This document provides information about the presentation of the drug Clacef® tablet. It begins with introducing the drug and contact information for the product executive. It then provides background on antibiotics in general, how they work, what they are used to treat. It discusses cephalosporins specifically, their classification and mechanism of action. It describes cefuroxime, clavulanic acid, and how their combination works to overcome antibiotic resistance from beta-lactamase producing bacteria. The document reviews indications for Clacef® and provides market analysis data on cefuroxime-containing brands. It concludes with actions to take to promote Clacef® to doctors and ensure proper stocking in pharmacies.

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

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. 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

37. 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

38. 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

39. Price
Product
Pack
Size
TP
(BDT)
TP + VAT
(BDT)
IP
Includin
g
VAT/Pac
k
(BDT)
IP
Includin
g
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

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

41. So…
Now the to prove ourselves

42. 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

43. 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.

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