I added some to my IDEV stake this morning - I now have a medium position. The company is historically snakebit, but given trospium is a widely used drug in Europe I expect the FDA to play nice and give them an approvable letter at the end of May.
Trospium is a good drug for urge incontinence with fewer side effects than other anticholinergics - only drawback compared with existing drugs is 2x daily.
Unlike oxybutynin it doesn't cross the blood brain barrier. (Oxybutynin and similar drugs apparently have cognitive side effects in some elderly patients). The NEJM had a review of treatments earlier this year - graded four drugs as 1/A - oxybutynin, propiverine (not available in the US), tolterodine and trospium.
Here's an abstract cited in the NEJM article:
>> Br J Urol. 1995 Apr;75(4):452-6. Related Articles, Links
Trospium chloride versus oxybutynin: a randomized, double-blind, multicentre trial in the treatment of detrusor hyper-reflexia.
Madersbacher H, Stohrer M, Richter R, Burgdorfer H, Hachen HJ, Murtz G.
Rehab-Centre, Bad Haring, Austria.
OBJECTIVE: To compare trospium chloride (TCl), a quaternary ammonium derivative with atropine-like effects and predominantly antispasmodic activity, with oxybutynin (Oxy) in terms of efficacy and adverse effects.
PATIENTS AND METHODS: In a randomized, double-blind, multicentre trial, 95 patients with spinal cord injuries and detrusor hyper-reflexia were studied.
Treatment consisted of three doses per day over a 2 week period, with either Oxy (5 mg three times daily) or with TCl (20 mg twice daily) with an additional placebo at midday. The results were evaluated with regard to changes in objective (urodynamic) data and subjective symptoms as well as the incidence/severity of adverse effects. RESULTS: With both drugs there was a significant increase in maximum bladder capacity, a significant decrease in maximum voiding detrusor pressure and a significant increase in compliance and residual urine; there were no statistically significant differences between the treatment groups. The percentage of patients who reported severe dryness of the mouth was considerably lower (4%) in those receiving TCl 2 x 20 mg/day than in those receiving Oxy (23%) 3 x 5 mg/day.
Withdrawal from treatment was also less frequent in those receiving TCl (6%) than in those receiving Oxy (16%). CONCLUSION: Trospium chloride and oxybutynin, judged in terms of objective urodynamic parameters, are of substantially equal value as parasympathetic antagonists. However, assessment of tolerance in terms of adverse drug effects showed that TCl had certain advantages.<<
Here's a MF article with basically the same analysis:
Motley Fool
Indevus' Big Score (Maybe)
Thursday April 8, 12:23 pm ET
By Charly Travers
Yesterday, small biotech Indevus (Nasdaq: IDEV - News) announced that it has reached an agreement with the European pharmaceutical company PLIVA to market Indevus' drug Sanctura (Trospium). The deal is especially noteworthy because PLIVA is paying Indevus $30 million now and another $120 million if the Food and Drug Administration (FDA) approves the drug next month.
The cash payments totaling $150 million are a huge amount for Indevus, a company with a market cap just under $300 million. Given the magnitude of this potential payment compared to the company's market cap, it is interesting that the stock price has barely budged compared to the $6.05 closing price the day before the deal was announced.
The FDA decision on Sanctura can be expected right around May 28. That is the Prescription Drug User Fee Act action date by which the FDA should choose whether or not to approve the drug. This can almost be viewed as make or break for Indevus, at least with respect to the company's near-term fortunes. The other drugs in its pipeline are years from commercialization. Therefore, an extreme price move on this decision is probably to be expected.
If the FDA signs off on Sanctura, Indevus would pocket another $120 million and would have an approved drug that should be pretty competitive in the overactive bladder market despite competition from companies like Pfizer (NYSE: PFE - News). Under that scenario, I think we could expect the stock to take off from its current level. On the other hand, if the FDA turns the drug down or asks for additional data, then a standard biotech stock nosedive is probably to be expected. In this situation the magnitude of the decline would depend upon the ability to address the FDA's concerns in a timely manner.
Sanctura has points in its favor. It has been on the market in Europe for years; unlike some of the approved drugs in this segment, it does not cross the blood-brain barrier; and clinical data suggest that it has a lower incidence of dry mouth than the competitors. That being said, guessing what the FDA will do can be playing with fire, and in this case it looks like the market is being cautious.
Peter |
