RYALTRIS™ is the only fixed-dose combination therapy that
provides relief for both nasal and ocular symptoms of seasonal
allergic rhinitis in one easy-to-use nasal spray
60 million Americans suffer from allergic rhinitis and
allergic conjunctivitis yet approximately 8.5 million are still
impacted by poor nasal symptom control
LONDON and MAHWAH, N.J.and MUMBAI, India, Aug. 30,
2022 /PRNewswire/ -- Hikma Pharmaceuticals PLC
(Hikma, Group), the multinational pharmaceutical company, and
Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals
Ltd. (Glenmark), an innovation driven global pharmaceutical
company, announced the launch of RYALTRIS™ (olopatadine
hydrochloride and mometasone furoate nasal spray) in the US.
RYALTRIS™ is approved by the US Food and Drug Administration (FDA)
for the treatment of symptoms of seasonal allergic rhinitis (SAR)
in adult and pediatric patients 12 years of age and
older. This launch builds upon Hikma's leading position as one of
the largest US providers of nasally administered medicines used for
treating seasonal allergies and advances its objective of growing
its specialty business in the US.
RYALTRIS™ is the only fixed-dose combination therapy that
provides relief for the symptoms of SAR, both nasal and ocular in
one easy-to-use nasal spray. The onset of action for nasal symptom
relief occurs within 15 minutes of a patient taking the first
dose.1,2,3
"Allergic rhinitis and allergic conjunctivitis are among the
most common chronic diseases in the US today, affecting 60 million
Americans each year,4 yet approximately one in seven US
adults have reported their nasal allergy symptoms are either poorly
controlled or not controlled at all,5 and ocular
symptoms are reported to be as severe as nasal
symptoms,"6 said Leonard
Bielory, M.D. Professor of Medicine, Allergy, Immunology and
Ophthalmology at Hackensack Meridian School of Medicine. "By
combining two of the most frequently prescribed medicines used to
address both the nasal and ocular symptoms of seasonal allergic
rhinitis into one, easy-to-use nasal spray, RYALTRIS™ provides an
important new treatment option for patients suffering from this
chronic condition affecting the nose and eyes."
Uncontrolled seasonal allergic rhinitis is a serious condition
that places a substantial burden on patients and society as whole.
The symptoms of allergic rhinitis can lead to chronic complications
including asthma, sinusitis, hearing impairment, and other
allergy-related
complications7,8,9,10 which can have a
significant impact on patients' quality of
life.11,12,13 There is an important need for new
treatment options like RYALTRIS™ to help treat seasonal allergic
rhinitis, as patients who do not experience adequate symptom relief
may require therapy escalation to more costly and higher-risk
treatments such as immunotherapy, biologics, and
surgery.14,15,16,17,18
"The launch of RYALTRIS™ is a significant step forward for Hikma
in expanding our US nasal spray leadership into branded medicines
and advancing our objective of growing our specialty business in
the US," said Brian Hoffmann,
President of Hikma Generics. "Importantly, it will allow us to
leverage our strong, existing specialty salesforce already calling
on doctors within our specialty portfolio. We look forward to
bringing this important new treatment option to the millions of US
patients suffering from seasonal allergic rhinitis."
"We are delighted to partner with Hikma for the launch of our
novel drug RYALTRIS™ in the United
States, making it our first global branded specialty product
to be marketed in the country. RYALTRIS™ is a result of our
consistent efforts to offer high-quality medicines that benefit
patients around the world. Available in major markets across the
globe, this launch is a major milestone for Glenmark and
demonstrates our focus in strengthening our global respiratory
leadership," said Brendan O'Grady,
Chief Executive Officer - Global Formulations Business, Glenmark
Pharmaceuticals Ltd.
About RYALTRIS™
The efficacy and safety of RYALTRIS™ was established in a robust
clinical studies program in over 4,000 patients with SAR.
Twice-daily RYALTRIS™ provided statistically significant
improvement in both nasal and ocular symptoms vs.
placebo,1,2,3 as well as statistically significant onset
of action in nasal symptom relief vs. placebo at 10-15
minutes,1,2,3 across three randomized, double-blind
phase 3 studies (P<0.05). RYALTRIS™ also provided significant
and clinically meaningful sustained improvements in nasal symptoms
versus placebo over 52 weeks with no evidence of tachyphylaxis in
patients with perennial allergic rhinitis (PAR).1,2,3
RYALTRIS™ demonstrated a safety profile consistent with placebo,
monotherapy, and comparator fixed-dose-combination
treatment.1,2,3
About Seasonal Allergic
Rhinitis
Allergic rhinitis is one of the most common chronic diseases in
the United States, affecting 60
million Americans annually.4 Season allergic rhinitis
(SAR) occurs in a specific pollen season, and is an allergic
reaction to pollen from trees, grasses, and weeds. According to the
most recent CDC data, almost 20 million adults in the United Sates
are affected by seasonal allergic rhinitis every
year.14 It is estimated to affect more than seven
percent of adults aged 18 years and over in the
US.13
Enquiries
Hikma Pharmaceuticals
PLC
Susan
Ringdal EVP, Strategic Planning
and Global Affairs
|
+44 (0)20 7399 2760/
+44 7776 477050 uk-investors@hikma.uk.com
|
|
|
Steve
Weiss David
Belian US Communications and
Public Affairs
|
+1 732 788
8279 +1 848 254
4875 uscommunications@hikma.com
|
|
|
Glenmark Pharmaceuticals Ltd.
