LCP-Tacro is being developed as a once-daily dosage tablet version of tacrolimus for the treatment of kidney transplant patients. Compared with Astellas Pharma Inc’s. Prograf, a twice-daily dosage capsule version of tacrolimus, Veloxis believes that LCP-Tacro has the following potential benefits:
Veloxis believes that physicians will have a preference for LCP-Tacro’s once-daily dosing given the potential for positive impact on compliance for patients, and based on physicians’ preference for non-generic products for molecules with a narrow therapeutic index.
No once-daily tacrolimus product is currently approved for sale in the United States. Advagraf, Astellas Pharma Inc.’s once-daily dosage form of Prograf, was approved by the EMA in mid-2007 and commercialized in the European Union and other regions. Astellas Pharma Inc. made an initial filing for regulatory approval in the United States in 2007, and in September 2012 announced that it had made a further submission in the United States in this regard. The product candidate has not been approved for sale in the United States as at the date of this annual report.
Transplant patients need to maintain a minimum level of tacrolimus in the blood in order to prevent organ rejection. On the other hand, if too much tacrolimus is administered, there is an increased risk of serious side effects such as kidney damage.
Since tacrolimus is a “narrow therapeutic index” drug, its concentration and dosing must be carefully managed, typically requiring transplant patients to visit the hospital for monitoring and dose adjustments after receiving a new organ. In Phase I, II and III clinical studies, LCP-Tacro has demonstrated improved and higher bioavailability when compared with Prograf.
LCP-Tacro is formulated using Veloxis’ MeltDose technology, and through this technology Veloxis has aimed to optimize the delivery kinetics of LCP-Tacro to provide “flat” pharmacokinetics, reducing the peak concentrations associated with standard tacrolimus formulations. The benefits of these flatter, less variable blood levels may potentially include a reduction in side effects, an improvement in efficacy and/or greater convenience to patients, including a less frequent need for dose adjustments. The development programme at Veloxis seeks to demonstrate data to support some or all of these potential benefits.
May 1, 2013
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