To the Presentation on

Clacef® TabletSultan Mahmud

Sr. Product Executive, PMDCell: 01713-374701

Cefuroxime BP 125 mg + Clavulanic Acid USP 31.25 mgCefuroxime BP 250 mg + Clavulanic Acid USP 62.5 mgCefuroxime BP 500 mg + Clavulanic Acid USP 125 mg

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."

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.

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.

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.

Classificationof

Cephalosporins

First-Generation Cephalosporins

cefadroxil cefazedone cefazolin cephalexin cephalothin cephradine cephaloridine

Second-Generation Cephalosporins

cefaclor cefamandole cefprozil cefuroxime

Third-Generation Cephalosporins

cefcapene cefdinir cefditoren cefetamet cefixime

Fourth-Generation Cephalosporins

cefepime cefluprenam cefozopran cefpirome cefquinome

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.

What is cefuroxime?

Cefuroxime, a classical 2nd generation cephalosporin can be the drug of choice due to-

Wide bacterial coverageGram Positive

Gram NegativeAnaerobes

Excellent safety profile

Mechanism of action

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.

Mechanism of action

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.

Cefuroxime is being

resistant

Due to…

The Overuse and Misuse of Cefuroxime

Increasing ß-lactamase enzyme producing bacteria

Increasing Extended Spectrum ß-lactamase(ESBL) producing organisms

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.

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

ß-lactam Ring Inactivation by the Beta Lactamase producing organisms

As Beta lactamase enzyme is the main reason of resistance,Beta lactamase inhibitor

should be added to Cefuroxime to Restore and Optimize

the efficacy.

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.

Major Indications

Respiratory Tract Infections Urinary Tract Infections Dental Infections Surgical Site Infections ENT infections Skin and Soft Tissue

Infections

Pregnancy category

Launching DHAMAKA !!!!!

Launching Literature Sample (Customized)Launching Gift

(Customized)

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

Launching Gift

Glass set

Brand Logo

Bottom View Inner view

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

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

Prescription share November_15

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

Price

ProductPackSize

 

TP(BDT)

 

TP + VAT

(BDT)

IPIncludi

ngVAT/Pack(BDT)

IPIncludi

ngVAT/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

Target Doctors

ENTMedicine specialistGynecologistOphthalmologistSurgeryPediatricGP

So…

Now the to prove ourselves

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

 

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.

Wish a successful launching & proper shelving of

Clacef®