FOSTER CITY, Calif. & MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and MicroDose Therapeutx, Inc. today announced that the companies have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of MDT-637, MicroDose’s inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV).
Under the terms of the agreement, Gilead will pay MicroDose an upfront payment and provide research funding to support MicroDose’s continued development of MDT-637 through Phase IIa clinical trials. Gilead can assume full responsibility for clinical development following Phase IIa. MicroDose also could receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as development fees and royalties on future potential net sales.
MDT-637 is a fusion inhibitor that has been shown to block RSV infection in preclinical testing. The product is formulated for pulmonary delivery via MicroDose’s proprietary dry powder inhaler, which allows for rapid delivery to the site of infection (in the respiratory tract). MicroDose plans to file the Investigational New Drug (IND) reactivation with the U.S. Food and Drug Administration (FDA) and to initiate a Phase I study this year with MDT-637.
“This strategic collaboration is a significant milestone in MicroDose’s vision to develop first-in-class therapies for major unmet medical needs,” said Anand Gumaste, President and CEO of MicroDose. “Given Gilead’s scientific and clinical expertise in virology, this partnership provides a strong validation of the potential for MDT-637 to become an important therapeutic advance for those affected by RSV infection.”
“There is an urgent need to improve upon RSV treatment and care,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We believe this program aligns well with our expertise in both antiviral and respiratory drug development and we look forward to working with the MicroDose team to advance MDT-637 into clinical testing.”
RSV is a pathogen that infects the human respiratory tract, potentially leading to infections such as bronchiolitis and pneumonia. While most otherwise healthy people recover from the virus within a few weeks, the Centers for Disease Control and Prevention (CDC) estimates that up to 125,000 infants are hospitalized due to RSV infection in the United States each year. There is an increased risk of severe disease in premature infants, the immune-compromised, individuals with chronic obstructive pulmonary disease (COPD) and asthma, and the elderly. Globally, the annual death rate from RSV is estimated at more than 160,000 and the clinical burden of RSV infection is comparable to that of influenza.
About MicroDose Therapeutx
MicroDose Therapeutx is a private pharmaceutical company dedicated to improving the quality of life for people suffering from serious diseases. The company focuses on developing proprietary products that address large unmet market opportunities, and on pulmonary and oral drug delivery platforms. The company develops its products and technologies independently, as well as in partnership with leading pharmaceutical companies. MicroDose’s current pipeline targets respiratory diseases such as asthma, COPD and RSV, as well as IBS-C and constipation. For more information, visit www.mdtx.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Gilead Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to the development of MDT-637 for RSV infection and MicroDose’s ability to file the IND reactivation and initiate a Phase I study with MDT-637 as currently contemplated. Further, there are risks related to MicoDose’s ability to enroll patients in such a study, the possibility of unfavorable results of the study, the need to modify or delay the study or to perform additional trials and the risk of failing to obtain approvals from the regulatory authorities. As a result, MDT-637 may never be successfully commercialized. In addition, Gilead and MicroDose may make a strategic decision to discontinue development of MDT-637. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2010, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).
Susan Hubbard, 650-522-5715
Nathan Kaiser, 650-522-1853
Scott Fleming, 732-355-2114
KEYWORDS: United States North America California New Jersey
INDUSTRY KEYWORDS: Health Biotechnology Hospitals Infectious Diseases Pharmaceutical General Health