"even though [URL Pharma has] been given seven years of marketing exclusivity for the familial Mediterranean fever indication, they only were given three years on the gout indication. After that, the FDA could approve a generic colchicine for gout if someone comes forward and applies.”
That's a main reason WHY URL only got $800 million for a drug doing $400 million per year - at the moment.
Generic competition is sure to come - soon.
That can not happen with Krystexxa until at least 2026!
My point being that bashers here are trying to say that URL only got $800 million for a $400 million per year drug.
Well, it is not what it appears to be on the surface.
No exclusivity left.
No patent protection.
Huge expenses for required 17 clinical studies.
So, kentwu, who lies here, me or the SVNT bashers?
So, the market exclusivity for Colcrys is OVER. Generic competition can now come in.
And, there is no patent protection for this OLD formulation that's been around forever.
Plus, URL has to do 14 clinical studies AND had to pay $45 million to FDA for their application!!
The profit margin for Colcrys is NOT going to be over 80% and how long before some entity comes out with a generic and Colcrys' sales plummet???!
"On July 30, 2009 the FDA approved colchicine as a monotherapy for the treatment of three different indications: familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares, and gave URL Pharma a three-year marketing exclusivity agreement in exchange for URL Pharma doing 17 new studies and investing $100 million into the product, of which $45 million went to the FDA for the application fee."
17 new studies required by FDA! So, what is the profit margin left to URL???
We don't know as it has been a private company.
Colcrys, more safety issues than Krystexxa:
COLCRYS is contraindicated in patients with renal or hepatic impairment who are concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as life-threatening or fatal toxicity has been reported. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors. Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children. Myelosuppression, thrombocytopenia, and leukopenia have been reported in patients taking colchicine at therapeutic doses. Rhabdomyolysis has been occasionally observed, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk. Monitoring is recommended for patients with a history of blood dyscrasias or rhabdomyolysis. The most common adverse events in clinical trials were diarrhea and pharyngolaryngeal pain