Herceptin [Trastuzumab]
BREAKING NEWS MAY 24, 2006
Herceptin is set to be lincensed for use in early stage of HER-2 positive
breast cancer by European regulators. Last month, it was announced a
committe at European Medicines Agency (EMEA) has recommended the
approval of Herceptin. A year's course of Herceptin costs about 20,000
pounds.
NEWS
Introduction
Herceptin (Trastuzumab) was approved for use alone for certain patients who
have tried chemotherapy with little success or as a first-line treatment for
metastatic disease when used in combination with paclitaxel (trade-name
Taxol) on September 25, 1998. It was described as a new biologic approach
for the treatment of metastatic breast cancer, or cancer that has spread beyond
the breast and lymph nodes under the arm.
About Breast Cancer
According to the American Cancer Society, an estimated 211,240 women will
be diagnosed with breast cancer and approximately 40,000 women will die of
the disease in the United States in 2005. Breast cancer is the most common
cause of cancer among women in the United States
Herceptin (Trastuzumab)
Herceptin (Trastuzumab) is actually a monoclonal antibody bioengineered
from a mouse antibody. Herceptin (Trastuzumab) binds to HER2 on the
surface of some normal cells and plays a role in regulating cell growth. In the
experimental studies, Herceptin (Trastuzumab) demonstrated its ability to
inhibit tumor cell growth by this binding action. In metastatic breast cancer
cells, about 30% of tumors produce excess amounts of HER2. Studies show
that cancer may be more aggressive when breast cancer tumors produce
excess amounts of the HER2 protein. In studies, patients suffered from breast
cancers showed better responses when they had higher levels of HER2
protein.
Recent Research Studies
About 20-25 percent of primary breast cancers are HER2 positive, and it is 2.5
times more likely to return than ordinary breast cancer. Researcher found that
use of trastuzumab (Herceptin) reduced the risk of a relapse among those with
the aggressive HER2 positive strain of the cancer by more than half in two
large clinical studies. [5]
Related Patents and Scientific Advancements
As of May 3, 2005, there are 77 patents related to trastuzumab (Herceptin)
issued in the United States. Genetech Inc. filed its first patent on
monoclonclonal antibodies directed to the HER2 receptor on March 17, 1998
[4]. This patent has three important claims: [1] an isolated human antibody
which specifically binds to HER2 receptor, [2] a human hybridoma producing a
human antibody which specifically binds to HER2 receptor and [3] a
composition comprising a human antibody wich specifically binds to HER2
receptor and a pharmaceutically acceptable vehicle.
Requirements
For the potentially benefit from treatment with Herceptin (Trastuzumab),
identification of the patients who over-express HER2 becomes critical. The test
to measure HER2 is called DAKO Hercep Test.
The package insert to for Trastuzumab was revised in 2002 to include Vysis
PathVysion HER2 DNA Probe, a FISH test for detecting HER2 gene
amplification as a method to select patients for therapy. [3]
Side Effects
The use of Herceptin (Trastuzumab) either alone or in combination with
chemotherapy can result in a weakening of the heart muscle. This can lead to
congestive heart failure. It may be dangerous for patients who Herceptin
(Trastuzumab) in combination with chemotherapy consisting of anthracyclines
and cyclophosphamide.
Other side-effects with Herceptin (Trastuzumab) plus chemotherapy include a
reduction of white blood cells (leukopenia), anemia, diarrhea, abdominal pain
and infections. Side-effects that occur some patients during the first infusion
with Herceptin (Trastuzumab) include chills, fever, pain, weakness, nausea,
vomiting and headache.
About Monoclonal Antibody
Herceptin (Trastuzumab) is the second monoclonal antibody approved to treat
cancer. The first, Rituxan (trade-name), was approved in November, 1997, for
patients suffered from one type of non-Hodgkin's lymphoma (a cancer of the
immune system).
Reconstitution of Herceptin (trastuzumab)
HERCEPTIN is provided as a sterile, preservative-free lyophilized powder for
intravenous (IV) administration along with a 30-mL vial of Bacteriostatic Water
for Injection USP, containing 1.1% benzyl alcohol as preservative for
reconstituting the product. 20 mL of bacteriostatic water for injection (BWFI) is
used to reconstitute the Herceptin (Trastuzumab) n. The BWFI can maintain the
stability and sterility of Herceptin (Trastuzumab) for only 28 days. The
constituted Herceptin (Trastuzumab) should be used immediately right after
reconstitution. During reconstitution, BWFI should be injected slowly into the
vial containing the lyophilized cake of Herceptin (Trastuzumab) to avoid foams.
Vial can be swirled gently to aid reconstitution. The resulting Herceptin solution
should be clear and colorless to pale yellow. Herceptin is added into saline for
IV infusion [1]
Market and Product Sales
Currently, Genentech is marketing Herceptin in the United States, Chugai in
Japan and Roche internationally. [5] U.S. sales of Herceptin (Trastuzumab)
increased 19 percent to $129.6 million from $108.7 million in the first quarter of
2004. [6]
What is going on in the R&D?
