Healthcare Industry News: Sheffield Pharmaceuticals
News Release - November 6, 2006
Pipex Therapeutics Merges With Sheffield PharmaceuticalsMerger Creates Public Specialty Pharmaceutical Company Developing Late Stage Products for Neurologic and Fibrotic Diseases
ANN ARBOR, Mich., Nov. 6, 2006 (Healthcare Sales & Marketing Network) -- Pipex Therapeutics, Inc. (OTC BB:SFPH.OB ), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has merged with Sheffield Pharmaceuticals, Inc.
COPREXA(tm) (oral tetrathiomolybdate)
Pipex's lead molecule, COPREXA(tm)(oral tetrathiomolybdate), is a novel, oral, anti-copper agent that has successfully completed two pivotal clinical trials for the treatment of neurologically-presenting Wilson's disease, a genetic neurodegenerative disease caused by the toxic effects of elevated levels of free copper in the central nervous system (CNS). COPREXA(tm) is a highly specific anti-copper agent unique in its ability to sequester and reduce free copper levels in the CNS.
COPREXA(tm)has also demonstrated potent anti-fibrotic effects in numerous animal models and has recently completed a 12-month, open label, phase II clinical trial for the treatment of refractory idiopathic pulmonary fibrosis (IPF). IPF is a debilitating and generally fatal disease marked by progressive scarring (fibrosis) of the lungs that affects an estimated 128,000 persons in the U.S. and is responsible for more deaths annually than breast or prostate cancer. There is currently no approved therapy for the treatment of IPF.
TRIMESTA(tm) (oral estriol)
Pipex is also developing TRIMESTA(tm) (oral estriol) for the treatment of relapse-remitting multiple sclerosis (MS). Estriol, an estrogenic molecule approved and marketed in Europe and Asia for the treatment of post-menopausal hot flashes for over 40 years but never introduced to the U.S., is a pregnancy hormone that is believed to be responsible for the high rates of spontaneous remission experienced by female MS patients during pregnancy.
TRIMESTA(tm) has completed an initial single-agent, crossover phase II clinical trial in the U.S. for the treatment of multiple sclerosis (MS) with highly encouraging results. In the relapsing-remitting MS patient group, the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79% (p=0.02) and the number of lesions by 82% (p=0.09) within the first three months of treatment with TRIMESTA(tm). During a re-treatment phase of this clinical trial, relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88% (p=0.008) and a decrease in the number of lesions by 48% (p=0.04) compared with original baseline scores (8).
Anti-CD4 802-2 (cnsnqic-cyclic)
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 MS and other animal models of autoimmune disease and is currently nearing completion of a dose ranging phase II clinical trial for the prevention of graft-versus-host disease. 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.
CORRECTA(tm) (clotrimazole enema)
Pipex is developing CORRECTA(tm), 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(tm) 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.
EFFIRMA(tm) (oral flupirtine)
Pipex is developing EFFIRMA(tm) (oral flupirtine), a centrally-active CNS oral therapy, for the treatment of fibromyalgia syndrome (FMS) for the North American market. FMS is a common centrally-mediated pain disorder characterized by chronic diffuse pain and other symptoms. This indication is supported by successful pilot clinical data obtained by a leading neuropharmacologist to whom refractory and difficult-to-treat FMS patients are frequently referred. We have exclusively licensed an issued U.S. patent covering the use of flupirtine for the treatment of FMS. Flupirtine was originally developed by Asta Medica and has been approved in Europe since 1984 for the treatment of pain and used clinically for chronic lower back pain although it has never been introduced to the U.S. market for any indication. SOLOVAX(tm)(MS T-Cell Vaccine)
SOLOVAX(tm) represents a novel approach to potentially vaccinate MS patients against their own misguided, myelin-reactive T-cells. In our treatment, T-cells reactive to myelin antigens are collected from the peripheral blood of an MS patient, expanded, attenuated, and reintroduced to the patient as a vaccine. These reintroduced T-cells are capable of invoking immune responses which educate the regulatory immune system of the patient to recognize and eliminate myelin-reactive T-cells.
About the Merger
The merged company will be headquartered in Ann Arbor, Michigan, and will continue the business operations of Pipex. The combined company will continue to be quoted on the OTC Bulletin Board under the symbol SFPH. Pipex intends to apply for listing on either NASDAQ or the American Stock Exchange.
The Merger was structured such that a newly-formed special purpose subsidiary of Sheffield merged with Pipex in a stock-for-stock transaction in which Sheffield issued shares of Sheffield common stock to holders of Pipex shares, based on an exchange ratio that resulted in Pipex shareholders receiving 34 million newly issued common shares of Sheffield. All outstanding options and warrants to purchase Pipex common stock have been assumed by Sheffield and will be converted into options or warrants to purchase Sheffield common stock. Pursuant to a Private Stock Purchase Agreement entered into between Pipex and Michael F. Manion, a majority shareholder of Sheffield and the former Chief Executive Officer and sole director of Sheffield. Mr. Manion sold to Pipex 2,426,300 shares of common stock which shares Pipex intends to retire.
About Pipex Therapeutics, Inc.
Pipex Therapeutics, 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). Pipex has three majority owned subsidiaries, Effective Pharmaceuticals, Inc, CD4 Biosciences, Inc. and Solovax, Inc. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Sheffield Pharmaceuticals, Inc. and Pipex Therapeutics, Inc. (``we'' or ``our'') current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of COPREXA(tm) for the treatment of neurologic Wilson's Disease and the prospects for regulatory filings for COPREXA(tm). 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(tm), TRIMESTA(tm), SOLOVAX(tm), EFFIRMA(tm) 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.
(1) Brewer, G.J., Askari, F., Lorincz, M.T., Carlson, M., Schilsky, M., Kluin, K.J., Hedera, P., Moretti, P., Fink, J.K., Tankanow, R., et al. 2006. Treatment of Wilson disease with ammonium tetrathiomolybdate: IV. Comparison of tetrathiomolybdate and trientine in a double-blind study of treatment of the neurologic presentation of Wilson disease. Arch Neurol 63:521-527.
(2) Brewer GJ et. al, Treatment of Wilson disease with ammonium tetrathiomolybdate: III. Initial therapy in a total of 55 neurologically affected patients and follow-up with zinc therapy. Arch Neurol. 2003 Mar; 60(3):379-85.
(3) Brewer, G.J. 2000. Wilson's Disease. Curr Treat Options Neurol 2:193-204.
(4) Brewer, G.J. 2005. Neurologically presenting Wilson's disease: epidemiology, pathophysiology and treatment. CNS Drugs 19:185-192.
(5) Brewer, G.J., Ullenbruch, M.R., Dick, R., Olivarez, L., and Phan, S.H. 2003. Tetrathiomolybdate therapy protects against bleomycin-induced pulmonary fibrosis in mice. J Lab Clin Med 141:210-216.
(6) Askari, F.K., Dick, R., Mao, M., and Brewer, G.J. 2004. Tetrathiomolybdate therapy protects against concanavalin a and carbon tetrachloride hepatic damage in mice. Exp Biol Med (Maywood) 229:857-863.
(7) Brewer, G.J., Dick, R., Ullenbruch, M.R., Jin, H., and Phan, S.H. 2004. Inhibition of key cytokines by tetrathiomolybdate in the bleomycin model of pulmonary fibrosis. J Inorg Biochem 98:2160-2167.
(8) Sicotte, NL, et. al. Treatment of multiple sclerosis with the pregnancy hormone estriol. Ann Neurol. 2002 Oct; 52(4):421-8.
Source: Pipex Therapeutics
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