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Developing The New Product Of Ivabradine Commerce Essay

This is a management research on developing the new product of Ivabradine in Aurabindho Pharmaceuticals, Hyderabad, in which, we will be discussing briefly on given topics.  We will take the help of different theories related to the topic and also we will go through the life cycle and development of the organisation, which will help us to evaluate the final product of the assignment.

Among the largest 'Vertically Integrated' pharmaceutical companies in India, Aurabindho has robust product portfolio spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterologicals, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil for both APIs & Formulations and has Global presence with own infrastructure, strategic alliances, subsidiaries & joint ventures. Aurabindho have so many branches worldwide. The company was promoted in 1986 by Nityananda Reddy and a small, highly committed group of professionals. It became a public venture in 1992 and commenced operations in the year 1988-89 with only a single unit manufacturing semi-synthetic penicillins (SSPs) at Pondicherry.

 Aurobindo Pharma went public in 1995 by listing its shares in various stock exchanges in the country. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular and gastroenterology. The company has an addressable market estimated at US $209 billion for its product basket. This buoyant trend for generics is expected to continue and Aurobindo will seek to ride the trend. Company chairman PV Ramprasad Reddy says, “We will be the best partner for all our stakeholders. I have a dream for Aurobindo as well as courage and stamina to transform ourselves into one of the top three pharmaceutical companies in the country aided by our dedicated team of over 6,900 people. We shall continue to shape our organization for the future and promote the interests of all our stakeholders.”

Introduce the Product:

Ivabradine is a specific heart rate lowering agent, acting by reducing the rate of pacemaker activity in the sinoatrial node. Within the sinoatrial node, Ivabradine is a selective inhibitor of If , an important current involved in generating the early phase of spontaneous diastolic depolarisation in pacemaker cells, thereby reducing the frequency of action potential initiation and lowering heart rate. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation or coronary vasomotricity.

Chronic stable angina pectoris is a common disorder; the annual incidence varies between ~0.2% in southern European countries and > 0.6% in northern Europe. In countries with relatively high coronary heart disease rates, the prevalence may be 3–4% of the total population. The term is primarily used for chest discomfort due to myocardial ischaemia associated with coronary artery disease (CAD), although it is recognised that there are other important causes of angina pectoris, such as aortic stenosis and hypertrophic cardiomyopathy. The symptoms occur when there is an imbalance between myocardial perfusion and the demands of the myocardium and the pathological substrate for this is almost invariably atheromatous narrowing of the coronary arteries. In daily life, symptoms typically occur in conditions associated with increased myocardial oxygen consumption, such as during exercise. (Fox,k 2003)

However, even instable angina pectoris, symptoms may vary from time to time, depending on such factors as ambient temperature and emotional stress. Prognosis of stable angina pectoris is relatively good in most patients, with an overall mortality rate of 2–3% per annum, although a further 2–3% each year will have a non-fatal myocardial infarction and some subgroups of patients, such as those with impaired left ventricular function, are at much higher risk. The primary goals in the treatment of stable angina pectoris are (1) to improve prognosis by preventing myocardial infarction and death and (2) to minimize or abolish symptoms. The treatment of angina includes attempts to halt progression of coronary atherosclerosis (e.g. by lifestyle changes), besides drugs and interventional techniques to accomplish these goals. Three main classes of drugs are used to control symptoms in chronic stable angina: nitrates, beta-blockers (e.g. Atenolol) and calcium channel blockers (e.g. Amlodipine). For symptom relief, generally sublingual short-acting nitrates are used whereas long-acting nitrates are used for intermittent prophylaxis as continuous treatment leads to tachyphylaxis. It is recognised that heart rate reduction is of paramount importance in the treatment of patients with coronary artery disease and angina. Heart rate reduction decreases oxygen consumption which prevents symptoms and has been shown as an independent factor for reducing morbidity and mortality in patients with CAD. Beta-blockers reduce heart rate and are usually the first-line prophylactic treatment for stable angina in Europe, based on their proven long-term anti-anginal effect as well as positive effects on clinical outcome. Calcium channel blockers are mostly a second-line alternative when beta-blockers are contraindicated or ineffective (or in combination when beta-blockers alone are insufficient). Currently, a new concept for therapeutic class of anti-ischaemic agents with specific negative chronotropic action has been developed, the If inhibitors. This new concept involves decreasing the heart rate and thereby prolongation of the duration of diastole, so as to improve the balance between myocardial oxygen supply and demand as well as coronary perfusion.(Fox,K 2003)

Benefits of the product:

