Long/short equity, biotech, healthcare, small-cap
Long/short equity, biotech, healthcare, small-cap
Contributor since: 2013
@Rbbrooke- thanks
@Mark Luo- Well your concern about illegal MLM pyramid scheme issue is valid but it is not going to harm USANA health sciences. We saw major dips in the shares of Nu Skin Enterprises Inc. following claims by People's Daily that the company was operating an illegal pyramid scheme in China. The Chinese government has recently begun an investigation on Nu Skin Enterprises, which has also affected the share price of several other companies with the same distribution model as investors fear that the investigation could extend to these direct selling companies as well. However, this won't hamper any meaningful long-run concerns for investors of USANA. because--
Nu Skin earns half of its revenue from China, USANA earns around 60% of its revenue from China. Still, USANA hasn't observed the skyrocketing growth in China that Nu Skin has lately, which shows-- there are very less chances that USANA too will catch the ire of the NU Skin. I don't see that current MLM pyramid scheme issue will harm investors' sentiments in long-run for USANA..
Hope it helps!
@Jacosa- I sincerely apologize for misspelling of your name in the previous comment.
@ jasoca--Thanks for your feedback
@P Salerno- At present reimbursement is available for breast cancer only and for colon cancer, it is in progress.
Regarding the prostate test-- Prolaris is the only test available in the market that demonstrates predictive value in both pre and post prostatectomy conditions. It is approved by the FDA for use in low-risk men with a Gleason score of 6, as well as for post-prostatectomy patients who are categorized in the high-risk zone for prostate cancer recurrence.
On the other hand, The Oncotype DX prostate cancer test measures the level of expression of multiple genes across multiple pathways that predict aggressive prostate cancer, overcoming issues related to tumor heterogeneity, biopsy under-sampling and under-staging to substantially improve individualized risk assessment at diagnosis, prior to treatment intervention. In short it predicts the recurrence of prostate cancer in pre-prostatectomy conditions.
Hope it helps.
I would say again, Vascepa which is a form of EPA, should produce positive results, considering JELIS study results. JELIS study was done in 2007 in order to identify effectiveness of EPAs. In JELIS trail EPA dose was 1.8 gm, and in REDUCE-IT Vascepa dose is 4 gm.
The patients who were enrolled in the JELIS study had a higher baseline level of omega-3 fatty acids than the patients in REDUCE-IT. I believe that with the Vascepa 4gm per day dose, the company may receive positive results upon the completion of the REDUCE-IT study as well.
Ethyl eicosapentaenoic acid (E-EPA) marketed as Vascepa, Epadel, EPAX, is a synthetic derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA). In Japan, E-EPA is often called EPA-E.
Please read this: http://bit.ly/N3oscx
and the hyperlink I shared in the article: http://bit.ly/IBm8fy
JELIS study tested the effects of long-term use of E-EPA (1800 mg/day) in addition to a statin in Japanese patients with hypercholesterolemia. In this study, AstraZeneca Epanova has showed superior efficacy compared to both Lovaza and Vascepa. As mentioned in my article.
I never said anywhere in my article that the Reduce-IT study has been scraped. My point was: The REDUCE-IT study still is ongoing, which will be evaluating Vascepa's safety and efficacy in reducing the cardiovascular events, or CVEs among the high level TG patients who are taking statins.
In the notice dated Oct 29, 2013, the FDA, with support of examples like ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE, inferred that these studies fail to support the hypothesis that a TG-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum TG levels.”
Consistent with the discussion at the October 16, 2013, Endocrinologic and Metabolic Drugs Advisory Committee (the “Advisory Committee”)
meeting at which the Advisory Committee voted to recommend against approval of the proposed label expansion for Vascepa® (icosapent
ethyl) capsules under the pending supplemental New Drug Application (the “sNDA”) that seeks to expand Vascepa labeling to include the
proposed ANCHOR indication, on October 29, 2013, Amarin Corporation plc (“Amarin”) received written notification from the U.S. Food and
Drug Administration (the “FDA”) that the FDA has rescinded the ANCHOR study special protocol assessment agreement because the FDA has
determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after
testing began. Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and
AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its
October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for
cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL).
Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug
intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.
The company hasn't disclosed about any partnership to fund its ongoing study. As in this article, I had mentioned about the cost reduction strategy, in which it has reduced the half of its workforce and the cost saved from this restructuring may be used by the company to continue its funding to run the study.
It is expected, if Amarin is able to receive the Complete response letter, CRL from the FDA, then the company based on the recommendation in the CRL will work on removing the deficiencies associated with Vascepa. This will results in improving the efficacy of Vascepa in treating TG patients.
In this article, I had focused on CKD and both the companies are developing their drugs to treat stage 3 and stage 4 CKD patients. Once Rayaldy receive the approval from the regulatory body, then it will be used to treat patients suffering with moderate CKD in the U.S. and elsewhere, with SHPT and Vitamin D deficiency. This is the reason for labeling Rayaldy as the competitor to Zerenex only for the treatment of CKD, not for NDD-CKD.
