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GLG News by Oncologists Specializing in Hematologic Malignancies in the U.S.

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April 14, 2008
Genentech still has a lucrative drug pipeline , but may not meet zelous estimates.
Analysis of: Genentech Profit Jumps By 12% on Solid Revenue | online.wsj.com
Author: GLG Expert Contributor
Genetech has an impressive inventory of block-buster drugs: Avastin, Rituximab,  and Herceptin,  whose sales have been increasing on a regular base. Hereceptin and Avastin will be getting more and more use with new indications and longer dosing schedules. However, given the sagging economy...
April 14, 2008
Hematide: a long acting ESA with more potential in chronic renal failure than in chemotherapy induced anemia.
Analysis of: Affymax and Takeda Report Long-Term Safety and Effectiveness Data of Hematide in Chronic Renal Failure Patients With Anemia | pharmalive.com
Author: GLG Expert Contributor
Affymax's Hematide is a long acting synthetic peptide that stimulates erythropoietin and acts as an ESA. Together with Takeda, the company sponsored a phase II trial that showed safety and efficacy in patients with chronic renal failure; phase 3 trials are underway. This drug amy overtake the currently...
April 10, 2008
Biosimilar " Neukine" will add to Amgen woes and is just tip of the iceberg!!!
Analysis of: Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market | www.pipelinereview.com
Author: GLG Expert Contributor
An indian product similar to Amgen's Filgastrim " G-CSF" showed comparable efficacy and safety in a trial in Europe and is expected to get EMEA approval in 2010.  " Neukine" is already in use in India and in several "developing countries" in the MiddlE Esat and Asia where it is available at less...
April 10, 2008
Oncophage approval in Russia: Following Sutton's Rule!!!
Analysis of: Oncophage(R) Approved in Russia for the Treatment of Intermediate-Risk Kidney Cancer | www.pipelinereview.com
Author: GLG Expert Contributor
Antigenics' Oncophage is a form of immunotherapy for patients with intermediate risk renal cancer that showed efficacy in improving recurrence free survival in a randomized trial . The approval in Russia, may be due in addition to the obvious reason of less regulatory restrictions, is that the company...
March 31, 2008
Immunoconjugates Are Better in Theory Than Practice
Analysis of: Immunomedics Develops New Immunoconjugates for Targeted Chemotherapy of Pancreatic and Other Cancers | www.pipelinereview.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Immunomedics has developed three new immunoconjugates between monoclonal antibodies and SN-38 i an effort to target colon, pancreas and lung cancer.  Preclinical data are effective in a metastatic colon cancer model but there are no clinical data.
March 14, 2008
Nplate: An effective parenteral therapy for refractory chronic ITP
Analysis of: Platelet Treatment Wins FDA Panel's Support | online.wsj.com
Author: GLG Expert Contributor
FDA panel recommned approval of Amgen's Nplate for patients with refractory/recurrent chronic ITP who have failed other therapies like steroids, immunoglobulins, Rituximab and spleenectomy. The safety/efficacy profile was favorable for this relatively narrow indication, although long term safet issues...
March 14, 2008
FDA panel recommendations means less sales of ESA'a and negative implications for Amgen
Analysis of: FDA Panel Backs Anemia Drugs For Cancer Patients, but With Limits | online.wsj.com
Author: GLG Expert Contributor
An FDA panel recommended NOT to use ESA's for treatment of chemotherapy induced anemia in Breast cancer patients and head and neck acncer patients, a significant number of cancer patients. It also voted overwhelmingly to limit ESA's for non-curable cancer patients in the setting of palliative care....
March 11, 2008
Avastin: Not for every one with breast cancer, but benefit is real for selected patients.
Analysis of: The High Cost of a Cancer Drug | www.nytimes.com
Author: GLG Expert Contributor
FDA's approval of Genentech's Avastin is backed both by efficacy data and aggressive political activism. Extension of PFS by almost 6 months and shrinking large tumors, thus improving quality of life, are tangible and real beneficial effects. Avastin was already being prescribed off-label. The approval...
March 10, 2008
Teva's generic Irinotecan will gradually cut into the brand name use
Analysis of: Teva Announces Approval Of Generic Camptosar(R) | www.pipelinereview.com
Author: GLG Expert Contributor
Pfizer's Irinotecan ( CPT-11) is mostly used in colorectal cancer with some limited use in sarcomas, glioblastoma multiforme, and other solid tumors. Teva's generic compound is expected to be cheaper, and with current economic situation, may be mandated by third party payers to cut costs, and this will...
March 10, 2008
AS1409 : Not so novel drug in an already crowded market
Analysis of: Antisoma starts phase I clinical trial of AS1409 in renal cancer and melanoma | www.pipelinereview.com
Author: GLG Expert Contributor
Antisoma's AS 1409 has just entered a clinical phase I trial for patients with advanced melanoma and renal cancer. While efficacy results are years ago, this "immunotherapy" will be competing with many approved targeted agents in renal cancer ( Sutent, Nexavar, Torisel) and with many other immunotherapeutic...

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