The main issue in the overall benefit/risk assessment was the potential place of Ivabradine in the current treatment of chronic stable angina pectoris, with beta blockers and calcium channel blockers respectively as established first- and second-line therapies. Ivabradine shares with beta-blockers similar heart rate reducing effects, which remain one key therapeutic objective instable angina. Beta-blockers have additional beneficial effects beyond reduction of heart rate and in contrast to beta-blockers; Ivabradine is devoid of anti-arrhythmic effect. Ivabradine showed comparable anti-anginal efficacy versus Atenolol. Safety data indicated a less favourable safety profile in terms of cardiac events, events leading to treatment discontinuations and deaths. Pharmacodynamic and clinical studies did not raise suspicion that Ivabradine itself would have detrimental effects on cardiovascular morbidity and mortality but data were limited. Final conclusions were difficult to draw, as these studies were not designed to show whether Ivabradine confers a benefit in terms of morbidity and mortality in patients with coronary artery disease. The benefit/risk ratio of Ivabradine was overall considered less favourable compared to Atenolol, and therefore Ivabradine was considered as an alternative treatment for those patients who have contraindication or intolerance to beta-blockers.( Tardif, J. C., Ponikowski 2008)

A second issue was whether further restriction of the indication would be warranted with regard to calcium antagonists. Overall, the benefit/risk ratio of Ivabradine was found comparable to that of Amlodipine. In contrast to Amlodipine, Ivabradine had the potential to induce bradycardia (risk factor for arrhythmia), which raised some concern in the absence of anti-arrhythmic efficacy and with the potential for pharmacokinetic interactions. However, the possibility of dosing patients with the Ivabradine dose of 10 mg twice daily was withdrawn and heart rate threshold for treatment initiation was raised to 60 bpm, thus minimising the risk of excessive bradycardia. No comparisons with nondihydropyridine Calcium channel blockers such as diltiazem were made.Overall, the CHMP concluded that Ivabradine had demonstrated anti-anginal and anti-ischemic effects in patients with chronic stable angina pectoris, and that Ivabradine safety profile was shown comparable to that of Amlodipine although no safety advantage was evidenced in the limited comparison of both treatments in study CL3-023.

The CHMP came to the conclusion that sufficient overall data had been provided for granting the MA for a second line indication: symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers. This indication, together with other recommendations and warnings in the SPC, addressed the current lack of evidence for add-on efficacy of Ivabradine in patients with insufficient response to either beta-blockers or calcium channel blockers, and also addressed the safety concerns regarding the combination of Ivabradine with beta-blockers and non-dihydropyridine calcium channel blockers. It enabled Ivabradine to become a treatment alternative when betablockers are not suitable There was no evidence to suggest that the frequently observed visual symptoms with Ivabradine (mainly phosphenes) represented a toxic effect of Ivabradine on the retina. The long-term ocular safety of patients exposed to Ivabradine was documented in the development programme up to one year. The data on QTcP changes did not raise safety concerns with respect to Ivabradine and the duration of ventricular repolarisation. The potential of Ivabradine to induce bradycardia was minimised in the target population with a treatment initiation heart rate raised to 60 bpm with the recommended therapeutic doses. Furthermore, the applicant submitted a relevant pharmacovigilance plan, detailing how some specific ophthalmic, cardiac or immune system adverse events will be addressed within ongoing or planned trials and within post-marketing pharmacovigilance activities.

In conclusion, Ivabradine has sufficient anti-anginal effect and acceptable safety profile, and thus provides a treatment alternative to patients with chronic stable angina pectoris with normal sinus rhythm who have a contra-indication or intolerance for beta-blockers.

Comparison with other products:

In the head-to-head comparisons of Ivabradine and Atenolol (CL-017/019-studies) the overall incidence of common AEs was higher with Ivabradine compared to Atenolol, which was mainly driven by higher rates on visual disturbance and cardiac disorders. Sinus bradycardia was reported under Ivabradine and Atenolol at frequencies of 5.7% and 5.1%, respectively. The rate of serious coronary artery disorders with Ivabradine was higher compared to Atenolol (3.8% vs. 1.5%). A further analysis of the subset of beta-blocker naive patients (30% of patients) showed a similar incidence of cardiac disorders with Ivabradine and Atenolol. The rates of serious arrhythmias with Ivabradine and Atenolol were 1.3% and 0.7% respectively. In head-to-head comparisons of Ivabradine and Amlodipine (CL3-023), the overall incidence of common AEs was higher with Ivabradine compared to Amlodipine, mainly driven, again, by higher rates on visual disturbance and sinus bradycardia (19.0% vs. 4.5% and 8.5% vs. 1.7%). The rate on the serious coronary artery disorders with Ivabradine was somewhat lower compared to Amlodipine (1.8% vs. 2.5%). Higher rates were observed with Ivabradine versus Amlodipine on serious cardiac arrhythmias, but absolute incidences were low in both treatment groups (0.6% vs. 0.2%, resp). No cases of serious sinus bradycardia were observed in either the Ivabradine or Amlodipine treatment group in the study.

