Specialty Pipeline Update

CLINICAL SOLUTIONS
→ New Drug Information
Specialty Pipeline Update
Tafinlar (dabrafenib): The Food and Drug
Administration (FDA) has approved GlaxoSmithKline’s
Tafinlar for the treatment of metastatic melanoma.
Tafinlar is similar in mechanism of action to Zelboraf ® .
Mekinist (trametinib): GlaxoSmithKline also received
FDA approval for Mekinist for metastatic melanoma.
This drug works by a different mechanism of action and
there are ongoing studies for use in combination with
Tafinlar. Both Tafinlar and Mekinist were approved with
a companion diagnostic test to identify gene mutations
that will respond to therapy.
Tivozanib: Aveo received a complete response letter
from the Food and Drug Administration (FDA) approval
for tivozanib for the treatment of advanced renal cell
carcinoma. The FDA had concerns related to the clinical
trial data.
→ New Indications
Drug Insights > June 2013
Revlimid ® (lenalidomide): Celgene received Food and
Drug Administration (FDA) approval for an additional
indication for the treatment of mantle-cell lymphoma
in patients whose disease has relapsed or progressed
after two prior therapies, one of which included Velcade ®
(bortezomib).
→ June News
“With Pfizer poised to hand off full promotional
responsibilities for Enbrel ® to its partner Amgen,
New England Journal of Medicine has published a study
suggesting that the $4 billion RA drug may not be worth
the premium price. Researchers found they could match
Enbrel’s effectiveness by combining sulfasalazine and
hydroxychloroquine with methotrexate, which is a
common RA therapy. They also compared this three-part
combination to an Enbrel-methotrexate combination,
which is not unusual.” 1
“Eli Lilly and Co and Incyte Corp said their experimental
drug was effective in reducing painful symptoms
associated with rheumatoid arthritis after 52 weeks of
treatment. The drug, baricitinib, is part of a new family
of medicines called JAK inhibitors that block enzymes
believed to be involved in the inflammatory process.” 2
“The monoclonal antibody ustekinumab (Stelara ® )
had sustained benefits through a year of treatment
among patients with active psoriatic arthritis,
even for those who had previously not done well
on a tumor necrosis factor (TNF) inhibitor. Among
those who had not previously received anti-TNF
treatment, patients who saw a 20% improvement
in their symptoms according to the criteria of the
American College of Rheumatology (ACR20) ranged
from 59% to 73% on ustekinumab (Stelara)…”
Some or all of the information contained in this document may contain confidential and/or proprietary information and should be treated accordingly. Prime Therapeutics LLC does not warrant that the
information contained herein is free from error and it should be used only as an informational guide. Nothing herein represents the promotion of any drugs or manufacturers by Prime Therapeutics LLC,
and no conclusions of formulary status shall be inferred from any discussion herein.

Drug Insights > Specialty Pipeline Update Page 2
Specialty New Product Approvals in the Past Twelve Months
Generic Name Brand Name Manufacturer Indication(s)
Route of
Administration Date Approved
cysteamine Procysbi Raptor Liposomal storage disease Oral May 2013
dimethyl fumarate Tecfidera Biogen Multiple sclerosis Oral March 2013
glycerol phenylbutyrate Ravicti Hyperion Long-term management
of ammonia levels
mipomersen Kynamro Genzyme Homozygous familial
hypercholesterolemia
IVIG Bivigam Biotest Pharmaceuticals Primary humoral
immunodeficiency
Oral February 2013
Subcutaneous
injection
Intravenous
injection
February 2013
January 2013
teduglutide Gattex NPS Pharmaceuticals Short bowel syndrome Subcutaneous
injection
January 2013
lomitapide Juxtapid ® Aegerion Homozygous familial
hypercholesterolemia
Oral January 2013
pasireotide diaspartate
injection
Signifor Novartis Cushing’s disease Subcutaneous
injection
raxibacumab N/A GSK/Human Genome
Sciences
Prevention and treatment
of anthrax infection,
administered prior to or
post-exposure
Intravenous
injection
December 2012
December 2012
cross-linked hyaluronate Gel One ® Zimmer Osteoarthritis of the knee Intra-articular
injection
November 2012
tofacitinib Xeljanz ® Pfizer Treatment of rheumatoid
arthritis (RA)
Oral November 2012
ocriplasmin Jetrea ® ThromboGenics Vitreomacular adhesions Intraocular
injection
October 2012
teriflunomide Aubagio ® Sanofi Multiple sclerosis Oral September 2012
elvitegravir, cobicistat,
emtricitabine, tenofovir
disoproxil fumarate
Stribild Gilead HIV – treatment naïve Oral August 2012
taliglucerase alfa Elelyso Pfizer/Protalix Gaucher’s disease Intravenous
injection
May 2012

