ESALY.PK - News and Analysis from Seeking Alpha 'ESALY.PK' Tag RSS Syndication from SeekingAlpha.com SeekingAlpha.com http://seekingalpha.com/symbol/esaly.pk Healthcare Profits: Assessing Company Sensitivity to Obamacare http://seekingalpha.com/article/170164-healthcare-profits-assessing-company-sensitivity-to-obamacare?source=feed 170164 National healthcare wherever it is implemented squeezes prices and profits of the private businesses involved in the system.

Obamacare in the U.S. will be no different. For investors in healthcare companies, it is a good idea to begin to think through which companies will be most severely negatively impacted or least impacted, to potentially make deletions or substitutions.

]]> Fri, 30 Oct 2009 08:39:30 -0400 Richard Shaw Richard Shaw (QVM Group) submits:

National healthcare wherever it is implemented squeezes prices and profits of the private businesses involved in the system.

Obamacare in the U.S. will be no different. For investors in healthcare companies, it is a good idea to begin to think through which companies will be most severely negatively impacted or least impacted, to potentially make deletions or substitutions.


Complete Story »]]> AGN AMGN AZN BIIB BMY BSX CELG ESALY.PK GENZ GILD GSK JNJ LLY MRK NVO NVS PFE RHHBY.PK SGP SNY STJ WYE Richard Shaw SuperGen-Glaxo Deal Couldn't Have Come at a Better Time http://seekingalpha.com/article/169282-supergen-glaxo-deal-couldn-t-have-come-at-a-better-time?source=feed 169282 With sales of its lead drug losing headway to rival Celgene’s (CELG) Vidaza, striking a deal with GlaxoSmithKline (GSK) to collaborate on cancer drug discovery was just the tonic that SuperGen's (SUPG) shares needed. Monday, the California group announced that it had inked a deal worth up over $375 million to utilize its novel drug discovery technique, Climb, causing a 13% jump in its stock to $2.70.

Under an early stage, and therefore heavily back-end loaded, deal, Glaxo agreed to buy shares worth $3 million and pay $2 million in cash in return for SuperGen pushing a range of cancer compounds through to proof of concept. The total development milestones could eventually reach $375 million, and the group will be entitled to double digit royalties on any products produced by the collaboration.

]]> Tue, 27 Oct 2009 17:53:23 -0400 EP Vantage EP Vantage submits:

With sales of its lead drug losing headway to rival Celgene’s (CELG) Vidaza, striking a deal with GlaxoSmithKline (GSK) to collaborate on cancer drug discovery was just the tonic that SuperGen's (SUPG) shares needed. Monday, the California group announced that it had inked a deal worth up over $375 million to utilize its novel drug discovery technique, Climb, causing a 13% jump in its stock to $2.70.

Under an early stage, and therefore heavily back-end loaded, deal, Glaxo agreed to buy shares worth $3 million and pay $2 million in cash in return for SuperGen pushing a range of cancer compounds through to proof of concept. The total development milestones could eventually reach $375 million, and the group will be entitled to double digit royalties on any products produced by the collaboration.


