OptumRx Pipeline Forecast
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Pending Drug Approvals
Brand Name
Generic Name
Company
Indication/Use
Expected FDA
Decision Date
Eperzan™
albiglutide
GlaxoSmithKline
Treatment of adults with type 2
diabetes mellitus
4/15/2014
TBD
apremilast
Celgene
Treatment of adult patients with
active psoriatic arthritis
3/2014
Ruconest®
recombinant human
C1 esterase inhibitor
Pharming Group
NV/Salix
Treatment of acute hereditary
angioedema attacks in patients
with hereditary angioedema
7/16/2014
TBD
empagliflozin
Boehringer
Treatment of adults with type 2
Ingelheim/Eli Lilly diabetes mellitus
3/25/2014
Afrezza®
insulin monomer
human (rDNA origin)
Mannkind
Treatment of adults with type 1
or type 2 diabetes mellitus for
control of hyperglycemia
4/15/2014
Ragwitek™
ragweed pollen
extract
ALK-Abello/
Merck
Prevention of ragweed (Ambrosia
artemisiifolia) pollen-induced allergic
rhinitis, with or without conjunctivitis,
in persons 18-65 years of age
3/2014
TBD
ramucirumab
Eli Lilly
Single-agent treatment of advanced
gastric cancer following disease
progression after initial chemotherapy
Q2:2014
recombinant Factor
VIII Fc
Biogen Idec/
Swedish Orphan
Biovitrum
Treatment of hemophilia A
6/12/2014
GlaxoSmithKline
Monotherapy for the treatment
of chronic obstructive pulmonary
disease, including chronic bronchitis
and emphysema
2/2014
Takeda
For reducing signs and symptoms,
inducing and maintaining clinical
response and remission, and
mucosal healing, and achieving
corticosteroid-free remission in adult
patients with moderately to severely
5/20/2014
active ulcerative colitis who have had
an inadequate response with, lost
response to, or were intolerant to
either conventional therapy or a tumor
necrosis factor-alpha antagonist
Eloctate
™
TBD
Entyvio®
umeclidinium
vedolizumab
TBD = To be determined
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Eperzan™ (albiglutide)
Albiglutide, a new molecular entity (NME), is a glucagon-like peptide-1 (GLP-1) receptor agonist being
developed by GlaxoSmithKline for the treatment of adults with type 2 diabetes mellitus. Albiglutide consists
of a GLP-1 peptide fused to albumin. The GLP-1 peptide helps to maintain normal blood glucose levels, and
the albumin component allows for once weekly subcutaneous dosing. If approved, albiglutide would be the
fourth GLP-1 agonist to the market. Other currently approved GLP-1 agonists include once-daily Victoza®
(liraglutide), twice-daily Byetta® (exenatide), and once-weekly Bydureon® (exenatide).1 The Harmony clinical
program evaluated the efficacy and safety of albiglutide.2,3 In Harmony 3, the reduction in hemoglobin A1C
(HbA1c) was statistically significant in the albiglutide group compared to those treated with Januvia® (sitagliptin)
(p = 0.0001) or glimepiride (p = 0.003). In Harmony 4 and 6, albiglutide was non-inferior to Lantus® (insulin
glargine) [95% confidence interval (CI): 0.04-0.27%] and Humalog® (insulin lispro) (p < 0.0001). In Harmony 5
and 7, non-inferiority was not achieved when albiglutide was compared to pioglitazone (p = 0.27) and Victoza
(p = 0.0846), respectively.4 Unlike Bydureon, which requires reconstitution prior to administration, Eperzan
will be available as pen devices. The United States Food and Drug Administration (FDA) is expected to make a
decision regarding the approval of Eperzan by April 15, 2014.5 If approved, analysts estimate that annual sales
of Eperzan will be approximately $440 million by 2018.6
TBD (apremilast)
Apremilast, a NME, is an oral phosphodiesterase-4 inhibitor being developed by Celgene for the treatment
of adult patients with active psoriatic arthritis (PsA). Apremilast works intracellularly to modulate a network of
pro-inflammatory and anti-inflammatory mediators.7 It is estimated that approximately 30% of people with
psoriasis is affected by PsA.7 Currently, the treatment options for PsA include injectable biologics [eg, tumor
necrosis factor-alpha (TNFα) inhibitors], following patients who have not responded to disease-modifying
