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RIMADYL - the history
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COX-2 SELECTIVE NSAID COMMENTS
The human cox-2 inhibitors are, at this time, under the microscope. It has become quite obvious that all is not known about the effects of cox-2 inhibition in humans. This inquiry into the safety of cox-2 specific NSAIDs should be extended to include the cox-2 specific veterinary NSAIDs. Much less is known about the effects of cox-2 inhibition in canines.
The veterinary cox-2 inhibitors include the mildly cox-2 selective carprofen (Rimadyl) and meloxicam (Metacam) as well as the cox-2 selective NSAIDs of the coxib class deracoxib (Deramaxx) and firocoxib (Previcox). (1) Firocoxib is the most cox-2 selective veterinary NSAID approved to date. (2)
All of the concerns about human drug approval, adverse drug events, and monitoring of the safety of cox-2 inhibitors exist and are magnified in veterinary medicine. This is primarily due to differences in pre and post-approval drug clinical trials, in the reporting of ADEs, in diagnostic procedures for pets and humans, in the treatment of illness available for pets and humans and the clients' ability to pay, and the value placed on human life as opposed to the value of the lives of animals.
Also, the veterinarian serves a dual role as both physician and pharmacist.
There are considerable differences between pre-approval and
post-approval clinical trials for canine NSAIDs and human NSAIDs. Pre-approval clinical trials for veterinary drugs are small, short and use only healthy subjects.
Almost eight years has passed since the first veterinary cox-2 inhibitor was brought to market. We now have at least 4 cox-2 inhibitors. Still, no good information exists as to dog breed differences in metabolism, effects on aged or unhealthy dogs, concomitant drug use, and consequences of long term use. Nevertheless, these drugs are commonly dispensed to dogs of all breeds, all ages, and in varying states of health, often for chronic, daily, long term use.
While it is sometimes the case that problems with human drugs are not identified until the drug is brought to market and used by extremely large numbers of people, this is always the case with veterinary drugs due to their very limited and small trials.
According to veterinary clinical pharmacologist Dawn Boothe: "Prelicensing and other experimental studies focus on dose-dependent effects and target a relatively small test population. It is not until a drug is placed in widespread clinical use that we see the idiosyncratic and other more subtle toxicities that are potentially serious." (3)
One of the problems in identifying Vioxx as a possible contributor to heart attack and stroke in humans was that these events commonly occur in the general population. Many cox-2 inhibitor adverse reactions in dogs may be being passed off as common occurrences of old age. Only through huge long-running post-approval clinical trials was the possible connection between Vioxx and heart problems discovered. These types of trials are not conducted with veterinary drugs.
Intensive monitoring within hospitals and analysis of health registers post drug approval is uncommon in veterinary medicine. (24)
There are also differences in the reporting of adverse drug events (ADEs) between veterinary and human drugs. It has been estimated that only about 1/10 of dog adverse reactions to medication are reported as compared to reporting of human adverse reactions. Veterinary clinical pharmacologist Mark Papich states that "the true incidence of adverse drug effects in domestic animals is not known because most are not reported". (17)
In addition, major differences exist in diagnostic procedures for
canines and humans. For example, while it is extremely common for physicians to diagnose heart attacks and strokes, it is uncommon for veterinarians to do so. Most veterinarians do not order MRIs or CT scans that are very common diagnostic tools for humans, and many veterinary clients could not pay for them anyway. According to FDA CVM: "Additional limitations in veterinary pharmacovigilance include the cost and availability of diagnostic tests and the lack of comprehensive postmortem information". (21)
Humans survive many cox-2 inhibitor related adverse reactions due to their ability to voice discomfort and to obtain medical treatment which is most often paid for by insurance benefits. For example, a human can voice stomach discomfort to his physician while a dog obviously cannot, and according to veterinary clinical pharmacologist Dawn Boothe: "Unfortunately, there is no sensitive indicator of gastrointestinal bleeding in dogs and damage may be quite extensive before signs are evident." (16) Therefore even the most common NSAID side effect of gastrointestinal damage is likely to be quite serious in canines. Many dogs who experience gastrointestinal damage, kidney failure, or liver toxicity from cox-2 inhibitors are euthanized because their owners cannot travel, many times out of state, to an advanced veterinary medical care facility for necessary diagnostics, nor pay for extended intensive medical treatment. Additionally, many
treatments available to humans are still investigational for pets.
