Tibone® (tibolone) technical discussion (training session)

Hormone Replacement Therapy

1. Launching Tibone® Tablet By MD.
Masum Chowdhury 1
Launching Presentation
on Tibone
®
(Tibolone)
The Tissue-Specific effects
of Tibone
®
(tibolone)
Presented By:
MasumChowdhury
Product Officer
Techno Drugs

2. This presentation was prepared in
the year 2005.
At that time I was a Product Officer
at Techno Drugs Ltd.
Launching Tibone® Tablet By MD.
Masum Chowdhury 2

3. Launching Tibone® Tablet By MD.
Masum Chowdhury 3
OUR CUSTOMERS IN THE
NEW AGE
•More Educated
•Wants to enjoy life in any age
•Aware of Competitive Product
(Livial, Uvilon)
•Aware about the adverse effects
of Conventional HRT
•Sensitive to Health and Social
issues
•Aware of Global Trand

4. •Choosing and tracking
appropriate customers for
Tibone
•Positioning your offering
•Interacting with those
customers who are Prescribe
and use Tibone
•Controlling the marketing
effort
•Continuity of performance

5. Characteristics of Climacteric Syndrome
•Hot flushes
•Night sweat
•Vaginal irritation
•Insomnia
•Depression

6. Launching Tibone® Tablet By MD.
Masum Chowdhury 6
Problems of Menopause
Vasomotor symptoms
Urogenital problems
Psychogenic problems
Osteoporosis
Coronary heart disease
Other problems

7. Launching Tibone® Tablet By MD.
Masum Chowdhury 7
VASOMOTOR SYMPTOM
Most womenwho seek medical
attention for menopausal symptoms
complain of vasomotor symptoms.
Hot Flashes or Flushes
Night Sweat
HotFlushes:Thisisexperienced
byabout65-85%ofwomenforabout
1-2yearsinherClimactericperiod

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Masum Chowdhury 8
Somatotrophic symptoms
Theseinclude:atrophic-inflammatory
changesofthevulva,vagina,bladder,
andurethra(urogenitalatrophy),
atrophyoftheskinandthebreasts,
pruritus,painonsexualintercourse,
urinaryincontinence,dysuria(painful
urination).

9. Constilation of Symptoms
Preceded by an aura
Finger temperature raises about 6
degrees
Pulse rate increases about 10
beats
Itisusuallytransient,butmaylast
upto30minutes.Itisthemajor
causeofinsomnia.

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Masum Chowdhury 10
Urogenital Problems
Vaginitis:Resultsfromatrophyofthegenital
epithelium.
Symptoms include:-
•Irritation
•Burning
•Pruritus
•Leucorrhoea

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Masum Chowdhury 11
Duetothevaginalmucosalchanges.
Symptoms include:-
•Dyspaerunia
•Vaginitis
•Vaginismus
•Physical discomfort
•Loss of sexual interest
Sexual Dysfunctions

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Masum Chowdhury 12
Due to atrophy of lower urinary tract
mucosa
Symptoms include:-
•Dysuria
•Cystitis
•Urethral caruncles
•Urethritis
Urinary Dysfunction

13. PsychogenicProblems
Emotional challenges particularly for
Newly menopausal woman are
Anxity
Depression
Insomnia
Headache

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Masum Chowdhury 14
Osteoporosis
Exaggereted bone mass loss particularly
trabecular bone leads to disabilities, like
Back pain
Decreased height
Decreased mobility
Increased risk of fracture of
Vertebral body (spinal compression)
Hip bones
Ribs, Humerus, etc.

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Masum Chowdhury 15
Coronary Heart Disease
Incidence of
Cononary Heart disease (CHD),
Congestive Heart Failure (CHF),
Atherosclerotic Cardiovascular
Disease (ACD)
Are significantly lower in
premenopausal women than men, but
after menopause rise above those for
men.
Oestrogens level is the prime factor
that makes the difference.

