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Q: Launch of Zantac over-the-counter in Europe (czh-ga has priority) ( Answered 5 out of 5 stars,   0 Comments )
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Subject: Launch of Zantac over-the-counter in Europe (czh-ga has priority)
Category: Health > Medicine
Asked by: victorchua-ga
List Price: $10.00
Posted: 24 Sep 2003 14:34 PDT
Expires: 24 Oct 2003 14:34 PDT
Question ID: 259870
Czh-ga gets first exclusivity on this request until 6pm PST, because
of his previous excellent work for me.  I need the results by tomorrow
noon GMT.

This question can be done in parallel with my contact lens question,
as some of the sites to be searched are the same.

I would like you to search for business information about the
over-the-counter launch of the anti-ulcer drug Zantac (ranitidine) in
Europe. This drug, invented and marketed by Glaxo, has been recently
approved as safe enough for over-the-counter use.

I would like you to search for business information about the launch.
What are the revenues in the big European countries?  How is the drug
marketed? How successful has Glaxo been at launching Zantac?  Who are
the European product managers for Zantac (I would like to phone them
up and interview them, so name and as much detail as possible).

I would expect you to search 
(1) the Internet
(2) Specialist market research firms who may have this information. Do
pull out the contents of any reports which have to be paid for,
because I may be able to get the reports through my hospital.
(3) Back issues of business journals such as the Harvard Business
Review, Harvard Business School Publishing, etc. for case studies.

I am a doctor doing some consulting work for a health care company,
and I would like you to give me a head start while I'm asleep in
London!

I expect that this will be about 1-1.5 hours of work.  A good answer
will attract a bonus of $30.

Request for Question Clarification by czh-ga on 24 Sep 2003 17:53 PDT
Hello again Victor,

Thank you for asking for me on your newest questions. I’ve started
researching them but I’m not finished with the answers and I will not
be able to work on them any more tonight. So I’m unlocking both
questions so that other Researchers can have a chance to answer you
before your deadline of noon tomorrow.

~ czh ~

Request for Question Clarification by czh-ga on 25 Sep 2003 00:04 PDT
Hello Victor,

I’m afraid I wasn’t able to finish researching your question. I’m
about to go to bed so I will not be able to meet your noon deadline. I
hope someone else can help in time. If not, I’d be happy to work on it
tomorrow. Let me know if you have some flexibility about the
timeframes for an answer. Thanks.

~ czh ~

Clarification of Question by victorchua-ga on 25 Sep 2003 02:50 PDT
I am going to work on this myself now and will let you know my own
results and what extra help I need later today.

Clarification of Question by victorchua-ga on 25 Sep 2003 06:35 PDT
Czh, I have not done any work on this. Feel free to work on this. Do
you think you can have results by the end of your day?

Request for Question Clarification by czh-ga on 25 Sep 2003 09:45 PDT
Hi Victor,

I'll be happy to work on this today. I'm surprised that it's a tougher
project than I expected because of the complexities of the regulatory
picture on ITC and RX drugs. More soon.

~ czh ~

Clarification of Question by victorchua-ga on 25 Sep 2003 22:57 PDT
That's great. If you need more time (Friday/Saturday/Sunday) that's
fine.

Remember that in both projects I am also looking for the names of the
right people to phone up and potentially interview.

I am happy to raise the potential bonus on Zantac to $50 to compensate
you for the extra time.

Great work on the Vistakon.  I'll add a rating as soon as I go through
it in detail!

Request for Question Clarification by czh-ga on 25 Sep 2003 23:43 PDT
I'm glad you didn't have a hard deadline. I'll do some more digging tomorrow. 

~ czh ~
Answer  
Subject: Re: Launch of Zantac over-the-counter in Europe (czh-ga has priority)
Answered By: czh-ga on 27 Sep 2003 03:51 PDT
Rated:5 out of 5 stars
 
Hello Victor,

This has been a most frustrating search. I’ve spent much more time
than I intended hoping to find the information you asked for on the
OTC release of Zantac in Europe and finding appropriate product
managers to contact. I’m afraid the picture is somewhat muddled. Let
me explain.

The pharmaceutical market place is very complex and there have been a
lot of mergers and acquisitions in the past 20 years. Pharmaceuticals
are also a highly regulated industry so some of the market practices
are greatly impacted by national and regional regulations. Zantac is a
mature product and it’s patent has expired and its licensing and
distribution in Europe was part of the merger agreement between
SmithKline Beecham and Glaxo Wellcome in December 2000. Under the
terms of the merger agreement, GlaxoSmithKline was required to divest
all of its U.S. and Canadian trademark rights to Zantac to Pfizer. In
the U.S. and Canada Glaxo only retains the exclusive use of the Zantac
name for prescription products that contain ranitidine while Pfizer
has the unrestricted ability to market the OTC Zantac products
worldwide.

Pinning down the history of Zantacn 75, the OTC version, in Europe
also proved problematic. Please look at the articles below to satisfy
your interest in the progress of this drug. It seems that in the UK
Zantac 75 was made available as a general sales list (GSL) medicine in
1999 but was still only distributed through pharmacies. That same year
there was a report that “Boehringer Ingelheim is launching Zantac for
Glaxo” in Germany. This information is contradicted by a 1995 report
that refers to the great success of Zantac75 in the UK OTC market and
mentions that Zantac is also approved for OTC in Denmark.

Researching the Zantac’s OTC status and history took me to a lot of
reports on the industry issues on how drugs get switched from
prescription to OTC status. This led to discussions of direct
marketing to consumers and the question of consumer education. The
discussions of Rx to OTC are frequently tied to the question of what
happens when a drug’s patent expires and the increasing competition
from generics.

All of these topics are explored in the context of a regulated
industry and how laws and regulations vary country-to-country. These
variations are all being examined in light of the emergency of the
European Union and the movement to harmonization.

There is an enormous amount of information available about the
pharmaceutical industry. Unfortunately, most of it is only available
in very expensive market research reports. I’ve identified many that
look very relevant to your search and I hope that just reading the
executive summary and table of contents for many of them will give you
a good idea of some of the issues involved with the marketing of
Zantac. I hope that you will be able to obtain some of these reports
through your hospital.

