BWD, "Sound in Logic"? For the plethora of Terry IDs/posts? Tax selling is over for those who wanted to use their losses in 2014 which assisted the BIO selloff.
Is this true or is "fly" a year off? Seems to be current from what I could gather!
December 22, 2014
07:24 EDT ECYT Endocyte risk/reward favorable, says RBC Capital
RBC Capital says that Endocyte's stock will rise to $15 in the most likely scenario, while the shares could jump to $31 in a bullish scenario. The firm says the company's Phase III assets have a 65% chance of succeeding.
True ($3k losses a year) but if you were carrying forward a $30K loss from 2013 and were able to gain $30K in 2014, these would then offset in 2014 and you would pay no tax on the gain (which was offset by the loss carried forward). GLTA
Don't remember seeing this one:
Pharmacovigilance Manager/Associate Director
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference. This position will initially be based in Monmouth Junction, New Jersey, but as of June 2014 will be based in our new Bridgewater, New Jersey headquarters.
SUMMARY: Reporting to the Vice-President, Regulatory Affairs, this position is responsible for identifying and assisting in the management of safety concerns with the drug product(s) owned by the company.
The Pharmacovigilance Manager/Associate Director ensures that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor. This role is also responsible for writing documents required for assessment and communication of product safety information for core safety documents.
The fact that there is no CURE for NTM (various) and the current cost to insurance/patients of continuing treatment just to "maintain" the disease will allow a reasonable cost/benefit price be charged. Insmed would not be that "stupid" to overcharge when they enter the market(s). $50K may be the higher of the range anyway (more like $35K). I would agree if Arikayce was just a treatment for maintenance. But that all changed last March-May-June when it became apparent that there were culture conversions in many of the patients.
Lots of upside
•EGRX creates value-added reformulations of industry-leading drugs.
•They use the 505b2 approval pathway to get to market quickly.
•Stock offers several shots on goal with upside above $40/share.
Eagle is a sub $200m specialty generics company with very little wall street research coverage and fairly small institutional ownership. The stock doesn't trade a lot either. Part of the reason is that some elements of the EGRX story are technical and may be hard to understand for generalists. However, hiding in the shadows of some technical detail is a high-return opportunity.
In July, EGRX received Tentative Approval for a 505b2 version of TEVA's Treanda. This approval means, that in May 2016, EGRX will be able to sell Treanda alongside TEVA. This is an $800m/yr market. Even with a modest 10-20% discount, EGRX should be able to capture a sizable portion of the Treanda business. That could mean $250-300m in Revenue for a couple of years. At the very least, EGRX could sell $500-$600m of drug cumulatively, or $21-$25/share after taxes and a 90% gross margin.
And there are several chances for a home-run scenario with the stock:
1) EGRX announced the results of their pivotal BE trial to administer their version of Treanda as a 10-minute infusion vs the current 30-60-minutes.
-First, this product is very attractive to centers, because they can treat more patients/day and increase the value of their infusion chairs.
-Second, this product received Orphan Drug Designation from the FDA on July 2 etc.
From SA article yesterday:
•Total prescriptions for Contrave was up 10%, while Belviq and Qsymia were down around 5% each.
•Combined, the trio produced a flat week, an improvement on last year, when Belviq and Qsymia combined were down 5%.
•Contrave's performance maintains a projected 100,000 total prescriptions for Q1 2015.
On Friday, the marketing authorisation application (or MAA) for weight loss drug Contrave/Mysimba was recommended by the Committee for Medicinal Products for Human Use (or CHMP) for use in all European Union member states as an adjunct to a reduced-calorie diet and physical activity. Based on the CHMP's opinion, the European Commission will make the final decision on the MAA. Finally, pricing and reimbursement will be determined by each country's national health system. In Europe, the rate of obesity ranges between 8.0% and 23.9% for women and 7.6% and 24.7% for men, but this data hasn't been updated since 2009. Romania accounted for the lowest percentages in both genders; on the other hand, it has the highest proportion of overweight people (35.9% in women, 49.9% in men). This comes on the heels of Thursday, when the European Court of Justice ruled that obesity may be a disability. While the case was about a worker with a claim for getting fired on grounds of discrimination, the verdict means employers will have an "active obligation" to cater to the needs of their obese employees, which may include treatment with weight-loss medication. These are excellent developments for Orexigen (NASDAQ:OREX), which owns the rights for Contrave/Mysimba in Europe. Orexigen has licensed Contrave rights to Takeda (OTCPK:TKPHF) to market in North America. Back on the U.S. side, new prescription numbers have been released by IMS for Belviq, Qsymia and Contrave. etc.
Vin, Have to see the subscription numbers to assess the US/Canada/Mexico revenue. But it looks very promising so far. As for Europe et al, we should see approval by mid February and sales before end of Match 2015 at worst. As for a partnership in Europe with Takeda...sure for 50% or more of the revenue and then we move into Asia.
Where the H did you come from? The fact that you come out of nowhere with this question (your only post here on this board) makes me think the smell is from you. To our knowledge (the long term posters of Insmed)
Fud has not posted on this board since last May (or maybe June). Probably sold out with the June spike. Either way what is the relevance of your post??
