Profile of Pharma Blockbuster Januvia

Product Management assignment: JANUVIA
PRODUCT MANAGEMENT ASSIGNMENT:
PROFILE OF PHARMA BLOCKBUSTER JANUVIA
CHARMI POPAT ROLL NO. 03 PRODUCT MANAGEMENT ASSIGNMENT MBA PHARMA TECH VTH YEAR
SVKMs NMIMS SPP SPTM
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TABLE OF CONTENTS SR NO.

1. 2. 3.
TOPIC
INTRODUCTION MARKET ANALYSIS STRATEGIES ADOPTED BY MSD TO LAUNCH JANUVIA ACROSS THE GLOBE
PG NO.
3-4 5-7 8 - 13
4.
STRATEGIES ADOPTED BY MSD TO LAUNCH JANUVIA IN INDIA
13 - 18
5. 6.
SUMMARY REFRENCES
19 20
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INTRODUCTION
What Are JANUVIA (sitagliptin) tablets? JANUVIA is a type of prescription diabetes medicine called a DPP-4 inhibitor that enhances the body's own ability to control blood sugar levels. JANUVIA helps your body to: Increase insulin production in your pancreas Decrease the sugar made in your liver
Increase insulin production when blood sugar is high, especially after you eat. This is when the body needs the most help in lowering blood sugar.
Reduce the amount of sugar made by your liver, especially after you eat, when your body doesn't need it.
How Does JANUVIA Work? With type 2 diabetes, pancreas does not make enough insulin. Liver may also make too much of sugar. Bodys cells may lose sensitivity to insulin (insulin resistance). Because some cells, such as muscle cells, are less sensitive to insulin, they cannot effectively absorb blood sugar, which is needed for energy. As a result, blood sugar level increases. Before taking JANUVIA: After meal body sends important
messages to pancreas to try to lower blood sugar. In response, pancreas tries to make more insulin & signal liver to release less sugar.
Figure 1
When you have type 2 diabetes: After taking JANUVIA: JANUVIA is type 2 diabetes medicines allow more messages to get through. This helps pancreas to release more insulin & liver make less sugar.
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Mechanism of action of JANUVIA:
First approved by FDA in 2006, the products sales grew by a spectacular 45.3 percent in 2011 to $3.66 billion, while Mercks fixed-dose combination formulation of Januvia and metformin, Janumet, added another $1.36 billion with 43.9 percent growth. History of JANUVIA:
1999 2000 2001
Merck initiates DPP-4 program In-licensed probiodrug P32/98 to jumpstart internal program. Later discontinued due to preclinical toxicities not related to DPP-4 inhibition Team discovers that selective DPP-4 inhibition may be important to a favourable safety profile major effort initiated to identify bestin-class DPP-4 inhibitor Identification of sitagliptin as a highly selective DPP-4 inhibitor
2001
2002 2006
Initiation of clinical trials
Approval of JANUVIA (sitagliptin) as 1st DPP-4 inhibitor
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MARKET ANALYSIS
About MSD: It is a Global Pharmaceutical Company. It operates in more than 140 Countries. Address major Global health issues by having its eminent presence in Diabetes (75% of diabetic population lives in emerging markets), Cardiovascular & Respiratory Diseases, Hepatitis C, Cancer, HIV and so on and so forth. Diverse Portfolio: Anti diabetic contributes to approximately 30% with just 2 diabetes medication (JANUVIA & COMBINATION WITH METFORMIN JANUMET).
Anti Diabetic Derma Gynaec. Hormones Respiratory Gastro Intestinal Anti-infectives VACCINES Others CARDIAC Pain / Analgesics HIV Neuro / CNS Blood Related
5% 30% 6% 12% 14% 23%
Source IMS health (2013)
It contributes 5.54% to overall Oral Anti diabetes market & is growing at 28.99% CAGR.
VALUE MAT (IN CRS.) COMPANY JUN'10 JUN'11 JUN'12 JUN'13 CAGR (%) MS (%) JUN'10 QTY MAT (000) JUN'11 JUN'12 JUN'13
MSD PHARMACEUTICAL
68.6
93.2
142.7
190.0
28.99%
5.54%
29622.7
41115.8
65876.7
90151.0
MSD is one of the top players in Oral Anti diabetes market.
