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NGNM (and RGDX):
Peter, thanks for the input. It's always good to hear from someone more knowledgeable regarding the technical aspects of news than myself.
With regard to RGDX (which, BTW, had been involved in potential partnering talks with NGNM in the past), the news is that GSK has taken a considerable position in the co., not unlike ABT's move to take a position in NGNM about 18 months ago. Read the following:
BRIEF-GlaxoSmithKline acquires shares in Response Genetics
http://www.reuters.com/article/2012/09/13/glaxosmithkline-brief-idUSWLA324120120913?type=companyNews&feedType=RSS&feedName=companyNews&rpc=43
"(Reuters) - GlaxoSmithKline Plc : * GSK acquires shares in Response Genetics Inc * Acquired five million newly issued shares of Response Genetics Inc * To acquire the shares in Response Genetics for US$1.10 per share in cash * As a result, GSK now owns approximately 15.2% of the expanded share capital"
Best,
AJ
NGNM: NeoGenomics Develops and Implements Proprietary Method for Automating and Interpreting Fluorescence In-Situ Hybridization Test Data
http://finance.yahoo.com/news/neogenomics-develops-implements-proprietary-method-110000278.html
"FT. MYERS, Fla., Sept. 13, 2012 /PRNewswire/ -- NeoGenomics, Inc. (NASD OTC BB: NGNM), a leading provider of cancer-focused genetic testing services, announced today it has begun using a new proprietary software that it developed for reading and interpreting Fluorescent in Situ Hybridization ("FISH") digital data. The company will use this software to further automate certain FISH analyses in its own laboratories and will consider sub-licensing it to other providers. The Company also announced that it has applied for a utility patent on this methodology and the related software.
The proprietary software, which is based upon a sophisticated machine learning technology known as Support Vector Machine ("SVM"), allows users to read and interpret specific types of FISH images more accurately and more quickly. Laboratory technologists and professionals can train different algorithms for specific types of FISH images, and a library of files for reading and interpreting various FISH probes can be easily compiled for general use in any FISH laboratory that has a sublicense to the SVM technology. The software can read and interpret most forms of digital FISH data acquired manually or by an automated system.
NeoGenomics has validated and is currently implementing a laboratory developed test using the new software to read ALK rearrangement FISH tests, and plans to expand its use for other FISH probes. FISH testing for ALK rearrangement is currently performed manually and only 50 cells are counted by most laboratories. This new computer-aided system enables a significantly higher number of cells to be counted and allows for increased accuracy and reduced subjectivity from case to case. ALK testing is very important for selecting appropriate therapy for lung cancer patients. The Company expects a modest incremental reimbursement associated with ALK testing in this initial application of SVM technology, because it will enable the use of computer assisted FISH CPT codes for billing.
Douglas VanOort, the company's Chairman and CEO, commented, "Development of this software is a result of our commitment to offer innovative solutions and uncompromising quality for cancer testing. This innovation resulted from our licensing agreement with Health Discovery Corp, which provides NeoGenomics the exclusive worldwide rights to use SVM technology for all types of laboratory developed tests in hematopoietic and solid tumor cancers. We expect SVM technology will help us to automate certain manual testing processes, provide more accurate results for those tests that were previously dependent on subjective interpretations, and increase the productivity of our lab operations. To our knowledge, we are the first laboratory in the world to use SVM technology to assist in reading and interpreting ALK FISH data."
Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented, "The science around using pattern recognition and computer-aided algorithms has improved significantly in the past few years. Our use of algorithms to interpret FISH digital data is just one step in a series of planned activities to adapt the SVM technology to cancer genetics testing. We believe these types of algorithms will be instrumental in helping to answer complex clinical questions and reducing the dependence on subjective interpretations."
The PR today is intriguing on several levels. It reports that the algorythms developed by HDVY, applied to FISH testing will help automate the testing process to the point that material savings can be realized. The PR also reports that this is a patent pending proprietary process that the co. thinks has value beyond internal use and will be available for sublicensing. If true on both fronts, this is a real winner and another step towards NGNM's developing intrinsic, distinct value.
There are 7 ph 3 trials, and my best estimate, having worked in this field is that they are about $150M each of external out of pocket spend. That's $1.05B.
That's quite a stimulus package courtesy of the PPHM investors; lots of good paying employment in that $1.05 billion. Glad that this isn't government stimulus, although them's that foot the bill will be itemizing their maximum deductions on the gains and losses sheet of their federal returns for some time to come.
NGNM: I believe the upgrade is cause for the days' activity. Any 28% kick with nearly 10X normal volume is a good sign indeed, IMO. I don't know the investment bank, Craig-Hallum, but they certainly aren't the typical sell side coverage. Peter, I don't expect a buyout anytime soon; if you look at insider ownership, this is a very tight group with lots of shares. There are not many options out there and the no. of shares issued is relatively small. Several small genetics testing labs have sold in the last couple of years for 2.5-6.5X trailing revenue, and if I read the comments from our last NGNM thread correctly (i.e. you or another reader in the know commenting on bidirecvtional genetics testing being cutting edge and not widely available), I would argue that our value here should be at the high end of this or even higher (maybe as high as 8X) giving a current buyout pricetag in the $400-500 million range, or close to $10/share. I think that mgmt would be satisfied with this, but also think they are driven to get beyond the psychological barrier of $100 million/year revenue before even looking up from the grindstone.