Financial Analysis of the Product:

The manufacturer estimated the net budget impact of ivabradine at £232k in 2007, based on an average duration of 6 months treatment in the first year, rising to a full year cost of £942k in 2008 and £1.9M in 2011. The estimate assumed 879 patients would receive ivabradine in 2007, based on use in 5% of patients who currently receive prophylactic nitrates or nicorandil, rising to 20% uptake in 2011. The budget impact is likely to be considerably smaller as SMC as restricted the use of the product to patients in whom beta-blockers and calcium channel blockers are contra-indicated or not tolerated. The number of patients with chronic stable angina and intolerant to current antianginals is estimated to be 1,605 in 2009/10, rising to 2,287 by 2013/14. The manufacturer estimated that in 2009/10, the net drug budget costs to manage this cohort could rise by £934k, from £107k to £1041k. In 2013/14 the net drug budget costs were forecast to rise by £1,331k from £153k to £1,484k. This assumed a 100% uptake of the drug amongst all eligible patients. The difference between net and gross costs is not calculated but is small. The only saving is on use of nitroglycerin, being £0.03 per attack; this is equivalent to about £2k a year with 1,605 patients.

Doses are shown for general comparison and do not imply therapeutic equivalence

Drug

Usual daily dose range

Cost *per year (£)

ivabradine

10-15mg

507

Calcium channel blockers

amlodipine

5-10mg

28-34

nifedipine twice daily (MR)

20-80mg

52-194

verapamil long acting (e.g Securon SR)

240-480mg

76-153

felodipine (Felogen XL)

5-10mg

89-156

diltiazem long acting (e.g Adizem-XL)

240-300mg

126-158

Nifedipine once daily (e.g. Coracten XL)

30-90mg

77-191

nicardipine

60-120mg

120-240

nisoldipine

20-40mg

228-456

Potassium channel activator

nicorandil

20-40mg

99-189

Nitrate

isosorbide mononitrate standard release

80-120mg

31-46

isosorbide mononitrate long acting (e.g.

Imdur)

60-120mg

145-290

Cost of relevant comparators

Drug

Dose regimen

Cost per year (£)

Ranolazine

375 to 750mg, twice daily, orally

594

Ivabradine

5mg to 7.5mg, twice daily, orally

507

Nicorandil

10mg to 30mg, twice daily, orally

99-288

Calcium channel blockers

diltiazem MR

90mg twice daily to 500mg once daily,

orally

95 to 177

nifedipine MR

10mg twice daily to 90 mg once daily,

orally

26 to 159

verapamil MR

240mg once or twice daily

74 to 147

Nicardipine

60mg to 120mg daily, orally

58 to 117

Diltiazem

180mg to 360mg daily, orally

43 to 87

Felodipine

5mg to 10mg once daily, orally

51 to 64

Verapamil

80mg to 120mg three times daily, orally

22 to 43

Amlodipine

5mg to 10mg once daily, orally

13 to 15

Nitrates

isosorbide dinitrate

30mg to 120mg daily, in divided doses,

orally

138 to 455

isosorbide dinitrate MR

20mg to 80mg twice daily, orally

34 to 165

isosorbide mononitrate

MR

25mg to 120mg once daily, orally

34 to 112

isosorbide mononitrate

20mg to 120mg in divided doses, daily,

Orally

14 to 28

Calculate Profitability: (www.aurabindo.com)

Highest ever quarterly Revenues and Operating Profit with improved Margins

Q2 FY09 Consolidated Revenues up 8.5% to Rs 724 Crores

Formulation business constitutes 44.1% of the Gross Sales

Operating Profit (EBIDTA) before Fx up 31.2% to Rs. 124.9 Crores

PAT before Fx higher by 68.8% to Rs 66.7 Crores

5 ANDA filings in USA in Q2 FY 2008-09, cumulative filings 141

Aurabindo Pharma Limited is pleased to announce the unaudited financial results for the second quarter (Q2) FY 2008-09.