antirheumatic drugs (DMARDS).7 In the PALACE-1,2,3 phase III clinical trials, the efficacy and safety of apremilast
were evaluated in patients with active PsA despite treatment with DMARDS and TNFα inhibitors. Results showed
that apremilast demonstrated statistical significance in achieving American College of Rheumatology (ACR) 20
score when compared to placebo.7 PALACE-4, a study evaluating the use of apremilast in treatment-naïve PsA
patients, showed that ACR20 response was achieved in 29.2-32.3% and 16.9% of patients in the apremilast
and placebo groups, respectively.8 A pooled safety data analysis showed no safety concerns with regards
to major cardiac events, malignancies, and reactivation of tuberculosis.7 The FDA is expected to make a
decision regarding the approval of apremilast by March 2014.5 Celgene estimates that apremilast annual
sales will generate between $1.5-2 billion by 2017.9
Ruconest® (recombinant human C1 esterase inhibitor)
Ruconest, a NME with orphan drug status, is a recombinant human complement 1 (C1) esterase inhibitor
that is being developed by Pharming Group NV and Salix Pharmaceuticals for the treatment of acute
hereditary angioedema attacks in patients with hereditary angioedema (HAE). HAE is a genetic disorder in
which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in episodes of
intense swelling of the extremities, face, trunk, genitals, abdomen, and upper airway.10 The efficacy and
safety of Ruconest were evaluated in two randomized placebo-controlled clinical studies.11 Both studies
showed statistically significant reductions in time to onset of HAE symptom relief with Ruconest (50 U/
kg: 122 minutes [95% CI: 72-136]; 100 U/kg: 66 minutes [95% CI: 0.08-0.34]) compared to placebo (495
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minutes [95% CI: 245-520]). Post-exposure antibody responses against Ruconest or host-related
impurities were not observed. Ruconest is unique among other C1 esterase inhibitor replacement products
(eg, Berinert®) because it is produced from transgenic rabbits rather than derived from human plasma
donors.1,12 Thus, the concern for infectious transmissions with Ruconest use is limited. The FDA is expected
to make a decision regarding the approval of Ruconest by July 16, 2014.13
TBD (empagliflozin)
Empagliflozin, a NME, is an oral sodium glucose co-transporter 2 (SGLT2) inhibitor being developed by
Boehringer Ingelheim and Eli Lilly for the treatment of adults with type 2 diabetes mellitus. If approved,
empagliflozin would be the third SGLT2 inhibitor on the market since the approval of Invokana™
(canagliflozin) and Farxiga® (dapagliflozin).1 In clinical trials, empagliflozin 10 mg and 25 mg showed mean
reductions in HbA1c as both monotherapy and add-on treatment; HbA1c reductions ranged from
-0.62% to -0.68% for 10 mg and 25 mg, respectively.14 When empagliflozin monotherapy was compared
to Januvia® (sitagliptin), the adjusted mean differences in change from baseline for HbA1c were -0.74%
(p < 0.0001) for empagliflozin 10 mg, -0.85% (p < 0.0001) for empagliflozin 25 mg, and -0.73%
(p < 0.0001) for Januvia.15 In a pooled analysis of clinical trials, there was a loss of 3.99 to 4.43 pounds
in body weight for empagliflozin compared to placebo.14 Although the incidence of urinary tract infections
in empagliflozin-treated patients was comparable to placebo, the incidence of genital infections (3.6-4.2%)
was higher than placebo (0.7%).14 The FDA is expected to make a decision regarding the approval of
empagliflozin by March 25, 2014.5 If approved, analysts estimate that empagliflozin will have a market share
of about 3%, or $1.6 billion, by 2017.16
Afrezza® (insulin monomer human [rDNA origin])
Afrezza is an inhaled ultra rapid-acting mealtime insulin therapy being developed by MannKind for the
treatment of adults with type 1 or type 2 diabetes mellitus for control of hyperglycemia. It is a drug-device
combination product, consisting of an Afrezza inhalation powder single-use cartridge and a small inhaler.
