Chapter 31 To Market, To Market - 1986

Abstract

Publisher Summary A record number of new chemical entities (NCEs) were marketed in the United States during 1986. This is the first time the NCEs for human therapeutic use introduced into the world marketplace and it exceeded yearly launches during the past two years by about 25%. More than 40% of these first time worldwide NCE launches occurred in Japan, with West Germany, the United States, France, Italy, and the United Kingdom, in aggregate, accounting for an equal percentage. Japan also topped the list of originators of the NCEs launched in 1986, followed by the United States, West Germany, and France. Interestingly, all the NCEs that originated in Japan also had their first launches in that country. This chapter includes four of these, butoconazole nitrate, dronabinol, muromonab-CD3, and trientine hydrochloride. These were first time worldwide launches. Butoconazole nitrate is an anti-fungal agent related to miconazole and other imidazole anti-mycotics. It is useful in the topical treatment of vulvovaginal candidiasis, being similar in effectiveness to miconazole and clotrimazole. Dronabinol (synthetic A Δ-THC) is an anti-nauseant approved for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetics. A related cannabinoid, nabilone, was introduced in Canada for this indication in 1982. Muromonab-CD3 is a murine monoclonal antibody to the T3 antigen of human T-cells that blocks their killing ability. It is useful in the treatment of acute allograft rejection in renal transplant patients. Trientine hydrochloride is a copper chelating agent recommended for the treatment of Wilson's disease, especially in patients intolerant of penicillamine therapy. Unlike the latter agent, trientine is not indicated in cystinuria or rheumatoid arthritis.