Bioprogress Share Discussion Threads

[johnny felopez] 19/3/2008 09:05

Gotcha

Thanks

[baton] 17/3/2008 21:06

Here is the FastWrap fact sheet and its link that appeared on the MDX website today.

[baton] 16/3/2008 21:37

Here is the Ibuprofen Case Study and its link which is mentioned in the 14 March 08 RNS in the above post 74:

[baton] 16/3/2008 21:25

Meldex International PLC
14 March 2008



14 March 2008

For immediate release

Meldex International plc
('Meldex' or 'the Company')

Technology, product, partnerships and approach update

Meldex International plc (AIM:MDX), the specialty pharmaceutical and healthcare
company, today provides an update on the latest progress of its enabling
technologies, product launches and partnerships as well as an update concerning
potential offers for the Company.

Technology, product and partnership highlights

•FastWrap version of ibuprofen is expected to have faster onset of action
than any other product currently marketed
•A novel combination based on FastWrap and XLWrap, has the potential to
improve sustained release products for the analgesic and anti-inflammatory
markets
•Key milestone achieved with Meltums technology; to deliver novel vitamin
and nicotine products
•Royalty payments received from FMC Magenta under NRobeTM technology
license
•Ronflux(R) for relief of snoring and Hypozalix(R) to treat discomfort
from Xerostomia to be launched in Italy in May 2008
•Launch in US of new range of cough/cold products, based on advances with
TabWrapTM and FastWrap, planned for 2008/9 season
•Distribution arrangements for Hypozalix(R) to be expanded to include
North America, Eastern Europe and the Middle East
•Continued expansion of commercial territories for novel local anaesthetic
patch, DBP149
•Heartburn treatments DBP272 and DBP274 to be outlicensed globally to
leading multi national pharmaceutical companies; including both OTC and
prescription versions
•Agreement with Silver Eagle Labs Inc. for launch in US of Meldex's
anti-snoring oral thin strips

Steve Martin, Chief Development Officer, said:
'The new data with ibuprofen and other significant progress with our enabling
technologies and products reflect the strength and quality of the scientific
platform which underpins Meldex. Together with our broad range of partnerships,
this demonstrates the powerful momentum within the business, which is moving
forward at an unprecedented rate. We are fully confident that this momentum will
translate in to value for shareholders.'

Technologies

FastWrap

Meldex has generated important new data which highlights the potential of
FastWrap, one of its key enabling technologies. This data is based upon studies
involving non-steroidal anti-inflammatory drugs and analgesics and has shown
that not only can the rate of dissolution of the active ingredient be enhanced -
hence an improved onset of action - but the solubility of the drug can also be
improved. This has implications for reducing the total amount of drug used per
dose while achieving the same therapeutic effect .

Importantly, the data demonstrates that the speed of release of Meldex's version
of ibuprofen is significantly faster than the current UK brand leading tablet
and also US liquid gelatin filled capsules. The results are currently being
assessed,with the objective of maximizing the benefits of this highly
significant technological news. A summary of the data will be provided on the
Company's website today.

Meldex, in conjunction with its preferred OTC partner in the US, is pursuing a
dual growth strategy for its products and developments involving its FastWrap
technology. It is developing a rapid commercialisation strategy which initially
competes with existing brands that claim rapid release in a market which is
undergoing significant growth. In addition, the Company is producing a range of
products that compete with existing brands both in the analgesic and cough/cold
markets by offering a value added proposition to both the retailer and consumer.

In addition to the data above, Meldex has developed a new concept of FastWrap in
combination with its XLWrap platform technology. The system is aimed at the
analgesic and anti-inflammatory market. Current sustained release products are
generally slow to work due to their site of release. By combining FastWrap for
instant release and also adding an element of increased duration, the
development is able to deliver significant patient benefits.

Meltums

Meltums is a novel melt-in-the-mouth lozenge. Meldex has successfully completed
the first phase of its machine design and build programme with the receipt of
equipment within its Cambridge facility. This is a key milestone for the
enabling technology.

The technology offers unique advantages over current lozenges and remains on
track to be able to launch its novel Vitamin and Nicotine products as previously
announced. The technology is being developed for the treatment of Alzheimer's
disease and work is ongoing to develop further the applications for the
technology.

