MONMOUTH JUNCTION, N.J. - (Business Wire) MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has acquired a portfolio of compounds for the potential treatment of respiratory syncytial virus (RSV) from ViroPharma Incorporated (Exton, PA). The lead investigational compound in the portfolio is an inhalable small molecule fusion inhibitor, now called MDT-637. This highly potent compound has demonstrated antiviral activity in preclinical studies in both prophylaxis and treatment, and was generally well tolerated in multiple adult volunteer Phase I studies. MicroDose plans to develop the newly acquired compound in dry powder format for inhalation via MicroDose’s novel dry powder inhaler (DPI). RSV is a highly contagious virus that is a major health threat to several high-risk populations and, with no effective treatments presently available, represents a major unmet medical need. RSV infects over 90% of children worldwide during the first two years of life and causes considerable morbidity and mortality in premature infants, the immuno-compromised, the elderly, and individuals with asthma and chronic obstructive pulmonary disease (COPD).
Commenting on the acquisition, Anand Gumaste, President & CEO of MicroDose said, “Earlier this year we announced that we would be expanding our mission by developing proprietary products that address large market opportunities and are enabled by our game-changing drug delivery technologies. The acquisition of ViroPharma’s portfolio is a perfect fit with this strategy, as it leverages our next generation inhaler platform as well as our experience in respiratory product development to address a large unmet need in RSV disease.”
“The unique capabilities of the MicroDose inhaler are ideal for the delivery of MDT-637 as it can realize the molecule’s broadest potential across the range of populations from pediatric to the elderly, groups not well served by today’s DPIs. The potential for both treatment and prevention across this spectrum of patients, combined with non-invasive inhaled delivery to the site of infection, could greatly expand this market,” explains Scott Fleming, MicroDose’s Sr. Vice President, Sales & Marketing.
About RSV disease
RSV is a pathogen that attacks the human respiratory tract. There are currently no treatment options approved in the U.S. for this virus among the infant, pediatric, and adult populations that are susceptible to it. The February 2009 edition of the New England Journal of Medicine stated that “RSV is associated with substantial morbidity in US children in both the inpatient and outpatient settings and..... its control is a worldwide priority.” Globally, the annual death rate from RSV is estimated at 160,000 and the clinical burden of RSV infection is comparable to that of influenza. The market opportunity for treatments addressing RSV is significant and growing. MedImmune’s monoclonal antibody, Synagis®, an intramuscular injection approved only for prophylactic use against RSV in premature infants, has annual worldwide sales in excess of $1 billion.
About MDT-637
MDT-637 is a clinical stage product that has been shown to effectively block RSV infection both in vitro and in the cotton rat, which is the accepted animal model for RSV infection. MDT-637 acts by targeting the viral fusion protein, which is the only validated target for RSV treatments. The compound is inhaled, which allows for rapid delivery to the site of virus infection, the lungs, and has been shown to be safe and well tolerated in multiple human safety trials. Results from animal studies indicate that MDT-637 could find use as both a preventative and a treatment of RSV infection. MDT-637 will be formulated for pulmonary delivery via MicroDose’s proprietary dry powder inhaler.
About MicroDose Therapeutx
MicroDose Therapeutx is a privately-held specialty 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 drug delivery platforms for the pulmonary, oral, and transdermal delivery of medications. The company develops its products and technologies independently, as well as in partnership with leading pharmaceutical companies. MicroDose’s products and platforms currently target respiratory disease states such as asthma, chronic obstructive pulmonary disease (COPD), and respiratory syncytial virus (RSV), as well as diabetes, hypertension, and hyperlipidemia. More can be found at our website; www.mdtx.com.
MicroDose Therapeutx Inc.
Scott Fleming, 732-355-2114
Senior V.P., Sales & Marketing
sfleming@mdtx.com
or
Ex Machina D x M
Judith Fleischer, 908-469-0554
jfleischer@exmachinadxm.com