Complete Story »]]> CELG ESALY.PK GSK JNJ SUPG EP Vantage Small Cap Stocks Battling Brain Cancer http://seekingalpha.com/article/160267-small-cap-stocks-battling-brain-cancer?source=feed 160267 Each year nearly 20,000 people in the U.S. are diagnosed with primary brain cancers (with a similar number in Europe), according to NCI/NIH statistics, with Schering-Plough's (NYSE:SGP) Temodar (temozolomide or TMZ is classified as a DNA-methylating chemotherapy drug) given to nearly every patient with a diagnosis of GBM (the most common and aggressive form of brain cancer). Newly diagnosed individuals with GBM typically undergo surgery (if possible) to remove the tumor, followed by radiation and chemotherapy with a median survival outcome of about 10-12 months.
In early May, Roche (RHHBY.PK) announced that the FDA granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma (GBM) that have progressive disease following prior therapy. Following initial treatment with chemotherapy and radiation, more than 90% of patients with GBM experience recurrence of the disease and few effective treatment options are available. In addition, Eisai (ESALY.PK) markets the Gliadel Wafer, which is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation as well as in patients with recurrent GBM as an adjunct to surgery.
Below is a selection of small and micro-cap stocks from my Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index that are involved in research activities to improve the treatment of brain cancer. In addition, three of the companies profiled below are among 10 stocks in the Mentor Capital Cancer Immunotherapy Index (MNTR.pk).
Northwest Biotherapeutics (NWBO.OB) is developing DCVax-Brain as an experimental autologous (patient-derived) cellular therapy that is designed to create a specific immune response against a patient’s cancer. DCVax-Brain utilizes a patient’s own dendritic cells (DC), and an extract of the patient’s own tumor cells to achieve an immune response.
In early April, Ark Therapeutics (ARKTF.PK) announced the first update of results for its Cerepro Phase 3 clinical trial as a novel gene-based medicine for the treatment of operable malignant glioma. The study is being conducted to confirm the safety and efficacy of Cerepro in patients with operable high grade glioma (brain cancer) against current standard treatment options, including (1) surgery and radiotherapy or (2) surgery and radiotherapy followed approximately 40 days post-op by temozolomide.
Significance levels associated with the main data have improved in the update analyses and 29 patients have yet to reach a primary endpoint event (versus 53 previously), of which 18 have been treated with Cerepro and 11 received standard of care treatment. Data suggests improved overall survival in patients receiving Cerepro after about 500 days with 56 patients in the trial still alive. A marketing approval application (MAA) in Europe for Cerepro was filed with the EMEA in 4Q08 and an opinion from the CHMP is expected during 4Q09.
Cerepro is a novel gene-based product for the treatment of patients with operable high grade glioma and utilizes a well-established adenoviral vector (Ad5) to introduce the gene that causes cells to express a protein called thymidine kinase ("TK"). Following the standard surgery to remove the solid tumor mass, Cerepro is injected through the wall of the cavity left behind by the surgical removal of the solid tumor, into the surrounding healthy brain tissue. In the following days, the healthy cells in the wall of the cavity express TK.
Five days after surgery, the drug ganciclovir (GCV) is given to the patient as part of the overall Cerepro treatment regimen. Neither TK nor GCV is individually active but they react together to produce a substance which destroys cells when they try to divide. Since cell division is a key characteristic of cancer and the normal brain cells are not dividing, cells that try to divide to form a new tumor around the site of the removal of the original tumor are targeted for destruction by the Cerepro treatment.
Exelixis (NASDAQ:EXEL) is co-developing XL184 (BMS-907351) along with Bristol-Myers (NYSE:BMY). A Phase 2 trial of XL184 in subjects with progressive or recurrent GBM in first or second relapse is ongoing. XL184 inhibits MET, VEGFR2, and RET, which are key drivers of tumor formation, growth, and metastasis. The Company is also co-developing XL765 along with Sanofi-Aventis (NYSE:SNY). XL765 targets both PI3K and mTOR, which are key elements in pathways leading to cell proliferation and is currently being evaluated in a Phase 1b/2 trial in combination with Temodar in GBM patients.
ImmunoCellular Therapeutics (IMUC.OB) is a cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs).

