Bespak Share Discussion Threads

[maywillow] 07/7/2004 08:41

RNS Number:5705A
Bespak PLC
07 July 2004


For immediate release Wednesday 7 July 2004



Bespak plc

Preliminary results for the 52 weeks to 1 May 2004

Financial performance ahead of expectations

Bespak (LSE: BPK), a leader in specialty medical devices, today announces its
preliminary results for the 52 weeks to 1 May 2004.

HIGHLIGHTS

* Sales of products and services increased by 1% to #80.8m (2003:
#79.9m) and, including sales of customer-funded tooling and equipment,
turnover decreased by 6% to #83.2m (2003: #88.3m)

* Profit before tax and exceptionals was up 174% to #11.6m (2003: #4.2m)
and, after exceptional costs of #2.5m arising from the restructuring
(2003: #0.9m exceptional costs net of gain on sale of associate),
profit before tax increased 177% to #9.1m (2003: #3.3m)

* Earnings per share before exceptionals increased by 176% to 31.7p
(2003: 11.5p) and, after exceptional items, increased by 136% to 24.8p
(2003: 10.5p)

* Operating cash flow was up 344% to #13.2m (2003: #3.0m)

* Net cash at year end of #12.3m (2003: #8.8m)

* Final dividend maintained at 12.1p per share (2003: 12.1p)

* Restructuring announced one year ago has been completed and cost
savings have been achieved in line with previously indicated
expectations

* Five year capital investment programme completed with opening of major
respiratory valve facility in King's Lynn in October 2003

* In March 2004 Pfizer and Aventis announced the European filing for
Exubera(R) inhaled insulin for which Bespak will manufacture the drug
delivery device

Commenting on the results, Mark Throdahl, Bespak's Chief Executive, said:

"We did what we said we would do one year ago. We reversed the negative earnings
performance in the preceding financial year while also progressing our long-term
growth agenda. Profit before tax and exceptionals nearly tripled and operating
cash flow quadrupled. Financial performance for last year was ahead of the
Board's expectations, with strong performances from our Respiratory and Device &
Manufacturing Services businesses."

For further information, please contact:

BESPAK plc Tel: [phone]
Mark Throdahl - Chief Executive
Martin Hopcroft - Group Finance Director

BUCHANAN COMMUNICATIONS Tel: [phone]
Tim Thompson / Mark Court / Mary-Jane Johnson




BESPAK PLC

PRELIMINARY RESULTS FOR THE 52 WEEKS TO 1 MAY 2004

OVERVIEW

Sales of products and services increased by 1% to #80.8 million (2003: #79.9
million). Respiratory sales were driven by stronger-than-expected HFA valve
demand in Europe and continuing CFC valve demand in the US. Our Device &
Manufacturing Services business benefited from unusually strong demand for our
major contract manufactured product, prior to normalisation of supply in the new
financial year. Including sales of customer funded tooling and equipment,
turnover decreased by 6% to #83.2m (2003: #88.3 million), reflecting the
completion of major industrialisation projects.

Profit before tax and exceptionals increased by 174% to #11.6 million (2003:
#4.2 million), exceeding the Board's expectations. This performance reflects the
impact of the restructuring announced one year ago, which has been completed.
The profit performance also reflects operational improvements from the many
investments over the past few years in new plant and equipment. After
exceptional items, profit before tax increased by 177% to #9.1m (2003: #3.3
million).

Exceptional operating expenses were #2.5 million this year and #4.8 million in
total over the past two financial years, substantially less than previously
indicated.

Earnings per share before exceptionals increased by 176% to 31.7p (2003: 11.5p).
After exceptional items, earnings per share increased by 136% to 24.8p (2003:
10.5p).

Cash flow from operations increased by 344% to #13.2 million (2003: #3.0
million) because of improved profitability. The Group finished the year with net
cash of #12.3 million (2003: #8.8 million), significantly exceeding our
expectations because of lower-than-budgeted capital expenditure. The Group has
taken a disciplined approach to capital management over the past year.

The Group's strong cash flow justifies maintaining the dividend, and therefore
the Board has proposed a final dividend of 12.1p per share (2003: 12.1p),
payable on 23 September 2004 to those on the shareholder register on 16 July
2004.

In January, Sir David Cooksey completed an eight-year tenure as Chairman, and it
was with deep appreciation that the Board bid Sir David farewell.

Having achieved a performance that exceeded our plan in the year just ended, we
remain confident in our future growth potential. We have established
considerable momentum in the MDI valve market, where we are well positioned for
share growth in the next few years. The Exubera(R) programme is moving toward
regulatory approval and full-scale manufacturing, and our collaboration with
Britannia to prevent surgical adhesions shows considerable long-term promise.
The Board is confident in the longer term future, although its expectations are
unchanged for next year.

