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U.S. patent issued covering combination of estriol and Copaxone® for multiple sclerosis

Synthetic Biologics, Inc, a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,372,826 entitled, Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases, to the Regents of the University of California which includes claims to the use of the Company's drug candidate, Trimesta™ (oral estriol), in combination with glatiramer acetate injection (Copaxone®).

Copaxone® is the number one selling drug for multiple sclerosis with approximately $4 billion in annual sales. Currently marketed exclusively by Teva Pharmaceutical Industries Ltd., Copaxone® is expected to face generic competition as certain patent terms begin to expire in 2014.[1] Through its wholly owned subsidiary, Synthetic Biologics holds the exclusive worldwide license to U.S. Patent 8,372,826 and 6,936,599 and pending patents for multiple sclerosis and other autoimmune diseases covering the uses of its drug candidate, Trimesta™...... Read More - http://www.ms-uk.org/index.cfm/trimesta

Like I've always said, the MS world of medications is a HUGE money making industry. Just as there appears to be some relief in the cost of these very expensive drugs, the companies involved circle the wagons and protect their cash cows....and the patient continues to pay and pay and pay!

Hi Harry,

Your comments over the years about the DMDs and the companies that make and market them always make me laugh. A new DMD just approved by the FDA (I forget its name) was originally used to FUMIGATE upholstered furniture! Yuck! How these companies can recycle such compounds into DMDs is beyond me.

Big pharma will take any compound, design some poorly designed studies, pay neuros grand sums to participate in trials, and then massage the data to show weak statistical significance with outcome measures that are barely higher than placebo. Finally, marketing will take over and start paying grand sums to prescribing neuros while charging ghastly sums to patients and insurance companies, BUT rarely, if ever, do the companies, themselves, perform long-term analysis of patients taking the DMDs.

Keep 'em coming, Harry!

HappyPoet wrote:Hi Harry,

Your comments over the years about the DMDs and the companies that make and market them always make me laugh. A new DMD just approved by the FDA (I forget its name) was originally used to FUMIGATE upholstered furniture! Yuck! How these companies can recycle such compounds into DMDs is beyond me.

Big pharma will take any compound, design some poorly designed studies, pay neuros grand sums to participate in trials, and then massage the data to show weak statistical significance with outcome measures that are barely higher than placebo. Finally, marketing will take over and start paying grand sums to prescribing neuros while charging ghastly sums to patients and insurance companies, BUT rarely, if ever, do the companies, themselves, perform long-term analysis of patients taking the DMDs.

Keep 'em coming, Harry!:)

Hi Happy Poet,

Over the years of making my comments (and there have been many ) I keep on hoping that something would change within big pharma in this area but that was naive thinking!

One of the biggest sellers these days is Copaxone, a drug that didn't reach statistical significance in its first trials so Teva ran more trials, massaged the hell out of the data and just barely got the numbers they needed for FDA approval. I can remember when the Cochrane Group, an independent medical conglomerate, wrote that Copaxone was all but useless in the treatment of MS...yet here it is today at the top of the money making list!!

Some things just never change!

Harry