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`PHARMACEUTICALS
`'Fast Money' faux pas: Firm
`draws FDA warning, DOJ
`subpoena
`
`Dan Mangan I @_DanMangan
`Monday, 13 Jan 2014 14:25 PM ET
`
`.fk C NBC
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`Screen shot of Marc Beer on CNBC
`
`way that enthusiastic comments by its CEO about its breakthro ug h
`cholesterol drug Juxtapid could lead to unwanted attention from
`federal drug regulators.
`
`The Food and Drug Administration accused CEO Marc Beer of
`"misbranding" Juxtapid by claiming it "is intended for new uses, for
`w hich it lacks approval and for which its labeling does not provide
`adequate d irections for use," according to an FDA warning letter sent
`to t he Cambridge, Mass.-based company.
`
`The FDA claimed Aegerion made "serious" violations after Beer went
`too far in his comments in two separate appearances on CNBC's " Fast
`Money" and left the impression that Juxtapid could be used alone as a
`t reatment for a rare genetic disease and that it could tackle heart
`conditions, and also that he failed to disclose the potentially serious
`side effects from the drug.
`
`The company disclosed last Thursday that it had received a Justice
`Department subpoena for documents relating to Juxtapid's sale and
`marketing, a revelation that sent the company's stock dropping
`sharply. It is not clear if that subpoena was spurred by the FDA warning
`over Beer's "Fast Money" remarks. or not-but the company suggested
`it was not.
`
`FDA spokeswoman Tara Goodin told CNBC.com in a prepared
`statement on Monday: "Regardless of the media or venue used to
`disseminate promotional messages about prescription drugs,
`pharmaceutical companies undermine the drug approval process and
`may put the public at risk when they promote drugs for uses that have
`not been proven safe and effective."
`
`Aegerion in a prepared statement said, "We've taken compliance very
`seriously since launch. It has always been Aegerion's policy to promote
`its products only in a manner consistent with t he FDA-approved
`product labeling."
`
`"We plan to cooperate fully with this investigation," the company said.
`"After meeting with FDA officials regarding the warning letter, we
`believe we have a path forwa rd to resolve outstanding FDA concerns
`as articulated in the warning letter. We don't plan to discuss the details
`of the ongoing government investigat ion."
`
`However, in an email before that statement was sent, Aegerion
`spokeswoman Amanda Murphy told a CNBC.com reporter, " I want to
`
`CFAD Ex. 1025 (1 of 4)
`
`

`
`be sure you are clear tnougn tnat we·re not certam tnat tne subpoena 1s
`related to Marc's statements on 'Fast Money,' and in fact, we believe it
`likely isn't."
`
`(Read more; Obamacare exchange visitors looking healthy)
`
`The FDA's Nov. 8 letter was sent after Beer appeared twice on the
`to talk about
`CNBC show-on June 5, 2013, and again on Oct. 31-
`Juxtapid, which received FDA approval in December 2012. A year's
`worth of the drug can cost close to $300,000.
`
`Juxtapid targets so-called bad cholesterol, also known as LDL-C,
`specifically in people with a rare genetic disease called HoFH, an
`acronym for homozygous familial hypercholesterolemia.
`
`According to its product label, Juxtapid is meant to be used as an
`adjunct in a low-fat diet and other lip id-lowering treatments. Its "safety
`and effectiveness" in patients who do not have HoFH "have not been
`established," and its effect on cardiovascular disease "has not been
`determined," according to the " limitations of use" labeling on the
`product.
`
`The FDA, in its warning letter, noted that Juxtapid "is associated with a
`number of serious risks," including toxicity to the liver, and it's not
`supposed to be used in pregnant women.
`
`Beer, in his appearance on JuneS's "Fast Money," noted that HoFH is a
`"devastating disease," and that people born with it are not often
`diagnosed until "they have a heart attack" at a young age.
`
`"If you can imagine a child having a heart attack at 8, 10, 12 years of
`age," Beer said. "And then they have another event, usually about
`every 18 months. and die by the age of 30. And we've found out that
`we can lower it signif icantly with this drug."