NGNM has been my little baby on this board. I can't search and show the post, but after finding this board, years ago, one of my very first posts was to ask about the relative value of interpretting the financing of a co. through SEDA's PIPE's etc., related to NGNM (although I didn't identify them at the time.) I have been around NGNM long enough to see them "mature" from this perspective, seen them bring in a CEO who knows the business and demonstrated his commitment by buying $600,000 of stock on the open market when we were down to 80c/share, (and also seen them run through 2 or 3 VP's of sales who were absolutely worthless, BTW) and all of their business evolution. It's been a real education for me and I am still learning.
The share price and volume "behavior" have been very positive, IMO, since the last quarter update. As a behavior scientist, I can't translate what I'm seeing to something objective, but "I know it when I see it" and I am all in until the co. is sold.
On a more personal note, I'm glad that some of you are/have benefitted from the likely ONLY pick that I've provided to this board.
Best,
AJ
SPPI: Can't say I understand this at all, but am holding and looking to add. Fusilev sales should continue to increase as there is no resolution to the generic leucovorin shortage.
aj
LH: Damned interesting. wonder if the private equity sees value in breaking this behemoth up into specific segments, offering each as publicly traded co.'s?
SPPI: Spectrum Pharma: Fusilev Drug Sales Smash Record in June
Fusilev sales totaled $49.7 million in June, according to monthly sales data from Wolters Kluwer released late Tuesday.
That means in June alone, Spectrum sold almost as much Fusilev as the $51 million recorded in the entire first quarter.
Spectrum won't announce second-quarter results until July 30, but Fusilev sales could top $90 million based on Wolters Kluwer monthly sales data, which have so far tracked accurately with actual, end-of-quarter reported sales.
Fusilev sales totaled $24.8 million in May and $22.3 million in April, according to Wolters Kluwer.
Spectrum continues to benefit from a shortage of generic leucovorin but now it seems doctors, particularly those in large oncology group practices, have turned to Fusilev as a permanent replacement for their colon cancer treatment regimens.
The predicted reversal in Fusilev sales growth has not materialized, even with leucovorin supply shortfalls easing somewhat. Instead, Fusilev sales continue to grow month over month with no sign of stopping.
Spectrum shares closed Tuesday at $15.63.
--Written by Adam Feuerstein in Boston.
http://www.thestreet.com/story/11637583/1/spectrum-pharma-fusilev-drug-sales-smash-record-in-june.html?puc=yahoo&cm_ven=YAHOO
Aricept and Brain Injury:
I've been reviewing the literature on use of Aricept for Traumatic Brain Injury patients. Is anyone aware of a Pfizer sponsored study that looked at this?
aj
SPPI/Zevalin:
This is a sample size of one, but every little bit helps (SPPI that is).
http://www.ncbi.nlm.nih.gov/pubmed/22820440
Second-Line 90Yttrium-Ibritumomab Tiuxetan (Zevalin) in a Patient With Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma Refractory to Rituximab.
Oellers P, Savar A, Samaniego F, Pro B, Esmaeli B.
*Section of Ophthalmology, Department of Head and Neck Surgery; and †Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A.
Abstract
Lymphoma of mucosa-associated lymphoid tissue (MALT) is the most common variety of lymphoma seen in the ocular adnexae. The authors present the case of a patient with MALT lymphoma refractory to treatment with rituximab. Subsequent treatment with 90Yttrium-Ibritumomab tiuxetan yielded a complete response.
NGNM: CMS’s rationale for prohibiting direct billing by the labs is to prevent double billing, is that correct?
Technically, that's correct, although it is not truly double billing, per se. Prior to the sunset, NGNM was allowed to bill for the technical component of the testing and the hospital would bill for the clinical interpretation of the results.
"This sort of testing is definitely the direction things are headed, but NGNM might actually be out in front of most oncologists and pathologists right now."
Peter, you are also correct. The co. acknowledges that this kind of testing is in anticipation of treatments designed for specific oncogenetic mutations and they state that the test will also help to identify what clinical trials a patient may qualify for.
aj
DGX and LH each reduce guidance
NGNM also reduced guidance for Q3, based on the sunset of the GF clause allowing independent tech billing for hospital accounts. In their CC yesterday, they announced that although this would be a drag on revenues for one quarter, they're sales staff was "out in front" of this, educating their accounts about the change and even indicating that, because of these changes, the accounts might be better served with NGNM providing more comprehensive services in a semi-exclusive relationship. Mgmt reported that the response has been good, with several clients signing up for this upgraded service, and that they have lost only one account because of the reimbursement change. They provided no guidance for additional revenue because they stated it was too early to gauge the potential for increased revenue.
The co. also responded to a question about recurring revenue by sector (eg. histology, FISH, targeted molecular genetics etc.) and part of that reply was to note that current molecular level testing was only 6% of current revenue, but is growing at 185% yoy. This information, along with the PR release from Wed (see below) suggests to me that NGNM continues to aggressively look for niche services that are in high growth demand areas and have cutting edge technology for delivery of those servcies. BTW, they also reported that they were now profitable with the low level comlexity testing, which had been a drag on profitability in the past.