OPERATING REVIEW

Last year was an encouraging period. The Group made satisfactory progress toward
its goal of returning to historical levels of profitability. Our MDI valve
business reflected the increased conversion from CFC to HFA formulations in
Europe as well as continuing CFC demand in the US. We satisfied the exceptional
demand for our major DMS product while reducing its cost considerably. We saw
Pfizer and Aventis announce the regulatory filing for Exubera(R) inhaled insulin
in Europe.

We completed a very significant restructuring programme that involved reducing
the workforce by more than 130 positions. While this was difficult, it has made
the Group more agile and responsive to customers. The restructuring also has not
impeded the achievement of our operational objectives.

The Group completed a multi-year capital investment programme which made it
possible to deliver an outstanding performance in our two UK manufacturing
plants. To meet increasing regulatory requirements, we continued strengthening
our quality systems, including those of our supply chain partners, many of whom
have embraced continuous improvement programmes similar to our own.

We are very proud of all our employees, whose hard work and commitment made this
performance possible.

Respiratory

Bespak designs, manufactures and sells MDI valves, actuators and accessories
used to deliver respiratory drugs to the lung. In the past few years, this
business has expanded to include systems to deliver systemic drugs to the
bloodstream through the nasal cavity.

Sales increased by 5% to #37.2 million (2003: #35.4 million). Continuing
conversion from CFC to HFA formulations in Europe generated strong HFA valve
sales growth. HFA sales represented 39% of total valve sales (2003: 28%). We
have also enjoyed strong sales of actuators. We won a significant number of new
HFA valve development programmes during the last financial year. Bespak's valves
continue to be used by the largest number of customers in the broadest array of
HFA drug formulations, both in Europe and the US.

HFA conversions are driven by international agreements to reduce ozone depletion
in the atmosphere by switching from CFC propellants to environmentally friendly
HFA propellants. This conversion process opens up the CFC formulations at every
pharmaceutical company to competition from all HFA valve suppliers, and the
resultant sales volume shift is not a smooth unit-to-unit conversion. The CFC
conversion in the US continues to be much slower than once expected. However, in
June, the FDA announced that it will issue a final ruling by the summer of 2005
detailing the timing for the transition from CFC to HFA propellants for
albuterol formulations in the US. It has been indicated that these formulations
will be discontinued sometime between mid-2006 and late 2009.

In October, we opened a major valve plant expansion in King's Lynn, with
state-of-the-art equipment and an innovative factory design. The facility has
been audited by regulatory authorities and customers, and we believe it is now
the most advanced in our industry. We have considerable capacity at this plant
to accommodate market share expansion.

In April 2003, we terminated nasal formulation development work, but at that
time we reiterated our commitment to develop novel nasal delivery devices, which
play to the Group's strengths. We have made public our proprietary nasal
targeting research which has stimulated interest from several customers.
Additionally, we continue to develop a single-use dry powder nasal device as
well as single- and multiple-use liquid nasal delivery devices.

Device & Manufacturing Services

Bespak provides device-related services to pharmaceutical and drug delivery
companies. We can take customers' devices from concept development through to
regulatory approval, supply chain management and full-scale manufacture. Our
customers benefit because Bespak can design the device for efficient
manufacturing and minimise the time from concept to market introduction. In most
cases, Bespak offers its development services on a fee-for-service basis.

Sales were unchanged at #37.7 million (2003: #37.8 million), with price
reductions offsetting unprecedented volumes of our major DMS product ahead of
the approval of an additional supplier. This required 7-day, 24-hour operation
of new manufacturing equipment in King's Lynn. Production has now been scaled
back to normal capacity utilisation, as previously indicated. Demand for the
leading drug associated with this device continues to grow significantly, and it
is now among the top ten selling drugs in the world.

Working in close collaboration with Nektar Therapeutics of San Carlos,
California, we have developed the manufacturing process for the inhaler device
that will deliver the world's first inhaled insulin. Nektar is in a
collaboration with Pfizer to develop the inhalation device and formulation
process for Exubera(R). Pfizer has also entered into an agreement with Aventis
to co-develop, co-promote and co-manufacture Exubera(R). In March 2004, Pfizer
and Aventis announced the regulatory filing for Exubera(R) in Europe. A similar
filing is anticipated in the US. Exubera(R) should benefit millions of diabetic
patients around the world and, therefore, the delivery device for this drug has
very significant potential to grow and broaden Bespak's revenue base.

