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To: bob zagorin who wrote (297)1/11/2000 11:21:00 AM
From: bob zagorin  Respond to of 562
 
RPI and Elan Complete Joint Venture Agreement

BOULDER, Colo., Jan. 11 /PRNewswire/ -- Ribozyme Pharmaceuticals, Inc. ("RPI") (Nasdaq: RZYM) today announced completion of a joint venture agreement with an affiliate of Elan Corporation, plc in accordance with the preliminary announcement of December 9, 1999. The joint venture (called Medizyme Pharmaceuticals Ltd.(TM)) will develop and commercialize RPI's ribozyme Herzyme(TM) against Human Epidermal Growth Factor Receptor Type 2 (HER-2) for treatment of breast and other cancers using Elan's proprietary MEDIPAD(R) Drug Delivery system.

Under the terms of the transaction, RPI has licensed Herzyme to Medizyme and contributed $12.0 million in initial funding to Medizyme in exchange for 80.1% of Medizyme's capital stock. The funds to provide this initial funding were the proceeds from the sale to Elan by RPI of Series A convertible preferred stock of RPI. Medizyme has licensed Elan's MEDIPAD(R) technology in return for a license fee.

RPI and Elan have estimated that the program will require funding in the aggregate of $15 million to cover future operating and development costs. Elan has made available a credit facility on a draw-down basis for RPI to use if desired to fund RPI's portion of Medizyme operating costs over a 30 month period. Elan may convert this debt into Series B convertible preferred stock of RPI in the future.

As part of the transaction, Elan has purchased shares of RPI common stock for a purchase price of $5.0 million and committed to purchase an additional $5.0 million of common stock in 15 months at a per share price based on the achievement of milestones. In addition, Elan has received warrants to purchase shares of RPI common stock. Elan has the right to exchange the Series A preferred stock for additional capital stock of Medizyme or convert it into RPI common stock.

Breast cancer remains a serious disease with a significant medical need. Over 180,000 new breast cancer cases are diagnosed each year in the U.S. alone. Approximately 30% of these patients overexpress the HER-2 gene and could benefit from Herzyme that specifically targets and downregulates HER-2. Herzyme is expected to have a benign side effect profile similar to other ribozymes in commercial development. In addition, use of the MEDIPAD delivery system is expected to provide a patient-convenient, at-home delivery method for Herzyme that, if successfully developed, would avoid hospitalization, intravenous delivery and doctor's office visits.

"We are very pleased to have consummated this joint venture with Elan, for it will allow us to move forward together to develop and commercialize Herzyme aggressively," said Ralph E. Christoffersen, President and CEO of RPI. "We believe that Herzyme is a potentially important new anti-cancer agent, and look forward to exploring the use of the MEDIPAD delivery system as a convenient and effective method of home delivery of Ribozymes."

Ribozymes are the product of Nobel Prize winning science and are synthetically engineered to act as "molecular scissors" capable of cleaving target RNA in a highly specific manner.

RPI, located in Boulder, Colorado, is the acknowledged leader in ribozyme therapeutic development. In addition to its collaboration with Elan, RPI is partnered with Chiron Corporation for the development and commercialization of ANGIOZYME(TM), an anti-angiogenic ribozyme designed to inhibit the growth of new blood supplies to tumors and prevent tumor growth and metastasis. RPI is also partnered with Eli Lilly and Company for development of an anti-HCV ribozyme for treatment of chronic Hepatitis C infection.

This press release contains forward-looking statements that involve risks and uncertainties, and actual events or results may differ materially. These risk factors include actions by the U.S. Food and Drug Administration, technological advances, ability to obtain rights to technology, ability to obtain and enforce patents, ability to commercialize and manufacture products and general economic conditions. These and additional risk factors are identified in RPI Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings.

SOURCE Ribozyme Pharmaceuticals, Inc.

CO: Ribozyme Pharmaceuticals, Inc.; Elan Corporation, plc; Medizyme Pharmaceuticals Ltd.