COMPANIES USV SUN* NOVARTIS INTL.* MSD PHARMACEUTICAL ABBOTT* SANOFI*
MAT value (2013) in crs. 560.9 323.4 223.7 190.0 182.9 172.3
Market share (2013) 16.36% 9.43% 6.52% 5.54% 5.33% 5.02%
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About JANUVIA & JANUMET: JANUVIA (sitagliptin phosphate) launched in India in April 2008 available in 3 different strength 25mg, 100mg & 50mg. Price to retailer being Rs. 227.8 per pack containing 7 tablets in each pack. In Dec 2008 combination product JANUMET (sitagliptin+ metformin phosphate) was introduced which was made available in 2 strengths (50mg + 1000mg) & (50mg + 500mg). Price to retailer being Rs. 234.7 per pack containing 14 tablets in each pack.
VALUE MAT (IN CRS.) BRANDS PACK_DESC JANUMET FILM C.TABS 1000 MG x 14 (/50) PROD_LNCH PTR JUN'10 JUN'11 JUN'12 JUN'13 JUN'10 QTY MAT (000) JUN'11 JUN'12 JUN'13
200812.0
234.7
8.5
13.9
24.8
35.8
5013.0
8263.8
14803.1
21346.5
JANUMET FILM C.TABS 500 MG x JANUMET 14 (/50) JANUVIA FILM C.TABS 100 MG x 7 JANUVIA FILM C.TABS 25 MG x 7 JANUVIA FILM JANUVIA C.TABS 50 MG x 7 Grand Total
200812.0
234.7
19.4
29.3
51.4
74.0
11436.6
17390.8
30637.4
44175.5
200804.0
227.8
35.0
41.2
53.6
61.8
10653.6
12590.6
16483.4
18992.4
200804.0
227.8
0.5
1.0
0.7
1.0
144.4
315.0
212.8
305.1
200804.0
227.8
4.9 68.2
7.8 93.1
12.2 142.7
17.4 190.0
1497.7 28745.3
2389.4 40949.6
3740.0 65876.7
5331.5 90151.0
JANUVIA (sitagliptin phosphate) is growing at CAGR of approx. 19% contributing to 42.19% share to MSD diabetes segment & 2.3% to overall OAD market. The brand ranks 5th in OAD segment & ranks 68th in overall pharma market with current market valuation of Rs. 802crs. (as of 2013) in India. JANUMET (sitagliptin phosphate + metformin) is growing at CAGR 41% contributing to 57.81% share to MSD diabetes segment & 3.2% to overall OAD market. The brand ranks 3rd in OAD segment & ranks 40th in overall pharma market with current market valuation of Rs. 1,098 crs. (as of 2013) in India.
MAT Values (INR M) CAGR BRANDS PROD_LNCH JUN'10 JUN'11 JUN'12 JUN'13 GR ('13) (%) % M.S. JUN'10 JUN'11 JUN'12 JUN'13 MAT Qty (000's) GR ('13) CAGR (%) % M.S.
JANUMET
200812
278
432
762
1,098
44%
41%
3.2%
16,450
25,655
45,441
65,522
44%
41%
0.8%
JANUVIA
200804
404
500
665
802
21%
19%
2.3%
12,296
20,436
24,629
21%
19%
0.3%
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Product features: Once daily, oral 24 hour inhibition of DPP-4 activity Substantial efficacy Weight neutral Low risk of hypoglycemia except when used with a SFU or insulin
Unmet needs at the time of development:
OPPORTUNITIES FOR JANUVIA: Many external factors combined to create the opportunity for JANUVIA success: 1. The growing global obesity epidemic, which is directly correlated with the global growing type 2 diabetes epidemic, has contributed to exponential growth of the overall market for type 2 diabetes products. 2. Fortunately for Merck, Novartis DPP-IV compound Galvus did not receive FDA approval, while Januvia did. 3. On top of that, physicians had been using a number of products to manage their patients type 2 diabetes, but many carried an increased risk of hypoglycemia and other side effects. Many physicians were looking for newer, safer approaches to treating type 2 diabetes, and the favorable safety profile of Januvia, combined with its efficacy story, led a lot of physicians to turn to this new class, 4. On top of this, Januvias positive safety profile has taken centre stage after negative warnings associated with thiazolidinedione use began to surface. As a class, TZDs have fallen off significantly in the past two years, leaving much of that share to be picked up by Januvia, largely due to its safety and efficacy association, 5. Januvias potential as an add-on to the popular drug metformin was another break for the product, says Riad El-Dada, senior VP and commercial group leader, diabetes franchise, Merck
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STRATEGIES ADOPTED BY MSD TO LAUNCH JANUVIA ACROSS THE GLOBE

