Michael Becker

Michael Becker
Contributor since: 2009
Company: MD Becker Partners LLC
TripNines,
We neither have an agenda nor have been lax in doing due diligence on Advaxis. The purpose of our article was to highlight the readouts from randomized Phase 2 or Phase 3 trials expected during the next 12-months, which could represent catalysts for the cancer immunotherapy sector. We solicited input from Advaxis and other immunotherapy companies as part of our research and Advaxis did not respond at all, which we assume meant that they did not have any Phase 2 or Phase 3 catalysts for 2012. Please note that initiating a trial doesn't qualify as a catalyst; rather only results from ongoing studies. Before you point fingers, please take time to observe the facts.
PEhrlich,
The majority of the programs with data readouts in 2012 appear to be non-autologous. Based on the Dendreon experience with Provenge, autologous products may be viewed as a greater commercial challenge. However, it really depends on whether or not the procedure fits within existing treatment paradigms. For example, leukapheresis is not part of the normal treatment of prostate cancer. In contrast, surgical removal of tissue is a common part of treating brain cancer - and if such tissue could be used to create a vaccine, this might be better received from a commercial perspective.
Thanks, Ted.
We do not comment on individual stocks.
No, as they are not a cancer immunotherapy company.
Your article is a nice overview of acute radiation syndrome [ARS] as it relates to the early hematopoietic effects. However, according to peer-reviewed literature, even in a severe form of ARS, this initial period can be managed with growth factors, such as Amgen’s (AMGN) granulocyte colony-stimulating factor [G-CSF, pegfilgrastim] along with additional supportive care and may no longer be the direct cause of death from ARS. Because large doses of radiation affect multiple systems, bone marrow recovery does not necessarily ensure survival. As a result, more attention should be focused on those organ systems that currently lack available treatment options, such as the lungs. None of the companies referenced in your article are focusing on the lung aspect of ARS.
To illustrate, the majority of ARS cases reported worldwide resulted from the April 1986 accident at the Chernobyl nuclear power station, which exposed about 200 people to large doses of total-body radiation. The diagnosis of ARS was confirmed in 134 persons from this accident, but there were no early fatalities among 91 [68%] patients with ARS grade II [2–4 Gy doses].
Of the 28 early deaths from Chernobyl, the majority occurred with people with whole‑body doses in excess of 6.5 Gy. This was before the availability of G-CSF, which is now available in stockpiles that have been developed in the U.S. and by the World Health Organization. In fact, Amgen’s G-CSF has recently demonstrated benefits in animal models of radiation exposure, as evidenced by approximate 80% survival at 60-days in animals exposed to 7.5 gy total body irradiation.
Because the lung is quite sensitive to the effects of radiation exposure, those people who survive early ARS through G-CSF and delivery of appropriate supportive care are potential candidates for the development of pulmonary complications. The radiation sensitivity of the lung is well established by the fact that it is a dose-limiting organ in cancer patients receiving total body irradiation [TBI] as part of a bone marrow transplantation regimen. This sensitivity was also evident after the Chernobyl accident, where a significant number of the early victims died from pneumonitis or as a direct result of their lung injuries [source: UNSCEAR. Sources, Effects and Risks of Ionizing Radiation. Report to the General Assembly,
Annex J: Exposures and Effects of the Chernobyl Accident. United Nations; New York: 2000].
ARS affects multiple organs beyond the hematopoietic system and bone marrow recovery does not necessarily ensure survival. Successful treatment of other organ failures, such as the lung, represents a large unmet medical need and deserves more attention.
Just curious, what is your source for "At least 50 cancer immunotherapy drugs are currently in clinical trials"?
The difference is that ipilimumab blocks a receptor with T-cell inhibitory activity and therefore increases T-cell activation across the board, while a bispecific antibody would only elicit a T-cell response when the target antigen (CD19) is bound to it. Ipilimumab acts directly on T-cells, whereas the bispecific antibody only engages T-cells in connection with the other end being bound to CD19. Both ipilimumab and bispecific antibodies are immunotherapies, but only ipilimumab is an "active" immunotherapy.
