Shire and Parion Sciences Enter into a Collaborative License Agreement to Advance P-321 for Ophthalmic Indications

Lexington, Massachusetts and Durham, North Carolina
(ots/PRNewswire) -

Demonstrates ongoing commitment to innovation in ophthalmics for
Shire

P-321 is a Phase 2 investigational topical treatment for dry eye
disease

Shire plc (LSE: SHP, NASDAQ: SHPG) and Parion Sciences, Inc. today
announced they have entered into an agreement granting Shire
exclusive worldwide rights to develop and commercialize P-321. Shire
will lead development of P-321, an investigational epithelial sodium
channel (ENaC) inhibitor for the potential treatment of dry eye
disease in adults, with the opportunity for Parion to co-fund.

P-321 is a Phase 2 compound being developed to address tear volume
deficiency and promote ocular surface healing. While further clinical
trials are needed to fully evaluate its safety profile and efficacy,
P-321 is a novel molecule that is believed to address dry eye disease
by inhibiting ENaC, which is thought to block the absorption of
tears, and help keep the ocular surface hydrated; current
prescription treatments target the effects of ocular inflammation.

"Ophthalmics is a continued focus for Shire, and the program for
P-321 will benefit from our development and commercial infrastructure
and expertise," said Flemming Ornskov, M.D., M.P.H., Chief Executive
Officer, Shire. "This is an opportunity to apply our knowledge and
experience from ophthalmics and dry eye disease for further
innovation in this space. If approved, P-321 would expand our eye
care portfolio."

"Advancing P-321 with Shire, an emerging global leader in
ophthalmics, offers the expertise and resources to move this
promising potential therapy for dry eye sufferers forward," said Paul
Boucher, President and Chief Executive Officer of Parion. "This
collaborative license agreement enables us the opportunity to
contribute and participate in P-321's success, while continuing our
drive to progress Parion's pipeline of novel therapies."

While specific terms of the deal were not disclosed, Shire will
make an initial $20 million upfront license payment with an
additional $20 million payment based on the achievement of a near
term development milestone. Parion will be entitled to receive
additional potential milestone payments, with a total potential deal
value of up to $535 million. Parion has the option to co-fund through
additional stages of development in exchange for enhanced tiered
double-digit royalties. In addition, Parion has the option to co-fund
commercialization activities and participate in the financial outcome
from those activities.

P-321 and Clinical Development Program

P-321 is a novel small molecule inhibitor of ENaC, which is
thought to block the absorption of tears, and help keep the ocular
surface hydrated. A Phase 1/2a placebo-controlled, dose escalation
clinical study in 53 patients has been completed, which evaluated the
safety and tolerability of P-321 in patients with mild to moderate
dry eye disease. Although the study -

P-321-101 - was not powered to assess efficacy signals, positive
trends were observed in improvement of signs and symptoms of dry eye
disease in subsets of patients, compared to placebo. At the highest
strength studied (0.01%), no discomfort or instillation irritation
was reported with P-321. The adverse events seen in the patients
assigned to P-321 were generally similar to or fewer than those that
occurred in the patients assigned to placebo, and none of the adverse
events were considered serious. A Phase 2b study is expected to begin
after consultation with health authorities.

Based on pre-clinical models of dry eye disease, ENaC inhibitors
are believed to have the potential to restore or improve tear volume
on the ocular surface. Further clinical trials are needed to evaluate
the safety profile, efficacy and mechanism of action of P-321.

About Chronic Dry Eye Disease

The prevalence of dry eye disease ranges from 6-34% in adults
globally. Dry eye disease is a multifactorial disease of the ocular
surface that is often chronic and may be progressive. The disease is
most commonly associated with eye dryness and overall eye discomfort,
as well as stinging, burning, a gritty feeling or fluctuating blurry
vision.

Eye care professionals can diagnose dry eye disease based on
patient reported symptoms as well as signs, which can be objectively
evaluated through various tests. Management options may include the
use of non-prescription and prescription treatments.

Aging and gender are recognized as traditional risk factors of
chronic dry eye disease while modern risk factors include prolonged
digital/computer screen time, contact lens wear and cataract or
refractive surgery. Dry eye is a common complaint to eye care
professionals.

About Parion Sciences

Parion Sciences is a development stage biopharmaceutical company
dedicated to research, development and commercialization of
treatments to improve and extend the lives of patients with innate
mucosal surface defense deficiencies of the eye or airway. Parion has
a diverse pipeline of pre-clinical and clinical candidates for the
treatment of these diseases via distinctive mechanisms of action and
approaches. Parion is at the forefront of ENaC development and is
leveraging our scientific expertise in epithelial biology to expand
our platforms and novel chemical compounds into new indications to
treat mucosal defects. Parion has received support and grant funding
from the National Institutes of Health and the Cystic Fibrosis
Foundation Therapeutics, Inc. For more information, please see our
website at http://www.Parion.com .

About Shire

Shire is the leading global biotechnology company focused on
serving people with rare diseases and other highly specialized
conditions. We strive to develop best-in-class products, many of
which are available in more than 100 countries, across core
therapeutic areas including Hematology, Immunology, Neuroscience,
Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal
Medicine / Endocrine and Hereditary Angioedema; and a growing
franchise in Oncology.