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Masum Chowdhury 16
OtherProblems
Marked thinning and wrinkling of skin
Loss of axillary and pubic hairs
Mild Hirsutism
Atrophy of Breast
Intraumbilical obesity due to fat
mobilization
Low HDL-Cholesterol and High LDL-
Cholesterol

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Masum Chowdhury 17
Metabolic Symptoms
Inaddition,metabolicchangesmay
alsotakeplace:atendencytogain
weight,osteoporosis,riseinlipids
(bloodfats),rheumaticchanges,and
atendencytogout.

18. SurgicalMenopauseoccurswhenovaries
removed,usuallyduringahysterectomy
(removaloftheuterus).Hysterectomyisthe
secondmostcommon majorsurgical
procedureamongreproductive-agedwomen.
HormonetherapyisthemosteffectiveFDA-
approvedmedicineforthesemenopausal
symptoms.
Why Surgical Menopause
Occurs

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Masum Chowdhury 19
Typical symptoms of Surgical Menopause
Hotflashes—flushingwithasensationofheatthat
mayincludesweatingoftenaccompaniedbyan
increasedpulserate,palpitations,andsometimes
followedbychills
•Nightsweats—hotflasheswithdrenching
perspirationoccurringatnight
Vaginaldryness—associatedwithitching,burning,
andirritation;sexualintercoursemayalsobemore
difficult,orevenpainful.Ifyouareexperiencingonly
vaginalsymptoms

20. Launching Tibone® Tablet By MD.
Masum Chowdhury 20
What is Tibolone
•Tibolone is tissue specific hormone
replacement therapy. Tibolone’s
tissue specific activity may be
explained by the interplay of
several mechanisms,

21. Launching Tibone® Tablet By MD.
Masum Chowdhury 21
What is Tibolone
•Such as
–Metabolic Conversion of tibolone to
compounds with different biological
activity.
–Classical interaction with steroid
receptor.
–Specific local metabolism within the
target tissue.

22. Launching Tibone® Tablet By MD.
Masum Chowdhury 22
Tibone
®
(Tibolone):
Clinical Experience
•Efficacy
•Climacteric Complaints
•Mood and sexual well -being
•Urogenital System
•Bone
•Safety
•Endometrium
•Breast
•Cardiovascular System

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Masum Chowdhury 23
Tibone
®
(tibolone): Efficacy

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Masum Chowdhury 24
Tibone and climacteric
complaints
•Climacteric complaints are common
and affect quality of life and well-being
•Tiboneis as effective as conventional
HRT in relieving hot flushes and
sweating

25. Launching Tibone® Tablet By MD.
Masum Chowdhury 25
Tibone:Effects on mood and sexual
well-being
•Tiboneimproves mood and libido in
postmenopausal women
•Tibonehas a beneficial effect on sexual well-
being by increasing sexual desire, frequency
of arousability, sexual fantasies and vaginal
lubrication
•Tibone also produces significant
improvement in sexual enjoyment compared
with conventional HRT with regard to coital
frequency and satisfaction

26. Launching Tibone® Tablet By MD.
Masum Chowdhury 26
Tibone and the urogenital
system
•Gives Oestrogenic effect on
vagina
•Improves vaginal atrophy and
urogenital symptoms

27. Launching Tibone® Tablet By MD.
Masum Chowdhury 27
The effects of Tibone on bone
•Tibone increases bone mineral
density by reducing bone turnover
and prevents osteoporosis in a
similar manner to Oestrogens

28. Launching Tibone® Tablet By MD.
Masum Chowdhury 28
The effects of Tibone
•Tiboneclosely matches the ideal product
profile treatment of prevention of bone loss in
postmenopausal women

29. Launching Tibone® Tablet By MD.
Masum Chowdhury 29
Tibone: Tolerability
•Tibonehas a different effect on
breast tissue compared with
conventional HRT; the incidence of
breast tenderness is lower
•Tiboneshows a high amenorrhoea
rate and significantly less irregular
bleeding than seen with
conventional HRT

