1. Ixabepilone Product name: Ixempra By Taylor Shepard and Tanya Welch Period 6/8 By Taylor Shepard and Tanya Welch Period 6/8 C 27 H 42 N 2 O 5 S

2. What is it? How does it work?  Ixempra was passed by the FDA on October 18th, 2007. The drug is used for the treatment of advance breast cancer.  Ixempra is part of the new class of chemotherapy drugs called epothilones. The function of these drugs are to prevent/hinder the growth of tumors by keeping cancer cells from successfully replicating.  The medicine works by inhibiting the protein β-tubulin. This protein is formed in the microtubules inside cancer cells and is necessary for the cell ’ s rapid reproduction. Ixabepilone attaches to the β-tublin and promotes β-tubulin polymerization. The drug forces the microtubules to stabilize, which causes the cancer cell to be unable to properly go through mitosis. The cancer cell is then put into arrest during the G2-M phase of the Cell Cycle which forces it into Apoptosis (otherwise known as programmed cell death). (Ixempra by Bristol-Myers Squibb Approved by FDA for Breast Cancer http://www.topix.com/forum/health/breast-cancer/TSNV29JP5K6VGALV2) http://www.topix.com/forum/health/breast-cancer/TSNV29JP5K6VGALV2 (ixabepilone http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+with) http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+with  Ixempra was passed by the FDA on October 18th, 2007. The drug is used for the treatment of advance breast cancer.  Ixempra is part of the new class of chemotherapy drugs called epothilones. The function of these drugs are to prevent/hinder the growth of tumors by keeping cancer cells from successfully replicating.  The medicine works by inhibiting the protein β-tubulin. This protein is formed in the microtubules inside cancer cells and is necessary for the cell ’ s rapid reproduction. Ixabepilone attaches to the β-tublin and promotes β-tubulin polymerization. The drug forces the microtubules to stabilize, which causes the cancer cell to be unable to properly go through mitosis. The cancer cell is then put into arrest during the G2-M phase of the Cell Cycle which forces it into Apoptosis (otherwise known as programmed cell death). (Ixempra by Bristol-Myers Squibb Approved by FDA for Breast Cancer http://www.topix.com/forum/health/breast-cancer/TSNV29JP5K6VGALV2) http://www.topix.com/forum/health/breast-cancer/TSNV29JP5K6VGALV2 (ixabepilone http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+with) http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+with

4. How is it used? How much does it cost?  Ixempra, which is either used alone or in combination with Capecitabine (product name: Xeloda), in patients who did not respond to other chemo drugs, specifically a anthracycline and/or taxane.  Ixempra is given as an injection through a needle placed into a vein. It takes about 3 hours to complete because it is given slowly through an IV infusion. The injection must be taken every 3 weeks.  A patient is given other medications an hour before they receive their Ixempra injection to prevent an allergic reaction. A steroid medication may also be given if the patient is known to have a reaction with the injection.  Because the drug, Ixempra, is extremely helpful a prediction for the price of the full treatment ranges from approximately 18,000 and 23,000 dollars.The high prices of Ixempra is estimated to bring in roughly 500 million dollars annually by 2010 for Bristol-Myers Squibb. (Ixempra - 2007 FDA Apprioals http://www.fiercebiotech.com/special-reports/ixempra-2007-fda- approvals)http://www.fiercebiotech.com/special-reports/ixempra-2007-fda- approvals  Ixempra, which is either used alone or in combination with Capecitabine (product name: Xeloda), in patients who did not respond to other chemo drugs, specifically a anthracycline and/or taxane.  Ixempra is given as an injection through a needle placed into a vein. It takes about 3 hours to complete because it is given slowly through an IV infusion. The injection must be taken every 3 weeks.  A patient is given other medications an hour before they receive their Ixempra injection to prevent an allergic reaction. A steroid medication may also be given if the patient is known to have a reaction with the injection.  Because the drug, Ixempra, is extremely helpful a prediction for the price of the full treatment ranges from approximately 18,000 and 23,000 dollars.The high prices of Ixempra is estimated to bring in roughly 500 million dollars annually by 2010 for Bristol-Myers Squibb. (Ixempra - 2007 FDA Apprioals http://www.fiercebiotech.com/special-reports/ixempra-2007-fda- approvals)http://www.fiercebiotech.com/special-reports/ixempra-2007-fda- approvals

