<span id="midArticle_start"/>(Repeating without changes to text for additional clients)
<span id="midArticle_0"/>By Deena Beasley
<span id="midArticle_1"/>LOS ANGELES May 26 (Reuters) - Two powerful andinnovative cholesterol drugs likely to be approved this summerboth target the same protein and have been shown to sharplylower LDL in high-risk patients. But there is at least onesignificant difference between the two offerings: the dosages inwhich they will be sold.
<span id="midArticle_2"/>Assuming approval from the U.S. Food and DrugAdministration, Amgen Inc. will offer its drug,Repatha, as a biweekly 140 mg injection or a monthly injectionof 420 mg, while Praluent, from Regeneron Pharmaceuticals Incand Sanofi, will be offered in biweekly injections of75 mg or 150 mg.
<span id="midArticle_3"/>The difference in dosages is likely to lead to verydifferent sales strategies for the two drugs, in what could be afierce competition for market share. Amgen's high-dose monthlyinjection could be seen as more convenient and might appeal todoctors because of its higher potency. Regeneron and Sanoficould enjoy a significant pricing advantage with their low-doseoption.
<span id="midArticle_4"/>Both drugs belong to a new class of antibodies that targetPCSK9, a protein that maintains "bad" LDL cholesterol in theblood, and are aimed at the millions of people who don't benefitfrom statins. Statin pills, like Pfizer Inc's Lipitor,work very differently, blocking the liver's production of LDLcholesterol.
<span id="midArticle_5"/>Neither Amgen nor Regeneron/Sanofi would talk about possiblepricing of their new drugs, but some industry experts suggestthat low-dose Praluent will be priced significantly belowRepatha to make it more attractive to health insurers who havebecome increasingly aggressive about keeping medication costsdown.
<span id="midArticle_6"/>Dr Jennifer Robinson, a University of Iowa epidemiologistand lead researcher on clinical trials of Praluent, believesSanofi and Regeneron "would be crazy not to" price its 75 mgdose below the 150 mg option.
<span id="midArticle_7"/>"Sanofi will say you can start off at this cheaper, lowerdose," Robinson said. "If you don't reach the LDL goal, you canmove up" to a higher dose, at the higher price.
<span id="midArticle_8"/> <span class="first-article-divide"/>Sanford Bernstein analyst Geoffrey Porges predicts thatlower-dose Praluent will cost $5,000 a year, with the higherdose at $10,000. He estimates Repatha's price at $10,000 peryear for both the biweekly and monthly versions. Manufacturersdo not necessarily charge less for lower doses of a medication.
<span id="midArticle_9"/>Amgen's high-dose injections could be appealing in light ofrecent clinical data that has shown that keeping LDL very lowcan better protect against heart attack and stroke in high riskpatients. Trial data has shown that both drugs produce greaterLDL reductions in higher doses.
<span id="midArticle_10"/>"It goes back to the patients we are trying to serve -patients with elevated, very high LDL cholesterol," said ScottWasserman, Amgen's head of cardiovascular and metabolictherapies. "We didn't feel that a low dose option would servethose patients."
<span id="midArticle_11"/>The FDA is due to decide on approval for Praluent by July 24and on Repatha by Aug. 27. The agency, which has convened expertpanels on June 9 and 10 to review both drugs, could also issue ajoint decision.
<span id="midArticle_12"/>The two PCSK9 drugs are each expected to generate about $2.5billion in annual sales by 2020, according to Wall Streetestimates compiled by Thomson Reuters Cortellis. Some predicttotal sales for the class rising to $20 billion by 2026.
<span id="midArticle_13"/> <span class="second-article-divide"/><span id="midArticle_14"/>PRICE MATTERS
<span id="midArticle_15"/>In March, new clinical trial data showed that both Repathaand Praluent, combined with statins, reduced LDL levelsdramatically, cutting in half the risk for heart attack, stroke,and other major cardiovascular problems. Sanofi/Regeneron andAmgen are conducting larger trials to confirm the benefits ofPCSK9 drugs in reducing cardiovascular risks.
