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Celebrex -- More Information

Main Page For Celebrex

Discounted Prices -- Celebrex

WSJ Article -- Celebrex Causes Death

FDA Report About Celebrex

Pfizer-Pharmacia Deal Means You'll Hear More of Celebrex

Celebrex Stomach Problems

Fact Sheet on Celebrex

Source

Medication Quantity Regular Price Sale Price
200 mg. 50 capsules $225.00  blank on original
200 mg. 100 capsules $400.00  
200 mg. 200 capsules $750.00  

Source

[drug]

 

Source

\

News Article
 

On 4/20/99, The Wall Street Journal reported that celecoxib (Celebrexä) has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhages. Five (four men age 45-88 and one woman age 75) of the 10 who died suffered from gastrointestinal bleeding or ulcers. Two deaths were attributed to heart attacks, one to drug interaction and one to kidney disorder. No cause of death was noted in one case.

In an interview, a Food and Drug Administration (FDA) official found it difficult to evaluate the significance of these reports in light of the high number of individuals currently taking Celebrex. Celebrex has been on the market for 13 weeks, and 2.5 million prescriptions have already been dispensed. Robert DeLap, director of the FDA office of drug evaluation, stated that more research is necessary before reaching any conclusions. However, he does not think that Celebrex poses any special risk at this time.

Editorial comment: The case reports of deaths from gastrointestinal hemorrhage in patients on Celebrex are worth noting, but the significance of these findings is unclear. Celebrex has been shown to have a lower GI toxicity profile based on short-term endoscopic studies showing less ulcers and gastric irritation compared to other NSAIDs. However, long term studies of the incidence of clinically significant GI bleeding are still forthcoming. These current reports may point out that Celebrex, while significantly safer that other NSAIDs, will continue to have some GI toxicity. It should be noted that these reports are extremely small in number in comparison to the large number of prescriptions written. Many of these prescriptions are undoubtedly written for patients with a greater risk of GI bleeding, such as the elderly, patients with prior ulcer disease or patients on anticoagulants. Practitioners should continue to use Celebrex with caution in patients with significant risk of GI bleeding.

Pfizer-Pharmacia Deal Means You'll Hear More  of Celebrex

Source

The Wall Street Journal  

July 16, 2002

HEALTH

Pfizer-Pharmacia Deal Means You'll Hear More of Celebrex

The Hype Machine Is Gearing Up,
But Is Aspirin Still a Better Option?

By RON WINSLOW and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL
 
 



 

CELEBREX ARTICLES
 

• Study Finds Celebrex as Likely to Cause Ulcers as Older Drugs6
06/10/02
 
• Pharmacia's Celebrex Shows Promise as a Cancer Weapon7
05/22/02
 
• FDA Hearings on Celebrex, Vioxx Labels Could Be Crucial in Arthritis-Drug Fight8
02/07/01
 
• Gastrointestinal Benefit Is Cited for Celebrex9
09/13/00
 
 


COMPANIES
Dow Jones, Reuters
Pfizer Inc. (PFE)
PRICE
CHANGE
U.S. dollars		 28.92
-0.34
11:02 a.m.


 
 
Pharmacia Corp. (PHA)
PRICE
CHANGE
U.S. dollars		 39.86
-0.62
11:02 a.m.


 
 
Merck & Co. Inc. (MRK)
PRICE
CHANGE
U.S. dollars		 43.86
-0.64
11:02 a.m.


 
 
* At Market Close

For patients, the $53 billion merger that would join Pfizer Inc. with Pharmacia Inc. means you will be hearing more pitches for a powerful but controversial pain drug.

Celebrex, the blockbuster arthritis pill, is at the center of the deal, and consequently Pfizer is likely to move quickly to try to enhance the medicine's status as the top-selling pain-killer and seventh-most popular prescription drug. Specifically, says Henry McKinnell, Pfizer's chairman and chief executive, the company will press more aggressively what he believes is the drug's major advantage over its biggest competitor, Merck & Co.'s Vioxx: Celebrex hasn't been linked to a risk of any heart problems, while the Merck pill has.

Pfizer Worked Hard to Win $53.4 Billion Pharmacia Deal1

 

Alliances Prove An Iffy Panacea For Drug Makers2

 

Pfizer, Pharmacia Combination Raises Little Antitrust Concern3

 

That could mean patients will see a wave of new direct-to-consumer print and television advertising, a strategy that has helped propel Celebrex to the ranks of top-selling drugs world-wide, with some 34 million people taking it since it first came to market three years ago. Pfizer may also focus marketing efforts on doctors.

