DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Monday, June 30, 2014
Sunday, June 29, 2014
Saturday, June 28, 2014
15 Highest-Paid Biopharma CEOs of 2013
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Read more: 15 Highest-Paid Biopharma CEOs of 2013 - FiercePharma http://www.fiercepharma.com/special-reports/15-highest-paid-biopharma-ceos-2013#ixzz359h33jrk
Subscribe at FiercePharma
Friday, June 27, 2014
Targeted failure of the week. Post No 158. Olaparib
AstraZeneca has suffered a setback with advisors to the US Food and Drug Administration recommending against accelerated approval of olaparib for ovarian cancer.
The agency’s Oncologic Drugs Advisory Committee has voted 11 to 2 that current evidence does not support early approval for use of olaparib as a maintenance treatment for platinum-sensitive relapsed ovarian cancer in women who have the germline BRCA mutation, and who are in complete or partial response to platinum-based chemotherapy. The vote comes after FDA staffers expressed concern about a subgroup retrospective analysis of Phase II data on the poly ADP-ribose polymerase (PARP) inhibitor which revealed a 7.1 month median improvement in progression-free survival.
AstraZeneca decided, in December 2011, not to progress olaparib into Phase III, but reversed that decision on the basis of results for the aforementioned subgroup. It received priority review status in April from the FDA but the latter’s staffers have questioned whether the reanalysis skewed the results.
The panel also mentioned safety issues such as bone marrow suppression, fatigue, nausea and abdominal pain and cases of myelodysplastic syndrome and acute myeloid leukaemia in study participants that had a small risk of being linked to olaparib.
Read more at: http://www.pharmatimes.com/Article/14-06-26/FDA_panel_fails_to_back_AZ_ovarian_cancer_drug_olaparib.aspx#ixzz35oFFDLgE
Tuesday, June 24, 2014
Monday, June 23, 2014
Sunday, June 22, 2014
Saturday, June 21, 2014
Smoking, alcohol and liver... The numbers
These are the key findings of an Office for National Statistics study for the aforementioned period which shows that liver cancer incidence increased 70% for males (to 2,449) and 60% (to 1,418) for females between 2003 and 2012
http://www.pharmatimes.com/Article/14-06-20/Steep_rise_in_liver_cancer_and_melanoma_in_England.aspx
Friday, June 20, 2014
Targeted failure of the week. 157. Orteronel
OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) announced today that it has voluntarily decided to end the development program for orteronel (TAK-700) for prostate cancer. The decision follows the results of two Phase 3 clinical trials in metastatic, castration resistant prostate cancer (mCRPC). The studies found while orteronel plus prednisone could extend the time patients lived before their cancer progressed, it did not extend overall survival in these patients. After careful consideration of the data from these trials, the company has determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC, given the availability of other therapies. Thursday, June 19, 2014
Wednesday, June 18, 2014
Erection - the critical resource of post-modern society!
Men in the UK suffering from erectile dysfunction (ED) are the first in the
world to get access to the first cream on the market for treating the
condition.Read more at: http://www.pharmatimes.com/Article/14-06-17/UK_men_first_to_get_erection_cream_Vitaros.aspx#ixzz34xuLJP4k
Follow us: @PharmaTimes on Twitter
Tuesday, June 17, 2014
Monday, June 16, 2014
Sunday, June 15, 2014
Saturday, June 14, 2014
Targeted failure of the week. Post No 156. Vantictumab and Fzd8-Fc.
OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) fell as much as $6.15 (25%) on Friday before closing the day off $2.19 to $22.71 after halting enrollment and dosing in Phase Ib trials evaluating the company's two Wnt pathway inhibitors to treat cancer. The move came as a result of mild to moderate bone-related adverse events in open-label, dose-escalation trials separately evaluating vantictumab (OMP-18R5) and Fzd8-Fc (OMP-54F28) in combination with other therapies. After market close, OncoMed said FDA placed the trials on a partial clinical hold.
OncoMed said the AEs were grade 1/2 fractures in line with the type seen with chemotherapies like tamoxifen and aromatase inhibitors. The company submitted amended protocols to FDA and the study sites' institutional review boards. The amendments include modified dosing regimens and updated risk mitigation measures.
