SAINT PAUL, Minn., Sept. 8, 2011 /PRNewswire/ -- Enterologics, Inc (ELGO.OB) announced today that it has completed its acquisition of The BioBalance Corporation and its subsidiary BioBalance LLC from New York Health Care, Inc. ("NYHC"). With this purchase Enterologics acquired its first probiotic biotherapeutic product, E. coli M17, or Probactrix®.
E. coli M17 has an active Investigational New Drug application (IND) with the FDA for the indication chronic pouchitis. Pouchitis is a complication that occurs in patients following surgical treatment of their ulcerative colitis. This involves removing the colon and reconstructing a rectal pouch, a procedure called restorative proctocolectomy or ilealanal pouch anal anastomosis. The pouch can become inflamed, accompanied by pain and frequent, sometimes bloody bowel movements, requiring antibiotic treatment. While the population of pouchitis sufferers is small, the unmet treatment need is significant. There are at present no FDA-approved drugs for treating this condition, although metronidazole and ciprofloxacin are typically prescribed off-label. Some patients require continuous antibiotic treatment to maintain remission of their symptoms, which is undesirable due to the side effects of the drugs and the increased likelihood for developing antibiotic-resistant bacteria. Enterologics will develop E. coli M17 as a maintenance therapy alternative to long-term use of antibiotics and their associated risks. The IND will permit the Company to initiate its first clinical trial, as soon as manufacturing is re-established and adequate financing is in place.
Probiotics are live microorganisms (in most cases, bacteria) that are similar to or derived from beneficial microorganisms found in the human gut. While most probiotics are sold through consumer channels without therapeutic claims, Enterologics' strategy is to obtain FDA approval for its probiotics as biologic drugs for treating specific diseases, subject to rigorous quality standards and testing in well-controlled clinical trials.
"This acquisition fulfills the first milestone in our strategy to commercialize high value probiotics as biologic drugs for specific gastrointestinal (GI) conditions. The E. coli M17 technology coupled with the new shelf-stable dosage form we are developing with Universal Stabilization Technologies provides us with the ideal platform for our first biologic drug product," said Bob Hoerr, Enterologics' president. "We believe that gaining FDA approval for the pouchitis indication targeted in IND should be possible with a focused clinical testing program at a reasonable cost."
Dr. Hoerr stated that the active IND for E. coli M17 means the Company can focus its resources on the clinical testing needed for FDA approval, rather than on the lengthy preclinical testing typically required for a new biologic. The acquisition also includes BioBalance's portfolio of patents, intellectual property and regulatory filings. Terms of the deal are detailed in the Company's 8-K filing dated September 7, 2011.
Enterologics, Inc (ELGO.OB) is a biotechnology company that is developing probiotics as biologic drugs for specific gastrointestinal disease indications. Probiotics are live microorganisms, in most cases, bacteria, that are similar to or derived from beneficial microorganisms that are found in the human gut (e.g. for more information see Introduction to Probiotics). They are also called "friendly bacteria" or "good bacteria." Enterologics intends to identify, in-license and develop unique probiotic strains for specific medical conditions, obtain regulatory approval and market these probiotics products as FDA-approved prescription drugs for specific label indications. The first probiotic product in its portfolio is E. coli M17, which is being developed for specific gastrointestinal indications.
Matters discussed in this release may constitute forward-looking statements. The U.S. Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation.
Forward-looking statements reflect our current views with respect to future events and financial performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The words "believe," "intend," "anticipate," "estimate," "project," "forecast," "plan," "potential," "may," "should," "expect" and similar expressions identify forward-looking statements.
The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, the consummation of the acquisition described above, the ability to obtain regulatory approval and market its products, availability of capital, management's examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.
Important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include our ability to identify and in-license and the ability to adequately fund such targeted acquisitions. Risks and uncertainties are further described in reports filed by Enterologics, Inc with the U.S. Securities and Exchange Commission.
SOURCE Enterologics, Inc