NRobeTM

Meldex confirms that NRobeTM, Meldex's powder enrobing technology that has been
licensed out to FMC Magenta, is delivering royalty payments under the terms of
the amended agreements,. The commercialisation of the enabling technology is
progressing successfully.

Product Launches

Meldex is to launch the Ronflux(R) and Hypozalix(R) brands through its Dexo
Italia subsidiary in May 2008. Dexo Italia has expanded its sales force in line
with a number of product launches within the first six months of 2008. These
launches are examples of the continuing synergies from product developments and
acquisitions within the Company's portfolio.

In line with its business model, and from advances in the TabWrapTM and FastWrap
development programme, Meldex is planning to launch a range of prescription
cough/cold products in the United States through its Dexo LLC subsidiary during
the 2008/09 cough/cold season. These products will be following the active
selling of a range of novel prescription Soluleaves products under the Ah-Chew
(R) brand.

Partnership Programmes

Meldex continues to actively progress its licensing and partnership programmes,
both with its existing development portfolio as well as third-party projects.
Key highlights are as follows:-

•Meldex is expanding the territories for distribution and marketing for
Hypozalix(R), the treatment for the discomfort caused by Xerostomia (dry
mouth). Territories include North America, Eastern Europe and the Middle
East. The expansion of these territories are subject to final due diligence
and contracts being signed. The product range, which will include enhanced
versions of the current portfolio, will be marketed to the patient
supportive care and oncology markets. Meldex will receive milestone and
royalty payments as well as entering into supply agreements.


•Meldex is continuing to expand the commercial territories for DBP149, its
novel local anaesthetic patch. The product will be sold in the OTC and oral
care markets. The Company will receive milestone and royalty payments as
well as entering into supply agreements.


•Meldex has an ongoing programme of licensing out its products DBP272 and
DBP274. The products, a group of novel liquid polymer formulations which
form a gastric raft for the treatment of heartburn, will be sold both as
prescription and OTC medicines. The products are expected to compete with
the market leading sodium alginate treatment. The global market for both
prescription and OTC gastro-intestinal medicines is estimated to reach $36.0
billion in 2008. The Company is working to license the products to
significant pharmaceutical companies who have a market leading brand. Meldex
is expecting to receive royalty payments, and to retain certain co-promotion
rights under its Rocgel(R) brand.


•Meldex has entered into an agreement with Silver Eagle Labs Inc., a US
based company, for the launch of Meldex's anti-snoring oral thin strips
under private label brands. Meldex will manufacture other oral thin strip
products for Silver Eagle Labs with the view toward increasing market share
within US and foreign markets.

Approach Update

Further to the announcement of 29 February 2008, Meldex announces that it is
currently in discussions with a number of parties that have approached the
Company. In addition it continues to receive further approaches. Meldex, which
is being advised by Houlihan Lokey, continues to explore and evaluate all
strategic options, which may or may not lead to an offer for the Company. There
can be no assurance that any definitive offer will be made, whether by parties
that have already expressed an interest in the Company, or by any additional
parties, or that any transaction will be recommended by the Board of Directors
or consummated.

Enquiries:

Meldex + 44 (0) 20 7098 9880
Richard Trevillion, CEO
Steve Martin, CDO
Hiral Patel, CFO

Houlihan Lokey + 44 (0)20 7839 3355
Brian McKay, Simon Raynor

Nomura Code Securities [phone]
Richard Potts

Corfin Communications [phone]
Martin Sutton, Harry Chathli

[baton] 30/12/2007 01:43

A new FastWrap and TabWrap pdf has just turned up on the Meldex Website.



Here is page 4 of the pdf showing the absorption rate of ibuprofen.

Here is a great quote from the page:

The results from all of the development work have shown that FastWrap is able to produce a faster dissolution rate against all of the current competition.

[baton] 28/12/2007 04:22

TabWrap mentioned in the RNS 21 December 07:

Meldex has also completed a licence agreement with another leading
pharmaceutical company for three products for the treatment of dementia and
Alzheimer's Disease using the Meltums technology and one product in the
treatment of obesity using the TabWrap enabling platform on a global basis. The partner has agreed to pay an initial significant licence fee and will be responsible for any clinical work to be undertaken. Meldex will retain the global manufacturing rights and will receive significant double digit royalties when the products are launched into the market. The molecules and terms of the licence agreement are kept confidential at the Licensee's request.