Great value is placed upon human life while animals are still generally legally considered property. Therefore physicians are subject to much liability whenever drugs are used improperly while veterinarians are subject to virtually none.
Finally, while in human medicine there exists the pharmacist to provide drug information and answer specific consumer questions about product use, no such intermediary exists in veterinary medicine.
A brief summary of a few of the highlights of the history of the
veterinary cox-2 inhibitor Rimadyl will serve to illustrate most of the above. In short term clinical trials for Rimadyl, the number of reports of adverse reactions were minimal. Most commonly reported were vomiting, lethargy, and appetite change. While an increase in serum activity of ALT was the most frequently reported clinicopathologic change, investigators did not relate any clinical signs to the elevations in ALT. It was reported that clinicopathologic abnormalities and mild adverse effects were the same for the carprofen group and the placebo control group. (4)(5) According to the FDA CVM, based on studies that were submitted for the drug approval process, "the risk of Rimadyl was thought to be negligible". (6).
Rimadyl hit the market in 1997 and was directly advertised to consumers through television commercials (featuring the recovery of old dogs from lameness) as well as full-page magazine ads, print stories, and radio reports. Consequently, it was widely used very quickly. By 1999 the CVM estimated that Rimadyl had been given to 2.5 million dogs. (6)
A brief chronology of select Rimadyl post-approval events 1997 to 2002:
May 1997 - CVM asked Pfizer to change the adverse drug reaction section of the label due to ADE reports received and asked Pfizer to send a "Dear Doctor" letter to veterinarians about Rimadyl's adverse effects. (6)
September 1997 - An extensive adverse reaction section was included in Rimadyl labeling. The existing possibility of a fatal outcome was included. (6)
1998 - 39% (no. 3626) of ALL ADE reports received by FDA CVM involved Rimadyl. About 13% involved death of the dog. (6)
April 28, 1999 - Dog owner Bob Sinclair spoke about Rimadyl and animal drug issues at the FDA Stakeholders meeting in Overland Park, Kansas. (22) (23)
Spring 1999 - Death was added to the adverse reactions section of the Rimadyl label. (6)
June 24, 1999 - Concerned consumers met with Pfizer officials and were presented with an advance proof print of a new Rimadyl Consumer Information Page. (7)
October 1999 - Jean Townsend of Johns Island, South Carolina brought a class action lawsuit against Pfizer alleging that neither she nor her vet were adequately warned of the possible adverse consequences of Rimadyl use. (8)
December 1, 1999 - The FDA CVM issued a Rimadyl Update. CVM stated that dog owners who had reported ADEs directly to the agency said they were not aware of any potential Rimadyl adverse effects. CVM advised: "As a NSAID with potentially serious side effects, however, the use of Rimadyl
should be carefully considered before being incorporated in any
therapeutic plan. Moreover, dog owners should have an active role in making that decision." (6)
March 9, 2000 - Another "Dear Doctor" letter was sent by Pfizer to veterinarians. Among other things, this letter informed veterinarians of an Owner Information Sheet to be attached, along with the product insert, to each bottle of Rimadyl Caplets and Rimadyl Chewable Tablets. Veterinarians were also informed that new bottles of Rimadyl would be offered in 2 week, 1 month, and 3 month supplies so that vets would be
able to dispense full bottles with the drug information attached. In addition Pfizer stated: "Pfizer, in conjunction with the FDA CVM, encourages veterinarians to provide owners with information about both risks and benefits associated with all potential therapeutic options." (9)
December 13, 2002 - Pfizer was asked by the Division of Surveillance FDA CVM to immediately stop dissemination of certain promotional materials judged to be misleading. (10)
Currently, the Rimadyl label includes the following adverse reactions based on voluntary post-approval drug reporting, listed in decreasing order of frequency by body system:
- Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis.
- Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers.
- Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.
- Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria.