Afrezza strives to mimic the release of mealtime insulin observed in healthy individuals, with time to peak
insulin levels at 12 to 15 minutes following administration.17 The phase III clinical program demonstrated
that Afrezza was non-inferior to Novolog® (insulin aspart) for HbA1c reduction. In addition, patients treated
with Afrezza experienced significantly fewer hypoglycemia episodes and less weight gain than Novologtreated patients.17,18 The most common respiratory side effect observed with Afrezza use in clinical trials was
a mild, transient, non-productive cough. Lung function changes were small and resolved once Afrezza was
discontinued.17 The FDA Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to discuss
Afrezza on April 1, 2014.19 The FDA is expected to make a decision regarding its approval by April 15, 2014.5
Ragwitek™ (ragweed pollen extract)
Ragwitek, a short ragweed (Ambrosia artemisiifolia) pollen allergen extract, is an oral immunotherapy.
It is being developed by Merck and ALK-Abelló A/S for the prevention of ragweed pollen-induced allergic
rhinitis, with or without conjunctivitis, in persons 18-65 years of age. Currently, allergen extracts are only
FDA-approved for use in subcutaneous allergen immunotherapy. Ragwitek is a sublingual, once-daily
administered tablet that is given at least 12 weeks prior to the onset of grass pollen season, and to be
continued through the season.20 Clinical trials measured a combined symptom and medication use score
over the course of a pollen season. Ragwitek demonstrated a 24-26% improvement in the combined
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symptom score during the ragweed pollen season compared to placebo.20 Common adverse events
with Ragwitek use included itching and swelling in and around the mouth.20 The FDA’s Allergic Products
Advisory Committee voted 6-2, with one abstention, in support of Ragwitek’s efficacy. However, the
Committee also recommended post-marketing trials targeted at unstudied or under-studied populations,
and rare adverse events seen in the clinical program.21 The FDA is expected to make its decision regarding
the approval of Ragwitek by March 2014.5
TBD (ramucirumab)
Ramucirumab, a NME with orphan drug status, is a human, receptor-targeted antibody that blocks the
vascular endothelial growth factor (VEGF) receptor 2. It is being developed by Eli Lilly as a single-agent
treatment of advanced gastric cancer following disease progression after initial chemotherapy. Currently,
ramucirumab is also being investigated for use in colorectal, hepatocellular, and lung cancers.22 If approved,
ramucirumab will be the first FDA-approved second-line therapy for advanced cancers of the esophagus and
stomach. In the REGARD study, median overall survival was 5.2 months in the ramucirumab group and
3.8 months in the placebo group (p = 0.047). In addition, hypertension rates observed in REGARD were
higher in the ramucirumab group (16%) compared to the placebo group (8%).23 In the RAINBOW trial,
a study of ramucirumab in combination with paclitaxel also prolonged overall survival from 7.36 to 9.63
months (p = 0.0169).24,25 The FDA is expected to make its decision regarding the approval of ramucirumab in
the second quarter of 2014.5 If approved, analysts project annual sales of ramucirumab to reach $3 billion.26
Eloctate™ (recombinant Factor VIII Fc)
Eloctate is a recombinant Factor VIII Fc fusion protein product being developed by Biogen Idec and Swedish
Orphan Biovitrum for the treatment of hemophilia A. Hemophilia A is a rare, inherited bleeding disorder
that occurs in approximately 1 in 5,000 male births annually, affecting about 16,000 people in the United
States.27 It is caused by having low or no Factor VIII activity, which is needed for normal blood clotting.
