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To: Montana Wildhack who wrote (6957)3/17/2001 5:19:26 PM
From: Cal Gary  Read Replies (2) | Respond to of 14101
 
Hi Wolf and threadsters,

The recent president's message and yesterday's RobTV interview has filled in many of the blanks. This reduces risk imo. I have pasted my notes from the interview below (sorry its messy) and after thinking overnight, a few comments. No too bad for a QA session with 8 Qs and A in 8 minutes. I liked the "ask the CEO with s/h email" format.

--------------------------------------------------

one on one viewers ask management

Overview - drug delivery product and focus on Pennsaid

Q1. status w/ JnJ and timing, distribution with the usa.
based on agreement cannot comment, still on track not diswayed from choice of partner

Q2. outstanding items for FDA approval process.
FDA act proscribed from discusing interactions
dialoge continuing
She uis positive for both Canadian and USA submissions

{Next Q&A, she mentions that FDA plant inspection has not been scheduled yet. A slip? I was going to move forward my expectation for FDA approval to the summer based on the NA launch comments and rumours. But with this statement, I'll leave my expectations for an autumn/end of calendar year approval.}

Q3. Canadaian and plant inspection
canadian and euro plant inspection done
us plant insp has not been scheduled yet

{This is revealing}

Q4. able to issuance of company targets
clear targets is in the EU
product approval in other member nations by second half of this year
expecting Canadian this year
Cdn Gov reviewed plus additional request for info , not in our control
preparing for Canadian launch

{This clarifies the preparation for NA launch is Canada, not US (or Mexico <gg>) }

Q5. market potential
cox2 celebrex and vioxx
5billion 40% of market
10% oa taking oral, nsaid - drug interaction, side effects
target just 10% = significant

{This was big news to me. First, Rebecca is now using COX2 actual sales $$, before its was NSAID numbers and estimate of market size. COX2 have captured an actual $5B USD of an estimated 12.5B market. I'll bet she will be using this when talking to new partners. Second, the 10% number!! These are OA people suffering pain that cannot tolerate the so called ""safer, easier to stomach"" COX2 pills.

For my own DD, I was using what each % of $5B USD would do for our revenue line and set an initial max of 5% based on good arguements from people on this board. Now I'll move it up a notch to 10%. I'll leave the $5B for now (its published numbers, I know the markets larger with the traditional NSAIDS) until several quarters of earnings are out or if some one has a good arguement on expanding market with the safer new products.

Based on another recent SI post, the additional Celebrex studies for the recent proposed label changes appears to be tainted. Upwards of 25% of people rejected for inclusion in the study, then 10% of study population suffers side effects. I take this as an opinion and not fact at this time until a publish document can be produced and posted. But I like it!}

Q6. management team have the experience skill max potential of company
issues addressed
become fully integrated
mission to market
transition essential to put in place internal structures
r&d to commercial costing taxation transfer prciing
teams internally can deal with this
substance and structure in place
confidence ever since purchase of facility

{Rebecca acknowledges this as an issue. She did not do the lawyer response, it was very clear to me. She did try to assure that teams can deal with the changing business.}

Q7. stock price- additional financing- cash levels
flexibility
jan pp with 50mm Cdn equity line, did one draw down
very flex innovative, draw down when we want
no penalty, but over 13 month
cash is not an issue
700-750k /month cash burn

{The 700-750 cash burn was expected. In DMX terms that's the overhead expenses. What is not said is how much is needed for inventory and plant and capital expansion/improvement.

But I agree, cash is no longer an issue for the next 13 months, given no big spending spree on R&D and new products.}

Q8. when trials anti fungal
now: preclinical with anti fung prep, method, formula
expect clinical start before calendar yearend

{Fungoff, I was hoping to hear about WF-10 and its expected phase III report. I guess I shouldn't bitch, I didn't have time to email in any questions.
Some one else did want to know the status of the anti fungal.

Hats off to the people taking time to email in the questions.}



To: Montana Wildhack who wrote (6957)3/18/2001 6:23:30 PM
From: Joe Krupa  Read Replies (1) | Respond to of 14101
 
Here's a copy of a link just posted by ticktalker over on SH:

sharecast.com

(Here's the text of the article as well)

Provalis drug
By Robin Davison
Fri 2 Mar 2001


LONDON (SHARECAST) - UK healthcare group Provalis is gearing up for the launch of a new drug later this month which could dramatically change its fortunes, but surprisingly the stock market has not yet attributed any value to it. Provalis

In three weeks' time, Provalis expects to launch Pennsaid, a topical version of the widely-used anti-inflammatory drug diclofenac, for treating pain associated with osteoarthritis (OA), one of the most common ailments affecting the over-65s. Provalis licensed UK rights to this product from the Canadian biotech firm Dimethaid Research in January, against what it says was stiff competition from a number of lager pharmaceutical companies.