Financials Consolidated:

Total Income up by 12.6% to Rs 709.5 Crores (Rs 630.2 Crores)

Gross Margin improves to 49.0% from 45.5%

Operating Margin before Forex loss (Fx) improves to 17.6% (15.1%)

Operating Profit before Fx up by 31.2% to Rs 124.9 Crores (Rs 95.2 Crores)

Earning is impacted by Fx Loss mainly due to restatement of FCCB (net of deposits)

by Rs 85.3 Crores. This is a non-cash charge

PBT before Fx higher by 37.4% to Rs 84.2 Crores (Rs 61.3 Crores)

PAT before Fx higher by 68.8% to Rs 66.7 Crores (Rs 39.5 Crores)

Formulation Sales up by 33.3% to Rs 319.3 Crores (Rs 239.7 Crores)

5 ANDA filings in USA in Q2 FY 2008-09, cumulative filings 141

Manufacture of the Product:

The product is presented as film coated tablets containing 5.390 mg Ivabradine hydrochloride corresponding to 5 mg Ivabradine base and 8.085 mg Ivabradine hydrochloride corresponding to 7.5 mg Ivabradine base as active substance. Other ingredients are lactose monohydrate, magnesium stearate, maize starch, maltodextrin, silica, hypromellose, titanium dioxide (E171), macrogol 6000, glycerol, yellow iron oxide (E172) and red iron oxide (E172). The tablets are packed in Aluminium/PVC blister strips packed in cardboard boxes.

Wet granulation was chosen as manufacturing process. The in process controls are adequate for this film coated tablet preparation. The batch analysis data presented show that the film coated tablets can be manufactured reproducibly according to the agreed finished product specifications, which is suitable for control of this oral preparation.

Drug Substance

Ivabradine hydrochloride is a white to slightly yellow powder. It is freely soluble in water, dimethylsulfoxide, methanol and methylene chloride, it is soluble in ethanol and slightly soluble in acetone. It has the chemical name 3-(3-{[((7S)-3, 4-Dimethoxybicyclo [4.2.0] octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. Ivabradine hydrochloride is optically active and corresponds to the S isomer.

Ivabradine hydrochloride is synthesised from azepan and butamine hydrochloride in one manufacturing step. Adequate in-process controls are applied during the synthesis. The specifications and control methods for intermediate products, starting materials and reagents, have been presented and are satisfactory. A reprocessing procedure is performed in case of non-compliance of the product. Batch analysis data is provided on 3 batches produced with the proposed synthetic route, and the batch analysis data show that the active substance can be manufactured reproducibly, and in compliance with the agreed specification.

Pharmaceutical Development

The main goal was to develop a rapid dissolution finished product to be administered orally. compatibility study involving the drug substance and a number of excipients was carried out to select the excipients in the finished product. Wet granulation was chosen as manufacturing process. During clinical development several formulations were manufactured and administered to subjects and patients. The minor differences in the compositions of the formulations used in the clinical phase studies were adequately explained. During the development the test methods were set up to the control: the manufacture of the granulate, the compression of the core tablets and the properties of film-coated tablets. The choice of excipients was initially oriented by the above-mentioned compatibility study. The formulation was thereafter modified to take into account the properties of each excipient to produce a robust pharmaceutical dosage form, from the production perspective, and to yield a drug product with immediate release characteristics. All the excipients used in the finished product comply with the Ph.Eur except the two coating agents, red and yellow iron oxides, which comply with the European Directive 95/45/EC. Lactose monohydrate is the only excipient of animal origin used and it is in compliance with the European Commission Decision 2001/2/EC regulating the use of material presenting risks as regards transmissible spongiform encephalopathy and the public statement "Lactose prepared using calf rennet: risk assessment in relationship to bovine spongiform encephalopathies (BSE) (EMEA/CPMP/571/02). The tablets are packed in a heat-sealed blister pack composed of polyvinyl chloride sheet (PVC) and aluminium foil. The blisters are packed in a cardboard box. The compatibility of the finished product with the primary packaging was demonstrated in the stability studies.

Product Specification

The product specifications include tests by validated methods for appearance, identification of Ivabradine (HPLC, TLC), average mass, disintegration time (Ph Eur), microbiological quality, drug substance content (HPLC, 95-105% of the label at release, 94-105% at shelf life) degradation products (HPLC), content uniformity (Ph Eur). Degradation products are controlled and their limits are justified by reference to stability studies and toxicology studies.