Trying to identify product managers for Zantac was also tough. I
suggest that you look at the web sites for both Pfizer and Glaxo that
I’ve provided and call them to try to identify the people you need to
talk to. These are large organizations and it may take several
attempts before you make the right connection.

Victor, I had not planned to do this much digging but my frustration
at not getting clear and simple answers kept me going. I saved what I
uncovered along the way since I think these resources will be helpful
to you in getting a picture of what is going on with the
gastrointestinal medications market.

I hope that you find this information useful. Good luck with your
project.

~ czh ~



===========================
OTC ZANTAC LAUNCH IN EUROPE
===========================

http://www.zantac75.com/consumer/index.shtml
Zantac®, Zantac 75® -- Pfizer Inc

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

http://www.pharmj.com/cgi-bin/htm_hl?DB=editorial&STEMMER=en&WORDS=zantac+&COLOUR=Red&STYLE=s&URL=http://www.pharmj.com/Editorial/19991016/clinical/gslzantac.html#muscat_highlighter_first_match
The Pharmaceutical Journal Vol 263 No 7067 p626
October 16, 1999 Clinical
GSL Zantac available next month

Ranitidine 75mg tablets (Zantac) are to be made available as a general
sale list (GSL) medicine in mid-November, according to the
manufacturer Glaxo Wellcome. Ms Grace Chu (OTC category manager) told
The Journal on October 7 that the product would be available, under
the name Zantac 75 Relief, in GSL packs of six or 12 tablets. The 24
tablet pack of Zantac 75 would continue to be categorised as
pharmacy-only (P) but current pharmacy-only packs of six and 12
tablets would be phased out by the end of the year.

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


http://www.rxtootcswitch.com/issues/article3.htm 
SWITCH 1999 IN REVIEW
’99 Switches in Major Markets Equal Moderate Pace of ’98

United Kingdom 
While Zantac (Ranitidine) has gained General Sales List (GSL) status,
the company intends to keep the drug in the pharmacy but in front of
the counter, similar to the 1997 strategy of Gaviscon. In this way it
will be more accessible to consumers but also retain support of the
pharmacist.
The UK has always been a leader in switching. Hopefully, the dam will
burst soon.

Germany 
All the H2s are now OTC. Will the launch in this market be a success
after the disastrous H2 business in both France and the UK? Boehringer
Ingelheim is launching Zantac for Glaxo, and Woelm, the German
subsidiary for J & J/Merck, is launching Pepcid.
Let’s hope that the German government leaves the combination
analgesics alone (see Belgium at left).

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


http://www.otc-bulletin.com/1999/otc990513.htm
13th May 1999
Glaxo Wellcome backs pharmacy for Zantac – 
Glaxo Wellcome has said it will only distribute Zantac 75 through
pharmacies in the UK, even if the brand gets general sale list status.
See page 8

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


http://www.pharmj.com/Editorial/20030412/products/products.html 
The Pharmaceutical Journal
Vol 270 No 7244 p510
12 April 2003
Counter medicines
Zantac 75 Dissolve tablets 
Zantac (ranitidine) 75 Dissolve tablets are being launched
(GlaxoSmithKline); retail price, 24 £7.89 (pharmacy medicine). Zantac
75 Relief Dissolve tablets are also being launched; retail price, 12
£4.29 (general sale list).

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


http://www.pslgroup.com/dg951220b.htm
http://www.pslgroup.com/dg/614A.htm
OTC Version of Zantac Cleared by FDA Aims For #1 Position
MORRIS PLAINS, N.J., -- Dec. 20, 1995 -- Warner Wellcome Consumer
Healthcare announced today that Zantac 75(TM) (ranitidine
hydrochloride), the over-the-counter version of Glaxo Wellcome's
Zantac(TM), received marketing clearance from the Food and Drug
Administration.

With more than 200 million Zantac prescriptions written in the U.S.
since 1983, Zantac 75 is one of the most exciting Rx-to-OTC switches
of all time.

In the United Kingdom, Zantac 75 surpassed both Tagamet(TM) 100 and
Pepcid(TM) AC, despite being third into the marketplace. By its fifth
month on the market, Zantac 75 had earned a 50 percent share of the
OTC H2 market. "We fully expect to repeat the prescription success of
Zantac and the U.K. OTC success of Zantac 75 in the U.S. OTC
marketplace," said Casale.

In addition to the United States, Zantac is approved for OTC use in
Denmark and the United Kingdom. Glaxo Wellcome has filed regulatory
submissions in major markets worldwide.

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


http://www.ukbusinesspark.co.uk/bpchem98.htm 
UK Activity Report 
Glaxo Wellcome is to end its over-the-counter drugs marketing joint
venture with Warner-Lambert, and will regain the rights for Zantac 75
in all markets outside North America. 04-Aug-98

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


http://www.reutersbusinessinsight.com/pdf/lcm_catalog.pdf 
Reuters Business Insight
The Lifecycle Management Series 2003
Winning Product Launch Strategies – July 2003
$1199/£745

***** See reference to Case Study Zantac in Chapter 5: Competing
Post-Patent Expiry



===========================================================
MERGER 2000 – GLAXO WELLCOME AND SMITH KLINE BEECHAM TO GSK
===========================================================

http://www.ftc.gov/os/2000/12/glaxoana.htm 
ANALYSIS OF PROPOSED CONSENT ORDER TO AID PUBLIC COMMENT 

The Consent Agreement effectively remedies the anticompetitive effects
in the market for OTC H-2 blockers by: (1) requiring Glaxo to divest
all of its U.S. and Canadian trademark rights to Zantac to Pfizer; (2)
removing all requirements on Pfizer to seek prior approval from Glaxo
for any product line extensions; (3) removing all restrictions on
Pfizer's ability to seek FDA approval of higher OTC dosage strengths
for Zantac; (4) reducing the cost to Pfizer if a higher dosage
strength is approved by the FDA for the OTC market to a payment not to
exceed $3 million; and (5) allowing Pfizer to use any FDA approved
form of the base active, ranitidine, in Zantac products. In the United
States and Canada, Glaxo only retains the exclusive use of the Zantac
name for prescription products that contain ranitidine. This gives
Pfizer the unrestricted ability to market the OTC Zantac products,
improve those products, and use the Zantac trademarks unfettered,
which will allow Pfizer to compete vigorously and effectively in the
OTC H-2 blocker market.

