I guess BG-12/BIOGEN is not a straight way to success ;D " In addition to Tysabri and Gilenya, Teva is aware of at least one investigational MS drug currently under FDA review that may be associated with other serious safety risks. In particular, Biogen recently posted some troubling information about the safety and effectiveness of Panoplin (dimethyl fumarate) capsules, also known as BG-12, on a publicly accessible website. In addition to constituting unlawful, pre-approval promotion of an unapproved drug product, the website contained animal toxicology data suggesting that dimethyl fumarate ("DMF"), the active ingredient in BG-12, may carry potential risks for renal adverse events. The website stated: Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys. Renal tubule epithelia regeneration, suggestive of tubule epithelial injury, was observed in all species. Renal tubular hyperplasia was observed in rats with life time dosing (2 year study). Cortical atrophy was observed in dogs and monkeys, and in monkeys, single cell necrosis and interstitial fibroses were observed in animals that received daily oral doses of dimethyl fumarate for 12 months at six times the RHD based on AUC. Although the website also stated that "[t]he relevance of these findings to humans is not known[,]" the fact that renal toxicity was seen across all species studied is concerning and suggests that there is a substantial probability the risk is applicable to humans as well. references: 43 Panoplin Website Screenshots (Exhibit 7) (accessed December 6, 2012). The website for Panoplin is active and publicly available at http ://warden.7te.net/index.html . Although it was revised in mid-December to refer to "Product X," it currently contains detailed product information about Panoplin as a "new" and "approved" oral MS medicine in direct contravention of FDA's pre-approval promotion restrictions. 44 Panoplin Website Screenshots (Exhibit 7). 45 Recent scientific evidence also suggests that DMF may be associated with PML and KS . In clinical trials, BG-12 therapy resulted in substantial declines in white blood cell and lymphocyte counts, and grade 3 or higher lymphopenia (lymphocyte counts ofless than 0.5x 109 per liter) was seen in between 4% and 5% of patients in the BG-12 groups versus less than 1% in the placebo groups. Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis, New England Journal of Medicine, 367:12, pp. 1087-1097 (Sept. 20, 2012); Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis, New England Journal of Medicine, 367:12, pp. 1098-1107 (Sept. 20, 2012). Although there were no reported cases of PML or KS in the pivotal clinical trials for BG-12, at least three cases ofPML and one case ofKS have been reported in patients treated with Fumaderm.
So what. Biogen will sell the hell out of this drug just like the two they have now that are dangerous not we'll tolerated and not nearly as effective as they want you to believe. They will do it just as before with lies and payoffs.Y
Why speculate on how animal renal events may effect humans in BG-12 when you already have the answer? It was published in DEFINE and CONFIRM this fall in The New England Journal of Medicine (the most credible journal in the world) with its use in over 2000 HUMANS. BG-12 will be another great option for patients in spite of Teva's fear mongering
Immunosuppressive BG-12 risks might take time to surface. The animal data is not very comforting and I guess the most likely approval/market introduction will be hurt by the concerns this and other worrying indications induce. Don't you think?
Until MS patients start dying from severe infections and the comment from you guys will be "so what, it's only a little collateral damage!" Just up the honorariums.
Minds in neuroimmunology, a hell of alot smarter than you ever wished you were, will review the NDA and render their decision. Their intellect is why they are experts in neuroimmunology and you are picking up take out at Olive Garden at lunchtime and delivering your canned 'messages". Now go & enter your "calls" for the week.
Yesirreee.....the same "minds" that reviewed Tysabri and said it was safe...well, that is until PML showed up!! Then it wasn't so safe.
As a MS patient myself I worry about the quick acceptance of this drug. I have been on my current therapy for 10 years with very little issues and will continue until I start to relapse. I fear that to many physicians and patients are going to experience less than favorable side effects and be forced to switch therapies again. Only time will tell and I hope my gut feelings are wrong but we have seen this company fail to be honest to many times in the past.
Biogen?? No, you can't be referring to the company that told us Tysabri was safe at the beginning! Don't for one second believe that Biogen will tell MS patients and the docs about any of the bad sides of BG-12. They will spin the benefits of this drug to make the FDA and most others believe it will be great for MS. And nobody is better at spinning than Biogen. When the truth starts to leak out, the honorariums start to go up
This isn't new information. These are old cases. Keep bashing your competitor's products. I understand it is your last resort. It won't work, but keep trying.
