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Wow, what a disgrace! whoever did the stat should be crucified publicly. CBI (down some 40% in TASE due to this fuck up), is going to have a conference call in 3 hours here on the matter. Bet they will plead "not guilty". Btw, one thing TEVA did right is dumping Andromeda... #msg-101189594
PS Israeli lawyers are quick - there's already a lawsuit against CBI
KMDA final results of phase-2/3 inhaled AAT trial
It appears the trial missed the primary and secondary endpoints for the ITT
http://maya.tase.co.il/bursa/report.asp?report_cd=919192-00&CompCd=1267&Type=Pdf
Seems like a simple error in the biopharmcatalyst site (that gets the figures from google finance). Perhaps they put the Market cap in Shekels instead of Dollars
BIIB033 anti-LINGO-1 phase I data
No reason to be disappointed yet Ian, MS patients only got two doses of BIIB033 in the phase I trial. We should wait for data from the following phase II trials (first to report is the one in AON and much later the MS trial), to discuss efficacy.
http://clinicaltrials.gov/ct2/show/NCT01721161?term=NCT01721161&rank=1
http://clinicaltrials.gov/ct2/show/NCT01864148?term=NCT01864148&rank=1
Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033
It's an open access article, you can read the full text here:
http://nn.neurology.org/content/1/2/e18.full
Genzyme’s oral treatment for Gaucher - Cerdelga (eliglustat)
Quite easy to do a lot better than a poor drug like Zavesca :)
Seriously, the way data look so far, I think Cerdelga will take a major market share (more than 50%) from ERTs in few years time.
Perhaps the war might also be another reason why PLX is so beaten lately.
FDA Approves Genzyme’s Cerdelga™ (eliglustat) Capsules
Only First-Line Oral Therapy Approved for the Treatment of Adults with Gaucher Disease Type 1
http://news.genzyme.com/press-release/fda-approves-genzymes-cerdelga-eliglustat-capsules
NVS/Gamida-cell
Finally!
(and a more cautious deal from NVS side, which only risks $35M).
Thanks for digging the figures. I assume the 30% medicare should grow in time and help Anoro.
GSK
GSK—mepolizumab should be a bright spot but will take few more years...
AGN—phase-2 stage 3 DARPin data in wet AMD
Even without the will for opposing the hostile offer from VRX, the program looks worthy for moving on to phase III. They still need to do better with purification to lower ocular inflammation (and by doing so efficacy might also be a bit better).
AGN new DARPin data
Dalbavancin (DALBAVANCIN HYDROCHLORIDE - DALVANCE)
I think everyone is skeptic about oral delivery of peptide and protein drugs.
On the CEO, I can't say I'll miss him
Correct on the 28 days.
They don't have safety/tox data to dose for a longer period, just shorter.
Phase 2a should have data by year end so I guess phase 2b could start by mid 2015 if results are good.
Btw, have you noticed the CEO is leaving?
On your btw, ditto
PRX-112 (oral drug) starts phase IIa in Gaucher:
http://finance.yahoo.com/news/protalix-biotherapeutics-initiates-phase-ii-113000649.html
Excluding Abacavir in a Tivicay-based regimen is needed and I was thinking that in the future Tivicay + generic Truvada would be a good single-pill co-formulation. There are more than 20% of patients who cannot start with an NNRTI (due to primary resistance and other reasons), plus Edurant's resistance profile is even weaker than that of Sustiva, so Tivicay + Edurant would not suit also patients with high baseline viral loads. Think the dual nuke + NNRTI or PI or II will maintain the lion share of treatment.
Recall Teva's ANDA for generic Baraclude got an FDA tentative approval in Oct. 2013 after earlier that year the Delaware District Court ruled that Baraclude's CoM patent was invalid. Seems that since the ruling in the Protonix case against Teva (and Sun), they are very careful about "at risk" launch.
Thanks for the link.
Novartis advanced their 2nd gen siponimod to phase III in SPMS not RRMS, so I will leave it out for now. As for the others, ponesimod also has some activity at S1P3 and that should be bad from the AE angle. Ceralifimod has the same activity at S1P1 and S1P5 that should help with efficacy but the price is in safety. My guess is the better choice is to target S1P1 mainly, as did Receptos and GSK (but GSK did not move their candidate beyond phase I, which implies they have seen unwanted AE).
Re: RCPT meets MS primary endpoint in phase-2 portion of trial
Will be interesting to see clinical trials data from other next generation S1P modulators, as there are differences between them regarding S1PR selectivity and potency and it remains to be determined which one has the best profile.
Octava tests
Octava Pink test suppose to help identify true negative mammography (the test has 95% specificity and 50% sensitivity).
Octava Blue for true positive mammography ( 50% specificity and 95% sensitivity).
So, yes - the 75% figure in the write-up in #msg-103005109 is an error.
Re: MRK tries qD Isentress again
Sorry, forgot the Haaretz article requires a subscription to read. Here is the article:
Teva unveils plan for separation of generic, specialty medicine units
Reorganization of generics business signals CEO Erez Vigodman’s dissatisfaction with the unit’s performance.