<span id="midArticle_0"/>Industry experts note that there are many unansweredquestions about the market for the drugs, including how widelythe FDA will allow them to be used, how aggressivelycardiologists will seek to lower LDL and whether otherdifferences between them will emerge from the larger trials thatwill yield results in 2017.
<span id="midArticle_1"/> <span class="third-article-divide"/>Some see Sanofi having an advantage purely due to its largermarketing force among heart doctors. Another possible factor inwhich drug will dominate the market is the success or failure ofa lawsuit Amgen has brought against Sanofi and Regeneron foralleged patent infringement.
<span id="midArticle_2"/>But in the meantime, with the main merits of the two drugsappearing nearly equal, their comparative dose and price willbecome much more important differentiators.
<span id="midArticle_3"/>Health insurers "are likely to view this as a class, one isthe same as the other," said Les Funtleyder healthcare portfoliomanager for ESquared Asset Management, which does not own sharesin any of the three drugmakers. "You could have a case where ifpayers pay, they'll only pay for one rather than the other."
<span id="midArticle_4"/>Express Scripts Holding Co is the largest U.S.manager of pharmacy benefit plans and successfully pressed forprice reductions on novel hepatitis C drugs earlier this year.
<span id="midArticle_5"/>Its chief medical officer, Dr. Steve Miller, said in aninterview that $10,000 per year for a new cholesterol drug is"an extraordinarily high price." As many as 15 million Americansare estimated to have high cholesterol that cannot be controlledby statins.
<span id="midArticle_6"/>"We are bullish on the health benefits, but they have tobring value," Miller said, adding that pricing would be a majorfactor in recommending either Praluent or Repatha for coverage.
<span id="midArticle_7"/>Dr Steven Nissen, chairman of the department ofcardiovascular medicine at the Cleveland Clinic, said he is mostconcerned about effectiveness: "What counts is how much you canlower LDL cholesterol," he said.
<span id="midArticle_8"/>But he acknowledges that if the lower dose also had a lowerprice, "there might be some people who find that appealing,"Nissen said. (Reporting by Deena Beasley, additional reporting by BillBerkrot in New York; Editing by Michele Gershberg and SueHorton)
<span id="midArticle_9"/>
<span id="midArticle_0"/>By Deena Beasley
<span id="midArticle_1"/>LOS ANGELES May 26 (Reuters) - Two powerful andinnovative cholesterol drugs likely to be approved this summerboth target the same protein and have been shown to sharplylower LDL in high-risk patients. But there is at least onesignificant difference between the two offerings: the dosages inwhich they will be sold.
<span id="midArticle_2"/>Assuming approval from the U.S. Food and DrugAdministration, Amgen Inc. will offer its drug,Repatha, as a biweekly 140 mg injection or a monthly injectionof 420 mg, while Praluent, from Regeneron Pharmaceuticals Incand Sanofi, will be offered in biweekly injections of75 mg or 150 mg.
<span id="midArticle_3"/>The difference in dosages is likely to lead to verydifferent sales strategies for the two drugs, in what could be afierce competition for market share. Amgen's high-dose monthlyinjection could be seen as more convenient and might appeal todoctors because of its higher potency. Regeneron and Sanoficould enjoy a significant pricing advantage with their low-doseoption.
<span id="midArticle_4"/>Both drugs belong to a new class of antibodies that targetPCSK9, a protein that maintains "bad" LDL cholesterol in theblood, and are aimed at the millions of people who don't benefitfrom statins. Statin pills, like Pfizer Inc's Lipitor,work very differently, blocking the liver's production of LDLcholesterol.
<span id="midArticle_5"/>Neither Amgen nor Regeneron/Sanofi would talk about possiblepricing of their new drugs, but some industry experts suggestthat low-dose Praluent will be priced significantly belowRepatha to make it more attractive to health insurers who havebecome increasingly aggressive about keeping medication costsdown.
<span id="midArticle_6"/>Dr Jennifer Robinson, a University of Iowa epidemiologistand lead researcher on clinical trials of Praluent, believesSanofi and Regeneron "would be crazy not to" price its 75 mgdose below the 150 mg option.
<span id="midArticle_7"/>"Sanofi will say you can start off at this cheaper, lowerdose," Robinson said. "If you don't reach the LDL goal, you canmove up" to a higher dose, at the higher price.