http://finance.yahoo.com/news/neogenomics-significantly-expands-molecular-testing-110000287.html
"The first NeoTYPE™ Panels will provide comprehensive molecular profiles of certain solid tumor cancers, but the Company expects to offer additional NeoTYPE™ Panels for hematopoietic cancers in the future. Each NeoTYPE™ Panel will profile the molecular abnormalities in a cancer by using high throughput, highly reliable Sanger sequencing and will use ancillary FISH testing if deemed necessary. These NeoTYPE™ Panels are specifically designed to help physicians better plan the therapeutic approach for their cancer patients as well as help determine if a patient would be a good candidate for one of the many new cancer therapeutics that are currently in clinical trials. The initial NeoTYPE™ Panels are based on sequencing combinations of the following 10 oncogenes: TP53, KRAS, NRAS, PIK3CA, BRAF, EGFR, c-KIT, IDH1, IDH2 and DNMT3A, however, additional oncogenes may be added or substituted depending on the type of cancer being targeted in each panel. The initial NeoTYPE™ Solid Tumor Profiles are:
•NeoTYPE™ Breast Tumor Profile
•NeoTYPE™ Colorectal Tumor Profile
•NeoTYPE™ Gastric Tumor Profile
•NeoTYPE™ Lung Tumor Profile
•NeoTYPE™ Solid Tumor (Other) Profile
Douglas VanOort, the Company's Chairman and CEO, commented, "NeoGenomics now has one of the most advanced molecular testing labs in the United States. Many of these new tests use bi-directional Sanger sequencing, currently the gold standard in molecular testing. Bi-directional sequencing is significantly more powerful than traditional polymerase chain reaction (PCR) analysis, which only allows for the analysis of specific point mutations on a certain gene. Bi-directional sequencing, on the other hand, allows us to analyze all the DNA sequences on a given gene, which enables us to detect a greater number of mutations. Dr. Albitar's extensive background in molecular testing is allowing us to rapidly accelerate our plans for our molecular laboratory to take advantages of the enormous growth opportunities in this segment of the market."
I am not sophisticated enough in genetics testing to know what the competition is like in this space, but the CC response to a question about this indicated that mgmt's opinion is that there are few, if any, labs providing this level of sophistication. Whether there is a market for these services and the extent to which they will be able to capture this segment remains to be seen, but the 185% growth number was impressive.
aj
SPPI: "Then what for the stock and company? Zevalin, Apaz, Belinostat, Allos are not the answer for continued growth"
There's potential for Zevalin, IMO. While I may be naive about the limits for this drug (and Dew has pointed them out), there is such domination from the competition, Rituxan, that anything positive could be used to take market share away. A head to head battle with a positive outcome for Zevalin would help, and we'll know something about the following study by the end of this year, according to the last CC.
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
http://clinicaltrials.gov/show/NCT00662948
Zevalin continue to be clinically measured for efficacy:
Spectrum Pharmaceuticals Announces Outstanding ZEVALIN® Clinical Data In Aggressive Relapsed/Refractory Lymphoma; Presented at the 17th Congress of the European Hematology Association
http://finance.yahoo.com/news/spectrum-pharmaceuticals-announces-outstanding-zevalin-110000224.html
and SPPI has a pipeline that inlcudes the following:
Spectrum Pharmaceuticals Launches Lucanthone Phase 2 Clinical Trial for the Treatment of Primary Glioblastoma Multiforme (GBM)"
http://finance.yahoo.com/news/spectrum-pharmaceuticals-launches-lucanthone-phase-110000665.html
although I haven't even looked at this drug.
The long time longs report that fotolyn is used by the same oncologists who use Fusilev and is not competitive, so adding this to a sales rep's kit bag might increase sales without bigt expense.
aj
SPPI: "I think SPPI's physician loyalty argument is hogwash."
That issue may be a personal bias on my part: I am a health care practitioner and observe physician prescribing predilections all the time. I don't interact professionally with oncologists but if one can tell a dying patient, "This is better than the generic because it is purer, likely to have fewer side effects, is covered by your insurance, and is more reliably supplied by the manufacturer." I suspect that they will prefer it as well.
The disincentive for using generic leucovrin can't be considered on an economic basis alone. The interaction of both disincentives is what I think will keep Fusilev profitable for years. Consider this as well. These meds must be rep'd by the co.'s who manufacture them and since the margins are so low on the generic, even if the co. could make it profitably, could the rep, rep it profitably?
aj
SPPI: While Seeking Alpha has a low regard, in general, on this board, the following article presents a well balanced rationale for investment. I won't post the whole article but will say that the argument that Fusilev sales will remain above expectations for numerous reasons (and particularly because of physician loyalty + compensation benefits) as well as the argument that the short position here has far from played out (and short capitulation/squeeze won't happen at least until above expected Q3 numbers come in, IMO) are well stated.
Spectrum Pharmaceuticals: Bears Beware, Fusilev Strength Points To Strong Second Quarter
http://seekingalpha.com/article/721201-spectrum-pharmaceuticals-bears-beware-fusilev-strength-points-to-strong-second-quarter?source=yahoo
Best,
aj
OT: Diamond in the rough
Hey, thanks, McBio for the link to the GIA interactive site. It's quite a well done site for examples of the gradations of the "4C's"
I have a strong avocation for rock hounding and gemology and now have the GIA site in my "gems" favorites.
As for OXPA, looks like an ugly rough stone to me as well.
(http://gia4cs.gia.edu/EN-US/fcd-color.htm )
OT: NFLX
first, thanks Dew for the technical assistance, quite helpful. Dav, I'm not one to dabble in investing in cutting edge tech (lost my stomach for that in the 90's) so won't guess at what NFLX will look like in 5 years, or what any of our media streaming will look like in 5 years! That said, the co. provides a good service and I am watching (literally and figuratively) first hand how our family is shaking off "programming" at long last. I watch very little video overall, but am streaming more and more, rather than to "watch" what some co. deems to put into a time slot.