But both Celebrex and Vioxx, members of a class of drugs called COX-2 inhibitors, have a number of critics. Questions have been raised about their safety and risks, and some people believe that most patients would fare just as well with much cheaper generic pills -- including aspirin and ibuprofen -- known as NSAIDs, nonsteroidal anti-inflammatory drugs.

An 8,000 patient study failed to prove that Celebrex, with an average wholesale price of $2.20 per 200 milligram tablet, was better when it comes to stomach side effects than a common NSAID called diclofenac, which sells for pennies a pill. As a result, the Food and Drug Administration won't allow the company to market the pill as a safer alternative to generic medicines.

"We didn't get a clear win," Mr. McKinnell acknowledges.

Since neither Celebrex nor Vioxx have proven any better at relieving pain than generic painkillers, the main reason for taking them would be to avoid the side effects of the older, cheaper anti-inflammatories. Consequently, Mr. McKinnell says Pfizer aims to demonstrate -- possibly including another trial -- that Celebrex has a better safety profile than NSAIDs, which have been found to cause annoying and occasionally severe stomach problems, such as ulcers, in a minority of patients who use them.

Near a Peak?

The debate over generics and the recent approval of Bextra, a new COX-2 drug from the Pfizer-Pharmacia team, have led many Wall Street analysts to conclude that Celebrex sales are near their peak. Nonetheless, Mr. McKinnell was already hammering away at Celebrex's virtues Monday, echoing a strategy Pfizer used with another acquired blockbuster, the cholesterol-lowering Lipitor.

ASSESSING THE PAIN KILLERS
 
How Celebrex compares to other drugs used for arthritis:

 

Drug Plus Minus
Celebrex/$2.39* Not associated with increased incidence of heart problems About the same amount of stomach problems as generic pain killers
Vioxx/$3.58 Causes fewer stomach problems than aspirin or naproxen Linked to higher incidence of heart problems
Diclofenac/64 cents Cheaper than brand name rivals Can cause ulcers and other stomach complications
Generic/30 cents Cheaper than brand name rivals Can cause ulcers and other stomach problems
*Price of a typical daily dosage

 

Sources: Drugstore.com; WSJ research

 

"We have to communicate that cardiovascular safety is a critical differentiation between Celebrex and Vioxx," he said in an interview.

In response, a spokesman for Merck said that Vioxx has fewer stomach-related side effects than Celebrex or the generic pain remedies. Vioxx "demonstrates a superior gastro-intestinal benefit," he said.

Pfizer and Pharmacia already co-market Celebrex with enormous success. It racked up sales of $3.1 billion last year. In a further effort to boost sales, Pfizer and Pharmacia have already laid out an aggressive research program to continue to develop the Celebrex not only for pain, but for cancer and other conditions. They are certain to devote a portion of their combined $7 billion in annual research spending to studies intended to expand its market.

Improved Outcome

Already, a small study presented in May showed Celebrex improved the outcome for lung cancer patients when given as a "pretreatment" before chemotherapy and surgery. As a result, the company plans to launch a larger trial in lung-cancer patients, one of about 100 trials on the drawing boards for using Celebrex in cancer. Another major effort is in prevention of colon cancer; the drug is already approved as a preventive treatment in patients with a precursor to a rare form of inherited colon cancer.

For the longer term, the company is also investigating the drug's potential as a treatment for such problems as atherosclerosis, Lou Gehrig's disease, Alzheimer's disease, schizophrenia, and migraine headaches. In each of these conditions, the COX-2 enzyme, the drug's principal target, is present in unusually high amounts -- raising the possibility that blocking the enzyme might be an effective treatment strategy.

-- Geeta Anand contributed to this article

Write to Ron Winslow at ron.winslow@wsj.com4 and Scott Hensley at scott.hensley@wsj.com5

URL for this article:
http://online.wsj.com/article/0,,SB1026758902994143760.djm,00.html

 
Hyperlinks in this Article:
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(2) http://online.wsj.com/article/0,,SB1026771857982838640,00.html
(3) http://online.wsj.com/article/0,,SB1026768462738630960,00.html
(4) mailto:ron.winslow@wsj.com
(5) mailto:scott.hensley@wsj.com
(6) http://online.wsj.com/article/0,,SB1023663252342174760,00.html
(7) http://online.wsj.com/article/0,,SB1022013618820210160,00.html
(8) http://online.wsj.com/article/0,,SB981499084575451998,00.html
(9) http://online.wsj.com/article/0,,SB968798501888755687,00.html

Updated July 16, 2002 3:55 p.m. EDT

 
Copyright 2002 Dow Jones & Company, Inc. All Rights Reserved

Printing, distribution, and use of this material is governed by your Subscription agreement and Copyright laws.