This approach is in the early stages of development, but has the potential to become a paradigm-shifting therapeutic approach to the treatment of cancer. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which can be used to develop targeted mAbs and CSC immunotherapy products.
Although CSCs account for a small proportion of the cells in a given tumor, a growing body of scientific literature suggests CSCs drive the process of tumor growth and recurrence (even after the disease is undetectable and thought to be eradicated). Current therapeutic options such as radiation therapy or chemo target the proliferating cells, which form the bulk of any tumor mass while the CSCs lie dormant and unaffected at the root of the disease. Thus, a non-detectable number of CSCs may persist even after a patient is in remission, leading to the potential for recurrence of the disease.
IMUC’s cancer immunotherapy candidate, ICT-121, is expected to begin Phase I/II clinical testing in humans in early 2010 as an off-the-shelf product (i.e. does not require obtaining cells from the patient as part of the manufacturing process). ICT-121 works by eliciting a targeted T cell immune response specific to MHC class I molecules (which are highly specific to CSCs and cancer cells) and CD133+ cells, since CD133 also occurs on normal cells at reduced levels (e.g. 4,500 copies on a normal cell versus 30,000-180,000 copies on a CSC).
Blockbuster potential exists for ICT-121 targeting an unmet medical need (brain cancer initially, then pancreatic cancer) and is designed for use in combination with the current standard of care (i.e. surgery, chemo, and radiation therapy) to target residual disease as a paradigm-shifting treatment with the goal of completely eradicating the presence of cancer cells and their future recurrence or spread. IMUC is also developing CSC-targeting mAbs for both therapeutic and diagnostic applications in the treatment of cancer.
Celldex Therapeutics (NASDAQ:CLDX) is developing CDX-110 as a cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). While originally discovered in GBM, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic prostate, colorectal, and head & neck cancers.
In collaboration with its partner, Pfizer (NYSE:PFE), Celldex is currently performing a Phase 2 study (the “ACT III” study) of CDX-110 in patients with newly diagnosed GBM. Objectives of the study are to investigate the anticancer activity, impact on survival, and safety of CDX-110 when administered during a 12 month course of maintenance temozolomide chemotherapy and then continuing until disease progression. Approximately 60 patients will receive CDX-110 as part of this study.
The National Cancer Institute’s (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is currently sponsoring a Phase I clinical trial to evaluate dose and safety of Curis Inc.'s (NASDAQ:CRIS) GDC-0449 in medulloblastoma patients up to 21 years of age, as well as a Phase II trial in adult patients with medulloblastoma (a malignant tumor of the cerebellum that represents the most common brain malignancy in children). GDC-0449 targets the Hedgehog signaling pathway, blocking the activities of cell surface receptors and suppressing signaling pathways, which play an important role in tissue growth and may lead to the uncontrolled proliferation of cells if mutations occur.
Peregrine Pharma (NASDAQ:PPHM) is developing Cotara as an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to a specific DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. This targeting mechanism enables Cotara to bind to dying tumor cells, delivering a radioactive dose to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue.
In addition to an ongoing Phase 2 trial in India, a dosimetry and dose confirmation trial in GBM patients at leading U.S. academic brain cancer centers is nearing completion. Cotara has been granted orphan drug status and fast track designation for the treatment of GBM and anaplastic astrocytoma by the FDA.
Arno Therapeutics (ARNI.PK) is developing its lead clinical compound (AR-67) as a novel, third-generation camptothecin analogue that inhibits Topoisomerase I activity. AR-67 has demonstrated activity and an excellent safety profile in clinical studies as well as improved pharmacokinetic properties when compared to approved second-generation products, including Hycamtin (topotecan) and Camptosar (irinotecan). The Company expects to begin a Phase 2 study during 2009 for AR-67 in the treatment of GBM.
YM BioSciences (AMEX:YMI) is evaluating its lead anti-cancer compound nimotuzumab (nimo) (an IgG1, humanized epidermal growth factor or EGFR targeting monoclonal antibody or MAb) in 11 Phase 2 and 3 international trials, including three by YMI and eight by its licensees. Nimo is in the same class as Erbitux (cetuximab), but has a better safety profile since it does not cause the severe (Grade 3 or 4) skin rash associated with these types of treatments. The lack of severe skin rash would otherwise be a clear advantage, but in this case the clinical effectiveness of EGFR inhibitors is thought to be linked with the occurrence of this side effect (see the Company's corporate presentation for more details and images of Grade 3 or 4 rash).
The following are expected milestones for nimo clinical data, with the majority representing studies in both children and adults with a variety of brain cancers:
  1. nimo post-marketing data 150 patients in epithelial-derived tumors 3Q09;
  2. nimo Phase 2 first-line NSCLC in 2010;
  3. nimo European final Phase 3 first-line pediatric glioma data in 2010;
  4. nimo European Phase 3 first-line adult glioma data in 2010;
  5. nimo North American Phase 2 recurrent pediatric glioma data in 2010;
  6. nimo esophageal Phase 2 first-line data (Brazil) in 2010;
  7. nimo Phase 2 (Japan) recurrent gastric cancer data possibly in 2010;
  8. recruitment by Oncoscience AG in nimo Phase 3 trial among newly diagnosed pediatric pontine glioma patients is concluded; and
  9. recruitment by Oncoscience AG in a Phase 3 trial for adult GBM grade IV will be completed in 2009.
Lixte Biotech (LIXT.OB) was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options - such as certain types of brain cancer (glioblastoma multiforme or GBM, neuroblastoma, and medulloblastoma) and pancreatic cancer.