- Behavioral: Sedation, lethargy, hyperactivity, restlessness,
- Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.
- Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.
- Immunologic or hypersensitivity: Facial swelling, hives, erythema.
- In rare situations, death has been associated with some of the adverse reactions listed above. (11)
This is quite an extensive list for a drug whose risk was thought to be negligible based on pre-approval trials. As of January 3, 2005, the cumulative total of Rimadyl possible ADE reports as posted on the CVM website was 12,919. 2,349 involved death of the dog. (12)
Problems continue to surround the use of Rimadyl and the other veterinary cox-2 inhibitors. A two year review of the consumer messages to the FDA CVM hotline which appeared in JAVMA News on January 15, 2004 revealed the following:
"Frequent comments from pet owners who contact the CVM hotline include these:
- They did not receive a client information sheet when one was available for a drug that was prescribed for their pet.
- The medication they received from their veterinarian was not dispensed in the CVM-approved container but was broken into aliquots that were taken home without the client information sheet or approved label.
- The veterinarian did not conduct or recommend blood testing before and after prescribing the drug, even though baseline testing and/or periodic monitoring was recommended on the label. Common examples include
heartworm products and nonsteroidal, anti-inflammatory drugs.
- After reading client information sheets and labels on the Internet about a drug prescribed for their pet, they discovered that their pet may have fallen into a category of animal for which a precaution or contraindication existed."
Article author Dr. Victoria Hampshire of the FDA CVM reminded practitioners that, "Drugs that come with client information sheets are intended to be dispensed in the manufacturer's container, with the sheets accompanying the prescription." (13)
The almost uniform failure of veterinarians to provide the Client Information Sheets for the veterinary cox-2 inhibitors led to the publishing of two additional articles by FDA CVM in 2004 bringing this to the attention of the veterinary community. In a FDA Veterinarian article "Adverse Drug Experience Reports Lead to Label Changes, Other Actions for Safer Animal Drugs", Dr. Thomas Moskal advised veterinarians
to communicate risk information for NSAIDs to clients and to be sure that the dog owner receives the Client Information Sheet. (14) In the article "Minimizing the risk factors of the veterinary NSAIDs" which appeared in JAVMA News April 15, 2004 Dr. Moskal stated: "Drug risk information is communicated to veterinary practitioners and to the
public through the product labeling...Drugs that come with Client Information Sheets are intended to be dispensed to clients with the Client Information Sheet accompanying the prescription." (15)
Companion animals cannot verbally notify owners when they are experiencing an adverse reaction to a cox-2 inhibitor. The pet owner who sees the dog every day must detect any problems, but can only do so if he or she knows what to watch for.
Veterinarians have failed in their role as physician by failing to
obtain informed consent when prescribing NSAIDs, and they have failed in their role as pharmacists by not providing adequate consumer drug information. Dogs have become family members in most households, and are cared for as such. Dog owners should not be left reeling in shock and
burdened by extreme guilt when their beloved canine companion suffers or dies from the use of a cox-2 inhibitor, because THEY HAD NO IDEA.
The FDA should not only request, but must enforce, that the FDA recommended and approved Client Information Sheets currently existing for the veterinary NSAIDs be given to pet owners. Pet owners are currently seeking legislation state by state mandating full disclosure of the risks of veterinary drugs such as the cox-2 inhibitors. They should not have to do so. The existing Medication Guide Rule which enforces the providing of FDA prepared Medication Guides for certain human drugs should be amended to include veterinary drugs with FDA
mandated and approved Client Information Sheets, or a Veterinary Medication Guide Rule should be implemented.
In addition, the current labels and Client Information Sheets for all of the veterinary NSAIDs should be posted on the FDA website, so that individuals seeking information on the internet do not have to wade through annals of promotional materials at the drug company websites to find FDA approved documents. Currently, the only US information for firocoxib (Previcox) available on the internet at this time is the
Freedom of Information Summary (18), which contains a paucity of information. Neither the Previcox label nor the Client Information Sheet may be accessed at the FDA website or elsewhere. A consumer must file a formal, written FOI request and pay a fee to obtain the Previcox label and CIS. (25)
Also, consumers should be able to view the causality
assessment scores for veterinary NSAID ADE data posted on the FDA CVM website.