For information about subscribing go to http://www.wsj.com
 

source

Celebrex Stomach Problems

Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation: Serious GI toxicity, such as bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Minor GI problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur. Only 1/5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for 1 year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

It is unclear, at the present time, how the above rates apply to CELEBREX (see CLINICAL STUDIES - Special studies in the complete prescribing information). Among 5,285 patients who received CELEBREX in controlled clinical trials of 1 to 6 months in duration (most were 3 month studies) at a daily dose of 200 mg or more, 2 (0.04%) experienced serious upper bleeding, at 14 and 22 days after initiation of dosing. Approximately 40% of these 5,285 patients were in studies that required them to be ulcer free by endoscopy at study entry. Thus it is unclear if this study population is representative of the general population. Prospective, long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking CELEBREX vs comparator NSAID products have not been performed.

NSAIDS should be prescribed with extreme caution in patients with a prior history of ulcer disease or GI bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for and adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high-risk patients, alternate therapies that do not involve NSAID products should be considered.

Source

  Key Drug Pipeline Databases on Dialog
  Lesson 4: Adis R&D Insight (File 107)		 back  

Sample Record from Adis R&D Insight (File 107) 
DIALOG(R)File 107:Adis R&D Insight
(c) 2001 Adis International Ltd. All rts. reserv.
00115699              006795
 DRUG NAME:            Celecoxib
RECORD REVISION DATE: 20010423
BRAND NAME:           Celebra; Celebrex; Niflam
SYNONYMS:             SC 58635; YM 177; Zycel
CHEMICAL NAME:        Benzenesulfonamide, 4-(1,1,1-trifluoromethyl- 5-(4-me
                      thylphenyl) pyrazol-1-yl)-
MOLECULAR NAME:       C17H14F3N3O2S
CAS REG. NO.:         169590-42-5
RELATED CAS REG. NO.: 194044-54-7
WHO ATC CODE:         L01X - Other Antineoplastic Agents; M01A-H - Coxibs;
                      M01A-H01 - Celecoxib; N02B - Other Analgesics and
                      Antipyretics
EPHMRA ATC CODE:      L1X - All Other Cytostatics; M1A3 - Anti-rheumatics,
                      COX-2 specific inhibitor; N2B - Non-Narcotics and
                      Anti-Pyretics
MECHANISM OF ACTION:  Cyclo-oxygenase 2 inhibitors; Oxidoreductase
                      inhibitors; Enzyme inhibitors
ORIGINATOR COMPANY:   Pharmacia Corporation (USA)
PARENT COMPANY:       Pharmacia Corporation
LICENSEE:             Pfizer; Roemmers; Yamanouchi
OTHER COMPANY:        Kendle International (CRO); Wood Worldwide;
                      Zydus-Cadila
HIGHEST PHASE:        Launched
DEVELOPMENT STATUS:   Launched, USA, Familial polyposis
                      Launched, Argentina, Osteoarthritis
                      Launched, Australia, Osteoarthritis
                      Launched, Belgium, Osteoarthritis
                      Launched, Brazil, Osteoarthritis
                      Launched, Canada, Osteoarthritis
                      Launched, China, Osteoarthritis
                      Launched, France, Osteoarthritis
                      Launched, Germany, Osteoarthritis
                      Launched, Italy, Osteoarthritis
                      Launched, Mexico, Osteoarthritis
                      Launched, New Zealand, Osteoarthritis
                      Launched, Spain, Osteoarthritis
                      Launched, Switzerland, Osteoarthritis
                      Launched, United Kingdom, Osteoarthritis
                      Launched, USA, Osteoarthritis
                      Launched, India, Rheumatic disorders
                      Launched, Argentina, Rheumatoid arthritis
                      Launched, Australia, Rheumatoid arthritis
                      Launched, Belgium, Rheumatoid arthritis
                      Launched, Brazil, Rheumatoid arthritis
                      Launched, Canada, Rheumatoid arthritis
                      Launched, China, Rheumatoid arthritis
                      Launched, France, Rheumatoid arthritis
