Nastech Pharmaceutical Company Inc has been issued U.S. Patent No. 6,451,848, entitled, "Compositions and Methods Comprising Morphine Gluconate." The patent contains 21 claims relating to a pharmaceutical composition of morphine gluconate or chemical equivalent thereof. The patent includes a method of making morphine gluconate, or chemical equivalent thereof, and a method for eliciting an analgesic or anesthetic response.

"Nastech''s intranasal morphine gluconate is the only morphine formulation that can couple a sufficient dose with the rapid onset of action necessary to treat opioid tolerant cancer patients with breakthrough pain, significantly increasing the percentage of breakthrough pain patients who may benefit from this important therapy," stated Steven C. Quay, Chairman, President, and Chief Executive Officer. "This is the second patent issued to Nastech directed to our intranasal morphine program and represents another positive step in our patent strategy to build shareholder value. Over the past 18 months we have filed dozens of patents to protect our proprietary position in the nasal delivery of both small and large molecule drugs."

Historically, morphine is the most commonly used opioid to control severe pain because of its wide availability, varied formulations, well-characterized pharmacological properties, safety, efficacy and relative ease of titration. However, it is currently not available in a nasal form. With intranasal delivery, a drug is absorbed directly into the systemic circulation, bypassing problems that occur with oral administration, including the inactivation of a portion of the administered dose by gastrointestinal and hepatic metabolism. As a result, plasma concentrations of a nasally administered drug often resemble those seen with injectable dosage forms, prompting fast onset of therapeutic effect without the discomfort and inconvenience of an injection.

According to IMS Health data, the United States prescription market for the treatment of moderate-to-severe pain exceeds $2 billion annually. Among the 1.2 million cancer patients diagnosed every year, 60 to 90 percent suffer from pain during the course of their disease with frequent episodes of breakthrough pain.

Nastech is currently conducting a Phase II clinical trial in cancer patients with breakthrough pain and expects to report data in 2002.