By Mary Welch
Demonstrating their commitment to continued development of an oral heparin, which is now in Phase II trials, Emisphere Technologies Inc. and Elan Corp. plc each invested $5 million in their 50-50 joint venture on the product.
The original pact, signed in October 1995, called for Emisphere, which specializes in oral delivery of large molecules, to provide the technology while Elan, of Dublin, Ireland, supplied $7.5 million in start-up money.
"That money is now exhausted, so this time both companies dipped in and anted up $5 million each because we are both really confident about the project," said Lillian Stern, vice president of corporate planning and investor relations at Tarrytown, N.Y.-based Emisphere.
In addition to the $12.5 million it has contributed to the venture, Elan purchased $7.5 million in Emisphere stock at the time the partnership was formed. In January, Elan exercised additional warrants, which were issued in 1995, and purchased another $4 million worth of Emisphere stock.
"In May, we started a three-arm Phase II study of oral heparin for the prevention of deep vein thrombosis [DVT] for patients who have undergone hip replacement surgery," Stern said. "Deep vein thrombosis, if left untreated, may develop in between 30 percent and 50 percent of all patients who undergo hip replacement surgery. DVT is not deadly, but it leads to pulmonary embolism, which is life-threatening. In other words, you have to treat it. You can't ignore deep vein thrombosis."
Phase III For Oral Heparin Slated For 1999
The Phase II studies, which are taking place in 23 sites with about 123 patients, are intended to demonstrate that orally administered heparin, utilizing Emisphere's technology, is comparable to injected doses of heparin. The trials should be complete by the end of this year, with Phase III trials planned in 1999.
Heparin is an anticoagulant, antithrombotic compound that is prescribed for a variety of cardiovascular indications.
DVT is currently treated with heparin, but it means patients must be injected up to three times per day. Other medications, such as Coumadin (crystalline warfarin sodium), may be taken orally, but tend to have undesirable side effects, Stern said. Coumadin, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors, is marketed by the DuPont Pharmaceutical Co., of Wilmington, Del.
"No one has developed an oral formulation and that's what Emisphere Technologies does," Stern said. "We develop oral formulations of proteins and other macromolecules. We believe that patients would prefer taking a drug that has fewer side effects and doesn't have to be injected. We think that would be very attractive. We see major opportunities."
In addition to an oral heparin, this year the companies decided to develop an oral formulation of low-molecular-weight heparin.
Stern said the partners also are studying other indications for an oral heparin, including cardiovascular and inflammatory bowel diseases. "We think there are other indications where heparin would be very effective," Stern observed, "but doctors don't prescribe it because patients would have to be injected. We think an oral heparin would open up a lot of markets that aren't exploited, such as in post-heart attack or post-stroke patients. They should be taking anticoagulants."
Elan and Emisphere, Stern said, may need help in developing and commercializing an oral heparin. They currently are talking with pharmaceutical companies.
Emisphere Technologies' stock (NASDAQ:EMIS) closed Thursday at $8.437, down $0.187. *