TransTech Pharma, Inc. Announces Completion of Company's First Phase I Clinical Trial.

Business Editors/Health/Medical Writers

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HIGH POINT, N.C.--(BUSINESS WIRE)--May 10, 2004

TransTech Pharma Inc., of High Point, North Carolina today announced the successful completion of Phase 1 clinical testing of its first drug candidate, TTP889. TTP889, an orally bioavailable selective inhibitor of the intrinsic coagulation pathway, is being developed as an anticoagulant for the treatment of thromboembolic disorders. TTP889 is the only known selective small molecule inhibitor of Factor IX/IXA, a key enzyme of the intrinsic pathway of the blood coagulation system. TTP889 has proven to be effective in preventing clot formation in several animal models of human disease, including stroke and pulmonary embolism, without any signs of the bleeding associated with traditional anticoagulants. The company will initiate Phase 2 testing of TTP889 in September 2004.

"We are extremely excited that our first drug will reach the Phase 2 testing stage in less than 40 months from project inception", said Dr. Adnan Mjalli, President and CEO of TransTech Pharma. " With TTP889 leading the way, we have a very rich pipeline of novel preclinical and clinical drugs discovered at TransTech which are being developed internally and in collaboration with partners. These new drugs target important diseases including thrombosis, Alzheimer's dementia, diabetes/obesity and cardiovascular complications. Our rapid progress is clear testimony to the robustness of our drug discovery platform, TTP Translational Technology(R), that has proven to be effective in translating biological targets into safe and effective clinical candidates in a timely and cost effective manner."

The thromboembolic therapeutic arena is growing rapidly and sales of anticoagulants for use in thromboembolic disorders could reach $15 billion in the next 10 years, according to Data Monitor (DMHC1962, 11-2003). Significant unmet medical need exists in this market and there are few breakthrough products on the horizon. TTP889 is expected to address many of the unmet needs in this market by providing physicians with a safe, orally active anticoagulant that does not have the associated bleeding inherent with existing anticoagulant therapies.

TTP889 was first administered to healthy subjects on November 8, in the Clinical Research Unit of MDS Pharma Services, in Lincoln Nebraska. The drug was safe at all doses, single and multiple, tested in both young and elderly healthy subjects at blood levels well above the predicted therapeutic range with no test-article related adverse events observed. TTP889 demonstrated an oral half life of approximately 20 hours making it ideal for once daily dosing. TTP889 also showed a predictable PK profile consistent with a well-behaved drug. Importantly, there were no bleeding events reported during the Phase 1 study. Phase 2 will be initiated in September 2004 in 200 patients across 25 sites in six European countries. TTP889 will be dosed once daily for three weeks beginning one week after discharge from hospital to patients following hip fracture surgery. The end-point will be reduction in incidence of DVTs versus placebo in these patients as determined by venography.

The coagulation cascade can be divided into two functional pathways. The extrinsic pathway is initiated by tissue damage and is primarily responsible for the desired clotting that occurs at the site of injury, limiting blood loss. It is the inhibition of this pathway by existing anticoagulant/antithrombotic agents that is believed to be responsible for the excessive bleeding associated with their use in treating or preventing thromboembolic disorders. Unlike these drugs, TTP889 has limited effects on this pathway.

The intrinsic pathway, on the other hand, is activated and causes unwanted clotting when blood encounters foreign material such as hemodialysis filters or artificial heart valves. It is also activated and causes unwanted clotting when venous blood is moving slowly (stasis), such as occur during and after major surgery. By targeting this pathway, rather than the extrinsic pathway, it is expected that TTP889 will provide protection from throboembolism with fewer of the bleeding complications associated with the use of existing anticoagulants.

To date, only one anticoagulant, warfarin, can be given orally; others require administration by injection. Initial results suggest that TTP889 can be administered as a pill or capsule. The use of warfarin is complicated by slow onset of action, multiple drug interactions and the requirement for frequent monitoring of its anticoagulant effect. TransTech believes that TTP889 will avoid some or all of these complications.

Thus, TTP889 offers the potential for a safer, more convenient, orally bioavailable anticoagulant for the treatment and prophylaxis of thromboembolic disorders.

TransTech Pharma is a privately held drug discovery company employing approximately 72 people. The Company's high-throughput drug discovery platform, Translational Technology(R) translates the wealth of information from genomics and proteomics into novel and effective small molecules as therapeutics. TransTech has developed several internal drug discovery programs in various stages of pre-clinical and clinical development for the treatment of human diseases of unmet medical need including thrombosis, Alzheimer's dementia, diabetes/obesity and the neutralization of potential biowarfare agents. In addition to its internal drug discovery programs, TransTech is actively involved in three research collaborations to discover and develop drug candidates with pharmaceutical/biotech companies Novo Nordisk A/S, Cephalon, Inc. and SIGA Technologies, Inc. For further information about the company, go to its web site at http://www.ttpharma.com.