5. Cautions  Ixempra may not be able to be receive by patients that have severe liver or heart disease, nerve problems in the hands or feet, diabetes, or bone marrow suppression.  Patients must tell the doctor if they are pregnant, or planning on getting pregnant, because the treatment could harm the unborn baby.  Ixempra can lower blood cells that help the body fight infections. This can make it easier for the body to bleed from an injury or get sick from being around others who are ill. The blood will need to be tested on a regular basis to make sure the blood cell count does not get too low.  The Patient should avoid drinking alcohol during the weeks that they are receiving Ixempra.  Ixempra may not be able to be receive by patients that have severe liver or heart disease, nerve problems in the hands or feet, diabetes, or bone marrow suppression.  Patients must tell the doctor if they are pregnant, or planning on getting pregnant, because the treatment could harm the unborn baby.  Ixempra can lower blood cells that help the body fight infections. This can make it easier for the body to bleed from an injury or get sick from being around others who are ill. The blood will need to be tested on a regular basis to make sure the blood cell count does not get too low.  The Patient should avoid drinking alcohol during the weeks that they are receiving Ixempra.

6. What are the side effects?  Common: Common side effects include feeling tired, having joint of muscle pain, hair loss, nausea, vomiting, diarrhea or constipation, stomach pain, loss of appetite, and white patches or sores inside the mouth or on the lips. (What are the possible side effects of IXEMPRA? http://www.ixempra.com/pdf/Patientinfo.pdf ) http://www.ixempra.com/pdf/Patientinfo.pdf  Common: Common side effects include feeling tired, having joint of muscle pain, hair loss, nausea, vomiting, diarrhea or constipation, stomach pain, loss of appetite, and white patches or sores inside the mouth or on the lips. (What are the possible side effects of IXEMPRA? http://www.ixempra.com/pdf/Patientinfo.pdf ) http://www.ixempra.com/pdf/Patientinfo.pdf  Serious: Patients should warn someone if they are experiencing serious side effects such as numbness, burning, pain, or tingly feeling in the hands or feet, sudden numbness or weakness, especially on one side of the body, chest pain or heavy feeling, fever, chills, body aches, flu symptoms, or redness, swelling, and pain on the palms of the hands or the soles of the feet. (What are the possible side effects of IXEMPRA? http://www.ixempra.com/pdf/Patientinfo.pdf ) http://www.ixempra.com/pdf/Patientinfo.pdf

7. Random Facts  Ixempra was granted priority review status by the FDA. This status, which cuts four months off the standard 10-month drug review time, is given to products that are considered to be an advance over existing therapies on the market.  Bristol-Myers is also studying the use of Ixempra for treatment of earlier-stage breast cancer, as well as ovarian, prostate, renal, pancreatic and non small cell lung cancers. (https://www.drugdigest.org/DD/Articles/News/0,10141,609206,00.html)https://www.drugdigest.org/DD/Articles/News/0,10141,609206,00.html  HISTORY: Based in New York City, USA, the Bristol-Myers Company began in 1887 when two friends - William McLaren Bristol and John Ripley Myers - founded a small manufacturing company that sold medicines directly to doctors.  Fun Fact: William Bristol is related to the Bristol family that donated the Bristol Gym. (The family is no longer involved in the Company though)  Ixempra was granted priority review status by the FDA. This status, which cuts four months off the standard 10-month drug review time, is given to products that are considered to be an advance over existing therapies on the market.  Bristol-Myers is also studying the use of Ixempra for treatment of earlier-stage breast cancer, as well as ovarian, prostate, renal, pancreatic and non small cell lung cancers. (https://www.drugdigest.org/DD/Articles/News/0,10141,609206,00.html)https://www.drugdigest.org/DD/Articles/News/0,10141,609206,00.html  HISTORY: Based in New York City, USA, the Bristol-Myers Company began in 1887 when two friends - William McLaren Bristol and John Ripley Myers - founded a small manufacturing company that sold medicines directly to doctors.  Fun Fact: William Bristol is related to the Bristol family that donated the Bristol Gym. (The family is no longer involved in the Company though)

