of five percent of the first ten million, four percent of the next ten million, three percent of the next ten million, two percent of the next ten million and one percent of net revenue in excess of forty million.

As part of the agreement, Panther will also gain access to a strong research and development network and a portfolio of domestic and international patents.