REVLIMID ( R ) Data For Newly Diagnosed Multiple Myeloma Reported At A Satellite Symposium During The 13th European Hematology Association Congress

Data from the ECOG E4A03 and SWOG 0232 studies were reported at a Satellite Symposium and showed that newly diagnosed multiple myeloma patients who are eligible for a transplant, obtain better outcomes when treated with REVLIMID ( lenalidomide ) plus dexamethasone. The data were presented by Dr A. Stewart, from Mayo Clinic at the 13th European Hematology Association ( EHA ) congress in Copenhagen, Denmark.

These data from ECOG E4A03 and SWOG 0232 studies, which were recently presented at American Society of Clinical Oncology ( ASCO ) Annual Meeting. More specifically, updated results from these two large cooperative group trials of REVLIMID in combination with dexamethasone in newly diagnosed patients reported a survival advantage and improved complete response rates for REVLIMID when combined with dexamethasone.

In a four-month landmark analysis of ECOG Phase III study E4A03, patients who continued on treatment of REVLIMID plus low-dose dexamethasone ( Rd ) achieved a two-year overall survival rate of 93 percent. In same landmark analysis, patients who went on to autologous stem cell transplant achieved same two-year survival rate of 93 percent.

Patients in landmark analysis who received Rd achieved an overall response rate of 89 percent and CR + VGPR of 56 percent. Patients in the SWOG 0232 Phase III study receiving REVLIMID plus dexamethasone ( RD ) achieved a progression-free survival rate of 77 percent at one year and CR + VGPR of 62 percent.

Results from these studies demonstrate that REVLIMID in combination with dexamethasone is highly active in newly diagnosed multiple myeloma regardless of age or transplant eligibility. Moreover, results from trials provide rationale for conducting future prospective trials comparing novel agents to stem cell transplant.

" REVLIMID is turning multiple myeloma into a chronic disease through durable disease control, manageable side effects, and freedom of oral dosing " commented Dr Brian Durie, Chairman of Board and Co-Founder, International Myeloma Foundation ( IMF ) .

Additional Data Support REVLIMID's Efficacy in Newly Diagnosed Patients

In a study conducted by Eastern Cooperative Oncology Group ( E4A03 ) of REVLIMID plus low-dose dexamethasone ( Rd ) versus REVLIMID plus a standard dose of dexamethasone ( RD ) in newly diagnosed multiple myeloma patients, clinicians reported complete response rates that hadn't been tabulated at previous presentations. Patients in Rd arm of study demonstrated a combined near complete response/very good partial response ( nCR/VGPR ) rate of 52 percent in Rd arm compared to 42 percent in the RD arm ( P=0. 06 ) . Also reported was a two-year overall survival of 88 percent for Rd arm compared to 78 percent in the RD arm ( p=0. 007 ) .

Grade 3 or higher non-hematologic toxicities in the RD vs. Rd arms of study included deep vein thrombosis ( DVT ) /pulmonary embolism ( PE ) ( 25% vs. 11% ) infection/pneumonia ( 16% vs. 8% ) cardiac ischemia ( 3% vs. 0. 5% ) and neuropathy ( 2% in both arms ) .

The Southwest Oncology Group also presented at ASCO updated results of a study ( SWOG 0232 ) evaluating REVLIMID plus dexamethasone ( RD ) versus dexamethasone ( D ) alone in newly diagnosed multiple myeloma patients. Highlighted in the presentation was a combined complete response rate ( CR ) plus very good partial response rate ( VGPR ) of 62 percent for RD compared to 19 percent for dexamethasone ( p <0. 002 ) . Additionally, patients in RD arm of study had a progression-free survival rate of 77 percent after one year compared to 55 percent for dexamethasone ( p=0. 002 ) . Overall survival for patients in RD arm at one year was 93 percent compared to 91 percent for dexamethasone. These data were confounded by fact that patients in D arm were given option to cross over into RD arm after study was halted early.