Strategies adopted by MSD to make JANUVIA a huge success: Riad El-Dada, senior VP and commercial group leader, diabetes franchise, Merck says: Our strategy is really built on seeking out patients who are on metformin, to encourage physicians and patients to make JANUVIA the next step, We have a product that is really the perfect add-on to metformin. Metformin is widely used in most parts of the world, its growing really fast. So we sort of hit the sweet spot with our marketing strategy. 1) TAILORED JANUVIAs CLINICAL PROGRAMS FOR DIFFERENT REGIONS: Brand team of JANUVIA customized the clinical trials data so that they have right indications for different regions and the right studies. They focused on strategy starting narrow and going wide earning a single approval as early as possible, then following up with a stack of additional indications to broaden access. Indications for JANUVIA were: added indications for third-line use, indication for use with insulin, indication for use with TZDs and metformin. Though all the indications were not filled initially because there was a huge competition from Novartis, BMS/Astrazeneca and so on & so forth but very rapidly they followed but with them. So they could launch the drug in a customized manner & fast & first before the competition.
2) EXTENSIVE LIFE CYCLE MANAGEMENT PROGRAM FOR SITAGLIPTIN:
Merck & Co., Inc. announced on Apr 2, 2007 within a year that the U.S. Food and Drug Administration (FDA) approved JANUMET, the first and only tablet combining a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as JANUVIA), and metformin for the treatment of type 2 diabetes.
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Core Phase III Program 1. Monotherapy (2 studies) 2. Combination therapy with metformin and PPAR 3. Renal dosing
1st Phase 1. Add-on to Metformin versus Sulfonylurea JANUMET Program
2nd Phase 1. Add on to Sulfonylurea Metformin
3rd Phase 1. Insulin add-on 2. Triple combination with PPAR / metformin 3. High baseline HbA1C metformin add-on study 4. Metformin comparison study 5. Initial combination with PPAR 6. Initial combination with metformin 7. Study in elderly 8. Mechanism of action studies
Ongoing/recently completed 1. Sitagliptin/ Pioglitazone FDC (MK-0431C) 2. Sitagliptin/ Simvastatin FDC (MK-0431D) 3. JANUMET Extended Release Program 4. Cardiovascular Outcomes Study
The key decision point brand team made was the choice to push a metformin combination early in development, before anyone really knew if JANUVIA would even be a success on its own, and then placing substantial marketing muscle behind the new combination when it was approved, even with the blockbuster JANUVIA already in hand. Development program for JANUMET was started very quickly and then really put a lot of emphasis on it when they could launch it. MSD announce its launch on Apr 2, 2007
JANUVIA FDA approved sitagliptin phosphate tablets (Januvia, made by Merck and Co, Inc) for use with diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. On October 17 2006
JANUMET FDA Approves Janumet for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet Apr 2, 2007
JUVISYNC FDA approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin. Oct. 7, 2011
JANUMET XR FDA approved JANUMET XR is a new treatment that adds oncedaily convenience to the powerful efficacy of JANUMET for patients with type 2 diabetes February 02, 2012
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3) JANUVIA: FIRST TO MARKET TAKES ALL The first DPP-IV inhibitor on the market was Januvia (sitagliptin). Januvia was in the right place at the right time.
United States: It was introduced in the U.S. in 2006 by Merck & Co. In the U.S., Januvia enjoyed three years of exclusivity in its class before AstraZeneca/BMS introduced Onglyza. During this period of 3 years, Januvia used strong promotion to gain early buy-in from stakeholders and to build a positive brand image. It secured its place as the gliptin, an image that AstraZeneca/BMS was unable to change despite heavy U.S. promotional investment. Novartiss Galvus (vildagliptin) was delayed in the U.S. due to questions of side effects. Tradjenta (linagliptin) have also entered the market, and the pipeline promises more to come. Europe: In Europe Januvia was first in class launched in 2007. Galvus,was launched in 2008.
