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Increased efficacy may be associated with long term side effects

December 22, 2008

Analysis of:Higher Chemo Drug Dose Prolongs Lives of Leukemia Patients | www.washingtonpost.com

The ECOG study showed increased overall survival in AML patients , aged 16-60 , with higher doses of the anthracyclin Daunorubcin combined with cytarabine. These preliminary studies need to be confirmed and do not extend to AML patients older than 60 where survival is the lowest. High cumulative doses of daunorucin are asociated with cardiomyoptahy which may not manifest till many years later and is a potentially fatal side effect in younger patients with AML who survive their disease.

In vitro findings unlikely to have a clinical impact

December 22, 2008

Analysis of:Novel Basis Identified for Tamoxifen Failure | pharmalive.com

The findings that Tamoxifen may enahnce breast cancer growth in cells with decreased expression of acthedrin is ynlikely to have clinical impact  for 2 reasons: 1- Most ER postive breast cancer patients by definition have higher expression of cathedrin 2- Tamoxifen is largely replaced by aromatase inhibitors which do not have this negative effect

New study confirms already known facts about LABA's

December 22, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

Chronic use of long acting agonists in children is already known to increase hospitlizations from mortality from asthma. This may reflect the severity of asthma in these children and poor access to medical care rather than a direct drug effect. Current Asthma gudelines advocate use of inhaled steroids ( alone or with beta agonists) for long term treatment of asthma in children and adults.  FDA is expected to stess its already released statements about risk of use of LABAs alone

Black Box warning un-neccesary-Read the "fine Print"!!!

December 22, 2008

Analysis of:Scientists recommend 'black box' for Avastin | www.fiercepharma.com

The data about increased risk of thrombosis with Avastin is inflated-to say the least. Avastin"COULD" increase risk of thrombosis by 12 % in a population of cancer patients who are already at increased risk of thrombosis. Moreover , very few clots were fatal. The benefit of increased survival in colorectal and head and neck cancer and may be in GBM will outweigh this thrombosis risk taht can be monitored . No need for Black box warning    

Great Deal for Exilexis!! I am not sure about BMS

December 22, 2008

Analysis of:Bristol-Myers, Biotech Firm to Develop Cancer Drugs | online.wsj.com

BMS is forking out a lot of cash ( $ 240 million) for two cancer drugs still in development. BMS may know something I don't!!!

Big Pharma will continue to thrive in new administration, but not insurnace companies

November 10, 2008

Analysis of:Pharma need not worry too much about President Obama | www.biovalley.ch

President elect Obama will try , most probably unsuccessfully, to take on insurance companies in orfder to fulfill his election promises of "close to universal" health care. Generics will thrive, but Big Phrama , especially those with innovative products and biotech companies will continue to prosper.

Rainfall unlikely to be direct culprit to the Autism Pandemic

November 10, 2008

Analysis of:Autism linked with rainfall in study | www.boston.com

A recent study infers taht periods of increased rainfall could be linked to increase in number of children dioagnosed with autism. The causla l;ink of rainfall is unlikely, but most probably reflects other factors like children staying more indoors and thus watch more TV, get less sun exposure and less VIT D production, and more exposure to cleaning products. New study will help to further confuse the picture about autism and adds fuel to the controversy without offering any practical solutions

Avastin for GBM: modest efficacy and soon to be approval

November 10, 2008

Analysis of:Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer | www.gene.com

Genetech's Avastin have shown modest increase in progresion free survival and overall survival in patients with gliobalstoma multiforme, the most common and most agressive malignant brain tumor With such data, Avastin is expected to join Temodar as chemotherapy agent approved for this tumor with high mortality

Apidra for Diabetes: No much innovation but will get some use

November 3, 2008

Analysis of:FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes | www.pipelinereview.com

Sanofi's rapid acting insulin formulation got FDA approval for use in children 4 years and older with Type I insulin dependent diabetes. The drug has rapid action so it may replace lispro and older short acting  insulin preparations, if the price tag is not prohibitive.

Nexavar - Vitamin "N" for Solid Tumors???

October 27, 2008

Analysis of:Phase II Trial of Sorafenib in Advanced Thyroid Cancer | jco.ascopubs.org

Two Phase II trials show meanigful prolonged pFS in patients with iodine-refractory thyroid cancer who are treated with Sorafenib ( bayer/Onyx) The benefit needs to be confirmed in larger trials and need also to establish a favorable safety profile. Studies are needed for combination with other targeted agents like Avastin ( Genentech) or Torisel ( Wyeth) After efficacy in advanced renal cell carcinoma and hepatocellular carcinoma, Nexavar may be on its way to be the Vitamin " N" for solid tumors as Rituximab is Vitamin R for hematological malignancies.

