Xechem International, Inc. Sues the University of Texas M.D. Anderson Cancer Center and the Board of Regents of the University of Texas System

ARCHIVED 2002–2016: Originally distributed via the eWire press wire service. Preserved as historical record.

SUBSCRIBE/UNSUBSCRIBE |

Corporate Responsibility

Science & Technology

Syndication Partners

**************************************************************************

E-WIRE PRESS RELEASE E-WIRE PRESS RELEASE E-WIRE PRESS RELEASE

**************************************************************************

FOR IMMEDIATE RELEASE:

Xechem International, Inc. Sues the University of Texas M.D. Anderson Cancer Center and the Board of Regents of the University of Texas System

to Correct Inventorship in U.S. Patent No. 5,877,205

for a New Formulation of Paclitaxel,

Breach of an Exclusive License Agreement and Related Causes of Action

NEW BRUNSWICK, NEW JERSEY, Apr. 17 -/E-Wire/-- Xechem International, Inc. (OTC BB ZKEM) today announced that it has sued the University of Texas M.D. Anderson Cancer Center and the Board of Regents of the University of Texas System (MDA/UT) to correct inventorship and ownership in U.S. Patent No. 5,877,205 for a new CremophorÂ®-free formulation of paclitaxel, and for breach of an exclusive license agreement and related causes of action.

The patented new formulation of paclitaxel completely eliminates the conventionally used carrier, polyoxyethylated castor oil, a suspected carcinogen, sold under the name CremophorÂ® EL that is used in the current FDA approved generic formulation, and instead uses the excipient, N, N-dimethylacetamide (DMA) as a carrier. DMA is used as an excipient in the FDA-approved formulation for the cancer drug, teniposide. The new formulation is thought to be a candidate for an alternative to the generic formulation in the billion plus dollar paclitaxel market.

In its suit, Xechem is seeking to change inventorship and ownership of the '205 formulation patent, which is the subject of an exclusive license agreement between Xechem and MDA/UT, in part or exclusively to Xechem employees and for a former employee of the University of Texas, MD Anderson Cancer Center. Xechem also seeks damages for breach of the license agreement and other related causes of action. The lawsuit has been filed in Federal District Court in Newark, New Jersey. MDA/UT is currently attempting to dismiss the suit based on its 11th Amendment state sovereign immunity and/or to transfer the action to a federal district court in Texas. "We feel we have a strong case and are committed to pursuing it to its conclusion." said Dr. Ramesh C. Pandey, President and CEO of Xechem.

Xechem has positioned itself to be a major supplier of paclitaxel with resources and capacity for large quantities of the rare and valuable natural product necessary for production of the anti-cancer drug through its Indian subsidiary and other Asian sources. The Company has a joint venture in China where the new formulation is currently undergoing further development. In the next few months Xechem is preparing to file an ANDA for FDA approval of its own generic paclitaxel formulation to compete with other generic manufacturers, i.e., Bristol-Myers Squibb's TAXOLÂ® brand and Ivax Corporation's PAXENEÂ® brand. Xechem has several other paclitaxel analog formulations under development to add to its product portfolio, some of which may be protected by the '205 patent.

Xechem International, Inc., headquartered in New Brunswick, NJ, with subsidiary companies in USA, India and joint venture partners in both Hong Kong and Peoples Republic of China, is a biopharmaceutical company of which Xechem, Inc. (a US subsidiary) is engaged in the research, development and production of generic and proprietary drugs from natural sources, specializing in the development of niche-generic, difficult to replicate anticancer, antiviral (including Human Immuno-deficiency Virus, HIV) and antifungal compounds. The Company also screens extracts and pure compounds from various parts of the world including China and India for their therapeutic use. (See press release of February 14, 2001)

XetaPharmâ¢ (another U.S. subsidiary) develops quality controlled nutritional products such as GinkgoOnceÂ®, GinsengOnceÂ®, GarlicOnceÂ®, Gugulonâ¢, and Co-Enzyme Q-10 and numerous products that are under development. (www.xetapharm.com)

This and past press releases of Xechem International, Inc. are available at Xechem's web site at www.xechem.com.

For further information, contact the President and Chief Executive Officer, Dr. Ramesh C. Pandey at (732) 247 - 3300.

Xechem International, Inc.

Dr. Ramesh C. Pandey, (732) 247 - 3300

http://http://www.xechem.com

**************************************************************************

To Transmit Your News Over E-Wire, visit http://www.ewire.com or

call 1-[REDACTED-PHONE]. E-Wire Is Broadcast To Millions Of Readers Worldwide

**************************************************************************