I want to give full credit here to Jake King of Propthink, who published these points as part of his article on Zerenex on Seeking Alpha, on March 13th 2013:
Highlights from KERX's conference call and the company's arguments that Zerenex IP is strong.
•Keryx believes that Zerenex is strongly protected in the market through 2024 based on issued API (active pharmaceutical ingredient), surface area, and intrinsic dissolution patents.
•The company refuted that OTC ferric citrate is a threat to Zerenex sales based on the concentration of iron in its formulation. According to KERX, there are 210mg of ferric iron in the 1g Zerenex tablet and 280mg ferric iron in the 1.3g tablet. The OTC version is a 25mg capsule, thus necessitating 8-11 capsules to equal 1 Zerenex tablet (Note that up to 12 grams of Zerenex are needed per patient per day).
•Keryx referenced its pending formulation patent (to protect Zerenex through 2029), which according to the company has already had an office action. KERX believes this patent will be issued.
•The company noted that standard bio-equivalency and PK assays do not apply to phosphate binders (blood levels irrelevant as the drug works in the intestinal tract). The company cited vancomycin as a key example of the difficulty in gaining generic approval for a product with these kinds of challenges.
(continued on next post)
last quarter they did 644 mill and guided to 12-15% sequential growth, or 721-740 mill, and they hit 738, or the higher end of the scale. Now they are guiding in-line so they should exceed the 704 by a few mill. I think 2014 will see accelerating earnings and revenues. It is still a buy.
and then this:
PBT2 rapidly improves cognition in Alzheimer's Disease: additional phase II analyses.
Faux NG, Ritchie CW, Gunn A, Rembach A, Tsatsanis A, Bedo J, Harrison J, Lannfelt L, Blennow K, Zetterberg H, Ingelsson M, Masters CL, Tanzi RE, Cummings JL, Herd CM, Bush AI.
Mental Health Research Institute, The University of Melbourne, Parkville, VIC, Australia.
PBT2 is a copper/zinc ionophore that rapidly restores cognition in mouse models of Alzheimer's disease (AD). A recent Phase IIa double-blind, randomized, placebo-controlled trial found that the 250 mg dose of PBT2 was well-tolerated, significantly lowered cerebrospinal fluid (CSF) levels of amyloid-beta42, and significantly improved executive function on a Neuro-psychological Test Battery (NTB) within 12 weeks of treatment in patients with AD. In the post-hoc analysis reported here, the cognitive, blood marker, and CSF neurochemistry outcomes from the trial were subjected to further analysis. Ranking the responses to treatment after 12 weeks with placebo, PBT2 50 mg, and PBT2 250 mg revealed that the proportions of patients showing improvement on NTB Composite or Executive Factor z-scores were significantly greater in the PBT2 250 mg group than in the placebo group. Receiver-operator characteristic analyses revealed that the probability of an improver at any level coming from the PBT2 250 mg group was significantly greater, compared to placebo, for Composite z-scores (Area Under the Curve [AUC] =0.76, p=0.0007), Executive Factor z-scores (AUC =0.93, p=1.3 x 10(-9)), and near-significant for the ADAS-cog (AUC =0.72, p=0.056). There were no correlations between changes in CSF amyloid-beta or tau species and cognitive changes. These findings further encourage larger-scale testing of PBT2 for AD.