BTW, I have the netflix app on my android phone as well, haven't used it, but with the new HTC EVO and its racehorse central processor (and 4G service), I'm looking forward to catching bits of some video on the fly (who could turn down a little Barney Miller.)
best,
aj
OT: NFLX
avg 37hrs per account i read..seems a bit over the top
Not so much, I have 3 teenaged daughters (and a wife) who do more streaming, these summer months, than watching regular programming, by far. We have even reached the limits of our bandwidth; I tried to log on and watch an old favorite, "Time Bandits" and netflix told me that there were too many users currently logged on and streaming in my house {;^\
OT: OCD
anyone who analyzes and tracks his stool microorganisms on a regular basis would, prima facie, seem to have a modicum of health-related anxiety, whether or not it is acknowledged.
Couldn't disagree with this statement more. Fecal analysis may be "the last frontier" of micro-lab analysis for human regulatory processes, but has both a very long history of utility dating back to traditional chinese medicine. Anyone following on with this tradition should be proud of the heritage.
OCD (Obsessive-Compulsive Disorder) is not the only "OCD" out there. Smarr (like many scientists and likely many readers here) is likely to have "Obsessive-Compulsive Personality Traits" (or maybe the Axis 2 disorder, but let's give him the benefit of the doubt.) People with the personality traits are perfectionistic, detailed and have skill in ordering things, bringing sense to complex and interacting datasets. They are not driven by anxiety so much as anger/frustration with chaos that they either have no control over, or have been unsuccessful in recruiting others to take care of.
JM2C,
aj
SPPI: Generic competitor recalls batches of Leucovorin. Fusilev sales have been hitting records, W-K data collection indicates that these increases will continue, and physician survey data indicate that they are likely to stay with Fusilev even when (IF) generic Luecovorin becomes available again. Bedford has not made available start dates on other dosing for Leucovorin (see http://www.bedfordlabs.com/content/dam/internet/opu/bedfordlabs/com_EN/documents/Availability%20Reports/Customer_Supply_Report_07032012.pdf )
Bedford Laboratories™ Issues Nationwide Voluntary Hospital/User-Level Recall Of Leucovorin Calcium Injection
http://finance.yahoo.com/news/bedford-laboratories-issues-nationwide-voluntary-194600479.html
Bedford Laboratories has informed the U.S. Food and Drug Administration (FDA) of its actions and is maintaining ongoing discussions with the agency. This voluntary recall is being conducted with the knowledge of the U.S. FDA.
The discovery was made due to a field product complaint for visible crystalline particulate and discovery of crystalline particulate in a retained sample. To date, there have been no reports of any adverse events for the lots being recalled. Our highest priority is the delivery of safe and effective medicines for the patients who need them.
As is standard practice, and as stated in the Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."
risperdal litigation It will be interesting to see how this plays out. The state of AR found J&J/Janssen liable for $1.2 billion in damages for the same issue. It is being appealed, but I wouldn't bet against a HUGE chunk of money coming AR's way.
aj
SPPI: Spectrum Pharmaceuticals Announces Outstanding ZEVALIN® Clinical Data In Aggressive Relapsed/Refratory Lymphoma; Presented at the 17th Congress of the European Hematology Association
•Impressive and statistically significant (p=0.03) overall survival rate of 91% with ZEVALIN plus high dose chemotherapy (Z-BEAM) vs. 62% with BEAM chemotherapy alone was seen in aggressive relapsed/refractory lymphoma.
•Early data published in January 2012 in “CANCER”, the Journal of the American Cancer Society, were updated.
•ZEVALIN has the potential to become an integral part of the standard of care in pre-treatment of patients with aggressive lymphomas who require an autologous stem cell transplantation (ASCT).
http://finance.yahoo.com/news/spectrum-pharmaceuticals-announces-outstanding-zevalin-110000224.html
This is a small sample size study, but the word that Zevalin is dead from a commercial standpoint appears to be premature.
Spectrum Pharmaceuticals, Inc. (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced new clinical data presented in an oral presentation for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA). In one of only four abstracts accepted for oral presentation in the meeting’s clinical transplantation session (Abstract # 1118), Dr. Avichai Shimoni (Chaim Sheba Medical Center, Tel Hashomer, Israel) presented an update with longer follow-up time from a multi-center, prospective randomized study, for which he reported that ZEVALIN administered in combination with BCNU, etoposide, cytarabine (Ara-C), melphalan (BEAM) therapy — Z-BEAM — resulted in a 91% two-year overall survival (OS) rate in patients with refractory/relapsed aggressive lymphoma, versus a 62% OS rate in patients administered BEAM alone (p=0.03). Based on these findings, which were updated from results published January 2012 in the journal "CANCER", the Journal of the American Cancer Society, Spectrum's development program for ZEVALIN has been expanded to include support for a larger, randomized international study using the Z-BEAM regimen as a preparative regimen for patients with lymphoma who receive autologous stem cell transplantation (ASCT). This international study, known as the “SPINOZA trial” (Study with Preparatory Induction Of ZEVALIN in Aggressive Lymphoma), recently started accrual.
“Patients with relapsed/refractory aggressive lymphomas have an abysmal prognosis and greatly reduced overall survival compared to those with indolent cancer. While stem cell transplantation has become the standard of care for appropriate patients in this setting, unfortunately there is no standard preparatory regimen prior to ASCT,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “We believe that these results, should they be confirmed in the broader clinical program currently underway, will be key in optimizing the preparative regimen by incorporating ZEVALIN and thus improving outcomes for these patients”.