In early July, Lixte announced that the results of studies characterizing the novel and potent anti-cancer activity and mechanism of action of its lead compound (LB-1.2) both alone and in combination with standard chemotherapy drugs were published in a leading scientific journal, the Proceedings of the National Academy of Sciences. The primary conclusion was that one of the Company's lead compounds appears to inhibit cancer cells by stimulating cancer cells to attempt to grow in the presence of a standard cancer drug and interferes with cancer cell defense mechanisms, with the end result being much greater damage to the cancer than occurs when treatment is limited to the standard anti-cancer drug.
The authors of this study concluded that treatment with the Company's compound LB-1.2 may be a general method for enhancing the therapeutic benefit of a number of standard cancer regimens, not limited to the original targets of brain tumors of adults and children. Based on the positive preclinical results for LB-1.2, Lixte believes its lead compounds have the potential to be used in combination with Temodar (for a similar commercial market opportunity) since nearly all patients with GBM relapse regardless of current treatments and the published study results offer a possible explanation for a synergistic mode of action that must be proven in human clinical trials
One lead compound (LB-1) is the most advanced in the process and Lixte plans to be ready for IND submission in mid-2010. The other lead compound (LB-2.5), which inhibits cancer cells by a different mode of action compared to LB-1, is anticipated to complete its evaluation by the end of 2010. If the Company is able to achieve a strategic partnership and funding from an established pharmaceutical company to co-develop its compounds, the development process is expected to occur more quickly since these two lead compounds are well characterized with regards to their activity and mechanism of action. The encouraging preclinical results for LB-1.2 as an add-on treatment for brain cancer, the unmet medical needs for effective brain and pancreatic cancer treatments, and the pending patents for Lixte’s lead compound should increase the awareness of the Company’s research and hopefully result in funding to expedite the process.
Disclosure: Long IMUC.OB, MNTR.PK
]]> Mon, 07 Sep 2009 09:01:14 -0400 Mike Havrilla Mike Havrilla submits:
Each year nearly 20,000 people in the U.S. are diagnosed with primary brain cancers (with a similar number in Europe), according to NCI/NIH statistics, with Schering-Plough's (NYSE:SGP) Temodar (temozolomide or TMZ is classified as a DNA-methylating chemotherapy drug) given to nearly every patient with a diagnosis of GBM (the most common and aggressive form of brain cancer). Newly diagnosed individuals with GBM typically undergo surgery (if possible) to remove the tumor, followed by radiation and chemotherapy with a median survival outcome of about 10-12 months.
In early May, Roche (RHHBY.PK) announced that the FDA granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma (GBM) that have progressive disease following prior therapy. Following initial treatment with chemotherapy and radiation, more than 90% of patients with GBM experience recurrence of the disease and few effective treatment options are available. In addition, Eisai (ESALY.PK) markets the Gliadel Wafer, which is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation as well as in patients with recurrent GBM as an adjunct to surgery.
Below is a selection of small and micro-cap stocks from my Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index that are involved in research activities to improve the treatment of brain cancer. In addition, three of the companies profiled below are among 10 stocks in the Mentor Capital Cancer Immunotherapy Index (MNTR.pk).
Northwest Biotherapeutics (NWBO.OB) is developing DCVax-Brain as an experimental autologous (patient-derived) cellular therapy that is designed to create a specific immune response against a patient’s cancer. DCVax-Brain utilizes a patient’s own dendritic cells (DC), and an extract of the patient’s own tumor cells to achieve an immune response.
In early April, Ark Therapeutics (ARKTF.PK) announced the first update of results for its Cerepro Phase 3 clinical trial as a novel gene-based medicine for the treatment of operable malignant glioma. The study is being conducted to confirm the safety and efficacy of Cerepro in patients with operable high grade glioma (brain cancer) against current standard treatment options, including (1) surgery and radiotherapy or (2) surgery and radiotherapy followed approximately 40 days post-op by temozolomide.
Significance levels associated with the main data have improved in the update analyses and 29 patients have yet to reach a primary endpoint event (versus 53 previously), of which 18 have been treated with Cerepro and 11 received standard of care treatment. Data suggests improved overall survival in patients receiving Cerepro after about 500 days with 56 patients in the trial still alive. A marketing approval application (MAA) in Europe for Cerepro was filed with the EMEA in 4Q08 and an opinion from the CHMP is expected during 4Q09.
Cerepro is a novel gene-based product for the treatment of patients with operable high grade glioma and utilizes a well-established adenoviral vector (Ad5) to introduce the gene that causes cells to express a protein called thymidine kinase ("TK"). Following the standard surgery to remove the solid tumor mass, Cerepro is injected through the wall of the cavity left behind by the surgical removal of the solid tumor, into the surrounding healthy brain tissue. In the following days, the healthy cells in the wall of the cavity express TK.
Five days after surgery, the drug ganciclovir (GCV) is given to the patient as part of the overall Cerepro treatment regimen. Neither TK nor GCV is individually active but they react together to produce a substance which destroys cells when they try to divide. Since cell division is a key characteristic of cancer and the normal brain cells are not dividing, cells that try to divide to form a new tumor around the site of the removal of the original tumor are targeted for destruction by the Cerepro treatment.
Exelixis (NASDAQ:EXEL) is co-developing XL184 (BMS-907351) along with Bristol-Myers (NYSE:BMY). A Phase 2 trial of XL184 in subjects with progressive or recurrent GBM in first or second relapse is ongoing. XL184 inhibits MET, VEGFR2, and RET, which are key drivers of tumor formation, growth, and metastasis. The Company is also co-developing XL765 along with Sanofi-Aventis (NYSE:SNY). XL765 targets both PI3K and mTOR, which are key elements in pathways leading to cell proliferation and is currently being evaluated in a Phase 1b/2 trial in combination with Temodar in GBM patients.
ImmunoCellular Therapeutics (IMUC.OB) is a cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs).