Our employees come to work every day with a shared mission: to
develop and deliver breakthrough therapies for the hundreds of
millions of people in the world affected by rare diseases and other
high-need conditions, and who lack effective therapies to live their
lives to the fullest.

http://www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts,
including without limitation statements concerning future strategy,
plans, objectives, expectations and intentions, the anticipated
timing of clinical trials and approvals for, and the commercial
potential of, inline or pipeline products, are forward-looking
statements. Such forward-looking statements involve a number of risks
and uncertainties and are subject to change at any time. In the event
such risks or uncertainties materialize, Shire's results could be
materially adversely affected. The risks and uncertainties include,
but are not limited to, the following:

- Shire's products may not be a commercial success;
- increased pricing pressures and limits on patient access as a
result of governmental regulations and market developments may
affect Shire's future revenues, financial condition and results of
operations;
- Shire conducts its own manufacturing operations for certain of its
products and is reliant on third party contract manufacturers to
manufacture other products and to provide goods and services. Some
of Shire's products or ingredients are only available from a single
approved source for manufacture. Any disruption to the supply chain
for any of Shire's products may result in Shire being unable to
continue marketing or developing a product or may result in Shire
being unable to do so on a commercially viable basis for some
period of time;
- the manufacture of Shire's products is subject to extensive
oversight by various regulatory agencies. Regulatory approvals or
interventions associated with changes to manufacturing sites,
ingredients or manufacturing processes could lead to, among other
things, significant delays, an increase in operating costs, lost
product sales, an interruption of research activities or the delay
of new product launches;
- certain of Shire's therapies involve lengthy and complex processes,
which may prevent Shire from timely responding to market forces and
effectively managing its production capacity;
- Shire has a portfolio of products in various stages of research and
development. The successful development of these products is highly
uncertain and requires significant expenditures and time, and there
is no guarantee that these products will receive regulatory
approval;
- the actions of certain customers could affect Shire's ability to
sell or market products profitably. Fluctuations in buying or
distribution patterns by such customers can adversely affect
Shire's revenues, financial conditions or results of operations;
- Shire's products and product candidates face substantial
competition in the product markets in which it operates, including
competition from generics;
- adverse outcomes in legal matters, tax audits and other disputes,
including Shire's ability to enforce and defend patents and other
intellectual property rights required for its business, could have
a material adverse effect on the Company's revenues, financial
condition or results of operations;
- inability to successfully compete for highly qualified personnel
from other companies and organizations;
- failure to achieve the strategic objectives, including expected
operating efficiencies, cost savings, revenue enhancements,
synergies or other benefits at the time anticipated or at all with
respect to Shire's acquisitions, including NPS Pharmaceuticals
Inc., Dyax Corp. or Baxalta Incorporated may adversely affect
Shire's financial condition and results of operations;
- Shire's growth strategy depends in part upon its ability to expand
its product portfolio through external collaborations, which, if
unsuccessful, may adversely affect the development and sale of its
products;
- a slowdown of global economic growth, or economic instability of
countries in which Shire does business, as well as changes in
foreign currency exchange rates and interest rates, that adversely
impact the availability and cost of credit and customer purchasing
and payment patterns, including the collectability of customer
accounts receivable;
- failure of a marketed product to work effectively or if such a
product is the cause of adverse side effects could result in damage
to Shire's reputation, the withdrawal of the product and legal
action against Shire;
- investigations or enforcement action by regulatory authorities or
law enforcement agencies relating to Shire's activities in the
highly regulated markets in which it operates may result in
significant legal costs and the payment of substantial compensation
or fines;
- Shire is dependent on information technology and its systems and
infrastructure face certain risks, including from service
disruptions, the loss of sensitive or confidential information,
cyber-attacks and other security breaches or data leakages that
could have a material adverse effect on Shire's revenues, financial
condition or results of operations;
- Shire incurred substantial additional indebtedness to finance the
Baxalta acquisition, which may decrease its business flexibility
and increase borrowing costs; and

a further list and description of risks, uncertainties and other
matters can be found in Shire's most recent Annual Report on Form
10-K and in Shire's subsequent Quarterly Reports on Form 10-Q, in
each case including those risks outlined in "ITEM 1A: Risk Factors",
and in Shire's subsequent reports on Form 8-K and other Securities
and Exchange Commission filings, all of which are available on
Shire's website.

All forward-looking statements attributable to us or any person
acting on our behalf are expressly qualified in their entirety by
this cautionary statement. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date hereof. Except to the extent otherwise required by
applicable law, we do not undertake any obligation to update or
revise forward-looking statements, whether as a result of new
information, future events or otherwise.

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
please contact:

Investor Relations

Ian Karp
ikarp@shire.com
+1 781 482 9018

Robert Coates
rcoates@shire.com
+44 1256 894874

Media

Gwen Fisher
gfisher@shire.com
+1 484 595 9836

Clotilde Houzé
chouze0@shire.com
+1 781 266 3567

Joe Schachle
jschachle@parion.com
+ 1 919 313 1194

Original-Content von: Shire Pharmaceuticals Group Plc, übermittelt durch news aktuell