(SKP.L) SkyePharma PLC Buy/Sell

RNS Number : 6798C Skyepharma PLC 18 November 2009

SKYEPHARMA PLC - BOARD CHANGE - CHAIRMAN

LONDON, UK, 18 November, 2009 - SkyePharma PLC (LSE: SKP) regrets to announce today that its Chairman, Jeremy Scudamore, has informed the Board that he intends to step down from the Board at the end of 2009 for health reasons.

Frank Condella, Non-Executive Director and former CEO of SkyePharma, has agreed to take over as Non-Executive Chairman with effect from 1 January 2010.

Dr Ken Cunningham, CEO of SkyePharma, commented: "The Board thanks Jeremy for his valuable contribution as Chairman of the Company since October 2007 and wishes him a speedy and successful recovery. We are very fortunate that Frank Condella is able to take over from Jeremy as Chairman of SkyePharma. Frank will bring a strong sense of continuity to the position as well as a deep understanding of the business and we all look forward to continuing to work with him in his new role."

Editors' Note

Frank Condella was Chief Executive Officer of SkyePharma PLC from 1 March 2006 until 1 September 2008 and has been a Non-Executive Director since 1 November 2008. Aged 55, Frank Condella is a Non-Executive Director of Fulcrum Pharma plc and an independent Director of Columbia Laboratories, Inc. Previously, he was President of European Operations at IVAX, Chief Executive officer of Faulding Pharmaceutical Co., Vice-President of the Specialty Care Products business at Roche and Vice-President and General Manager of the Lederle unit of American Home Products.

For further information please contact:

SkyePharma PLC Ken Cunningham, Chief Executive Officer +44 207 491 1777 Peter Grant, Chief Financial Officer

Financial Dynamics
Jonathan Birt/Susan Quigley +44 207 831 3113

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

This information is provided by RNS The company news service from the London Stock Exchange

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RNS Number : 3761C
  Skyepharma PLC
  12 November 2009
   

SKYEPHARMA PLC - INTERIM MANAGEMENT STATEMENT

LONDON, UK, 12 November - SkyePharma PLC (LSE: SKP) today publishes its Interim Management Statement ("IMS") including an update on key matters since the announcement of interim results on 21 August 2009.

Trading update

Trading continues to be in line with the Board's expectations.  As anticipated, the second half of 2009 is benefiting from the cost reductions which have already been implemented and the continuing effect of price increases which were negotiated in the first half of the year on a number of manufactured products.  

Unrealised foreign exchange gains and losses on the translation of net debt have so far had a cumulative negative impact on the Group's results for the year, although the effect on actual cash flows is minimised through the use of natural hedges. 

Cash

As reported in the 2009 interim results, as at 30 June 2009, the Group had £23.8 million in cash and facilities and sufficient funds for the foreseeable future.  Since then £5.0 million net cash was received in July from the settlement with Novartis and a sub-contractor on the termination of the Foradil® Certihaler® contract and, in October, a milestone of £1.5 million was received following the initiation of Phase III trials by a long-standing licensing partner on an undisclosed product.  Cash usage since 30 June 2009 has been in line with the Board's expectations.

Product and pipeline update

Flutiform*

As previously announced, the Group's European development and marketing partner, Mundipharma International Corporation Limited, has successfully completed the final Phase III clinical study for the European development of Flutiform*.  The European Marketing Authorisation Application is on track to be filed as planned in Q1 2010.

As previously disclosed, a meeting has been held with the Food & Drug Administration ("FDA") in the United States and it has been confirmed that it will be necessary to provide more data on dosing to support the New Drug Application ("NDA").  The NDA remains under review, which the FDA is scheduled to complete in Q1 2010, with a PDUFA (Prescription Drug User Fee Act) goal date of 20 January 2010.  Once the FDA has completed its review of the NDA, further discussions will be arranged to agree the detailed protocols for the additional clinical work needed to provide the data on dosing. It is expected, therefore, that the additional clinical work will not begin before Q2 2010, although preparations are already underway. As a result it is unlikely that Flutiform will be approved and launched in the United States before 2012.

In Japan, Kyorin is making good progress with recruitment for two Phase II clinical studies and the development programme remains on track. 

The Group continues to hold discussions with a view to transferring the responsibility for the Flutiform* supply chain to a third party.  Discussions with one party have ceased and those with other parties are at a preliminary stage.

Solaraze®

In Q3 2009 sales of Solaraze® in all territories maintained the strong growth seen in the first half of 2009. 

Requip® Once-a-day

In Q3 2009 sales of Requip® Once-a-day were £31 million compared with £15 million for Q3 2008 with most of this growth coming from Europe.  

Lodotra*

In April 2009, Lodotra®, the novel night-time release formulation of low dose prednisone, utilising SkyePharma's proprietary Geoclock* technology and developed with Nitec Pharma AG, was launched in Germany by Merck KGaA (Nitec's licensee for Germany and Austria). Nitec concluded a distribution agreement with Mundipharma for the rest of Europe and further European launches are expected during 2010.  Nitec continues to work towards registration in the United States, and announced positive results in September from the second and final pivotal Phase III trial (a 12-week, multicentre, double blind trial involving 350 patients).  The NDA filing with the FDA is targeted to take place in Q2 2010. 

