"Novartis will seek regulatory approval this year for a new kind of antiinflammatory heart drug though some experts fear fatal infection risks and a high price may overshadow the medicines limited benefits.  FILE PHOTO A general view shows the Rhine river and the headquarters of Swiss pharmaceutical company Novartis AG in Basel Switzerland March  . REUTERSArnd Wiegmann Keenly awaited clinical trial results released on Sunday showed heartattack survivors on one of three doses of canakinumab were  percent less likely to suffer another major cardiac event than those on a placebo.  Novartis had said in June that the drug met its goal in the study but details were only unveiled at European Society of Cardiology meeting in Barcelona. One leading expert described the benefit as modest.  Patients getting canakinumab also suffered significantly more deaths from infections than those on placebo  but on the positive side they appeared to be at lower risk of cancer.  There was no significant difference in the rate of deaths from all causes between the placebo group and those on canakinumab.  The modest absolute clinical benefit of canakinumab cannot justify its routine use in patients with previous myocardial infarction until we understand more about the efficacy and safety tradeoffs and unless a price restructuring and formal costeffectiveness evaluation supports it wrote Dr. Robert Harrington chair of the Stanford University School of Medicine in an editorial in the New England Journal of Medicine.  Canakinumab had stirred considerable scientific interest because it appears to finally deliver proof that fighting inflammation offers a promising new way to counter heart disease in patients who already get cholesterollowering treatment.  Subsequently some analysts boosted their revenue estimates for the Novartis medicine into the billions of dollars while awaiting the data announced on Sunday.  Canakinumab is already approved as Ilaris for rare autoimmune conditions.  Vas Narasimhan Novartiss head of global drug development said the drugmaker plans to go to regulators in the fourth quarter to seek approval for canakinumab to treat heartattack victims with high levels of inflammation.  He downplayed critics who said the benefit was small saying that one large subgroup in the socalled Cantos trial had shown a  percent reduction in cardiovascular risk.  Novartis also plans to underscore canakinumabs potential cancer fighting properties with the European Medicines Agency and the U.S. Food and Drug Administration.  SEPARATE TRIALS  Thats after an analysis of Cantos data found total cancer mortality among patients getting canakinumab was significantly lower than in those receiving the placebo.  Narasimhan who said the company now plans to start separate cancer trials for canakinumab said the drug could be particularly suitable for smokers with risks of both lung cancer and heart problems.  With the oncology findings promising but only preliminary the company is planning additional studies in lung cancer starting next year he said.  Ilaris now costs about  per patient annually for treating rare immune conditions and brings in some  million in yearly sales for the Swiss company though its price is likely to be slashed should it win approval in the heart setting.  Novartis initially struggled with the sluggish launch of its last heart drug the peryear Entresto so it is understandably concerned about the reception for canakinumab.  While Narasimhan said it was too early to discuss pricing he argued socalled PCSK cholesterol drugs that cost about  annually should not be relied on as a yardstick.  In view of the additional oncology findings we dont think you should just think about this as a cardiovascular drug Narasimhan said. I dont think you can necessarily just make comparisons to existing benchmarks such as the PCSKs.  Even so Tim Anderson a Bernstein analyst said the marginal data are not compelling enough to dispel what for Novartis will remain a pricing conundrum should canakinumabs approval be expanded for heart patients.  If the company cuts the price of the product in its current orphan indications then it instantly sacrifices sales which currently total about  million per year with the hope that future sales in a new CV setting will more than offset this Anderson said in a note.  Some have wondered whether a particularly highrisk subgroup could be identified where canakinumabs current price can be justified he said. We are not hopeful here.  Reporting by John Miller Editing by Ben Hirschler and Ralph Boulton Our StandardsThe Thomson Reuters Trust Principles. httpthomsonreuters.comenaboutustrustprinciples.html"