                      Launched, Germany, Rheumatoid arthritis
                      Launched, Mexico, Rheumatoid arthritis
                      Launched, New Zealand, Rheumatoid arthritis
                      Launched, Switzerland, Rheumatoid arthritis
                      Launched, United Kingdom, Rheumatoid arthritis
                      Launched, USA, Rheumatoid arthritis
                      Registered, Sweden, Osteoarthritis
                      Registered, Mexico, Pain
                      Registered, USA, Pain
                      Registered, USA, Postoperative pain
                      Registered, Sweden, Rheumatoid arthritis
                      Phase III, USA, Barrett's oesophagus
                      Phase III, USA, Bladder cancer
                      Phase III, USA, Colorectal cancer
                      Phase II, Japan, Osteoarthritis
                      Phase II, Japan, Rheumatoid arthritis
                      Clinical (Phase Unknown), France, Ankylosing
                      spondylitis
                      Clinical (Phase Unknown), USA, Oesophageal cancer
                      Clinical (Phase Unknown), USA, Skin cancer
                      Preclinical, USA, Breast cancer
PHARMACOLOGY OVERVIEW:
  Pharmacodynamics:
  Analgesic effects; inhibition of crypt formation in rat colon; anti-
  inflammatory and antirheumatic effects; significantly reduces polyp
  numbers in patients with FAP
  Mechanism of action:
  Cyclo-oxygenase 2 inhibitors
     Oxidoreductase inhibitors
        Enzyme inhibitors
  --------------------------------------
  tmax (h) (oral)   1.75 - 2.08  (Adult)
  t (1/2) beta (h)  9.1 - 10.5   (Adult)
  Cl (L/h)          32.5 - 36.3  (Adult)
  --------------------------------------
  Linear kinetics: Yes
CLINICAL OVERVIEW:
  Route(s) of Administration: PO
  Comparative Efficacy:
  >=  Ketoprofen   (Ankylosing spondylitis, PO)
  =   Aspirin      (Postoperative pain, PO)
  =   Diclofenac   (Rheumatoid arthritis, PO)
  =   Naproxen     (Osteoarthritis, PO)
  =   Naproxen     (Rheumatoid arthritis, PO)
  Adverse events:
  occasional: Dizziness, Gastrointestinal disorders, Headache.
  Drug Interactions:
  Minimal. Therapy with celecoxib and warfarin requires monitoring of
  anticoagulant activity; administering celecoxib with cytochrome
 P450 2C9 inhibitors requires caution; therapy with celecoxib and
lithium requires close monitoring of lithium plasma levels . . . .
Adverse Events:
 General adverse events: the Medical Products Agency of Sweden has
stated that rofecoxib and celecoxib seem to have a similar
tolerability profile to other NSAIDs in patients with risk
factors (e.g. advanced age) for adverse effects such as fluid
retention, hypertension, heart failure and renal dysfunction.
The agency has advised that the same precautions and
contraindications apply to rofecoxib and celecoxib as for
other NSAIDs, particularly concerning patients with active
peptic ulcers, GI bleeding, severe heart failure and a history
of heart failure, hypertension and oedema. Up to September 2000,
no suspected cases of rofecoxib- or celecoxib-related
thromboembolic cardiovascular reactions were reported in Sweden;
however, such cases have been
. . . .
Case report of gastropathy: a 69-year-old woman with arthritis developed
 gastropathy during treatment with celecoxib (Celebrex sup((R))).
 The woman had Helicobacter pylori antibodies and was treated with
 lansoprazole, amoxicillin and clarithromycin. Two weeks later,
 her medication for arthritis was switched from tramadol to
 celecoxib 100mg bid. During treatment with celecoxib, the woman
 experienced severe epigastric pain. She was given another 2-week
 course of treatment for H. pylori infection. Six weeks after
 starting celecoxib, she was
. . . .
Pharmacokinetics:
Administration of a single oral dose of celecoxib to fasting European
and Japanese male volunteers, respectively, resulted in the following
pharmacokinetic values: C sub(max), 797 and 948 ng/ml; t sub(max), 1.75
and 2.08h; AUC, 6264 and 6730 ng x ml sup(-1) x h; t sub(1/2), 9.10 and
10.5h; and apparent clearance, 606 and 543 ml/min. When administered
as a capsule dosage form on an empty stomach, celecoxib was rapidly