30. Launching Tibone® Tablet By MD.
Masum Chowdhury 30
Tibone: Safety

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Masum Chowdhury 31
Tibone and the endometrium
•Endometrium
•Tissue-Specific endometrial
conversion into D
4
-metabolite
•Progestogenic dominant effect on
the endometrium
•No endometrial stimulation
•No withdrawal bleeds

32. Launching Tibone® Tablet By MD.
Masum Chowdhury 32
Breast safety HRT and diagnosis of
breast cancer
•Mammography is the best
diagnostic test in women over 50
•HRT can induce mammographic
changes

33. Launching Tibone® Tablet By MD.
Masum Chowdhury 33
Tibone and the breast Conclusions
•Tiboloneis a tissue-specific steroid with Oestrogenic,
progestogenic and androgenic activity
•In vitrostudies show that Tibolone inhibits the
production of estradiol in breast cells.
•Tibonehas an effect on the breast that is different from
that of Oestrogens

34. Launching Tibone® Tablet By MD.
Masum Chowdhury 34
How does Tibone works
Tibolone
Active Metabolites
3 -OH-Tibolone D 4 -Isomer
Oestrogenic receptorsProgesterone receptorsAndrogenic Receptors
Bone:Decreases bone turnover
Improves bone density
Vagina: Improves vaginal
dryness
Reduce Dyspaerunia
Brain:Improves libido
Increase Sexual well-being
CVS: Stimulation cardiac output,
blood flow, vessel relaxation.
Reduce serum HDL
Endometrium:
No endometrial
proliferation
3 α -OH-Tibolone

35. Launching Tibone® Tablet By MD.
Masum Chowdhury 35
Tibone and the Cardiovascular System
•Stimulates cardiac output, blood flow, vessel
relaxation.
•Stimulates fibrinolysis, no effect on
coagulation
•Decreases total cholesterol, triglycerides and
lipoprotein(a)
•Animal studies suggest a strong anti -
atherosclerotic effect
•To date, there is no evidence of an increase in
CHD risk

36. Launching Tibone® Tablet By MD.
Masum Chowdhury 36
Tibone : Efficacy
•Efficacy
•Tiboneis as effective as conventional HRT in relieving
hot flushes
•Tiboneenhances mood and libido in postmenopausal
women
•Tibonehas a beneficial effect on sexual well-being by
increasing sexual desire, vaginal lubrication and by
improving sexual enjoyment
•Tibonetreats vaginal atrophy and improves urogenital
symptoms
•Tiboneis as effective as conventional HRT in preventing
bone loss in postmenopausal women
•Tiboneincreases bone density in osteoporotic women

37. Launching Tibone® Tablet By MD.
Masum Chowdhury 37
Tibone: Clinical Experience
•Tolerability
•Tibonehas a different effect on breast
tissue compared with conventional HRT;
the incidence of breast tenderness is
lower
•Tiboneshows a significantly less
irregular bleeding than seen with
conventional HRT

38. Launching Tibone® Tablet By MD.
Masum Chowdhury 38
Tibone: Safety Profile
•Tolerability
•Tibonedoes not stimulate the
endometrium
•Tiboneshows no stimulation of the
breast and no increase in mammographic
density has been observed
•Tibonehas beneficial effects on several
cardiovascular parameters
•

39. Launching Tibone® Tablet By MD.
Masum Chowdhury 39
Action Plan
Tibone
®
•Tibone
®
(TibolonelNN2.5mg)Tabletfororal
administration.

40. Launching Tibone® Tablet By MD.
Masum Chowdhury 40
Tibone
®
•Presentations:It is a white tablet.
Tibone (Tibolone lNN 2.5 mg)
•DosageForm:Tablet
•RoutesofAdministrations:Oral

41. Launching Tibone® Tablet By MD.
Masum Chowdhury 41
Objectives
•1.Firstyoushouldneedtoknowthatour
visionistoenternewhorizon.Weare
optimistictoourTibone
®
.
•2.EstablishTechnoProductsTibone
®
asthe
1
st
ChoiceinMenopausalsymptoms
management.
•3.Prescriptionisprestige.Soyouconvinceat
least5Gynaecologistsormoreatyourterritory
toprescribeourTibone
®

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Masum Chowdhury 42
Objectives
•1.Take extra care on Tibone
®
for steady
growth of those presentations in every month
•2.Try to increases 100% prescription share
and sales of Tibone
®
from General
Physicians, Medicine Doctors, Gynaecologists,
Orthopaedic Doctors and Endocrinologists etc.
•3.To achieve the individual territorial target of
Tibone
®
Tablet in the month of
September’05from the rural market and urban
market.
•4.Highlight the product benefits to the Doctors.

