Pharma
Tysabri has been back on the market for 2 years now. A whopping 17,800 people are taking it in the US, with 13,400 more world-wide. No new cases of confirmed PML have been seen, but only 6,600 people have been on Tysabri for more than 18 months.
So far, so good!
Oh wait, that's only good news for shareholders. Guess we shouldn't get our good news from financial reporters.
Anyway, enjoy the snazzy new higher prices on Avonex, Tysabri, Rebif, etc.
Some of this article is a bit difficult to follow, and money is probably a major motivator behind ProNeuron’s accusations that Teva has sabotaged clinical trials. But ProNeuron claims it has evidence that lower doses of COP-1, the active ingredient in Copaxone, may be effective for some neurodegenerative diseases, and it suggests that this might have implications for MS users of Copaxone. ProNeuron claims that Teva has not pursued this because they want to reap the benefits of having patients inject Copaxone daily.
Between currents studies of double dose Copaxone and this article, it sounds like the story about the most effective dosage for Copaxone is far from over. It would be worth tracking this law suite to see if the claims are indeed true.
Maybe I was asleep at the wheel, but I think this is the first time I've seen the drug BioMS is developing referred to by anything other than MBP8298. Apparently, it is called 'dirucotide' now.
Compared with placebo, treatment with laquinimod 0.6 mg per day showed a 40.4% reduction of the baseline adjusted mean cumulative number of Gd+ lesions per scan on the last four scans; treatment with 0.3 mg per day showed no significant effects (3.9 [5.5] vs placebo, p=0.6740). Both doses of laquinimod were well tolerated, with some transient and dose-dependent increases in liver enzymes.
Bayhill Therapeutics is working on an MS "vaccine." They recently withdrew their IPO, claiming the market is not favorable. No mention of what effect this would have on drug development.
Teva Pharmaceuticals said its multiple sclerosis drug met goals of a mid-stage trial, and the company will conduct further research before advancing to Phase III trials.
The drug, ATL/TV1102, is being developed by Israel's Teva and Australia's Antisense Therapeutics. In a study of 77 patients in six European countries, the drug was shown to reduce the number of new brain lesions by 54.4 percent after eight weeks, compared with placebo.
ATL/TV1102, initially discovered by Isis Pharmaceuticals Inc. and then licensed to Antisense Therapeutics, is known as an antisense drug as it targets disease-causing proteins, preventing them from functioning.
Peptimmune, Inc. announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases.
Not a lot of detail in this announcement, but Bionomics is developing a new generation of treatments for inflammatory disorders, based upon blockers of the Kv1.3 potassium ion channel and Merck is licensing them to treat diseases including MS. A bit more science info here.
Yet another MS drug candidate to watch out for.
BaroFold Inc. announced that it has initiated a two-stage Phase 1, repeat dosing, single-center, double-blinded study in up to sixty healthy volunteers to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of BaroFeron(TM) (IFN beta-1b).
It will be interesting to see if this improves the effects of the drug on MS. Once they test in people with MS, that is.

