WYTHEVILLE, Va. and TIVERTON, R.I., June 26 /PRNewswire/ -- Wythe Therapeutics, Inc. (Wythe) and VeroScience LLC (Vero) announced today the completion of the worldwide exclusive license for the manufacture, marketing and distribution of Cycloset(R) from Vero to Wythe. Vero is seeking approval to market Cycloset(R), a patented novel oral formulation of bromocriptine mesylate, for the treatment of Type-2 Diabetes.
Charles P. Sutphin, CEO of Wythe, said, “We are extremely excited to work with Vero to bring this unique and important therapy to market. If approved, Cycloset(R) will be a ‘First in Class’ compound in the treatment of Type II Diabetes utilizing a CNS mode of action. Type 2 Diabetes currently affects over 20 million Americans, and the number of affected individuals is growing over 5% annually. Wythe believes Cycloset(R) will provide patients and doctors a new and additive weapon in the treatment of this devastating disease, which is nearing pandemic proportions.”
Mr. Sutphin continued, “In the coming months, while Vero is managing the completion of the Cycloset(R) phase III b safety trial, Wythe’s responsibility will be focused on preparing for the commercialization of Cycloset(R) in the United States and Canada. We intend to explore various public and private financing opportunities to launch and manage the commercialization of Cycloset(R). Additionally, it is our intention to consider a sound commercial partner to assist in launching the drug in both the endocrinology and FP/GP market sectors. Wythe also intends to seek strategic partnerships for international commercialization, as we have no current plans to establish a worldwide infrastructure.”
Brian G. Shrader, President of Wythe, said, “It is truly a privilege for us to work with Dr. Cincotta and Vero to bring to market what we believe can be a new paradigm in the treatment and management of diabetes. Dr. Cincotta is a pioneer in the development of therapies for the treatment and management of diabetes via the central nervous system, and we are excited that Vero chose us as a partner to assist in making Cycloset(R) available to millions of patients.”
Anthony Cincotta, President of Vero said, “The executives at Wythe are well seasoned pharmaceutical professionals with a proven track record of success in marketing novel approaches to treat cardiovascular related disorders. They have the right skill sets, background, vantage point, and mindset to bring a novel therapy like Cycloset(R) to the medical community.”
About Cycloset(R)
Cycloset(R) is not yet approved for use by the Food and Drug Administration [or Health Canada]. Cycloset(R) is believed to act within the central nervous system principally as a direct dopamine agonist to reset neural pathways controlling peripheral metabolism. Results of published clinical studies of varying designs and patient populations suggest that treatment with Cycloset(R) may improve hyperglycemia, glucose intolerance hyperlipidemia, or aspects of insulin resistance, while maintaining body fat neutrality or inducing fat reduction.
Cycloset(R) use for the treatment of Type 2 Diabetes has been studied in several Phase II and three Phase III studies. An NDA for the drug’s use in the treatment of Type 2 Diabetes has received an approvable letter setting out what remaining data are required for approval. Among the considerations raised by FDA, the approvable letter primarily required a large, simple safety trial, which Vero is currently conducting and Wythe is funding. The study is a randomized, double blind, placebo controlled trial in 3,000 subjects with Type 2 Diabetes. The study is fully enrolled and completion is expected by the end of 2006. Vero is also conducting a clinical study to determine the effectiveness of Cycloset as add-on therapy in type 2 diabetes subjects whose blood sugar is not adequately controlled on Metformin therapy. Vero expects to file an amended Cycloset(R) NDA (a complete response to the approvable letter) in the first half of 2007. Cycloset(R) and its use to treat Type 2 Diabetes are claimed within several patents and patent applications (United States and world region), including patents that are eligible for listing in the Orange Book and that expire in 2014, and may be extended into 2015 if pediatric exclusivity is obtained.
About Wythe Therapeutics, Inc.
Wythe is a privately held specialty pharmaceutical company, headquartered in Bristol, Tennessee and with offices in Wytheville, Virginia. Wythe seeks opportunities in the pharmaceutical industry through in-licensing arrangements, co-promotions, and acquisitions, of novel branded prescription pharmaceutical products.
About VeroScience, LLC
VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, Rhode Island. VeroScience has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabolism, immunology, reproduction, and oncology. VeroScience leverages its intellectual property and products in out-licensing and collaborative arrangements with appropriate industry partners.
Wythe Therapeutics, Inc.
CONTACT: Brian G. Shrader, President, or Charles P. Sutphin, CEO of WytheTherapeutics, Inc., +1-866-764-1923; or Anthony H. Cincotta, PhD, ofVeroScience LLC, +1-401-816-0525