Vantictumab is in Phase Ib trials for untreated pancreatic cancer, locally advanced or metastatic HER2-negative breast cancer and as second- and third-line treatment of advanced non-small cell lung cancer (NSCLC). Fzd8-Fc is in Phase Ib trials for recurrent platinum-sensitive ovarian cancer, previously untreated pancreatic cancer and as first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC).
OncoMed and Bayer AG (Xetra:BAYN) are partnered to discover and develop antibodies, proteins and small molecules targeting the Wnt signaling pathway for cancer. Under the 2010 deal, Bayer has an option to exclusively license vantictumab and Fzd8-Fc at any point up to the completion of Phase I testing.
Friday, June 13, 2014
Thursday, June 12, 2014
Targeted failure of the week. Post No 155. Cyramza (ramucirumab)
Patients enrolled in the trial previously had failed to benefit from standard chemotherapy for liver cancer.
"Liver cancer is a very difficult-to-treat tumor type and no Phase III study has been able to demonstrate improved survival in the second-line setting," Lilly said in a release.
Cyramza also failed in an earlier study to improve outcomes for patients with breast cancer.
But the drug has proven effective in a late-stage trial against the most common form of lung cancer, and Lilly is also testing it against colorectal cancer.
Investment bank Cowen and Co has predicted Cyramza will generate annual sales of $1.2 billion by 2020, assuming it is approved for at least one additional type of cancer, beyond stomach cancer.
http://finance.yahoo.com/news/lillys-cyramza-fails-liver-cancer-125440855.html
http://finance.yahoo.com/news/lillys-cyramza-fails-liver-cancer-125440855.html
Wednesday, June 11, 2014
Targeted failure of the week. Post No 154. Herceptin!!!
Believe it or not THE targeted drug herceptin is not very much targeted:
As many as one in 10 women taking the breast cancer drug trastuzumab (Herceptin) will experience some type of heart problem, according to new research.
http://www.webmd.com/breast-cancer/news/20140610/breast-cancer-drug-herceptin-linked-to-risk-of-heart-problems-study
http://www.webmd.com/breast-cancer/news/20140610/breast-cancer-drug-herceptin-linked-to-risk-of-heart-problems-study
Sede effects for Gleevec? What side effects?
Now, though, Novartis says that at least 10,000 cases were uncovered and may never have been reported – and that the cover-up was actually in connection with 10 different medicines. These include the two leukemia treatments – Gleevec and Tasigna – as well as the Xolair asthma drug; the Exelon patch for Alzheimer’s and Parkinson’s diseases, and the Neoral medicine used to mitigate organ rejection.
I am just reasoning - according to modern paradigm Gleevec is a first targeted drug and shouldn't have any side-effects at all! Something is not correct here!
Tuesday, June 10, 2014
"Targeted failure approach" is going to be stopped by Big Pharma?...
It looks like somebody in Big Pharma would like to change the situation with modern inefficient approach in drug development process:
Quote:
One of the key reasons for this lack of success was that “we were very siloed”, Mr Viehbacher argued, saying that collaboration is vital and companies need to go where the science is. This view was echoed by Paul Stoffels, Johnson & Johnson’s chief scientific officer, who said that if there are no biotech companies, “the pharmaceutical world will not survive”, adding that there is almost universal backing for collaboration being the only way forward.
Don't spend billions on drug sure to fail
Dr Stoffels noted the staggering amounts spent on drugs that have failed to get to market, adding that pharma knows it cannot afford to spend more billions on a product that it knows is going to fail. He also argued that nearly every new drug developed today involves 30 new technologies, warning that we must recognise that innovative technology has to be paid for, and urged regulators to collaborate with firms on accelerating approvals and access to medicines.
Mr Viehbacher told attendees that “no-one here wants us to stop spending billions of dollars” on research, but the lack of reward needs addressing urgently. He added that “we are going to have to reconcile patent length” with the time it takes to develop a drug, as currently the “clock starts” when a molecule is registered, though development could take 20 years, as is the case with Sanofi’s dengue fever vaccine.
