FDA soon will issue a suspension of present trials as it is compromised and ask OREX to conduct fresh trials and stop sale of Contrave until that date.
Commenting of if the company will release or is required to release the 50% interim data, the analyst said, " We’re not sure about the answer to the first, and for the 2nd, by whom? We believe that with the FDA's requirement of the conduct of a second CVOT, and that the original design of the LIGHT study having been dependent on the first interim (25% events), the 50% and 75% interims are, for the most part, "administrative". That said, if the data continue to suggest a CV benefit from Contrave, we suspect that Orexigen may, in the least, file for updated or additional patents based on the new data."
1/50000 person has HAE also following drugs already in the Market New FDA-approved HAE treatments provide patients and their physicians with choices and an opportunity to develop an HAE treatment plan tailored to meet each patient’s unique needs.
Cinryze ™ brand of C1-inhibitor has been FDA-approved for preventing HAE attacks. Cinryze ™is delivered intravenously and is approved for home infusion.
Berinert® brand of C1-inhibitor has been FDA-approved for treating acute abdominal, facial or laryngeal HAE attacks. Berinert® is delivered intravenously and is approved for on-demand treatment through self-administration.
Kalbitor® brand of plasma kallikrein inhibitor has been FDA-approved to treat acute HAE attacks in patients 12 years of age and older. Kalbitor® is delivered through subcutaneous injections.
Firazyr® brand of bradykinin receptor antagonist has been FDA-approved for treating acute HAE attacks in patients 18 years and older. Firazyr® is delivered by subcutaneous injection and is approved for self-administration
Ruconest® brand of C1-inhibitor [recombinant] has been FDA-approved for treating acute HAE attacks in adults and adolescents. RUCONEST is delivered intravenously and is approved for self-administration.
Achillion Pharmaceuticals, has already crossed the finish line for posting successful trial results that boast lowered treatment times.
Piper Jaffray Defend Orexigen (OREX) on Contrave Hub was right...He shuts up many analyst and short interest with $26 Price Target.
Forbes this line explains everything....."FDA has not offered formal guidance on the issue", Kaul said
Achillion was able to achieve a 100% cure rate in HCV1 patients within six weeks, in trials that used the company’s experimental HCV drug ACH-3102, along with Gilead’s Sovaldi. The company has now embarked on a similar study designed to try and lower treatment duration to four weeks.
Gilead stated that as many as 90,000 HCV patients started Sovaldi or Harvoni treatment during the first three months of the year. This makes it incredibly important for Gilead to keep continue research in the HCV drug space, to always remain one step ahead of competition.
The company recently posted cure rates of 93%, in previously untreated HCV1 patients in only six weeks, in trials that involved the administration of Sovaldi and two experimental drugs, GS-5816 and GS-9857. The same trial failed to cut treatment time to four weeks, with patients demonstrating cure rates of just 27%.
Merck is likely to file for FDA approval of its HCV combo by the first half of this year, and it could reach the market by mid-2016. The combo treatment demonstrated a 95% cure rate in a treatment-naïve, broader group of HCV patients in a late-stage study - but within the usual 12-week treatment time. Also, two of Merck’s drugs have received breakthrough therapy designation for genotype 4 patients and cirrhotic genotype 1 patients.
What's next for gold? Surprisingly, some market experts are still bullish.
Jeffrey Gundlach, the well-known investing guru who runs the money management firm DoubleLine Capital, is reported to have said in a presentation earlier this week that he thinks gold could rebound to $1,400 an ounce.
His reasoning? Negative bond yields in Europe will make gold look more attractive.
Gold is an asset that often outperforms in times of both inflation and deflation. In other words, when the market is scared of something, people flock to gold.
And those negative bond rates are a tell-tale sign of deflation worries. Investors are so spooked by the prospect of falling prices that they are willing to tolerate a small loss on government bonds rather than risk bigger losses in other parts of the market.
If you are invested in Arena Pharmaceuticals (NASDAQ:ARNA), some news delivered today by competitor Orexigen (NASDAQ:OREX) is something that you need to consider. Orexigen received approval to sell Mysimba (Contrave) in Europe. This event nearly doubles the addressable market for Orexigen and allows the competitor to keep up the pressure it has here in the United States.
Arena's Belviq has not been approved in Europe though an application is slated to be filed in March of 2016. Even at that, Belviq must pass through both CHMP and then the European Commission in order to gain possible approval. With a submission in Q1 of 2016, the possible decision may not be reached until late that year or early the next.
