Posted by rob on May 28, 2005 under Uncategorized | 
The European Union on Friday cleared the creation of world’s largest generic medicine producer but told Swiss drug maker Novartis AG it must shed some products in EU member states.
Under the EU-approved deal, Novartis acquired German generic drug maker Hexal and 67.7 percent of the U.S. company Eon Labs Inc.
The deal must still win clearance from the U.S. Federal Trade Commission, which submitted a request to Novartis on April 6, asking for additional information about the transaction.
(Novartis has a manufacturing plant northeast of Lincoln.)
Novartis will sell off some drugs in Poland, Germany and Denmark. The Swiss drug company must sell to a competitor Cacihexal, used to treat osteoporosis, in Poland. It also must sell an anti-rheumatic drug called Diclac in Germany and two drugs, Apurin and Allopurnol, in Denmark.
In the specific markets concerned, combining Novartis and Hexal drugs would have led to a dominant position.
Novartis purchased the privately owned Hexal along with a majority stake in New York-based Eon Labs from the Struengmann family for $8.3 billion in cash.
Novartis offered to divest products in selected markets after the EU extended its investigation of the takeover an additional two weeks.
Lincoln Journal Star Online
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Hot-air balloons fly above Debrecen, 226 kms east of Budapest, Hungary during the 14th European Hot-Air Balloon Championships organized by the Federation Aeronautic International (FAI).
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For all the wonders of modern medicine, experts say that some aspects of cancer care remain old-fashioned. Many diagnoses are still made with light microscopes — technology that’s hundreds of years old, says Michael Heinrich, a professor at Oregon Health & Science University in Portland. And doctors have relatively few ways to tailor chemotherapy for individuals. “We give them all the same poison and there’s no way to tell who is going to respond and who isn’t,” Heinrich says.
Thanks to a better understanding of genes, however, doctors are finding new ways to provide more personalized therapies.
At the annual meeting of the American Society of Clinical Oncology in Orlando last week, scientists described a way to tailor therapy for a rare cancer called neuroblastoma. The tumor, a malignancy of the sympathetic nervous system, is the most common cancer in infants, striking about 650 children a year, typically at 17 months.
Because treatments can harm such small children, doctors are looking for ways to determine which children need aggressive treatments and which might benefit from gentler regimens, says Edward Attiyeh, a hematology/oncology fellow at Children’s Hospital of Philadelphia.
Treatments match genetics
Attiyeh and his colleagues say they have found a clue. Children whose tumors are missing part of chromosome 11 are more likely to die than other young patients. A study of more than 900 children found that only 65% of patients with the genetic change survived three years, compared with 83% of the other kids. That tells doctors which children need aggressive care and which can scale back treatment and avoid some toxic side effects. He hopes to isolate the genes involved, which could help researchers develop even better therapies.
In some cases, genetic markers help identify which patients will respond to particular drugs. The experimental drug Revlimid, for example, appears especially promising for some patients with myelodysplastic syndromes, or MDS, a cancer in which the bone marrow fails to make enough functioning blood cells. The disease strikes up to 15,000 people a year.
MDS patients receive transfusions as often as once or twice a month to treat their anemia and fatigue, says Alan List, a professor at the H. Lee Moffitt Cancer Center in Tampa. But repeated transfusions can lead to a toxic buildup called “iron overload” that can damage the heart, liver and pancreas.
Early studies suggested that Revlimid produces dramatic recoveries in people whose cancers are missing a hunk of chromosome 5, or about 20% to 30% of patients.
Based on that study, List and his colleagues tested Revlimid in 148 patients with this genetic change in a study funded by the drug’s manufacturer, Celgene Corp.
Doctors had hoped the drug would treat the symptoms of MDS. In some cases, however, Revlimid treated the disease itself, List says. After treatment, 97 patients no longer needed transfusions. Even more impressive, the drug erased all signs of the cancer’s genetic cause in 51 patients, putting the cancer into remission. List says it’s too soon to say if these patients are cured.
Doctors don’t know how long remissions will last. Patients who take other targeted therapies, such as Gleevec, need to take the drugs indefinitely to prevent relapse. And even Gleevec will eventually stop working for some patients.
Serious risks involved
But unlike Gleevec, which causes few severe side effects, Revlimid can pose serious risks, such as suppressing infection-fighting white blood cells and platelets, which aid clotting. Two-thirds of Revlimid patients had to lower their dose because of those problems, according to the study. Fifteen patients in the trial died, including two deaths that doctors suspect were caused by the drug. Revlimid, which has not been approved by the Food and Drug Administration, is similar to thalidomide, which caused birth defects in the 1950s. Doctors today are testing thalidomide in a blood cancer called multiple myeloma.
Patients such as Lynn Nance already are benefiting from this new research. Nance, a turkey farmer from Monroe, N.C., was diagnosed with MDS in 2000. He needed transfusions as often as twice a month before beginning Revlimid about a year ago.
Nance has only required one transfusion since. Although the drug has lowered his white cells and platelets, Nance is again able to work full time.
“It’s given me my life back,” says Nance, 69. “Now, I can go all day.”
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Oregon Health & Science University in Portland
Story from REDNOVA NEWS:
http://www.rednova.com/news/display/?id=151802
Published: 2005/05/25 06:00:00 CDT
RedNova News – Health – Tailored Treatments Take Aim at Cancer
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Cornet AD, Issa AI, Loosdrecht AA, Ossenkoppele GJ, van Schijndel RJ, Johan Groeneveld AB
Eur J Haematol. 2005 Jun ; 74(6): 511-6
OBJECTIVES: Poor survival of patients with a haematological malignancy admitted to the intensive care unit (ICU) prompts for proper admission triage and prediction of ICU treatment failure and long-term mortality. We therefore tried to find predictors of the latter outcomes. METHODS: A retrospective analysis of charts and a prospective follow-up study were done, of haemato-oncological patients, admitted to our ICU in a 7-year period with a follow-up until 2 yr thereafter. Clinical parameters during the first four consecutive days were taken to calculate the simplified acute physiology (SAPS II) and the sequential organ failure assessment (SOFA) scores, of proven predictive value in general ICU populations. RESULTS: From a total of 58 patients (n = 47 with acute myelogenous leukaemia or non-Hodgkin lymphoma), admitted into ICU mostly because of respiratory insufficiency, sepsis, shock or combinations, 36 patients had died during their stay in the ICU. Of ICU survivors (n = 22), 20 patients died during follow-up so that the 1-year survival rate was only 12%. The SAPS II and particularly the SOFA scores were of high predictive value for ICU and long-term mortality. CONCLUSIONS: Patients with life-threatening complications of haematological malignancy admitted to ICU ran a high risk for death in the ICU and on the long-term, and the risk can be well predicted by SOFA. The latter may help us to decide on intensive care in individual cases, in order to avoid potentially futile care for patients with a SOFA score of 15 or higher.
Sequential organ failure predicts mortality of patients with a haematological malignancy needing intensive care.