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


http://www.throughtheloop.com/focus/GS400.PDF
January 2001 -- Merger finally completed
After several postponements, the merger of SmithKline Beecham and
Glaxo SmithKline was finally completed on 27 December 2000. Shares
started trading in London the same day and in New York the following
day.

A new corporate Web site will be launched on 8 January 2001 at
www.gsk.com.  One of the issues that has delayed the merger is the
market position in certain product sectors. As a result Warner-Lambert
Consumer Group has acquired OTC Zantac as SmithKline Beecham owns
Tagamet although the latter remains a prescription medicine. Glaxo
SmithKline will continue to hold the rights to ranitidine products for
prescription only with Pfizer having authority in the OTC area.

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

http://www.ftc.gov/opa/2000/12/skb.htm
For Release: December 18, 2000 
Resolving Competitive Concerns, FTC Agreement Clears $182 Billion
Merger of SmithKline Beecham and Glaxo Wellcome

The Federal Trade Commission today accepted a proposed consent order
that would allow the merger of pharmaceutical manufacturers SmithKline
Beecham plc ("SB") and Glaxo Wellcome plc ("Glaxo"), while addressing
a range of competitive concerns that would have resulted from the
transaction as originally proposed. Through the proposed order, the
companies would be required to make divestitures in six significant
product markets, including:

Terms of the Proposed Order
5) divest Glaxo's U.S. and Canadian Zantac trademark rights to Pfizer,
thereby removing restrictions on the ability of Pfizer's Zantac 75 to
compete in the OTC H-2 blocker acid relief market;



==============================================
EUROPEAN MARKET FOR ZANTAC AND OTHER OTC DRUGS
==============================================

http://www.james-dudley.co.uk/pdfs/sping2002.pdf
European OTC Publication News – Winter/Spring 2002
Time for the European OTC industry to plan strategies to meet major
changes to its distribution channel networks.

***** This is a very interesting article about the major drivers that
are changing the OTC market place throughout Europe. The 7-page report
illustrates its points with tables and charts on the market realities
throughout Europe.

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


http://www.bizintelagents.com/reports/kt12523_otc_toc.html
Rx-to-OTC 2003 (3rd Annual Edition) 
Published by : Visiongain 
Pub Time: 2003/02
Price US $1600 (Single user License: Electronic Version) 

15. Rx-to-OTC Switching in the UK Market
15.1 MCA Guidelines for Reclassification of Prescription Only
Medicines in the UK
15.2 The UK OTC Market and Resale Price Maintenance 
Table 48: Impact of RPM Abolition on OTC Sales in Key Markets 

16. Guidelines on Rx-to-OTC Switching in the European Regions
16.1 Switching from Rx-to-OTC Under EC Directive 
16.2 The EU switching procedure 
16.3 Sample Case for Switching in the European Marketplace:Rx-to-OTC
Switching in the German Market
16.3.1 The definition of Rx in the German Medicines Law 
16.3.2 Criteria for an Rx-to-OTC-switch Under the German System 
16.3.4 The Switch Procedure in Germany 
16.3.5 Rx to Switch Target Time Table 

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


http://www.james-dudley.co.uk/OTCjan2002_details.htm
OTC Distribution in Europe - the New 2002 Edition
New Challenges – New Strategies to 2006

Deregulation, EU harmonisation, leading pharmaceutical wholesalers’
strategies, and the ambitions of mass market operators’, as well as
developments in e-commerce are among a combination of evolving themes
driving change in the distribution channel systems serving the
European OTC medicines market. This study explores these change
drivers and makes them relevant to managers seeking to develop
strategies to meet the new challenges and exploit opportunities
emerging from the supply chain

Published: Spring 2002 
Details: 370 pages, 200 graphs, tables & figures
Price: £ 1,495, € 2,718, US$ 2,545, ¥273,585 

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


http://www.marketresearch.com/map/prod/859174.html
REPORT: The OTC Outlook to 2007: Extending revenue streams and product
lifecycles after patent expiry
PUBLISHED BY: Reuters Business Insight
DATE PUBLISHED: 2/1/2003
LENGTH: 150 Pages
PRICE: US $ 1,199
Countries covered: Japan, France, Germany, United Kingdom, United
States

Abstract
The impending expiry of the patents covering 18 major prescription
drugs has encouraged pharmaceutical companies to look towards the OTC
market for revenue protection and lifecycle extension for their major
products. Although certain sectors of the OTC market are maturing,
growth opportunities do exist in emerging markets, possible product
switches and novel indications. As self-medication is more widely
adopted and healthcare payers seek to contain costs, the OTC market
seems set for significant future growth. The OTC Outlook to 2007, a
new management report by Reuters Business Insight, analyses the recent
performance of the OTC markets in the US, Japan, Germany, the UK and
France. Market data is allied to an evaluation of strategies, trends
and growth drivers to forecast future revenue potential in therapeutic
and national markets and growth opportunities are identified for all
companies throughout OTC sectors.

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


http://www.reutersbusinessinsight.com/rbi/content/rbhc0090m.pdf
REUTERS BUSINESS INSIGHT
Business Intelligence for the Pharmaceutical Industry
The OTC Outlook to 2007: Extending revenue streams and product
lifecycles after patent expiry
PRICE: £745/€1199/$1199
+44 20 7675 7533
info@rbi-reports.com

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


http://leda.law.harvard.edu/leda/data/121/mkisloff.html
The H2 Blockers' Rx-to OTC Switch: For Whom Will It Spell Relief?

The "third class" nossibility. The United States is one of the few
developed countries with only two classes of drugs. Most countries,
including all of the European Community, have a third class of drugs,
known as the "legend" or "pharmacy only" class. In these countries,
most non-prescription drugs can only be purchased from licensed
pharmacists65. The idea, of course, is that the pharmacist will serve
as the necessary intermediary to supply information and answer
questions about drug interactions, efficacy, possible side effects,
and the like.
 
***** This is a 26 page paper by a student at Harvard. It is somewhat
dated but some of the points about the European market are useful.

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


http://www.otc-bulletin.com/1999/otc990330.htm
OTC Bulletin -- 30th March 1999
Germany to be big test for OTC H2-antagonists - Can manufacturers of
OTC H2-antagonists prove the sceptics wrong in Europe's largest OTC
market?

