ANN ARBOR, MI -- (MARKET WIRE) -- January 12, 2007 -- Pipex Pharmaceuticals, Inc. (OTCBB: PPXP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has completed the previously disclosed planned acquisition of its majority-owned subsidiary, Effective Pharmaceuticals, Inc. (EPI). As a result of this acquisition, Pipex has gained broader control of Effective Pharmaceuticals, Inc.'s (EPI) lead products, Anti-CD4 802-2 and CORRECTA™, both of which are in phase II clinical stage of development.
Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex stated, “Consummation of this transaction gives Pipex improved economics and greater control with respect to our important Anti-CD4 802-2 and CORRECTA programs.”
Anti-CD4 802-2
Pipex is developing a series of rationally designed small molecule/peptidomimetic inhibitors of the highly important CD4 co-receptor of T-cells. Pipex’s lead anti-CD4 molecule, Anti-CD4 802-2, is a cyclic heptapeptide that has demonstrated efficacy in a number of animal models of multiple sclerosis and other animal models of autoimmune disease and is currently nearing completion of a dose ranging phase I/II clinical trial for the prevention of graft-versus-host disease (GvHD), a life threatening transplant disease. Preliminary data from the study appears to show suppression of GvHD in treated patients. In addition, Pipex plans to broaden the therapeutic utility of these molecules through additional preclinical and clinical studies for other CD4-mediated diseases. Some of these diseases might include, induction of immune tolerance to widely marketed exogenous biologic agents, multiple sclerosis, psoriasis, transplant-related ischemic reperfusion injury, lupus, asthma and rheumatoid arthritis. Anti-CD4 802-2 may represent the first clinical stage, non-biologic molecule capable of inducing immune tolerance for a variety of CD4-mediated autoimmune diseases. Anti-CD4 802-2 has also demonstrated oral activity animal models of disease.
This Anti-CD4 program is the subject of 41 issued and pending patents including composition of matter and method of use patents, which have been exclusively licensed from Thomas Jefferson University (TJU). This program has received substantial development support in the form of grants from the National Institutes of Health, as well as a $3.5 Million grant from the Trustees of Thomas Jefferson University.
CORRECTA™
Pipex is developing CORRECTA™, a proprietary retention enema formulation of the widely used topical antifungal agent clotrimazole, for the treatment of acute refractory pouchitis, a subset of inflammatory bowel disease related to ulcerative colitis (UC). CORRECTA™ is currently the subject of a double-blinded, placebo-controlled, multi-center, four-week treatment period, phase II clinical trial for acute pouchitis. This clinical trial, called the “CAPTURE” study, is currently being funded by a $750,000 grant from the FDA’s Orphan Drug Group. Pipex has expanded this study to additional clinical centers in order to increase enrollment and expedite completion of the study.
About the Transaction
The acquisition was consummated when EPI merged with and into a wholly owned subsidiary of Pipex, Effective Acquisition Corp., with EPI being the surviving corporation. In the transaction, Pipex issued approximately 2.29 million unregistered shares of common stock of Pipex, warrants and options (many of which are contingent upon various developmental and regulatory milestones being achieved) to purchase 695,183 shares of Pipex common stock to the minority shareholders of EPI comprising approximately thirty-three percent (33%) of EPI that Pipex did not already own.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. (“Pipex”) is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex’s strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the U.S. and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information, please visit, www.pipexpharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. and its subsidiary Effective Pharmaceuticals, Inc. (“we” or “our”) current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential uses of CORRECTA™ and Anti-CD4 802-2, as well as its prospects for regulatory filings in the treatment of neurologic Wilson’s disease. Where possible, the Company has tried to identify these forward-looking statements by using words such as “anticipates,” “believes,” “intends,” or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA™, TRIMESTA™, SOLOVAX™, EFFIRMA™ or Anti-CD4 802-2, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements.
For Further Information Contact:
Steve H. Kanzer, CPA, Esq. Chairman and Chief Executive Officer (734) 332-7800
Charles Bisgaier, Ph.D. President (734) 332-7800
SOURCE: Pipex Pharmaceuticals, Inc.
