Key Developments: Shire PLC (SHP.L)

SHP.L on London Stock Exchange

4,870.00GBp
11 Jul 2014
Price Change (% chg)

270.00p (+5.87%)
Prev Close
4,600.00p
Open
4,596.00p
Day's High
4,870.00p
Day's Low
4,577.00p
Volume
3,201,761
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2,606,922
52-wk High
4,925.00p
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2,116.96p

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Latest Key Developments (Source: Significant Developments)

AbbVie Inc raises bid for Shire Plc
Tuesday, 8 Jul 2014 07:50am EDT 

AbbVie Inc:Says outline its revised proposal of 22.44 pounds in cash and 0.8568 ordinary shares of New AbbVie for each Shire share.Says fourth proposal represents an indicative value of 51.151 pounds as of July 7.Indicative value of the fourth proposal represents increase of about 11 percent and about a 3 bln pounds increase to indicative offer value of 46.26 Pounds per share.Says increase of 2 pound and about 10 pct in cash per Shire share.Says premium of 75 pct to Shire's closing share price of 29.25 pound on April 17 and about 13 bln pounds of incremental aggregate value for Shire's shareholders.Says premium of 48 pct to Shire's closing share price of 34.67 pounds on May 2 and about 10 bln pounds of incremental aggregate value for Shire's shareholders.Says In addition, this revised indicative proposal increases the ownership that will be held by Shire shareholders to about 24 pct of new holding company of the combined group.  Full Article

Shire Plc announces Vyvanse patents found to be infringed and valid by U.S. District Court
Wednesday, 25 Jun 2014 02:00am EDT 

Shire Plc:Judge Stanley R. Chesler of the U.S. District Court for District of New Jersey granted Shire's summary judgment motion in patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse (lisdexamfetamine dimesylate) were both infringed and valid.Ruling prevents five pharmaceutical manufacturers ( ANDA- Defendants) who have filed Abbreviated New Drug Applications (ANDAs) from launching generic versions of Vyvanse until earlier of either successful appeal to U.S. Court of Appeals for Federal Circuit, or the expiration of these patents in 2023.To appeal successfully, the ANDA-Defendants must overturn the Court's rulings for each of the 18 patent claims.Court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound.Says method of using lisdexamfetamine dimesylate for the treatment of ADHD.  Full Article

Shire Plc confirms rejection of AbbVie proposal
Friday, 20 Jun 2014 03:42am EDT 

Shire Plc:Confirms that on May 30 Shire received an unsolicited and highly conditional proposal from AbbVie (the Proposal) regarding possible cash and share offer for Shire.This Proposal has been rejected.Proposal comprised 20.44 pounds in cash and 0.7988 AbbVie shares per Shire share.Proposal involved a new US listed holding company with a UK tax domicile.Based on AbbVie's 30 day volume weighted average share price of US$54.10, proposal represents value of 46.11 pounds per Shire share (comprising 44 pct cash and 56 pct AbbVie shares).Proposal represents premium of 23 pct to Shire's share price of 37.38 pounds on June 19 and premium of 30 pct to Shire's 30 day volume weighted average share price of 35.43 pounds.Proposal follows two earlier proposals, which were also rejected. At AbbVie's request, Shire met with AbbVie to enable AbbVie to explain key aspects of proposal.Following this meeting, the Board of Shire decided unanimously to reject proposal on the basis that it fundamentally undervalued the company and its prospects.  Full Article

AbbVie Inc made an indicative approach to Shire Plc with merger proposal
Friday, 20 Jun 2014 02:00am EDT 

Shire Plc:Says AbbVie Inc. notes the recent press speculation and confirms it made an indicative approach to Shire plc (Shire) with merger proposal which was rejected by the Board of Shire.There can be no certainty that any firm offer will be made.Discussions are no longer ongoing.AbbVie's initial cash and share proposal in early May 2014 represented an indicative offer of 39.50 pounds for each Shire share.1.AbbVie's third and latest cash and share proposal when made represented an indicative offer of 46.26 pounds for each Shire share.2.AbbVie reserves the right to introduce other forms of consideration and/or vary the mix of consideration.AbbVie also reserves the right to make an offer at any time for less than the equivalent of 46.26 pounds for each Shire share with the agreement or recommendation of the Shire Board.If a third party announces a firm intention to make an offer for Shire which, as at the date AbbVie announces a firm intention to make an offer for Shire, is valued at a lower price than the equivalent of £46.26 for each Shire share; or.Following the announcement by Shire of a whitewash transaction pursuant to the takeover code.  Full Article

