Sorrento Therapeutics said today it signed an exclusive option to acquire oncology drug developer Igdrasol, in a deal the buyer said would strengthen its cancer portfolio by adding therapeutic candidates with Phase II data for multiple solid tumor indications, and combining what the companies called synergistic drug discovery and development platforms for personalized medicine.
The price and other financial terms were not disclosed.
The combined pipeline would be led by Igdrasol’s late clinical stage paclitaxel-loaded micellar product candidate Cynviloq™, designed as an easy-to-administer injectable for delivering drugs into tumor tissues. Igdrasol holds exclusive U.S. distribution rights to Cynviloq issued by South Korean-owned Samyang Biopharmaceuticals, which has won approvals to market the drug in its home country under the trade name Genexol-PM®, for metastatic breast cancer (MBC) and non-small cell lung cancer (NSCLC).
“Cynviloq provides us with a high-value asset that has near-term revenue potential in MBC and NSCLC, and longer-term revenue potential in pancreatic, ovarian, bladder, and gastric cancers. These combined addressable markets represent more than 50% of cancer cases in the U.S.,” Henry Ji, Ph.D., Sorrento’s president and CEO, said in a statement. “This transaction is transformational for [Sorrento] as early- and late-stage product candidates, technologies, and development expertise combine to create an oncology franchise and pipeline with tremendous value potential.”
In the U.S., Igdrasol has completed Phase II testing of Cynviloq for potential advancement into registration trials, and said it is preparing for an "End of Phase II" meeting with FDA set for the first half of 2013 regarding the drug. As a formulation of paclitaxel, Cynviloq is potentially eligible for approval via FDA's 505(b)(2) bioequivalence regulatory pathway compared with Celgene’s albumin-bound paclitaxel (Abraxane®) in its currently-approved MBC and NSCLC indications.
Abraxane recently demonstrated overall survival benefit in a pivotal phase III study as a first line combination therapy with gemcitabine in advanced pancreatic cancer. On the MBC indication alone, Abraxane racked up $427 million in sales last year, up 11% from 2011, and has been projected to generate peak sales of more than $1.6 billion in the U.S. alone.
During the fourth quarter, however, Abraxane’s $106 million marked a 3% increase from Q4 2011, with international sales near-doubling year-to-year at $22 million while U.S. sales of $84 million dipped 3% from the year-ago quarter due to restoration of the full supply of generic paclitaxel, the shortage of which boosted Abraxane sales in 2011.
Established in 2006 and headquartered in San Diego, Sorrento focuses on developing biotherapeutics for cancer, inflammation, metabolic, and infectious diseases.
Sorrento finished the third quarter of 2012 with a net loss of more than $1.2 million, up from 702,288 in Q3 2011, according to its most recently available quarterly results. For the first nine months of last year, the company’s net loss widened to about $3.1 million from almost $2.5 million in the first three quarters of 2011. The losses reflect increasing operations costs and came despite an increase in revenues due to increased activities under two active NIH Grants in the three months ended September 30. Revenues were $134,506 for Q3 2012, compared with $91,756 in Q3 2011.
As part of the deal, Sorrento will acquire a tocopherol polyethelyene glycol succinate (TPGS)-based drug formulation technology that the company said could serve as a foundation for new next-generation targeted therapeutics competitive against current antibody-drug conjugates (ADCs). Effective immediately, Sorrento said, it will assume responsibility for operating expenses related to development of these next-generation antibody-formulated drug conjugates (AfDCs).
“The transaction will enable the combined team to leverage [Sorrento’s] extensive human antibody G-MAB® libraries and preclinical antibody programs, including those targeting metabolic, autoimmune, and infectious diseases, together with Igdrasol's expertise in drug formulation and drug development to deliver a strong pipeline of targeted tumor therapies,” Sorrento said in the statement.
Headquartered in Fountain Valley, CA, privately-held Igdrasol focuses on developing oncologic agents for the treatment of MBC and other cancers.
The boards of both companies have approved the deal, subject to undisclosed closing conditions.