absorbed achieving C sub(max) between 1-4h. The relationship between
. . . .
Clinical studies: familial adenomatous polyposis celecoxib 200 or 800
mg/day significantly reduced the number of polyps by 11.9 and 28%,
respectively, compared with placebo (4.3%) in patients with familial
adenomatous polyposis. When patients with complete spontaneous polyp
regression were excluded from the analysis, celecoxib treatment was
associated with a 5% decrease in the number of polyps and a 30%
decrease in polyp size compared with baseline. Patients received
celecoxib bid for 6 months/31/.
Pharmacodynamics (Rheumatic Disease):
Celecoxib inhibited carrageenan-induced paw oedema and adjuvant-
induced arthritis in rats. Oral administration of celecoxib
0.1-2.0 mg/kg inhibited prostaglandin E sub(2) production
in the carrageenan air pouch model of inflammation/32/.
Therapeutic Trials:
Cancer:
Dosage and administration - familial adenomatous polyposis:
celecoxib is marketed as Celebrex sup(TM) 100 and 200mg capsules,
and are administered as an adjunct to usual care.
Treatment of familial adenomatous polyposis: after 6 months'
treatment with oral celecoxib 800 mg/day, patients with familial
adenomatous polyposis experienced a significant 28% reduction
in the number of polyps compared with those given placebo.
Those who received the 200 mg/day dose had a 12% reduction
in polyp number, which was not significantly different
from the reduction seen in placebo recipients/ 31/.
.. . . .
REFERENCES:
1.    Gannedahloand E-L, Yue Q-Y. Coxibs and the reporting of adverse
      reactions. Medical Products Agency. 11: 74-77, Dec 2000.
      (Swedish).
2.    Simon LS, Lanza FL, et al. Preliminary study of the safety and
      efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor:
      efficacy and safety in two placebo-controlled trials in
      osteoarthritis and rheumatoid arthritis, and studies of
      gastrointestinal and platelet effects. Arthritis and Rheumatism.
      41: 1591-1602, Sep 1998. (English). 800712861
3.    Geis GS, Hubbard RC, et al. Efficacy of celecoxib, a specific
      cyclooxygenase-2 inhibitor, in osteoarthritis of the hip. Annals
      of the Rheumatic Diseases. : 205, 6 Jun 1999. (English).
      800743413
4.    Brugger AM, Richardson ET, et al. Comparison of celecoxic,
      hydrocodone/acetaminophen, and placebo for relief of post-
      surgical pain. 18th Annual Scientific Meeting of the American
      Pain Society. :  (2 pages), 21 Oct 1999. (English).
5.    Silverstein FE, Faich G, et al. Gastrointestinal toxicity with
      celecoxib vs nonsteroidal anti-inflammatory drugs for
      osteoarthritis and rheumatoid arthritis: the CLASS Study: a
      randomized controlled trial. Journal of the American Medical
      Association. 284: 1247-1255, 13 Sep 2000. (English). 800839353
6.    Lichtenstein DR, Wolfe MM. COX-2-selective NSAIDs. Journal of the
      American Medical Association. 284: 1297-1299, 13 Sep 2000.
      (English).
7.    Goldstein JL, Silverstein FE, et al. Reduced risk of upper
      gastrointestinal ulcer complications with celecoxib, a novel COX-
      2 inhibitor. American Journal of Gastroenterology. 95: 1681-1690,
      Jul 2000. (English). 800837873
8.    Pharmacia Corporation and Pfizer Inc. Findings from Celebrex (R)
      safety study show traditional NSAID comparators can cause serious
      GI complications within first few days of treatment. Media
      Release. :(4 pages), 23 May 2000. Available from: URL:
      http://www.pnu.com.  (English).
9.    Geis GS, Hubbard R, et al. Safety and efficacy of celecoxib, a
      specific COX-2 inhibitor, in patients with rheumatoid arthritis.
      Arthritis and Rheumatism. 41 (Suppl.): 364, Sep 1998. (English).
      800726754
10. Geis GS, Stead H, et al. Efficacy and safety of celecoxib, a
      specific COX-2 inhibitor, in patients with rheumatoid arthritis.
      Arthritis and Rheumatism. 41 (Suppl.): 316, Sep 1998. (English).
      800726737
11.   Mohammed S, Croom II DW. Gastrophy due to celecoxib, a
      cyclooxygenase-2- inhibitor. New England Journal of Medicine.
      340: 2005-2006, 24 Jun 1999. (English). 800755209
11. Crofford LJ, Oates JC, et al. Thrombosis in patients with
      connective tissue diseases treated with specific cyclooxygenase 2