JANUMET: United States: In the U.S., Mercks products were the first to market both for the single-compound therapy (Januvia) and the combination therapy (Janumet).
Europe: In contrast, Merck delayed launching its fixed-dose combination product, Janumet (sitagliptin/metformin) until a year after Januvia, its single-compound product, was on the market. Janumet was the second-to-market combination product. In fact, it lagged behind Eucreas by a full two years in the U.K. Uptake of Eucreas did not match that of Janumet across the top five European countries likely because Janumet benefited from Januvias established patient base.
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4) CLOSING TIME GAP: The time lag between first global launch and the first entry into a pharmerging market was reduced. JANUVIA (sitagliptin) was launched in Brazil just 6 months after its first global entry to speed up the pace of their outreach to the pharmerging sector. JANUMET launched 4.5 months after JANUVIA. JANUVIA & JANUMET were launched globally within 4 years from 2006 to 2009. JANUVIA launched in 81 countries & JANUMET launched in 52 countries
EU JANUMET EU JANUVIA US JANUMET & BRAZIL JANUVIA
JANUVIA JANUMET in India & Japan
US JANUVIA
5) COMMUNICATING WITH PHYSICIANS & PATIENT EDUCATION PROGRAM: Merck invested heavily in educating physicians about the DPP-IV class prior to the approval of any product
The team made a significant investment in academics and diabetes thought leaders early on, because the mechanism was new and the science was new. They also worked with professional societies on education. They worked with the American Diabetes Association and others and used them to help with outreach, not just to patients but also to physicians. In communicating directly with physicians and patients, Januvias managers have leaned on the good old-fashioned sales force still probably the most important channel Establishing trust with physicians is a top priority for our marketing and sales organization,
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Brand team provided a lot of support to help physicians help their patients by organizing unbranded programs that gave them additional credibility with their customers. Brand team also presented several periodic safety updates both general safety updates and safety updates that would pertain to particular issues, for example cardiovascular safety updates. Mercks brand team also came up with hypoglycemia awareness campaign: Discusshypo.com which was deployed across multiple channels, including journal advertising, edetails, direct mail, and waiting room posters, and which was not a branded campaign, but instead a disease awareness campaign & for which it was nominated for a Best Disease-Awareness Campaign Manny Award in 2011.
Target
audience
of
JANUVIA were both Healthcare professionals (M.D., Pharm D etc.) & Nonprofessionals & Caregivers) Healthcare (Patients
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6)
HUGE INVESTMENT MADE ON TRADITIONAL & DIGITAL MEDICAL EDUCATION CHANNELS
Brand team has invested in both traditional and digital DTC, medical education, and a significant convention presence, among other things.
Product promotion of JANUVIA highly focused on following parameters:

Parameters % contribution to communication
Efficacy Safety Other benefits Patient access Administration Comparison MOA
11 26 7 37 4 10 4
Marketing channels used to promote JANUVIA were as follows:

Parameters % usage of communication channel
Conference Web / Internet Medical office, hospital, pharmacy Publications Manf-sponsered programs TV
6 1 36
22 35
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STRATEGIES ADOPTED BY MSD TO LAUNCH JANUVIA IN INDIA

MSD/ JANUVIA: The Game Changing Launch in INDIA! India pharmerging market a different Game: The dynamics for first-to-market products are less rigid in the Tier 1 and Tier 2 pharmerging markets than weve observed in developed markets. In Brazil, Russia, and India, for example, Mercks JANUVIA was launched before Novartiss GALVUS. Neverthelessand unlike mature marketsNovartiss family of products accounted for more than 50 percent of the DPP-IV market in 2011. Most of this success is attributable to EUCREAS, which has outperformed JANUMET considerably. Meanwhile, GALVUS has held its own against JANUVIA; its uptake has been comparable to that of JANUVIA in Brazil and Russia, and greater than JANUVIA in India.
