Shire plc Shire Plc : District Court Issues Ruling Finding Adderall Xr(R) Patents Infringed

TIDMSHP 
 
 
   District Court Issues Ruling Finding Adderall XR(R) Patents Infringed 
 
   Cambridge, Mass., USA - March 23, 2018 - Shire plc (LSE: SHP, NASDAQ: 
SHPG) announces that its subsidiary, Shire Development LLC, welcomes 
yesterday's favorable ruling against Abhai LLC in connection with their 
Abbreviated New Drug Application (ANDA) for a generic version of Shire's 
ADDERALL XR.  ADDERALL XR is indicated for the treatment of attention 
deficit hyperactivity disorder in children and adults. 
 
   Following a bench trial in the U.S. District Court of the District of 
Massachusetts, the judge issued a ruling holding that the proposed ANDA 
formulation infringes the claims of patents RE42,096 (a reissue of US 
6,322,819) and RE41,148 (a reissue of US 6,605,300).  Accordingly, Abhai 
is prohibited from marketing its ANDA product until the expiration of 
the patents. 
 
   In addition, the court sanctioned Abhai for its litigation misconduct 
and directed that a certified copy of the court's opinion be sent to 
FDA's attention in light of what the court described as Abhai's 
"pervasive corporate unwillingness to play by the rules."  The amount of 
monetary sanctions to be paid to Shire will be determined at a later 
date. 
 
   Shire is pleased with the decision and will continue to vigorously 
defend its patents to protect the innovation and value Shire products 
bring to patients. 
 
   For further information please contact: 
 
 
 
 
Investor Relations 
Christoph Brackmann   christoph.brackmann@shire.com    +41 795 432 359 
Sun Kim               sun.kim@shire.com                +1 617 588 8175 
Robert Coates         rcoates@shire.com               +44 203 549 0874 
 
Media 
Katie Joyce           kjoyce@shire.com                 +1 781 482 2779 
 
 
 
   NOTES TO EDITORS 
 
   About Shire 
 
   Shire is the global leader in serving patients with rare diseases. We 
strive to develop best-in-class therapies across a core of rare disease 
areas including hematology, immunology, genetic diseases, neuroscience, 
and internal medicine with growing therapeutic areas in ophthalmics and 
oncology. Our diversified capabilities enable us to reach patients in 
more than 100 countries who are struggling to live their lives to the 
fullest. 
 
   We feel a strong sense of urgency to address unmet medical needs and 
work tirelessly to improve people's lives with medicines that have a 
meaningful impact on patients and all who support them on their journey. 
 
   www.shire.com 
 
   Forward-Looking Statements 
 
   Statements included herein that are not historical facts, including 
without limitation statements concerning future strategy, plans, 
objectives, expectations and intentions, projected revenues, the 
anticipated timing of clinical trials and approvals for, and the 
commercial potential of, inline or pipeline products, 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, Shire's results 
could be materially adversely affected. The risks and uncertainties 
include, but are not limited to, the following: 
 
 
   -- Shire's products may not be a commercial success; 
 
   -- increased pricing pressures and limits on patient access as a result of 
      governmental regulations and market developments may affect Shire's 
      future revenues, financial condition and results of operations; 
 
   -- Shire depends on third parties to supply certain inputs and services 
      critical to its operations including certain inputs, services and 
      ingredients critical to its manufacturing processes. Any disruption to 
      the supply chain for any of Shire's products may result in Shire being 
      unable to continue marketing or developing a product or may result in 
      Shire being unable to do so on a commercially viable basis for some 
      period of time; 
 
   -- the manufacture of Shire's products is subject to extensive oversight by 
      various regulatory agencies. Regulatory approvals or interventions 
      associated with changes to manufacturing sites, ingredients or 
      manufacturing processes could lead to, among other things, significant 
      delays, an increase in operating costs, lost product sales, an 
      interruption of research activities or the delay of new product launches; 
 
   -- the nature of producing plasma-based therapies may prevent Shire from 
      timely responding to market forces and effectively managing its 
      production capacity; 
 
   -- Shire has a portfolio of products in various stages of research and 
      development. The successful development of these products is highly 
      uncertain and requires significant expenditures and time, and there is no 
      guarantee that these products will receive regulatory approval; 
 