SKP-1041

Somnus Therapeutics Inc has recently successfully completed two Phase I studies of the controlled release sleep maintenance drug SKP-1041, which also employs SkyePharma's proprietary Geoclock* technology.  Plans are being prepared for a Phase II study expected to begin in 2010.

Dr Ken Cunningham, CEO of SkyePharma, commented, "We continue to trade in line with the Board's expectations for the full year, with our focus on tight control of costs helping our second half performance.  Flutiform is on track in Japan and Europe, with Phase III studies by our European partner, Mundipharma, successfully meeting their primary endpoints.  We are also working to ensure that additional dosing data requested by the FDA can be gathered in a timely way." 

For further information please contact:

 SkyePharma PLC

 Ken Cunningham, Chief Executive Officer  +44 207 491 1777
 Peter Grant, Chief Financial Officer

 Financial Dynamics
 Jonathan Birt/Susan Quigley              +44 207 831 3113

    
About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

This information is provided by RNS
The company news service from the London Stock Exchange
 
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RNS Number : 8971B Skyepharma PLC 03 November 2009

For Immediate Release 3 November 2009

SkyePharma PLC ("the Company")

The Company was informed on 3 November 2009 that as a result of transactions on 3 November 2009 by the SkyePharma PLC Share Purchase Plan (the "Plan") (an approved all employee share purchase plan) the Trustees of the Plan purchased an additional 3,180 Ordinary Shares of the Company at a price of £0.94 per share.

As a result of these transactions, Peter Grant, a Director of the Company, has the following additional interests as a result of his personal participation in the Plan:-

Partnership Shares purchased Matching Shares Total number of
on 3 November 2009 at £0.94 awarded on 3 Partnership and
per share November 2009at Matching Shares held
£0.94 per share on 3 November 2009
133 133 3,039

In accordance with the rules of the Plan, Mr Grant has been awarded Matching Shares on the basis of one Matching Share (Ordinary Share) for each Partnership Share (Ordinary Share).

The beneficial ownership of the Matching Shares will pass to Mr Grant in three years' time subject to continued employment and the retention of the underlying Partnership Shares.

The execution of the transaction noted above did not involve any of the Company's Directors or any persons discharging managerial responsibility.

This notification relates to transactions notified in accordance with Disclosure and Transparency Rule 3.1.4R(1)(a).

This information is provided by RNS The company news service from the London Stock Exchange

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RNS Number : 7582B Skyepharma PLC 02 November 2009

FOR IMMEDIATE RELEASE

SkyePharma Announces Successful Completion of

Flutiform* EU Clinical Trial Programme

LONDON, UK, 2 November, 2009 - SkyePharma PLC (LSE: SKP) today announces that its development and marketing partner Mundipharma International Corporation Limited ("Mundipharma") has successfully completed the final Phase III clinical study for the European development programme for Flutiform*, with the higher dose strength study (FLT 3503) meeting its primary endpoints. This will enable the regulatory filing with the European authorities to take place in Q1 2010 as planned.

Study FLT-3503 included 529 patients, who met the requirements for the "per protocol" analysis, and were suffering from severe, persistent and reversible asthma. They were treated in an eight week double-blind, double dummy, randomised multiple centre four arm parallel group study to assess the efficacy and safety of Flutiform*. The four treatment arms were: (1) Flutiform* (fluticasone 500 *g/formoterol 20 *g); (2) Flixotide (fluticasone 500 *g) and Foradil (formoterol 24 *g) administered concurrently; (3) Flutiform* (fluticasone 100 *g /formoterol 10 *g); and (4) Flixotide (fluticasone 500 *g). Enrolled patients had to have a disease history of at least six months.

The changes in the mean pre-dose FEV1 (Forced Expiratory Volume in the first second) at baseline to the pre-dose FEV1 and the two hour post-dose FEV1 at eight weeks, were the primary endpoints measured and the top line analysis confirms that Flutiform* produces similar results (statistically not inferior) when compared with the concurrent administration of Flixotide and Foradil. The results demonstrated that Flutiform* was well tolerated in the study patients. The analysis of multiple secondary endpoints is ongoing.

Dr Ken Cunningham, CEO of SkyePharma, said: "We are very pleased that study FLT-3503 has met its primary endpoints. Results from the study confirm the efficacy of the high dose strength of Flutiform* (fluticasone 500 *g and formoterol 20 *g). The successful completion of this study will enable the European Marketing Authorisation Application to be filed as planned in Q1 2010."

SkyePharma PLC Ken Cunningham, Chief Executive Officer +44 (0) 207 491 1777 Peter Grant, Chief Financial Officer

Financial Dynamics
Jonathan Birt +44 (0) 207 831 3113

Susan Quigley

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

About Flutiform*

Flutiform* HFA-MDI is a fixed-dose combination of fluticasone and formoterol in a metered dose inhaler (MDI). The product incorporates the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a long-acting beta-agonist (formoterol fumarate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane (HFA) and is being developed for asthma. The rights for commercialisation of Flutiform* outside the Americas and Japan are licensed to Mundipharma International Corporation Limited.

This information is provided by RNS The company news service from the London Stock Exchange

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