***** You may want to review this article if you have access to this
newsletter.

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


http://www.washtimes.com/upi-breaking/20030915-121501-2281r.htm
http://www.atimes.com/atimes/South_Asia/EI12Df05.html
9/15/003 -- U.S. drug companies create OTC barrier
CALCUTTA, India, Sept. 15 (UPI) -- The World Trade Organization meet
at Cancún, Mexico, ended as a failure, particularly for the developed
nations like the United States and European Union. However it appears
that the U.S. pharmaceutical industry, at least, may be succeeding in
outmaneuvering developing-world drug makers, despite the fact that the
WTO rubber-stamped an agreement last month to allow poorer nations to
import cheap generics to beat major killers such as AIDS and malaria.

Using Rx to OTC as a tactical strategy is a phenomenon that U.S. drug
makers are also using to boost sales of their products, says Ellis of
Front Line. A good example is the H2-antagonist class of drugs -- such
as Tagamet, Zantac, and Pepcid -- indicated as a prescription drug to
treat ulcers. When the newer class of ulcer treatments, known as
proton pump inhibitors (such as Prilosec) arrived to the prescription
market, Tagamet's sales suffered. Tagamet then went OTC citing that it
had a new cure for heartburn, and was granted 3 years of market
exclusivity. Shortly after going OTC, Tagamet's revenues were about
3.5 times greater than its prescription revenues.

***** Although this article addresses the concerns of Indian drug
manufacturers, the article presents a good review of how US laws and
regulations effect the worldwide market for medications.

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


http://www.twnside.org.sg/title/twr131b.html
Third World Network
Patents and monopoly prices 
In a country where alternative or generic medicines are available, a
branded product is usually priced lower due to the competition it
faces from the cheaper alternatives. The same brand may be sold at
higher prices in other countries where there is no competition from
generic producers.

A 1998 Health Action International survey on Zantac, an anti-ulcer
drug manufactured by Glaxo, indicated that the company lowered the
price of the drug in India (marketed as Zinetac) because of
competition.  Several generic manufacturers in India produce
ranitidine, the generic name for the active substance contained in
Zantac. The survey showed that 100 tablets (150mg) of Zantac were sold
for $2 in India, $3 in Nepal, $9 in Bangladesh, $30 in Vietnam, $37 in
Thailand, $41 in Indonesia, $55 in Malaysia, $61 in Sri Lanka, $63 in
the Philippines and $183 in Mongolia. It was also sold at $23 in
Australia, $77 in Canada, $196 in Chile, $132 in El Salvador, $150 in
South Africa and $97 in Tanzania.4

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


http://www.marketresearch.com/map/cat/183.html
Life Sciences - Over-the-Counter Drugs

***** You can choose from many geographically specific market research
reports.

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


http://www.pharmj.com/Editorial/20000527/forum/aesgp.html
OTC products need "more visibility"

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


http://www.nicholashall.com/cgi-bin/public/view.cgi?template=layouts/template.tpll&dis_pg=report_home
Nicholas Hall publishes a growing range of special reports, including
the “must have” OTC Yearbook and a well-received series of regional
Market Guides, and is exclusive marketing agent for external reports
on Switch and China.


====================================
EUROPEAN PRODUCT MANAGERS FOR ZANTAC
====================================

http://www.gsk.com/sitemap.htm 
http://corp.gsk.com/index.htm 
http://www.gsk.com/contact/contact.htm 
http://www.gsk.com/worldwide.htm
GlaxoSmithKline Worldwide

***** Links to worldwide GSK offices with contact information for each
location.

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


http://www.pfizer.com/europe/
http://www.pfizer.com/europe/europe.htm
Pfizer Europe
***** Links to European offices

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


http://www.the-infoshop.com/study/dc15564_phama_sale_forces_toc.html
http://www.datamonitor.com/~436e6c1da8df420baebfdc3063a2e7c5~/Products/DMV/Free/Report/DMHC1904/020DMHC1904.htm
Pharmaceutical Sales Forces: Benchmarking sales force management by
geographical market and product lifecycle
Product Code: DMHC1904
Price: $12800
Publication Date: 01-AUG-2003

Sales force expansion has not generated the expected returns.
Companies are under pressure to match the promotional spend of
competitors to maintain their sales force 'share of voice,' i.e. the
number of reps detailing a particular drug. Datamonitor defines the
key problems in promotional investment through benchmark analysis and
investigates strategies to improve sales force effectiveness.

Pharmaceutical Sales Forces: Benchmarking sales force management by
geographical market and product lifecycle provides an in-depth profile
of 56 sales forces' size and structure from 41 companies operating in
Japan, US, UK, Spain, Italy, Germany and France. Breakdown includes
rep allocation by target audience, therapy area/indication and region,
which is correlated with the marketing portfolio.


==============
ZANTAC HISTORY
==============

http://www.expressindia.com/fe/daily/19970707/18855573.html
Monday, July 7 1997 
Glaxo may emerge as sourcing base as Zantac goes off patent

Within five years, Zantac, principally a tablet but also an
injectible, became a $1 billion product for UK-based multinational
Glaxo and the world's top selling medicine.
 
Annual sales of the product exceeded -- 1 billion before the end of
1988, nearly half the company's turnover. And, by the end of 1994,
sales touched a mind-boggling -- 2.5 billion.

But what are the implications on Glaxo-Wellcome's bottomline after the
Zantac patent expiry in the US? Glaxo Wellcome estimates that in the
"worst case" scenario, 70-80 per cent of Zantac's current US sales of
-- 1 billion could be eroded in the first year due to generic
competition.

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


http://www.rxtootcswitch.com/trends/article1.htm 
SWITCH® Prediction
The Inevitable Major Growth of Dual Regulatory Status 
Structural Change in US Rx & OTC Market Provides 
Problems and Opportunities
Recent Dual Status Results In the US
OTC Category        Success             Failures
Gastrointestinal    Pepcid 1995 	Tagamet 1995
                                        Zantac 1995

There should be a number of future switches preparing for some form of
dual status. Unfortunately, most will fail because they were unwilling
to create scenarios that realistically and objectively put their
product in a competitive context.**

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


http://www.mtdaily.com/mt1/news/n123195.html
Zantac 75  (ranitidine hydrochloride): The FDA recently granted
marketing clearance for Zantac 75 to be sold OTC for treatment of
heartburn, acid indigestion, and sour stomach in adults and children
12 years of age and older. This represents a major Rx-to-OTC switch.
Zantac 75 is a five-sided tablet that will initially be sold in 4-,
10-, and 20-tablet packs. The recommended dose for children over 12
and adults is one tablet swallowed whole with water, not to exceed two
tablets in 24 hours, and it can be taken at the maximum daily dose for
up to two weeks. Zantac 75 is expected to be on store shelves early in
1996. Mfg: Glaxo Wellcome. Source: Business Wire via NewsPage
12/19/95.