Of the cox-2 selective veterinary NSAIDs carprofen (Rimadyl), meloxicam (Metacam), deracoxib (Deramaxx), and firocoxib (Previcox), the most is currently known about carprofen, and therefore I have focused on its history in this discussion. The other three drugs are much less well known because they are much newer drugs.
The coxib Deramaxx, approved August 21, 2002, is thus far responsible for 2400 possible ADEs. 550 involved death of the dog. (12) No data for the coxib Previcox, approved July 21, 2004 (18) has been posted on the FDA CVM website to date. (12)
Previcox is the more extreme cox-2 inhibitor. In in vitro canine whole blood assays, Previcox exhibits approximately 380-fold selectivity for cox-2 over cox-1. (2) Deramaxx is structurally related to Celebrex, while Previcox is structurally related
to Vioxx. (26)
Current evidence suggests that cox-2 is produced constitutively in the brain, spinal cord, kidney, ovary, uterus, placenta, thymus, bone, cartilage, synovia, endothelia, prostrate, and lung. (27)
It is responsible for homeostatic mechanisms in the body and plays an important part in healing. (16) More research is needed regarding the safety of currently available cox-2 inhibitors on the kidney and other organs. According to veterinary clinical pharmacologist Mark Papich: "Some of the prostaglandins that play an important role in salt and
water regulation and hemodynamics in the kidney are synthesized by cox-2 enzymes." (19)
Prostaglandins mediated by cox-2 are induced when
gastrointestinal erosion occurs. Veterinary clinical pharmacologist Dawn Boothe states that "cox-2 appears to be the isoform mediating repair of damaged tissues with expression being greatest within the first 10 days
of damage". (16)
A study released January 17, 2005 found that when mice that are genetically prone to hardening of the arteries were treated with a cox-2 inhibitor, their condition worsened. (20) Several studies have linked the human cox-2 inhibitor Vioxx to increased risk of heart attack and stroke. There is concern regarding this with the cox-2 inhibitors Celebrex and Bextra. Indeed, this is the reason the current meetings are taking place. There is no evidence that this is not a concern in dogs,
only evidence that such is much less likely to be detected through the voluntary ADE reporting system, for reasons already mentioned in these comments.
In light of the history of carprofen and the current concerns about extreme cox-2 inhibition in humans as well as in animals, one wonders why the extreme cox-2 inhibitor firocoxib (Previcox) was approved as recently as July 2004.
A panel should be convened to discuss the safety of the veterinary NSAIDs and how to improve the current circumstances. This panel should include consumer representatives. Much human suffering is also
associated with the sickness and loss of beloved canine companions.
Thank you for considering these comments.References
(1) Papich, Mark. Nonsteroidal Anti-Inflammatory Drugs. Antech Diagnostics News, January 2005.http://www.antechdiagnostics.com/clients/antechNews/2005/jan05_01.htm.
(3) Boothe, Dawn M. Clinical Perspectives on Current and Future Options in Canine NSAID Therapy. Advances No. 3, Pfizer Animal Health - Practical information about the art, science, and research of veterinary medicine. May 2002.
(4) Holtsinger RH, Parker RB, Bealse BS, et al. The therapeutic efficacy of carprofen (Rimadyl) in 209 clinical cases of canine degenerative joint disease. Vet Comp Orthop Traumatol 1995; 5: 140-144.
(5) Vasseur PB, Johnson AL, Budsberg SC, et al. Randomized controlled trial of the efficacy of carprofen, a nonsteroidal anti-inflammatory drug, in the treatment of osteoarthritis in dogs. J Am Vet Med Assoc 1995; 206: 807-811.
(6) CVM Update. http://www.fda.gov/cvm/index/updates/rimadyl2.html
(13) Hampshire, Victoria. Emerging issues regarding informed consent. JAVMA News, 01/15/04.