   -- the actions of certain customers could affect Shire's ability to sell or 
      market products profitably. Fluctuations in buying or distribution 
      patterns by such customers can adversely affect Shire's revenues, 
      financial conditions or results of operations; 
 
   -- failure to comply with laws and regulations governing the sales and 
      marketing of its products could materially impact Shire's revenues and 
      profitability; 
 
   -- Shire's products and product candidates face substantial competition in 
      the product markets in which it operates, including competition from 
      generics; 
 
   -- Shire's patented products are subject to significant competition from 
      generics; 
 
   -- adverse outcomes in legal matters, tax audits and other disputes, 
      including Shire's ability to enforce and defend patents and other 
      intellectual property rights required for its business, could have a 
      material adverse effect on the Shire's revenues, financial condition or 
      results of operations; 
 
   -- Shire may fail to obtain, maintain, enforce or defend the intellectual 
      property rights required to conduct its business; 
 
   -- Shire faces intense competition for highly qualified personnel from other 
      companies and organizations; 
 
   -- failure to successfully execute or attain strategic objectives from 
      Shire's acquisitions and growth strategy may adversely affect the Shire's 
      financial condition and results of operations; 
 
   -- Shire's growth strategy depends in part upon its ability to expand its 
      product portfolio through external collaborations, which, if unsuccessful, 
      may adversely affect the development and sale of its products; 
 
   -- a slowdown of global economic growth, or economic instability of 
      countries in which Shire does business, could have negative consequences 
      for Shire's business and increase the risk of non-payment by Shire's 
      customers; 
 
   -- changes in foreign currency exchange rates and interest rates could have 
      a material adverse effect on Shire's operating results and liquidity; 
 
   -- Shire is subject to evolving and complex tax laws, which may result in 
      additional liabilities that may adversely affect the Shire's financial 
      condition or results of operations; 
 
   -- if a marketed product fails to work effectively or causes adverse side 
      effects, this could result in damage to Shire's reputation, the 
      withdrawal of the product and legal action against Shire; 
 
   -- Shire is dependent on information technology and its systems and 
      infrastructure face certain risks, including from service disruptions, 
      the loss of sensitive or confidential information, cyber-attacks and 
      other security breaches or data leakages that could have a material 
      adverse effect on Shire's revenues, financial condition or results of 
      operations; 
 
   -- Shire faces risks relating to the expected exit of the United Kingdom 
      from the European Union; 
 
   -- Shire incurred substantial additional indebtedness to finance the Baxalta 
      acquisition, which has increased its borrowing costs and may decrease its 
      business flexibility; 
 
   -- Shire's ongoing strategic review of its Neuroscience franchise may 
      distract management and employees and may not lead to improved operating 
      performance or financial results; there can be no guarantee that, once 
      completed, Shire's strategic review will result in any additional 
      strategic changes beyond those that have already been announced; and 
 
 
   a further list and description of risks, uncertainties and other matters 
can be found in Shire's most recent Annual Report on Form 10-K and in 
Shire's subsequent Quarterly Reports on Form 10-Q, in each case 
including those risks outlined in "ITEM1A: Risk Factors", and in Shire's 
subsequent reports on Form 8-K and other Securities and Exchange 
Commission filings, all of which are available on Shire's website. 
 
   All forward-looking statements attributable to us or any person acting 
on our behalf are expressly qualified in their entirety by this 
cautionary statement. Readers are cautioned not to place undue reliance 
on these forward-looking statements that speak only as of the date 
hereof. Except to the extent otherwise required by applicable law, we do 
not undertake any obligation to update or revise forward-looking 
statements, whether as a result of new information, future events or 
otherwise. 
 
   This announcement is distributed by Nasdaq Corporate Solutions on behalf 
of Nasdaq Corporate Solutions clients. 
 
   The issuer of this announcement warrants that they are solely 
responsible for the content, accuracy and originality of the information 
contained therein. 
 
   Source: Shire plc via Globenewswire
(END) Dow Jones Newswires
March 23, 2018 05:30 ET (09:30 GMT)
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