Bespak Share Discussion Threads

[echo64] 27/1/2006 08:09

Bespak ready to start producing Exubera's inhaler following EU regulatory OK


LONDON (AFX) - Bespak PLC said it ready to start commercial production of
the device that delivers Pfizer Inc's inhaled insulin Exubera, which was granted
marketing approval by European medicine watchdogs yesterday evening.
The green light from US regulators is expected any day.
The manufacture of the device will be a key growth driver for Bespak. The
company believes the product has the potential to add 25 pct to sales and
profits over the next three to five years.
By the end of five years, if demand grows as expected, it could be
generating revenues of 20 mln stg a year.
Exubera itself is seen generating sales of more than 1 bln usd in five years
for the US drugs giant.
The British medical group helped develop the inhaler for Pfizer, and will
manufacture the device along with another company in the US.
Exubera is a major breakthrough in the treatment of diabetes, which
according to the World Health Organization has reached epidemic proportions,
affecting approximately 48 mln people in Europe alone.
It is the first non-injectable, inhalable form of insulin to be approved
since the discovery of insulin in the 1920s.
"We are delighted that Exubera, a drug with the potential to achieve
blockbuster sales, has been approved in Europe and we look forward to the start
of commercial production of the drug's delivery device," Bespak's chief
executive Mark Throdahl said in a statement.
Bespak shares closed yesterday at 585 pence, valuing the company at 164 mln
stg.

[echo64] 20/1/2006 17:57

wcjan25

hope you didn't take out that short

[vector] 20/1/2006 15:26

Big rise today - someone expects Exubera announcement soon?

[ved] 19/1/2006 22:34

Tiltonboy - Thanks for your reply. I do not have L2 and hence at a disadvantage. I will log on tomorrow - after 9 am and see if I can secure a deal. I am not looking for a large number just about 500 shares. Thanks again. Good night.

[tiltonboy] 19/1/2006 22:01

Ved,

If you are online tomorrow morning I will tell you who is on the offer and in what size.

The problems are being caused by the decision of the LSE to move a large number of stocks to SETS MM. The marketmakers are no longer willing to make prices in any size, and the spreads have widened markedly. If you go on the board yourself, somebody puts an order in inside your price in just a few shares.

I had orders to buy the stock when the shares were around 485p, but I had enormous difficulty in dealing, on what I considered to be a sensible spread.

tiltonboy

[ved] 19/1/2006 21:49

Tiltonboy - You got in just in time. I questioned my broker citing the purchase of 2500 shares (probably yours). I was told there were none on sale except the 100 shares. This is the first experience of this type in my years of trading. I will try my luck again tomorrow. Thanks.

[tiltonboy] 19/1/2006 21:34

Ved,

You are obviously with the wrong broker. We bought 2500 this morning with little problem, and when I answered your previous question, I checked with the market and you could have bought 500 shares easily, and perhaps more.

tiltonboy

[ved] 19/1/2006 21:05

Tiltonboy - I did try on the phone but was offered only 100 shares at 580p which I refused. It may be a different story tomorrow. Thanks very much.

[tiltonboy] 19/1/2006 16:05

Ved,

This is a SETS MM stock, which makes it even more difficult. You should be able to buy 500 with a phone call.

tiltonboy

[ved] 19/1/2006 15:49

There seems to be a shortage of stock. Can't buy even 200. Anyone with L2 care to comment?

[vector] 19/1/2006 08:54

Looking good as long term buy I think. Must be lots of profit in it if they get to dominate the HFA valve market. There will be a big uplift if Exubera is announced. One manufacturer which is safe from Chinese competition

[wcjan25] 16/12/2005 10:12

lots of eggs in small number of baskets

[echo64] 14/12/2005 10:10

Very risky

[wcjan25] 12/12/2005 10:57

risky short here?

[echo64] 02/12/2005 15:08

Anyone know why the price has dropped recently. The Exubera device must be close to launch. Seems strange to sell now.

[waldron] 14/11/2005 07:32

Trading Statement

RNS Number:0493U
Bespak PLC
14 November 2005


For immediate release 14 November 2005



Bespak plc

Trading update for the 26 weeks to 29 October 2005


Bespak plc (LSE: BPK), a leader in specialty medical devices, announces that
trading in the first half was in line with its expectations. There has been
replenishment of the CFC valve supply chain in the US following the FDA ruling
on phase-out of CFC albuterol formulations, continuing growth in HFA valve sales
and inventory building by customers of US-manufactured products in advance of
closure of the Cary facility.


