Valeritas FDA 510(k) Clearance for the V-Go™ Disposable Insulin Delivery Device

December 8, 2010 - V-Go provides Type 2 diabetic patients a simple option for basal-bolus insulin therapy - Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced that the US Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).

"The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind," said Valeritas CEO Kristine Peterson. "We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control." ... Valeritas' Press Release -

Merck to Acquire SmartCells, Inc.

Dec. 2, 2010 - Merck & Co., Inc., (NYSE:MRK) and SmartCells, Inc., announced that they have entered into a definitive agreement under which Merck will acquire SmartCells, a private company developing a glucose responsive insulin formulation for the treatment of diabetes mellitus.

"Maintaining control of blood glucose levels represents a daily challenge for people living with diabetes," said Nancy Thornberry, senior vice president and head, diabetes and obesity franchise, Merck Research Laboratories. "Through the acquisition of SmartCells we have obtained innovative technology that may enable us to develop glucose-responsive insulins. If this investigational technology is ultimately approved for use with patients, it could provide an important new therapy for the treatment of diabetes. This holds the potential to significantly impact the treatment of this disease."

Under the terms of the agreement, Merck will acquire all outstanding stock of SmartCells, Inc. In return SmartCells shareholders will receive an upfront cash payment and be eligible to receive clinical development and regulatory milestones for products resulting from the transaction for potential aggregate payments in excess of $500 million. Sales-based payments for products resulting from the transaction will also be payable. SmartCells' board of directors has unanimously approved the transaction... Merck & Co's Press Release -