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


http://www.milliman.com/health/publications/consultants_corner/17ccr_frk_patent.pdf
A Closer Look: The Impact of Prescription Drugs Coming Off Patent

In 1995 Zantac was the 4th leading drug dispensed (based on
prescriptions) in the United States, but one year after patent
expiration (1998) it was 134th on the list with its generic equivalent
Rantidine at 127th. The above data shows that by 1999 the cost of
Zantac was insignificant to this HMO but its generic utilization
continue to grow.



===============================
PFIZER FINANCIALS AND MARKETING
===============================

http://finance.yahoo.com/q?s=PFE
Pfizer Inc (PFE)

http://www.pfizer.com/are/investors_reports/annual_2002/p2002ar28.htm
http://www.pfizer.com/are/investors_reports/annual_2002/pfizer2002.pdf
Financial Review
PFIZER INC AND SUBSIDIARY COMPANIES
Annual Report 2002

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


http://www.pfizer.co.uk/template2.asp?pageid=48
Pfizer Global Pharmaceuticals (PGP) is the key driver behind Pfizer's
outstanding performance. PGP brings the prescription medicines of our
industry - leading research pipeline to patients and physicians
through an organisation of dedicated professionals.

The sales force operate from four regional offices that have been
established in order to align activities with differing parties and
needs of the NHS across the country. The regional offices in
Birmingham, Edinburgh, Manchester and Watford allow Pfizer Limited to
be close to our customers in every part of the UK.

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


http://www.mult-sclerosis.org/news/Sep2002/BiogenSeronoPfizerJointMarketingAgreements.html
September 8, 2002 -- Joint Marketing Reward Pharma Industry

Pharma companies have long used joint marketing agreements to gain
additional reach for their products and to fill unused capacity in
their sales forces. Biotech and pharma companies made over 300 such
agreements in the 1980s and 1990s. However, Pfizer has gone further
than any other big pharma player to make co-promotion a part of its
business strategy. Its co-promotion deals (others include Pharmacia,
Warner-Lambert, UCB, and Eisai) are redefining how the pharma
marketing game is played, and they're catching the attention of
investors.

Without access to physicians, the economics of having a large
dedicated sales force are lousy. As doctors have played hard to get,
sales force productivity has fallen almost 50 percent. In 1995, 36,000
sales reps completed 51 million calls. In 2000, 83,000 reps completed
only 62 million calls. Pfizer has figured out that co-promoted
products give it better access to doctors. The company not only earns
commission payments, but also significantly improves the productivity
of its sales reps.

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


http://www.millenniapartners.com/News/NewsView.asp?NewsID=12
Atlanta, GA -May 5, 2003
Pfizer Moves Broadband Out to Sales Force with Netifice

Pfizer Inc. plans to have about 10,000 of its 13,000 field sales
workers hooked up by year's end to either high-speed cable modem or
Digital Subscriber Line services -- a project that analysts said would
create the largest corporate broadband network built for remote
workers thus far.

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


http://www.euromonitor.com/Pfizer_Inc_(OTC_Healthcare)#
Back to > Previous page > OTC healthcare homepage > World homepage

Report on Pfizer Inc
Chapters: 35
Charts: 1
Tables: 20
Pub Date: Apr 2003
Cost: USD300

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


http://www.investorcanada.ca/stockbriefs.php?stockID=378&ad=1
Pfizer Inc (N.PFE)

Pfizer Inc. is one of the world's largest pharmaceutical and consumer
healthcare companies. The Company was formed in June 2000, following
the pooling of interests merger between Pfizer and Warner-Lambert
Company. The Company now represents a significant consumer business
encompassing many of the world's best-known brands including Halls,
Tetra, Benadryl, Sudafed, Listerine, Desitin, Schick, Visine, Ben Gay,
Lubriderm, Zantac 75 and Cortizone. The Company operates through four
main operating units: Pfizer Pharmaceuticals Group, Warner-Lambert
Consumer Division, Pfizer Animal Health Group and Pfizer Global
Research and Development.


==============================
GLAXO FINANCIALS AND MARKETING
==============================

http://www.mizuho-int.com/system/images/mizuho/research_material/7489.27908972841-1051517092_10358.pdf
28 April 2003 – Mizuho International plc, Credit Comment
GlaxoSmithKline

Generic competition has also been fostered by regulation, primarily in
Europe, where France, Germany, Belgium,
Denmark and the Netherlands have all passed laws to promote generic
drugs. In these countries, pharmacists
must always select the cheaper generic form of a drug where it is
available. With rising healthcare costs, ageing
populations etc. and pressures on fiscal budgets, the market share of
generic drugs is likely to continue rising.

With the exception of the US and Germany, pharmaceutical prices are
generally restricted by price controls and
can vary significantly from country to country. This, together with
differences in reimbursement rates and VAT
creates arbitrage opportunities which lowers general prices. As such,
margins on pharmaceuticals tend to be
higher in the U.S. and Germany.

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


http://www.gsk.com/financial/reports/ar2001/annual-report-01/gskrep34.html
Annual Report – 2001 
2000 Year -- In accordance with US SEC disclosure requirements, the
following discussion compares results for the year to 31st December
2000 with the results for the year to 31st December 1999.

Zantac continued to decline in the face of competition from generic
products and alternative anti-ulcerant treatments. The rate of decline
slowed to 11 per cent in 2000. Zantac's largest market is now Japan,
where sales remained stable.

Offsetting these strong performances were a decline in sales of
Augmentin, due to a mild 'flu season and the impact of generic
competition in the UK and Germany, and the continuing decline in
Zantac. Avandia was launched in the UK and Germany in late 2000.