As an extension to our customary DMS business model, in October we announced an
agreement with Britannia Pharmaceuticals to develop a novel clinical approach to
prevent the formation of surgical adhesions - serious post-surgical
complications that in the US alone require nearly $2 billion in hospital and
surgical costs to correct. Under the terms of a development agreement, Bespak
will develop at its own expense the delivery device for Britannia's AdSurf(R),
which is now in Phase III clinical trials. Interim clinical trials data are
anticipated shortly. We will together seek a licensing partner to manage
world-wide sales of the product, and Bespak and Britannia will share in
milestone payments and royalties from AdSurf(R) sales. Bespak may utilise this
self-funded business model in future on high potential device programmes which
do not compete with our other DMS products.

Consumer Dispensers

Bespak designs and manufactures customised spray pumps and closures for
dispensing household products, toiletries and fragrances. As a result of weak
demand from a number of customers, sales declined by 14% to #5.8 million (2003:
#6.7 million).

Growth in this business relies on new products. We are encouraged by initial
reactions to a new proprietary spray pump, which was launched in June. The new
pump offers superior delivery performance on viscous formulations such as hair
sprays. It has exceptional spray characteristics, producing finer particles and
a better plume shape than existing pumps. We also introduced new lotion pump
actuator designs, which have also generated customer interest.

Acquisitions

Our strategic objective is to build a track record of consistent and
accelerating sales and earnings growth while we broaden our customer and product
base. We want to grow organically as well as by acquisitions that can take
advantage of the Group's un-geared balance sheet and cash-generative businesses.

FINANCIAL REVIEW

Trading performance

Sales of products and services increased by 1% to #80.8 million (2003: #79.9
million), arising from growth in HFA valves in Respiratory and exceptional
volumes offset by the full year impact of a price reduction on a major DMS
product. Including sales of tooling and equipment that are customer-funded,
turnover declined by 6% to #83.2 million (2003: #88.3 million).

The restructuring programmes were completed in the year and cost savings have
been achieved in line with previously indicated expectations. The share of joint
ventures and associates has declined as a result of the sale of an associate
last year, whilst net interest income was similar to last year in view of the
comparable level of net cash.

As a result, profit on ordinary activities before taxation and exceptional items
increased by 174% to #11.6 million (2003: #4.2 million), which was ahead of the
Board's expectations, with the profit margin increasing to 14% (2003: 5%). More
notably, the performance last year follows a breakeven result in the second half
of the prior year.

Exceptional operating expenses have been incurred on the restructuring to
re-align the cost base with the activity levels. Over the past two financial
years, total restructuring costs of #4.8 million have been incurred, which are
well within expectations. By comparison, an exceptional gain was made on the
sale of an associate in the prior year.

After exceptional items, profit on ordinary activities before taxation increased
by 177% to #9.1 million (2003: #3.3 million).

Tax

The overall tax charge in the year of 27% has benefited from tax credits on
research and development expenditure. The effective tax rate is expected to
increase over time once accumulated tax losses in the US have been fully
utilised.

Earnings per share

Basic earnings per share before exceptional items increased by 176% to 31.7p
(2003: 11.5p). After exceptional items, basic earnings per share increased by
136% to 24.8p (2003: 10.5p).

Dividends

The Board is recommending a maintained final dividend per share of 12.1p (2003:
12.1p), such that the total dividend for the year amounts to 19.1p (2003:
19.1p). The final dividend will be paid on 23 September 2004 to shareholders on
the register on 16 July 2004.

Cash flow

The net cash inflow from operating activities increased to #13.2 million (2003:
#3.0 million), reflecting improved profitability offset by planned operational
increases in working capital and increased outflows for exceptional operating
expenses.

The net cash inflow before management of liquid resources and financing was #2.0
million (2003: #16.6 million outflow). The improvement reflects improved
profitability and finalisation of significant capital expenditure programmes.

Net cash flow in the period is stated after the cash impact of current year and
prior year exceptional operating expenses of #3.6m (2003: #0.7m).

Over the past few years, Bespak has undertaken and completed significant capital
expenditure programmes and customer-funded projects. In the immediate future,
capital expenditure is expected to be at or below depreciation, although there
is always uncertainty over the timing of new projects.

Treasury

At the year end, the Group had net cash of #12.3 million (2003: #8.8 million),
and un-drawn committed facilities of #11.7 million (2003: #4.2 million).

Transactions in foreign currencies are matched wherever possible and the net
position is hedged using forward contracts. The treasury function does not
operate as a profit centre and no speculative treasury transactions are
undertaken.

