AfrezzaTreatment for Diabetes Type 1, Diabetes Type 2
Update: Afrezza (insulin human) Now FDA Approved - June 27, 2014
Emisphere Technologies Receives Milestone Payment from MannKind Corporation
CEDAR KNOLLS, N.J.--(BUSINESS WIRE)--May 21, 2009 - Emisphere Technologies, Inc. today announced that it has received a $500,000 milestone payment from MannKind Corporation in connection with MannKind's recent filing and the U.S. Food & Drug Administration's (FDA's) acceptance of MannKind's New Drug Application for Afresa, an ultra rapid-acting insulin.
In February 2008, Emisphere sold to MannKind certain Emisphere patents and a patent application relating to diketopiperazine technology for a total purchase price of $2.5 million. An initial payment of $1.5 million was received in February 2008. An additional $500,000, now received, was to be paid no later than July 5, 2009. The remaining $500,000 is due to be paid to Emisphere no later than October 5, 2010.
MannKind is seeking FDA approval of Afresa for the treatment of adults with Type 1 or Type 2 Diabetes mellitus for the control of hyperglycemia.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of therapeutic molecules or nutritional supplements using its Eligen® Technology. These molecules and compounds could be currently available or in development. Such molecules are usually delivered by injection; in many cases, their benefits are limited due to poor bioavailability, slow on-set of action or variable absorption. The Eligen® Technology can be applied to the oral route of administration as well other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. The company's website is: www.emisphere.com.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, Emisphere's ability to fund such efforts with or without partners, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 000-17758) filed on March 16, 2009.
Contact: Emisphere Technologies, Inc.
Michael R. Garone, 973-532-8005
Chief Financial Officer
Rx Communications Group:
Eric Goldman, 917-322-2563
Paula Schwartz, 917-322-2216
Posted: May 2009
- FDA Approves Afrezza to Treat Diabetes - June 27, 2014
- MannKind Updates Status of New Drug Application for Afrezza - April 7, 2014
- FDA Advisory Committee Recommends Approval of Afrezza - Investigational Drug to Treat Diabetes - April 2, 2014
- MannKind Resubmits New Drug Application to U.S. FDA for Afrezza for the Treatment of Adults with Diabetes - October 14, 2013
- MannKind Reports Positive Data from a Phase 3 Clinical Study of Afrezza in Patients with Type 1 Diabetes - August 14, 2013
- MannKind Confirms Design of Pivotal Studies for Afrezza - August 12, 2011
- MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza - January 20, 2011
- MannKind Updates Status of New Drug Application for Afrezza - December 28, 2010
- FDA Accepts Afrezza Complete Response Resubmission and Sets Target Action Date - July 20, 2010
- FDA Requests Additional Information Regarding Afrezza in Complete Response Letter to MannKind - March 15, 2010
- MannKind Updates Status of Afrezza New Drug Application - January 13, 2010
- MannKind Submits NDA for Afresa for Treatment of Diabetes - March 16, 2009