`
`He also said: " It's a devastating disease that causes early death. And
`the drug is a corrective against that disease, and that's the most
`important thing."
`
`Beer added, "this product has the potential of taking a patient that
`would die at 30 and allow t hem to meet their grandkids."
`
`During his second "Fast Money" appearance last Halloween, while
`wearing a Boston Red Sox jacket, Beer compared Aegerion's "team" to
`the Sox, who had just won the World Series the night before wit h Beer
`in attendance.
`
`"We've got a passionate group," Beer said. "Everybody's on a mission
`to get t hese patients t reated, because these patients are going to die
`of a heart attack or stroke if we don't have them on therapy."
`
`In its Nov. 8 letter, w hich cited Beer's statements. the FDA wrote.
`"These statements misleadingly suggest that Juxtapid is safe and
`effective for use in decreasing the occurrence of cardiovascular events
`including heart attacks and st rokes, and increasing the lifespan of
`patients with HoFH, and thus will have an effect on cardiovascular
`morbidity and mortality as well as overall mortality."
`
`The FDA noted t hat Juxtapid "is approved only as an adjunct to a low(cid:173)
`fat diet and other" cholesterol-lowering treatments, and t hat its
`labeling makes clear that its effect on cardiovascular disease "has not
`been determined."
`
`(Read more: Health spending growing slowly)
`
`"Additionally, while the statements cited above includes substantial
`and repeated efficacy claims for Juxtapid, the presentation fails to
`
`CFAD Ex. 1025 (2 of 4)
`
`

`
`commumcare any or me nsKs assoe~area w 1rn mese new 1menaea uses
`or its approved use," said the letter, which underlined and bolded the
`word "any."
`
`u:
`
`:hildren.
`: (68•F to n •F),
`between 1s•c
`I"F and 86•f ).
`>d
`
`ricals,lnc.
`I
`
`PN 400141
`
`Source: Drugs_com
`
`NDC 76431-105~01
`
`~ 28~
`Juxtapid~
`Oomilapide) capsules
`
`Aegerion•
`'
`
`~z
`
`Rxo
`Dosage a
`see packc
`Dispense the a
`Medi<:ation Gu
`patient.
`
`~'~~,IJ
`
`"The repeated statements regarding Juxtapid, including the claims that
`patients taking the drug will 'meet their grandchildren' misleadingly
`suggests that Juxtapid lacks significant risks," the FDA said.
`
`The letter requested that "Aegerion immediately cease misbranding
`Juxtapid and introducing it into interstate commerce for unapproved
`uses for which it lacks adequate d irections."
`
`The FDA asked for a written response to its letter by Nov. 22, and,
`"because the violat ions described above are serious," also asked that
`the response "include a comprehensive plan of action to disseminate
`truthful, non~m islead i ng and complete corrective messages about the
`issues discussed in this letter to correct any misimpressions about the
`approved use of Juxtapid."
`
`TRANSMinEO BY FACSIMILE
`
`Marc Beer
`Chief Exewtive Officer
`Aegerion Pham'laeeutieals. Inc.
`101 Main S treet, Suite 1850
`Cambridge, MA 02142
`
`RE: NOA 203858
`JUXTAPID .. {IOrnitapide) capsules. for oral use
`MA#31
`
`WARNING LETIER
`
`Oeat Mt. Beer:
`
`This letter notifies Aegerion Pharmaoeuti<:.als. Inc. (Aegerion) that the Office of Prescription
`Drug Promotion (OPDP) of the U.S. Food aod 0~ Adm~isuation (fDA) has become aware
`of stalements that you made regardi ng JUXTAPIO
`(lomttapide) capsules, for oral use
`(Juxtapid) during bloadcast interviews on CNBC's television show. "Fast Money," that aired
`on June 5, 2013, aod Oetober 31, 2013. The statements ptovide evideoee that J uxtapid is
`intended for new u ses, for which it lacks approval and for which its labeling does not provide
`adequate directions for use. which renders Ju.xtapid misbranded vnthin the meaning of the
`Federal Food Drug and Cosmelle Act (FO&C Act) and makes its<listnbution violative of the
`FO&C Act. See 21 U.S .C. 352(1)(1), 331(a); 21 CFR 201.5, 201.100, 201.1 15, 201.128.
