Profile: Shire Plc (SHPGY.O)

Shire plc, formerly Shire Ltd., incorporated on January 28, 2008, is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), and gastrointestinal (GI) diseases, as well as opportunities in other therapeutic areas. Substantially all of the Company’s revenues and net assets are attributable to the research and development (R&D), manufacture, sale and distribution of pharmaceutical products within two operating segments: Specialty Pharmaceuticals and HGT. The Company’s key marketed products as of December 31, 2008, include VYVANSE (lisdexamfetamine dimesylate); DAYTRANA (methylphenidate transdermal system); ADDERALL XR (mixed salts of a single-entity amphetamine); PENTASA (mesalamine); LIALDA (mesalamine)/ MEZAVANT(mesalazine); FOSRENOL (lanthanum carbonate); CALCICHEW (calcium carbonate range); CARBATROL (carbamazepine extended-release capsules); REMINYL/REMINYL XL (galantamine hydrobromide); XAGRID (anagrelide hydrochloride); REPLAGAL (algalsidase alfa); ELAPRASE (idursulfase), FIRAZYR (icatibant).

In August 2008, the Company, through its wholly owned indirect subsidiary, Shire Deutschland Investments GmbH, acquired 81% interest in Jerini AG. In April 2008, Shire announced the acquisition of arylsulfatase-A (ASA), an enzyme replacement therapy (ERT) in Phase I-II clinical trials for metachromatic leukodystrophy (MLD) from the Danish company, Zymenex A/S (Zymenex). The newly acquired ASA product, known as METAZYM, has completed a Phase Ib clinical trial in 12 MLD patients in Europe and an extension to this study is ongoing. The product has received the FDA approval for its investigational new Drug (IND) application to initiate a Phase II clinical trial and has been granted orphan drug designation in the United States and in the European Union.

Treatments For ADHD

VYVANSE is a new chemical entity for the treatment of attention deficit and hyperactivity disorder (ADHD) and is the first pro-drug stimulant, where the amino acid l-lysine is linked to d-amphetamine, which is therapeutically inactive until metabolized in the body. DAYTRANA is a methylphenidate transdermal delivery system for the once daily treatment of ADHD. DAYTRANA, is the first and only patch medication approved by the United States Food and Drug Administration (FDA) to treat the symptoms of pediatric ADHD. It is available in four dosage strengths of 10 milligram, 15 milligram, 20 milligram and 30 milligram, all designed for once-daily use.

ADDERALL XR is an extended release treatment for ADHD, which uses MICROTROL drug delivery technology and is designed to provide once daily dosing. It is available in 5 milligram, 10 milligram, 15 milligram, 20 milligram, 25 milligram and 30 milligram capsules and can be administered either as a capsule or sprinkled on soft food. Ulcerative colitis is a serious chronic inflammatory disease of the colon in which part, or all, of the large intestine becomes inflamed and often ulcerated.

Treatments for GI diseases

PENTASA controlled release capsules are indicated for the induction of remission and for the treatment of patients with mild to moderately active ulcerative colitis. PENTASA is an ethylcellulose-coated, controlled release capsule formulation designed to release therapeutic quantities of mesalamine throughout the gastrointestinal tract. PENTASA is available in the US in 250 milligram and 500 milligram capsules. LIALDA is indicated for the induction of remission in patients with mild to moderately active ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine for induction of remission.

Treatments for diseases in other therapeutic areas

FOSRENOL is a phosphate binder that is indicated for use in end-stage renal failure patients receiving dialysis. It is estimated that there are approximately 1.5 million patients worldwide with end-stage renal disease on dialysis. In April 2008, Shire and Abbott Laboratories Inc. mutually agreed to terminate their Co-Promotion Agreement for FOSRENOL in the United States. Shire will continue to promote FOSRENOL on its own in the United States and throughout Europe.

The CALCICHEW range of calcium and calcium/vitamin D3 supplements are indicated for the adjunctive treatment of osteoporosis in the United Kingdom and Republic of Ireland. CARBATROL is an anti-convulsant for individuals with epilepsy. Approximately 2.7 million people in the United States suffer from epilepsy, a disorder that is characterized by a propensity for recurrent seizures and is defined by two or more unprovoked seizures. REMINYL and REMINYL XL are indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.

Myeloproliferative disorders (MPDs), including essential thrombocythemia (ET) and polycythemia vera, are a group of diseases in which one or more blood cell types are overproduced. the United States anagrelide hydrochloride is marketed (under the trade name AGRYLIN) for the treatment of thrombocythemia secondary to a MPD.

Human Genetic Therapies

REPLAGAL is a treatment for Fabry disease. Fabry disease is a rare, inherited genetic disorder resulting from a deficiency in the activity of the lysosomal enzyme alpha-galactosidase A, which is involved in the breakdown of fats. REPLAGAL is a fully human alpha-galactosidase A protein that replaces the deficient alpha-galactosidase A with an active enzyme to ameliorate the clinical manifestations of Fabry disease. ELAPRASE is a treatment for Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II). As of December 31, 2008 ELAPRASE was approved in 43 countries. FIRAZYR is a first-in-class peptide-based therapeutic developed for the symptomatic treatment of acute attacks of HAE.

The Company competes with Johnson & Johnson, GlaxoSmithKline, Cortex Pharmaceuticals Inc., Eisai Inc., BMS , AstraZeneca, Pfizer, Merck, Schering-Plough/Organon, PsychoGenics, Supernus and Abbott .