Immunotherapy can generally be divided into two segments - "passive" and "active" immunotherapy. The main focus of our article was active immunotherapy, not passive immunotherapy - which is how we classify Micromet's approach.
Passive immunotherapy typically refers to a monoclonal antibody that is developed outside of a patient's body. They are designed to attack foreign substances directly and do not stimulate a person's immune system to play an active role in fighting the disease. Because most antibodies developed and marketed to date have these characteristics (Herceptin, Erbitux, etc.), some people mistakenly label Bristol-Myers' Yervoy (ipilimumab) as passive immunotherapy instead of calling it an active immunotherapy.
However, an active immunotherapy (sometimes referenced as a "cancer vaccine") aids and/or stimulates the immune system to take an active role in attacking cancer cells. It is designed to trigger a response from a patient's immune system to fight tumor cells. In this regard, Bristol-Myers' Yervoy (ipilimumab) is really an active immunotherapy because of its direct effect on a patient's T cells.
It was not a mistake, as the article solely focused on "active immunotherapies" and Genta's product candidate (Genasense) does not qualify - as it inhibits production of a protein called Bcl-2. With regard to the "promising results" you mention, Genta's product failed to meet the co-primary endpoint of progression-free survival in a Phase 3 melanoma study. The drug also failed to meet secondary endpoints of overall response rate and disease control rate.
A single therapy is not likely to work for ARS. As a potentially multi-organ failure, ARS requires global therapy, beyond the hematopoietic syndrome to include treating the gastrointestinal syndrome and also the lungs.
Further, there is general agreement that Amgen’s (AMGN) granulocyte colony-stimulating factor (G-CSF, Neupogen) is an acceptable choice for treatment of hematopoietic or bone marrow syndrome in individuals receiving a whole-body radiation dose of 3 Gy or more. G-CSF is available in radiation stockpiles that have been developed in the U.S. and by the World Health Organization. Amgen’s Neupogen has also demonstrated superior survival data to Cleveland Biolabs’ CBLB502 in animal models, as evidenced by approximate 80% survival at 60-days in animals exposed to 7.5 gy total body irradiation (TBI) compared to approximate 70% survival at 40-days in animals exposed to lower TBI radiation (6.5 gy) in a similar CBLB502 study.
Agreed, a comprehensive analysis of the topic is beyond the scope of our brief article. However, I agree with your "cyclical" concept - as in addition to clinical stage preference, certain targets and diseases can be in vogue at one time, but out of favor at another. This can impact partnering. Also, the broader financial markets can impact whether capital is even available - and if so, at what price, which can impact a company's decision to go alone versus partner. On your last comment, I actually think that truly novel compounds or targets can sometimes attract the biggest partnerships or acquisitions, whereas "me too" product candidates may not.
Nice follow-up story titled "Copying Dendreon" by Brett Chase of Minyanville at link below:
www.minyanville.com/bu...
If you read the article, you'd notice that I did not fail to mention the point, as evidenced by the following quote from the article: "Such a strategy requires that the company can access resources and capital to develop and launch its product globally."
Agreed, moving along...
While I am flattered that you think the extensive list of companies that we’ve discussed in our articles over the years are clients (see our list below), that is not the case. Further, we do not get paid to write articles. Justin, as they say - "in a battle of wits, it is best not to show up unarmed."