In the Z-BEAM study, 43 patients with CD20-positive, aggressive lymphoma (34 with diffuse large B-cell lymphoma (DLBCL); 9 with transformed follicular lymphoma) were randomized to a treatment arm (Z-BEAM, N=22) or control arm (BEAM alone, N=21). Patient and disease characteristics were well matched between the groups. Median follow-up was 39 months, and at the time of analysis, all patients had reached the primary endpoint of 2-year overall survival. Results for overall survival were improved for patients receiving Z-BEAM compared to BEAM in 34 patients with DLBCL (2-year OS 94% Z-BEAM versus 56% BEAM, p=0.01). These and other findings from the study led the study researchers to conclude that “standard-dose ZEVALIN combined with BEAM high-dose chemotherapy is safe and possibly more effective than BEAM alone as conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.”
Colonoscopy: This was some years ago, but my PCP ran a full colonscopy on me, unmedicated and had the machine turned around so I could watch the screen all the way to my cecum as he blew me up like a balloon! As I was virtually overwhelmed by the subjective "feeling" associated with an inflated colon, he would point out the minor AVM's and engage me in conversation. All I could remember was being glad that I knew that the "urge" was phantom, and the utter relief as he deflated me.
Several years later, I did a follow-up with a gastroenterologist who used verced. As I recovered from the aneasthetic, one of his partners tried to pigeon hole me about his mother-in-law, who had Fronto-temporal dementia and what he and his wife should do. I was too whacked out to tell him to F*&K off and make an appointment!
aj
CPRS: Share price hammered as the co. announces an offer in an attempt to raise operating cash. I track this after someone posted about the co. It is down better than 34% on the news. Their lead candidate, CPP-109 in in phase II-B for cocaine addiction and if memory serves, they are working on this phase II-B in the VA system. Reading the posts on the YMB leads one to think that the longs there have NO faith in mgmt, and there was a clear mass exodus today on the news of dilution.
http://www.bizjournals.com/southflorida/news/2012/05/24/catalyst-pharma-plans-4m-offering.html?ana=yfcpc
Catalyst Pharmaceutical Partners announced a stock offering that could raise $4 million.
The Coral Gables-based developmental-stage company (NASDAQ: CPRX) plans to issue 6 million units, with each unit consisting of one share of common stock plus a warrant to purchase another share in the future, for 80 cents each. The five-year warrants can be used to purchase Catalyst shares for $1.04.
Cowen and Co. is the book-running manager for the offering, while Roth Capital Partners is the co-manager. The company expects the offering to close by May 30.
Catalyst said it would use the $4 million in proceeds, which is net of expenses from the offering, to fund its clinical trials and the potential commercial launch of its drugs.
The company has two drug candidates. CPP-109 is in a Phase II(b) study for the treatment of cocaine addiction, and Catalyst hopes the drug could treat other forms of addition as well. Its CPP-115 is being evaluated for both addiction treatment and epilepsy. A Phase I(a) study for CPP-115 recently found that patients tolerated the drug without harmful effects. A future trial would test the drug’s effectiveness.
The company lost $1.09 million in the first quarter, following its $6.39 million loss in 2011. It has no revenue.
Catalyst shares fell 15 cents to 72 cents in early morning trading. The 52-week high was $2.25 on June 10. The 52-week low was 75 cents on April 20.
Bernie Sanders Offers Plan To Cut Prescription Drug Prices
A DOA plan but I am curious what members here think of the proposal.
http://www.huffingtonpost.com/2012/05/19/bernie-sanders-prescription-drug-prices_n_1528332.html
WASHINGTON -- Sen. Bernie Sanders (I-Vt.) is promoting a new plan to encourage the development of better, cheaper prescription drugs: an innovation fund rewarding companies for inventing important new HIV and AIDS medications. In exchange for accepting an innovation award, drugmakers would agree to sell their new medicines at low prices.
Drugs developed over the past two decades have dramatically improved life expectancy for those living with HIV, but the medications remain unaffordable in many nations hit hardest by the epidemic. High drug costs also hamper relief programs In the U.S., where 2,759 low-income Americans are currently on waiting lists seeking treatment, according to the National Alliance of State and Territorial AIDS Directors.
"One of the great moral issues of our day is that there are people in our country suffering and in some cases dying because they are not able to afford a medicine that can be produced for pennies per treatment," Sanders said during a Tuesday hearing in Congress. "The simple fact is that the prices of patent medicines are a significant barrier to access to health for millions of uninsured and underinsured Americans and people die because of it."
Drug prices are dramatically inflated by the restrictive American patent system, which grants companies long-term monopolies on new drugs they develop. The problem is particularly acute for AIDS drugs, which require decades of constant use to be effective. During the hearing, Sanders discussed one such drug, Atripla, which he said costs roughly $25,000 a year for a single patient in the U.S., where it is marketed jointly by Gilead Sciences and Bristol-Myers Squibb. In countries that allow generic drugs to compete with Atripla, treatment is just $200 a year.
Each patient enrolled in the taxpayer-funded AIDS Drug Assistance Program costs an average of about $9,400 a year, said Mohammad N. Akhter, director of the Washington, D.C., Department of Health, at Tuesday's hearing. HIV medications cost more than $300,000 per person over the course of a single patient's lifetime. The U.S. Centers for Disease Control and Prevention estimates 50,000 Americans are diagnosed with HIV every year.
Drug companies say patents allow them to recoup the hefty costs associated with researching and developing new drugs and winning regulatory approval to sell them. But public health experts say the existing system leads to needless death. Although many countries reject patents for important medications, developing nations face intense political pressure to adopt American-style drug patents in order to receive trade perks and other economic benefits from the U.S.