Looking ahead, two key events will continue to influence Bespak's performance.
Firstly, customers in the US are continuing to develop their marketing plans for
the replacement of CFC with HFA in albuterol formulations by December 2008.
Secondly, Bespak awaits the approval of Exubera(R). In September the FDA's
clinical advisory panel recommended approval of Exubera(R) in the US, whilst in
October the Committee for Medicinal Products for Human Use (CHMP) of the EMEA
recommended approval of Exubera(R) in Europe.


In the second half, we expect additional expenditure to strengthen the
businesses, general inflationary cost pressures and reversal of inventory
building by customers of previously US-manufactured products that have been
transferred to the UK, which leads us to be cautious in the short term. However,
we are increasingly confident in the prospects for growth from Exubera(R).


Bespak will report its interim results on 18 January 2006.


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


About Bespak plc

Bespak, a specialty medical devices company, is at 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, which has
facilities in King's Lynn and Milton Keynes in the UK, is a public company
quoted on the Official List of the London Stock Exchange (LSE: BPK). For more
information, please visit www.bespak.com.





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

TSTZGMMMNMZGKZM

[grupo guitarlumber] 14/10/2005 12:07

Exubera Update

RNS Number:6952S
Bespak PLC
14 October 2005


For immediate release 14 October 2005

Bespak plc

Welcomes Positive Opinion on Exubera(R)

Bespak plc (LSE: BPK), a leader in specialty medical devices, is pleased to note
that Pfizer Inc announced yesterday that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Evaluations Agency (EMEA) has
issued a positive opinion recommending the approval of Exubera(R) inhaleable
insulin for the treatment of type 1 and type 2 diabetes in adults.

The proposed therapeutic indication for Exubera(R) is for the treatment of adult
patients with type 2 diabetes not adequately controlled with oral antidiabetic
agents and requiring insulin therapy; and for the treatment of adult patients
with type 1 diabetes, in addition to long or intermediate acting subcutaneous
insulin, for whom the potential benefits of adding inhaled insulin outweigh the
potential safety concerns.

Exubera(R), which is the product of a joint-development program between Pfizer
and sanofi-aventis, is an inhaled rapidly acting insulin that is inhaled into
the lungs prior to eating, using a proprietary inhalation device and powdered
insulin formulation developed by Nektar Therapeutics. The product represents a
major advance in insulin delivery and will be the first non-injectable form of
insulin available since the discovery of the drug in the 1920s.

Bespak, in conjunction with Nektar, has developed the production process and
will manufacture the proprietary inhalation device for Exubera(R).

Exubera(R) was filed with the US Food & Drug Administration (FDA) on 2nd March
2005, and an FDA advisory committee recommended the approval of Exubera(R) on
8th September for the treatment of adults with type 1 and 2 diabetes. Pfizer
awaits the approval by the FDA in the US as well as approval by the European
Commission.

It is anticipated that once fully launched, Exubera(R) will be a significant
source of revenue growth for Bespak's Device & Manufacturing Services division.

Mark Throdahl, Bespak's Chief Executive, said: "We are delighted by this
recommendation from the CHMP, which moves us closer to European regulatory
approval of this important new treatment for diabetes."


For further information please call:

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

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

Notes for Editors:

About Bespak plc

Bespak, a specialty medical devices company, is at 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, which has
facilities in King's Lynn and Milton Keynes in the UK, 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 diabetes

It is estimated that nearly 180 million people worldwide suffer from diabetes,
and the number is expected to rise to 300 million people in the next 20 years.
Currently, diabetes and its complications account for more than $100 billion in
healthcare costs annually in the United States.


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

[echo64] 14/10/2005 07:13

Nektar Therapeutics Reports Exubera(R) Receives Positive Opinion from CHMP for the Treatment of Type 1 and Type 2 Diabetes
13.10.2005 19:21:00


Nektar Therapeutics (Nasdaq:NKTR) today reported thatthe Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Evaluation Agency (EMEA) has issued a positiveopinion recommending approval of Exubera(R) (insulin human), aninhaleable form of insulin for the treatment of type 1 and type 2diabetes.

The proposed therapeutic indication for Exubera is for thetreatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiringinsulin therapy; and for the treatment of adult patients with type 1diabetes mellitus, in addition to long or intermediate actingsubcutaneous insulin, for whom the potential benefits of addinginhaled insulin outweigh the potential safety concerns.

Exubera, the product of a joint-development program betweensanofi-aventis and Pfizer, is an inhaled rapid-acting insulinpreparation that is inhaled into the lungs prior to each meal, using aproprietary inhalation device and powdered insulin formulationdeveloped by Nektar Therapeutics. Exubera closely mimics the normalphysiological insulin response to meals by quickly being absorbed intothe bloodstream to reduce meal-related spikes in glucose levels inpeople with diabetes.