Immunotherapy for cancer, still have ways to go

October 27, 2008

Analysis of:Cell Genesys Announces Termination of VITAL-1 Phase 3 Trial of GVAX Immunotherapy for Prostate Cancer | pharmalive.com

Genesys terminated its studies of its cancer Vaccine for patients with refractory prostate cancer.  Cancer vaccine therapy remains limted to modest advantages in minimal residual diseases and in limted cases of melanoma and NHL

Genomics and protemics will be future determinants of "individualized " cancer therapy

October 27, 2008

Analysis of:Genetic Research May Help Pick Patients' Best Cancer Drugs | online.wsj.com

Genetic testing is the wave of the future to define targets for cancer therapy. EGFR, K-Ras and FLT-3 testing is just the beginning and affects the use of drugs such as Tarceva ( OSI-Genentech), Erbitux ( Imclone) , Veibitix ( Amgen) and Lasteurinib ( cephalon). The ultimate goal is to use more sophisticated tests such as genomics and proteomics to design drugs taht not only produce maximum rfficacy , but also least toxicity.

K-ras testing will be a reality soon, Bad news for EGFR inhibitors, but good news for Avastin

October 27, 2008

Analysis of:Targeting EGFR in Colorectal Cancer | content.nejm.org

K-Ras mutaions analysis in colorectal cancer may become a pre-requiste for use of anti-EGFR antibodies in therapy Erbitux and Vecitibix use may be relegated to less number of cases. This will benefit Avastin ( Genentech) whose mechanism of action is independent of these mutations

Avastin may not get approval of "cost-conscious" EMEA

July 30, 2008

Analysis of:Roche Files Avastin for Wider Label in EU | www.therapeuticsdaily.com

Avastin ( Roche/Genentech) extended time to progression when combined with Docotaxel ( Sanofi-Aventis) in patients with metastatic breast cancer as compared to Docotaxel alone, but did not prolong survival. Unlike approval by the FDA,the EMEA is more cost conscious and may be reluctant to approve 2 pretty expensive agents ( Avastin and Docotaxel).

Doctors and cancer medications: the pressure should be shifted to health plans

July 28, 2008

Analysis of:Pricey Drugs Put Squeeze on Doctors | online.wsj.com

Doctors can not remain in the middle between pharmaceutical companies and insurance and health plans. Reimbursement for oreal and IV drugs should be comparable , in order to avoid over-prescription of IV drugs , even if they are not as efficacious or more toxic. The patient's helath plan ( the government in many cases) should negotiate pricing with drug providers and offer the precriber a fixed margin , and thius remove the MD as a miidleman. This may limit options for patients, and can be interpreted by some, as socialized medicine , but this solution is needed to fix a corrupt and very expensive system.

Lilly is replacing oine of its compounds with another in a subset of NSCLC

July 28, 2008

Analysis of:Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients With Advanced-Stage Non–Small-Cell Lung Cancer | jco.ascopubs.org

Pemetrexed (lilly) with Cisplatinum is less toxic and may be more efficacious in a subset of patients with advanced NSCLC than Gemcitibine ( another Lilly compound) /Cisplatin combination. he real question is how this comapres to Avastin ( Genentech) or even the antibody Cetuximab ( Imclone) in this patient poulation.

OLD news, but positive results and higher visibility will definitely benefit Bayer

July 28, 2008

Analysis of:Sorafenib in Advanced Hepatocellular Carcinoma | content.nejm.org

The New England Journal of Medicine report confirms that Bayer/Onyx Nexavar prolongs median survival and time to progression in patients with advanced HCC. This trumor is a world wide health problem, so such positive news, although old, in a reputable journal, will lead to wider use of this oral , targted. well tolerated, yet expensive agent.

Erbitux may add to chemotherapy in a subset of NSCLC patients

July 28, 2008

Analysis of:Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy | jco.ascopubs.org

In a US multicenter Phase II study, Erbitux ( Imclone) added to efficacy of Carboplatinum and Palcitaxel in a subset of NSCLC patients whose tumors had extra copies of EGFR that is targeted by Cetuxiamb. FISH techniques still has problems with standardization and larger number of patients are needed for validation, but this is good news for IMclone.

GSK's Lapatanib: ways from competing with Herceptin

June 30, 2008

Analysis of:Efficacy and Safety of Lapatinib As First-Line Therapy for ErbB2-Amplified Locally Advanced or Metastatic Breast Cancer | jco.ascopubs.org

In a recent JCO article, Laptanib showed clinical efficacy and acceptable safety in a non-randomized trial involving newly diagnosed patients with advanced oe metastatic breast cancer. Larger trials are needed to confirm efficacy and explore if it is more potent than Genentech's Herceptin. For now, Laptanib will be relegated to second and third line therapy.

Avastin for front-line treatment of metastatic breast cancer: Not a big market

June 30, 2008

Analysis of:Roche decision denies cancer drug to Britons | www.ft.com

Avastin's recent FDA approval for m-breast cancer ( m-BCA) was lukewarm at best with no overall survival benefit yet and modest PFS data. European regulatory agencies usually require cost efficacy data and more strict data, which are not readily available for Roche/Genetech. The British market is not big for innovative agents like Avastin, so the company's decision is unlikely to impact a large company like Roche.

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