"Current incentive systems fail to generate enough research and development, in either the private or public sectors, to address the health care needs of developing countries concluded an April report by the World Health Organization. "There is therefore an economic case, based on market failure, for public action. There is also a moral case. We have the technical means to provide access to lifesaving medicines, and to develop new products needed in developing countries, but yet millions of people suffer and die for lack of access to existing products and to those that do not yet exist."
Sanders has introduced legislation that would offer companies a big up-front prize for developing new, innovative AIDS drugs. In return for the big payday, pharmaceutical firms would agree to allow generic versions of their medicines to hit the market immediately. The fund would total $3 billion for its first year.
"Moving from a patent system to an effective prize system, using the power of the competitive marketplace to ensure the efficient dissemination of medicines, is a critical step in creating [a] more efficient innovation system," Nobel Prize-winning economist Joseph Stiglitz said at Tuesday's hearing.
Despite the big prize fund, some economists said they expect the plan would actually reduce the federal budget deficit. By making much cheaper generic versions of expensive drugs available to government programs like Medicare and Medicaid, Sanders said he hopes to ultimately save taxpayers money. According to economist Dean Baker, Americans pay a total of $270 billion more each year on prescription drugs than they would without patent-granted monopolies on medicine. The Congressional Budget Office has not scored Sanders' proposal for its budget impact, and is unlikely to do so barring pressure from Democratic Party leadership.
Sanders' proposal enjoys support from public health experts. Pharmaceutical companies that profit handsomely with the status quo are resistant.
And so is the Obama administration. The White House agency responsible for negotiating trade pacts, the Office of the U.S. Trade Representative, is currently pushing for restrictive intellectual property standards that would not only cement the American drug financing system abroad, but actually go further in establishing intellectual property-based monopolies on medicine abroad. The trade representative is currently negotiating intellectual property and other issues with eight nations, in a deal dubbed the Trans-Pacific Partnership. House Oversight Committee Chairman Darrell Issa (R-Calif.) leaked the text of the draft intellectual property chapter to his website on Tuesday, out of separate concerns that the trade representative's position would undermine Internet and technology innovation.
The Office of the U.S. Trade Representative emphasizes that it is seeking to eliminate tariffs on medicines, which should play some role in lowering prices, but said that robust intellectual property standards encourage the development of useful new drugs.
Intellectual property rights "provide important incentives for the invention and development of new medicines to treat a wide range of diseases and conditions -- medicines that should and do become available for generic production," trade representative spokeswoman Carol Guthrie told HuffPost. "The United States is working with stakeholders across the spectrum to strike the right balance" in the Trans-Pacific Partnership.
"It's a nightmare for global health advocates," said Judit Rius, U.S. manager of Doctors Without Borders Access Campaign. "It's one of the biggest threats we've seen promoted by the U.S. government to the sustainability of public health in the developing world. ... They say they are trying to save more lives, treat more people as soon as possible with newer and better drugs." But the intellectual property proposal in the Trans-Pacific Partnership "would delay access to these drugs for a very long time," Rius said.
ABT licenses prostate-cancer biomarkers from Stanford University:
I have great hope that this will have big ramifications for NGNM because ABT owns 10% of us and this is what we all were looking for when the deal was signed!
aj
Semi-OT: J&J/Janssen and Risperdol
This is huge for our state. The fine, if it stands, will likely save our state medicaid system from the eventual implosion that is likely to occur in many of the other states facing the same or similar funding problems with regard to the medicaid program.
AR law requires that the money recovered be used exclusively for medicaid funding and, in function, will serve as a trust with funds that will be north of $80 million per year for medicaid.
The large dollar verdict (in comparison to much smaller verdicts/settlements in much larger states) occured because of the specific law that levies fines for each instance of the consumer protect law. The state had documentation of 1000's of letters sent to doctors about risperdol.
I'm not a legal expert, but given the fine, would expect an appeal, if it is allowed. I don't hold much hope out for that process however. AR's tobacco litigation settlement funds amounted to $446 million. Last year, that fund generated $56 million in income.
AJ
SPPI did bounce off 9 ,on the face its looks decent @ 10's, the phase 3 failure counterbalanced with aquisition news on same day is weird,lol
I don't think weird, more like calculated.
The acquisition will be a long-term positive although the big question is whether sales of Fusilev will continue to show growth and at what level. Sales of Zevalin and Folytin combined are paltry, but with modest growth potential.
aj
etanercept and Alzheimer's
Just as your news item's date indicates, this has been around for some time and the general lack of follow-up reporting generates pause in considering the initial observations. Very small sample size-based observational reports are a good starting point in medical research, but often lead to diminishing (and sometimes nonextistent) cause and effect relationships.
