Genteric Announces Broad Patent Coverage for Its Gene Pill Platform Company Given Notice of Allowance by U.S. Patent & Trademark Office for All Secreted Proteins.

Business Editors & Health/Medical Writers

BIOWIRE2K

ALAMEDA, Calif.--(BW HealthWire)--June 20, 2001

Genteric, Inc. today announced it has received a Notice of Allowance from the U.S. Patent Office that will extend the intellectual property coverage for its Gene Pill technology platform to include all secreted proteins. This allowance follows the recent patent that the Company was issued (U.S. Patent 6,225,290 entitled "Systemic Gene Therapy By Intestinal Cell Transformation) which gave Genteric claim to the delivery of the human insulin gene, using the Gene Pill Platform. The new patent significantly extends the coverage of the existing technology.

Genteric's Gene Pill technology enables the oral administration of an engineered gene that encodes a therapeutic protein. The gene is taken-up by cells of the intestine which then produce the protein. Once the protein is produced, it is secreted into the patient's bloodstream providing the desired therapeutic effect. This revolutionary approach will likely replace many of the current array of injectable protein drugs. The market for injectable proteins exceeds $20 billion and includes blockbuster medications such as human insulin, EPO, human growth hormone, Factor VIII and Factor XI. Gene Pill applications for these drugs and many more are claimed within the new patent.

The Company believes this technology platform will also spawn the development of many new protein drugs, which will otherwise not come to market because of their prohibitive development and production costs and the inconvenience of delivery (by injection).

"Protein drugs are the medicines of the future, but their delivery is problematic due to the expense and to the discomfort of delivery," remarked Roland Scollay, Ph.D., Genteric's vice president of research and chief scientific officer. "Gene therapy provides an efficient alternative mode of protein delivery and, delivered orally, will revolutionize this kind of therapy. The Genteric 'Gene Pill' patent signifies the beginning of this revolution."

"Orally delivered gene therapy represents the final frontier of genetic medicine. Our Gene Pill program promises uncomplicated gene therapy to compliment the sequencing of the human genome," said Martin D. Cleary, president and chief executive officer of Genteric. "Although much work needs to be done, the patent that follows this Notice of Allowance will ensure Genteric owns the necessary intellectual property to lead the commercialization effort. We are eager to partner this program with forward thinking pharmaceutical and biotech companies."

Challenges with Conventional Gene Delivery

Conventional delivery of therapeutic genes to patients involves an injection directly into the bloodstream or tissue. This direct injection method has several barriers, including: 1) difficult and inefficient gene delivery to target cells; 2) unpredictable and quickly diminishing gene activity; and 3) adverse reactions from the patient's immune response to the vector, or "vehicle," used to deliver the genes.

Genteric's Gene Pill Approach

Researchers from Genteric have invented a new method of gene delivery that employs the patient's own gastrointestinal tract to produce and secrete therapeutic proteins into the bloodstream. In the therapy's mature stage, the patient could swallow a pill containing engineered DNA that encodes the needed protein. The DNA would then be "taken up" by the cells lining the luminal space of gastrointestinal tract (the side of the intestine that normally absorbs food material), which then produce and secrete proteins into the bloodstream to achieve the desired therapeutic results. A key feature of these intestinal cells is that, like skin cells, they are constantly replaced. Thus, the gene is expelled with the dying cells on a regular basis -- about every other day. This natural feature enhances safety and efficient dose control.

This new oral gene therapy method presents the following advantages:

-- Oral administration is simple, painless and convenient.

-- Oral administration allows different dose levels to be given according to
patient needs.

-- The body replaces cells at this site quickly, which gives greater control of
gene delivery and helps to avoid long-term side effects.

Genteric's next steps are to continue current experiments and follow into Phase I/II clinical trials. During these stages, researchers will address challenges in oral delivery, such as methods to adjust the amount of the protein drug expressed and durability of coating materials used to protect the DNA as it is delivered to cells in the intestinal tract.

About Genteric, Inc.

Established in 1997, Genteric is a privately held biotechnology company, which owns exclusive rights to several proprietary technology platforms invented at both the San Francisco and Davis campuses of the University of California. The company has pioneered new methods of gene-based drug delivery that employ the secretory organs of the patient's gastrointestinal system to produce and release therapeutic proteins into the bloodstream.

The company encourages inquiries regarding licensing and partnering opportunities for its technologies.

For additional information, please visit Genteric's web site at www.genteric.com.