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


http://www.newswire.ca/releases/February2003/12/c9381.html
Preliminary Announcement of Results for the Year Ended 31st December
2002

Zantac sales were $573 million (down 21%) with declines in most
markets.

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


http://education.guardian.co.uk/print/0,3858,4465504-108340,00.html
July 21, 2002 -- Drugged and disorderly
In January 2000, when GlaxoWellcome bought SmithKline Beecham for £114
billion at the height of the boom, the move was explained in visionary
terms.

Sceptics were dismissed for suggesting that the reason for the deal
had been cost-cutting, not R&D, and that once the £1bn had gone, Glaxo
- reeling from the patent expiry on blockbuster ulcer treatment Zantac
- might well need another partner.


=======================================
GENERAL MARKETING ISSUES  -- RX VS. OTC
=======================================

http://www.studentbmj.com/back_issues/0902/news/310a.html
Increasing use of over the counter drugs across Europe 
Consumers are becoming more willing to make healthcare decisions and
experiment with alternative medicines without consulting a doctor,
says a new report from independent market analysts Datamonitor.

"Obviously, pharmaceutical companies are like rabid dogs at the
gate--they would love to make more medicines over the counter" says
Neil Broome, consumer analyst and author of the report. He believes
the government has encouraged this shift towards self medication in a
bid to cap future healthcare spending, saying: "We have seen the
setting up of NHS Direct and lots of medicines becoming available over
the counter such as Zovirax,
Zantac, and nicotine patches."

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


http://faculty.fuqua.duke.edu/~dbr1/Berndt/LingDTC21.doc
http://faculty.fuqua.duke.edu/~dbr1/Berndt/LingDTCCharts21.xls
Deregulating Direct to Consumer Marketing of Prescription Drugs: 
Effects on Prescription and Over-the-Counter Product Sales
DRAFT DOCUMENT DATE: 23 November 2002

ABSTRACT
This paper examines the impact and interrelationships between
direct-to-consumer (DTC) and physician-oriented marketing on the sales
composition of the prescription (Rx) and over-the-counter (OTC)
versions of antiulcer and heartburn medications.

In this paper we examine recent DTC marketing efforts and Rx to OTC
switches involving the H2-antagonist class of drugs, which treats a
wide variety of gastrointestinal disorders including duodenal and
gastric ulcers, hypersecretory conditions, acid indigestion, and
heartburn.  These top-selling Rx medications all switched from Rx to
OTC in 1995-96 -- Pepcid to Pepcid AC, Tagamet to Tagamet HB, Zantac
to Zantac 75, and Axid to Axid AR.  The Rx version of Tagamet lost
patent protection in 1994, as did Rx Zantac in 1997, Rx Pepcid in
2001, and Rx Axid in 2002.  For some of these drugs, DTC advertising
has occurred for both the Rx and OTC formulations.

***** This is a 40-page scholarly paper with full documentation of
sources and a lengthy bibliography. Although the report addresses
specific US history and market issues, the content gives an excellent
grounding in the subject.

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


http://www.ipsos-reid.com/media/dsp_displaypr.prnt.cfm?ID_to_view=1908
Doctors Play Key Role in Sales of Non-Prescription Drugs 
Doctor’s Role Greatest When Rx Product Moves To OTC, Reveals Ipsos
PharmTrends®
September 17, 2003

New York, NY – Prescription (Rx) drug manufacturers aren’t the only
drug companies marketing products directly to physicians.
Over-the-Counter (OTC) drug makers have discovered the power of “just
what the doctor ordered.”

Currently, just over one-quarter of OTC H2 Antagonist buyers treating
acid indigestion/GERD are purchasing due to a doctor’s recommendation.
This class includes OTC products such as Zantac 75, Pepcid AC, Pepcid
Complete and Tagamet HB. However, with the switch of Prilosec OTC, the
H2 proportion is expected to reach levels similar to Claritin OTC --
as competitors strive to defend market share against Prilosec OTC’s
market entry (a new class of OTC treatment for heartburn/acid
indigestion).
Since 1997 — when branded direct-to-consumer campaigns from Rx drug
manufacturers were allowed — OTC manufacturers have responded with
their own professional marketing programs.

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


http://www.researchandmarkets.com/reports/1331
http://www.researchandmarkets.com/reports/1331/1331.htm
Gastric Relief Rx-to-OTC Switch US Market Survey: Revised Analysis 
& Forecast - Technology, Sales & Company Profiles
Number Of Pages : 244
Date Published : 01/08/01
Hard Copy   EUR  2,943
Hard Copy   USD  2,750

Description : 
This report covers all major strategic issues including an extensive
product and market analysis, key Rx and OTC strategies, competitive
analysis and profiles of major manufacturers, opportunities and
threats.

Exec Summary :
The gastric relief marketplace is comprised of Rx and OTC product
markets, whose main mechanism of action is managing gastric acid. OTC
products help relieve ailments such as heartburn, indigestion, sour
stomach, gas, and lactose intolerance. Rx products are indicated for
the more serious ulcer problems and reflux (backflow of stomach acid
into the esophagus, also known as GERD). Historically, the OTC market
has been comprised mainly of antacids which manage the pH of stomach
acid. Traditionally the Rx market has been primarily comprised of
products which reduce the release of acid, which is a more effective
mechanism of action.

The first generation technology of these acid reducers (H2
antagonists) first build the Rx market in the early 1980s and early
1990s and then was largely switched to OTC status in the mid-1990s.
The second generation of acid reducer technology (proton pump
inhibitors) has lead the gastric market to an unprecedented level of
nearly $10 billion sales in 2000.

***** The very detailed Table of Contents gives you a good idea of the
issues involved in the gastric relief medication market.

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


http://www.ecrm-epps.com/Expose/V6_15/30.pdf
Gastrointestinal Market Overview

http://www.ecrm-epps.com/Expose/V7_2/4.pdf
Rx to OTC Switches
Prilosec OTC 
Prilosec, one of the world’s top selling prescription drugs in its
class, was approved by the U.S. Food and Drug Administration for sale
over-the-counter for frequent heartburn on June 20, 2003. The launch
of Prilosec OTC is anticipated to be one of the largest Rx to
over-the-counter (OTC) switches ever in terms of retail sales. The
product will be available to consumers in Fall 2003.