A proportion of operating assets are denominated in US dollars, which are
broadly matched by US dollar borrowings, thereby hedging the balance sheet
exposure.

Last year, the average rate of exchange between sterling and the US dollar was
1.71 (2003: 1.56), whilst the year-end rate of exchange was 1.77 (2003: 1.60).
Around 10% of the Group's sales from the UK are denominated in US dollars.

Pensions

Bespak operates a defined benefit pension scheme in the UK, which is closed to
new members. The latest triennial actuarial valuation under SSAP 24 as at 30
April 2002 disclosed net assets of #17.0 million and a deficit of #4.0 million.
After consultation, contributions by employees have been increased in order to
eliminate the deficit over a 15-year period. Bespak continues to account for
pensions under SSAP 24. The net deficit under FRS 17 was #8.9 million as at 1
May 2004. New employees are eligible to join a defined contribution pension
scheme.

International Financial Reporting Standards

Preparations are in progress to implement the new international accounting
standards, which are expected to be implemented for the first time in the year
ending 29 April 2006. There are expected to be impacts from changes to the
accounting including pension costs and share options.

OUTLOOK

We have had an encouraging recovery. Looking ahead, we expect continuing
conversion from CFC to HFA valves in Respiratory, reduced volumes of a major
product and reduced industrialisation income on Exubera(R) in DMS, and the
launch of new products in Consumer Dispensers. Also, the results will benefit
from the full year impact of cost savings arising from the restructuring
together with operational improvements from past capital expenditure, as offset
by the impact of a weaker US dollar. We continue to implement improvements in
our US manufacturing operation, where our facilities remain under-utilised.

We are reassured by the significant growth prospects of our businesses with
opportunities such as Exubera(R). Having achieved performance that exceeded our
plan in the year just ended, our expectations for next year are unchanged. We
remain confident in our future growth potential and strong underlying cash
generation.

[maywillow] 07/7/2004 08:25

(Adds further detail from results statement)
LONDON (AFX) - Medical devices company Bespak PLC said underlying pretax
profits almost tripled in the year to May 1 as cost cuts and efficiency gains
more than offset a 6 pct fall in turnover.
The group said its financial performance in the year was ahead of board
expectations and looking ahead, it added its expectations are unchanged for the
current year.
Pretax profit before exceptionals rose 174 pct to 11.6 mln stg from 4.2 mln
a year earlier as overall turnover slipped 6 pct to 83.2 mln stg.
"We did what we said we would do one year ago," said chief executive Mark
Throdahl. "We reversed the negative earnings performance in the preceding
financial year while also progressing our long-term growth agenda."
He added: "Financial performance for last year was ahead of the board's
expectations, with strong performances from our Respiratory and Device &
Manufacturing Services businesses."
Bespak said its results for the current year will see the benefit of a full
year of cost cuts from restructuring and operating improvements from past
capital spending but it added this will be partly offset by the impact of the
weak dollar.
"Having achieved performance that exceeded our plan in the year just ended,
our expectations for next year are unchanged," the group said. "We remain
confident in our future growth potential and strong underlying cash generation."
The group held its final dividend at 12.1 pence a share, leaving the payout
for the year unchanged at 19.1 pence.
At the per share level, earnings before exceptionals almost tripled to 31.7
pence from 11.5 pence and after exceptionals it rose to 24.8 pence from 10.5
pence.
[e-mail]
cw

[maywillow] 07/7/2004 08:23

LONDON (AFX) - Bespak PLC 52 weeks to May 1 2004
Sales - 83.18 mln stg vs 88.31 mln
Pretax profit before exceptionals - 11.55 mln stg vs 4.2 mln
Pretax profit - 9.09 mln stg vs 3.28 mln
EPS before exceptionals - 31.7 pence vs 11.5
EPS - 24.8 pence vs 10.5
Final div - 12.1 pence, unchanged
Total div - 19.1 pence, unchanged

vjt/

[maywillow] 06/5/2004 07:28

RNS Number:3459Y
Bespak PLC
06 May 2004


For Immediate Release 6 May 2004


Bespak plc


Trading Update

Bespak plc (LSE: BPK), an innovator in drug delivery devices, anticipates that
Group operating profit for the year ended 1 May 2004 will be moderately ahead of
the Board's expectations as a result of improved sales and ongoing cost
controls.

Sales performance in the second half has benefited from continuing growth in HFA
valves in Europe, improved demand for CFC valves in the United States and
sustained high volumes of the major Device & Manufacturing Services product.
Additionally, the restructuring programme announced a year ago has been
completed and exceptional charges will be lower than previously anticipated.