Other FDA-approved recombinant Factor VIII products include Advate®, Xyntha®, Kogenate® FS, Helixate®
FS, Recombinate®, and ReFacto®.1 Eloctate has orphan drug status and was developed using Biogen Idec’s
monomeric Fc fusion technology, which results in a longer circulating half-life.28 Existing therapies require
prophylactic infusions 2-3 times per week or every other day.1 Trials have studied Eloctate as individualized
prophylactic therapy (given every 3-5 days with individual pharmacokinetics [PK]-guided dosing
adjustments) and as weekly prophylactic therapy.28 The safety and efficacy of Eloctate was evaluated in the
A-LONG clinical trial. Results showed that Eloctate’s median annualized bleeding rates, or projected number
of yearly bleeding episodes, for prophylaxis and episodic treatments were 1.6-3.6 and 33.6, respectively.28
The FDA is expected to make its decision regarding the approval of Eloctate by June 12, 2014.5 If approved,
analysts estimate Eloctate annual sales to reach $700 million by 2020.29
TBD (umeclidinium)
Umeclidinium is a once-daily inhaled long-acting muscarinic acetylcholine receptor antagonist being
developed by GlaxoSmithKline for the treatment of chronic obstructive pulmonary disease (COPD),
including chronic bronchitis and emphysema. Umeclidinium, in combination with vilanterol, is a component
of the FDA-approved product, Anoro™ Ellipta™.1 In a clinical trial, umeclidinium significantly improved mean
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change from baseline in trough forced expiratory volume in 1 second (FEV1) compared with placebo
(p < 0.001).30 In another trial, umeclidinium showed comparable increases in FEV1 to Spiriva® (tiotropium).31
The FDA is expected to make its decision regarding the approval of umeclidinium by February 2014.5
Entyvio® (vedolizumab)
Vedolizumab, a NME, is an anti-α4β7 integrin humanized monoclonal antibody. It is being developed
by Takeda for reducing signs and symptoms, inducing and maintaining clinical response and remission,
and mucosal healing, and achieving corticosteroid-free remission in adult patients with moderately to
severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a TNFα antagonist. In a phase III induction trial, the proportion
of patients with clinical response was significantly greater in the vedolizumab group (47.1%) relative to
the placebo group (25.5%).33 In the maintenance trial, clinical remission was achieved by 41.8-44.8% of
patients receiving vedolizumab compared to 15.9% of those receiving placebo (p < 0.0001).33 Though the
mechanism of action for vedolizumab is similar to that of Tysabri® (natalizumab), a product that has been
associated with progressive multifocal leukoencephalopathy (PML), no cases of PML have been observed
thus far in the vedolizumab clinical program.32 Vedolizumab is administered intravenously, with a proposed
maintenance dosing schedule of once every eight weeks. The FDA’s Gastrointestinal Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee voted 21-0 in support of
vedolizumab’s approval.33 The FDA is expected to make its decision regarding the approval of Entyvio by
May 20, 2014.5
Expected Generic Launches
Brand Name
Generic
Name
Company
Strength(s) and
Formulation(s)
Indication/Use
Expected
Launch Date*
Avelox®
moxifloxacin
Bayer
400 mg tablets
Sinusitis, chronic bronchitis,
community acquired pneumonia,
2/2014
skin & skin structure infections,
intra-abdominal infections
Copaxone®
glatiramer
Teva
20 mg/mL injection
Relapsing-remitting
multiple sclerosis
5/2014
Humalog®
lispro
Eli Lilly
100 units/mL
injection
Type 2 diabetes mellitus
6/2014
* Estimated launch dates are subject to change based on various factors (e.g., FDA approvals, manufacturer decisions, litigation, and company agreements).
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References
1.Clinical Pharmacology [database online]. Tampa, FL: Gold Standard,
Inc.; 2014. http://www.clinicalpharmacology.com.
2.GSK announces data from five Phase III studies of albiglutide,
an investigational once-weekly treatment for type 2 diabetes.
GlaxoSmithKline website. http://www.gsk.com/media/pressreleases/2013/gsk-announces-data-from-five-phase-iii-studies-ofalbiglutide--a.html. Accessed February 9, 2014.
3.GSK announces new 52-week data from phase III study of once-weekly
albiglutide in type 2 diabetes. GlaxoSmithKline website. http://us.gsk.
com/html/media-news/pressreleases/2012/2012-pressrelease-1125277.
htm. Accessed February 9, 2014.