In Europe, approximately 22.5 million people suffer from diabetes.Type 2 diabetes accounts for 85 percent to 95 percent of all diagnosedcases. Although insulin is a very important treatment for diabetes,healthcare providers and patients are often reluctant to initiate orintensify insulin treatment. The reasons for this include concernsabout lifestyle changes, compliance, disease progression andinjection-related factors.

Complications commonly associated with uncontrolled or poorlycontrolled diabetes include cardiovascular disease, kidney failure andblindness. A large study in eight major European countries has shownthat the total direct medical costs for type 2 diabetes are estimatedto be (euro) EUR 29 billion each year, of which hospitalizationsaccount for (euro) EUR 15.9 billion.

Pending approval of the European Commission, Exubera wouldrepresent a major advance in insulin delivery and would be the firstnon-injectable insulin available in Europe since the discovery ofinsulin in the 1920s.

[monkeyjuice] 12/9/2005 06:46

From todays Times:

"A VOTE by the US Food and Drug Administration to approve Pfizer's inhaled insulin treatment triggered a near- 10 per cent gain for Bespak, which makes the drug's inhaler....Exubera is expected to generate £20 million a year in sales"

[monkeyjuice] 09/9/2005 09:10

That link doesn't appear to work, so here's a cut and paste of it

BESPAK (BPK).
Investors Chronicle, Jan 23, 2004

Bespak's recovery is gaining momentum. The company endured a torrid 2002-03, due to a combination of enforced price reductions on inhalers supplied to GlaxoSmithKline, a glut of CFC valves in the US, and a disappointing lack of progress in sales of new HFA-propelled products. But these problems now appear to be behind it.

Cost savings, which should reach GBP9m on an annualised basis this year, have mitigated the impact of price reductions. The CFC glut in the US has been cleared, and HFA sales are building. The cost-cutting programme is also generating significant benefits. It helped lift operating profits by 43 per cent, to GBP5m, despite falling sales. And cash generation is improving, too, thanks to an easing of capital spending after Bespak completed a new manufacturing facility in King's Lynn.

The main excitement now centres on Pfizer's inhaleable insulin drug Exubera - Bespak makes the drug's delivery device. Exubera has passed trials in the US, but Pfizer has yet to file for regulatory approval. The delivery device could be worth about GBP15m to GBP20m in annual sales.

Numis Securities expects full-year, adjusted, pre-tax profits of GBP13m, with EPS of 5.5p. The broker has lifted its 2004-5 forecast from GBP15m to GBP23m, with EPS of 62.8p.

[monkeyjuice] 09/9/2005 09:07

rc

I've seen this sort of figure mentioned in a number of articles over the last couple of years. I don't have them to hand but here's one I just found in Google's cache from last year:



It puts the max sales at 20m GBP, so I may have very slightly overstated. But still significant.

[echo64] 09/9/2005 08:25

A mention on the BBC too:

Inhaler may replace insulin shots
Diabetes insulin injection
Many people with diabetes must have regular insulin shots
US health experts have recommended the approval of a form of insulin that can be inhaled rather than injected.

The drug, Exubera, is designed to offer diabetics an alternative to their daily insulin injections.

Exubera can be used for Type 2, the most common form of diabetes, but will not replace insulin injections needed by many of those with the rarer Type 1.

However US regulators have questioned the safety of the drug when used by people who smoke or have lung disease.

They expressed concern about the long-term effects of the drug and its manufacturers - Pfizer, Sanofi Aventis and Nektar Therapeutics - have agreed to continue studies until 2019.

"We understand the need to assess the long-term effects on pulmonary function," a spokesman for Pfizer told the Associated Press news agency.

Diabetics who are likely to benefit have already said they are thrilled by the prospect of reducing, or even eliminating, the need for insulin injections.

The recommendation to approve the Exubera was made by a panel of Food and Drug Administration (FDA) advisers.

The FDA usually follows the recommendations of its advisory committees, but is not required to.

[rottcodd] 09/9/2005 08:23

Where does the $37m figure come from?

This equates to 21m sterling. Profit margin of 10% would give 2.1m additional profit. A 26% rise on current levels. Today's rise could have some way to go based on these figures.

[echo64] 09/9/2005 07:51

This is also the first inhaled insulin device that is likely to hit the market for the next few years. There won't be a competitor for quite some time due to the long development approval cycle for pharmaceutical products.

The choice is to inject or breathe in, I know which one i'd go with.