Novartis bolsters innovative dermatology portfolio through acquisition of Ziarco Group Limited
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Novartis International AG /
Novartis bolsters innovative dermatology portfolio through acquisition of Ziarco
Group Limited
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* Acquisition to add a once-daily oral H(4) receptor antagonist, ZPL389, to
treat atopic dermatitis, commonly known as eczema, to the Novartis industry-
leading pipeline
* Investigational ZPL389 showed a clinically and statistically significant
improvement of eczema lesions, leading to a 50% reduction in EASI score
compared to placebo after eight weeks of treatment with a favorable safety
profile
* Eczema is a chronic, inflammatory skin condition affecting millions of
children and adults worldwide[1] with an unmet need for effective and safe
oral treatments
Basel, December 16, 2016 - Novartis announced today that it has entered into a
definitive agreement for the acquisition of Ziarco Group Limited, a privately
held company focused on the development of novel treatments in dermatology. This
acquisition would add a once-daily oral H(4) receptor antagonist in development
for atopic dermatitis (AD), commonly known as eczema, to complement the growing
Novartis dermatology portfolio and pipeline. The transaction is subject to
customary closing conditions, including regulatory approval. The financial
details of this transaction are not disclosed.
Ziarco's lead investigational product, ZPL389, is a potential first-in-class
oral treatment for moderate-to-severe eczema. Eczema is a chronic, itchy,
inflammatory skin condition found in millions of children and adults
worldwide[1]. In addition, it is associated with sleep loss and a significant
reduction in quality of life[2]. Currently, no safe, effective, and well-
tolerated oral treatments are available for the moderate-to-severe form of this
condition.
"There is an unmet need for innovative, effective and safe oral treatment
options for people living with eczema," said Vasant Narasimhan, Global Head,
Drug Development and Chief Medical Officer, Novartis. "We are proud of our
dermatology capabilities shown by the recent successful launches of Cosentyx and
Xolair. Now we're excited about a potential new medicine for people with eczema
through the acquisition of Ziarco and the addition of a first-in-class oral H(4)
receptor antagonist to our growing pipeline."
In a proof of concept study, ZPL389 showed a clinically and statistically
significant reduction of eczema. After eight weeks of treatment, the compound
reduced the Eczema Area and Severity Index (EASI) score by 50% (placebo: 27%,
(p=0.01)) in a study of 98 patients. In addition, there was a statistically
significant improvement in SCORing Atopic Dermatitis (SCORAD) and body surface
area (BSA) scores affected by eczema for ZPL389. The study also showed a
decrease in itching, which was numerically greater in the active treatment arm.
Both the EASI and SCORAD sub-scores related to itching showed positive results
and there was a statistically significant decrease in sleep loss for the active
comparator. Itch is a major cause for sleep loss in eczema patients[2]. In
clinical studies conducted to date, ZPL389 has a favorable safety profile.
Eczema poses a significant burden on health-care resources and patients' quality
of life with recent data showing that its prevalence is still increasing[3].
Eczema affects up to 10% of the population in the US alone[4],[5], with
approximately 15% of children and 70% of adults having the moderate-to-severe
form of the disease[6]. Treatment does not cure eczema but can control symptoms
and potentially improve quality of life[7].
About the Novartis dermatology portfolio
Novartis is committed to addressing the unmet medical needs of patients living
with dermatological conditions and improving their overall quality of life by
providing innovative medicines. The Novartis Dermatology portfolio includes
Cosentyx (secukinumab) for the treatment of moderate-to-severe psoriasis and
Xolair (omalizumab) for the treatment of chronic spontaneous urticaria.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "to add," "to treat," "pipeline," "investigational," "agreement
for the acquisition," "would," "subject to customary closing conditions,"
"potential," "excited," "committed" or similar terms, or by express or implied
discussions regarding potential completion of the announced acquisition of
Ziarco Group Limited, or regarding potential marketing approvals for ZPL389, or
regarding potential future revenues from ZPL389 and the other products in the
Novartis dermatology portfolio. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that the proposed
acquisition will be completed in the expected form or within the expected time
frame or at all. Nor can there be any guarantee that Novartis will be able to
realize any of the potential strategic benefits, synergies or opportunities as a
result of the acquisition. Neither can there be any ZPL389 will be submitted or
approved for sale in any market, or at any particular time. Nor can there be any
guarantee that ZPL389 or the other compound in the Novartis dermatology
portfolio will be commercially successful in the future. In particular,
management's expectations regarding ZPL389 could be affected by, among other
things, unexpected regulatory actions or delays or government regulation
generally, including an unexpected failure to obtain necessary government
approvals for the acquisition of Ziarco Group Limited, or unexpected delays in
obtaining such approvals; the potential that any other closing conditions for
acquisition of Ziarco Group Limited might not be met; the potential that the
strategic benefits, synergies or opportunities expected from the acquisition of
Ziarcro Group Limited may not be realized or may take longer to realize than
expected; the uncertainties inherent in research and development, including
unexpected clinical trial results and additional analysis of existing clinical
data; the company's ability to obtain or maintain proprietary intellectual
property protection; general economic and industry conditions; competition in
general; global trends toward health care cost containment, including ongoing
pricing pressures; unexpected safety, quality or manufacturing issues, and other
risks and factors referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. Novartis is providing the information
in this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Bieber T. Atopic Dermatitis. N Engl J Med. 2008;358:1483-1494
[2] Patel T. et al. Nocturnal Itch: Why do we itch at night? Acta Derm Venereol.
2007;87:295-298
[3] Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr
Metab. 2015;66(suppl 1):8-16
[4] Silverberg et al. Adult eczema prevalence and associations with asthma and
other health and demographic factors: A US population-based study. J Allergy
Clin Immunol. 2013; 132 (5): 1132-1138.
[5] Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema Prevalence in the United
States: Data from the 2003 National Survey of Children's Health. J. Invest.
Dermatol. 2001; 131:67-73.
[6] Hanifin JM, Reed ML. A population-based survey of eczema in the United
States. Dermatitis. 2007;18(2):82-91.
[7] American Academy of Dermatology (AAD) website. Atopic Dermatitis. Available
at: https://www.aad.org/public/diseases/eczema/atopic-dermatitis#treatment. Last
accessed December 2016
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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Novartis Global Media Relations Novartis Global Pharma Communications
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.12.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 513343
Anzahl Zeichen: 11731
contact information:
Town:
Basel
Kategorie:
Business News
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