Also the TabWrap analgesic products recently launched are mentioned:

In line with recent announcements, Meldex is currently undertaking the
fulfilment process for products for the German and US markets.




Here is the full RNS:

Meldex International PLC
21 December 2007


For Immediate Release 21 December 2007


Meldex International plc

('Meldex' or 'the Company') (AIM: MDX)

Licensing, registration and commercialisation update


Meldex, the specialty pharma and healthcare company, today announces an update
on its product development pipeline, licensing agreements and recent
prescription medicine commercialisation programmes.


Key highlights:


•Licensing agreement for three products: two using the Meltums technology
and one of which is a novel prescription analgesic; the third is a liquid
SoluPol product for the treatment of Gastric Reflux Disease
•Licensing agreement involving three treatments for Alzheimer's Disease
and dementia using the Meltums technology and a further treatment for
obesity using TabWrap technology
•Regulatory application in the UK for an analgesic with novel onset of
action
•Regulatory filing and launch plans for Collunovar Oradisc for mouth
ulcers in Eastern Europe and Middle East
•Orders received for unregulated Nicotine products from third party
customers; anticipated increase in demand in Q1 2008
•New orders received for sore throat treatment, Hypozalix, with several
licensing deals anticipated in the coming months
•Manufacturing and stocking in of anti-inflammatory and analgesic products
in the US and German markets


Commenting on this update, Richard Trevillion, Chief Executive Officer, Meldex
International PLC, said:


'Together with our recent OTC product update, this announcement demonstrates
strong performance of both operating divisions, Dexo and Melbrosin. The
successful progress of our pipeline, combined with achievement of commercial
milestones, reinforces our confidence in continuing the Group's fast organic
growth and ability to meet expectations. Meldex has the strongest development
pipeline of its peers giving the business strength, security and organic
growth.'


Steve Martin MRPharmS, Chief Development Officer, Meldex, said:


'Meldex has gained a reputation for innovation in its product development
pipeline. 2008 is expected to see further partner discussions announced. The
Company is keeping to the fundamental principle of enhancing molecules for the
benefit of patients. '


Licensing


Meldex has licensed two products using the Meltums technology and the
non-exclusive marketing rights to DBP274 in certain EU markets. Meldex has
received an initial licensing payment together with a separate technical and
supply agreement including royalties. The Meltums products in development
include a novel prescription analgesic. DBP274 is a liquid SoluPol product for
the treatment of Gastric Reflux Disease. The product is expected to be filed for
regulatory approval during 2008 in the major EU markets. The molecules for the
Meltums and terms of the licence agreement are kept confidential at the
Licensee's request. Meldex is currently discussing with the partner extending
territorial rights to DBP274 for further licence payments


Meldex has also completed a licence agreement with another leading
pharmaceutical company for three products for the treatment of dementia and
Alzheimer's Disease using the Meltums technology and one product in the
treatment of obesity using the TabWrap enabling platform on a global basis. The
partner has agreed to pay an initial significant licence fee and will be
responsible for any clinical work to be undertaken. Meldex will retain the
global manufacturing rights and will receive significant double digit royalties
when the products are launched into the market. The molecules and terms of the
licence agreement are kept confidential at the Licensee's request.


With the increasing average life span, the prevalence of Alzheimer's Disease has
been shown to be increasing and currently stands at an incidence rate of 0.75%
of the population in the 7 major markets (population 730m). The US National
Institutes of Health estimates up to 4.5 million Americans suffer from
Alzheimer's disease. The largest pharmaceutical product in the category is
donepezil which has a global turnover of $2.16bn to year ending March 2007. The
condition is associated with patient compliance issues and Meldex has created an
innovative new concept with its Meltums melt-in-the mouth system to assist
patients in remembering to take their dose. Using its novel printing techniques,
tablets will be identified for morning dosage or evening dosage on the lozenge
itself as well as using novel packaging techniques.


New registration


Meldex is also pleased to announce that it has submitted for regulatory approval
in the UK the novel analgesic DBP167, which has a rapid onset of action for pain
relief. DBP167 uses a creative and patented mix of polymers and excipients and
is able to deliver known analgesics into the blood stream extremely rapidly.
Traditional pharmaceutical products, such as paracetamol and ibuprofen, will
take 40-90 minutes before patients will see the benefit. This novel technology
will show that this can be reduced down to less than 15 minutes. Therefore, the
product can be used for breakthrough pain as an alternative to opiates, migraine
treatment, dental pain and also in the OTC arena.


