The favorable risk/benefit and safety bodes well for FDA approval. The first of its kind device!
Excerpt from CBS news story:
A Food and Drug Administration advisory committee meets Tuesday to consider the premarket application of a new surgically implanted weight-loss device for patients with severe obesity.
The device, called the Maestro Rechargeable System, works by delivering an electronic signal called VBLOC therapy to the trunks of the vagus nerve, a cranial nerve which extends from the brain stem to the abdomen and plays a role in transmitting feelings of hunger.
By suppressing neural signals carried by the vagus nerve trunks, the manufacturer says the device decreases hunger pangs, digestive enzyme secretion and calorie absorption, while increasing the feeling of fullness.
Its manufacturer, Minnesota-based EnteroMedics, Inc., says it could be an alternative for extremely overweight people who have failed at traditional weight loss programs but either can't or don't want to undergo more extreme bariatric surgery.
The system is currently under clinical investigation and it has not yet been approved for use in the United States. However, it is now available for commercial use in Australia, and doctors have successfully implanted the device in several patients at Hadi Hospital in Kuwait City, Kuwait.
The device works by delivering high-frequency (5000 Hertz), controllable electrical pulses to the vagus nerve trunks in the abdominal region. The system is powered by an internal battery, which can be recharged by an external mobile charger and transmit coil that a patient uses for a short time every week.
In a study involving 239 patients, investigators found that after 12 months, the patients who had undergone treatment with the device lost an average of just over 26 percent of their excess weight, which is higher than the minimum 10 to 15 percent at which patients usually experience positive health effects. The study also showed nearly 57 percent of patients with the device lost 20 percent or more of their excess weight.
"The totality of naloxegol data provides evidence for durable and consistent benefits for most
patients with OIC, which outweighs the observed risks."
AXA comes out against AstraZeneca board, Threadneedle supports
LONDON (Reuters) - AstraZeneca AZN.'s shareholders remain split over the UK pharmaceuticals giant's decision to reject a $118 billion offer from U.S. rival Pfizer (PFE.N: Quote, Profile, Research, Stock Buzz), with AXA coming out against it while Threadneedle supported it.
"It is the view of AXA IM UK that the board of AstraZeneca should not prevent an offer from Pfizer of 55 pounds ($92.67) per share from being put to the shareholders of the company," Jim Stride, head of UK equities at AXA Investment Managers, said on Wednesday.
AXA is the third biggest shareholder in AstraZeneca, with a 4.51 percent stake.
"Many shareholders - but not necessarily all - will find this an attractive offer. Accordingly we believe that the board was arguably wrong and acted too hastily to dismiss the latest proposal from Pfizer," Stride added.
Meanwhile Threadneedle, which is the fifteenth biggest shareholder with a 1.39 percent stake, said it supported AstraZeneca's decision to reject Pfizer's proposal.
"As long-term investors in AstraZeneca, we continue to support the board's stance on the Pfizer offer. We feel the full implications of the proposed acquisition have not been sufficiently understood and addressed by Pfizer," a spokeswoman for Threadneedle said.
"The company has made notable progress under (Chief Excecutive) Pascal Soriot and is a strong, stand-alone UK business with a good product pipeline."
(Reporting By Jemima Kelly; Editing by Chris Vellacott)
Capitulation this morning to the $25 level and an impressive comeback to almost unchanged on excellent volume suggests that a floor may have been set...
In conjunction with our US biotech team we conducted a survey of 78 US physicians who treat COPD
to gauge physician sentiment towards COPD therapies with particular focus on GSK launches Breo (LABA/ICS) and Anoro (LAMA/LABA).
Overall we believe the survey is supportive of our Breo and Anoro peak sales forecasts of $2bn and $3bn respectively, and importance of GSK’s single inhaler device platform (90% of docs said being able to keep the same device through successive lines of therapy was important). The conclusions are important given the
initial poor launch of Breo due to reimbursement hurdles, which GSK claims are now largely removed, and the recent launch of Anoro.
Survey suggests improving Breo/Anoro prospects
Breo share expectations exceed our ests, suggest inflection.
Key Breo conclusions are:
1) Breo share expected to reach 27% of the LABA/ICS market and 20% of overall COPD market after 3 years.
This is greater than even our peak (2023) forecast of 20% LABA/ICS or c7% COPD share;
2) 62% of docs see a high need for once-daily LABA/ICS and 96% believe daily dosing improves compliance;
3) Reimbursement is the key reason for physicians not prescribing Breo.
We expect this to improve as coverage improves (now 70% PartDcoverage).
Per the GSK conference call, Medicare part D coverage is now 70% (jump from 25% in february to 50% in march to 70% now)
Very interesting webcast and Question and Answer session (link on THRX website). They call the TD 9855 results "a home run" and also reassure investors that consistent with their guidance and expectations, the Breo launch is gaining steam from an expected shallow initial launch.
Apr 30, 2014
2:00 PM PT Theravance Conference Call – Results From a Phase 2 Study of
TD-9855 in Patients With Fibromyalgia
Webcast Listen to webcast
Shire being an ethical company will probably release the trial data any time now. And per their agreement with the FDA (no appeal), if the results are poor all the generic manufacturers (Mylan, Impax etc) have to stop selling generic midodrine . Chelsea is sitting pretty....
there is still hope for cangrelor!
THRX spinoff TBPH (Theravance Biopharma) is suddenly much more valuable to either GSK or as a stand-alone entity.
Multiple sources are touting the same info (from stock talk on seeking alpha to twitter)
WhiteSandLLC: $THRX form 10 filled ratio 1;3.5 for Theravance Biopharma spin off
chensj: $THRX Theravance biopharma spinoff set for June, spin ratio 1/3.5, spinco to trade under $TBPH
It sounds true, lottaluckeh and is bullish for the stock spinoff especially given the breaking news about TD- 9855
According to the link, (if true!)
At the time of the spin-off, you will receive one ordinary share of Theravance Biopharma for every 3.5 shares of Theravance common stock that you hold at 5:00 p.m., Eastern Time, on May , 2014, the record date for this dividend. However, if you sell your shares of Theravance common stock prior to or on June , 2014, the distribution date, you also will be selling your right to receive ordinary shares of Theravance Biopharma. We will not issue any fractional shares of Theravance Biopharma, so if you otherwise would have been entitled to a fractional share of Theravance Biopharma in the spin-off, you will receive the net cash value of such fractional share instead. We have applied to have the ordinary shares of Theravance Biopharma listed on the Nasdaq Global Market to trade under the symbol "TBPH". Shares of Theravance will continue to be listed on the Nasdaq Global Market when the spin-off is completed and will trade under the symbol "THRX".
on Twitter, there is a link posted to Edgar/SEC filing (a google search- twitter THRX- will lead one to the site) detailing the spinoff ratio etc.
If true, how come there was no announcement/press release?