The tests and limits of the specifications for the finished product are appropriate to control the quality of the finished product for their intended purpose. Batch analysis data are presented for two full scale batches and six pilot scale batches of 5 mg tablets and for two full scale batches and seven pilot scale batches of 7.5 mg tablets. The presented data confirm consistency and uniformity of the product from batch to batch. (Fox, K. et al. Guidelines on the management of stable angina pectoris2003).

The active substance specification includes tests for appearance, solubility, identification (HPLC and IR), assay (99.0-101.0%, Potentiometric titration), related substances (HPLC), water content, sulphated ash, heavy metals, chloride content, chloride identification (Ph Eur), residual solvents (GC), R isomer content (HPLC), specific optical rotation and particle size (Laser Granulometry). The specifications reflect all relevant quality attributes of the active substance. The analytical methods used in the routine controls are suitably described. The validation studies are in accordance with the ICH Guidelines. Impurity limits in the specification are justified by toxicology studies.

Stability of the Product

Stability of Ivabradine hydrochloride has been shown under long term, intermediate and accelerated conditions according to the ICH/CPMP guidelines and in addition at 30°C/70% RH in the reduced size industrial bulk packaging (cardboard drum) up to 3 years for two pilot scale batches an up to 3 years for one industrial scale batch. The parameters tested were, appearance, water content, IR-spectrum, assay of the active substance (HPLC and potentiometry), related substances and R-isomer content. The specifications were met for all batches at all storage conditions. No noticeable signs of degradation and no increase of impurities were observed. Based on these results the proposed re-test period is acceptable when stored in the original container closure system.

Stability data of three pilot batches of each strength packed in the proposed marketing immediate packaging was provided. The batches were stored under ICH conditions at 40ºC/75% RH for 6 months, at 30ºC/60% RH for 12 months and 25ºC/60% RH, and at 30ºC/70% RH for 36 months. The parameters investigated were appearance, odour, average mass, uniformity of mass of tablet halves (for 5 mg tablets only), disintegration time, microbiological quality, assay, degradation products, and uniformity of content. Stress towards temperature and photostability stability testing were performed in one 5 mg and 7.5 mg pilot batch packed in heat-sealed aluminium/polyvinyl chloride blister. For photostability testing, the tablets were directly exposed. Based on the results, it was concluded that extreme temperature had no effect on the quality of the tablets and no light resistant packaging was needed. Based on available stability data, the proposed shelf life and storage conditions as stated in the SPC are acceptable. (Gibbons, R. J. et al. ACC/AHA 2002)

Marketing of the Product

In clinical research organisation, marketing is quite different from other products. Before introduce the new drug it has to authorize my FDA (Food and Drug Administration). The main aim of clinical trials is safety and efficacy of the customers. Phase-IV is the last stage of clinical trials and this is very important stage of developing a new drug. This is a post marketing stage.

Marketing Segmentation:

Ivabradine, its a new drug in the market. It is a specific heart rate lowering agent, acting by reducing the rate of pacemaker activity in the sinoatrial node. Within the sinoatrial node, Ivabradine is a selective inhibitor of If , an important current involved in generating the early phase of spontaneous diastolic depolarisation in pacemaker cells, thereby reducing the frequency of action potential initiation and lowering heart rate. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation or coronary vasomotricity. So this drug normally use for heart related diseases, it is so costly and who has got the symptoms of this particular disease they are only use this drug. Chronic stable angina pectoris is a common disorder: the annual incidence varies between ~0.2% in southern European countries and > 0.6% in northern Europe. In countries with relatively high coronary heart disease rates, the prevalence may be 3–4% of the total population. The term is primarily used for chest discomfort due to myocardial ischaemia associated with coronary artery disease (CAD), although it is recognised that there are other important causes of angina pectoris, such as aortic stenosis and hypertrophic cardiomyopathy. The symptoms occur when there is an imbalance between myocardial perfusion and the demands of the myocardium and the pathological substrate for this is almost invariably atheromatous narrowing of the coronary arteries.

Targeting:

The organisation they have different thinking for their marketing strategy because angina pectoris is a rare disorder so they are targeting to show the better results in the market. So every Clinical Research Organisation might concentrate on cure of the disorder in the mean time they have think safety and efficacy of the patients. This is the main thing in every clinical research organisation. Then only it will get the permission from all drug authorities. A market is a group of potential customers who have similar needs and are willing to purchase goods or services to satisfy those needs. Good marketers focus on the customer and develop marketing mixes for very specific target markets. On the other hand, poor marketers focus on their products when defining markets, leading to missed opportunities and questionable customer satisfaction. The point here is that a market is external to an organization.