Shire Plc agrees to FDA request to conduct clinical trials investigating the potential use of Vyvanse (lisdexamfetamine dimesylate) in preschool-age children with ADHD
Thursday, 12 Jun 2014 09:01am EDT 

Shire Plc:Says it has agreed to written request by Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate potential use of Vyvanse (lisdexamfetamine dimesylate) for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, ages 4 to 5.Upon FDA confirmation of timely submission and review of data that adheres to requirements of written request, Shire will be entitled to benefits of Best Pharmaceuticals for Children Act, including six-month extension to exclusivity afforded by Shire's patents for Vyvanse, which expire in 2023.  Full Article

Shire Plc plans to submit New Drug Application to FDA for lifitegrast for dry eye disease in adults
Friday, 16 May 2014 11:44am EDT 

Shire Plc:Intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015, as it complete remaining chemistry and manufacturing work.Says it will be assessing the need for gathering additional clinical data in support of the U.S. and potential international regulatory submissions.  Full Article

Shire Plc to acquire Lumena Pharmaceuticals
Monday, 12 May 2014 07:00am EDT 

Shire Plc:Acquisition of Lumena Pharmaceuticals, biopharmaceutical co with late stage rare disease pipeline assets.Will acquire Lumena Pharmaceuticals for an upfront payment of $260 mln in cash, plus payment for net cash at closing, and near-term contingent milestone payments related to ongoing clinical trials.  Full Article

Shire Plc raises FY 2014 EPS outlook
Thursday, 1 May 2014 07:04am EDT 

Shire Plc:Increases guidance for the FY 2014 and expect to deliver Non GAAP earnings per ADS growth in the mid-to-high twenty percent range.Reported EPS of $2.45 in FY 2013.FY 2014 EPS of $3.12 - Thomson Reuters I/B/E/S.  Full Article

Shire Plc announces updates from Phase 3 clinical program for Lifitegrast in Adults With Dry Eye Disease
Wednesday, 30 Apr 2014 09:00am EDT 

Shire Plc:Presented study results from pivotal Phase 3 OPUS -2 study investigating lifitegrast (5 pct ophthalmic solution) in adults with dry eye disease.In addition comapny announces top-line results from prospective, randomized, double-masked, placebo-controlled, long-term (one-year) Phase 3 SONATA safety study.Symptom of improvement in dry eye compared with placebo (P<0.0001), but did not meet the second co-primary endpoint of the sign of inferior corneal staining (P=0.6186).Secondary endpoints were only descriptive in nature and were consistent with improvement in symptoms and lack of improvement in signs.There were no ocular serious treatment-emergent adverse events (TEAEs) or drug-related serious TEAEs reported.Says most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2 pct vs. 0.3 pct for placebo), instillation site irritation (7.8 pct vs. 1.4 pct for placebo).Says instillation site reaction (7 pct vs. 1.1 pct for placebo), and visual acuity reduced (5.0 pct vs. 6.4 pct for placebo).  Full Article

Shire Plc announces elections for interim dividend
Monday, 3 Mar 2014 10:30am EST 

Shire Plc:On Feb. 13, an interim dividend of 16.93 US cents per Ordinary Share payable on April 8 to shareholders on the register of members at the close of business on March 7.Shareholders are reminded that the final date for submission of elections to receive UK sourced dividends via the income access share arrangements is March 7.In the absence of any such elections, previous elections or deemed elections will remain in force.Shareholders who do not elect (or have not been deemed to elect) to receive UK sourced dividends through the income access share arrangements are reminded that their dividends will be Irish sourced.Subject to Irish dividend withholding tax unless the Company's Registrar is in possession of a valid exemption form by 5pm on March 7.  Full Article

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Shire confirms in talks with AbbVie on takeover bid

- Shire Plc on Friday confirmed it has held a meeting with U.S. drugmaker AbbVie Inc to discuss AbbVie's takeover bid for the Dublin-based maker of drugs for rare diseases.

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