Shire Adds New Technology Platform And Phase 2 Product Candidate To Its Regenerative Medicine Business

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has signed an agreement to acquire substantially all the assets of Pervasis Therapeutics. Shire will provide Pervasis with an upfront payment, plus potential post-closing milestone payments that are dependent on Shire’s achievement of certain clinical development, regulatory and sales targets.

• Clinical stage development assets bring to Shire a new cell-based technology platform (endothelial cell technology) with potential global opportunity, and leverage many existing capabilities—specialized marketing approach, cell-based manufacturing, unique reimbursement, outpatient call point
• Establishes technology relationship with world-leading scientist Elazer Edelman, MD, PhD, professor of Health Sciences and Technology at MIT, professor of medicine at Harvard Medical School, and coronary care unit cardiologist at the Brigham and Women’s Hospital in Boston
• Acquisition complements the 2011 purchase of Advanced BioHealing, further demonstrating Shire’s commitment to investing in and building out its portfolio of regenerative medicine therapies as the partner of choice for development-stage companies
• Lead program (Vascugel^®) addresses significant unmet medical need for acute vascular repair technologies focused on improving hemodialysis access for patients with end-stage renal disease (ESRD)
• Strong strategic fit with existing product, Dermagraft, which is indicated for diabetic foot ulcers. Diabetes is the global leading cause of ESRD, and accounts for approximately 40% of ESRD patients treated in the U.S.ⁱ   Diabetic patients on dialysis have a greater risk of developing a diabetic foot ulcer than diabetics not receiving dialysis treatmentⁱⁱ
• Shire will initially focus on completing a Phase II program to address maturation and maintenance of arteriovenous (AV) access for hemodialysis patients, which will instruct future development pathway

Shire’s Regenerative Medicine President, Kevin Rakin says:

“There are currently no approved therapies that directly target the underlying physiological processes associated with the creation of AV access sites in hemodialysis patients, including inflammation, thrombosis, and restenosis. As a result, there remains a significant unmet need for technologies that improve hemodialysis access for patients with ESRD. We believe Vascugel has the potential to enhance the rate of blood vessel repair while also providing for increased maintenance of the access site for a prolonged period of time as compared to current treatments. This acquisition marks a very important step for Shire in building a Regenerative Medicine business focused on tissue repair and regeneration.”

“Shire’s vision of bringing new regenerative medicine therapies to patients with chronic diseases was a critical factor in our decision to proceed with this transaction,” said Frederic Chereau, President and Chief Executive Officer at Pervasis. “I am excited to be partnering with Shire, which has demonstrated both the capability and commitment to bringing this promising cell-based technology to the patients with end stage renal disease who need it.”

The closing of the acquisition is subject to ancillary conditions.

About VASCUGEL

Vascugel is an endothelial cell-based therapy in development for enhancing blood vessel repair and improving hemodialysis access for patients with end-stage renal disease. Vascugel utilizes adult allogeneic endothelial cells embedded into a polymer matrix, and is placed on the outside of the blood vessel at the arteriovenous (AV) access site during the surgical intervention to create the access. Vascugel has received Orphan Product designation from the U.S. Food and Drug Administration and the European Medical Agency.

About Arteriovenous (AV) Access for Hemodialysis

End-stage renal disease (ESRD) is an advanced and irreversible kidney disease, treated mainly by hemodialysis or kidney transplantation. It is estimated that each year, there are more than 570,000 patients with ESRD treated in the U.S. and more than 250,000 patients in the EU^i,iii. Approximately 70% of these patients receive hemodialysisⁱ. Before patients can undergo hemodialysis, an arteriovenous (AV) access site must be created where blood can be removed, filtered and returned to the body. The majority of AV access is achieved through either an AV fistula, where the vein is connected directly to the artery, or an AV graft, where the vein and artery are connected via a tube. There are an estimated 100,000 AV fistulas and 60,000 AV grafts occurring annually in the U.S.^iv,v  Unfortunately, complications following AV access procedures are common and can include infection, blood clots, and narrowing of the vessel, which frequently lead to AV access failure. An estimated 60% of AV grafts fail after one year, requiring a procedure to restore flow or to create another AV access site^vi,vii.

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Notes to editors

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com.

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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.

ⁱ 2011 United States Renal Data System Annual Data Report (http://www.usrds.org/2011/view/default.asp).

ⁱⁱ Ndip et al. Dialysis treatment is an independent risk factor for foot ulceration in patients with diabetes and stage 4 or 5 chronic kidney disease. Diabetes Care. 2012; 33:1811-1816.

ⁱⁱⁱ Policy Options for Kidney Health in Europe. European Kidney Health Alliance (http://www.era-edta.org/images/2012_EKHA-policy_paper.pdf)

^iv Fistula First Breakthrough Initiative 2011 dashboard (http://www.fistulafirst.org/AboutFistulaFirst/FFBIData.aspx)

^v National Kidney Foundation Kidney Disease Outcome Quality Initiative Guidelines (http://www.kidney.org/professionals/KDOQI/guideline_upHD_PD_VA/index.htm)

^vi Dixon et al. DAC Study Group.Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009; 360: 2191-2201.

^vii Hayashi et al. Vascular access for hemodialysis. Nat ClinPractNephrol. 2006; 2: 504-513.