Udaykumar Murthy
DGM, Corporate Communications
|
+91 9960377617
corpcomm@glenmarkpharma.com
|
|
|
About Hikma
Hikma helps put better health within reach every day for
millions of people around the world. For more than 40 years, we've
been creating high-quality medicines and making them accessible to
the people who need them. Headquartered in the UK, we are a global
company with a local presence across the
United States (US), the Middle
East and North Africa
(MENA) and Europe, and we use our
unique insight and expertise to transform cutting-edge science into
innovative solutions that transform people's lives. We're committed
to our customers, and the people they care for, and by thinking
creatively and acting practically, we provide them with a broad
range of branded and non-branded generic medicines. Together, our
8,700 colleagues are helping to shape a healthier world that
enriches all our communities. We are a leading licensing partner,
and through our venture capital arm, are helping bring innovative
health technologies to people around the world. For more
information, please visit: www.hikma.com
Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC:
HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB-/stable S&P and
Ba1/stable Moody's)
About Glenmark
Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is
an innovation-driven global pharmaceutical company with a presence
across Specialty, Generics and OTC businesses. It focuses on the
key therapeutic areas of respiratory, dermatology and oncology. The
company has 10 worldclass manufacturing facilities spread across 4
continents and operations in over 80 countries. Glenmark is ranked
among the world's top 100 biopharmaceutical companies (Top 100
Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip
100) and among the world's top 50 companies in the off-patent
sector (Top 50 Generics and Biosimilars Companies ranked by Sales,
2020, by Generics Bulletin/In Vivo). The company was listed on the
Dow Jones Sustainability Index (DJSI), one of the world's most
respected and widely accepted sustainability benchmarks, under the
category of emerging markets (2021) for the fourth consecutive
year. For more information, visit www.glenmarkpharma.com.
Follow us on Social Media:
LinkedIn (Glenmark Pharmaceuticals) and Instagram
(glenmark_pharma)
U.S. Important Safety Information
for Ryaltris™
- Ryaltris™ is an intra-nasal spray and should not be
administered orally, instilled in the eyes, ears or applied to the
skin.
- In clinical studies, the most common adverse events that were
observed in those 12 years of age and over using Ryaltris™, were
altered taste (3%), nose bleeds (1%) and nasal discomfort
(1%).
- Ryaltris™ should not be used by anyone who has had an allergic
reaction to olopatadine or mometasone.
- Close medical supervision is required in anyone who has a
weakened immune system, including those who have had infections
with opportunistic pathogens. Increased risk of occurrence or
potential worsening of pre-existing infections (e.g. tuberculosis)
with fungi, bacteria or viruses can occur; including fatal
chickenpox, measles and herpes infections in susceptible
patients.
- Ryaltris™ should be used under close medical supervision in
anyone who has had nose bleeds or nasal perforation. Recurrence,
worsening or persistence of these nasal problems can occur.
- Close growth monitoring of pediatric patients (12 years and
over) by a medical practitioner is recommended with the use of
Ryaltris™.
- Ryaltris™ effect on pregnancy and through transmission in
breast milk is not known. Talk to your doctor if you are pregnant,
plan to become pregnant or breastfeeding, to ensure it is safe for
you to use.
For more information, please see the full
Prescribing Information and Patient Information
1 Patel P, et. al. Ann Allergy Asthma Immunol.
2019;122(2):160-166
2 Gross GN, et. al. Ann Allergy Asthma Immunol.
2019;122(6):630-638
3 Hampel FC, et. al. Allergy Asthma Proc.
2019;40(4):261-272
4 Meltzer EO. Immunol Allergy Clin North Am.
2016;36(2):235-248
5 Meltzer E, et al. Allergy Asthma Proc. 2012;33
(suppl 1):113-141.
6 Bielory L, et al. Allergy Asthma Proc. 2014
;35(3):211-8.
7 National Institute for Health and Care Excellence.
Complications allergic rhinitis. Updated April 29, 2019. Accessed January 2020.
8 Settipane RA. Allergy Asthma Proc.
1999;20(4):209-213.
9 Skoner, DP. J Allergy Clin Immunol. 2000;105(6
Pt 2) :S605-S609.
10 Chirakalwasan N, et al. Asian Pac J Allergy
Immunol. 2014;32(4):276-286.
11 D'Alonzo, GE Jr. J Am Osteopath Assoc.
2002;102(6 suppl 2):S2-S6.
12 Marple et al. Otolaryngol Head Neck Surg.
2007;136(suppl 6):S107-S124.
13 Meltzer EO, et al. Allergy Asthma Proc.
2012;33(suppl 1):S113-S141.
14 Seidman MD, et al. Otolaryngol Head Neck Surg.
2015;152(1S):S1-S43.
15 Bhattacharyya N, et al. The Laryngoscope.
2019;129:1969–1975.
16 ICER 2018 Final Report of Biologic Therapies for
Treatment of Asthma Associated with Type 2 Inflammation. *2018
Wholesale Acquisition Costs x 1 year of dosing for allergic asthma
(on-label indication). Use of biologics for SAR is off-label &
dosing strategies are not established.
17 Gevaert P, et al. J Allergy Clin Immunol.
2013;131:110-6.
18 Wu A, et al. J Allergy Clin Immunol Pract.
2021;9:1107-17.
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SOURCE Hikma Pharmaceuticals USA Inc.