15.Roden M, Weng J, Eilbracht J, et al. Empagliflozin monotherapy with
sitagliptin as an active comparator in patients with type 2 diabetes: a
randomised, double-blind, placebo-controlled, phase 3 trial. Lancet
Diab & Endo. 2013;1(3):208-219.
16.Lilly Bullish On Diabetes/Oncology Products; Analysts Skeptical. Elsevier
Business Intelligence website. http://www.elsevierbi.com/publications/
the-pink-sheet-daily/2013/10/3/lilly-bullish-on-diabetesoncologyproducts-analysts-skeptical. Accessed February 9, 2014.
17.Afrezza- a first-in-class ultra rapid-acting insulin. MannKind
Corporation website. http://www.mannkindcorp.com/product-pipelinediabetes-afrezza.htm. Accessed February 9, 2014.
4.Pratley R, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus
once-daily liraglutide in patients with type 2 diabetes inadequately
controlled on oral drugs (HARMONY 7): a randomised, open-label,
multicentre, non-inferiority phase 3 study. Lancet Diab & Endo. 2014;1-9.
18.MannKind announces positive clinical data for Afrezza; both AFFINITY
Phase 3 studies meet primary dndpoints. MannKind Corporation website.
http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irolnewsArticle&id=1847436. Accessed February 9, 2014.
5.Estimated FDA User Fee Review Goals For Pending NDAs/BLAs. Elsevier
Business Intelligence website. http://www.pharmamedtechbi.com/
publications/pharmaceutical-approvals-monthly/19/2/estimated-fda-userfee-review-goals-for-pending-ndasblas. Accessed February 26, 2014.
19.MannKind announces tentative date of FDA Advisory Committee
Review of Afrezza. Mannkind Corporation website. http://www.
investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=irolnewsArticle&ID=1889734&highlight=. Accessed February 27, 2014.
6.New GSK diabetes drug works, but faces tough competition. Reuters
website. http://www.reuters.com/article/2013/06/24/glaxosmithklineidUSL5N0F01BG20130624. Accessed February 9, 2014.
20.FDA Briefing Document: BLA for Ragwitek (standardized allergen
extract, short ragweed [Ambrosia artemisiifolia] sublingual tablet for
oral use). Allergenic Products Advisory Committee Meeting.
January 28, 2014.
7.Data from Phase III Randomized Controlled Study (PALACE 3) of
Apremilast in Psoriatic Arthritis Presented at EULAR. Business Wire
website. http://www.businesswire.com/news/home/20130613005438/
en/Data-Phase-III-Randomized-Controlled-Study-PALACE. Accessed
February 9, 2014.
21.Merck’s Ragwitek wins FDA panel nod but faces post-approval studies.
Elsevier Business Intelligence website. http://www.elsevierbi.com/
publications/the-pink-sheet-daily/2014/1/28/mercks-ragwitek-wins-fdapanel-nod-but-faces-postapproval-studies. Accessed February 9, 2014.
8.Oral apremilast monotherapy demonstrated long-term clinical benefits
in psoriatic arthritis patients naïve to previous DMARD therapy. Celgene
website. http://ir.celgene.com/releasedetail.cfm?releaseid=821060.
Accessed February 9, 2014.
22.FDA grants Lilly's ramucirumab priority review as a potential singleagent treatment for advanced gastric cancer. Eli Lilly website. https://
investor.lilly.com/releasedetail.cfm?ReleaseID=799222. Accessed
February 9, 2014.
9.Celgene drug results fall short of earlier trial. The Wall Street Journal
website. http://online.wsj.com/news/articles/SB100014241278873234
78304578336251308169618. Accessed February 9, 2014.
23.Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for
previously treated advanced gastric or gastroesophageal junction
adenocarcinoma (REGARD): an international, randomised, multicentre,
placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39.
10.Santarus and Pharming announce submission of RHUCIN biologics
license application to FDA. Santarus website. http://ir.santarus.com/
common/mobile/iphone/releasedetail.cfm?ReleaseID=538999&Company
ID=SNTS&mobileid#. Accessed February 9, 2014.