Commercialisation


Further to the previous announcement, Meldex has commenced the commercialisation
of the Collunovar Oradisc product for mouth ulcers. The Company is planning to
launch this product under partnership agreements in Eastern Europe and the
Middle East with planned filing for registration in H1 2008.


Meldex confirms orders have been received for the unregulated nicotine products
from third party customers to meet Q1 2008 expectations.


As part of the patient supportive care franchise, Hypozalix is currently
undergoing rapid roll out to multiple territories. In addition to territories
already announced, the Company is in receipt of new orders for the OTC market.
Meldex is expecting to finalise several licensing deals for various products
which will involve milestone payments in the coming months.


In line with recent announcements, Meldex is currently undertaking the
fulfilment process for products for the German and US markets.

[ry4nj] 19/12/2007 21:27

60p hear we come!.

[baton] 19/12/2007 02:01

[From the MDX Serious Investors Thread]

Marick - 18 Dec'07 - 10:37 - 4022 of 4069

Baton,

In answer to your question on molecule, I think it will be an ent wrapped acetyl salycilic acid. That is the active in the trademarked aspirin. I am told that the ent wrapped aspirin has a market of over 200million people who should be taking this daily as part of their regime to thin the blood. Yes that is per day. The figures for this are absolutely mind blowing, even with a tiny market share we would have a massive business. I believe that Aspirin is the no.2 best seller for its global owner but can't see where I read this!!

Regds

[baton] 18/12/2007 01:54

It's interesting to re-read old RNSes relating to TabWrap to pick up clues to what else is now due to be announced at anytime.

In the interims RNS of 28 Sept 06 we were told that "Stability product trials with two of the Company's global pharmaceutical external partners have proved successful in validating BioProgress's new approach. Both of these address current problems with marketed blockbuster products."

These partner products are still there, yet to be announced.

In the 6 Feb TabWrap Update RNS about the new tablet cores we are told that "the Company has initiated three [tablet]core development projects in parallel with third party partner programmes based upon products that will be coming to market through its own Dexo division. The products, which are focussed upon pain relief, are being developed initially for the US, Japan and Middle East territories."

This ties in with Friday's RNS which says: "Meldex continues to pursue its planned strategy of also partnering its FastWrap(TM) technology, both on a pan-European and global basis, to significant branded pharmaceutical companies."

So are we going to see a launch of TabWrap ibuprofen and paracetamol in Japan and the Middle East next? What about the CEE and CIS regions which MDX seem to favour for launches with other products and have set up distribution channels. I'd expect these TabWrap analgesics to be launched there sooner rather than later. Pan-European? How about France and Italy where MDX have companies based. Will Dexo have their own branded products to sell alongside the partnering to "significant branded pharmaceutical companies." Then there is the rest of the world's regions. How about China and India? After-all, there are distribution channels set up there already for the SCP. It is not difficult to see that these fantastic and superior analgesic products will be in great demand and will be rolled out globally, just as MDX say they will be.

So the two Dexo TabWrap products from the Interims have turned out to be ibuprofen and paracetamol using the new tablet cores mentioned on the 6 Feb RNS but what is the third? Is it the "additional unspecified prescription ingredient" mentioned in last Friday's RNS or is it something else.

And which one in EntWrapped, or is that still to come. It was mentioned in the 28 Sept RNS.

From the 28 Sept 06 Interims:
"In addition, product led work with TabWrap(TM) led to the parallel development of EntWrap enabling solvent free enteric tablet coating; a major problem solving system for the oral dosing market. Work is already underway with the company's first EntWrap product with an estimated launch in 2007."

Also remember the updated TabWrap FAQ's mentions external partners as well:

"These products include two Dexo products and two for external partners. This phase is scheduled to take place during Q2 and Q3 2007. There are a number of other partner and Dexo products due for launch thereafter." Will these additional launches be in the New Year?

