STRENGTH OF PHASE II DATA FOR LEAD DRUG CANDIDATE ARIKACE(TM) DRIVES CONTINUED CLINICAL EXPANSION
MONMOUTH JUNCTION, N.J., Oct. 2 /PRNewswire/ -- Transave, Inc., a biopharmaceutical company focused on developing innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, today announced that it has secured a $12.5 million venture loan from CIT Healthcare and Compass Horizon Funding Company LLC, an affiliate of Horizon Technology Finance Management LLC.
In June, Transave, Inc. reported positive Phase II data on Arikace(TM) (liposomal amikacin for inhalation) from a randomized, placebo-controlled, 15-center study conducted in Europe. The study demonstrated that Arikace, delivered once daily for 28 consecutive days using a novel inhalation device, an Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), produced a significant improvement in lung function, was well-tolerated, and had a side-effect profile comparable to placebo in the treatment of Pseudomonas aeruginosa, a lung infection common in cystic fibrosis (CF) patients. The improvement in lung function was dose-dependent and was sustained at 28 days after completion of dosing, which was day 56 of the study. The data were presented at the European Cystic Fibrosis Society Conference in Prague, Czech Republic. Cystic Fibrosis Foundation Therapeutics, the nonprofit affiliate of the Cystic Fibrosis Foundation, provided a $1.7 million award to support the development of Arikace. The Foundation is the leading organization devoted to curing and controlling cystic fibrosis.
"Our ability to close this financing in a difficult financial services environment speaks to the commitments and deep industry experience of CIT Healthcare-Life Sciences and Horizon. The potential benefits this drug may hold for patients -- as demonstrated in the recently completed Phase II study -- is very promising," said Chris Morell, senior vice president and director, of CIT Healthcare.
"This financing, in addition to a $35M Series D financing closed in March, will enable us to complete our Arikace Phase II program for the treatment of Pseudomonas infections in cystic fibrosis patients," said Tim Whitten, Transave's chief executive officer. "It also allows us to broaden the Arikace clinical trial program by initiating a Phase II clinical trial in a second area of high unmet need: bronchiectasis patients who have pseudomonas lung infections."
Based on the strength of the Arikace clinical profile to date, the company has initiated a Phase II trial to evaluate the compound for treating Pseudomonas infections in patients with non-cystic fibrosis-related bronchiectasis in Europe and India. The U.S. Food and Drug Administration (FDA) has also agreed to the company's plans to expand this trial into the United States. Bronchiectasis is the permanent widening of the bronchi (the large tubes which begin at the bottom of the trachea and branch into the lungs). Individuals with bronchiectasis are vulnerable to recurrent respiratory infections, which often have a Pseudomonas component.
Kristen Kosofsky, managing director of Horizon, noted, "Our goal at Horizon is to support the growth and success of innovative companies like Transave that develop important next-generation technologies that serve as the cornerstone for improving human health and quality of life."
About Arikace (liposomal amikacin for inhalation)
Arikace is a form of the antibiotic amikacin that is enclosed in nanocapsules of lipid called liposomes. This proprietary next-generation liposomal technology prolongs release of amikacin in the lung while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micrometers), neutrally-charged liposomes that enable biofilm penetration and are highly efficient, with very low lipid-to-drug ratio (0.65). Arikace can be effectively delivered through nebulization since the small aerosol droplet size (~3.0 micrometers) facilitates lung distribution. Arikace has been granted orphan drug status in the United States by the FDA and has received an orphan drug designation in Europe by the European Medicines Agency (EMEA) for the treatment of Pseudomonas infections in patients with CF.
About Transave, Inc.
Transave, Inc. is a biopharmaceutical company focused on the development of innovative, inhaled pharmaceuticals for the site-specific treatment of serious lung diseases. The company's major focus is on developing inhaled antibiotic therapy delivered via next-generation liposomal technology in areas of high unmet need in respiratory disease. Transave is dedicated to leveraging its advanced liposomal development and commercialization expertise, along with its intellectual property, to bring life-extending and -enhancing medicines to patients. For more information about Transave's technology and development programs, visit http://www.transaveinc.com/.
CIT is a global commercial finance company that provides financial products and advisory services to more than one million customers in over 50 countries across 30 industries. A leader in middle-market financing, CIT has more than $70 billion in managed assets and provides financial solutions for more than half of the Fortune 1000. A member of the S&P 500 and the Fortune 500, CIT maintains leading positions in asset-based, cash flow, and Small Business Administration lending, equipment leasing, vendor financing, and factoring. The CIT brand platform, Capital Redefined, articulates its value proposition of providing its customers with the relationship, intellectual, and financial capital to yield infinite possibilities. Founded in 1908, CIT is celebrating its Centennial throughout 2008. For additional information, please go to www.cit.com.
Horizon Technology Finance Management is a privately-held independent venture debt finance company that provides senior and subordinated venture debt financing solutions to venture capital-backed technology and life science companies through its affiliated investment finance company Compass Horizon Funding Company LLC. The Horizon team has provided over $2 billion in financing to more than 750 venture capital-backed technology and life science companies over a span of 20 years. Horizon provides a compelling alternative to the restrictive structures offered by banks and corporate finance companies. Horizon's team has over 150 years of collective venture and commercial lending experience and uses its extensive knowledge, expertise, and industry relationships to provide custom venture debt products and financing solutions for its customers. Horizon has offices in Farmington, CT and the San Francisco, CA area. For more information, please visit www.horizontechfinance.com.
About PARI Pharma and the Investigational eFlow Nebulizer System
Arikace is delivered by the Investigational eFlow Nebulizer System. The Investigational eFlow Nebulizer System uses eFlow Technology to enable extremely efficient aerosolization of liquid medications via a vibrating perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System is proprietary to PARI Pharma and can be optimized to specific drug formulations.
PARI Pharma focuses on the development of aerosol delivery devices and therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow technology. Online at www.PariPharma.com.
CONTACT: Jennifer Corrigan for Transave, Inc., +1-732-382-8898,
Web site: http://www.cit.com/