<span id="midArticle_8"/> <span class="first-article-divide"/>Sanford Bernstein analyst Geoffrey Porges predicts thatlower-dose Praluent will cost $5,000 a year, with the higherdose at $10,000. He estimates Repatha's price at $10,000 peryear for both the biweekly and monthly versions. Manufacturersdo not necessarily charge less for lower doses of a medication.
<span id="midArticle_9"/>Amgen's high-dose injections could be appealing in light ofrecent clinical data that has shown that keeping LDL very lowcan better protect against heart attack and stroke in high riskpatients. Trial data has shown that both drugs produce greaterLDL reductions in higher doses.
<span id="midArticle_10"/>"It goes back to the patients we are trying to serve -patients with elevated, very high LDL cholesterol," said ScottWasserman, Amgen's head of cardiovascular and metabolictherapies. "We didn't feel that a low dose option would servethose patients."
<span id="midArticle_11"/>The FDA is due to decide on approval for Praluent by July 24and on Repatha by Aug. 27. The agency, which has convened expertpanels on June 9 and 10 to review both drugs, could also issue ajoint decision.
<span id="midArticle_12"/>The two PCSK9 drugs are each expected to generate about $2.5billion in annual sales by 2020, according to Wall Streetestimates compiled by Thomson Reuters Cortellis. Some predicttotal sales for the class rising to $20 billion by 2026.
<span id="midArticle_13"/> <span class="second-article-divide"/><span id="midArticle_14"/>PRICE MATTERS
<span id="midArticle_15"/>In March, new clinical trial data showed that both Repathaand Praluent, combined with statins, reduced LDL levelsdramatically, cutting in half the risk for heart attack, stroke,and other major cardiovascular problems. Sanofi/Regeneron andAmgen are conducting larger trials to confirm the benefits ofPCSK9 drugs in reducing cardiovascular risks.
<span id="midArticle_0"/>Industry experts note that there are many unansweredquestions about the market for the drugs, including how widelythe FDA will allow them to be used, how aggressivelycardiologists will seek to lower LDL and whether otherdifferences between them will emerge from the larger trials thatwill yield results in 2017.
<span id="midArticle_1"/> <span class="third-article-divide"/>Some see Sanofi having an advantage purely due to its largermarketing force among heart doctors. Another possible factor inwhich drug will dominate the market is the success or failure ofa lawsuit Amgen has brought against Sanofi and Regeneron foralleged patent infringement.
<span id="midArticle_2"/>But in the meantime, with the main merits of the two drugsappearing nearly equal, their comparative dose and price willbecome much more important differentiators.
<span id="midArticle_3"/>Health insurers "are likely to view this as a class, one isthe same as the other," said Les Funtleyder healthcare portfoliomanager for ESquared Asset Management, which does not own sharesin any of the three drugmakers. "You could have a case where ifpayers pay, they'll only pay for one rather than the other."
<span id="midArticle_4"/>Express Scripts Holding Co is the largest U.S.manager of pharmacy benefit plans and successfully pressed forprice reductions on novel hepatitis C drugs earlier this year.
<span id="midArticle_5"/>Its chief medical officer, Dr. Steve Miller, said in aninterview that $10,000 per year for a new cholesterol drug is"an extraordinarily high price." As many as 15 million Americansare estimated to have high cholesterol that cannot be controlledby statins.
<span id="midArticle_6"/>"We are bullish on the health benefits, but they have tobring value," Miller said, adding that pricing would be a majorfactor in recommending either Praluent or Repatha for coverage.
<span id="midArticle_7"/>Dr Steven Nissen, chairman of the department ofcardiovascular medicine at the Cleveland Clinic, said he is mostconcerned about effectiveness: "What counts is how much you canlower LDL cholesterol," he said.
<span id="midArticle_8"/>But he acknowledges that if the lower dose also had a lowerprice, "there might be some people who find that appealing,"Nissen said. (Reporting by Deena Beasley, additional reporting by BillBerkrot in New York; Editing by Michele Gershberg and SueHorton)
<span id="midArticle_9"/>
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