That said, read on about what a local friend and top alzheimer's reseracher has to say about the phenomenon:
Commentary
Perispinal etanercept: Potential as an Alzheimer therapeutic
W Sue T Griffin
Correspondence: W Sue T Griffin griffinsuet@uams.edu
http://www.jneuroinflammation.com/content/5/1/3
Tumor necrosis factor-alpha (TNF) is one of a number of systemic and immunomodulating cytokines that generally act to promote acute-phase reactions but can drive degenerative changes when chronically elevated. Traditional focus on TNF has been directed at these inflammation-related functions. Of particular relevance to intersections between neuroinflammation and neurodegeneration is the ability of TNF to increase expression of interleukin-1 (IL-1), which in turn increases production of the precursors necessary for formation of amyloid plaques, neurofibrillary tangles, and Lewy bodies. More recent data have revealed that TNF, one of the few gliotransmitters, has strikingly acute effects on synaptic physiology. These complex influences on neural health suggest that manipulation of this cytokine might have important impacts on diseases characterized by glial activation, cytokine-mediated neuroinflammation, and synaptic dysfunction. Toward such manipulation in Alzheimer's disease, a six-month study was conducted with 15 probable-Alzheimer patients who were treated weekly with perispinal injection of Etanercept, an FDA-approved TNF inhibitor that is now widely used for treatment of rheumatoid arthritis and other systemic diseases associated with inflammation. The results demonstrated that perispinal administration of etanercept could provide sustained improvement in cognitive function for Alzheimer patients. Additionally, the authors were impressed by the striking rapidity with which these improvements occurred in the study patients. An example of this rapid improvement is presented in this issue as a case report by Tobinick and Gross. Such rapid gain of function inspires speculation about the role of gliotransmission or other equally rapid synaptic events in the relationship of TNF to Alzheimer-impacted neurophysiology. Because of the inability of large molecules such as etanercept to cross the blood brain barrier following conventional systemic administration, it is likely that the more direct drug delivery system pioneered by Tobinick also contributed to the effectiveness of the treatment. If so, this system could be useful in drug delivery to the brain in other neural disorders, as well as in animal research studies, many of which currently employ delivery strategies that inflict damage to neural cells and thus engender neuroinflammatory responses.
Commentator observations
In this section, my comments reflect my own thoughts on this treatment strategy and my own experiences in viewing it, and are accompanied by a few of my own remarks directed toward the necessity of giving attention to this novel treatment. I first became aware of this treatment when a reporter from The Los Angeles Times contacted me in 2006 for a comment on an article he was writing on a novel and successful Alzheimer treatment trial. Although my interest was piqued by this, it was only more recently when Dr. Tobinick contacted me and sent a preprint of the findings discussed in the Times [3] that I decided to go and see for myself the treatment and talk to the patients and family members. I called the day before, and was invited to visit the next day, November 7, 2007. Each of the three patients I saw treated had been tested and diagnosed with probable Alzheimer's disease by a neurologist before perispinal etanercept treatment had begun. They and their families invited me to be present during the treatment and in the interviews before and after. I noticed clinical improvement in each of the three patients within minutes following treatment. My first impression was that there was a clear, easily discernible, difference in each. They were more cheerful, more at ease, and more attentive. My impressions were the same as those shared by each of the families (please see the movie for example). This rapid turn around brought to mind the first time, now almost two decades ago[17], that I was the original witness to the remarkable overexpression of immune cytokines in activated glia in Alzheimer patients and even in fetuses and neonates with Down's syndrome – I was amazed!
Conclusion
The most important outcome of this case, in the mind of the commentator, is that we endeavor to reduce the bias that is inherent and important in scientific thinking, but which, unfortunately, can impede timely consideration of new scientific approaches. Recognition of the role of cytokines in the pathogenesis of Alzheimer's disease provided a new paradigm for the Alzheimer research community [18]. And now, the therapeutic intervention in this case report provides a new approach to regulation of the role that cytokines play in pathogenesis. In view of this, constructive scientific approaches to examine and further investigate the beneficial results reported for perispinal etanercept treatment should be undertaken. Taking advantage of what we have learned in the past will allow for synthesis of new hypotheses toward our common goal of solving the riddle of Alzheimer's disease. Such efforts are imperative for the millions who suffer, for their families, and for the social and economic health of our society. As pointed out dramatically by Andrew Grove in a speech at the meeting of the Society for Neuroscience this year, a new and more productive approach to researching, discovering, and bringing to the public the news of effective treatments for neurodegenerative diseases is long overdue. This case report is published in an effort to broaden the spectrum of such potential treatment strategies for Alzheimer's disease, and for other diseases mediated by cytokines. Hopefully, our efforts will be supported by rapid allocation of the resources necessary for both basic and clinical scientific investigations that will answer Mr. Grove's revolutionary challenge.
SPPI: Agreed with regard to your "here to stay" statement. I believe that SPPI has already commented publicly that Fusilev will again have increased sales and because leucovorin is not exactly the same, there will continue to be a bias from physicians to use the branded product as well as a headwind in marketing leucovorin. The article suggests that the generic manufacturing of leucovorin has evaporated because of this headwind and if so, will propel Fusilev sales higher yet. The shortage, however, is not as simple as that, and manugacture will likely rebound to some degree. What is interesting is that manufacturers of leucovorin have started marketing their products directly to hospitals rather than to wholesalers and this is likely to take a long time to roll out, with Fusilev benefiting from the change in marketing. If Fusilev is also being marketed directly to hospitals, I would guess that the markup is proportional to the cost and Fusilev would be a better deal for the hospitals. Hospitals need all the help they can get with their billing margins.
I like the current price and status of SPPI. It is profitable, has a decent (and possibly quasiblockbuster) pipeline, and is growing. Most of the past threads have been about how disappointing Zevalin would be, and I have no problems with that argument. Even here, though, there is some upside potential.
JM2C,
aj
SPPI: A bit surprised that there has been no response to this post. I have had SPPI on my watch list for some time, had read previous threads here about the limitations of this co.'s products as well as the general tenor of opinion regarding Seeking Alpha articles. All that said, there appears to be a real opportunity here, at least in the intermediate term. Does anyone think that the Seeking Alpha analysis is just plain wrong?
AJ
i honestly think ipad and similiar devices are clearly the future in many,many uses,we are just scratching the surface.