ACAD, ACOR, ADLR, AEZS, AGEN, AGN, ALKS, ALPMF.PK, ALTH, ALXN, AMAG, AMGN, AMLN, ANDS, ARIA, ARNA, ARQL, ASTM, ATHX, AUXL, AVGN, AZN, BAYRY.PK, BHRT, BIIB, BMRN, BMY, BPAX, BVTI.PK, CBST, CEGE, CELG, CEPH, CGRB, CRME, CRTX, CTIC, CUR, CVTX, CYCC, CYPB, CYTK, CYTR, CYTX, DCTH, DEPO, DNA, DNDN, EMIS, END, ENDP, ENZN, ESALY.PK, EXEL, FACT, FOLD, FRX, GENT, GENZ, GERN, GILD, GNMSF.PK, GPRO, GSK, GTXI, HALO, HEB, HGSI, ICGN, IDEV, ILMN, IMCL, IMGN, IMMU, IPXL, ISIS, ITMN, JNJ, KERX, LBF, LIFE, LJPC, LLY, MAPP, MAXY, MDCO, MDT, MEDX, MEMY, MIPI, MITI, MNKD, MPHSF.PK, MRK, MYGN, NBI, NPSP, NRGN, NRGX.OB, NVO, NVS, OGXI, ONXX, OPXA, OSIP, OSIR, OXBDF.PK, PANC, PARD, PCYC, PFE, PGNX, PHYOY.PK, PLX, PPHM, PRAN, PRGO, PSTI, PTN, QGEN, REGN, RGN, RHHBY.PK, RPRX, SEPR, SGEN, SGMO, SHPGY, SLXP, SNSS, SNTA, SNTS, SNY, SPPI, SQNM, SRDX, STEM, SUPG, TARG, TECH, TELK, TEVA, TKPHF.PK, TRBN, UTHR, VICL, VNDA, VPHM, VRTX, VVUS, WCRX, WPI, WYE, XNPT, XOMA, ZIOP
Of the 33 articles Justin Hall has authored on SA (not counting instablogs), 28 include mention of Spectrum Pharma (SPPI). The majority of those articles are solely focused on SPPI.
Actually, you neglected to read the title and focus of the article: "frontline" AML therapies. Sunesis is going after relapsed/refractory, but they were included in Table 2 by way of background.
Nice article, Jason. Good points on the market reaction to the news...
The prostate cancer trial has been on a five-year hiatus. As highlighted in our 150-page report "Cancer Vaccine Therapies: Failures and Future Opportunities” (lifesciencedigest.com/.../), in January 2005, NWBO.OB received clearance from the FDA to initiate a Phase III trial of DCVax®-Prostate. However, according to ClinicalTrials.gov, the Phase III trial for DCVax®-Prostate was terminated (update as of June 23, 2005). See reference: ClinicalTrials.gov Identifier NCT00043212. With regard to the GBM study, it is not currently enrolling patients.
Since you have so much advice to offer, perhaps you should author original articles to convey your thoughts rather than sitting back and commenting on the work of others? Where is your biography and background? You are naïve regarding the competitive landscape for other cancer vaccines (especially from those that are not autologous). With regard to EMEA, have you seen NICE reject support for several other cancer products? And you are wrong - there are several immunotherapies approved for the treatment of cancer, they are called monoclonal antibodies. The distinction would be "active" immunotherapies, for which Provenge was the first to be approved in the U.S.
JustTwice - First, the article was not meant to provide a full description of the advantages of Provenge. We are advocates of active cancer immunotherapy and discussed the landscape in our recent 150-page report on the subject. Second, I don't appreciate being lumped together with the crowd you reference - but opinions are like noses and everyone has one. Third, median survival is the only fair metric to use at this point to justify the cost of therapy - and I clearly indicated that the price of Provenge is consistent with Taxotere when all costs are considered. Quality of life is very important (I launched an oral mucositis treatment in my career, so I'm familiar with the importance of supportive care...), but again this is outside the scope of an article designed to help explain the dramatic decline in Dendreon's stock since approval of Provenge.
No, it is taking the cost of treatment and dividing it by median survival.
Perhaps you should read the article again. No where did I reference "average" versus median survival.
They are profiled in our full report, this article is the executive summary.
You are correct, 1,000 to 2,000 serious ADEs (versus the incorrect 100k to 200k).