What Arena investors need to consider is that Orexigen was already aggressive in the pricing on Contrave in the United States. In fact Arena and its partner Eisai were forced to react to the pricing strategy of the competitor and lower the price of Belviq. This put a damper on the revenue story, and in fact could have already pushed out possible milestone payments by at least a year or more. The next available milestone payment for Arena is at net sales of $250,000,000 in a year. If net sales are at $90 per bottle, it would take nearly 2.8 million bottles to achieve that level of sales. For some perspective, Eisai related sales this year are pacing to about 900,000. Sales need to increase by a factor of 3 to get to milestones. Under the old pricing of Belviq there would be about 2.3 million in sales.
Cannell joins Orexigen after 27 years at Merck where he held a variety of senior leadership roles. He brings strong experience in global commercialization, consumer marketing, and sales operations and management. Recent assignments have included President of Merck Canada and Head of Marketing and Strategy for MSD Japan. Earlier he served in general manager roles for a U.S. sales division and as leader of a Merck business unit, managing a multi-billion dollar product portfolio and thousands of employees. He has strong consumer experience, having served as General Manager, New Commercial Model, U.S., where he designed and successfully piloted an innovative customer centric commercial model for Merck's U.S. business.
New interim data on its obesity management drug Contrave. The data shows that the drug may not only help fight obesity, but potentially heart disease as well. Because the data is preliminary, the label for Contrave will not say that it protects heart health, and doctors will not officially be saying that it does either. But our view of the recent data? It is the first long-term cardiovascular (heart safety) outcomes study to show statistically significantly better results on the heart disease front for those taking the drug being studied. - See more at:
The other areas that Arena is targeting are Pain, AutoImmune diseases, Thrombotic Diseases, and Pulmonary Arterial Hypertension. I think the company has a good pipeline going and I like this biotech better than the other obesity drug biotech stocks. I think Arena should do better than Vivus, and Orexigen over the long term!
Can anybody challenge this?...
DUBLIN, March 16, 2015 /PRNewswire/ --
•Company Focused on Moving Forward with its Growth Strategies and Active Pipeline of Acquisition Targets
Endo International plc (NASDAQ: ENDP) (TSX: ENL) today confirmed that it is withdrawing its cash and stock proposal to acquire Salix Pharmaceuticals, Ltd. Endo is moving forward with its growth strategies and active pipeline of acquisition targets across its three core platforms – U.S. Branded Pharmaceuticals, U.S. Generic Pharmaceuticals and International Pharmaceuticals.
Endo issued the following statement:
"While we are disappointed with this outcome, we have been and will continue to be disciplined in our approach to potential acquisitions. We would like to wish Salix and Valeant continued success as they move forward with their transaction. As a next step, Endo is focusing our attention on other opportunities in our robust deal pipeline and on maximizing our organic growth initiatives including progressing our R&D pipeline. We will continue to drive Endo's growth as a global leader in specialty pharmaceuticals and look forward to creating value for our shareholders while improving patients' lives."
Orexigen Therapeutics (NASDAQ:OREX) saw a large drop in short interest in the month of March. As of March 13th, there was short interest totalling 34,283,822 shares, a drop of 14.0% from the February 27th total of 39,845,839 shares, American Banking & Market News reports. Based on an average daily trading volume, of 19,739,350 shares, the short-interest ratio is currently 1.7 days. Approximately 33.5% of the shares of the company are short sold.
Several analysts have recently commented on the stock. Analysts at RBC Capital raised their price target on shares of Orexigen Therapeutics from $10.00 to $14.00 and gave the companya “buy” rating in a research note on Friday. Analysts at Leerink Swann raised their price target on shares of Orexigen Therapeutics from $8.00 to $11.00 and gave the company an “outperform” rating in a research note on Wednesday, March 4th. Analysts at Piper Jaffray raised their price target on shares of Orexigen Therapeutics from $16.00 to $26.00 and gave the company an “overweight” rating in a research note on Tuesday, March 3rd. Finally, analysts at Zacks reiterated a “neutral” rating and set a $6.25 price target on shares of Orexigen Therapeutics in a research note on Friday, February 27th. One research analyst has rated the stock with a hold rating and six have issued a buy rating to the company. The stock currently has a consensus rating of “Buy” and a consensus target price of $13.18.
HAE is a relatively rare condition, affecting only about 4500 people in the U.S., according to Dr. Adelman. While he explained that it's too early in the development process to estimate a market size for DX-2930, he did mention that the competitors' products in the market are "very expensive."
In a note released on Wednesday morning, Bank of America analysts project $530 million in U.S. sales for the drug in 2029.