You mean BONAFIDE? - sincerely; without intention to deceive. Try it. Now go to the board a write this word (spelled correctly) 1000 times and then buy 1000 shares of OREX. OR you tell us WHY this company will FAIL etc. But please check your spelling before posting
Sentiment: Strong Buy
Stealin, Takeda makes the most sense because they "save" on the royalties and milestones and probably take Mysimba into Asia, Australia and other countries. But the key will be the price. I initially thought $2B would be reasonable but after the CHMP decision has been digested, more like $3B, which would be close to $25/shr. I think it was jd that said there actually might be a bidding war possible. Let's see what the "Analysts" have to say come Monday or next week. No way does the PT stay $10-$11 (52 week estimate).
They can if they choose (depends on pricing and cost of sales force):
•Contrave will be marketed as Mysimba in Europe.
•Regulators have recommended approval.
•The European Commission will likely adopt the recommendation in early 2015.
Orexigen (NASDAQ:OREX) The company announced this morning that its anti-obesity drug, which is marketed as Contrave in the United States and will be marketed as Mysimba in Europe, received a positive recommendation by CHMP, the EU regulating body that assesses prescription drugs. With a positive recommendation in hand, the adoption by the European Committee is expected in early 2015. Qsymia from Vivus was rejected by CHMP, and Arena pulled its application for Belviq when it was apparent that a rejection was the likely outcome based on concerns outlined by CHMP.
The news of the positive CHMP recommendation is meaningful for Orexigen in a few ways:
•The company will be the only "new" anti-obesity drug sold in Europe. A second drug was approved in 1998.
•The company has retained all rights to Europe. This means that Orexigen has options. It can do it alone and reap all of the revenue, or seek out a partner and garner an up-front sum worth multiple millions.
•Knowing that it will have Europe to itself (at least for the time being) could allow the company to be even more aggressive in marketing Contrave in the United States.
Dec. 19, 2014 2:22 PM ET (google the title for full article)
•Orexigen will have a bigger market to tap into after positive recommendation by CHMP.
•Orexigen just gained a lot of leverage in the marketplace as well as with Wall Street.
•2015 weight loss season is now more critical than ever.
Many people may not realize it, but the news of Orexigen (NASDAQ:OREX) gaining a positive opinion from CHMP in Europe is quite substantial to the sector. The ramifications and implications of this news will be felt not only in the short term, but in the longer term as well. Investors in Vivus (NASDAQ:VVUS) and Arena (NASDAQ:ARNA) need to pay close attention, because where Vivus and Arena have failed, Orexigen may see success...
With the news today, the risk of setting a low price point is now somewhat mitigated. The reason is that Contrave can set the market and the bar in Europe in a relatively unfettered manner. There will be no competition from Belviq or Qsymia (at least not initially). If the EU approval brings about a domino effect of other countries, then Orexigen will be able to expand these advantages. Simply stated, Contrave has a much bigger potential market. The EU covers 28 member countries and carries close ties with 3 more....
If we look at the broad definition of the addressable market, the United States has about 80 million potential patients. The size of the market in EU participating nations has been estimated to be between 40 million and 60 million. For the purpose of presentation I will use 50 million. Essentially, Contrave will be able to market to a population that is 60% bigger than its competition simply with the members of the EU. If other nations follow suit, Contrave could potentially be available to an addressable market twice the size of its competitors. The numbers are enough to carry an impact. etc.
Sentiment: Strong Buy
Added another 1K too. Now only have 5K shares but will hold until 4/1/15 minimally. GLTA
Now that OREX has the "market" cornered in Europe and growing sales in the US and eventually Japan, China etc. What would the value be for any big Pharma to want to own this product? More than $2B market cap (over $16/shr) one would think. So, with that said, unless you have to, try not to sell today because there should be even better days ahead. Of course this is just my opinion. GLTA
European regulators recommended the approval of Orexigen Therapeutics (OREX) weight-loss pill on Friday, opening a new commercial market opportunity closed off to the company's competitors.
I've long described Contrave as the Goldilocks of weight-loss pills, meaning its advantage is a mix of efficacy and safety sitting right in the middle between Vivus' (VVUS) Qsymia and Arena's (ARNA) Belviq. So far, being "just right" is working for Orexigen. Contrave market share in the U.S. is growing faster than the competition, and now, European approval is at hand. Previous efforts by Arena and Vivus to secure approval for their respective weight-loss drugs in Europe have been rejected.
Orexigen and its partner Takeda will change the brand name of Contrave to Mysimba for marketing in Europe, once final approval is granted early next year.
Here's an excerpt from the summary opinion for Mysimba announced today by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency:
"The effectiveness of Mysimba was assessed in four pivotal studies that included obese and overweight patients with and without weight-related conditions treated for one year. All patients enrolled in trials were required to change their lifestyle to incorporate a reduced-calorie diet and regular physical activity. Across these studies, more patients treated with Mysimba achieved clinically-relevant weight loss than patients treated with placebo.
The main safety and tolerability concerns identified with Mysimba were related to central nervous system and gastrointestinal adverse events, and uncertainties with regard to cardiovascular outcomes in the longer term. Interim results from an ongoing cardiovascular outcome trial were reassuring in terms of risk of serious cardiovascular disease related to treatment with Mysimba. A second study is planned in order to continue monitoring longer-term cardiovascular safety with the medicine. "