      inhibitors: a report of four cases. Arthritis and Rheumatism. 43:
      1891-1896, Aug 2000. (English). 800844220
12. Crouch TE, Stafford CT. Urticaria associated with COX-2
      inhibitors. Annals of Allergy, Asthma & Immunology. 84: 140, Jan
      2000. (English). 800818414
14.   Nachimuthu S, Volfinzon L, et al. Acute liver injury induced by
      celecoxib. Gastroenterology. 118 (Suppl. 2): 1471, Part 2, Apr
      2000.  (English). 800827845
15. Galan MV, Gordon SC, et al. Celecoxib-induced cholestatic
      hepatitis. Annals of Internal Medicine. 134: 254, 6 Feb 2001.
      (English). 800860047
16.   Lantz MS, Giambanco V. Acute onset of auditory hallu
ADIS EVALUATION:
  Colorectal cancer 90 (PO).
  Familial polyposis 90 (PO).
  Pain 84 (PO).
  Osteoarthritis 83 (PO).
  Rheumatoid arthritis 81 (PO).
COMMERCIAL SUMMARY:
  Alzheimer's / COX-2 inhibitor
  ---------------------------------------------------------------------
  Company           Region    Launch Date   Peak Sales   Patent Expiry
  ---------------------------------------------------------------------
  Pfizer            Wrld      2004          $500m        2013
  Pharmacia Corp    Wrld      2004          $500m        2013
  ---------------------------------------------------------------------
  Arthritis / COX-2 inhibitor
  ---------------------------------------------------------------------
  Company           Region    Launch Date   Peak Sales   Patent Expiry
  ---------------------------------------------------------------------
  Pfizer            Japan     2002          $300m        2013
  Pfizer            US        Feb-1999      $2500m       2013
  Pfizer            ex US     1999          $500m        2013
  Pharmacia Corp    Japan     2002          $300m        2013
  Pharmacia Corp    US        Feb-1999      $2500m       2013
  Pharmacia Corp    ex US     1999          $500m        2013
  ---------------------------------------------------------------------
  Cancer prevention / COX-2 inhibitor
  ---------------------------------------------------------------------
  Company           Region    Launch Date   Peak Sales   Patent Expiry
  ---------------------------------------------------------------------
  Pfizer            Wrld      2002          $500m        2013
  Pharmacia Corp    Wrld      2002          $500m        2013
  ---------------------------------------------------------------------
  Cancer, prostate and pancreatic / Tyrosine kinase inhibitor
  ---------------------------------------------------------------------
  Company     Region     Launch Date     Peak Sales     Patent Expiry
  ---------------------------------------------------------------------
  Schwarz     Eur        2008            $150m          N/A
  ---------------------------------------------------------------------
  Rheumatoid arthritis, osteoarthritis / COX-2 inhibitor
  ---------------------------------------------------------------------
  Company        Region    Launch Date    Peak Sales    Patent Expiry
  ---------------------------------------------------------------------
  Yamanouchi     Jap       2002           $300m         n/a
  ---------------------------------------------------------------------
  Copyright (C) Lehman Brothers International. All rights reserved.

Source

CELECOXIB

Celebrex®
A COX-2 specific NSAID for the treatment of osteoarthritis & rheumatoid arthritis

TRADE NAME: Celebrex® Manufacturer: Searle Ltd & Pfizer Ltd
Status: PL 08821/0057-58 Launch date: May 2000
Committee’s Verdict: APPROPRIATE Anticipated BNF: 10.1.1

PDF VERSION OF VERDICT SHEET AVAILABLE

 

Celecoxib is only licensed for the treatment of osteoarthritis (OA) and rheumatoid arthritis (RA). It is appropriate for GPs to prescribe celecoxib as an alternative to currently available NSAIDs. However prescribers should note that:

  • Celecoxib appears no more effective than conventional NSAIDs.
  • Overall celecoxib demonstrates a similar pattern of adverse events to conventional NSAIDs*.

Celecoxib does however appear to be associated with a reduced incidence of endoscopic gastroduodenal ulcers. The clinical significance of this is not yet known. Celecoxib is not without risk for gastrointestinal adverse events.

 

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