There is a lot to look forward to, with so much more to come. Friday's RNS is really just the beginning of a global rollout of TabWrap products, and not just the analgesics ones. Remember Table 11 from the May Nomura BN. Here we have at least two separate external partners developing TabWrap for anti-counterfeiting as well as another two for CNS (Central Nervous System) products with one being a patent extension. It's all there in front of us and this is only what we have been allowed to know about. I know that some investors have always doubted that MDX would ever be able to make it happen, but Friday's RNS told us that it is starting to happen, right now.

[baton] 16/12/2007 02:59

[From the MDX Serious investors Thread]



I_AM_A_WALRUS - 16 Dec'07 - 01:24 - 3930 of 3931


Well all, in my view we have had a massive RNS and I would like to make a few points on just why I think it is really ground breaking.

At first glance I think it would be fair if the casual observer read the latest RNS and grouped it in with all others prior to it. That would be a big mistake. This is the first time an X-Gel based, Pharmaceutical Grade proprietary dosage formatted product is being LAUNCHED. All other RNS' before it were in an "exploratory" category. FMC and Perrigo are examples of the intent and hope to market X-Gel IP based product, but with no machine, product, or customer in mind. They were concept agreements. This is quite the contrary - Meldex is in the TabWrap business, and in a BIG way.

The German agreement is good, and I am really pleased that TWO TabWrap products and a dosage variation to the pediatric market are being launched. This will be a great start, but Germany has around 24,000 pharmacies and there is obviously lots of work to be done to increase market exposure there.

The Jewel in the RNS crown goes to the Totally "out of left field" announcement of a US PARTNERSHIP with "a major own-label producer of OTC medicines within the U.S. market".

Now whom might that be? Well a really good clue to that question is in the MANNER in which the analgesics market was described in the RNS:

"The U.S. OTC business is estimated to be worth $11.2 billion for the year ending July 2007 (source: Information Resources Inc) across all distribution channels, excluding Wal-Mart which accounts for an additional 30%."

Now why break out Wal-Mart???? Well one very simple explanation is the name Perrigo. Since Perrigo just happens to be THE supplier of "Own Label" OTC Generic drugs AND a "major producer of same", I suspect there might just be a link.

So we have an indication Perrigo is back in the saddle, this time with a much better contract for Meldex (thanks Perrigo for thinking you could design your own machine!), and if $3+ Billion of annual sales is not enough - how about this:

"The U.S. FastWrap(TM) range will compete with one of the key U.S. analgesic brands within the OTC market" - anyone hear of Tylenol?

No? It's BIG.

And then there is this:

"The Company has increased the range of products from initially one simple analgesic, DBP216, based around the paracetamol molecule, to a range of different combination analgesics."

The combination products include:

DBP310 Paracetamol
DBP314 Paracetamol with decongestant
DBP316 Paracetamol with decongestant + antihistamine
DBP318 Paracetamol with decongestant + cough suppressant
DBP320 Non-Drowsy Day - Night Cold & Flu Combination


Can you say FULL FRONTAL ATTACK?

Take a look at the target...

I believe we have just been told that Meldex and Perrigo are not only going to market with their own suite of analgesic combinations, they will be taking on Brand Tylenol!

They could not only control the $3 Billion+ USD market Wal-Mart ALREADY has but they can "capture a significant percentage of the branded product."

And here is the really SWEET news.

McNeil had to back off their "Fast Acting" claim with their laser drilled tablets because they had no clinical data to support that statement - so they agreed to amend the claim to "Fast Release" instead.

Now Meldex provides FastWrap and can claim not only "Fast Release" but "Faster than Tylenol"! What is McNeil to do?! If they challenge the claim of "Faster" -why dadgum! There is clinical data to support just that! No, we don't have FDA approval to say "Faster Acting" (we'll get that soon enough), but neither does McNeil, and we DO have clinical data supporting the faster than Tylenol claim...

So what is McNeil to do? In my view - keep quiet, and HOPE their advertising keeps a finger in the dam. But rest assured it will be a band aid. First, the consumer WILL figure out it does work faster. Second, the FDA approval will be looming ahead.

Of course at some point McNeil MIGHT find no other choice than to acquire the technology or suffer a massive blow.

But who cares if they don't? How much of an $11 Billion USD market would you like?