Prilosec OTC is the first proton pump inhibitor (PPI) made available
over-the-counter, and it will be available at the 20 mg prescription
strength. Prilosec OTC is the only OTC therapy specifically indicated
for frequent heartburn (heart- burn that occurs two or more days per
week). According to a 2003 National Heartburn Alliance (NHBA) survey,
frequent heartburn affects more than 50 million adult Americans, and
25 million have heartburn symptoms daily.

Procter & Gamble obtained the U.S. marketing rights for the OTC
version of Prilosec from AstraZeneca, and is licensed to develop,
market, package, and distribute the OTC version of Prilosec in the
U.S., Puerto Rico and US territories.

***** These two market review pieces give you excellent insights into
the workings of the Rx to OTC conversion and the fierce competition in
the gastrointestinal products marketplace.

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


http://www.urchpublishing.com/publications/product.html?p=69
Title:  Rx to OTC Switching in the pharma industry
Author: Perry & Mansel
Publication date: September 2000
Price: print £350

Summary
Engineering a truly successful Rx to OTC switching strategy has become
increasingly challenging for pharmaceutical companies. The high costs
associated with the sales and marketing of consumer goods and the
relatively low levels of return, in comparison to prescription drugs,
has created major challenges.

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


http://216.239.51.104/search?q=cache:AOUCDzQth7MJ:www.urchpublishing.com/resources/Drivers%2520for%2520Rx.htm+zantac+OTC+launch+europe&hl=en&ie=UTF-8
Drivers for Rx-to-OTC switching

The commercial and financial interests of pharmaceutical companies and
national governments are behind the key driving forces to switch drugs
from prescription to OTC status in today’s global pharmaceutical
market.
Several other parties can also be seen to be influencing the switch
process in individual countries, in particular the healthcare
professionals, including pharmacists and physicians, as well as the
patient consumer.
The pharmaceutical company’s primary interest is the long-term success
of its drug products and their resulting profitability. Since the late
1970s, pharmaceutical companies have increasingly viewed the OTC
self-medication market as critical to the long-term strategy of a
pharmaceutical brand. A number of specific driving forces underlying
the trend of pharmaceutical companies to contemplate switching have
been identified and are discussed below.

***** This is an overview of the above fee-based report.

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


http://www.throughtheloop.com/focus/whatis.html
Corporate Focus Healthcare was launched at the beginning of 2000 to
provide subscribers with high level of ongoing corporate news and
analysis.
Corporate Focus Healthcare covers the leading consumer healthcare
marketers. Product areas covered analgesics, gastro-intestinal,
dermatological, diagnostics, vitamins & minerals, cough & cold,
allergy and smoking cessation

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


http://www.rxtootcswitch.com/index.htm
Francesco International (http://www.franint.com) is an international
publishing and consulting firm specializing in the overall prediction
and management of Rx-to-OTC Switches.

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


http://www.franint.com/main.asp?view=about
No one is more qualified to cover the Rx-to-OTC switch market than
SWITCH®. That's because no one has an international network that
compares in quality or scope. Our contacts are industry--insiders not
journalists. They are people who know the market, have lived it,
succeeded in it--and continue to face the same worries and challenges
you face today.
SWITCH® HardCopy. One year subscription: US$995.
Current SWITCH® Newsletter on the Web
Current SWITCH® + Online Search of All issues on the Web

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


http://aspe.hhs.gov/pic/pdf/6723.PDF
Analysis of Prescription Drug to Over-the-Counter (Rx to OTC) Switch
Movement
Final Report, February 28, 1998
Institute for Health Services Research and Policy Studies
Northwestern University

***** This is a 176 page report

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


http://www.otc-bulletin.com/
OTC bulletin is firmly established as the most comprehensive and
frequent source of news, views and analysis dedicated to current OTC
developments.

http://www.otc-bulletin.com/switch_report/report.htm
Entering the Third Age of Switching
£995 – May 2002

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


http://www.cgey.com/life/pdf/VR03ExecSum.pdf
Prescriptions for the Smart & Lean Pharmaceutical Company 

In early 2003, Cap Gemini Ernst & Young, together with INSEAD,
conducted extensive discussions, workshops and market research
covering the viewpoints and needs of pharmaceutical customers and
their evolving relationship with the pharmaceutical industry. The
topic has evoked great interest - data collected from our
transatlantic survey of 4000 consumers, a little under 1500 physicians
and more than 100 pharmaceutical executives and payers form the basis
of the report. This primary research enables us to provide a
privileged insight into the evolution of the pharmaceutical customer.

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


http://knowledge.insead.fr/category.cfm?catid=10
Health Matters

***** Free registration to access articles from INSEAD instructors.

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


http://www.leu.com/pdf/pharma_en.pdf
December 2001 -- Sector Report, Pharmaceuticals Europe – Hopes Focus
on Biotechnology

***** This is a 57-page report that gives an excellent review of the
industry.

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


http://www.dtcperspectives.com/
DTC Perspectives Inc., formerly Rx Insight, Inc. is a publishing,
conferences/training, and consulting company specializing in consumer
marketing of pharmaceuticals. Our business is providing information to
industry professionals responsible for doing DTC work for
pharmaceutical companies, agencies or industry suppliers of services.

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


http://www.strategicreports.com/about/
http://www.strategicreports.com/reports/samples/AltanaSamples.pdf
Founded in 1991, Strategic Reports Inc. specializes in producing
high-quality multi-client reports covering a broad range of healthcare
topics. Our PharmaForce International division was launched in July
2001 to focus exclusively on pharmaceutical sales and marketing
benchmarking on a global basis.

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


http://www.cgey.com/life/pdf/PerspectivesSpecial2005.pdf
Life Sciences – Special Edition 2002
Beyond 2005: The Future of Pharmaceutical Marketing and Sales

***** This is a 40 page presentation covering the major trends in
pharmaceutical marketing.

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


http://www.medical-communities.de/eyeforpharma/Pharma%20Trends%20MS%202005%20final%20version.ppt
Pharmaceutical Trends for 2005
Cap Gemini Ernst & Young, October 2001

***** This is a 57 slide presentation that addresses all the major
trends in the pharmaceutical industry. Lots of statistics and graphs.



