US FDA Grants Orphan Drug Status To Immtech's Pafuramidine For Treatment Of African Sleeping Sickness

Main Category: Tropical Diseases
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 20 Sep 2007 - 0:00 PDT

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Immtech Pharmaceuticals, Inc. (Amex: IMM) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pafuramidine (DB289) for treating Human African Trypanosomiasis (HAT), also known as African sleeping sickness. Orphan drug designation provides Immtech with numerous financial and regulatory benefits during pafuramidine's development, including government grants for conducting clinical trials, waiver of New Drug Application submission fees, tax credits, and a seven-year market exclusivity upon final FDA approval.

Pafuramidine is currently in phase III clinical trials for African sleeping sickness at six trial sites in Africa. The infectious disease, spread by tsetse flies, threatens approximately 60 million people in over 30 countries in sub-Saharan Africa. Current treatments for the disease are associated with high levels of toxicity and are difficult to administer. Safety data for pafuramidine has been positive to date, and the FDA and Ethics Committees responsible for the study oversight currently allow adolescents, pregnant women and nursing mothers to participate in these clinical trials. These groups are particularly vulnerable to the disease.

"The FDA's decision reflects the significant need for new treatments for African sleeping sickness," stated Carol Olson, MD, PhD, Immtech's Sr. Vice President and Chief Medical Officer. "Pafuramidine has the potential to be the first oral treatment for this fatal and neglected disease. Patients often put off screening and treatment because current drugs must be given by injection. A safe and effective pill that is readily available should facilitate cure for more patients in the early stage of the disease. Because pafuramidine is more user-friendly than existing therapies, we anticipate that it would be available in community clinics as well as at current African sleeping sickness treatment centers. Patients could be treated close to home, rather than traveling long distances to specialized centers."

Pafuramidine has previously been granted Orphan Drug Designation for treatment of pneumocystis pneumonia (PCP) and malaria. In addition to trials for African sleeping sickness, pafuramidine is currently in Phase III clinical trials for PCP, and in Phase II trials targeting malaria treatment and malaria prophylaxis.

"This is another positive milestone for Immtech as pafuramidine advances towards commercialization," commented Eric L. Sorkin, Immtech's Chairman and Chief Executive Officer. "We will continue to work closely with our consortium of scientists, and global collaborators to develop safer and more effective therapies for this and other global health threats."

About Immtech Pharmaceuticals, Inc.

Immtech Pharmaceuticals, Inc. is focused on developing and commercializing drugs to treat infectious diseases, and the Company is expanding its targeted markets by applying its proprietary pharmaceutical platform to treat other disorders. Immtech has advanced clinical programs that include new oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (HAT or African Sleeping Sickness), and a well defined, expanding library of compounds targeting drug-resistant Gram-positive bacteria, fungal infections, Hepatitis C and other serious diseases. Immtech holds the exclusive worldwide licenses to certain patents, patent applications and technology for products derived from a proprietary pharmaceutical platform. For additional information, please go to http://www.immtechpharma.com

"Safe Harbor" Statement under the Private Securities Reform Act of 1995: Statements in this press release regarding Immtech Pharmaceuticals, Inc.'s business, including the future prospects for PCP, which are not historical facts are "forward- looking statements" that involve risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the headings "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Immtech's annual report on Form 10-K for the year ended March 31, 2007 and in its other SEC filings and include: (i) Immtech's ability to develop commercially viable products; (ii) Immtech's ability to achieve profitability; (iii) Immtech's ability to retain key personnel; (iv) the ability of Immtech's scientists and collaborators to discover new compounds; (v) the availability of additional research grants; (vi) Immtech's ability to obtain regulatory approval of its drug candidate, including PCP; (vii) the success of Immtech's clinical trials; (viii) dependence upon and contractual relationship with partners; (ix) Immtech's ability to manufacture or to have a third party manufacture its drug candidate at a reasonable cost; (x) Immtech's ability to protect its intellectual property; (xi) competition and alternative technologies; (xii) Immtech's ability to obtain reimbursement from third party payers for any product it commercializes; and (xiii) potential exposure to significant product liability.

Immtech Pharmaceuticals, Inc.
http://www.immtechpharma.com