Merck may work on developing a method of treating cancer which comprises
administering a therapeutically effective amount of a compound and paclitaxel
or trastuzumab [Herceptin].[7]
SciClone Pharmaceuticals, Inc. (San Mateo, CA) may work on a method for
reducing the severity of chemotherapy side effects in cancer patients by
administering thymosin .alpha..sub.1 in conjunction with the administration of
a chemotherapy agent, e.g. trastuzumab [Herceptin], to the patient. [8]
Bristol-Myers Squibb may work on developing a method of treating cancer
which comprises administering a therapeutically effective amount of a
compound and trastuzumab [Herceptin].[9]
CombinatoRx, Inc. may also work on developing a method of treating cancer
which comprises administering a therapeutically effective amount of a
compound and trastuzumab [Herceptin] [10]
REFERENCES
[1] Susan D. Hellmann, MD, MPH, Important prescribing information, Genentech, Inc.,
September 23, 1999. [2] New monoclonal antibody approved for advanced breast cancer,
HHS News, Food and Drug Administration, September 25, 1998.[3] Karen D. Weiss, M.D.,
Food and Drug Administration , Letter to Genentech, Inc. BL 103792/5008, August 28,
2002[4] Hudziak RM et al, Monoclonal antibodies directed to the HER2 receptor, Patent
no. 6165464. [5] Even more good news about Herceptin, breast caner less likely to come
back. Medical News Today, UK, April 28, 2005.[6] Genentech Announces First Quarter
2005 Results, Press Release, April 11, 2005.[7] Fraley , et al, Tyrosine kinase inhibitors,
Patent no. 6,313,138, issued on November 6, 2001.[8] Rudolph , et al, Method of
reducing side effects of chemotherapy in cancer patients, 6,462,017, October 8, 2002.[9]
Lee; Francis Y, Synergistic methods and compositions for treating cancer, 6,537,988,
March 25, 2003.[10] Borisy; Alexis et al, Combinations of drugs for the treatment of
neoplastic disorders, 6,846,816, January 25, 2005. [11] Herceptin set to get EU approval
BBC News, May 24, 2006.
This article is for your reference only. If you have any question, please, consult with
your doctor or investiment manager. ALL RIGHT RESERVED 2006
BREAKING NEWS MAY 24, 2006
Herceptin is set to be lincensed for use in early stage of HER-2 positive
breast cancer by European regulators. Last month, it was announced a
committe at European Medicines Agency (EMEA) has recommended the
approval of Herceptin. A year's course of Herceptin costs about 20,000
pounds.
NEWS
Introduction
Herceptin (Trastuzumab) was approved for use alone for certain patients who
have tried chemotherapy with little success or as a first-line treatment for
metastatic disease when used in combination with paclitaxel (trade-name
Taxol) on September 25, 1998. It was described as a new biologic approach
for the treatment of metastatic breast cancer, or cancer that has spread beyond
the breast and lymph nodes under the arm.
About Breast Cancer
According to the American Cancer Society, an estimated 211,240 women will
be diagnosed with breast cancer and approximately 40,000 women will die of
the disease in the United States in 2005. Breast cancer is the most common
cause of cancer among women in the United States
Herceptin (Trastuzumab)
Herceptin (Trastuzumab) is actually a monoclonal antibody bioengineered
from a mouse antibody. Herceptin (Trastuzumab) binds to HER2 on the
surface of some normal cells and plays a role in regulating cell growth. In the
experimental studies, Herceptin (Trastuzumab) demonstrated its ability to
inhibit tumor cell growth by this binding action. In metastatic breast cancer
cells, about 30% of tumors produce excess amounts of HER2. Studies show
that cancer may be more aggressive when breast cancer tumors produce
excess amounts of the HER2 protein. In studies, patients suffered from breast
cancers showed better responses when they had higher levels of HER2
protein.
Recent Research Studies
About 20-25 percent of primary breast cancers are HER2 positive, and it is 2.5
times more likely to return than ordinary breast cancer. Researcher found that
use of trastuzumab (Herceptin) reduced the risk of a relapse among those with
the aggressive HER2 positive strain of the cancer by more than half in two
large clinical studies. [5]
Related Patents and Scientific Advancements
As of May 3, 2005, there are 77 patents related to trastuzumab (Herceptin)
issued in the United States. Genetech Inc. filed its first patent on
monoclonclonal antibodies directed to the HER2 receptor on March 17, 1998
[4]. This patent has three important claims: [1] an isolated human antibody
which specifically binds to HER2 receptor, [2] a human hybridoma producing a
human antibody which specifically binds to HER2 receptor and [3] a
composition comprising a human antibody wich specifically binds to HER2
receptor and a pharmaceutically acceptable vehicle.
Requirements
For the potentially benefit from treatment with Herceptin (Trastuzumab),
identification of the patients who over-express HER2 becomes critical. The test
to measure HER2 is called DAKO Hercep Test.
