REG - Hikma Pharmaceutical - Hikma launches RYALTRIS

Hikma PharmaceuticalsAnnouncement

30/08/2022 12:30

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RNS Number : 6131X  Hikma Pharmaceuticals Plc  30 August 2022

Hikma launches RYALTRIS™ seasonal allergic rhinitis nasal spray in the US

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, New Jersey, and Mumbai; August 30, 2022 - 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 complications(7,8,9,10) 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(TM) in the United States, making it our first global branded
specialty product to be marketed in the country. RYALTRIS(TM) 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)

 

 

- ENDS -

 

 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.

1(0) Chirakalwasan N, et al. Asian Pac J Allergy Immunol. 2014;32(4):276-286.

1(1) D'Alonzo, GE Jr. J Am Osteopath Assoc. 2002;102(6 suppl 2):S2-S6.

 1 (2) Marple et al. Otolaryngol Head Neck Surg. 2007;136(suppl 6):S107-S124.

 1 (3) 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.

 

 

Enquiries

Hikma Pharmaceuticals PLC

 Susan Ringdal                                +44 (0)20 7399 2760/ +44 7776 477050

 EVP, Strategic Planning and Global Affairs   uk-investors@hikma.uk.com (mailto:uk-investors@hikma.uk.com)

 Steve Weiss                                  +1 732 788 8279

 David Belian                                 +1 848 254 4875

 US Communications and Public Affairs         u (mailto:sweiss@hikma.com) scommunications (mailto:sweiss@hikma.com)
                                              @hikma.com (mailto:sweiss@hikma.com)

 

Glenmark Pharmaceuticals Ltd.

 

Udaykumar
Murthy
+91 9960377617

DGM, Corporate
Communications
corpcomm@glenmarkpharma.com (mailto: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 (http://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
(file:///C%3A/Users/90034441/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/SM89SCRG/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 here:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=382eac74-a7ce-4f42-ac0a-b253308f335f
(https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=382eac74-a7ce-4f42-ac0a-b253308f335f)
 

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