Pharma Chronicle June-2011

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Pharma Chronicle

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PHARMA CHRONICLEAN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALSR&C/AJ/PDS/1978

ISSUE 68

PHARMA C HRONICLESince 2009

June 2011

Readers TestimonialsI enjoyed reading it and more important I could get some very interesting information in our field It is always very interesting. Good continuation! It is very instructive and I think could be of interest to all of us. ...I like the new look! I always forward your chronicle to my colleagues. This effort is very informative and productive for Professional with special concern of up date forPharma Industries in the world; We are getting up date knowledge through this effort

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PHARMA CHRONICLE

JUNE 2011

For more information about PSI, please visit www.psi.com.sa

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PHARMA CHRONICLE

JUNE 2011

For more information about PSI, please visit www.psi.com.sa

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PHARMA CHRONICLEAN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALS

CONTENTSINSIDE THIS ISSUE:CHRONICLE SPOTLIGHT NEWS FROM THE GULF INSIGHTS: The Worlds Biggest R&D Spenders P RODUCT LAUNCH F EATURE: AstraZeneca Pulls Plug On Free Trips For Doctors DRUG MARKET: A Snapshot Of Cholesterol Drug Market NEWS UPDATE F DA APPROVALS E MA NEWS F UNNY PHARMA CARTOON AREEGMENTS & COLLABORATIONS P HARMA ARTICLES

JUNE 2011

512 13 14 16 17 18 19 1923 24 2426 27 28 29 30 3038 39 3940 41 42 43 4346

eyeforpharma ARTICLESUPCOMING EVENT IN VIENNA, AUSTRIA UPCOMING CONFERENCE IN LONDON, UNITED KINGDOM

eyeforpharma ARTICLES

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PHARMA CHRONICLEAN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALS

CHRONICLE SPOTLIGHTGERMANY SUSPENDS TOP TAKEDA DIABETES DRUG ACTOSMoves follow study showing slightly raised cancer risk.Germany has joined France in suspending the use of Takeda Pharmaceutical's Actos diabetes drug, due to worries about a possible link to cancer.

JUNE 2011

The move is a blow for the Japanese firm, whose best-selling drug has worldwide sales of close to $5 billion, though the financial impact will be limited by the fact the drug faces looming generic competition in key markets. Shares in Takeda fell 2.9 percent on Jun. 10, 2011, against a0.5 percent rise in the benchmark Nikkei average.

On Jun. 9, 2011, France's drug safety authority suspended use of both Actos and Competact -which combines Actos and an older drug called metformin -- after an official French study found they appeared to slightly raise the risk of bladder cancer. Germany's Federal Institute for Drugs and Medical Devices (BfArM) said it had decided to follow suit after receiving results of the study by France's national health insurance body, which tracked patients on diabetes drugs between 2006 and 2009. BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone, the German regulator said in a statement. A Takeda spokesman had earlier said the German authorities had informed the company of their intentions. Both the French and German regulators said patients currently being prescribed Actos should continue to take their medicines until they could consult with their doctors, since they could be in danger if they stopped treatment. Other European countries are holding fire on Actos and a spokeswoman for the European Medicines Agency said it was not aware of any other national authorities taking action. The European agency, based in London, initiated a review into the safety of Actos in March and its experts will discuss the latest data on the drug at a June 20-23 meeting. Britain's drugs regulator said it was not recommending any changes to Actos use while the European review was going on and the Danish medicines agency also told Reuters it had no plans to go it alone on suspending the drug.

NO ACTION FROM FDAIn the United States, the FDA initiated a safety review of Actos last September, but Takeda said U.S. regulators had not signaled any intention to request a recall.

Japan's health ministry also said the body had no plans for a recall of the blockbuster product, which had global sales of 387.9 billion yen ($4.8 billion) in the year ended on March 31, accounting for 27 percent of Takeda's revenues.Actos belongs to the same drug class as GlaxoSmithKline's Avandia, which was pulled

from the market in Europe and had severe restrictions imposed on its use in the United States last September, after being linked to heart risks.GSK's drug has not been associated with bladder cancer. Actos was approved for use in Europe in 2000 but its potential bladder cancer risk, seen in tests of male rats, has long been a topic of discussion. Interim results from trials being conducted by U.S. health insurer Kaiser Permanente, one of which began in 2003 and is slated to last 10 years, have so far not confirmed a clear association between Actos and bladder cancer. (Source: http://www.chicagotribune.com/business/breaking/chi-germany-suspends-toptakeda-diabetes-drug-actos-20110610,0,5901033.story Germany suspends top Takeda diabetes drug Actos by James Topham and Ben HirschlerReuters Jun. 8, 2011)