This approach is in the early stages of development, but has the potential to become a paradigm-shifting therapeutic approach to the treatment of cancer. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which can be used to develop targeted mAbs and CSC immunotherapy products.
Although CSCs account for a small proportion of the cells in a given tumor, a growing body of scientific literature suggests CSCs drive the process of tumor growth and recurrence (even after the disease is undetectable and thought to be eradicated). Current therapeutic options such as radiation therapy or chemo target the proliferating cells, which form the bulk of any tumor mass while the CSCs lie dormant and unaffected at the root of the disease. Thus, a non-detectable number of CSCs may persist even after a patient is in remission, leading to the potential for recurrence of the disease.
IMUC’s cancer immunotherapy candidate, ICT-121, is expected to begin Phase I/II clinical testing in humans in early 2010 as an off-the-shelf product (i.e. does not require obtaining cells from the patient as part of the manufacturing process). ICT-121 works by eliciting a targeted T cell immune response specific to MHC class I molecules (which are highly specific to CSCs and cancer cells) and CD133+ cells, since CD133 also occurs on normal cells at reduced levels (e.g. 4,500 copies on a normal cell versus 30,000-180,000 copies on a CSC).
Blockbuster potential exists for ICT-121 targeting an unmet medical need (brain cancer initially, then pancreatic cancer) and is designed for use in combination with the current standard of care (i.e. surgery, chemo, and radiation therapy) to target residual disease as a paradigm-shifting treatment with the goal of completely eradicating the presence of cancer cells and their future recurrence or spread. IMUC is also developing CSC-targeting mAbs for both therapeutic and diagnostic applications in the treatment of cancer.
Celldex Therapeutics (NASDAQ:CLDX) is developing CDX-110 as a cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). While originally discovered in GBM, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic prostate, colorectal, and head & neck cancers.
In collaboration with its partner, Pfizer (NYSE:PFE), Celldex is currently performing a Phase 2 study (the “ACT III” study) of CDX-110 in patients with newly diagnosed GBM. Objectives of the study are to investigate the anticancer activity, impact on survival, and safety of CDX-110 when administered during a 12 month course of maintenance temozolomide chemotherapy and then continuing until disease progression. Approximately 60 patients will receive CDX-110 as part of this study.
The National Cancer Institute’s (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is currently sponsoring a Phase I clinical trial to evaluate dose and safety of Curis Inc.'s (NASDAQ:CRIS) GDC-0449 in medulloblastoma patients up to 21 years of age, as well as a Phase II trial in adult patients with medulloblastoma (a malignant tumor of the cerebellum that represents the most common brain malignancy in children). GDC-0449 targets the Hedgehog signaling pathway, blocking the activities of cell surface receptors and suppressing signaling pathways, which play an important role in tissue growth and may lead to the uncontrolled proliferation of cells if mutations occur.
Peregrine Pharma (NASDAQ:PPHM) is developing Cotara as an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to a specific DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. This targeting mechanism enables Cotara to bind to dying tumor cells, delivering a radioactive dose to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue.
In addition to an ongoing Phase 2 trial in India, a dosimetry and dose confirmation trial in GBM patients at leading U.S. academic brain cancer centers is nearing completion. Cotara has been granted orphan drug status and fast track designation for the treatment of GBM and anaplastic astrocytoma by the FDA.
Arno Therapeutics (ARNI.PK) is developing its lead clinical compound (AR-67) as a novel, third-generation camptothecin analogue that inhibits Topoisomerase I activity. AR-67 has demonstrated activity and an excellent safety profile in clinical studies as well as improved pharmacokinetic properties when compared to approved second-generation products, including Hycamtin (topotecan) and Camptosar (irinotecan). The Company expects to begin a Phase 2 study during 2009 for AR-67 in the treatment of GBM.
YM BioSciences (AMEX:YMI) is evaluating its lead anti-cancer compound nimotuzumab (nimo) (an IgG1, humanized epidermal growth factor or EGFR targeting monoclonal antibody or MAb) in 11 Phase 2 and 3 international trials, including three by YMI and eight by its licensees. Nimo is in the same class as Erbitux (cetuximab), but has a better safety profile since it does not cause the severe (Grade 3 or 4) skin rash associated with these types of treatments. The lack of severe skin rash would otherwise be a clear advantage, but in this case the clinical effectiveness of EGFR inhibitors is thought to be linked with the occurrence of this side effect (see the Company's corporate presentation for more details and images of Grade 3 or 4 rash).
The following are expected milestones for nimo clinical data, with the majority representing studies in both children and adults with a variety of brain cancers:
  1. nimo post-marketing data 150 patients in epithelial-derived tumors 3Q09;
  2. nimo Phase 2 first-line NSCLC in 2010;
  3. nimo European final Phase 3 first-line pediatric glioma data in 2010;
  4. nimo European Phase 3 first-line adult glioma data in 2010;
  5. nimo North American Phase 2 recurrent pediatric glioma data in 2010;
  6. nimo esophageal Phase 2 first-line data (Brazil) in 2010;
  7. nimo Phase 2 (Japan) recurrent gastric cancer data possibly in 2010;
  8. recruitment by Oncoscience AG in nimo Phase 3 trial among newly diagnosed pediatric pontine glioma patients is concluded; and
  9. recruitment by Oncoscience AG in a Phase 3 trial for adult GBM grade IV will be completed in 2009.
Lixte Biotech (LIXT.OB) was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options - such as certain types of brain cancer (glioblastoma multiforme or GBM, neuroblastoma, and medulloblastoma) and pancreatic cancer.
In early July, Lixte announced that the results of studies characterizing the novel and potent anti-cancer activity and mechanism of action of its lead compound (LB-1.2) both alone and in combination with standard chemotherapy drugs were published in a leading scientific journal, the Proceedings of the National Academy of Sciences. The primary conclusion was that one of the Company's lead compounds appears to inhibit cancer cells by stimulating cancer cells to attempt to grow in the presence of a standard cancer drug and interferes with cancer cell defense mechanisms, with the end result being much greater damage to the cancer than occurs when treatment is limited to the standard anti-cancer drug.
The authors of this study concluded that treatment with the Company's compound LB-1.2 may be a general method for enhancing the therapeutic benefit of a number of standard cancer regimens, not limited to the original targets of brain tumors of adults and children. Based on the positive preclinical results for LB-1.2, Lixte believes its lead compounds have the potential to be used in combination with Temodar (for a similar commercial market opportunity) since nearly all patients with GBM relapse regardless of current treatments and the published study results offer a possible explanation for a synergistic mode of action that must be proven in human clinical trials
One lead compound (LB-1) is the most advanced in the process and Lixte plans to be ready for IND submission in mid-2010. The other lead compound (LB-2.5), which inhibits cancer cells by a different mode of action compared to LB-1, is anticipated to complete its evaluation by the end of 2010. If the Company is able to achieve a strategic partnership and funding from an established pharmaceutical company to co-develop its compounds, the development process is expected to occur more quickly since these two lead compounds are well characterized with regards to their activity and mechanism of action. The encouraging preclinical results for LB-1.2 as an add-on treatment for brain cancer, the unmet medical needs for effective brain and pancreatic cancer treatments, and the pending patents for Lixte’s lead compound should increase the awareness of the Company’s research and hopefully result in funding to expedite the process.
Disclosure: Long IMUC.OB, MNTR.PK