So the statement made at the end of the RNS by SM:

Steve Martin MRPharmS, Chief Development Officer, Meldex International, said:

"This is a milestone in the development of Meldex. Taking product from concept to launch in two years, including overcoming all the technical and engineering challenges, has been a Herculean effort by the Meldex staff. Meldex has the ability to create innovative product, target specific markets and to generate sustainable growth revenues. The Company is leading the way in innovative regulatory strategies and customer benefits by focusing upon the needs of its partners and their consumers."

I think it is a MASSIVE understatement. I think we are seeing the beginning of a FULL FRONTAL ATTACK on a MASSIVE market - and it looks like we'll prime the pump with Wal-Mart's $3 Billion UDS sales volume.

And some would like to quibble over the definition of "Launch"! ROFLMAO!

Thanks RT, SM, and the rest of the team. Things look pretty good about now.


Walrus

[alchemy] 14/12/2007 11:09

Well done Baton

Your thread comes of age.

[baton] 04/12/2007 10:00

[From The MDX Serious Thread.]

mrsloth - 4 Dec'07 - 09:55 - 3533 of 3533


Interesting to see that things seem to be moving faster than originally thought...

Comparing todays latest pipeline update with the NC BN from May 2007 the changes I can see are as follows:

Rx
DBP149 Oral pain Oradisc 2009 Filed in the UK end Nov 07, will go through MRP New
DBP214 Antihistamine Soluleaves 2007 Accuhist Ultra Soluleaves Now Rx
DBP215 Cough and cold Soluleaves 2007 Ah-Chew Ultra Soluleaves Now Rx
DBP220 Pain Paediatric Solupol 2009 Filing H1 2008 with launch 2009 Now Rx bought forward was 2011
DBP222 Migraine Adult Solupol 2009 Filing H1 2008 with launch 2009 Bought forward was 2011
DBP224 Breakthrough pain TabWrap/FastWrap 2010 Filing H2 2008 launch expected 2010 Bought forward was 2011
DBP226 Pain Nrobe 2010 Filing H2 2008 launch expected 2010 Bought forward was 2011
DBP230 Flu symptoms Sachet 2010 Filing H2 2008 launch expected 2010 Bought forward was 2011
DBP232 Flu symptoms TabWrap/FastWrap 2010 Filing H2 2008 launch expected 2010 Bought forward was 2011

OTC
DBP121 Smoking cessation Soluleaves 2009 PK studies with known comparators H1 08 Delayed was PK studies H2 07
To be launched in early 2008 in unregulated markets New
DBP122 Smoking cessation Meltums 2009 Chewable lozenge, to be launched in early 2009 in unregulated markets New
DBP240 Analgesic TabWrap 2007 Will launch in Germany end 2007 New
DBP241 Analgesic FastWrap 2009/10 Talking to possible global partners New
DBP272 Gastric Reflux Solupol 2008 (EU) Combination product with antacid Partner product
DBP312 Analgesic TabWrap/FastWrap 2009 Analgesic with codeine. Will file H2 08 Bought forward was 2010
DBP314 Analgesic FastWrap 2008/09 With phenylephrine. Will file H2 08 in EU, Launch US H2 08 Bought forward was 2010
DBP350 Analgesic XLWrap 2009 Sustained release analgesic - filing H2 2008 EU New
DBP351 Analgesic XLWrap 2009 Sustained release analgesic - filing H2 2008 EU New
DBP352 Analgesic XLWrap 2009 Sustained release analgesic - filing H2 2008 EU New
DBP355 Analgesic TabWrap 2009 Novel Analgesic/NSAID combination - filing H2 2008 Global New partner product
DBP356 Analgesic TabWrap 2009 Novel Analgesic/NSAID combination - filing H2 2008 Global New partner product

Interesting to see how many new partner products appear in the next pipeline update...

[baton] 04/12/2007 09:16

Updated pipeline pdf has just appeared on the Meldex website, showing the updates given in the 30 Nov 07 RNS which is shown in the above posts 62 and 63.

Note the confirmation of the launch dates of the two TabWrap analgesic products DBP 216 and 240 which are confirmed as being before the end of 2007.

[baton] 03/12/2007 01:14

For your convenience, here is a section of the 30 November 07 RNS referring to TabWrap products alongside the 21 May 07 Nomura Code Broker's Note Table 10 showing the Product Development. You can then see more details of DBP 310, 312, 314, etc, referred to in the RNS. Note that the imminent launch of the German market analgesic DBP240 is not shown in Table 10.