`
`Background
`
`B~ow are the indication and summary Of the most serious and most oommon risks
`associate<! WJttl the use of Ju:o:1apid.,
`
`According to the INDICATIONS AND USAGE section Of the FOA·approved prOdud labeling
`(PI) fOt Ju:xtapicl (emphasis original):
`
`JUXT APIO is ind•cated as an adjurn;t to a lOW· fat diet and other lipid lowering
`lleatments. inCluding LOL apheresis where available. to reduce low-density hpoptotein
`cholesterol (LOL·C), total cho1esterol (TC), apolipoprotein B (apo B), and OOfl·high·
`density lipoprotein cholesterol (non·HDL-C) in patients with hOmozygous familial
`hypetd'lolesteroremia (HoFH}.
`
`' This lnloonatJon Is lot bookgroood purposes only end does not r.eoessariyte-pJese-nt the rls.Jc.lntOfmlltion 1M1
`sJ"oould t>o mc~G4 in ttoo PfOmOC)(II\81 ee~rrii>OS CltOd in trus 1011or.
`
`Last Thursday, in a press release on Aegerion's website announcing
`preliminary 2013 sales data, the company disclosed that the Boston
`U.S. attorney's office had issued a subpoena to it asking for
`"documents regarding the company's marketing and sale of Juxtapid."
`
`"The company intends to cooperate fully with the government
`investigation," the release said. "Aegerion is fully committed to
`complying w ith all applicable laws, rules and regulations, and has
`compliance policies in place consistent with this commitment."
`
`A spokeswoman for the Boston U.S. attorney's office declined to
`comment, saying only, "We don't confirm or deny investigations."
`
`Aegerion's stock fell more than 12 percent in extended trading after it
`released news of t he subpoena. The stock had traded close to $74 per
`share before the disclosure, but was trading close to $65 as of Monday.
`
`CFAD Ex. 1025 (3 of 4)
`
`

`
`(l<eaa more: ~lu cou1a n1t ousmess nara tn1s season)
`
`The company also could face a shareholder lawsuit. On Friday, the law
`firm Glancy Binkow & Goldberg, which has offices in New York and Los
`Angeles, announced that it was "investigating potential claims on
`behalf of shareholders of Aegerion Pharmaceuticals ... concerning
`possible violations of federal securities laws." Glancy Binkow asked for
`people who had bought Aegerion stock between April 30 and last
`Friday to contact the firm.
`
`The firm said its investigation was focused on Aegerion's statements
`regarding its operations, financial performance and prospects. The firm
`specifically noted both the FDA warning letter and the Justice
`Department subpoena.
`
`CNBC.com left messages for t wo Glancy Binkow lawyers named in its
`announcement, but had not received a response.
`
`In its statement to CNBC.com, Aegerion also said, "It has always been
`Aegerion's policy to promote its products only in a manner consistent
`w ith the FDA-approved product labeling."
`
`" Our field force is trained to reinforce with prescribers the labeled
`indication of HoFH. In addition, prescribers must be certified under the
`Juxtapid Risk Evaluation and Mitigation Strategy (REMS), receive
`training on Juxtapid's risks and their mitigation, and attest that the
`patient has a clinical or laboratory diagnosis consistent with HoFH
`before a Juxatpid prescription can be f illed," the company said.
`
`-By CNBC's Dan Mangan. Follow him on Twitter @_DanMangan.
`
`Dan Mangan
`Health Ca re Report er
`
`1:1 0 111
`
`RELATED SECURITIES
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`Symbol
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`Price
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`18.035
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`Change
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`hnp:/lwww.cnbe.oomf.cl/ 101327742 Thu Jul OQ 2015 11:0 7:34 G MHI500 {Cermal Daylight Ti'ne)
`
`CFAD Ex. 1025 (4 of 4)