BEECHAM's EMINASE HAS BEEN STUDIED IN "AT LEAST 1,000" PATIENTS worldwide, the company's U.K. pharmaceutical research manager Harry Ferres, PhD, told a press symposium Sept. 15 tied to Eminase (APSAC) clinical presentations at the World Congress of Cardiology meeting in Washington, D.C. Although APSAC has not yet reached the market either in the U.S. or overseas, Beecham anticipates approvals "toward the middle of next year" in two European countries, Ferres said. The thrombolytic agent, now in Phase III studies in the U.S., is active in 25 research centers in the U.S., including a five-center study in 200 patients directed from Salt Lake City, Utah. The "major advantage" of APSAC treatment over other thrombolytic agents, including urokinase, streptokinase, and tissue plasminogen activator (TPA), Stewart Hillis, MD, a clinical investigator, noted, "is that it can be given slowly for five minutes" and, therefore, can be made "available to either community physicians . . . or paramedics." Hillis was one of three investigators at the symposium presenting APSAC clinical data at the cardiology congress. Ferres pointed out that APSAC is administered in a 30 mg bolus injection over five minutes time. APSAC's administration compares with infusion treatments of approximately an hour for urokinase and streptokinase, and possibly longer for TPA. Ferres said that with TPA "the infusion rate has commonly been something like three hours, with proposals and some of the latest clinical trials going up even beyond that time." APSAC also has a longer half-life than any of the other thrombolytic agents, Ferres said. "With a half-life of an hour and a half, that means you have fibrillating activity in the blood stream for several hours," Ferres observed. "That contrasts with TPA, for example, that has a half-life of five minutes and streptokinase and urokinase which have half-lives of 15 minutes." Ferres asserted that the longer half-life of Eminase makes it possible to avoid the long infusion rates and reduces the danger of reocclusion.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