Complete Story »]]> ARKTF.PK BMY CLDX CRIS ESALY.PK EXEL IMUC.OB LIXT.OB NWBO.OB PFE PPHM RHHBY.PK SGP SNY YMI Mike Havrilla 31 Pan Asia Dividend Aristocrats http://seekingalpha.com/article/155145-31-pan-asia-dividend-aristocrats?source=feed 155145 Standard & Poor’s is a US based provider of financial market intelligence which includes ratings, investment research, risk evaluation and data, and various types of indices. Among multiple different indices with different focus areas, one index is the dividend aristocrat index.

]]> Mon, 10 Aug 2009 13:07:02 -0400 TIP Guy Standard & Poor’s is a US based provider of financial market intelligence which includes ratings, investment research, risk evaluation and data, and various types of indices. Among multiple different indices with different focus areas, one index is the dividend aristocrat index.


Complete Story »]]> CAJ CCLAY.PK CHEUY DNZOY.PK ESALY.PK FBRWY.PK HDB HMC HNP HTSUF.PK ITOCY.PK MTU NJ TKPHF.PK TM TIP Guy FDA Calendar Updates: Rigel Pharma, GlaxoSmithKline, Eisai, SuperGen http://seekingalpha.com/article/147896-fda-calendar-updates-rigel-pharma-glaxosmithkline-eisai-supergen?source=feed 147896 Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 250 entries as of 7/9/09. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.
The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.
On 7/9/09, Rigel Pharma (NASDAQ:RIGL) announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.
On 7/9/09, GlaxoSmithKline (NYSE:GSK) announced that the World Health Organization (WHO) has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to Merck's (NYSE:MRK) Gardasil.
On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.
On 7/8/09, Eisai (ESALY.PK) [TYO:4523] announced that the FDA has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen (decitabine for injection) to treat patients with myelodysplastic syndromes (MDS). MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen submitted to the FDA is a single daily dose with a significantly reduced administration time.
SuperGen (NASDAQ:SUPG) receives royalties on Dacogen sales based on a 2004 license agreement entered into with MGI Pharma (which was acquired by Eisai in January 2008) for the exclusive rights to the development, manufacture, commercialization, and distribution of Dacogen. The PDUFA action date for the sNDA is 3/8/10 for a possible FDA decision as part of a 10-month, standard review.
Disclosure: No positions.
]]> Thu, 09 Jul 2009 10:02:00 -0400 Mike Havrilla Mike Havrilla submits:

