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ProEthic Pharmaceuticals Completes Pre-IND Meetings on Two Fast-Acting Diclofenac Products

Montgomery, Alabama, November 3, 2005 - ProEthic Pharmaceuticals Inc., a Montgomery, Alabama-based specialty pharmaceutical company, announced today that it has successfully completed two Preliminary Investigational New Drug meetings (Pre-IND’s) with the FDA for its two proprietary, fast-acting diclofenac products.

The first Pre-IND meeting, on PRO-571 was held on August 30, 2005, with the Division of Anesthesia, Analgesia and Rheumatology. The division agreed that the 505(b)2 pathway to approval is appropriate due to the enhanced pharmacokinetic profile of the drug. The Division also agreed with ProEthic’s clinical development strategy in seeking an indication for the “treatment of mild to moderate pain” for 14 days or less.

The second Pre-IND meeting, on PRO-513 was held on October 19, 2005, with the Division of Neurology Products. The division agreed that the 505(b)2 pathway was once again the appropriate route to approval as a result of the enhanced pharmacokinetic profile of the drug. The Division also agreed that “treatment of migraines with or without aura” is an approvable indication if ProEthic’s clinical development strategy is successfully executed. They also agreed to accept data from the existing European Common Technical Document (CTD) as a basis for the IND. The data in the European CTD is owned by Novartis and has been licensed by ProEthic for use in the U.S. and Canada. Upon completion of the Phase III study, a 505(b)2 NDA will be submitted, which will include these study results as well as the relevant data from the CTD and/or literature.

ProEthic anticipates filing both IND’s in early December and will begin simultaneous clinical programs in January of 2006. ProEthic expects to file both NDA’s by the end of 2006.

About ProEthic Pharmaceuticals, Inc.

ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. ProEthic also markets niche generic prescription pharmaceutical products through Midlothian Laboratories LLC, a wholly owned subsidiary. For more information, please visit the ProEthic website at: www.proethic.com.