Agreed, and if I ever get off my ass and finish learning to write Java code and android app code (the books are languishing on my bedside bookshelf), I will be putting some psychotherapy apps on the market myself!
aj
AAPL: ...now if they invented the i-glucose meter attachment/app it wouldnt be OT here,lol.
Not so far off as you think! I have long maintained some ideas about smart phones that could be portable ECG's, providing real-time "holter monitor" data, sent directly to the physician. Looks like there are more that just a few of these app's being developed as we speak!
http://appsparq.com/blog/?p=1033
Katie Matlack, is a medical analyst at Software Advice. She writes an interesting blog on medical devices.
Recently she had one blog entry that covered some recent interesting Smartphone medical devices and one that followed it up with medical devices she wishes we had!
5 Medical Peripherals for the iPad or iPhone is an interesting blog entry that talks about the iBGStar Glucose Meter, AliveCor ECG, Withings BP Monitor, ECEM Pulse Oximeter, and the Mobius SP1 Ultrasound Imaging Device. This blog has covered the AliveCor ECG before and the Ultrasound monitor before but the other devices are interesting to know about.
The Glucose meter is an add on that attaches to the bottom of the iPhone and is supposed to be better in accuracy than existing ones.
The Pulse Oximeter is also interesting and Katie’s blog entry has a link to an interesting demo video.
Katie’s follow up on 3 iPhone and iPad Medical Devices We’d Like to See is also a very interesting blog entry. The Diabetic Risk Calculator is an interesting idea that can go beyond just measuring and reporting Glucose Levels especially those that suspect that they may have pre-diabetic conditions and want to check it out!
CAMH: Two pieces of news that should make some difference in the use of MTWA but probably won't. I post these for reasons of nostalgia; CAMH was the co. that led me to this board some 6 years or so ago.
New Study Published in Heart Rhythm Journal Shows Patients with Positive Test Result Are Nearly Nine Times More Likely To Experience Sudden Cardiac Arrest
http://finance.yahoo.com/news/study-finds-cambridge-heart-mtwa-111500157.html
We have known this for years but cardiology in the US hasn't yielded to the use of MTWA as a second order criteria for ICD placement yet.
Cambridge Heart Announces Microvolt T-Wave Alternans Receives Reimbursement Coverage in Japan
http://finance.yahoo.com/news/cambridge-heart-announces-microvolt-t-111500996.html
Japan has always been more realistic in the use of science over business in their medical decision making; with some luck, CAMH will start selling units there. I still have a small position for shiggles.
AJ
Will partying now be an allowable medical tax deduction?
Please say yesOT:
Only if your insurance coverage includes birth control and you are on an HSA!
Sexual Deprivation Increases Ethanol Intake in Drosophila. Science 2012;335(6074):1351-5.
The brain’s reward systems reinforce behaviors required for species survival, including sex, food consumption, and social interaction. Drugs of abuse co-opt these neural pathways, which can lead to addiction.
Of course this explains both the proliferation of bars and barflies!
India Orders Bayer to License a Patented Drug
Natco’s drug will be for use only in India, the decision said.
Yeah, you can count on THAT happening!
aj
Seroquel case:
DAV's reply notwithstanding, it would seem nonsensical to me that a warning about possible development of glocuse intolerance would not be included in the generic version as the risk would be exactly the same as the branded drug. Is this what the labeling issue is for the generic?
aj
NGNM: Upwards guidance
Unfortunately, this was a counterpunch to the news regarding a 2% cut in medicare lab fees with a twist complicating billing arrangements between hospitals and free standing labs.
In Fixing Physician Medicare Pay, Congress Enacts Yet Another Cut in Clinical Laboratory Test Fee Schedule
http://www.darkdaily.com/in-fixing-physician-medicare-pay-congress-enacts-yet-another-cut-in-clinical-laboratory-test-fee-schedule-022012#axzz1nuCxNyMW
NGNM's CEO reports, "...However, we are disappointed that anticipated changes in the TC Grandfather Clause will now require us to concentrate on changing our billing practices rather than on improving cancer genetic testing. Until we can quantify the implications of these regulatory changes, we are suspending our full-year 2012 guidance. Over the next few months, we will focus on developing strategies to offset the potential negative impacts from this new legislation in the event that the TC Grandfather Clause is not extended further."
Apparently, there will be no more direct billing if the grandfather clause is not reinstated, so on top of a 2% cut in technical component reimbursement, there will likely be a cashflow disruption as the company (and all free standing labs) work out arrangements with each hospital for whom they perform testing. Frankly, I was expecting a bigger hit today.
AJ
Hasn't there been just a bit of research into LSD for clinical depression?
More than just a bit, I'd say. Nice little synopsis of the history of LSD research can be found at the following link:
http://www.psychedelic-library.org/grofhist.htm
The noted existential analyst RD Laing was known to investigate the psychotherapeutic efficacy of LSD as a tool used by the therapist to understand schizophrenia. I hold this man in special esteem for this!
aj
Are you sure it’s hype? Maybe Ketamine really is an effective antidepressant in the acute setting.
Bad choice of words. It actually appears to be quite effective, but there will be a strong headwind before getting it into the clinic (or more appropriately, into the ER/inpatient Psych setting) because of the abuse potential. Much more likely will be the emergence of scopalamine, which apparently has some of the same immediate effects.
http://www.medscape.org/viewarticle/545534
I meant "hype" as it applies to generating interest, valid or not, in companies developing it (as you probably guessed.)
The other club drug that appears to have significant potential is ecstacy.
FWIW,
aj