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 250 entries as of 7/9/09. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.
The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.
On 7/9/09, Rigel Pharma (NASDAQ:RIGL) announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.
On 7/9/09, GlaxoSmithKline (NYSE:GSK) announced that the World Health Organization (WHO) has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to Merck's (NYSE:MRK) Gardasil.
On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.
On 7/8/09, Eisai (ESALY.PK) [TYO:4523] announced that the FDA has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen (decitabine for injection) to treat patients with myelodysplastic syndromes (MDS). MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen submitted to the FDA is a single daily dose with a significantly reduced administration time.
SuperGen (NASDAQ:SUPG) receives royalties on Dacogen sales based on a 2004 license agreement entered into with MGI Pharma (which was acquired by Eisai in January 2008) for the exclusive rights to the development, manufacture, commercialization, and distribution of Dacogen. The PDUFA action date for the sNDA is 3/8/10 for a possible FDA decision as part of a 10-month, standard review.
Disclosure: No positions.

Complete Story »]]> ESALY.PK GSK RIGL SPPI SUPG Mike Havrilla FDA Calendar Updates: Novo Nordisk, Eisai, Acura, King and Myriad Pharma http://seekingalpha.com/article/146900-fda-calendar-updates-novo-nordisk-eisai-acura-king-and-myriad-pharma?source=feed 146900 Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoz in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending.

]]> Sun, 05 Jul 2009 03:30:41 -0400 Mike Havrilla Mike Havrilla submits:

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoz in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending.


Complete Story »]]> ACUR ESALY.PK KG MYGN NEPH.OB NVO Mike Havrilla New Index of Health Product Innovators http://seekingalpha.com/article/113192-new-index-of-health-product-innovators?source=feed 113192 Click to enlarge


The accompanying table includes statistics and all 23 companies in the ETF Innovators [ETFI] Global Health Innovators Index of companies with market caps over $250M which received FDA approval in the past 12 months for an original new drug product or medical device.

]]> Mon, 05 Jan 2009 07:14:56 -0500 Mike Havrilla Mike Havrilla submits:

Click to enlarge


The accompanying table includes statistics and all 23 companies in the ETF Innovators [ETFI] Global Health Innovators Index of companies with market caps over $250M which received FDA approval in the past 12 months for an original new drug product or medical device.


Complete Story »]]> AMGN CEPH CVTX ESALY.PK IBB IHI PJP PPH THOR VPHM WPI XLV Mike Havrilla Will TorreyPines Sale of Its Alzheimer Genetics Research Save the Company? http://seekingalpha.com/article/105365-will-torreypines-sale-of-its-alzheimer-genetics-research-save-the-company?source=feed 105365 TorreyPines Therapeutics, Inc. (TPTX) Tuesday announced that it has agreed to sell its Alzheimer’s disease genetics research program to Eisai Co., Ltd. for an upfront cash payment. TorreyPines and Eisai have collaborated on the genetics program since 2002, with the most recent agreement between the parties concluding on September 30, 2008. The Alzheimer’s disease genetics research program focused on the discovery of Alzheimer’s disease targets using whole-genome family-based association screening.

TorreyPines stock is down ~97% on the year and they are running out of cash so I can’t imagine they got a great deal on this program (hence withholding the price), but when you’re fighting to stay alive, any cash that gets you to the next milestone is important.

]]> Tue, 11 Nov 2008 10:58:36 -0500 Eben Tessari Eben Tessari submits:

TorreyPines Therapeutics, Inc. (TPTX) Tuesday announced that it has agreed to sell its Alzheimer’s disease genetics research program to Eisai Co., Ltd. for an upfront cash payment. TorreyPines and Eisai have collaborated on the genetics program since 2002, with the most recent agreement between the parties concluding on September 30, 2008. The Alzheimer’s disease genetics research program focused on the discovery of Alzheimer’s disease targets using whole-genome family-based association screening.

TorreyPines stock is down ~97% on the year and they are running out of cash so I can’t imagine they got a great deal on this program (hence withholding the price), but when you’re fighting to stay alive, any cash that gets you to the next milestone is important.


Complete Story »]]> ESALY.PK TPTX Eben Tessari Eisai Victorious Over Teva and Dr. Reddy’s in Aciphex Compound Patent Case http://seekingalpha.com/article/86158-eisai-victorious-over-teva-and-dr-reddys-in-aciphex-compound-patent-case?source=feed 86158 Eisai v. Dr. Reddy's and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008)

Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR. In an opinion released Monday, the Federal Circuit affirmed the nonobviousness of rabeprazole, the active ingredient in Aciphex.  This follows adecision last year affirming the nonobviousness of pioglitazone, the active ingredient in Actos.

