Abstract
The year 1994 is of substantial importance in medical science. A total number of 44 new chemical entities (NCEs), including several genetically engineered products, was introduced for human therapeutic use into the world market for the first time during this year. Having been the most active market for the new pharmaceuticals for several years, Japan once again took a significant lead in 1994 with 24 NCE introductions, accounting for 55% of the total new launches. The United States was second with nine NCEs and the United Kingdom held the third place with four NCEs. The remainder of new drugs was introduced in six other countries— namely, Sweden, the Netherlands, and Canada, each with two NCEs, and Italy, France, Germany, and Austria, each with one NCE. Japan was also the leader in the category of originators for the NCEs with an impressive number of 21 that is nearly half of the total. The United States, where 11 NCEs were originated, followed as the second place again. Germany was the third with three and the United Kingdom, Switzerland, the Netherlands, France with two each, and lastly, Austria had one new drug. Anti-infectives were the most active therapeutic category in terms of worldwide new launches. Eight new drugs, including four anti-viral agents and two carbapenems, reached the market for the first time. Anti-neoplastic and cardiovascular drugs were two other active therapeutic groups with seven and six NCEs, respectively. The central nervous system (CNS) and anti-inflammatory drugs followed with five NCEs each. Several new drugs in 1994 reflected real advances in the treatment of certain serious diseases. Highlights include donase alfa, the first new drug released in 30 years for cystic fibrosis, the most common among deadly genetic diseases in the United States; imiglucerase, the recombinant enzyme replacement product for type-1 Gaucher's disease; and sobuzoxane, the first available therapeutic agent for malignant lymphoma and adult T-cell Ieukernia lymphoma (ATLL).
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