43. Launching Tibone® Tablet By MD.
Masum Chowdhury 43
Target Doctors
•MedicineDoctors,
•Gynecologists(speciallyladyGynecologists)
•Endocrinologists
•Orthopaeditricians
•GeneralPhysicians

44. Launching Tibone® Tablet By MD.
Masum Chowdhury 44
Positioning
•Tibone
®
istheworldfamoushormone
replacementtherapyformenopausalwomen.
•Tibone
®
istheDrugofchoicefor
Menopausalsymptomssuchas
•1. Vasomotorsymptoms
•2. Osteoporosis
•3. Urogenitalproblems
•4. Psychogenicproblems
•5. Coronaryheartdiseasesetc.

45. Launching Tibone® Tablet By MD.
Masum Chowdhury 45
How to promote Tibone ®with Doctors
RefreshyourproductknowledgeofTibone®
®
by
reviewingtheactionplantodetailthebrandconfidentlyto
thetargetDoctors.
SelectandmakealistofGynaecologistsinyour
territoryforpromotingTibone®
Requestyourgenuinecustomers(Doctors)to
prescribeonemoreprescriptionperday.
 HighlightthesurprisingnewsaboutHRTand
highlightthathormonereplacementtherapyisthe
basicRightofeverywomen

46. Launching Tibone® Tablet By MD.
Masum Chowdhury 46
•HighlightthatTibone®therapyduringmenopause
protectsbonemassandhelpsprotectagainsttherisk
ofosteoporoticfractures.
•HighlightthatTibone®successfullypreventtheHot
flushes,nightsweats,Decreasedlibido,vaginal
dryness.Osteoporosisetc.
•PleaseidentifytheDoctorswhoarecurrently
prescribingUbilon/Livial®offerthemthebenefits
andreasonablepriceofTibone®andensure
prescriptionsgenerationfromthem.
How to promote Tibone ®with Doctors

47. Launching Tibone® Tablet By MD.
Masum Chowdhury 47
Tibone -PRODUCT LIFE CYCLE
Launching Tibone
INTRODUCTION
GROWTH
MATURITY
DECLINE
Tibone

48. Launching Tibone® Tablet By MD.
Masum Chowdhury 48
Pack size and Price Information's
Brand
Name
Generic
Name
Dosage
Form
Pack
Size
MRP
Tibone ®Tibolone
lNN 2.5 mg
Tablet 3x10
Tablets
Tk.
450.00

49. Launching Tibone® Tablet By MD.
Masum Chowdhury 49
Major Competitors
Brand
Name
Company
Name
Dosage
Form
Pack SizeMRP
Livial Organon Tablet 1x28
Tablets
Tk.
1100.00
Ubilon Incepta Tablet 3x10
Tablets
Tk.
600.00

50. Launching Tibone® Tablet By MD.
Masum Chowdhury 50
Major Responsibility
Aggressive Promotion to the Doctors, Chemist
Shop, Selective Society is needed.

51. Launching Tibone® Tablet By MD.
Masum Chowdhury 51
A Final Note About Tibone
Tibone –Improves Lives
Tibone –Extands Lives
Tibone –Save Lives
Tibone –One Tablet a Day Keeps Menopause Away

52. Launching Tibone® Tablet By MD.
Masum Chowdhury 52
Thank You Very Much
Believe in Yourself,
Wish you a Great Success
Keep Win –Win Attitude

53. Present Position (June 7, 2013)
Masum Chowdhury
Manager,
Strategic Brand Management Department
Asiatic Laboratories Ltd.
[email protected],
[phone], [phone]