Grade 3/4 adverse events were more frequent in multiple myeloma patients who received the combination of lenalidomide/dexamethasone compared to dexamethasone alone. Neutropenia ( 13. 8% vs. 2. 4% ) and infections ( 18. 9% vs. 9. 8% ) were most frequently reported adverse events. DVT occurred in 27% of patients receiving REVLIMID and dexamethasone compared to 14. 6% with dexamethasone alone.

About REVLIMID�

REVLIMID is an IMiDs� compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U. S. and foreign issued and pending patent applications including composition-of- matter and use patents.

About Multiple Myeloma

Multiple myeloma ( also known as myeloma or plasma cell myeloma ) is a cancer of blood in which malignant plasma cells are overproduced in bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein ( or M protein ) that does not benefit body. In addition, malignant plasma cells replace normal plasma cells and other white blood cells important to immune system. Multiple myeloma cells can also attach to other tissues of body, such as bone, and produce tumors. The cause of disease remains unknown.

About Celgene International Sárl

Celgene International Sárl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit Company's website at http: //www. celgene. com.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under Company's control, which may cause actual results, performance or achievements of Company to be materially different from results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by Food and Drug Administration and other regulatory authorities, and those factors detailed in Company's filings with Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.

Celgene International Sárl

Health advice that you can't refuse

What you have to know buying Zithromax.

uses of Zithromax Zithromax is an antibiotic ( macrolide-type ) used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It'll not work for viral infections ( e. g. , common cold, flu ) . Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

how to use of Zithromax Take Zithromax by mouth with or without food, usually once a day, or as directed by your doctor. You may take Zithromax with food if stomach upset occurs.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take Zithromax at the same time each day.

Continue to take Zithromax until full prescribed amount is finished even if symptoms disappear after a few days. Stopping medication too early may allow bacteria to continue to grow, which may result in a relapse of infection.

Antacids may decrease absorption of Zithromax. If we take an antacid, wait at least 2 hours after taking this medication.

Inform your doctor if your condition persists or worsens.

side effects of Zithromax Stomach upset, diarrhea/loose stools, nausea, vomiting, or stomach/abdominal pain may occur while use Zithromax. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Zithromax because he or she has judged that benefit to we is greater than risk of side effects. Many people using Zithromax don't have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

Seek immediate medical attention if any of these rare but very serious side effects occur:

Zithromax may rarely cause a severe intestinal condition ( pseudomembranous colitis ) due to a resistant bacteria. This condition may occur while use Zithromax weeks after treatment has stopped. Don't use anti-diarrhea products or narcotic pain medications if you have following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of Zithromax for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection ( oral or vaginal fungal infection ) . Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A serious allergic reaction to Zithromax is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

An allergic reaction to Zithromax may return even if we stop drug. If we have an allergic reaction, continue to watch for any of the above symptoms for several days after your last dose.

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

precautions of Zithromax Before taking Zithromax, tell your doctor or pharmacist if we are allergic to it; or to other macrolide antibiotics such as erythromycin, clarithromycin; or if you have any other allergies.

Before using Zithromax, tell your doctor or pharmacist your medical history, especially of:

Zithromax should be used only when clearly needed during pregnancy. Discuss risks and benefits with your doctor.

Zithromax passes into breast milk. Consult your doctor before breast-feeding.

interactions of Zithromax See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change dosage of any medicine before checking with them first.

Before using Zithromax, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of:

Zithromax may decrease effectiveness of combination-type birth control pills. This can result in pregnancy. We may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

Other drugs besides Zithromax which may affect heart rhythm ( QTc prolongation in the EKG ) include amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, propafenone, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for more details, and for instructions on how we may reduce your risk of this effect.

This document does not contain all possible interactions. Therefore, before using Zithromax, tell your doctor or pharmacist of all products you use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Zithromax with EU delivery

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