no you haven't, rt. You are correct, and your wisdom shall be rewarded handsomely. ;-)
In all seriousness, I agree with you. PRAN is still very much undiscovered, in part because it is an offshore company, in part because it is chasing a disease that is riddled with drug failures, and in part because very few investors have researched metal protein attenuating compounds like PBT2. Here is a summary from the NIH:
"Alzheimer’s disease (AD), the most common form of dementia in the elderly, is characterized by elevated brain iron levels and accumulation of copper and zinc in cerebral β-amyloid deposits; e.g., senile plaques. Both ionic zinc and copper are able to accelerate the aggregation of Aβ, the principle component of β-amyloid deposits. Copper (and iron) can also promote the neurotoxic redox activity of Aβ and induce oxidative cross-linking of the peptide into stable oligomers. Recent reports have documented the release of Aβ together with ionic zinc and copper in cortical glutamatergic synapses following excitation. This, in turn, leads to the formation of Aβ oligomers, which, in turn, modulate long-term potentiation (by controlling synaptic levels of the NMDA receptor). The excessive accumulation of Aβ oligomers in the synaptic cleft would then be predicted to adversely affect synaptic neurotransmisson. Based on these findings, we have proposed the “Metal Hypothesis of Alzheimer’s Disease” which stipulates that the neuropathogenic effects of Aβ in AD are promoted by, and possibly even dependent upon Aβ-metal interactions. Increasingly sophisticated pharmaceutical approaches are now being implemented to attenuate abnormal Aβ-metal interactions without causing systemic disturbance of essential metals. Small molecules targeting Aβ–metal interactions, e.g. PBT2, are currently advancing through clinical trials and show increasing promise as disease-modifying agents for AD based on the “metal hypothesis”.
you, my friend ldfenster, are an idiot. PBT2 has received more attention in the medical community than many other ALZ drug candidates. Harvard, Stanford, and many other medical centers.
very transparent short post. A long would never post this without some facts behind it. It didn't open up this morning with a large drop, and there is no news to suggest it might tomorrow, so your post is merely a stupid scare tactic, as if it matters.
I think PBT2 will be the start of a whole new class of drugs that work on metal imbalances. My bet right now is that PBT2 in HD failed to show statistical significance, while in AD it will. I think that's why they delayed the HD results - so they can mine for a successful subgroup and then present both data sets - HD and AD - at one time, leading with the success of the AD trial. That's the only way to keep the stock price from imploding. Of course, if they release successful data from HD early - this stock will absolutely explode upward. I am hoping for a 10 bagger at least here.
Sentiment: Strong Buy
I think both RMTI and KERX get taken out in 2014. Fresenius and DaVita would be two candidates, but there are many, including Amgen. Both co's should sell north of $30/share.
well, the shares soared past $6 to $6.89 just a day earlier - they probably could have gotten away with a $6 price instead of $5.50!
Regardless of the reasons that this priced at $4.80, I think Oppenheimer left money on the table for NWBO. This should have been priced at $5.50 and there would have been plenty of demand. I think Linda Powers threw Oppenheimer a good deal because of her past dealings with CIBC and Oppenheimer when she was global finance VP at Enron: "On November 4, 2007, CIBC announced from Toronto that they agreed to sell to Oppenheimer & Co. its U.S. domestic investment banking, equities, leveraged finance and related debt capital markets businesses. The transaction also included CIBC's Israeli investment banking and equities business, and certain parts of other U.S. capital markets-related businesses located in the UK and Asia. The formal agreement dictated that Oppenheimer would borrow $100 million from CIBC in the form of a subordinated debt as well warehouse facility provided by the Canadian bank. The warehousing facility initially up to $1.5 billion would allow the newly formed Oppenheimer U.S. entity to finance and hold the syndicated loans for U.S. middle market companies. Underwriting of loans pursuant to the warehouse facility will be subject to joint credit approval by Oppenheimer and CIBC. In doing so, CIBC would benefit from the future success of Oppenheimer & Co. Some speculated that this sale was the result of the 2005 settlement of the civil lawsuits related to CIBC's entanglement with Enron for about $3 billion. It was one of the largest such settlements to date and believed to adversely affect CIBC operations. For many CIBC World Markets employees who remained from the original Oppenheimer & Co., the sale was reunification of sorts. The deal closed on January 14, 2008, yet both entities will share infrastructure for sometime and possibly office buildings. This includes 300 Madison Avenue, the building once set out to be the New York, CIBC Center..."
Oh, and backlog in 2007 was around $112 million. Now it's $145 million and climbing. I've been tracking this since $7, but for a variety of reasons didn't buy until now. I mainly wanted to see a solid and sustained breakout in their revenues.