Rosa and FOCUS-IP Announce Strategic Alliance for Enhancing Proof-of-Concept Drug Development and Licensing Opportunities

SAN CARLOS, CA, May 05, 2011 (Press-News.org) Rosa & Co. LLC (www.rosaandco.com) today announced that it has formed a strategic scientific alliance with FOCUS-IP (www.focus-ip.de), a leading EU-based drug development advisory firm. FOCUS-IP sources novel new drug candidates from European academic research centers and emerging biotechnology companies, leads the exploratory development of these compounds from preclinical through proof-of-concept studies, and forms early-stage strategic development partnerships with established global pharmaceutical organizations. The Rosa-FOCUS-IP alliance will strengthen FOCUS-IP's innovative exploratory development programs and candidate licensing evaluations with the systematic use of Rosa's best-in-class in silico drug-disease modeling & simulation (M&S) capabilities.

"The strategic alliance between Rosa and Focus-IP will allow us to bring best-in-class technology to the management of our clients' exploratory development programs" said Wolfgang Greb, MD, Ph.D., Managing Director and Co-Founder of Focus-IP. "In silico modeling & simulation is a proven scientific method that can leverage early in vitro and in vivo data towards predictions of human exposure, safety, and efficacy. It broadens our understanding of novel mechanisms and highlights implications for dosing and patient selection in exploratory clinical trials, and supports claims of a drug's value in communications with regulators or partners. Together, we can deliver greater scientific insight and more predictive and reliable proof-of-concept data for our clients."

The new partnership will provide clients of both companies access to a synergistic combination of value-driven exploratory study design, a global licensing and deal-flow network, and extensive in silico M&S expertise. The allied companies also bring extensive clinical expertise in a wide variety of disease areas, including oncology, immune dysfunctions, respiratory disorders, inflammation, metabolic disorders, antiinfectives/antivirals, and CNS disorders that comprise both neurological and neurodegenerative diseases.

Emerging companies benefit from this alliance by designing more informative exploratory studies and by gaining a deeper understanding of their novel drug candidates, especially with respect to their mechanisms of action. This will allow emerging companies to make better decisions for and reduce the risk in future trials when choosing such critical parameters as dose levels, dose regimens, endpoints, measurement times, and patient selection criteria. This ability will substantially increase the value of an emerging company's portfolio of assets. In addition, the combined capabilities of Rosa and FOCUS-IP can be delivered to emerging companies through pre-arranged co-development agreements with established pharmaceutical manufacturers via FOCUS-IP's global network of licensing partners.

Established biopharmaceutical clients benefit from the alliance by gaining access to a steady stream of innovative product candidates that match pre-defined competitive product profiles and specified patient populations. The known efficacy and safety profiles of each candidate are precisely-characterized by their M&S package, thus reducing risk in each licensing transaction and streamlining the subsequent development program.

"This alliance is a powerful extension of our current strategic collaborations with both emerging and established bio-pharmaceutical clients," said Ron Beaver, Ph.D., CEO and Founder of Rosa. "It allows emerging companies to use M&S in a more systematic manner, earlier in the discovery and development process, to enhance the value of their assets. And it directly addresses the essential strategic challenge of established companies - improving the quantity and quality of candidates entering their clinical development pipeline."

About Rosa
Rosa informs our customer's most critical decisions - from preclinical through clinical development - with the creation and use of mathematical models that simulate disease physiology, drug action, patient variability, and trial outcomes. To address the full spectrum of related issues, Rosa offers two customized approaches: classic pharmacokinetic/ pharmacodynamic (PK/PD) models and Rosa's innovative PhysioPD models. With these approaches, Rosa's clients collaborate in model creation and testing, retain the final model, and acquire the ability to use it and understand its implications for their drug development programs.

Rosa's staff have unparalleled experience in drug-disease modeling and simulation (M&S) in drug development, spanning hundreds of applications and dozens of clients over close to two decades of professional experience. Rosa is unique in their breadth and depth of disease area experience, including metabolic and cardiovascular diseases, oncology, gastro-intestinal disease, inflammatory diseases, immune dysfunction (including rheumatoid arthritis), pain, skin conditions, respiratory, and antibacterials/parasitals/virals. For more information, visit http://www.rosaandco.com.

About FOCUS-IP
FOCUS-IP was founded as a sister company of the well-known European early drug development company /CRO FOCUS Clinical Drug Development. Focus-IP leverages the experience gained over more than 20 years of working at the interface of drug discovery and drug development.

As an experienced consulting firm, we advise academic inventors and biotechs how to best generate strategic value for their drug candidates. We assess and design single individual projects, and we perform early pipeline reviews. The FOCUS-IP team possesses deep clinical pharmacology R&D understanding of novel product needs, which allows us to recognize promising innovations and advise clients as a "thought-partner" in the development process. We perform pipeline gap analysis, and provide new ideas in drug discovery projects. This results in reducing the risk and increasing the value of a drug candidate, and thus, provides higher out-licensing potential. For new technology companies, we design and perform landmark (proof-of-concept) projects to demonstrate commercialization feasibility. We also offer the option of supporting clients with FOCUS IP's value-driven project management and co-development option arrangements with established pharmaceutical companies.

Both academic and emerging business clients benefit from the fact that Focus-IP has contacts with established pharmaceutical manufacturers that strategically prefer to explore novel product opportunities in the very early stages of development; these companies are highly interested in efficient access to excellent academic research on molecules with product potential. FOCUS-IP explores the drug potential of a compound and the feasibility of bringing it to market (its "developability"). This clear definition of product potential at an early stage benefits both sides of the licensing transaction.