Hoopdreamerz - According to the company's press release from Friday, "of the estimated 35,000 patient exposures to date, 40 serious adverse events have been reported, an approximate rate of 0.1 percent." This is actually a lower rate of serious hypersensitivity reactions than reported in the prescribing information (3 out of 1,726 patients, or 0.2%). However, as you point out - by extrapolating the .1% to .2% rate of serious reactions to number of patients per million, you get a rate of 100,000 to 200,000 per one million patients treated. When compared to the rate of 12 to 58 per events per one million patients treated with four other formulations of intravenous iron referenced in our article (several of which carry a black box warning...), the rate of serious hypersensitivity reactions does appear much higher with Feraheme. While this isn't "new" information, as it is included in the product's prescribing information, a product's safety profile (along with cost, administration convenience, etc.) could ultimately play a role in physician prescribing preference and/or market penetration.
A comprehensive review of the Parkinson's disease therapeutic landscape is beyond the scope of our article. Accordingly, we focused only on those companies with "new" information following our August article. Note that the company you referenced did not report any information regarding its Parkinson's program during this period. Further, the title of our article is "Developments for Parkinson's Disease Ignite Investor Enthusiasm," and based on the recent price action there is apparently little investor enthusiasm for the company you referenced. Lastly, when you begin a message with incorrect grammar [eg, "why you don't mentioned"], it is difficult to take your "illiterate bushman" comment seriously.
On Nov 17 03:51 PM Vitautas wrote:
> Mr. Becker! Why you don't mentioned Newron Pharma when you talk about
> drugs against PD? They have an adavanced product with good results!
> Because you don't know them? Because their product is worthless?
> Because you think everyone outside the U.S. is an illiterate bushman?
Thank you. Unfortunately, we did not perform the currency translation - it was done by SA.
On Nov 17 01:55 PM maxiedog wrote:
> Check your UK pence to USD calculation. 10p is £0.1 not £1.
Justin,
Regarding any potential conflicts, I refer you to SA's seven conditions of Gold Standard Certification at: seekingalpha.com/page/...
In particular, read section "3. Disclosure of Conflicts of Interest"
the fact that "Authors agree to disclose any material relationships with companies whose stocks they write about or parties that stand to gain in any way from the viewpoint they are outlining."
As I have stated, I hold no such positions...
On Oct 13 12:53 AM Justin M. Hall wrote:
> I have tried to post something several times this evening, but to
> no avail.
>
> I'm floored as to why the sentiment is so negaitve about Zevalin.
> You may be right. To be fair, would you please disclose what companies
> you receive your income from Mr. Becker?
>
> Since I can no longer post anything at this blog, I am at a loss.
>
>
> Justin
I would not count on near-term Zevalin sales as driving the share price higher. Q2 '09 sales of $3.3 million from Zevalin might have been up 25% over Q1 '09, but that translates into growth from $2.6 million to $3.3 million, or an increase of a mere $700,000. More importantly, for 2006, Biogen Idec reported $16.4 million in U.S. Zevalin sales, which translates into average quarterly sales of $4.1 million - so no matter how you slice it, quarterly Zevalin sales today are lower than back in 2006. Lastly, an October 12, 2009, article by Adam Feuerstein reports that Amar Singh, Spectrum's chief commercial officer, says it will take three or four months before Spectrum has a clear view on how Zevalin sales are progressing.
Actually, what is making news (and hence, the topic of the article) is that Bayer AG (BAYRY.PK) entered into an $800 million deal with Algeta ASA (OSE: ALGETA) for its "first-in-class" alpha-pharmaceutical, Alpharadin [eg, Bayer's bold new bet]. The deal was announced on September 3, which is when our article first published on our blog site. Certainly not as intriguing as all of the unfounded conspiracy theories being advanced in this comment thread, but factually accurate nonetheless.
On Sep 06 05:07 PM User 482664 wrote:
> article has nothing to do with zevalin being approved for another
> indication ,which is what is making news
> ,its about bayer did not buy sppi
> y you did not write about all these drawbacks of zevakin before
>
> y did u choose the day it got approved to trash it
> because u have some shorties u want to help
> u should be ashamed of urself