Shire Acquires Lotus Tissue Repair, Inc.

                   Shire Acquires Lotus Tissue Repair, Inc.

  PR Newswire

  LEXINGTON, Massachusetts, January 8, 2013

LEXINGTON, Massachusetts, January 8, 2013 /PRNewswire/ --

- HGT Pipeline Enhanced with Protein Replacement Therapy Being Investigated
for the Treatment of Dystrophic Epidermolysis Bullosa

Shire plc (LSE: SHP, NASDAQ: SHPG), announces that it has signed an agreement
to acquire Lotus Tissue Repair, Inc. of Cambridge, MA, a privately held
biotechnology company developing the first and only protein replacement
therapy currently being investigated for the treatment of dystrophic
epidermolysis bullosa (DEB). DEB is a devastating orphan disease for which
there is no currently approved treatment option other than palliative care.
Subject to customary government approvals, Shire will purchase the company for
an upfront payment and certain contingent payments based on the achievement of
certain safety and development milestones.

Epidermolysis Bullosa (EB) is a set of rare, genetic diseases characterized by
the presence of extremely fragile skin and recurrent blister formation
resulting from minor mechanical friction or trauma. DEB is one of the more
severe of the genetic disorders that comprise EB. Severe cases of DEB may also
include internal blistering of the mouth, esophagus, lower GI tract, upper
airway and GU tract.

Shire's Human Genetic Therapies business will undertake the further
development of Lotus Tissue Repair's lead product candidate, a proprietary
recombinant form of human collagen Type VII (rC7), an intravenous protein
replacement therapy for the treatment of DEB. The product is in late
pre-clinical development and has the potential to be a first-in-class systemic
therapy for the treatment of DEB. This acquisition expands Shire's commitment
to finding treatments for EB, which also includes ABH001, Shire's Regenerative
Medicine product currently being investigated as a dermal substitute therapy
for the treatment of non-healing wounds in patients with EB.

"DEB is one the most devastating orphan diseases, severely impacting the lives
of patients and their families, many of whom have few or no treatment options
other than palliative care," said Dr. Philip J. Vickers, Global Head of
Research and Development, Shire Human Genetic Therapies. "rC7 protein
replacement therapy has the potential to provide a first-in-class
disease-modifying treatment for these children. We plan to apply our proven
ability to develop protein replacement therapies for rare genetic diseases to
progress rC7 as a possible groundbreaking treatment that offers hope to
patients with DEB."

"This acquisition of Lotus Tissue Repair by Shire further underscores the
potential of this proprietary rC7 technology to dramatically change the
treatment landscape for DEB patients and their families," said Dr. Mark de
Souza, founding Chief Executive Officer of Lotus Tissue Repair. "We are
thrilled that this program will become part of the innovative pipeline at
Shire and the company's growing commitment to this patient community."

Lotus Tissue Repair is a private company launched in 2011 by a proven team of
biotechnology entrepreneurs, world-leading experts in rC7 protein replacement
therapy for DEB and top-tier life sciences investor, Third Rock Ventures.

About Type VII Collagen

Type VII collagen (C7) is a collagen found in the skin of humans and other
animals. It is localized in the basement membrane zone (BMZ) between the
epidermis and dermis in large structures called Anchoring Fibrils (AFs), which
are composed of C7. The AFs hold the epidermis and dermis together. Purified
human C7 can be extracted in very small quantities from human skin, human
amnion, and skin cells such as keratinocytes or dermal fibroblasts. However,
large amounts of C7 cannot be generated from these sources in this manner.

About Recombinant Collagen VII (rC7)

Dr. Mei Chen and Dr. David Woodley, co-founders of Lotus Tissue Repair Inc.,
are the co-inventors of recombinant collagen type VII (rC7) technology and
leading experts on its use as protein replacement therapy. Lotus is developing
its rC7 technology as the first and only protein replacement therapy for
dystrophic epidermolysis bullosa (DEB) . This approach directly addresses a
primary driver of the condition: deficiency or dysfunction of C7. Pre-clinical
findings to date are promising, showing in multiple pre-clinical models that
rC7 as a protein replacement therapy is potent, long-lasting, and is
specifically retained in the skin and other affected tissues after intravenous
injection.

About ABH001

ABH001 is an engineered, human fibroblast-derived dermal substitute generated
by culturing human neonatal dermal fibroblasts onto a bioresorbable
polyglactin mesh scaffold. The PGLLA mesh which serves as the scaffolding onto
which fibroblasts are grown, they secrete dermal collagen, other extracellular
matrix proteins, growth factors, and cytokines, creating a three-dimensional
human tissue containing metabolically active living cells. The final product
consists of a well-developed dermal matrix and evenly dispersed neonatal
dermal fibroblasts.

About DEB

Epidermolysis bullosa (EB) is a set of rare, genetic diseases characterized by
the presence of extremely fragile skin and recurrent blister formation
resulting from minor mechanical friction or trauma. Dystrophic epidermolysis
bullosa (DEB) is one of the more severe forms of the genetic disorders that
comprise EB and is caused by a deficiency or dysfunctionality of collagen type
VII. The recessive form of DEB is extremely painful and patients suffer from
severe skin blistering, extremely fragile skin and mucosa of the mouth,
esophagus, and anus, mutilating scarring of the hands and feet, joint
contractures, and strictures of the esophagus. In the second or third decade
of life, these patients develop aggressive squamous cell carcinomas in
chronically wounded areas that often lead to metastasis and death. There are
no adequate treatments available for this painful, debilitating and costly
disease.

Notes to editors

Shire enables people with life-altering conditions to lead better lives.

Through our deep understanding of patients' needs, we develop and provide
healthcare in the areas of:

  *Behavioral Health and Gastro Intestinal conditions
  *Rare Diseases
  *Regenerative Medicine

as well as other symptomatic conditions treated by specialist physicians.

We aspire to imagine and lead the future of healthcare, creating value for
patients, physicians, policymakers, payors and our shareholders.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995

Statements included herein that are not historical facts 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, the Company's results could be materially
adversely affected. The risks and uncertainties include, but are not limited
to, risks associated with: the inherent uncertainty of research, development,
approval, reimbursement, manufacturing and commercialization of the Company's
Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine
products, as well as the ability to secure new products for commercialization
and/or development; government regulation of the Company's products; the
Company's ability to manufacture its products in sufficient quantities to meet
demand; the impact of competitive therapies on the Company's products; the
Company's ability to register, maintain and enforce patents and other
intellectual property rights relating to its products; the Company's ability
to obtain and maintain government and other third-party reimbursement for its
products; and other risks and uncertainties detailed from time to time in the
Company's filings with the Securities and Exchange Commission.

For further information please contact:

    Investor Relations
    Eric Rojas                    erojas@shire.com     +1-781-482-0999
    Sarah Elton-Farr              seltonfarr@shire.com +44(0)1256-894157
    Media
    Jessica Mann (Corporate)      jmann@shire.com      +44(0)1256-894-280
    Jessica Cotrone (Human
    Genetic Therapies)            jcotrone@shire.com   +1-781-482-9538
 
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