Alza Corp. and Sandoz Pharmaceuticals Corp. announced at H&Qon Tuesday that they have submitted a new drug application(NDA) to FDA for a controlled-release version of Sandoz's anti-hypertensive medication isradipine.
The result of a joint development agreement between Alza ofPalo Alto, Calif., and Sandoz of East Hanover, N.J., DynaCirc CRuses Alza's proprietary OROS osmotic controlled-releasetechnology for once-a-day treatment of hypertension. Sandozconducted safety and efficacy trials of DynaCirc.
Following approval, the product will be manufactured by Alzaand marketed by Sandoz. Alza will receive royalties.
AGOURON GETS APPROVAL FOR TRIAL
Agouron Pharmaceuticals Inc. announced at the H&Qconference Tuesday that FDA has authorized a second clinicalstudy of the company's topical anti-psoriatic drug designatedAG-85.
The study, to be conducted concurrently at the Skin ResearchFoundation of California in Santa Monica and the University ofCalifornia, Irvine, will involve up to 24 psoriasis patients, theSan Diego company said.
Agouron (NASDAQ:AGPH) developed AG-85 to halt theabnormal proliferation of psoriatic skin cells by inactivating akey enzyme, thymidylate synthase. In an initial pilot study,completed last April, 0.1 percent AG-85 was applied topicallyto 10 psoriasis patients. The upcoming study will evaluate a1.25 percent topical cream formulation and will require aboutsix months to complete, the company said.
The drug has a lot in common mechanistically withmethotrexate, Peter Johnson, Agouron's president and chiefexecutive officer, told BioWorld.
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