(14) Moskal, Thomas J. Adverse Drug Experience Reports Lead to Label Changes, Other Actions for Safer Animal Drugs. FDA Veterinarian, March/April 2004. http://www.fda.gov/cvm/index/fdavet/fdavettoc.html
(15) Moskal, Thomas J. Minimizing the risk factors associated with veterinary NSAIDs FDA-CVM offers suggestions based on postmarketing experience. JAVMA News, April 15, 2004.http://avma.org/onlnews/javma/apr04/040415g.asp
(16) Boothe, Dawn. The new nonsteroidal anti-inflammatory drugs. The Central Veterinary Conference, Aug. 2004.
(17) Papich Mark. Adverse drug reactions of clinical significance. The Central Veterinary Conference, Aug. 28-31, 2003.
(19) Papich, Mark. Anti-inflammatory drugs: how to sort out the choices. The Central Veterinary Conference, Aug. 28-31, 2003.
(24) Maddison, Jill. Adverse Drug Reactions. Ettinger's Textbook of Veterinary Internal Medicine Fifth Edition, Vol. 1. Pennsylvania, Saunders, 2000.
(25) Personal correspondence with Linda Grassie, FDA CVM.
(27) Dowling, Patricia. Nonsteroidal Anti-Inflammatory Drugs. The Central Veterinary Conference, Aug. 2004.
HISTORY OF CARPROFEN - RIMADYL
- From: LuSwinton
- Date: Fri, 20 Aug 2004 08:29:20
I am once again sending this to the list
for our newer subscribers.
The history of carprofen (Rimadyl) was first posted to
doghealth2 on November 4, 2002 by Jane and Bob Sinclair.
Subj: [doghealth2] History of Carprofen
Date: 11/04/2000 12:47:50 PM Eastern Standard Time
From: firstname.lastname@example.org (Jane Sinclair)
To those of you who are new to the list, you
may not be aware of where Carprofen (Rimadyl) came from.
Here's a history of this old drug, now the darling
of the vets and considered some kind of safe new
wonder drug for dogs.
Years ago Hoffman La Roche (a Swiss company) set out
to find a cure for arthritis and came up with Carprofen
which they called Imadyl. But early tests showed that
the drug performed no better than those of dozens of
competitors. Roche was stymied. Imadyl lacked what drug
companies call a USP, a unique selling proposition.
So back to the labs went Imadyl to find something "unique".
When new tests showed that Imadyl might spare users
the ulcers that sometimes occur in users taking the
existing drugs, only then did Imadyl get a big launch
that made it a big hope for Roche in 1983. This is the
origin of the current slogan vets use today -
"safer than Aspirin". However, Imadyl never became
a block buster drug,and some years later Roche withdrew it
from the European human market for commercial reasons.
Carprofen ended up in Roche's Animal Health.
SmithKline Beecham bought Roche's Animal Health in 1993
and then decided to concentrate on human drugs.
So, sold their Animal Health to Pfizer in 1995.
Pfizer had been in drugs for feed animals and now got
into drugs for companion animals. By October 1996,
Pfizer had gotten Carprofen through the FDA/CVM approval
process and in January 1997 the new wonder drug for dogs
was launched. Pfizer had rights to the molecule in all
but the countries where it was called Zenecarp
(UK, Ireland, Australia, and New Zealand). In April 1999,
Pfizer acquired Carprofen in the Zenecarp countries,
changed the name to Rimadyl, and now owned the drug
Some drug company got Carprofen approved for humans in
the US in 1987,maybe Roche, but it never made it to market.
Pfizer's US ad campaign for Rimadyl for dogs was Pfizer's
most successful before Viagra. The Rimadyl campaign created
a craze for the drug. In September 1997 my vet switched
my little dog from Aspirin to Rimadyl and, in ignorance,
I put my Misty through months of Hell. My dog suffered
terribly before I found out about the harm I was doing
to her,and then we had to put her to sleep to stop her
misery. Misty's Rimadyl experience changed my life.
Since her death, I have worked with other BARKS people
to inform unknowing dog owners about this potentially
dangerous drug. Pfizer and its reps continue to play
the statistics game with vets and most of the vets are
still in love with the drug. In spite of FDA actions
and cautions, dogs are still getting sick or dying and
dog owners are still not being informed.