8. First Part of Bibliography  FDA Approves Chemotherapy Drug Ixempra For Advanced Breast Cancer http://www.medicalnewstoday.com/articles/85905.php http://www.medicalnewstoday.com/articles/85905.php  Ixabepilone http://www.cancer.gov/dictionary/db_alpha.aspx?expand=i#ixabepilone  FDA Approval for Ixabepilone http://www.cancer.gov/cancertopics/druginfo/fda-ixabepilone  Ixabepilone http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+wi th http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+wi th  Ixempra (Ixabepilone) http://breastcancer.about.com/od/treatments/a/ixempra.htm  Ixempra http://www.drugs.com/ixempra.html  Ixabepilone http://en.wikipedia.org/wiki/Ixabepilone  Tubulin http://en.wikipedia.org/wiki/Tubulin  FDA Approves Chemotherapy Drug Ixempra For Advanced Breast Cancer http://www.medicalnewstoday.com/articles/85905.php http://www.medicalnewstoday.com/articles/85905.php  Ixabepilone http://www.cancer.gov/dictionary/db_alpha.aspx?expand=i#ixabepilone  FDA Approval for Ixabepilone http://www.cancer.gov/cancertopics/druginfo/fda-ixabepilone  Ixabepilone http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+wi th http://cancernet.nci.nih.gov/Templates/drugdictionary.aspx?searchTxt=epothilone+B&sgroup=Starts+wi th  Ixempra (Ixabepilone) http://breastcancer.about.com/od/treatments/a/ixempra.htm  Ixempra http://www.drugs.com/ixempra.html  Ixabepilone http://en.wikipedia.org/wiki/Ixabepilone  Tubulin http://en.wikipedia.org/wiki/Tubulin

9. Second Part of Bibliography  What are the possible side effects of IXEMPRA? http://www.ixempra.com/pdf/Patientinfo.pdf  Bristol on Comeback Trail in Cancer Drugs, CEO Says http://blogs.wsj.com/health/2007/10/17/  Ixempra – 2007 FDA approvals http://www.fiercebiotech.com/special-reports/ixempra-2007-fda-approvals Google images -  http://vbaulin.front.ru/research/images/microtubule.gif http://vbaulin.front.ru/research/images/microtubule.gif  http://www.prescribingreference.com/images/Products/ixempra.gif http://www.prescribingreference.com/images/Products/ixempra.gif  http://www.rttnews.com/home/storyimg/Bristol-Myers-BMY-101607.jpg http://www.rttnews.com/home/storyimg/Bristol-Myers-BMY-101607.jpg  What are the possible side effects of IXEMPRA? http://www.ixempra.com/pdf/Patientinfo.pdf  Bristol on Comeback Trail in Cancer Drugs, CEO Says http://blogs.wsj.com/health/2007/10/17/  Ixempra – 2007 FDA approvals http://www.fiercebiotech.com/special-reports/ixempra-2007-fda-approvals Google images -  http://vbaulin.front.ru/research/images/microtubule.gif http://vbaulin.front.ru/research/images/microtubule.gif  http://www.prescribingreference.com/images/Products/ixempra.gif http://www.prescribingreference.com/images/Products/ixempra.gif  http://www.rttnews.com/home/storyimg/Bristol-Myers-BMY-101607.jpg http://www.rttnews.com/home/storyimg/Bristol-Myers-BMY-101607.jpg