Under the terms of the agreement, Adventrx will issue, and SD Pharma stockholders will receive, approximately 2,100,000 shares of Adventrx common stock. The agreement and plan of merger has been approved by the boards of directors of both companies and by the stockholders of SD Pharma.
Subject to the closing of the transaction, Adventrx will acquire worldwide intellectual property rights to eight oncology and infectious disease product candidates, including ex-US rights to SDP-012 (ANX-530, vinorelbine emulsion), to which the company already has US rights.
Certain product candidates that Adventrx would acquire as a result of the merger are based on a nano-emulsion technology for both soluble and insoluble parenteral drugs. The nano-emulsion technology was developed by Dr Andrew Chen and is designed to enable the delivery of vein-irritating or difficult to dissolve drugs without excipient-induced adverse effects.
The SD Pharma product portfolio includes novel formulations of the active ingredients in Bristol-Myers Squibb’s Taxol, Sanofi-Aventis’ Taxotere, and GlaxoSmithKline’s Navelbine, among others.
Many of the product candidates are based on currently approved drugs and may qualify for the 505(b)(2) regulatory process. This allows the FDA to approve a follow-on drug on the basis of data in the scientific literature or data used by the FDA in the approval of other drugs. This procedure potentially makes it easier for drug manufacturers to obtain rapid approval of new forms of drugs based on proprietary data of the original drug manufacturer.
“We believe that this transaction will provide tremendous value for our stockholders by strengthening our product pipeline with near-term product candidates in oncology and infectious disease,” said Evan Levine, Adventrx president and CEO. “We plan to build on our 505(b)(2) regulatory experience and our familiarity with Dr Chen’s nano-emulsion technologies and to apply these skills to compounds with even larger market opportunities.”
The closing of the merger is subject to the fulfillment of a number of conditions that both companies currently expect will be satisfied.