Shire Acquires Lotus Tissue Repair, Inc.
LEXINGTON, Massachusetts, January 8, 2013 /PRNewswire/ –
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)
[http://lotustissuerepair.com/DEB.php ]. 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
SOURCE Shire plc