ST: Colorado

IN: BIO MTC

SU: JVN

01/11/2000 09:01 EST prnewswire.com



To: bob zagorin who wrote (297)1/11/2000 11:24:00 AM
From: bob zagorin  Read Replies (1) | Respond to of 562
 
Antihepatitis C Ribozyme IND Filed by Lilly and RPI

INDIANAPOLIS, Jan. 11 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Ribozyme Pharmaceuticals, Inc. (RPI) (Nasdaq: RZYM), announced today that an Investigational New Drug Application (IND) has been submitted to the U.S. Food and Drug Administration (FDA) to begin clinical testing of RPI's antihepatitis C ribozyme, LY466700 (previously referred to as "Heptazyme"). If the Food and Drug Administration approves the IND, the initial clinical study will consist of a safety and pharmacokinetic study in normal volunteers followed by a second study in hepatitis-C-infected, treatment-naive patients. The second study will be a multidose clinical study designed to examine safety, pharmacokinetics and the extent of HCV RNA reduction in the blood.

LY466700 is a chemically synthesized ribozyme that is designed to selectively cut hepatitis C virus (HCV) RNA and inhibit viral replication. It is expected to be effective against all known HCV genotypes since it targets a conserved region of HCV RNA, and is also expected to be effective even after infection or replication has been established.

HCV is the most common chronic bloodborne infection in the U.S. and is considered an epidemic by the Centers for Disease Control with a four-fold higher prevalence than HIV. More than 4 million people are infected in the U.S. and 125 million people are reported to be infected worldwide. Chronic infection can lead to liver inflammation, cirrhosis, cancer and death. Current treatment options for patients are limited, clearing virus in only 20 percent to 40 percent of patients, and can be associated with some serious side effects.

"We are pleased with the progress made to date in our collaboration and are looking forward to being able to move forward into human studies with this potentially exciting product," said Gail H. Cassell, Ph.D., vice president of infectious diseases discovery research and clinical investigation for Lilly. "There clearly are unmet medical needs for effective management of hepatitis C viral disease in the United States and throughout the rest of the world."

"Since HCV remains such a serious disease with limited treatment options, we are very pleased that our Lilly collaboration has resulted in rapid IND filing following initiation of the collaboration in March, 1999," said Ralph E. Christoffersen, Ph.D., chief executive officer and president of RPI. "The preclinical results appear quite promising, and we look forward to initiating clinical trials with this anti-HCV ribozyme."

Ribozymes are the product of Nobel Prize winning science and are synthetically engineered to act as "molecular scissors" capable of cleaving target RNA in a highly specific manner. Preclinical studies presented recently at the American Association for the Study of Liver Disease conference demonstrated specific inhibition of chimeric HCV-poliovirus replication in cell culture with a ribozyme mechanism of action. In addition, uptake in liver cells in mice was shown following either subcutaneous or intravenous administration. LY466700 has also shown an enhanced effect when combined with interferon in cell culture studies.

Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions which enable people to live longer, healthier and more active lives.

RPI, located in Boulder, Colorado, is the acknowledged leader in ribozyme therapeutic development. In addition to its collaboration with Lilly for development of an anti-HCV ribozyme, RPI is partnered with Chiron Corporation for the development and commercialization of ANGIOZYME(TM), an antiangiogenic ribozyme designed to inhibit the growth of new blood supplies to tumors and prevent tumor growth and metastasis. RPI is also partnered with Elan Corporation for development and commercialization of HEKZYME(TM), an anti-her2 ribozyme for treatment of breast and other cancers.

This press release contains forward-looking statements that involve risks and uncertainties, and actual events or results may differ materially. These risk factors include actions by the U.S. Food and Drug Administration, technological advances, ability to obtain rights to technology, ability to obtain and enforce patents, ability to commercialize and manufacture products and general economic conditions. These and additional risk factors are identified in Lilly and RPI Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings.

SOURCE Eli Lilly and Company

CO: Eli Lilly and Company; Ribozyme Pharmaceuticals, Inc.

ST: Indiana, Colorado

IN: MTC

SU:

01/11/2000 08:01 EST prnewswire.com