With regard to the financial year beginning 2 May 2004, the Board reiterates the
sales outlook provided at the interim results and that its expectations for
Group operating profit are unchanged.

There is expected to be continuing conversion from CFC to HFA formulations in
Europe, which will generate positive growth in HFA valve sales. As previously
indicated, volumes of the major Device & Manufacturing Services product will be
scaled back to levels associated with normal capacity utilisation. Following the
recent European regulatory filing by Pfizer and Aventis of Exubera(R), an
inhaled insulin product, Bespak's device programme is progressing towards
production scale-up and, consequently, industrialisation and service income will
decline; the timing of approval of the product and of full-scale manufacturing
remain uncertain. As a result of the restructuring programme, there will be a
full year benefit of cost savings in the new financial year, whilst operational
improvements are anticipated from past capital expenditure.

Bespak's preliminary results will be announced on 7 July 2004.

For further information please call:

Bespak plc
Mark Throdahl - Chief Executive [phone]
Martin Hopcroft - Group Finance Director

Buchanan Communications

Tim Thompson/Mark Court/Mary-Jane Johnson [phone]


Notes to editors about Bespak plc:

Bespak is an innovator in drug delivery devices for the pharmaceutical industry,
with a product range covering metered dose inhalers, dry powder inhalers,
actuators and medical components. The group has facilities in King's Lynn and
Milton Keynes in the UK and in Cary, North Carolina, in the USA. Bespak is a
public company quoted on the Official list of the London Stock Exchange (LSE:
BPK). For more information, visit www.bespak.com.



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

END

[grupo guitarlumber] 05/5/2004 11:55

RNS Number:3105Y
Schroder Investment Management Ltd
05 May 2004

FORM SAR 5

Lodge with a RIS or Newstrack if appropriate and the Takeover Panel.

A copy must also be sent to the company the shares of which are being sold.

Date of disclosure

05 May 2004...............................................................

DISCLOSURE UNDER NOTE 3 OF RULE 5 OF THE RULES GOVERNING SUBSTANTIAL
ACQUISITIONS OF SHARES ("SARs")

Date of sale

04 May 2004...............................................................

Sale of (name of company)

Bespak PLC...............................................................

1. Class of voting shares (eg ordinary shares)

10p...............................................................

Number of shares/rights over shares sold

14,200........................Shares........................Rights

If rights over shares sold, as opposed to the shares themselves, specify nature
of rights

...............................................................

2. Resultant total holding of voting shares (and % of total voting shares in
issue)

6,426,921.......... 23.976%

Resultant total holding of rights over shares (and % of total voting shares in
issue)

.......... ..........%

Total percentage

23.976%

3. Party making disclosure

Schroder Investment Management Limited .......................................
........................

4. (a) Name of person selling shares or rights over shares

Schroder Investment Management Limited on behalf of institutional clients on a
non-beneficial basis

and, if different, beneficial owner

...............................................................



(b) Names of any other persons acting by agreement or understanding

...............................................................

Signed, for and on behalf of the party named in (3) above

...............................................................

(Also print name of signatory)

Alison Dunn ...............................................................

Telephone and extension number

020 7658 2959...............................................................

Note. The resultant total percentage holding of voting shares and rights over
shares is to be calculated by reference to the percentage held and in issue
outside treasury.

For full details of the SARs disclosure requirements, see Rules 3 and 5 of the
SARs. If in doubt, contact the Panel on Takeovers and Mergers, Monitoring
Section, Tel. No: 020 7638 0129. E-mail: [e-mail]


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

[grupo guitarlumber] 18/3/2004 11:21

LONDON (AFX) - Bespak PLC, the drug delivery group, has announced a
co-marketing agreement with US conglomerate Cardinal Health Inc, a provider of
products and services supporting the health care industry.
Under the agreement, Bespak will promote Cardinal Health's inhalation
formulation development and analytical and clinical manufacturing services while
Cardinal Health will leverage Bespak's drug delivery device technologies.
No financial terms were disclosed.
"The collaboration is a natural fit, both in terms of service-offerings and
geographic proximity, and will facilitate a seamless transition from product
design and formulation to manufacturing and packaging of respiratory products,"
said Sylvia Rossi-Montero, Bespak senior director of business development, North
America.
Following the news, Numis analyst Robin Gilbert reiterated a 'buy'
recommendation on Bespak, with a 650 pence price target.
"Longer term this could be important for Bespak as it should boost their
bargaining position with bigger companies, and build their business away from
just a few customers," he said in a note.
Gilbert said it is also likely that Cardinal Health was one of the many
companies interested in trying to buy Bespak last year.
At 9.45 am, shares in Bespak were unchanged at 547-1/2.
[e-mail]
el/bam

[ariane] 13/3/2004 11:34

13 March 2004
Latest News In Life Sciences



Bespak is to manufacture new inhaler device in MK
By Alice Walker, 12 March 2004, viewed 66 times, emailed 20 times


Bespak, the drug delivery innovator with major operations in Milton Keynes and King’s Lynn, saw its shares rise 22.5p to 557.50p after partners Pfizer and Aventis received consent to file a marketing authorisation for Exubera, an inhaled human insulin powder, in Europe.



