Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Affymax Swings $42 Million Financing To Push Hematide

This article was originally published in The Pink Sheet Daily

Executive Summary

Private/public infusion will see synthetic ESA through trials and approval.

You may also be interested in...



R&D In Brief

Zetia/Lipitor combo NDA becomes Merck's latest cardiovascular casualty: FDA refused to file Merck's NDA for a fixed-dose combination pill of ezetimibe (Merck's Zetia) and atorvastatin (Pfizer's Lipitor) known as MK-0653C, the drug maker revealed in a filing with the SEC on Nov. 2. "FDA has identified additional manufacturing and stability data that are needed, and the company is assessing the FDA's response in order to determine a new timetable for filing," Merck said. Ezetimibe, a cholesterol absorption inhibitor, is approved in the fixed-dose combination Vytorin with a different statin, simvastatin (Merck's Zocor and generics), that has faced its share of controversy. The ENHANCE study found that Vytorin was no better than simvastatin alone in preventing the formation of arterial plaque, despite lowering cholesterol (1"The Pink Sheet," April 21, 2008). Other Merck attempts at expanding its cardiovascular franchise have also hit roadblocks, including the heart failure candidate rolofylline, which flunked a Phase III trial in April, and the combination of niacin with the novel anti-flushing agent laropitant, which was deemed "not approvable" in 2008 and is not expected to be refiled until at least 2013 (2"The Pink Sheet" DAILY, June 20, 2008)

R&D In Brief

Zetia/Lipitor combo NDA becomes Merck's latest cardiovascular casualty: FDA refused to file Merck's NDA for a fixed-dose combination pill of ezetimibe (Merck's Zetia) and atorvastatin (Pfizer's Lipitor) known as MK-0653C, the drug maker revealed in a filing with the SEC on Nov. 2. "FDA has identified additional manufacturing and stability data that are needed, and the company is assessing the FDA's response in order to determine a new timetable for filing," Merck said. Ezetimibe, a cholesterol absorption inhibitor, is approved in the fixed-dose combination Vytorin with a different statin, simvastatin (Merck's Zocor and generics), that has faced its share of controversy. The ENHANCE study found that Vytorin was no better than simvastatin alone in preventing the formation of arterial plaque, despite lowering cholesterol (1"The Pink Sheet," April 21, 2008). Other Merck attempts at expanding its cardiovascular franchise have also hit roadblocks, including the heart failure candidate rolofylline, which flunked a Phase III trial in April, and the combination of niacin with the novel anti-flushing agent laropitant, which was deemed "not approvable" in 2008 and is not expected to be refiled until at least 2013 (2"The Pink Sheet" DAILY, June 20, 2008)

Phase III for Affymax's ESA Hematide to finish by year-end

Phase III trials of Affymax/Takeda's erythropoiesis-stimulating agent Hematide will wrap-up by year-end, Affymax announced Sept. 9. The 400 clinical trial sites will complete treatment of patients by the end of 2009, a timeline allowed due to the firms securing of $42 million in private and public financing in February (1"The Pink Sheet" DAILY, Feb. 17, 2009). The Phase III program includes 2,600 chronic renal failure patients enrolled in four open-label non-inferiority trials. Two of the trials are in patients on dialysis, and are evaluating Hematide's ability to maintain hemoglobin levels in the target range when patients are switched from epoetin alfa or epoetin beta. The other two trials are in patients not on dialysis, and are comparing Hematide to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time. The controversy over safety problems with ESAs for chemotherapy-induced anemia caused the firms to suspend development last year of Hematide for that population (2"The Pink Sheet" DAILY, Aug. 29, 2008). The companies expect to report top-line results and file the NDA in 2010

Related Content

Topics

UsernamePublicRestriction

Register

PS068997

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel