June 2013
Prime Specialty Pipeline Monthly Update
INFORMATION ON NEW PRODUCTS AND NEW INDICATIONS
New Drug Information

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

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:
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“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.”
http://www.mmm-online.com/study-shows-old-school-meds-as-effective-asenbrel/article/298431/
“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.”
http://www.reuters.com/article/2013/06/13/us-lilly-arthritis-idUSBRE95C0FZ20130613
“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)
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.
© Prime Therapeutics LLC 06/08
ranged from 59% to 73% on ustekinumab (Stelara)…”
Specialty New Product Approvals in the Past Twelve Months
Generic Name
Brand Name
Manufacturer
Indications
cysteamine
Procysbi™
Raptor
dimethyl fumarate
glycerol phenylbutyrate
Tecfidera™
Ravicti™
Biogen
Hyperion
mipomersen
Kynamro™
Genzyme
IVIG
Bivigam™
teduglutide
Gattex™
lomitapide
Juxtapid®
Biotest
Pharmaceuticals
NPS
Pharmaceuticals
Aegerion
pasireotide diaspartate
injection
raxibacumab
Signifor™
Novartis
Liposomal storage
disease
Multiple Sclerosis
Long-term
management of
ammonia levels
Homozygous familial
hypercholesterolemia
Primary Humoral
Immunodeficiency
Short bowel
syndrome
Homozygous familial
hypercholesterolemia
Cushing's disease
N/A
GSK/Human
Genome Sciences
cross-linked
hyaluronate
tofacitinib
Gel One®
Zimmer
Xeljanz®
Pfizer
ocriplasmin
Jetrea®
ThromboGenics
teriflunomide
elvitegravir, cobicistat,
emtricitabine, tenofovir
disoproxil fumarate
taliglucerase alfa
Aubagio®
Stribild™
Sanofi
Gilead
Elelyso™
Pfizer/ Protalix
Prevention and
treatment of anthrax
infection,
administered prior to
or post-exposure
Osteoarthritis of the
knee
Treatment of
rheumatoid arthritis
(RA)
Vitreomacular
adhesions
Multiple Sclerosis
HIV – treatment
naïve
Gaucher’s Disease
Route of
Administration
Oral
Date Approved
Oral
Oral
March 2013
February 2013
Subcutaneous
injection
Intravenous
injection
Subcutaneous
injection
Oral
February 2013
Subcutaneous
injection
Intravenous
injection
December 2012
Intra-articular
injection
Oral
November 2012
Intraocular
injection
Oral
Oral
October 2012
Intravenous
injection
May 2012
May 2013
January 2013
January 2013
January 2013
December 2012
November 2012
September 2012
August 2012
New Indications For Approved Specialty Products:
Generic Name
Brand Name
Manufacturer
Indications
Date Approved*
tocilizumab
Actemra®
Genentech
Polyarticular juvenile idiopathic
arthritis (age 2 and older)
May 2013
canakinumab
Ilaris®
Novartis
golimumab
Simponi®
Johnson & Johnson
Active systemic juvenile
May 2013
idiopathic arthritis in patients aged
2 years and older
Moderate to severe ulcerative
May 2013
colitis
efavirenz
Sustiva®
Bristol-Myers Squibb
everolimus
Zortress®
Novartis
onabotulinumtoxinA
Botox®
Allergan
deferasirox
Exjade®
Novartis
HIV-1 infected children as young
as 3 months and weighing at least
3.5 kg
prevent organ rejection in adult
patients receiving liver
transplantation
Treatment of overactive bladder
May 2013
Chronic iron overload due to
nontransfusion-dependent
January 2013
February 2013
January 2013
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.
© Prime Therapeutics LLC 06/08
thalassemia (NTDT).
tocilizumab
Actemra®
Roche
ranibizumab
Eylea®
Regeneron
ranibizumab
Lucentis®
immune globulin
(IVIG)
First-line therapy in combination
with methotrexate or other drugs
typically given prior to TNF
inhibitors
Macular edema following central
vein occlusion
October 2012
Genentech/Roche
For the treatment of diabetic
macular edema.
August 2012
Gammagard
Liquid®
Baxter
Treatment of multifocal motor
neuropathy
July 2012
emtricitabine/
tenofovir
Truvada®
Gilead
July 2012
foscarnet sodium
injection
Foscavir®
Clinigen
To reduce the risk of getting HIV
in people at high risk of getting
HIV
Treatment of CMV retinitis in
patients with HIV and acyclovirresistant mucocutaneous herpes
simplex virus infections in
immune-compromised patients
October 2012
May 2012
Oncology Product Approvals in the Past Twelve Months
Date Approved
Metastatic melanoma
Route of
Administration
Oral
GlaxoSmithKline
Metastatic melanoma
Oral
June 2013
Xofigo™
Bayer
Prostate Cancer
May 2013
Pomalyst®
Celgene
Multiple Myeloma
Intravenous
injection
Oral
ado-trastuzumab
emtansine
Kadcyla™
Genentech
Intravenous
injection
February 2013
ponatinib
Iclusig™
Ariad
Breast Cancer –
antibody-drug
conjugate
CML
Oral
December 2012
cabozantinib
Cometriq™
Exelixis
Oral
November 2012
regorafenib
Stivarga™
Bayer
Oral
November 2012
omacetaxine
mepesuccinate
bosutinib
Synribo™
Teva
medullary thyroid
cancer
Colorectal cancer -2nd
line therapy
CML
November 2012
Bosulif®
Pfizer
CML
Subcutaneous
injection
Oral
ziv-aflibercept
Zaltrap™
Sanofi
Marqibo®
Talon
Intravenous
injection
Intravenous
injection
August 2012
vincristine
liposomal
carfilzomib
Kyprolis™
Onyx
Second-line treatment
of colorectal cancer
Philadelphia
chromosome negative
ALL
Multiple Myeloma
July 2012
pertuzumab
Perjeta™
Genentech
Intravenous
injection
Intravenous
injection
Generic Name
Brand Name
Manufacturer
Indications
dabrafenib
Tafinlar™
GlaxoSmithKline
trametinib
Mekinist™
radium-223
dichloride
pomalidomide
First-line treatment of
HER2-positive
metastatic breast
cancer
June 2013
February 2013
September 2012
August 2012
June 2012
New Indications for Approved Oncology Drugs
Generic Name
Brand Name
Manufacturer
New Indication
Date
Approved*
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.
© Prime Therapeutics LLC 06/08
lenalidomide
Revlimid®
Celgene
Mantle-cell lymphoma
June 2013
regorafenib
Stivarga®
Bayer
Treat patients with advanced
gastrointestinal stromal tumors (GIST)
February 2013
imatinib
Gleevec®
Novartis
January 2013
protein-bound
paclitaxel
Abraxane®
Abraxis BioScience
everolimus
Afinitor® Disperz Novartis
everolimus
Afinitor®
Novartis
everolimus
Afinitor®
Novartis
pazopanib
Votrient®
GlaxoSmithKline
Treat children newly diagnosed with
Philadelphia chromosome positive (Ph+)
acute lymphoblastic leukemia (ALL).
First-line therapy in combination with
carboplatin for patients with non-small
cell lung cancer that is not amenable to
surgery or radiation.
Treatment of children (1 year and older)
who have tuberous sclerosis complex
(TSC) and subependymal giant cell
astrocytoma (SEGA)
Used in combination with Aromasin for
the treatment of hormone receptor
positive, HER-2 negative breast cancer
Treatment of adults with renal
angiomyolipoma and tuberous sclerosis
complex (TSC) not requiring immediate
surgery
Treatment of soft-tissue sarcoma in
people who have already received
chemotherapy
October 2012
September 2012
July 2012
May 2012
May 2012
Pipeline Watch:
Generic Name
Brand Name
Manufacturer
Indications
Route of
Administration
Anticipated
Approval date
BAX 326 (Factor
IX, recombinant
[rFIX])
tacrolimus
extended-release
N/A
Baxter
Hemophilia B
Intravenous
Infusion
July 2013
Advograf™
Astellas
Oral
July 2013
riociguat
N/A
Bayer
Oral
August 2013
turoctocog alfa
(factor VIII)
dolutegravir
N/A
Novo Nordisk
Prevent rejection of
transplanted livers in
men and transplanted
kidneys in adults
Pulmonary arterial
hypertension
Hemophilia A
August 2013
N/A
Viiv
HIV
Intravenous
Infusion
Oral
macitentan
Opsumit™
Actelion
Oral
August 2013
simeprivir
N/A
J&J
Oral
September 2013
afatinib
N/A
Oral
October 2013
lipegfilgrastim
Lonquex™
Boehringer
Ingelheim
Teva
N/A
Teva
catridecacog
(Factor XIII)
alemtuzumab
N/A
Novo Nordisk
Lemtrada®
Genzyme
Relapsing MS
Intravenous
Infusion
Intravenous
Infusion
Intravenous
Infusion
Intravenous
Infusion
October 2013
balugrastim
Pulmonary arterial
hypertension (PAH)
Hepatitis C (protease
inhibitor in combination
with Peg-interferon)
Non-small cell lung
cancer
Long-acting G-CSF
(neutropenia)
Long-acting G-CSF
(neutropenia)
Hemophilia A
August 2013
November 2013
November 2013
November 2013
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.
© Prime Therapeutics LLC 06/08