========================================
PHARMACEUTICAL LICENSING AND REGULATIONS
========================================

http://www.info.doh.gov.uk/doh/intpress.nsf/page/2003-0301?OpenDocument
Monday 11th August 2003
ADVERTISING RESTRICTIONS ON NON-PRESCRIPTION MEDICINES TO BE SWEPT
AWAY
The current ban on advertising certain over the counter (OTC)
medicines to the public will be lifted, said Health Minister, Lord
Norman Warner today.
There will be no change to the strict ban on advertising prescription
only medicines direct to consumers.

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


http://pharmacos.eudra.org/F3/g10/docs/synthesis.pdf
Overview of Pharmaceutical Pricing and Reimbursement Regulations in
Europe

***** This is a 31-page paper giving an excellent overview of market
conditions in light of regulations. The charts and tables are
especially helpful.

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


http://knowledge.insead.fr/category.cfm?catid=10
DTC Ads for Rx 
The Benefits of Prescription Drug Commoditization 

Europe has long resisted direct-to-consumer advertising for
prescription drugs. Opponents say DTC commercials “commoditize” drugs,
leading to increases in unnecessary treatment, higher health care
costs and poor doctor-patient relationships. However, in this recent
article for DTC Perspectives Magazine, Professor Leonard Lerer argues
that rather than heralding the downfall of social health insurance,
the commoditization of prescription drugs will actually benefit
European patients.

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


http://www.mhra.gov.uk/aboutmhra/aboutmhra.htm
The Medicines and Healthcare products Regulatory Agency (MHRA)
From 1 April 2003, the Medicines and Healthcare products Regulatory
Agency (MHRA) replaced the Medical Devices Agency (MDA) and the
Medicines Control Agency (MCA). The MHRA is an Executive Agency of the
Department of Health with trading fund status.
Our statutory functions
The MHRA is the Competent Authority for medical devices and the
Licensing Authority for pharmaceuticals.

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


http://www.plgeurope.com/index.php
European Pharma Licensing Council
As there are now nine individual Pharmaceutical Licensing groups in
Europe, the European Council was set up in 2001 to facilitate the
communications and organisation between the individual pharmaceutical
licensing groups across Europe.

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


http://www.mca.gov.uk/ourwork/licensingmeds/european/europelic.htm#Introduction
Licensing of medicines: European Licensing
Last updated 11/04/03

In 1995 a new European system for the authorisation of medicinal
products came into operation. This was the result of many years of the
European Community working together towards a single EU-wide market
for pharmaceuticals, removing barriers to trade that previously
existed, so that a medicine marketed in on EC country can also be made
available in the same way and subject to the same conditions, in other
EC countries. At the same time, the Community has ensured that there
are proper safeguards as to the safety, quality and efficacy of
medicinal products made available to consumers. The new system is
based around two procedures, the "centralised" and "mutual
recognition" procedures.

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


http://www.aesgp.be/
The Association of the European Self-Medication Industry
It is the role of AESGP to further the use of non-prescription
medicines and self-care products.  In future, self-care and
self-medication will play an even more important part within the
framework of public health policy.

***** This is a very interesting and comprehensive site that provides
a huge selection of resources for information about self-medication
and moving pharmaceuticals from Rx to OTC status.

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


http://www.coe.int/T/E/Social%5FCohesion/soc%2Dsp/Public%5FHealth/Pharma%5Fand%5FMedicine/presentation%20Medicines.asp#TopOfPage
Medicines subject to prescription
This Committee, as a subsidiary body of the Committee of experts on
pharmaceutical questions, deals with problems specifically related to
regulation concerning the prescription-only medicines

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


http://www.rpsgb.org.uk/pdfs/dtcarev0212.pdf
Direct-to-consumer advertising (DTCA) of prescription
medicines: fourth quarterly update - October to December 2002
3 January 2003

This report is the fourth quarterly update for 2002 tracking
developments in direct-to-consumer advertising of prescription
medicines in Europe and the US (see earlier updates for details).
This is the final regular update on DTCA to be produced for the RPSGB.

***** This is an interesting paper that reviews the current status of
the regulatory environment on direct to consumer advertising of
prescription drugs and the many issues related to this subject.

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


http://www.healthwatch-uk.org/dtc.pdf
Healthwatch Position Paper on Direct to Consumer Advertising of
Prescription Medicines

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


http://www.efpia.org/1_efpia/default.htm
The European Federation of Pharmaceutical Industries and Associations
(EFPIA) is the representative voice of the pharmaceutical industry in
Europe.

http://www.efpia.org/4_pos/
Review of the European Pharmaceutical Legislation



===============
SEARCH STRATEGY
===============

zantac OTC launch Europe
pharmaceuticals marketing europe
zantac otc Europe
OTC H2 market
"OTC H2" market European
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otc regulations europe

Request for Answer Clarification by victorchua-ga on 28 Sep 2003 03:45 PDT
Many thanks for your perseverence.  I'll add a rating when I've gone
through it in detail.

I was just wondering--generally what is you availability in terms of
days of the week and times?  Some of my colleagues are impressed with
your skills and would like to use you too (they would probably route
the requests through me).  It would be great to know when you are
generally available.  I would love to be able to call you to find out
your availability, but I guess that isn't permitted by Google?

Clarification of Answer by czh-ga on 29 Sep 2003 00:34 PDT
Hello Victor,

I’m glad to hear that you like my approach to answering your
questions. I’m in California and my schedule is varied and flexible. I
tend to be a night owl so I frequently find myself working on Google
Answers late in the evening but if something interesting comes along
in the morning I’ll jump on it. Since Google Answers is a worldwide
service, there are researchers available around the clock. What
questions we get to answer is frequently a matter of luck unless a
customer specifically asks for us by name. I’d be delighted to keep
working with you. Thank you for the feedback.

~czh ~

Request for Answer Clarification by victorchua-ga on 30 Sep 2003 09:08 PDT
Great. I haven't managed to go through your answer yet, but will do so
in next 1-2 days and rate it.  Still busy working on contact lenses.

Clarification of Answer by czh-ga on 30 Sep 2003 11:34 PDT
Thanks Victor.

~ czh ~

Clarification of Answer by czh-ga on 01 Oct 2003 12:33 PDT
Thanks Victor. I'll look for your new questions.

~ czh ~
victorchua-ga rated this answer:5 out of 5 stars and gave an additional tip of: $50.00
Another excellent piece of work. We'd like you do more work for us!
(see separate questions)

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