Bespak, the drug delivery innovator with major operations in Milton Keynes and King’s Lynn, saw its shares rise 22.5p to 557.50p after partners Pfizer and Aventis received consent to file a marketing authorisation for Exubera, an inhaled human insulin powder, in Europe.

The European Medicines Evaluation Agency accepted the filing for Exubera, which Pfizer and Aventis are targeting at diabetes sufferers. The partners have also been working with the US Food and Drug Administration to determine the appropriate timing for submission of Exubera in the US.

Bespak will manufacture the drug delivery device for Exubera in its Milton Keynes manufacturing facility under an arrangement with Nektar Therapeutics, which developed the device and formulation. The timing of full scale production is as yet unknown and will depend in part on the speed of the regulatory review process.

Bespak is in the forefront of developing new delivery systems for the pharmaceutical industry. The company has a product range covering metered dose inhalers, dry powder devices, actuators and compliance aids. It also develops and manufactures drug delivery devices for leading global pharmaceutical companies.

[grupo guitarlumber] 05/3/2004 08:59

(Repeating to clarify nature of deal, adds share price other background)
LONDON (AFX) - Bespak PLC said the European Medicines Evaluation Agency had
accepted a filing by Pfizer Inc and Aventis SA who are both seeking rights to
market Exubera, a diabetes treatment which is inhaled in powdered form.
Bespak said it will manufacture the drug delivery device under an
arrangement with Nektar Therapeutics, Inc, a US company which developed both
Exubera and the means of delivering it.
In a statement, Bespak said the timing of full scale production is as yet
unknown and will depend in part on the speed of the regulatory review process.
Pfizer and Aventis are seeking approval to market Exubera to adult patients
with Type 1 and Type 2 diabetes.
At 8.20 am Bespak was among the best performing small-cap stocks in the
London market, gaining 22-1/2 pence, or 4.2 pct, to 557-1/2.
rhb/rn

[calleva] 05/3/2004 08:54

What is BPK's cut in the deal?

[grupo guitarlumber] 05/3/2004 07:37

LONDON (AFX) - Bespak PLC said the European Medicines Evaluation Agency had
accepted a filing by Pfizer Inc and Aventis SA who are seeking rights to market
the UK drug delivery development group's inhaled human insulin powder treatment,
Exubera.
Pfizer and Aventis are seeking approval to market Exubera to adult patients
with Type 1 and Type 2 diabetes, Bespak said in a statement.
rhb

[grupo guitarlumber] 05/3/2004 07:21

RNS Number:1770W
Bespak PLC
05 March 2004


For immediate release 5 March 2004

Bespak plc

Welcomes regulatory filing of Exubera in Europe

Bespak plc (LSE: BPK), an innovator in drug delivery, is pleased to note that
Pfizer Inc and Aventis announced that the European Medicines Evaluation Agency
(EMEA) has accepted the filing of a marketing authorisation application for
Exubera(R) (inhaled human insulin powder).

Pfizer and Aventis are seeking approval to market Exubera(R) to adult patients
with Type 1 and Type 2 diabetes.

Bespak will manufacture the drug delivery device for Exubera(R) in its Milton
Keynes manufacturing facility under an arrangement with Nektar Therapeutics,
which developed the device and formulation. The timing of full scale production
is as yet unknown and will depend in part on the speed of the regulatory review
process.

Pfizer and Aventis have also been working with the US Food and Drug
Administration to determine the appropriate timing for submission of the
Exubera(R) new drug application in the US.

Mark Throdahl, Bespak's chief executive, said: "We are delighted with the
European filing of Exubera(R) and look forward to participating in the
commercial success of the drug by supplying its delivery device."


