(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

BOAGLBDBRSBGGCI

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
 
  END 
 
IMSCKDKNOBDDBDD

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

RDSFSSFWDSUSEFF

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

MSCILFIILSLFIIA

RNS Number : 0696A Skyepharma PLC 01 October 2009

For Immediate Release 1 October 2009

SkyePharma PLC ("the Company")

The Company was informed on 1 October 2009 that as a result of transactions on 1 October 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 3,420 Ordinary Shares of the Company at a price of £0.8965 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 1 October 2009 at £0.8965 awarded on 1 October Partnership and
per share 2009 at £0.8965 per Matching Shares held
share on 1 October 2009
139 139 2,773

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

RDSFSUFEFSUSEFS

RNS Number : 7058Y Skyepharma PLC 08 September 2009

TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARES

1. Identity of the issuer or the underlying issuer of SKYEPHARMA PLC

existing shares to which voting rights are attached:

2 Reason for the notification (please tick the appropriate box or boxes): An acquisition or disposal of voting rights An acquisition or disposal of qualifying financial instruments which may result in the acquisition of shares already issued to which voting rights are attached
X

An acquisition or disposal of instruments with similar economic effect to qualifying financial instruments An event changing the breakdown of voting rights Other (please specify):

3. Full name of person(s) subject to the notification GLG Partners LP

obligation:

4. Full name of shareholder(s) (if different from 3.): N/A
5. Date of the transaction and date on which the threshold 04/09/09

is crossed or reached:

6. Date on which issuer notified: 07/09/09
7. Threshold(s) that is/are crossed or reached: <10%

8. Notified details: A: Voting rights attached to shares

Class/type of Situation previous Resulting situation after the triggering transaction
shares to the triggering
transaction

if possible using the ISIN CODE
Number Number Number Number of voting % of voting rights
of of of shares rights
Shares Voting
Rights
Direct Direct Indirect Direct Indirect

B: Qualifying Financial Instruments Resulting situation after the triggering transaction

Type of financial Expiration Exercise/ Number of voting % of voting
instrument date Conversion rights that may be rights
Period acquired if the
instrument is
exercised/
converted.

C: Financial Instruments with similar economic effect to Qualifying Financial Instruments Resulting situation after the triggering transaction

Type of financial Exercise Expiration Exercise/ Number of voting % of voting rights
instrument price date Conversion rights instrument
period refers to
Nominal Delta

ConvertibleBond converting
into ISIN: 9.57%
GB00B3BFNB64 05/24/2024 To Expiry 2,291,105 9.57%

GB00B3BFNB64 N/A N/A N/A 81,683 0.34% 0.34%

Total (A+B+C)

Number of voting rights Percentage of voting rights
2,372,788 9.91%

9. Chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held, if applicable: GLG Partners is an investment management firm investing money on behalf of clients and investment funds

Proxy Voting:

10. Name of the proxy holder:

11. Number of voting rights proxy holder will cease to hold:

12. Date on which proxy holder will cease to hold voting rights:

13. Additional information:

14. Contact name: Dan Johnson
15. Contact telephone number: 020 7016 1426

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

HOLLVLFBKKBZBBF

RNS Number : 3007Y Skyepharma PLC 01 September 2009

For Immediate Release 1 September 2009

SkyePharma PLC ("the Company")

The Company was informed on 28 August 2009 that as a result of transactions on 28 August 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 1,920 Ordinary Shares of the Company at a price of £1.14 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 28 August 2009 at £1.14 per awarded on 28 August Partnership and
share 2009 at £1.14 per Matching Shares held
share on 28 August 2009

110 110 2,495

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

RDSSSWSUFSUSESU

RNS Number : 2862Y Skyepharma PLC 01 September 2009

SKYEPHARMA PLC - Flutiform* U.S. Filing Update

LONDON, UK, 1 September 2009 - SkyePharma PLC (LSE: SKP) today provides an update following a meeting held with the US Food and Drug Administration (FDA) to discuss the previously announced potential review issues in respect of the New Drug Application (NDA) for its lead development product, Flutiform* (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12 years of age and older.

As previously announced, in June 2009 the FDA gave preliminary notice of some potential review issues which it had identified in its preliminary evaluation of the NDA, which had been accepted for substantive review. As a result, the Company announced that it appeared likely that some additional clinical work may be required to provide more data on dosing and that a meeting was being sought with the FDA with a view to agreeing how the potential review issues may be addressed.

A meeting has now been held with the FDA and it has been confirmed that additional clinical work will be required to provide more data on dosing. The Board believes that it is unlikely that Flutiform* will, therefore, be approved in the US before the second half of 2011. In the meantime the review of the NDA is continuing.

Under the current license agreement Abbott is responsible for paying for additional clinical or other trials required by the FDA, and is entitled to recoup such costs out of up to 25 per cent. of any approval or post-approval milestones and royalties.

The potential review issues are not expected to have an impact upon the development of Flutiform* for Europe or Japan, which remain on track.

Dr Ken Cunningham, Chief Executive Officer, said:

"We now have greater clarity from the FDA on its approach to our filing and we are working to address these issues as soon as possible. Flutiform* remains on track in Europe and Japan, and we remain confident that, once approved and launched in its various markets, Flutiform* will be a successful product for SkyePharma in terms of both revenues and cash flows."

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 +44 207 831 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* in the U.S. are licensed to Abbott Respiratory LLC, a wholly-owned subsidiary of Abbott.

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

RESEASNFELLNEEE