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"The Board of Directors has decided to pursue the sale of the company'sclinical and preclinical drug assets," said Steven C. Gilman, Ph.D., Chairmanof ActivBiotics. "We believe that our anti-inflammatory Phase II drugcandidate and our antibacterial library of compounds are of significant valueto companies in those therapeutic areas," added Gilman. Bidding packages havebeen assembled and are ready to be distributed subject to a potentialpurchaser entering into a standard form confidentiality agreement.
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The Company assets available for sale include:
1. A superoxide dismutase (SOD) mimetic program consisting of twoclinical-stage drug candidates, M40403 and M40419, and a library of 250 smallmolecules which have potential as novel therapeutic agents for the treatmentof inflammatory diseases. M40403, which has been studied in approximately 700patients/subjects, has an active IND, and a protocol on file with the FDAunder which a Phase II clinical trial for the treatment of post-operativeileus can be conducted, and a protocol to initiate a Phase II clinical trialfor the treatment of oral mucositis. The Company has submitted and expects toshortly receive Orphan Drug Designation status in Europe and has an OrphanDrug application pending with the US FDA for the treatment of oral mucositisin subjects with advanced head and neck cancer. In addition to theseindications, the SOD mimetics have potential therapeutic uses in a variety ofinflammatory disorders including asthma, chronic obstructive pulmonarydisease, and radiation protection, stroke, and ischemia reperfusion injury.
2. An antibacterial library of compounds consisting of approximately 800small molecules, all new chemical entities (NCEs), which may be developed forthe treatment of serious bacterial infections, including complicated skin andskin structure infections, endocarditis, osteomyelitis, foreign-bodyinfections, Clostridium difficile-associated diarrhea (CDAD), as well aspeptic ulcer disease due to Helicobacter pylori, and disease due to Chlamydiainfections. In addition, these NCEs have the potential to be administered astopical agents for the treatment of acne and for the eradication ofStaphylococcus aureus in nasal passages.
3. Rifalazil, a clinical stage compound which has been tested inapproximately 600 patients, is a potent antibacterial agent with activitymainly against pathogenic Gram-positive bacteria. Rifalazil was foundefficacious in a Phase II Chlamydia STD clinical trial, and, separately, aprotocol has been submitted to the FDA to begin a Phase II clinical trial incarotid artery atherosclerosis. Rifalazil has been granted Fast Trackdesignation for the treatment of CDAD. The Company has open INDs to continuerifalazil development for infectious diseases, and atherosclerosis-relateddisease.
Request for Further Information
Interested parties can obtain a bidder's package by contacting Joseph F.Finn, Jr., CPA ([email protected], phone 781-237-8840), Finn, Warnke &Gayton, 167 Worcester Street, Suite 201, Wellesley Hills, MA 02481-3613. Thepackage is intended to provide prospective purchasers with informationconcerning the Company's Sale of Assets and conveyancing documents
