Elanile täna hea trigger vähemalt lühiajaliseks turnaroundiks ja ca kuu/kahe perspektiivis 15 peale purjetamiseks.
Biogen (BIIB) tuli täna enne turgu tulemustega ja Tysabri performis üle ootuste hästi. Q3 yoy kasv 172%, prognoosid jõuda 2010 aastaks 100 000 ravimit tarbiva patsiendini on jõus.
Seega on 2 põhilist argumenti, mille tõttu ELN 20 pealt 10 peale peksti mitte tõeseks osutumas. Esiteks Tysabrit ei korjata turult ära ja teiseks kartused, et 2 PMLi juhtu tekitavad meeletu müügi raugemise, mis heal juhul taastub aastatega, on alusetud.
Lisaks on Pfizer farmas positiivset sentimenti loomas. PFE +2,5%; BIIB +2,5%; ELN +5%
BIIB: Notified of case of PML in one MS patient taking Tsyabri - filing
On October 29, 2008, relevant regulatory agencies were notified of a confirmed case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis (MS) patient treated with TYSABRI in the commercial setting in the United States. Additional information about this case is set forth below.
The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.
Background:
- Patient has a history of MS and prior disease modifying therapies, including beta-interferons and glatiramer acetate.
- Patient had also received prior therapy with methotrexate for a rheumatological condition.
- Patient received 14 infusions of TYSABRI monotherapy.
- Clinical vigilance led to early identification of signs and symptoms of possible PML and to clinical evaluation which included MRI scanning and CSF testing.
- Patient is under the care of patient's treating physician.
The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.
Background:
- Patient has a history of MS and prior disease modifying therapies, including beta-interferons and glatiramer acetate.
- Patient had also received prior therapy with methotrexate for a rheumatological condition.
- Patient received 14 infusions of TYSABRI monotherapy.
- Clinical vigilance led to early identification of signs and symptoms of possible PML and to clinical evaluation which included MRI scanning and CSF testing.
- Patient is under the care of patient's treating physician.
Vt. 2. punkt. '- Clinical vigilance led to early identification of signs and symptoms of possible PML'
See tähendab, et TOUCH™ Prescribing Program täitis talle pandud eesmärgi ja PML keiss suudeti piisavalt vara avastada. Seega vähemalt ravimi turult tagasikutsumise alust ei näe.
Samas Tysabri müüginumbritele tõenäoliselt järjekordset lühiajalist tagasilööki saamas ja investorite kartused uute keisside ilmnemisest suurenenud.
Meanwhile, guugeldades sattus ette Tysabrit tarbiva MS patsiendi blogi. http://tysabrihelp.blogspot.com/
See tähendab, et TOUCH™ Prescribing Program täitis talle pandud eesmärgi ja PML keiss suudeti piisavalt vara avastada. Seega vähemalt ravimi turult tagasikutsumise alust ei näe.
Samas Tysabri müüginumbritele tõenäoliselt järjekordset lühiajalist tagasilööki saamas ja investorite kartused uute keisside ilmnemisest suurenenud.
Meanwhile, guugeldades sattus ette Tysabrit tarbiva MS patsiendi blogi. http://tysabrihelp.blogspot.com/
Kes on lähemalt tuttav ELN ja TTHI ühisprojektiga AD ravimi ELND005 arendamislooga ( pikemalt saab sellest lugeda siit :http://www.lhv.ee/news/index.cfm?id=1188828), siis täna said investorite ootused ämbritäie külma vett kaela seoses ELND005 teise faasi ohutusriskidega, mis ähvardavad kogu projektile kriipsu peale tõmmata.
Elan and Transition Therapeutics announce modifications to ELND005 Phase II Clinical Trials in Alzheimer's Disease (6.70)The two cos (ELN and TTHI) notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer's disease. The AD201 study is evaluating three dose levels of ELND005 compared to placebo in 353 patients. Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily). The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily. The decision by the cos to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established. The ISMC and both companies concur that the tolerability and safety data are acceptable among patients receiving the 250mg dose and that the blinded study should continue for this dose and the placebo group.
Elan and Transition Therapeutics announce modifications to ELND005 Phase II Clinical Trials in Alzheimer's Disease (6.70)The two cos (ELN and TTHI) notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer's disease. The AD201 study is evaluating three dose levels of ELND005 compared to placebo in 353 patients. Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily). The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily. The decision by the cos to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established. The ISMC and both companies concur that the tolerability and safety data are acceptable among patients receiving the 250mg dose and that the blinded study should continue for this dose and the placebo group.