Pharmaceutical Solutions Industry Tel: +966 2 6361383 - Fax: 966 2 6379460 Kingdom of Saudi Arabia. For more info, visit www.psi.com.sa

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PHARMA CHRONICLEAN ESSENTIAL SOURCE FOR PHARMA PROFESSIONALS

CHRONICLE SPOTLIGHTli Lilly & Co. won a ruling in a lawsuit brought by Amylin Pharmaceuticals Inc., which wants to prevent Lilly from using the same people to sell Amylins diabetes drug and that of a competitor.

JUNE 2011

L ILLY WINS RULING IN DIS PUT E WIT H AMYLIN GROUP OF BP DRUGS NOT LINKED TO CANCERE D espite concerns that blood pressure drugs may increase the riskof cancer, a new study suggests that a particular such drug may not be linked to that risk. Angiotensin-converting enzyme inhibitors, usually referred to as ACE inhibitors, are not associated with a higher rate of cancer,

A federal judge in San Diego denied Amylins request for a preliminary order that would have imposed restrictions on Lillys diabetes sales force, the Indianapolis-based drugmaker said in a statement today. We are pleased with the courts decision, Robert A. Armitage, Lillys general counsel, said in the statement. We believe that Amylins allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.Amylin, based in San Diego, sued Lilly last month, saying the manner in which Lilly plans to implement an agreement to develop and sell Boehringer Ingelheim GmbHs type 2 diabetes drug breached its agreement to develop and commercialize Amylins competing drugs. Amylin said in a statement today it will pursue the litigation.

according to a study by researchers at University Hospitals Case Medical Center in Cleveland. "There were worries in the scientific community that ACE inhibitors were associated with cancer," study co-author Dr. Ilke Sipahi told Reuters Health. The study results, he added, "confirm the safety of ACE inhibitors as far as cancer goes."ACE inhibitors lower blood pressure by blocking the production of

Amylin continues to believe that Lillys conduct violates our diabetes collaboration agreements, is anti-competitive and limits patients treatment options, the company said. It is important to note that the courts decision did not make any findings on the merits of our claims, but merely declines to award injunctive relief, based on the conclusion that monetary damages would be sufficient. The lawsuit is filed under seal and court documents werent immediately available.(Source: http://www.bloomberg.com/news/2011-06-08/lilly-wins-ruling-in-disputewith-amylin-over-marketing-of-diabetes-drugs.html Lilly Wins Ruling in Dispute With Amylin Over Marketing of Diabetes Drugs by Edvard Pettersson Bloomberg News Jun. 9, 2011)

a chemical that causes blood vessels to contract. In addition to controlling blood pressure, they are used to improve survival after heart attacks, and prevent strokes. Before this study, there was a mixed picture about whether ACE inhibitors were linked to cancer. A previous study by Sipahi's group, for example, found that a similar group of drugs, known as angiotensin receptor blockers, was associated with an increased likelihood of cancer. In the new study, published in The American Journal of Cardiology, the researchers reviewed existing trials of ACE inhibitors that measured how many patients developed or died of cancer. One of those previous studies linked ACE inhibitors to an increased risk of digestive system cancers, but the authors did not find any association in this review. Sipahi did caution that the reviewed studies followed patients for a maximum of 5 years, so the team could not determine the effect of ACE inhibitors on the risk of developing cancer over a period longer than 5 years. Still, the limitations of the data mean that more research is needed, Dr. Christopher Phillips, of Morehouse School of Medicine in Atlanta, Georgia, told Reuters Health. Phillips, who was not involved in the study, noted that the authors only dove deeply into data for one type of ACE inhibitors, enalapril, marketed as Vasotec. The study showed that enalapril does not increase the risk of cancer, he said. But "can we attributethat to all the ACE inhibitors or just enalapril?"

ZIOPHARM PLANS EARLY TRIALS OF NEW CANCER DRUGSiopharm gets FDA approval to conduct human trials of a potential melanoma treatment. Ziopharm Oncology Inc. said on Jun. 10, 2011 that the Food and Drug Administration will allow it to conduct human testing of an experimental melanoma

Z

drug. The company said the FDA accepted its application for the drug. It des