For further information please call:


Bespak plc
Mark Throdahl - Chief Executive [phone]
MartinHopcroft - Group Finance Director [phone]

Buchanan Communications
Tim Thompson/Mark Court/Mary-Jane Johnson [phone]


Notes to editors

About Bespak plc

Bespak is in the forefront of developing new delivery systems for the
pharmaceutical industry. The company has a product range covering metered dose
inhalers, dry powder devices, actuators and compliance aids. The company also
develops and manufactures drug delivery devices for leading global
pharmaceutical companies. The group has facilities in King's Lynn and Milton
Keynes in the UK and in Cary, North Carolina, in the USA. Bespak is a public
company quoted on the Official list of the London Stock Exchange (LSE: BPK).
For more information, please visit www.bespak.com.

About Pfizer Inc

Pfizer discovers, develops, manufactures and markets leading prescription
medicines for humans and animals, and many of the world's best known consumer
products.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In 2003, Aventis
generated sales of Euro 16.79 billion, invested Euro 2.86 billion in research and
development andemployed approximately 69,000 people in its core business.
Aventis corporate headquarters are in Strasbourg, France. For more information,
please visit: www.aventis.com.

About Nektar Therapeutics

Nektar Therapeutics provides industry-leading drug delivery technologies,
expertise and manufacturing to enable the development of high-value,
differentiated therapeutics. Nektar's advanced drug delivery capabilities are
designed to enable the company's biotechnology and pharmaceutical partners to
solve drug development challenges and realize the full potential of their
therapeutics, from development of new molecular entities to managing the
lifecycles of established products.



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

RAPDXGDXIGGGGSS

[openportal] 18/2/2004 05:11

Would agree on Hold for now.

[davidmoran] 16/2/2004 22:25

This little star has run out of steam.

I'm out for profit taking.

Focusing on Pharmaceticals e.g. CEN

[vector] 21/1/2004 17:13

Is this share cheap or expensive ?

Operating profit 1st half pre exceptional £5m, say £12-15m for full year. Not bad compared with capitalisation of £150m with further cost savings to come through.

Negative is comment that volumes will drop next year on their lead product - presumably the Diskus inhaler (Why are they so coy about naming this now/)

Positive is the shift towards HFA in an increasing number of drugs in Europe. Will the US move to HFA? That would be very positive

Approval for Exubera would obviously be mega positive but there doesn't seem to be mush movemnet on this and the shares could take another dive if the news is bad

Anyone with opinions please?

[maywillow] 20/1/2004 18:28

LONDON, January 20 (New Ratings) — Analyst I Broadhurst of Dryden Financial issues a "hold" rating on Bespak (BPK.L).

[garth] 20/1/2004 09:50

Morning all.

Bespak results out this morning brought this to my attention.

"In November, we formally opened our new valve manufacturing plant in King's
Lynn. This #10m facility offers our customers the latest valve moulding and
assembly infrastructure and provides us with highly efficient manufacturing
capacity for future market share growth. During the past five years we have
committed over #55m of capital expenditure to the expansion and renewal of our
manufacturing facilities, culminating in completion of the King's Lynn valve
plant. We are achieving productivity improvements from this investment."




Previous IGE press release:

"Project Alliance
3 May 2002

Image Scan, a leading provider of multi-view, 3D X-ray imaging for the security and industrial inspection markets, has signed a Memorandum of Understanding ('Memorandum') with Bespak. The Memorandum stipulates that Image Scan and Bespak have agreed to work together to produce a novel multiple-view X-ray imaging system to inspect a range of Bespak's assembled pulmonary, nasal drug delivery and dispensing products to identify potential manufacturing and/or assembly faults.

VIXion is a high resolution, in-line X-ray imaging system that can obtain 2D, 3D and multi-view X-ray images in real-time. The system has been designed for applications involving the inspection of safety critical or high value components that contain hidden features that cannot be readily seen with conventional imaging systems and is therefore ideally suited to this application.

Nicholas Fox, Chief Executive, said:

'We are delighted that we have formed a project alliance with Bespak to develop a particular application for this advanced technology. It is particularly exciting that we are able to focus our technology on safety critical components within respiratory drug delivery solutions.'"





Part of ISH's strategy has been to work towards establishing key reference sites for their technology. Kings Lynn one of those????

Just conjecture.

More on Image Scan Holdings at:


G.

[maywillow] 20/1/2004 07:54

LONDON (AFX) - Bespak PLC said its pretax profit before exceptional items
rose 24 pct in the first half to Nov 1 2003.
The innovator in drug delivery said pretax profit before exceptional items
increased to 5.1 mln stg from 4.1 mln stg in the year-earlier period. However,
pretax profit dropped 45 pct to 3.1 mln stg after exceptional costs of 2.0 mln
associated with the continuing restructuring.
The company also said it appointed John Robinson, former chief executive of
Smith & Nephew, as the new chairman with immediate effect.
Robinson is currently chairman of George Wimpey and chairman of Paragon
Healthcare Group.
[e-mail]
jc

[davidmoran] 13/1/2004 21:31

Roll on 20th Jan
With all the activity on the buy side for weeks, those "better informed" may suggest it can only be impressive.