However, its shares moved little in response to the deal and have traded within a narrow range since then. The shares closed at 19.25p yesterday, capitalising the company at £45m and valuing its technology at just £33m, subtracting its year-end cash balance of £12m. |

Pennsaid can be rubbed directly on to the joints affected by OA to relieve the painful swelling that characterises the condition. Despite the fact that the localised nature of OA would normally lend itself to site-specific treatment, the poor efficacy of available topical drugs means that most patients receive so-called non-steroidal anti-inflammatory drugs (NSAIDs) orally, which are well known to cause side effects. The most problematic of these is damage to the stomach and gut, which in the UK alone causes some 12,000 hosptial visits and 2,000 deaths per year (usually as a result of bleeding ulcers).

Pennsaid is a solution of diclofenac containing an agent called DMSO which allows it to penetrate through the skin. Its nearest competitor is Voltaren Emulgel, a topical gel form of diclofenac sold by Swiss pharmaceutical group Novartis, which is popular in the UK despite the problem of poor absorption.

However, Provalis will want to position Pennsaid to compete in the oral market for NSAIDs. The NSAID market is dominated by oral products and valued at some £220m per year in the UK. If Provalis can capture only a small portion of this, it would dramatically increase the sales of its healthcare division, which are currently running at just over £5m per year on an annualised basis.

Provalis will, however, face stiff competition from the major players in the pharmaceutical industry and has only 42 sales representatives. But Dimethaid’s studies with Pennsaid give the drug an enviable profile and show that it provides better pain relief than either diclofenac, naproxen (another commonly used NSAID) and even the blockbuster drug Celebrex, sold by the US pharmaceutical giant Pharmacia.

Provalis has not disclosed its pricing strategy for Pennsaid, although chief executive Phil Gould said it will be “competitive on the basis of treatment cost per day”. Gould is reluctant to comment on sales projections as he is keen to avoid the risk of disappointing the market, but said Pennsaid could easily become Provalis’s top-selling product.

John Kwok, analyst at house broker Old Mutual Securities, predicts £6m peak sales for Pennsaid in 2006, but said this figure is likely to be very conservative if Pennsaid takes sales from oral NSAIDs. Gould said Provalis will also make a good gross margin on Pennsaid, which it will buy as a finished product from Dimethaid.

The Pennsaid launch comes as Provalis also enjoys success with its other main product, the Glycosal point-of-care testing system for glycated haemoglobin. The system measures the quality of glucose control in diabetes and the test is typically taken once every three months. Glycosal recently received its approval in the US and Japan and has already been launched in more than 40 countries in Europe and other regions.

To date, Provalis has shipped 1,500 Glycosal instruments, which sell to users for an average of $800, and 170,000 individual tests, which retail for an average of $8. Demand is also growing fast and Provalis has increased the manufacturing runs to 135,000 tests per month.

Provalis is using revenue from its healthcare (pharmaceutical marketing) and medical diagnostics divisions to fund therapeutics research and development, which is focused on developing a range of vaccines for infectious disease. These include vaccines for streptococcus pneumoniae, which causes pneumonia in adults, and Group B streptococcus, which affects infants. Both vaccines are ready for clinical development.

Provalis reported its results for the half year to December 31 yesterday, showing a 56% reduction in net losses to £2.1m on revenues from continuing operations of £3.6m, up 13%.


Send your comments to Robin Davison



To: Montana Wildhack who wrote (6957)3/18/2001 8:28:12 PM
From: Tom Drolet  Read Replies (1) | Respond to of 14101
 
Wolf: Article on Yahoo this pm --Hollywood's most recent movie hit--like the title!!

"Sunday March 18 7:10 PM ET
Seagal-DMX Thriller Is Top Movie". The movie, which co-stars rapper DMX, was Seagal's best opening ever, topping the $14 million debut of ``Under Siege'' in 1992."

But, unfortunately, unlike Hollywood, real life is often different. Joe K. explored the edge of what I say here (only I conclude the opposite intent) in post 6959.

One lateral way of looking at DMX's focus on the hazards of Celebrex and Vioxx etc recently.-- is that they (the Royal They--DMX, the Board and Rebecca) -- wish to set up DMX share owners for a possible eventual message that 'Pennsaid--the income earner soon in the UK and maybe Europe--will not get FDA approval in the USA'--i.e. DMX is in good company with acceptance problems all around us. The companion thought of that is that 'we may have issues--but so does the competition'.

All the WF 10 hopes, nail fungus and...etc -- would not overcome that particular message and its effect on DMX's share price in the short to middle term.

Just an unhappy lateral thought for a Sunday before another ugh! week on the markets--except for energy.

Japan--a real worry for the markets.

Tom D.