]]> Wed, 23 Jul 2008 03:24:06 -0400 Aaron F. Barkoff Aaron F. Barkoff submits:

Eisai v. Dr. Reddy's and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008)

Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR. In an opinion released Monday, the Federal Circuit affirmed the nonobviousness of rabeprazole, the active ingredient in Aciphex.  This follows adecision last year affirming the nonobviousness of pioglitazone, the active ingredient in Actos.


Complete Story »]]> ESALY.PK RDY TEVA Aaron F. Barkoff Eisai Wins Preliminary Injunction Against Teva's Generic Altheimer's Drug http://seekingalpha.com/article/70548-eisai-wins-preliminary-injunction-against-teva-s-generic-altheimer-s-drug?source=feed 70548 Eisai Co., Ltd. (ESALY.PK), the Japanese manufacturer of Aricept (donepezil hydrochloride), has won a preliminary injunction against Teva Pharmaceuticals USA, Inc. (TEVA), keeping Teva's generic version of Aricept off the market for the time being. Aricept, which accounts for $1.6 billion in annual U.S. sales, is reportedly the world's most prescribed treatment for Alzheimer's disease.

In the decision (pdf file), released Friday, the district court found that Eisai is likely to succeed on its claim of infringement because Teva's sole defense, that U.S. Patent No. 4,895,841 is unenforceable for inequitable conduct, lacks substantial merit. Initially, Teva also asserted that the '841 patent is invalid for obviousness. However, in December, Teva acknowledged that it had dropped its obviousness defense. Teva stipulated to infringement of claims 8, 10 and 13 of the '841 patent, which are directed to the active ingredient in Aricept, donepezil hydrochloride, pharmaceutical compositions thereof, and a method for treating Alzheimer's disease by administering the compound.

]]> Mon, 31 Mar 2008 09:23:10 -0400 Aaron F. Barkoff Aaron F. Barkoff submits:

Eisai Co., Ltd. (ESALY.PK), the Japanese manufacturer of Aricept (donepezil hydrochloride), has won a preliminary injunction against Teva Pharmaceuticals USA, Inc. (TEVA), keeping Teva's generic version of Aricept off the market for the time being. Aricept, which accounts for $1.6 billion in annual U.S. sales, is reportedly the world's most prescribed treatment for Alzheimer's disease.

In the decision (pdf file), released Friday, the district court found that Eisai is likely to succeed on its claim of infringement because Teva's sole defense, that U.S. Patent No. 4,895,841 is unenforceable for inequitable conduct, lacks substantial merit. Initially, Teva also asserted that the '841 patent is invalid for obviousness. However, in December, Teva acknowledged that it had dropped its obviousness defense. Teva stipulated to infringement of claims 8, 10 and 13 of the '841 patent, which are directed to the active ingredient in Aricept, donepezil hydrochloride, pharmaceutical compositions thereof, and a method for treating Alzheimer's disease by administering the compound.


Complete Story »]]> ESALY.PK TEVA Aaron F. Barkoff Japan's Eisai to Acquire MGI Pharma for $3.9B http://seekingalpha.com/article/56788-japan-s-eisai-to-acquire-mgi-pharma-for-3-9b?source=feed 56788

Eisai Co., Ltd. (ESALY.PK) of Japan has entered a merger agreement to wholly acquire MGI Pharma, Inc. (MOGN) for $41.00/share or approximately $3.9 billion, in an all cash transaction, representing a 23% premium to its Friday close of $33.45. The merger has been unanimously approved by MGI Pharma's Board and follows a late November press release from the company saying the Board had "authorized management to evaluate possible strategic alternatives." MGI Pharma said it retained the services of Lehman Brothers, which served as its exclusive financial advisor. The transaction is expected to close during Q1-2008, pending customary closing conditions and regulatory approvals. Eisai said it plans to acquire MGI Pharma shares via tender offer followed by a cash merger.

]]> Mon, 10 Dec 2007 07:53:14 -0500 Steven Towns

Eisai Co., Ltd. (ESALY.PK) of Japan has entered a merger agreement to wholly acquire MGI Pharma, Inc. (MOGN) for $41.00/share or approximately $3.9 billion, in an all cash transaction, representing a 23% premium to its Friday close of $33.45. The merger has been unanimously approved by MGI Pharma's Board and follows a late November press release from the company saying the Board had "authorized management to evaluate possible strategic alternatives." MGI Pharma said it retained the services of Lehman Brothers, which served as its exclusive financial advisor. The transaction is expected to close during Q1-2008, pending customary closing conditions and regulatory approvals. Eisai said it plans to acquire MGI Pharma shares via tender offer followed by a cash merger.


Complete Story »]]> ESALY.PK MOGN Steven Towns