Positioning:

The final stage in developing a strategic marketing plan is to analyze the target market to identify where competitors are positioned, and which attributes are most important when customers are making a purchase. A product’s position is the way the product is defined by consumers on important attributes. The place, a product occupies in consumers’ minds relative to competing products. There are so many existing angina pectoris products in the market, but there is a lot of difference between new drug and existing drugs. So customers and consumers believe this product.

Below table summarises the number of healthy volunteers, subjects (patients having a disease other than coronary artery disease or stable angina pectoris) or patients who received at least one dose of Ivabradine or its main active metabolite S 18982 during the clinical development programme.

Ivabradine

S 18982

i.v

Oral

i.v.

and oral

Total

i.v.

Oral

i.v. and oral

Total

Healthy

Volunteers

Subjects

Completed Studies

88

446

24

558

0

72

12

84

On-going studies

0

102

0

102

0

0

0

0

Completed Studies

63

17

12

92

0

0

0

0

On-going studies

9

39

0

48

0

0

0

0

Patients

Completed studies

17

2953

0

2970

0

0

0

0

On-going studies

0

570

0

570

0

0

0

0

Number of healthy volunteers, subjects or patients who received at least one dose of Ivabradine or metabolite S 18982 during the clinical programme Ivabradine S 18982.

The above table explain that Ivabradine give better results in the market and most of the patients cured by this new drug.

Promotion:

Promotion is part of marketing segmentation. It is one of the key aspects of marketing mix. It plays most important role in market the new product. Promotion is the business of communicating with customers. It will provide information that will assist them in making a decision to purchase a product or service. The cost associated with promotion or advertising goods and services often represents a sizeable proportion of the overall cost of producing an item. However, successful promotion increases sales so that advertising and other costs are spread over a larger output. Though increased promotional activity is often a sign of a response to a problem such as competitive activity, it enables an organisation to develop and build up a succession of messages and can be extremely cost-effective. And Journals also play a most important role in to promote the Ivabradine drug to the market.

Distribution Strategy:

Ivabradine is a new product so organization develops a new strategy for this product. Brand name also comes into the picture in distribution. Aurabindo Pharma Ltd has a good brand name in the Pharma industry. And the organization uses the TV channels, Journals, News papers and internet for the distribution of the product.Part of the challenge of marketing is figuring out which distribution method to use for your business. As soon as you decide which business or product category to compete in, distribution decisions must be made based upon what your competition is doing. Service businesses may or may not be subject to the same physical distribution limitations as product-based businesses. For example, financial planning services may be offered from printed material, sold at retail, sold by consultants face-to-face, or delivered electronically by computer, by phone and by correspondence — a multitude of different distribution systems.

Distribution decisions have significant implications for:

product margins and profits

marketing budgets

final retail pricing

sales management practices

The organization follow the below options for distribution.

Retail  — stores selling to final consumer buyers (one store, or a chain of stores)

Wholesale  — an intermediary distribution channel that usually sells to retail stores

Direct mail  — generally catalog merchants that sell directly to consumer buyers at retail prices plus shipping.

Telemarketing — merchants selling directly to consumer buyers at retail via phones

Cyber marketing — merchants selling directly to consumer buyers at retail prices, or business-to-business products and services at wholesale prices via computer networks

Wholesaler

Retailer

Consumer

Consumer

Manufacture

Manufacture

Intensive distribution

Aims to provide saturation coverage of the market by using all available outlets. For many products, total sales are directly linked to the number of outlets used. Intensive distribution is usually required where customers have a range of acceptable brands to choose from. In other words, if one brand is not available, a customer will simply choose another.

Selective distribution

Involves a producer using a limited number of outlets in a geographical area to sell products. An advantage of this approach is that the producer can choose the most appropriate or best-performing outlets and focus effort (e.g. training) on them. Selective distribution works best when consumers are prepared to "shop around" - in other words - they have a preference for a particular brand or price and will search out the outlets that supply.

Exclusive distribution

It is an extreme form of selective distribution in which only one wholesaler, retailer or distributor is used in a specific geographical area.

The long term growth strategies being put in to action include,

Develop a broad portfolio of DMFs/ANDAs through non-infringing processes and intellectual properties and become a significant player in the generics market, especially in the regulated markets.

Manage cost efficiently in a mega-manufacturing environment approved by USFDA/European regulatory authorities; and in the process, enhance the attractiveness of Aurabindo Pharma to alliance partners.

Resolve complex chemical challenges and offer advanced drugs to the global markets.

Globalise and further penetrate through joint ventures/subsidiaries/organic means into China, Brazil and other Latin American countries.