Drug Insights > Specialty Pipeline Update Page 3
New Indications For Approved Specialty Products
Generic Name Brand Name Manufacturer Indication(s) Date Approved
tocilizumab Actemra ® Genentech Polyarticular juvenile idiopathic arthritis
(age 2 and older)
May 2013
canakinumab Ilaris ® Novartis Active systemic juvenile idiopathic arthritis
in patients aged 2 years and older
May 2013
golimumab Simponi ® Johnson & Johnson Moderate to severe ulcerative colitis May 2013
efavirenz Sustiva ® Bristol-Myers Squibb HIV-1 infected children as young as 3 months
and weighing at least 3.5 kg
May 2013
everolimus Zortress ® Novartis prevent organ rejection in adult patients
receiving liver transplantation
February 2013
onabotulinumtoxin A Botox ® Allergan Treatment of overactive bladder January 2013
deferasirox Exjade ® Novartis Chronic iron overload due to nontransfusiondependent
thalassemia (NTDT)
January 2013
tocilizumab Actemra ® Roche First-line therapy in combination with
methotrexate or other drugs typically given
prior to TNF inhibitors
October 2012
ranibizumab Eylea ® Regeneron Macular edema following central vein occlusion October 2012
ranibizumab Lucentis ® Genentech/Roche For the treatment of diabetic macular edema August 2012
immune globulin (IVIG) Gammagard
Liquid ®
Baxter Treatment of multifocal motor neuropathy July 2012
emtricitabine/tenofovir Truvada ® Gilead To reduce the risk of getting HIV in people
at high risk of getting HIV
July 2012
foscarnet sodium
injection
Foscavir ® Clinigen Treatment of CMV retinitis in patients with
HIV and acyclovir-resistant mucocutaneous
herpes simplex virus infections in immunecompromised
patients
May 2012

Drug Insights > Specialty Pipeline Update Page 4
Oncology Product Approvals in the Past Twelve Months
Generic Name Brand Name Manufacturer Indication(s)
Route of
Administration Date Approved
dabrafenib Tafinlar GlaxoSmithKline Metastatic melanoma Oral June 2013
trametinib Mekinist GlaxoSmithKline Metastatic melanoma Oral June 2013
radium-223 dichloride Xofigo Bayer Prostate cancer Intravenous
injection
May 2013
pomalidomide Pomalyst ® Celgene Multiple myeloma Oral February 2013
ado-trastuzumab
emtansine
Kadcyla Genentech Breast cancer —
antibody-drug conjugate
Intravenous
injection
February 2013
ponatinib Iclusig Ariad CML Oral December 2012
cabozantinib Cometriq Exelixis Medullary thyroid cancer Oral November 2012
regorafenib Stivarga Bayer Colorectal cancer —
second-line therapy
omacetaxine
mepesuccinate
Synribo Teva CML Subcutaneous
injection
Oral November 2012
November 2012
bosutinib Bosulif ® Pfizer CML Oral September 2012
ziv-aflibercept Zaltrap Sanofi Second-line treatment of
colorectal cancer
vincristine liposomal Marqibo ® Talon Philadelphia chromosome
negative ALL
Intravenous
injection
Intravenous
injection
carfilzomib Kyprolis Onyx Multiple myeloma Intravenous
injection
pertuzumab Perjeta Genentech First-line treatment of
HER2-positive metastatic
breast cancer
Intravenous
injection
August 2012
August 2012
July 2012
June 2012

Drug Insights > Specialty Pipeline Update Page 5
New Indications For Approved Oncology Drugs
Generic Name Brand Name Manufacturer New Indication Date Approved
lenalidomide Revlimid ® Celgene Mantle-cell lymphoma June 2013
regorafenib Stivarga ® Bayer Treat patients with advanced gastrointestinal
stromal tumors (GIST)
imatinib Gleevec ® Novartis Treat children newly diagnosed with Philadelphia
chromosome positive (Ph+) acute lymphoblastic
leukemia (ALL)
protein-bound paclitaxel Abraxane ® Abraxis BioScience First-line therapy in combination with carboplatin
for patients with non-small cell lung cancer that
is not amenable to surgery or radiation
everolimus Afinitor ® Disperz Novartis Treatment of children (1 year and older) who
have tuberous sclerosis complex (TSC) and
subependymal giant cell astrocytoma (SEGA)
everolimus Afinitor ® Novartis Used in combination with Aromasin for the
treatment of hormone receptor positive,
HER2-negative breast cancer
everolimus Afinitor ® Novartis Treatment of adults with renal angiomyolipoma
and tuberous sclerosis complex (TSC) not
requiring immediate surgery
pazopanib Votrient ® GlaxoSmithKline Treatment of soft-tissue sarcoma in people
who have already received chemotherapy
February 2013
January 2013
October 2012
September 2012
July 2012
May 2012
May 2012

Drug Insights > Specialty Pipeline Update Page 6
Pipeline Watch
Route of
Administration Date Approved
N/A Baxter Hemophilia B Intravenous
infusion
July 2013
Advograf Astellas Prevent rejection of
transplanted livers in men
and transplanted kidneys
in adults
Oral July 2013
Generic Name Brand Name Manufacturer Indication(s)
BAX 326 (factor IX,
recombinant [rFIX])
tacrolimus extendedrelease
riociguat N/A Bayer Pulmonary arterial
hypertension
turoctocog alfa
(factor VIII)
N/A Novo Nordisk Hemophilia A Intravenous
infusion
Oral August 2013
August 2013
dolutegravir N/A Viiv HIV Oral August 2013
macitentan Opsumit Actelion Pulmonary arterial
hypertension (PAH)
Oral August 2013
simeprivir N/A J&J Hepatitis C (protease
inhibitor in combination
with Peg-interferon)
Oral September 2013
afatinib N/A Boehringer Ingelheim Non-small cell lung cancer Oral October 2013
lipegfilgrastim Lonquex Teva Long-acting G-CSF
(neutropenia)
balugrastim N/A Teva Long-acting G-CSF
(neutropenia)
catridecacog
(factor XIII)
Intravenous
infusion
Intravenous
infusion
N/A Novo Nordisk Hemophilia A Intravenous
infusion
alemtuzumab Lemtrada ® Genzyme Relapsing MS Intravenous
infusion
References
1 http://www.mmm-online.com/study-shows-old-school-meds-as-effective-as-enbrel/article/298431/
2 http://www.reuters.com/article/2013/06/13/us-lilly-arthritis-idUSBRE95C0FZ20130613
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