Dr Stoffels noted the staggering amounts spent on drugs that have failed to get to market, adding that pharma knows it cannot afford to spend more billions on a product that it knows is going to fail. He also argued that nearly every new drug developed today involves 30 new technologies, warning that we must recognise that innovative technology has to be paid for, and urged regulators to collaborate with firms on accelerating approvals and access to medicines.
Mr Viehbacher told attendees that “no-one here wants us to stop spending billions of dollars” on research, but the lack of reward needs addressing urgently. He added that “we are going to have to reconcile patent length” with the time it takes to develop a drug, as currently the “clock starts” when a molecule is registered, though development could take 20 years, as is the case with Sanofi’s dengue fever vaccine.
End quote.
Monday, June 9, 2014
Sunday, June 8, 2014
Saturday, June 7, 2014
Friday, June 6, 2014
Thursday, June 5, 2014
Wednesday, June 4, 2014
Checkpoint inhibitors... WTF? Is targeted approach dead???
Another THE thing in novel oncology Products development: http://www.fool.com/investing/general/2014/06/02/asco-2014-doubling-down-on-next-gen-cancer-drugs.aspx
Checkpoint inhibitors act by removing built-in brakes on the immune system to boost the response to tumor cells.
Tuesday, June 3, 2014
Targeted failure of the week. Post No 152 and 153. Neratinib, tykerb and herceptin.
Puma Biotechnology Inc. (NYSE:PBYI) fell $19.37 (25%) to $57.06 on Monday on Phase II data for the company's neratinib (PB272) for HER2-positive breast cancer in patients with brain metastases and concerns about prospects of neratinib as an adjuvant treatment of HER2-positive breast cancer. In the Phase II TBCRC 022 trial, once-daily oral neratinib led to three partial responses in a cohort of 40 HER2-positive breast cancer patients with brain metastases. There were four cases of stable disease for six months or greater and 12 cases of stable disease for less than six months. Median progression-free survival (PFS) was 1.9 months and median overall survival (OS) was 8.7 months. All patients had received prior radiotherapy.
Data were presented at the American Society of Clinical Oncology meeting in Chicago. The trial, which was sponsored by the Dana-Farber Cancer Institute, is enrolling two additional cohorts of HER2-positive breast cancer patients with brain metastases.
Investors may also have been concerned that the failed Phase III ALTTO trial of two marketed HER inhibitors makes it unlikely neratinib will succeed as an adjuvant treatment of HER2-positive breast cancer (see below).
Neratinib, an oral inhibitor of HER1, HER2 and HER4 kinases, is also in Phase III testing as third-line treatment of HER2-positive metastatic breast cancer and Phase II testing in patients with solid tumors who have an activating HER2 mutation. Additionally, neratinib will be included in the Phase III I-SPY 3 trial for the neoadjuvant treatment of breast cancer, which is slated to start this year. Puma has exclusive, worldwide rights to develop and commercialize the compound from Pfizer Inc. (NYSE:PFE).
http://www.biocentury.com/dailynews/clinical/2014-06-02/adjuvant-tykerb-herceptin-miss-in-phase-iii-altto-trial
Adjuvant treatment of HER2-positive early breast cancer with oral Tykerb lapatinib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) plus IV Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit missed the primary endpoint of improving disease-free survival (DFS) vs. Herceptin alone in the Phase III ALTTO trial. Adjuvant treatment with Tykerb plus Herceptin led to a four-year DFS rate of 88% vs. 86% for Herceptin alone (p=0.048). The primary endpoint was designed to test for superiority of Tykerb plus Herceptin vs. Herceptin alone with a p-value of 0.025 or less.
ALTTO was sponsored by GSK and conducted in collaboration with NIH's National Cancer Institute, the North Central Cancer Treatment Group and the Breast International Group. The open-label, international trial enrolled 8,381 patients with HER2-positive early breast cancer. Data were presented at the American Society of Clinical Oncology meeting in Chicago.
Herceptin is a humanized mAb against HER2. Tykerb is a HER1 and HER2 kinase inhibitor. Monday, June 2, 2014
Sunday, June 1, 2014
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