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

In Brief: Alpha Therapeutic's AlphaNineSD

Executive Summary

Alpha Therapeutic's AlphaNineSD: Solvent Detergent Treated/Virus Filtered Factor IX product for prevention and control of bleeding in Hemophilia B patients approved by FDA June 7, the Los Angeles-based company announced July 11. The product is the first plasma-derived coagulation factor concentrate to incorporate more than one method of viral reduction, the company says. Previously AlphaNine was only solvent detergent treated. The new Factor IX now also includes a nanofiltration process for removing viruses. The two processes together reduce HIV-1 by 12 logs, HIV-2 by 6 logs, non-lipid-enveloped agents by 4 logs and markers for hepatitis B and C by 5 logs, Alpha Therapeutic notes. The new version of AlphaNine will be available in July. Alpha Therapeutic announced in March that is also has implemented additional product lot testing of the final product container as another safety step. Alpha Therapeutics sold 80 mil. units of AlphaNine last year..

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1132098

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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