This document provides information about the antibiotic Clacef® tablet, which combines cefuroxime and clavulanic acid. It discusses how antibiotics and cephalosporins work, the issues of antibiotic resistance from beta-lactamase enzymes, and how clavulanic acid helps restore the efficacy of cefuroxime by inhibiting these enzymes. The document then reviews the indications, dosage, and competition of Clacef® tablet before outlining the launch and marketing strategy to target physicians and gain market share.

1. To the Presentation on
Clacef® Tablet
Sultan Mahmud
Sr. Product Executive, PMD
Cell: 01713-374701
Cefuroxime BP 125 mg + Clavulanic Acid USP 31.25 mg
Cefuroxime BP 250 mg + Clavulanic Acid USP 62.5 mg
Cefuroxime BP 500 mg + Clavulanic Acid USP 125 mg

2. What are antibiotics?
The US National Library of Medicine1 says that
antibiotics - powerful medicines that fight bacterial
infections - can save lives when used properly.
Antibiotics either stop bacteria from reproducing or kill
them. "Your body's natural defenses can usually take it
from there."

3. How do antibiotics work?
Although there are a number of different types of
antibiotic they all work in one of two ways:
 A bactericidal antibiotic kills the bacteria. Penicillin is a
bactericidal. A bactericidal usually either interferes with
the formation of the bacterium's cell wall or its cell
contents.
 A bacteriostatic stops bacteria from multiplying.

4. What are antibiotics used for?
An antibiotic is given for the treatment of an infection
caused by bacteria. Antibiotics target microorganisms
such as bacteria, fungi and parasites. However, they are
not effective against viruses.

5. Cephalosporins
 The cephalosporins are the largest and most diverse
family of beta-lactam antibiotics.
 Cephalosporin compounds were first isolated from
cultures of bacteria Cephalosporium acremonium found
in a sewage outfall off the Sardinian coast in 1948 by
Italian scientist Giuseppe Brotzu. The first agent
cephalothin (cefalotin) was launched by Eli Lilly in 1964.

6. Classification
of
Cephalosporins

7. First-Generation Cephalosporins
 cefadroxil
 cefazedone
 cefazolin
 cephalexin
 cephalothin
 cephradine
 cephaloridine

8. Second-Generation Cephalosporins
 cefaclor
 cefamandole
 cefprozil
 cefuroxime

9. Third-Generation Cephalosporins
 cefcapene
 cefdinir
 cefditoren
 cefetamet
 cefixime

10. Fourth-Generation Cephalosporins
 cefepime
 cefluprenam
 cefozopran
 cefpirome
 cefquinome

11. What is Beta-lactamases
Beta-lactamases are enzymes produced by some bacteria
that provide resistance to β-lactam antibiotics like penicillins,
cephamycins.
Beta-lactamase provides antibiotic resistance by breaking the
antibiotics' structure.
These antibiotics all have a common element in their
molecular structure: a four-atom ring known as a β-lactam.
Through hydrolysis, the lactamase enzyme breaks the β-
lactam ring open, deactivating the molecule's antibacterial
properties.

12. What is cefuroxime?
Cefuroxime, a classical 2nd generation cephalosporin
can be the drug of choice due to-
Wide bacterial coverage
Gram Positive
Gram Negative
Anaerobes
Excellent safety profile

13. Mechanism of action

14. What is Clavulanic acid
Clavulanic acid is a β-lactam drug that functions as a
mechanism-based β-lactamase inhibitor.
It is not effective by itself as an antibiotic, when
combined with penicillin-group antibiotics.
it can overcome antibiotic resistance in bacteria that
secrete β-lactamase, which otherwise inactivates most
penicillins and Cephalosporins.

15. Mechanism of action

16. Antibiotic resistance
Antibiotic resistance occurs when bacteria change in
some way that reduces or eliminates the effectiveness
of drugs, chemicals, or other agents designed to cure
or prevent infections. The bacteria survive and
continue to multiply causing more harm.

17. Cefuroxime is being
resistant

18. Due to…
 The Overuse and Misuse of Cefuroxime
 Increasing ß-lactamase enzyme producing bacteria
 Increasing Extended Spectrum ß-lactamase
(ESBL) producing organisms

19. Health Protection Agency, UK Stated
that…
Extended-Spectrum Beta- Lactamases (ESBLs) are
enzymes that can be produced by bacteria
making them resistant to the most widely used
antibiotic Cefuroxime in 2013.