[maywillow] 07/1/2004 08:56

RNS Number:9233T
Bespak PLC
07 January 2004


Immediate Release 7th January 2004

Bespak plc

Notification of Interim Results
for the 26 weeks ended 1st November 2003


On behalf of our client, Bespak plc, we notify the London Stock Exchange that
the Company will be announcing its Interim Results for the 26 weeks ended 1st
November 2003 on Tuesday 20th January 2004.

An analyst meeting will be held at 09:30 am on the day of the results. A press
meeting will follow at 11:00 am. Both meetings will be held at the offices of
Buchanan Communications, 107 Cheapside, EC2.

[vector] 18/12/2003 17:05

Up 17.5p on the day. spread narrowed to 15p from 25p

[vector] 18/12/2003 10:20

Still no one on the board. results are due January and price is now moving up on no volume. MMs have have the share on a ridiculously wide spread. It has been very hard to buy even very small lots of the share. What does it all mean? I suspect good prospects and the MMs discouraging buyers

[vector] 19/11/2003 15:39

This looks to have good recovery prospects. Why is there no one on the board? Review in Investors chronicle a few weeks ago was very interesting

BESPAK (BPK)

393p - inhaler manufacturer - Bespak's shares were savaged last year when the company delivered an ugly profit warning in November. This included an admission that sales in the 2002-03 financial year would be £8m lower than expected because a glut of stock in the US market was curbing demand for the company's CFC-propelled valves.

As if November's profit warning wasn't bad enough, full-year results in July were also blighted by the second of two price reductions on the Diskus inhaler, manufactured on behalf of GlaxoSmithKline. And there was more bad news. In Europe, sales of Bespak's valves should have received a boost from the switch to inhalers using HFA, a more environmentally-friendly propellant. But the approval process for a number of HFA products hit a series of snags.

It was also disappointing that the launch of Pfizer's inhalable form of insulin, Exubera, has been delayed by concerns over the effect the drug has on lung function. Bespak is making the delivery device for Exubera, and the contract represents its greatest potential source of income. The company could have stomached some of these setbacks if it had delivered the cost savings due on the manufacture of its Diskus device on schedule. Unfortunately, it didn't.

But despite these setbacks, Bespak now appears to be on the mend. In an August trading update, chief executive Mark Throhdahl revealed that sales of CFC valves have returned to normal now that the stock build-up has cleared, while the switch to HFA valves is gathering pace as more products gain approval. Of the 17 HFA products now licensed, Bespak supplies valves for 12 of them - 11 on an exclusive basis. Customers include pharma heavyweights, such as Boehringer Ingelheim and Aventis.

The Exubera programme also appears to be back on track. At the American Diabetes Association's conference in June, Pfizer presented data that addressed the US Food and Drug Administration (FDA)'s concerns about the product. These showed that there was no deterioration in lung function in patients who used it for more than a year. Bespak believes Pfizer will file for approval of the drug and its delivery system in the next three to six months. "Exubera will free a patient from the need to inject himself three to four times a day," says Mr Throhdahl. "It is an enormous breakthrough that should lead to much tighter [patient] compliance with diabetes regimes," he adds. Bespak is the sole European manufacturer of the delivery system for the drug.

Bespak's cost-cutting programme is also back on track. It has ceased development of nasal drug formulations, saving £1.9m a year, and cut more than 130 jobs. This should help the company generate £9m of annualised savings (fully effective in the year ending 2005), at a total cost of £6m. Unit cost reductions are also now flowing through on the Diskus device. Productivity should gain a further boost from the scheduled opening in October of a new valve plant in King's Lynn. The financial performance for the 2003-04 financial year will bear the brunt of the cost of this investment, as well as the restructuring charges. Thereafter, though, the business should start to reap the rewards of slicker manufacturing facilities.

In April, Bespak admitted that it had received approaches from a number of potential bidders. But in its trading statement in August, it said that it had terminated these talks. While this news could be seen as negative, it underlines the board's growing confidence in the company's prospects. Mr Throhdahl said none of the offers on the table - which investors chronicle understands were upwards of 400p a share - reflected the benefits of the upturn in trading, and the potential of Exubera. Such confidence underlines the argument that this is one recovery play worth buying. Buy.



Today there seem to be over a million sold with no price movement. Ability tro buy is very restricted. I think the market makers are expecting good newsflow