IPC's lead products in the generic, controlled-release pharmaceutical category are Dexmethylphenidate XR (dexmethylphenidate hydrochloride), a generic version of Focalin XR, which is an extended-release capsule for the treatment of Attention Deficit Hyperactivity Disorder, and Carvedilol CR (carvedilol phosphate), a generic version of Coreg CR
, which is an extended release capsule for the treatment of high blood pressure.
will utilize Flamel's proprietary Micropump[R] technology, which controls the delivery of carvedilol helping to maintain appropriate amounts of medicine in the body over a 24-hour span.
Product sales and services during the fourth quarter of 2011, related primarily to production of Coreg CR
microparticles, were $4.
The availability of once-a-day COREG CR
eases the pill burden for patients who previously had to take Coreg(R) (carvedilol) twice-a-day.
will be available in four dosage strengths: 10 mg, 20 mg, 40 mg and 80 mg.
Completion of new supply agreement with GlaxoSmithKline (NYSE: GSK) for the production of Coreg CR
was developed with Micropump(R) technology by Flamel Technologies and is designed to control dissolution and absorption of carvedilol in the body, allowing for once-a-day dosing.
Micropump is the intellectual platform licensed by GlaxoSmithKline for the development of Coreg CR
Data presented at this week's American College of Cardiology 55th Annual Scientific Session show that COREG CR
was superior to placebo in reducing blood pressure over the full 24-hour dosing interval.
Product sales and services, relating to the supply of Coreg CR
which the Company has continued to furnish to GSK while a new supply arrangement is being negotiated, were $1.
Flamel also announced today that it has received a Paragraph IV certification letter from Lupin Pharmaceuticals with respect to Coreg CR
[R] and the Flamel patent listed in the Orange Book regarding the use of the Micropump platform for Coreg CR
that it has licensed to Glaxo SmithKline (GSK).
Flamel and GSK are in negotiations for a new supply agreement for Coreg CR
following the expiration of the old supply agreement on December 31, 2010; Flamel expects that these will be successful.
Flamel Receives FDA Response Letter Regarding Coreg CR
Other revenues in the first quarter, consisting primarily of royalty revenues from GSK related to sales of Coreg CR
, were $2.
The increase was led by higher license and research revenue as well as product sales and services, offset by lower Coreg CR