Emerge as a leading player in global high quality innovative speciality generic formulations and domestic brand segments.

Project Implementation :

Status in the implementation on this particular project called introduction of an Ivabradine, specific heart rate lowering agent.

Idea generation

Ideas screening

Concept development and testing

Business analysis

Product development

Market testing

Commercialization.

Idea Generation: After going through several product introduction ideas, looking into many aspects like the initial investment, flexibility of doing the business, the types of profits, different types of risks involved, getting authorization from ethical committees and this idea of introduction of this drug coming into the pharma industry.

Idea screening: for generating ideas we have separate teams and we generate so many ideas its helpful for develop the project. In that the special team screens the best idea and finally the implement their ides in the project and get the good results.

Concept the Development and Testing: To introduce this new product in the market for who is having heart diseases like angina pectoris. It gives better result for them and in manufacturing process so many committees was approve the drug then only we launch this new product in the market.

3.2. Marketing Strategy Development: Based on the concepts doubt in the concept of open tender testing station these marketing strategies also will be developed. Does this product is new to the Pharma marketing will be effectively utilized.

Business Analysis: The overall cost of the Ivabradine drug was estimated to be around £39 per 28 days , it is so costly medicine and at the same time the patients are they have take the medicine regularly. So the marketing ads are no need to give much publicity of this. And this can be easily sold at a price of £39 which will be very competitive and of when compared to all such angina medicines the category of Ivabradine.

Product Development: The ingredients to be used in the process are how the product should be prepared, the way how the patients are satisfied should be done in this stage.

Market Testing and Commercialization: Testing of the marketability of this product can be done in many ways. This may be initially introduced as a parasite drug in the market in the well known pharmacies and topmost hospitals and clinical research centres. We already discussed about ethical committees like MHRI and FDI. After analyzing the acceptability of the product this can be introduced through an excuse you Pharmaceutical outlet.

3.3. Monitoring and Evaluation Progress: The following figure illustrates about my products penetration and sustainability of product.

Marketing Strategy

Product Variety: This is a type of product and which is not available anywhere in the world; this uniqueness in product will serve as unique selling point.

Quality: Quality is placed a very important role in the manufacturing of the product. if the product have good quality it gives better results I the future. And we have separate teams for quality management.

Design: Product design is very important criteria which should appeal to the customers. Suggestions from the medical professionals can be sought to design different variants of the product which could you can need to appeal organization.

Brand Name: Branding decisions should be taken well to promote the product is a brand or the company as a brand.

Competitive Pricing: there is no competition of this drug Ivabradine because it’s a new drug and it gives better results in the market.

Pricing Promotion: Emphasis should be made on pricing, showing that a foreign origin and ivabradine drug is available at high cost and it is need for patients.

Promotion

Sales Promotions: Sales promotion through all channels of communication is very important, through getting special corporate types, any other endorsements.

Advertising: extensive advertisement should be given initially as this product is very new to the pharma industry. These advertisements should aim at indicating the usage of or the ways and means of consumption of this product.

Public Relations: Charity works, brand endorsements, other voluntary activities will increase the public relations with the people of Canada through which penetration of a new product will be very easy.

Total Quality Management: The mission and vision of the companies to give a better result of the drug, at a low price. Quality is the only feature of the product which has the ability to satisfy the expected needs of the patients. To ensure this all the employees are trained to always involve in the team and give quality drugs to the patients.

Quality Chain: Quality is a core principle to attract customers. Quality chain is the part of value chain, where the quality he is to be maintained throughout the value chain. Maintaining quality starts right at the procurement of the raw material, maintaining quality while presentation, maintaining quality while serving to the patients.

Milestone Charting: Milestone charting is very important while implementing a project. Coming to a pharma industry, there will be several milestones distributed into two phases. Milestone sought to be set like quality of the drug, product design, market testing, government permissions, procurement decision, production systems, processes and systems. The other sets of milestones become active once the product release in the market. These milestones are attaining quality standards, achieving volumes in customers, earning good profits.

Auditing: This is to evaluate the various aspects of implementation of the project. Auditing can be done on milestone achievements, quality benchmarks, financial controls, human efficiencies, processes.

Developing Feedback Systems: Getting continuous feedbacks is very important while implementing a project as well as introducing new drug in the market new environment. Several feedback measures are to be employed in the system to get the information from the system to reveal the situation of the project implementation and the quality of the product. This can be done through periodical review meetings and also through customer satisfaction surveys.

