NEWARK, CA, USA I October 1, 2014 I Revance Therapeutics, Inc. (RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the company has initiated a study to confirm this quarter the successful transfer of production of the topical RT001 drug product to Revance’s U.S. commercial manufacturing facility. Following successful confirmation of this transfer, Revance plans to initiate its first U.S. Phase 3 RT001 pivotal study for the treatment of lateral canthal (crow’s feet) lines, with results now anticipated during the first quarter of 2015. Previously, Revance expected to report results from the first U.S. Phase 3 pivotal study by the end of 2014.
“To confirm success of the production transfer, we decided to initiate an open-label clinical study using RT001 drug product made in our commercial manufacturing facility,” said Dan Browne, Revance’s President & CEO. “We believe taking the extra time to complete this short duration clinical study to confirm successful manufacturing transfer of RT001 prior to enrolling patients in our Phase 3 pivotal studies has the potential to benefit our pipeline of RT001 product candidates.”
“The recently initiated open-label study is a four-week, multi-center study of up to 60 patients. We plan to provide a clinical program update on both of our product candidates, topical RT001 and injectable RT002, during our third quarter earnings conference call in November,” added Browne.
About Revance Therapeutics, Inc.
Revance is a specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic applications. Revance is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS(R) peptide delivery system to address unmet needs in the large and growing aesthetic and therapeutic botulinum toxin market. Revance’s proprietary TransMTS(R) technology enables transcutaneous delivery of botulinum toxin A, eliminating the need for injections. Revance’s lead product candidate, RT001, is a topical formulation of botulinum toxin type A, which has the potential to be the first commercially-available non-injectable dose form. RT001 is being evaluated in a broad clinical program that includes aesthetic indications such as crow’s feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating) and migraine headache. Revance’s second product candidate is RT002, a novel injectable formulation of botulinum toxin type A designed to be more targeted and longer lasting than currently available botulinum toxin injectable products.
SOURCE: Revance Therapeutics
Post Views: 135
NEWARK, CA, USA I October 1, 2014 I Revance Therapeutics, Inc. (RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the company has initiated a study to confirm this quarter the successful transfer of production of the topical RT001 drug product to Revance’s U.S. commercial manufacturing facility. Following successful confirmation of this transfer, Revance plans to initiate its first U.S. Phase 3 RT001 pivotal study for the treatment of lateral canthal (crow’s feet) lines, with results now anticipated during the first quarter of 2015. Previously, Revance expected to report results from the first U.S. Phase 3 pivotal study by the end of 2014.
“To confirm success of the production transfer, we decided to initiate an open-label clinical study using RT001 drug product made in our commercial manufacturing facility,” said Dan Browne, Revance’s President & CEO. “We believe taking the extra time to complete this short duration clinical study to confirm successful manufacturing transfer of RT001 prior to enrolling patients in our Phase 3 pivotal studies has the potential to benefit our pipeline of RT001 product candidates.”
“The recently initiated open-label study is a four-week, multi-center study of up to 60 patients. We plan to provide a clinical program update on both of our product candidates, topical RT001 and injectable RT002, during our third quarter earnings conference call in November,” added Browne.
About Revance Therapeutics, Inc.
Revance is a specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic applications. Revance is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS(R) peptide delivery system to address unmet needs in the large and growing aesthetic and therapeutic botulinum toxin market. Revance’s proprietary TransMTS(R) technology enables transcutaneous delivery of botulinum toxin A, eliminating the need for injections. Revance’s lead product candidate, RT001, is a topical formulation of botulinum toxin type A, which has the potential to be the first commercially-available non-injectable dose form. RT001 is being evaluated in a broad clinical program that includes aesthetic indications such as crow’s feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating) and migraine headache. Revance’s second product candidate is RT002, a novel injectable formulation of botulinum toxin type A designed to be more targeted and longer lasting than currently available botulinum toxin injectable products.
SOURCE: Revance Therapeutics
Post Views: 135