Under the deal, Sandor will oversee the Caldolor regulatory activities and advance distribution and sales operations in the territory.
Sandor Medicaids will make upfront and milestone payments, a transfer price and sales based royalties of Caldolor to Cumberland.
for the commercialization of Caldolor in Australia and New Zealand, and DB Pharm Korea Co.
According to the terms of the agreement, Alveda Pharma will seek Canadian regulatory approval for Caldolor and, upon approval, handle ongoing regulatory requirements as well as product marketing, distribution and sales throughout Canada.
In addition to upfront and milestone payments as well as a transfer price, Cumberland will receive royalties on future sales of Caldolor.
We are pleased to partner with Phebra to make Caldolor available in Australia and New Zealand," said A.
Seventy-four percent of Caldolor treated patients became afebrile by the end of first dosing interval.
The recommended dosing for pediatric patients ages six months to twelve years of age is 10 mg/kg up to a maximum single dose of 400 mg Caldolor every four to six hours as necessary.
We are delighted to work with our partner Seqirus to bring Caldolor
into Australia, offering a new level of patient care as ibuprofen advances to IV," said A.
Patients receiving Caldolor
required less morphine and experienced fewer adverse events relative to those who received placebo.
2 million FDA fee during the first quarter associated with the submission of the Caldolor
pediatric data and request to update that product's label.
sNDA submitted and accepted for review by FDA[[/para]]
These developments include top-line results from the Company's Hepatoren Phase II study, submission of a supplemental New Drug Application (sNDA) with pediatric data for Caldolor
and initiation of patient enrollment in the Boxaban Phase II clinical trial.