Oso Biopharmaceuticals Manufacturing, LLC has purchased the Albuquerque, NM-based sterile injectables manufacturing business of Catalent Pharma Solutions. Terms of the transaction were not disclosed.
   
The unit provides cGMP glass vial filling and lyophilization services for injectable drugs and biologics for both commercial and clinical projects. Oso Biopharmaceuticals will retain all employees associated with the business and continue to serve existing the unit's customers in North America and Europe.
   
Dr. Stuart Rose, chief executive officer and president of Oso Biopharmaceuticals, said, “We are delighted to have been successful in acquiring Catalent's sterile injectables business based in Albuquerque. It fits exceedingly well with our strategy to build a world class, high quality contract manufacturing company. We will work tirelessly with the talent pool in Albuquerque to meet the highest demands and expectations of our global customer base.”
   
Richard Yarwood, group president of sterile technologies for Catalent, said, “We are pleased to have completed this planned step in the evolution of our Sterile Technologies business. We are also pleased that Oso Biopharmaceuticals has acquired this business, as we expect they will continue to provide the facility’s customers the high degree of quality and compliance they have received in the past. We also appreciate the commitment Oso Biopharmaceuticals has demonstrated to the future of the business, and to the dedicated employees at the site.”

Dr. Bernard Tisserand and Dr. Jonny L. Salyer have been named executive medical directors for respiratory disorders and metabolic disorders, respectively, MDS Pharma Services.
   
"Pharmaceutical companies are pursuing clinical research programs to address these disorders, and we have made a strategic decision to become a leader in these key therapeutic arenas by establishing dedicated teams headed by experienced medical professionals," said MDS Pharma Services President David Spaight. "In the past 10 years, MDS Pharma Services has managed more than 150 clinical projects involving respiratory conditions and metabolic disorders. With expert project teams in Africa, Asia Pacific, Europe, Latin America and North America, we can offer our clients worldwide access to patients with these conditions."
   
Dr. Tisserand has held a number of senior positions in clinical operations and project management at MDS Pharma Services. In his earlier roles, he managed teams of project directors, project leaders and clinical research associates supporting studies in asthma, allergic rhinitis, COPD, CAP and other major therapeutic areas. He has been with the company for 18 years.
   
Dr. Salyer has 30 years of relevant experience in research, medicine and the contract research industry. Prior to joining the company, she worked for a leading provider of central lab services in Indianapolis, where she served as director of medical affairs since 2001, supporting Phase I-IV clinical research.  

KAI Pharmaceuticals has initiated enrollment in a Phase I study of KAI-1678, a first-in-class, isozyme-selective inhibitor of the epsilon protein kinase C pathway. KAI-1678 has been shown to be highly effective at reducing pain responses in a wide variety of preclinical pain models.
   
“Epsilon PKC has been shown to have an important role in both inflammatory and neuropathic pain. KAI-1678 is the first clinical-stage compound that is a specific inhibitor of epsilon PKC,” commented Gregory Bell, senior vice president of development and chief medical officer. “Current therapies for the management of pain, such as opioids and nonsteroidal anti-inflammatory drugs (NSAID), can be limited by side effects and inadequate efficacy. There is a need for novel therapeutics with unique mechanisms of action that provide effective pain relief with reduced side effects.”
   
The randomized, double-blind, placebo-controlled, rising dose study will evaluate the safety, tolerability and pharmacokinetics of KAI-1678 in healthy males. The study will enroll five cohorts and is expected to complete this quarter.  

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