11.Zuraw B, Cicardi M, Levy RJ, Nuijens JH, Relan A, Visscher S, Haase
G, Kaufman L, Hack CE. Recombinant human C1-inhibitor for the
treatment of acute angioedema attacks in patients with hereditary
angioedema. J Allergy Clin Immunol. 2010;126(4):821-827.
12.Davis B and Bernstein JA. Conestat alfa for the treatment of
angioedema attacks. Ther Clin Risk Manag. 2011;7:265-273.
13.Salix and Pharming Announce Extension of PDUFA Action Date for
RUCONEST. Salix website. http://www. salix.com/news-media/news/
index/salix-and-pharming-announce-extension-of-pdufa-action-datefor-ruconest. Accessed February 27, 2014.
14.Phase III data show investigational compound empagliflozin
significantly reduced blood glucose in adults with type 2
diabetes. Eli Lilly website. https://investor.lilly.com/releasedetail.
cfm?ReleaseID=773114. Accessed February 9, 2014.
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24.Lilly announces second positive ramucirumab Phase III gastric cancer
study meets primary endpoint; Phase III Lilly/TRIO breast cancer study
misses primary endpoint. Eli Lilly website. https://investor.lilly.com/
releasedetail.cfm?ReleaseID=793403. Accessed February 9, 2014.
25.Wilke H, Cutsem EV, Oh SC, et al. RAINBOW: A global, phase III,
randomized, double-blind study of ramucirumab plus paclitaxel versus
placebo plus paclitaxel in the treatment of metastatic gastroesophageal
junction (GEJ) and gastric adenocarcinoma following disease
progression on first-line platinum- and fluoropyrimidine-containing
combination therapy rainbow IMCL CP12-0922 (I4T-IE-JVBE). J Clin
Oncol. 2014;32(3):abstract LBA7.
26.Lilly aims to submit five new drugs for approval. Indianapolis Business
Journal website. http://www.ibj. com/lilly-aims-to-submit-five-new-drugsfor-approval/PARAMS/article/39437. Accessed February 26, 2014.
27.New Phase 3 data confirm long-lasting characteristics of Alprolix and
Eloctate across multiple hemophilia populations. Biogen Idec website.
https://www.biogenidec.com/press_release_details.aspx?ID=14712& Action
=1&NewsId=2261&M=NewsV2&PID=61997. Accessed February 9, 2014.
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OptumRx Pipeline Forecast
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28.Leading hematology journal publishes pivotal Eloctate data that
demonstrated efficacy and safety of investigational long-lasting therapy
for Hemophilia A. Biogen Idec website. http://www.biogenidec.com/
press_release_details.aspx?ID=14712&Action=1&NewsId=2150&M=Ne
wsV2&PID=61997. Accessed February 9, 2014.
29.Biogen Sees Eloctate FDA Delay Pushing Marketing to Mid-2014 (2).
Business Week website. http://www.businessweek.com/news/2013-1112/biogen-sees-eloctate-fda-delay-pushing-market-entry-to-mid-2014.
Accessed February 9, 2014.
30.Trivedi R, Richard N, Mehta R, et al. Umeclidinium in patients
with COPD: a randomised, placebo-controlled study. Euro Resp J.
2014;43(1):72-81.
31.Donohue JF, Anzueto A, Brooks J, et al. A randomized, double-blind
dose-ranging study of the novel LAMA GSK573719 in patients with
COPD. Respir Med. 2012;106(7):970-979.
32.FDA Briefing Document. Joint Meeting of the Gastrointestinal
Drugs Advisory Committee (GIDAC) and the Drug Safety and Risk
Management Advisory Committee (DSaRMAC). December 9, 2013.
33.FDA Advisory Committee recommends approval of Takeda's investigational
biologic vedolizumab. Takeda website. https://www.takeda.com/
news/2013/20131210_6094.html. Accessed February 9, 2014.
optumrxsales@optum.com | optumrx.com
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The information contained herein is compiled from various sources and is provided for informational purposes only.
Due to factors beyond the control of OptumRx, information related to prospective drug launches is subject to change
without notice. This information should not be solely relied upon for formulary decision-making purposes.
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