20. Extended Spectrum ß-lactamase(ESBL)
The enzyme that capable of breaking down a wide range
of penicillin & Cephalosporin type antibiotics of oral and
a limited number of intravenous treatment options.
Producing organisms:
Klebsiella species
Escherichia coli (E. coli), &
S. aureus

21. ß-lactam Ring Inactivation by the Beta
Lactamase producing organisms

22. As
Beta lactamase enzyme
is the main reason of resistance,
Beta lactamase inhibitor should be
added to Cefuroxime to
Restore and Optimize
the efficacy.

23. Clavulanic acid is added with Cefuroxime
Because Clavulanic Acid:
 A suicidal inhibitor of ß-lactamase enzyme.
 Irreversibly binds with ß-lactamase enzyme.
 Increases the spectrum and
 Restores antimicrobial activity of Cefuroxime
against ß-lactamase producing bacteria.

24. Major Indications
 Respiratory Tract Infections
 Urinary Tract Infections
 Dental Infections
 Surgical Site Infections
 ENT infections
 Skin and Soft Tissue Infections

25. Pregnancy category

26. Launching DHAMAKA !!!!!
 Launching Literature
 Sample (Customized)
 Launching Gift (Customized)

27. Dear Sir/Madam,
In this visual you can see that
a man is fastening with rope
that’s why he can not move
normally as a result his daily
activity is hampered,
Like that, Bacterial resistance
limits the activity of Antibiotic

36. Launching Gift
Glass set

39. Brand Logo
Bottom View Inner view

40. Market Analysis IMS_2nd_QTR_15
Brand Company Value (BDT) Cr. Growth (%)
CEFUROXIME AXETIL 340.04 12.67
Cefotil Square 37.99 -0.53
Furocef Renata 32.65 -4.93
Cerox-cv ACI 26.92 200.66
Cefaclav Incepta 25.98 17.38
Kilbac Incepta 19.09 -7.40
Clavusef Opsonin 17.89 -27.07
Furotil Health vare 13.54 49.50
Furoclav Renata 12.14 129.54
Turbocef Beximco 12.06 6.40
Zinnat GSK 11.25 -18.65
Kefuclav Eskeyaf 9.26 79.45
Sefur Opsonin 9.11 -18.11
Furex drug international 8.90 10.49
Famicef Acme 7.69 3.50
Axim Aristo pharma 7.64 -0.31

41. Brand Company Value (BDT) Cr. Growth(%)
CLAVULANIC ACID + Others 167.73 45.18
Cerox-cv Aci 26.92 200.66
Cefaclav Incepta 25.98 17.38
Moxaclav Square 22.00 15.10
Clavusef Opsonin 17.89 -27.07
Fimoxyclav Samsul Alamin 13.17 64.27
Furoclav Renata 12.14 129.54
Fuclav Drug international 7.62 69.76
Tyclav Beximco 6.69 33.32
Xiclav Ziska 4.32 175.68
Cefotil plus Square 3.79 999.00
Market Analysis IMS_2nd_QTR_2015

42. Prescription share November_15
Brand Company Rx share
Clavusef Opsonin 17.96
Cefaclav Incepta 10.32
Cerox-cv ACI 9.59
Cefotil plus Square 8.72
Fuclav Drug int 6.92
Secoclav General 6.8
Famiclav ACME 6.76
Furoclav Renata 6.73

43. Price
Product
Pack
Size
TP
(BDT)
TP + VAT
(BDT)
IP
Including
VAT/Pack
(BDT)
IP
Including
VAT/Unit
(BDT)
Clacef® 125
Tablet
4 x 4 215.90 250.44 288.00 18.00
Clacef® 250
Tablet
4 x 3 269.87 313.04 360.00 30.00
Clacef® 500
Tablet
4 x 2 299.85 347.82 400.00 50.00

44. Target Doctors
ENT
Medicine specialist
Gynecologist
Ophthalmologist
Surgery
Pediatric
GP

45. So…
Now the to prove ourselves

46. Actions to be taken
 Ensures adequate shelving of Clacef® 125
mg, 250 mg, 500 mg Tablet.
 Inform all the potential doctors about Clacef®
125 mg, 250 mg, 500 mg Tablet And
explain the superiority over other

47. Actions to be taken
 Strictly monitor & identify the prescribers of direct
competitor- Cerox CV (ACI), Clavusef (Opsonin),
Cefaclav (Incepta) & indirect competitor-
Cefuroxime Prescriber like Cefotil (SQR), Furocef
(Renata), Kilbac (Incepta), Furex (DI), Sefur
(Opsonin); Amoxicillin-Clavulanate prescriber
like- Fimoxyclave (Aventis); Moxaclav (SQR),
Demoxil-Plus (DI) and pursue them to prescribe
Clacef® by highlighting superiority.
We hope and believe that Clacef® will help to
strengthen our position in antibiotic market.

48. Wish a successful launching & proper shelving of
Clacef®