Aurabindo has implemented   Standard Operating Procedures that get your study up-and-running when you need it. Our experienced staff of Project Managers, Trainers, and Quality Assurance Professionals will make sure that your study is deployed in a timely, efficient manner that accommodates your deadlines.

Shortest Time from Final Protocol to Study Launch

Set-up time for the data entry screens and database is minimal. Using its proven ProBuild Tool, Aurabindo links data-entry fields to the corresponding database fields through a point-and-click interface. This makes it easy to create and edit messages and to warn of data-entry errors at the field level. There is no need to design specific EDC (Electronic Data Capture) screens or write code, which delays study roll-out. Through ProBuild, data-entry screens for visits can be posted and deployed to sites as soon as they are finalized. Mid-study changes are completed with the same ease and quick turnaround as start-up using this same process, eliminating delays and additional costs that are often associated with other EDC systems. Testing and posting of new forms are completed within hours of receiving change requests, without disruption to the sites and keeping costs at a minimum.

Experienced project management

Exceptional customer service is the cornerstone of Aurabindo's success. With over 20 years deploying clinical trials, our Project Management experience is unsurpassed in the industry. All of our PMs are fully trained to guide the eCRF design, edit specification approval, training and data export programming; while keeping you informed and involved every step of the way. Sponsors benefit from having one Senior Project Manager, one Associate Project Manager and one Account Manager dedicated to their study. Our project managers are trained in the life science industry to provide the expertise where the project needs.

SAS and data export programming

Aurabindo will perform the initial data export and SAS programming to ensure that your clinical trial data is ready for analysis at any point in the study. That means any user with designated data management privileges is able to generate real-time SAS data sets during a study with the click of a button. You can get instant data exports in SAS format in an automatically zipped file. Perform real-time SAS data analysis in an easy-to-use point-and-click interface, anytime, anywhere.

Clinical Study Monitoring:

Experienced Clinical Research Associates (CROs) monitor and manage the clinical trials in the Aurabindo Organization. Initiation, monitoring and close out visits are run according to sponsors' requirements and reporting methods, documented in the Clinical Monitoring Plan. Our experience ranges from outpatient trials to complex inpatient trials, and across a range of organisations and therapeutic areas.

Staff training includes Good Clinical Practice (ICH-GCP), Standard Operating Procedures (SOP's), technology, scientific & medical topics, and updates on industry developments. Our CRA's work closely with sites to collect clean data quickly. All studies have a lead CRA and a back-up. Clear SOP's, responsibilities and good communications ensure consistency in working processes across the clinical trial CRA team.

Medical Monitoring

Medical monitoring is achieved through partnership with highly experienced local experts specialised in this area. Aurabindo does not retain staff medical monitors.

Site Monitoring

Aurabindo provides monitoring of clinical trials. At each monitoring visit, according to project scope, CRA's review:

• Protocol compliance 

• Case Report Form (CRF) accuracy and completeness 

• Serious Adverse Event (SAE) reporting to the required bodies 

• Tracking of mandatory reporting to Ethics (IRB) & Regulatory authorities 

• Enrolment & suitability of participants 

• Trial progress & review of strategy 

• Continued acceptability of investigator and facilities 

• Filing and maintenance of source documents 

• Investigational Product inventory and accountability records 

• Compliance of investigator's document file 

• Collection of data for interim analysis 

Following each site visit, Aurabindo prepares a monitoring report in accordance with clients or sponsor SOP’s as specified.

Reporting, Filing & Archiving

Formal reporting, correspondence, filing and archiving are an important part of clinical trial work. Aurabindo takes these responsibilities seriously, to report clearly and accurately within the specified timeframe and to keep records in compliance with sponsor and regulatory requirements.

Site & Study Close-Out

At the conclusion of the study, final data needs to be gathered, investigational products accounted for, and any outstanding issues resolved with sites, both for the benefit of the study and for future involvement of the site in further studies. At this time, Aurabindo CRA's:

• Ensure that Case Report Forms (CRF’s) and any queries or addenda are collected 

• Complete an inventory of investigational product supplies 

• Reconcile accountability and distribution forms 

• Review all relevant documentation 

• Return investigational product supplies or destroy as required 

• Give final instructions to sites’ investigators and personnel 

• Ensure final reports and notifications go to Ethics & Regulatory authorities

Aurabindo works closely with the sponsor during this process to ensure all data for the study is collected and reported, compliance with regulatory authorities and ethics requirements are met, and loose ends (if any), are tidied up for stakeholders.

Conclusion:

The main aim of this project was safety and efficacy of the customers and also explain implementation, planning and monitoring of the project. This is totally clinical trials project and developing a new product in the market.

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