By Yoram Gabison and TheMarker | 03:02 03.06.14 | 0
Teva Pharmaceuticals is introducing a new organizational structure that divides the company’s global operations into generic medicine and specialty medicine units, with the aim of creating a “less complex, integrated” business.
The reorganization, which goes into effect July 1, will bring with it a series of top-level appointments, including Sigurdur Olafsson, who will be coming in as president and CEO of the generics business, Teva said. Olafsson, who will be based in the United States, had been president of Ireland’s Actavis, responsible for the company’s generics business.
“The new organization structure and leadership team will better position Teva to deliver sustainable growth and create short- and long-term value,” Erez Vigodman, who took over as CEO in February, said in a statement.
Vigodman has been leading a turnaround of the company – the world’s biggest maker of generic drugs, and Israel’s biggest company by market capitalization – after a stormy period under his predecessor, Jeremy Levin.
Teva is under pressure to find substitute revenue streams now that the patent for its best-selling multiple sclerosis treatment is expiring, opening it up to generic competition. But the company has also been accused of having a top-heavy management and inefficient board, which the reorganization, it appears, aims to address.
The announcement was made close to the end of the trading day on the Tel Aviv Stock Exchange Monday, where Teva’s share edged down 0.06%, to close at 176.50 shekels ($50.78). In New York, however, Teva shares were up 2.55% at $51.78 early afternoon local time.
“We must capitalize first on our existing assets and capabilities, and exploit opportunities and synergies emanating from the full integration of all business activities – most importantly, generic and specialty – while leveraging our global R&D and operations capabilities,” Vigodman said.
The new generics unit will put all of Teva’s regional generics business under one roof, a move it said underscores the company’s “commitment” to the segment. The unit will also be responsible for Teva’s growing over-the-counter business, which is run in a joint venture with Procter & Gamble in the United States.
Teva said its global specialty medicine business would continue to be led by Rob Koremans.
The reorganization of its generics business – which is still the foundation of Teva’s operations, despite an expanding portfolio of proprietary drugs – signals Vigodman’s dissatisfaction with the unit’s performance. By bringing in an outsider to run it, it also suggests he was unhappy with the generics business’ current management.
In response to the reorganization, BMO Capital said Monday that the hiring of Olafsson is “tremendously” good news. BMO said Teva’s new structure could be pointing to an eventual separation of the company’s generic and proprietary medicine units, although such a move is very unlikely anytime soon.
Other organization changes unveiled Monday include a newly formed corporate development, strategy and innovation group, which will be responsible for developing new market initiatives, identifying partners and new technologies. Teva said it had yet to name a leader for the division.
The company will also be forming a global corporate marketing excellence and communications group, which will be led by Iris Beck-Codner, who is being promoted from senior vice president and chief communications officer to a group executive vice president.
Her group will be responsible for marketing, brand management, corporate communications and social affairs, Teva said.
Eric Drape, who has been head of sterile, respiratory and specialty operations since last year, was named a group executive vice president and global head of quality, Teva said. Drape joined Teva from the Ipsen Group in France, and before that held positions at Novo Nordisk in France and Denmark.
Eyal Deshe, who served as interim CEO before Vigodman took over, will stay on as chief financial officer and a group executive vice president. He will also take on additional responsibilities for investor relations, together with Vigodman.
Here is Yoram Gabison's comment (he is a respected reported who covers Teva for many years):
Teva unveils plan for separation of generic, specialty medicine units
http://www.haaretz.com/business/.premium-1.596806
I meant MNTA ( #msg-23807195 ).
Re: Approval requirements for generic Copaxone
No, didn't notice. Thanks for the pointer.
I was wrong on generic Lovenox and probably on generic Copaxone, as for both I didn't believe the FDA was/is willing to approve a complexed generics without clinical studies. Luckily as you know, at least the Lovenox saga had a good economic outcome for me
OT - Why females get MS at 4X males: S1PR2
In other recent papers and the original manuscript of the one you linked to, the female/male ratio in MS is estimated to be near 3:1 and may be increasing according to some reports. On the other hand, males have usually a more rapid progression and worse outcome.
One more general caution about the Klein group results in humans is data came from only 10 MS specimens and while quantitative IHC showed significantly higher levels of vessel-associated S1PR2 in patients with MS compared with that in patients without MS, in female vs males it was only a trend.
KMDA reported results of phase-2/3 inhaled AAT trial:
http://finance.yahoo.com/news/kamada-announces-preliminary-results-phase-113000181.html
Missed the primary (time to first moderate or severe exacerbation) and hit one secondary endpoint (frequency of severe exacerbation).
The deal is off:
Novartis abandons plans to buy Gamida Cell
http://www.globes.co.il/en/article-novartis-abandons-plans-to-buy-gamida-cell-1000935583
No, I never owned either but followed DiaPep277 out of respect for Irun Cohen and scientific curiosity.
Btw, Teva sold its share in Andromeda (~16%) back to to CBI, for $72M about 2 months ago.