So the final history of Imadyl/Rimadyl has yet to be written.
For Misty and all the Rimadyl dogs
Important Information on Rimadyl
Printed with permission
I sent this Rimadyl information to the VetMed list this morning in answer to a member that didn't have much information about the drug. Just passing it on in case there are new people on the Doghealth2 list who might find it useful. It's a brief history of carprofen with some useful links.
Carprofen is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen, naproxen, and ketoprofen. Carprofen is an old drug tested on horses, cows, pigs, dogs, cats, and humans. In Europe it was used in humans for about 10 years. One of the trade names was Imadyl. It was withdrawn from the market for commercial reasons.
In January 1997 Pfizer launched Carprofen in the US market under the trade name Rimadyl with a first-of-its-kind Direct to Consumer (DTC) advertising campaign. The campaign claimed that Rimadyl is "safe and effective", "safer than aspirin", "safe for older dogs", and "safe for long-term use". The campaign won awards and was so effective that within 6 months, 500,000 dogs had been prescribed Rimadyl.
In July 1997, Pfizer wrote a Dr. Doctor letter that singled out a study at Colorado State University that "substantiated an acute hepatopathy which is evident 16-21 days after initiation of Rimadyl therapy. The affected dogs, all Labrador Retrievers, were presented initially for loss of appetite and/or vomiting. Jaundice was evident in all dogs. All six recovered after the medication was stopped and supportive care was provided. We have received a number of other reports of possible hepatic involvement in Labrador Retrievers and other breeds."
You can read the letter at: http://www.srdogs.com/Pages/rimadylnews.html
A subsequent study was done at CSU, "Hepatocellular toxicosis associated with administration of carprofen in 21 dogs". J Am Vet Med Assoc 1998 Jun 15;212(12):1895-901.
In May 1998, The United States Pharmacopea Practitoners' Reporting Network (USP PRN) stated "The diligence of veterinarians and their support staffs in reporting adverse reactions to Rimadyl resulted in a product labeling change early in the drug's life span and will ultimately affect the future health of canine patients." Here's the link to the report:
Also in May 1998, Pfizer published a technical bulletin about the first-year clinical experience with Rimadyl. You might ask your veterinarian for a copy. You can also read excerpts at the Senior Dogs site. See the link above. The bulletin lists possible adverse events (ADEs) associated with Rimadyl and says, "Clients should be made aware of signs of drug intolerance prior to dispensing any prescription medication, including NSAIDs." The bulletin says that the reported rate of suspected ADEs is low, but "the nature and frequency of adverse events are reported here in the interest of fully informing veterinarians about the product's safety profile".
On October 29, 1998, the FDA/CVM released the 1997 Summary of ADEs reported for carprofen. There were 1244 reports and 195 deaths.
In January 1999, the January/February issue of the FDA Veterinarian Newsletter contained an article by Dr. Neal Bataller, titled "FDA/CVM 1997 ADE Reports - A Descriptive Overview". This article points out that Rimadyl (carprofen) accounted for 33.3% of all "possible" Animal Injury Reports in calendar 1997. Here's the link:
http://www.fda.gov/cvm/fda/infores/fdavet/1999/jan.htmlOn May 11, 1999, in a conversation with an FDA veterinarian, we were told that the pace of Rimadyl ADEs in 1998 (not yet published) was running about the same as in 1997.
Jean (name withheld by webmaster), and many other dog owners including ourselves whose dogs suffered or died from the uninformed use of Rimadyl, have but one plea: Improvements in the exchange of information between the pharmaceutical manufacturers, their distributors and sales representatives, the veterinary community, and the consumers of animal drugs. What we're missing today is the assurance that information about the drugs we give to our animals is accurate, timely and up-to-date, unbiased, specific and comprehensive, and useful.
We made this plea at the April 28, 1999 FDA/CVM Stakeholders Meeting at Overland Park, Kansas. This plea and a set of proposals were well received by FDA officials and officials of the AVMA. We had the privilege of meeting Jean (name withheld by webmaster) at that meeting. Her comments and questions, and ours, are now part of the public record in the FDA Dockets.
We hope you find this information useful.