Definitely, Zerenex is able to reduce the use of expensive IV iron and ESAs, and may be approved as anemia drug. However, my focus is on CKD, and looking at Rayaldy's ability to treat moderate CKD, and SHPT patients, it will able to reduce the further chances of renal disease and hence my point to label Rayaldy with Zerenex.

@mswyman There are no plans disclosed by the companies for developing combinational therapy of Rayaldy and Zerenex. Both these companies are developing their drugs to enhance their own revenue and focusing on developing their drug portfolio stronger.
Contrary, if both the drugs are used as the combination then they may pose high efficacy, and the combination will be all-in-one drug to treat CKD, NDD-CKD, SHPT, Iron deficiency, and Vitamin D deficiency in my view.
Opko's Rayaldy is used to treat SHPT, which is prevalent in 40%-60% patients suffering with moderate CKD and 90% in severe CKD. If Rayaldy is able to treat SHPT patients with its full efficacy then it is supposed to generate the competition to Zerenex in CKD drug market.
Definitely, Zerenex possess the secondary properties of reducing the use of IV iron and ESAs, however the “competition” is just based on their individual efficacy for the treatment of CKD only.
Opko is having “Alpharen” a new phosphate binder consisting of iron magnesium hydroxy carbonate, or FMH in its trial phase, which I haven't covered in this article as my focus was on CKD only. Alpharen may also create competition to Zerenex in future in treating iron-deficiency patients and any plan by the company on the developing the combinational therapy of Rayaldy and Alpharen is expected to generate deeper competition to Zerenex.
@gstanleyjr- Thanks for the appreciation

@lancem59-- Do you really think this will make mockery of mine? No! it won't.
one suggestion-- don't use offensive language.
Thank you guys for updating me about this Depomed deal..
@PJafferyAnalyst45-- despite of being termed as gonged by you ,I am glad that you are waiting for my next article...
@biochemist- I agree with what you said but the idea behind to compare BIIB with PDLI is that both share one common platform-- Receiving royalty revenues from other drug companies.
"Biogen Idec derives most of its income from sales of multiple sclerosis therapeutics Avonex and from partnership royalties on Rituxan from Genentech"
Hope it helps.
Definitely the Depomed deal is a positive sign for PDL BioPharma's dying royalty revenue....The deal will allow PDL BioPharma to expand its royalty source. The deal, retroactive to Oct. 1, ends when PDLI receives $481 million from Depomed. This will give a short-term growth to the dying revenue stream. I will wait for some more positive deals like this one to happen for PDLI in order to have solid long-term growth..
@speculative and IRBAHTAN
It is Natural Calamity... Nobody knows when it will hit.. This is what exactly happened with this article. No signs/rumors of any development till the date I submitted it..
chasingthealpha- Thanks for sharing the data. But just upon these data I can’t surpass the benefits of Rolapitant over NEPA or Emend. As discussed” The three ongoing Phase III studies are more than 90% enrolled …… If Rolapitant achieve the primary endpoint, Tesaro's first commercial product will reach the market in 2015.” With the progression of development of both Rolapitant oral and IV formulation, it has a competitive advantage over its competitors. When comparing the PARP inhibitors, Niraparib is not less than Olaparib. Niraparib is likely to be dosed once daily while Olaparib is taken twice daily (400mg BID). Tesaro’s NOVA trial includes both gBRCA and non-gBRCA cohorts whereas the SOLO program is restricted only to the gBRCA population. Keeping all these points in mind, I believe that Tesaro has better potential in long-run.
@MichaelFleming- As discussed above Tesaro's future growth depends mainly upon Niraparib and Rolapitant. Till now Niraparib has shown positive data’s in all the development phases. And it is very likely that Niraparib will read out positive data in Phase III studies, which is expected to complete in March 2016. Even though the company is small in front of its competitors, these two products are strong enough to challenge the big players. I do agree that its stock has not moved beyond $40 in last couple of months. But, we can’t neglect its long-term growth potential. So, selling the stock at this stage won’t be a good idea. Hold it for next few months and you will see the positive outcomes.
@investinginvestor -- which article are you talking about? And what repeated error are you talking about?
@Asraf: Before reaching a conclusion, care to share -- Where exactly I wrote: Qualcomm license ARM's Cortex designs??
@krish -- Read the "to sum up" part. You will get your answer and in tandem read the IDC report on SDN.
@ctyank: That's the plan
@sham: why would you say that
I agree with every bit of research the author has gathered. Kudos! I think Nokia is a masterpiece in making and tis dip provides another buying window. It is covering up its losses in past quicky, which also would require a mention here.
@gwynfyn - I agree. It would be intersting to see when Apple will bring its devices to a lower price, realizing that Samsung and Nokia are already waiting for it there. Samsung Grand for instance --- was an excellent handset bringing the features for Galaxy & Note series at a very low price. As far as Nokia is concerend, it was a low-cost champ at one time, but then the smartphone era washed it away. But they know, how the market works, and they should be soon covering up!!
@gwynfyn I think Nokia's focus as a whole is on Lumia currently as it drives the margins for the company. However, I agree that Samsung has the best marketing strategy of all! And they were the ones to break the market.