ALKERMES ANNOUNCES CLINICAL TRIALS PROGRESS -- PLANS TO ADVANCE INTO PHASE II CLINICAL TRIALS OF RMP-7 IN PATIENTS WITH BRAIN TUMOR.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--January 10, 1995--Alkermes, Inc. (NASDAQ:ALKS) today announced at the Hambrecht and Quist Life Sciences Conference in San Francisco that it has completed patient enrollment in three separate Phase I/II clinical trials RMP-7 administered in combination with therapeutic drugs in patients with brain tumor and cryptococcal meningitis, an infection of the central nervous system. A total of 49 patients were enrolled in these studies, which were designed to study the safety, tolerability and pharmacokinetics of escalating doses of RMP-7 in combination with either carboplatin (brain tumor patients) or amphotericin B (cryptococcal meningitis patients).

In addition, the company announced the completion of a Phase I study of RMP-7 which provided quantitative data supporting RMP-7's effect on increasing brain tumor permeability to a pharmaceutical compound.

Based on a preliminary analysis of the results of these trials, the Company intends to begin enrolling patients during the first quarter of 1995 in Phase II studies in the U.S. and Europe of RMP-7 with carboplatin, an FDA approved cancer chemotherapeutic compound, in patients with recurrent glioma, a type of brain tumor. Further Company-sponsored study in the cryptococcal meningitis indication is not being planned at the current time due to a significant decline in the incidence of the disease.

"RMP-7 has now been administered to over 150 subjects in the U.S. and U.K." said Richard F. Pops, Chief Executive Officer of Alkermes. "Through careful clinical research in Phase I and Phase I/II we are developing a significant amount of data regarding the safety, tolerability and pharmacokinetics of RMP-7 and compounds administered along with it. These data will help us design and assign priorities to our subsequent preliminary efficacy studies in Phase II."

Patient Enrollment in Three Phase I/II Studies Completed

By year end 1994 Alkermes had completed patient enrollment in two separate Phase I/II studies of RMP-7 administered with carboplatin in patients with recurrent glioma. These studies were designed to study the safety, tolerability and pharmacokinetics of escalating doses of RMP-7 and carboplatin in patients. One study was conducted by investigators at the University of California, San Francisco. The second study was conducted by investigators in the United Kingdom. A total of 23 patients were enrolled in the two studies.

Enrollment was also completed in a double-blind, placebo controlled Phase I/II clinical trial of RMP-7 administered with amphotericin B in patients with cryptococcal meningitis. Due to a significant decline in the incidence of cryptococcal meningitis following the commencement of the study and the resulting slow rate of patient enrollment. Enrollment was completed after 26 of a planned 36 patients had received treatment. The study was designed to test the safety, tolerability and pharmacokinetics of escalating doses of RMP-7 and amphotericin B in patients.

Results from the three Phase I/II studies will be made available following the completion of the studies and analysis of the data.

Quantitative Permeability Changes Observed in Brain Tumors

The Company has also completed a Phase I safety study of RMP-7's effect on cerebral blood flow and permeability in volunteers and patients with brain tumor. The study was conducted at the Hospital of the University of Pennsylvania and enrolled a total of five volunteers and ten patients with recurrent glioma. Positron emission tomography (PET) was used to calculate cerebral blood flow. In a positive safety finding, RMP-7 produced only a small, well tolerated dose-related decrease in cerebral blood flow in patients and volunteers. In addition, another brain imaging technique, single photon emission computed tomography (SPECT), was used to calculate brain tumor permeability to a radioactive tracer. SPECT scans from eight of ten brain tumor patients were evaluable, and seven of the eight had an increase in brain tumor permeability to the radioactive tracer with a mean increase of 57 percent (SD 38 percent, p<.004).

"This study provides convincing evidence that RMP-7 can significantly increase the permeability of brain tumors in man," said Abass Alavi, M.D., Chief of the Department of Nuclear Medicine and principal investigator of the study.

Results from the Phase I study will be presented in February at the 2nd International Symposium on Drug Transport to the Brain in Leiden, Netherlands.

RMP-7 Background

RMP-7 is a proprietary compound developed by Alkermes to transiently increase the permeability of the blood-brain and blood-ocular barriers. Following injection, Alkermes believes that RMP-7 binds to receptors on these barriers and triggers a brief relaxation of their tight cellular junctions. RMP-7 exerts its effect on the blood vessel walls and does not itself bind to or serve as a carrier for compounds administered with it. RMP-7 can be administered either intravenously or intra-arterially and is intended to be used as an independent adjunct to increase the utility of other therapeutic and diagnostic compounds. Drugs that could be administered along with RMP-7 include cancer chemotherapeutic and anti-infective drugs not currently used effectively in central nervous system and ocular disorders because of limited penetration of the blood-brain or blood-ocular barriers.

RMP-7 is being developed by Alkermes for Alkermes Clinical Partners, L.P., a limited partnership which raised $46 million in 1992 to develop RMPs. Alkermes has the option to purchase the partnership's technology.

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Alkermes, Inc. is an emerging pharmaceutical company focused on the development and commercialization of innovative products based on its sophisticated drug delivery technologies and its expertise in central nervous system disorders. In addition to its Cambridge, MA headquarters. Alkermes operates a medical affairs office in Cambridge, England. The Company currently employs approximately 100 people worldwide.

CONTACT: Alkermes, Inc.

             Richard F. Pops, 617/494-0171
             Pearson Communications
             Thomas A. Pearson, 610/995-9730
             Clarence Swearngan, Jr.
             Burns McClellan, 212/505-1919