(Author's name withheld by Webmaster.)
VIAGRA, CELEBRIX, RIMADYL . . .
apparently not . . . perhaps this most recent business maneuver
will result in drugs that will allegedly counteract the adverse
reactions caused by the drugs currently being aggressively
Updated: 02:17 AM EST
Cytos And Pfizer In Animal Health Drug Pact
Edited Press Release
SCHLIEREN, Switzerland -(Dow Jones)-
Cytos Biotechnology AG said Thursday it has entered
a research and marketing pact with Pfizer Inc (PFE)
for two of its animal health products.
Cytos announced that it has signed a research and
commercial license option agreement with Pfizer for the
testing of immunodrugs for animal health applications. Pfizer
gains exclusive access to test two drug candidates in
its models and, if the commercial license agreement is
executed, exclusive development and commercial rights to
these two animal health product candidates of Cytos.
In return Cytos Biotechnology will receive an upfront payment,
and has the opportunity to earn milestones and additional fees.
If products are successfully launched, Cytos will earn royalties
on Pfizer net sales. Additionally Pfizer has the first claim to
negotiate for any further drug candidates in the same
therapeutic area, developed by Cytos for animal health.
The two companies have negotiated and agreed terms,
including program initiation fees, milestone payments and
royalties on net sales, for additional programs where Pfizer
has the option to contribute its own proprietary disease
antigens for other animal health disease indications.
"We are proud to announce this new deal with Pfizer, the world's premier animal healthcare company" said Mark Dyer, Executive Vice President of Business Development at Cytos. "The agreement represents a first for us in the animal health field and could extend the reach of our market opportunities beyond human healthcare."
Company Web site: http://www.cytos.com
* * * * *
About Cytos Biotechnology AG
Cytos Biotechnology AG is a public Swiss biotechnology
company that specializes in the discovery, development
and commercialization of a new class of biopharmaceutical
products – the Immunodrugs™.
Immunodrugs™ are intended for use in the treatment and
prevention of common chronic diseases, which afflict
millions of people worldwide. Immunodrug™ candidates are
designed to instruct the patient’s immune system to
produce desired therapeutic antibody or cytotoxic T-cell
responses that modulate chronic disease processes.
Taking advantage of the high flexibility of its Immunodrug™
platform, Cytos Biotechnology has built a pipeline of
27 different ImmunodrugTM candidates in various disease areas,
which are developed both in-house and together with Novartis.
Founded in 1995 as a spin-off from the Swiss Federal Institute
of Technology (ETH) in Zurich, the company is located in
Schlieren (Zurich). Currently, the company has 110 employees.
Cytos Biotechnology AG has been listed on the SWX Swiss
Exchange (SWX:CYTN) since October 2002.
MEANWHILE, keep on smiling, but don't stop "flossing"!
per the New York Times
Pfizer to Halt 'Good as Floss' Listerine Ads
Pfizer, the maker of Listerine mouthwash, will spend
$2 million to replace what a judge called misleading advertising
suggesting that the product is as effective as flossing at fighting
plaque and gingivitis.
About 4,000 workers will be deployed around the country
to place stickers over the claim on Listerine bottles and
to remove similar advertisements that hang on bottlenecks,
a lawyer for Pfizer told a federal judge yesterday.
Television, print and medical journal ads using the campaign
are also being stopped, and the as-effective-as-floss
campaign has been removed from the Listerine Web site,
the lawyer, Tom Smart, said.
Judge Denny Chin of United States District Court in Manhattan
ruled Friday that the ads pose a public health risk and could
undermine the message of dental professionals.
Judge Chin said dentists had been urging patients to floss
for decades because the benefits "are real; they are not
McNeil-PPC, a unit of Johnson & Johnson, the health care products
maker based in New Brunswick, N.J. sued Pfizer over the campaign,
saying it posed an unfair threat to its sales of dental floss.
The suit might still go forward, and a Pfizer spokesman,
Tom Sanford, said the company was considering an appeal.
May my beloved partner ROMI rest in peace
- no matter wherever her bits and pieces/frozen carcass
may be held hostage.
[what's in YOUR "urn" ?
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