The package insert to for Trastuzumab was revised in 2002 to include Vysis
PathVysion HER2 DNA Probe, a FISH test for detecting HER2 gene
amplification as a method to select patients for therapy. [3]
Side Effects
The use of Herceptin (Trastuzumab) either alone or in combination with
chemotherapy can result in a weakening of the heart muscle. This can lead to
congestive heart failure. It may be dangerous for patients who Herceptin
(Trastuzumab) in combination with chemotherapy consisting of anthracyclines
and cyclophosphamide.
Other side-effects with Herceptin (Trastuzumab) plus chemotherapy include a
reduction of white blood cells (leukopenia), anemia, diarrhea, abdominal pain
and infections. Side-effects that occur some patients during the first infusion
with Herceptin (Trastuzumab) include chills, fever, pain, weakness, nausea,
vomiting and headache.
About Monoclonal Antibody
Herceptin (Trastuzumab) is the second monoclonal antibody approved to treat
cancer. The first, Rituxan (trade-name), was approved in November, 1997, for
patients suffered from one type of non-Hodgkin's lymphoma (a cancer of the
immune system).
Reconstitution of Herceptin (trastuzumab)
HERCEPTIN is provided as a sterile, preservative-free lyophilized powder for
intravenous (IV) administration along with a 30-mL vial of Bacteriostatic Water
for Injection USP, containing 1.1% benzyl alcohol as preservative for
reconstituting the product. 20 mL of bacteriostatic water for injection (BWFI) is
used to reconstitute the Herceptin (Trastuzumab) n. The BWFI can maintain the
stability and sterility of Herceptin (Trastuzumab) for only 28 days. The
constituted Herceptin (Trastuzumab) should be used immediately right after
reconstitution. During reconstitution, BWFI should be injected slowly into the
vial containing the lyophilized cake of Herceptin (Trastuzumab) to avoid foams.
Vial can be swirled gently to aid reconstitution. The resulting Herceptin solution
should be clear and colorless to pale yellow. Herceptin is added into saline for
IV infusion [1]
Market and Product Sales
Currently, Genentech is marketing Herceptin in the United States, Chugai in
Japan and Roche internationally. [5] U.S. sales of Herceptin (Trastuzumab)
increased 19 percent to $129.6 million from $108.7 million in the first quarter of
2004. [6]
What is going on in the R&D?
Merck may work on developing a method of treating cancer which comprises
administering a therapeutically effective amount of a compound and paclitaxel
or trastuzumab [Herceptin].[7]
SciClone Pharmaceuticals, Inc. (San Mateo, CA) may work on a method for
reducing the severity of chemotherapy side effects in cancer patients by
administering thymosin .alpha..sub.1 in conjunction with the administration of
a chemotherapy agent, e.g. trastuzumab [Herceptin], to the patient. [8]
Bristol-Myers Squibb may work on developing a method of treating cancer
which comprises administering a therapeutically effective amount of a
compound and trastuzumab [Herceptin].[9]
CombinatoRx, Inc. may also work on developing a method of treating cancer
which comprises administering a therapeutically effective amount of a
compound and trastuzumab [Herceptin] [10]
REFERENCES
[1] Susan D. Hellmann, MD, MPH, Important prescribing information, Genentech, Inc.,
September 23, 1999. [2] New monoclonal antibody approved for advanced breast cancer,
HHS News, Food and Drug Administration, September 25, 1998.[3] Karen D. Weiss, M.D.,
Food and Drug Administration , Letter to Genentech, Inc. BL 103792/5008, August 28,
2002[4] Hudziak RM et al, Monoclonal antibodies directed to the HER2 receptor, Patent
no. 6165464. [5] Even more good news about Herceptin, breast caner less likely to come
back. Medical News Today, UK, April 28, 2005.[6] Genentech Announces First Quarter
2005 Results, Press Release, April 11, 2005.[7] Fraley , et al, Tyrosine kinase inhibitors,
Patent no. 6,313,138, issued on November 6, 2001.[8] Rudolph , et al, Method of
reducing side effects of chemotherapy in cancer patients, 6,462,017, October 8, 2002.[9]
Lee; Francis Y, Synergistic methods and compositions for treating cancer, 6,537,988,
March 25, 2003.[10] Borisy; Alexis et al, Combinations of drugs for the treatment of
neoplastic disorders, 6,846,816, January 25, 2005. [11] Herceptin set to get EU approval
BBC News, May 24, 2006.
This article is for your reference only. If you have any question, please, consult with
your doctor or investiment manager. ALL RIGHT RESERVED 2006
| Herceptin [Trastuzumab] Zhion Feb 25, 2008 zhion@zhion.com |
PHARMCEUTICAL
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
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Coating-Nutrateric
SR
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Drug Industry
Drug
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Materials
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Drug Dev -
2005Q1
Drug Dev-
2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Lyrica
(pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium
Carbonate
Clinical Research
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
DRUG NOTES
[under
construction]
Double-blind
Study
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-loweri
ng
Drug-Terminologi
es
Packaging
Materials
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev-
2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Lyrica
(pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium
Carbonate
Clinical Research
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
DRUG NOTES
[under
construction]
Double-blind
Study