TheraQuest Receives Orphan Drug Status for its Abuse Deterrent, Once-Daily Tramadol

Blue Bell, Pennsylvania – February 17, 2005 – PR Newswire – TheraQuest Biosciences, a development stage pain management company today announced that the FDA Office of Orphan Products Development has granted Orphan Drug Designation for TQ-1017, its abuse deterrent once-daily extended release tramadol for the treatment of painful HIV-associated neuropathy.

HIV infection and HIV medications are both associated with the development of neuropathy and neuropathic pain. Symptoms include burning sensations and numbness, which are similar to the neuropathies seen with diabetes. According to Dr. Richard Payne, Professor of Medicine and Director, End of Life Care Institute at Duke University, “Patients with painful HIV-associated neuropathy experience sensations ranging in intensity from bothersome to excruciating from normal daily activities, such as putting on socks. At this time, no drug is approved for painful HIV-associated neuropathy and few effective therapies are available to treat this debilitating condition.”

“TQ-1017 was engineered from the outset as a secure-release formulation of once-daily tramadol”, said Najib Babul, PharmD, President and Chief Executive Officer of TheraQuest. “As such, recreational drug users cannot easily tamper with it for inhalation or to obtain rapid euphoria from high blood levels. Without a secure release once-daily tramadol, rapid absorption from intentional or inadvertent crushing has the potential deliver a massive dose all at once and produce neurological toxicity, including agitation, seizures, coma and respiratory failure.”

Dr. Arthur Lipman, Professor of Pharmacotherapy, College of Pharmacy and Director of Clinical Pharmacology at the Pain Management Center, University of Utah Hospitals and Clinics notes, “Recent experience with the long-acting opioid pain reliever oxycodone has demonstrated that intentional crushing or extraction of the active ingredient from the formulation by addicts and recreational drug users can destroy the timed-release mechanism and result in a rapid surge of drug into the bloodstream. Serious side-effects and death have been reported from such misuse.”

Babul adds, “We are particularly pleased to have been granted an Orphan Drug Designation for tramadol. Orphan status affords us seven years of market exclusivity, 50% R&D Tax Credits, exemption from FDA Prescription Drug User Fee and access to research grants from the Office of Orphan Products Development for TQ-1017, our abuse deterrent once-daily tramadol formulation the treatment painful HIV-associated neuropathy.”

About Tramadol Abuse

According to the Drug Enforcement Agency (DEA), “Tramadol is abused for its opiate effects. The current pattern of tramadol abuse in the US involves street drug addicts, chronic pain patients, and health professionals. As an uncontrolled substance, there are no Controlled Substance Act regulations regarding manufacturing, distribution, or prescription of this medication.” (http://www.deadiversion.usdoj.gov/drugs_concern/tramadol.htm).

According to the 2002 National Survey on Drug Use and Health (NSDUH), approximately one million individuals have taken tramadol (Ultram®) for non-medical use. This is approximately the same incidence of non-medical use reported for Dilaudid® and approximately 50% of the incidence reported for OxyContin®. Among non-medical OxyContin users, 18.3% also reported consuming Ultram for non-medical reasons. The U.S. FDA’s MedWatch database has received approximately 1000 reports of abuse, dependence and withdrawal with short-acting tramadol.

In the two most recent annual reports of the American Association of Poison Control Centers Surveillance System (TESS), tramadol ranked only second to oxycodone in the number of opioid exposure cases. A study published in the September 2004 issue of the Journal of Forensic Sciences of 66 deaths in which short-acting tramadol was detected in the decedent’s blood notes that “…tramadol may be a significant contributor to lethal intoxication when taken in excess with other drugs …”

About TheraQuest Biosciences

TheraQuest Biosciences, LLC is a private, development-stage pain management company building a diversified portfolio of pharmaceutical products to address a critical area of unmet medical need. Despite their limitations, current treatments for acute and chronic pain yield worldwide sales in excess of $30 billion. The TheraQuest team has contributed to the development of numerous analgesics approved in the U.S. over the past 20 years. TheraQuest’s strategy is to use its expertise to identify, develop and commercialize product candidates with strong market potential that have lower development costs and reduced regulatory risk than new chemical entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.

TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania. Additional information is available at www.theraquestinc.com.

Ultram®, Dilaudid® and OxyContin® are trademarks of Johnson & Johnson Corporation, Abbott Laboratories Corporation and Purdue Pharma L.P., respectively.