QUOTE AND NEWS
FierceBiotech  2 hrs ago  Comment 
Shire has nailed down another deal to fuel its growing rare disease unit. The pharma group has tapped the Cambridge, MA-based startup Nimbus Discovery, which will use its computational approach to find small-molecule drugs for rare genetic...
FierceBiotech  May 2  Comment 
Flemming Ornskov Shire's ($SHPG) new CEO wasted no time in putting his stamp on the company's global operations. In his first quarterly report this morning, the newly minted Chief Executive Flemming Ornskov divvied up the marketing...
StreetInsider.com  May 2  Comment 
Visit StreetInsider.com at http://www.streetinsider.com/Earnings/Shire+Pic+%28SHPG%29+Tops+Q1+EPS+by+7c/8297529.html for the full story.
Benzinga  May 1  Comment 
Shire plc (NASDAQ: SHPG), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse^® (lisdexamfetamine dimesylate) Capsules, (CII) as a maintenance...
TechCrunch  May 1  Comment 
If you aren't at Disrupt NY or watchin' the livestream back at home, you just missed something … pretty special. Our own Josh Constine took the stage with the co-founders of Rap Genius for a conversation that quickly went from talk of metrics...
StreetInsider.com  Apr 25  Comment 
Visit StreetInsider.com at http://www.streetinsider.com/Corporate+News/Shire+plc+%28SHPG%29+Settles+INTUNIV+Litigation+with+Actavis+%28ACT%29%2C+Watson+%28WPI%29/8278519.html for the full story.
Sydney Morning Herald  Apr 24  Comment 
Queanbeyan City and Palerang Shire Councils could be merged under a proposal put forward by the Independent Local Government Review Panel.     
FierceBiotech  Mar 25  Comment 
Fast-changing Shire ($SHPG) is on a deal spree. This morning the biotech announced it is buying Brisbane, CA-based SARcode Bioscience for $160 million upfront and an unspecified slate of milestones. The buyout lands another ophthalmology asset for...




 

Shire Plc is a biopharmaceutical company that focuses largely on human genetic therapies (HGT), gastrointestinal (GI) diseases, and therapies for attention deficit hyperactivity disorders (ADHD). It also has products that treat rare diseases, and infectious diseases such as HIV and Hepatitis B. The company also develops therapies through its collaborations with companies such as GlaxoSmithKline, 3TC and Zeffix. Shire markets most of its products in the U.S., Europe, Latin America, and the Asia Pacific.[1]

Business Growth

In 2010 Shire product sales grew by 16% fom 2009 to $3,128 million. It was due to strong growth in its core products driven by its lead product VYANSE.[1]

Trends and Forces

Tightening Food and Drug Administration (FDA) Regulations

Beginning in 2009, the FDA implemented a series of reforms that include stricter monitoring of drug adverse events, more funding for the agency, stronger ability to force product recalls, more scientific expertise within the agency, more transparency. Even before 2009 the result has been a much more conservative FDA, demanding more product information.[2]

Politics and Insurance

Like other global pharmaceutical companies, Shire faces constant pressure from governments and activist organizations to increase access to medications by either lowering prices substantially or removing patent restrictions so generics can be manufactured.

Medicare and Medicaid policies have an important impact on Shire's sales. Medicare is the federal government's health subsidy plan while Medicaid generally falls to the states. Policies allow the government to bargain for lower prices; essentially the government caps prices for a large number of plans. This lowers revenues while increasing the amount of medications sold. Additionally, the government often requires rebates be paid at the end of the year. Limits by Medicare, Medicaid, and other third party payors may reduce the demand for Shire's products.[1]

Additionally, country specific price regulations must be dealt with. In Europe price applications must be conducted on a country-by-country basis. This slow process has delayed the launch of approved products in some countries by up to two years.[1]

Competition

Shire’s largest revenue segment is its therapies for the treatment of ADHD. At the end of 2010 the company held 24.6% of the U.S. ADHD market.[1]

Key competitors include[1]:




References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 Shire Plc 2010 10k
  2. The FDA: A tough tonic
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