The reason why Novartis family of products (GALVUS & EUCREAS) outperformed MSD family of products (JANUVIA & JANUMET) was Novartis entered India in 2009 with GALVUS & EUCREAS and at the same time (i.e. 2009) Novartis entered in a Co-marketing agreement with USV (2009), a leading pharmaceutical companies with Oral Anti Diabetes segments and it introduced two brands JALRA & JALRA-MET. This helped Novartis to outdo MSDs product market demand & increase its product distribution & reach. First to Market in India for MSD was not beneficial as it did enter in the Co-marketing agreement
SVKMs NMIMS SPP SPTM Page 14
unlike its competitor Novartis. MSD entered India in 2008 with JANUVIA & JANUMET but it entered Co-marketing with SUN in 2011 i.e. 3years after the launch of JANUVIA & 2 years after the launch of JANUMET which was the reason why MSD market share is lower as compared to Novartis till date.
Timeline of JANUVIA launch in India:
PRE-LAUNCH STAGE: 1) AFFORDABILITY: With generally lower levels of income and greater emphasis on out-of-pocket or private payment for healthcare, affordability is an important consideration for launching in pharmerging markets. Many multinational companies are implementing discounted price schemes to overcome this potential hurdle. MSD undertook rigorous market research, quantitative & qualitative, involving 350 Physicians and 200 patients which helped them arrive at differential pricing. MSD came up with different prices for different market. In case of JANUVIA per unit cost (cost per tablet) in US is $8.84 & India is Rs. 16.76
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2) DIVESED AN INTEGRATED DISEASE MANAGEMENT PROGRAM:
Brand team devised an integrated disease management program involving physician & patients. This program helps to implement and expand the Diesease management program under the brand name-SPARSH. MSDs SPARSH Program was launched to Complement Prescriber Focused Efforts. MSD tied up with Thyrocare, a company that provides specialised tests for comprehensive health evaluation.
3) Created class awareness via extensive communication in medical journals (explained earlier) 4) Positioning the product with targeted physician/diabetologists in specified geographical area (explained earlier) POST LAUNCH STAGE: 1) Putting Patients First: SPARSH Health line (Patient support services) Launched on Date: Jan-09 Services provided by SPARSH
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Counseling services1 Counseling over telephone by trained personnel, based on needs assessed by physician, patients, counselor Awareness about the disease and its management Practical situations, complications; diet counseling with customized diet charts and personalized follow ups Exercise counseling with suggested lifestyle changes, do's and don'ts
2) JOINT VENTURE WITH INDIAS SUN PHARMA "Our emerging markets strategy is driven by our focus on applying innovations across our business from introducing novel compounds to broadening our focus on innovative branded generics," MSD President (Emerging Markets) Kevin Ali said. Indian pharma major Sun Pharmaceutical Industries on April 11, 2011 announced a 50:50 strategic joint venture partnership with global drugmaker Merck and Co Inc to develop, manufacture and commercialise new innovative drugs in emerging markets over the next 2-3 years. MSD established Joint Venture with India's Sun Pharma to develop novel combinations of branded generics for emerging markets. Sun Pharma will sell the sitagliptin under brand name ISTAVEL launched on June 2011 and sitagliptin plus metformin under brand name ISTAMET launched on Aug 2011; different brand names in India as part of an India-specific strategic partnership agreement with Merck
3) Free sample to encourage trials (explained earlier)
4) Lifecycle Management Strategies: Successful launch of Janumet (FDC with Metformin), targeted at tier 2 cities (explained earlier)
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LAUNCH STAGE: 1) Launched Januvia at a differential pricing (explained earlier)
2) Launch at CME events : National level CMEs with KOLs from other countries CMEs with regional KOLs
3) Gatherings of 7-8 physicians to discuss and exchange information on DPPIVs facilitated by MSD reps 4) Marketing based on product clinical profile only Selling not the focus
5) Made CSR an integral part of business which helped in creating goodwill among Physicians/Patients 6) Going Forward: DIABETES & OBESITY FRANCHISE STRATEGY: Develop new therapies for Type 2 diabetes mellitus to help patients achieve and maintain optimal glucose control across the spectrum of disease, with mechanisms that: Increase insulin secretion Decrease glucose production Increase insulin sensitivity
Continue to lead in DPP-4 inhibitor class
Sitagliptin on track to be a leading global branded oral agent Extensive sitagliptin life cycle management program with several fixed dose combinations in sequential development
Strategic expansion with portfolio of novel mechanisms Discover and develop novel therapies for obesity
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SUMMARY
Factors that help JANUVIA success globally & in India are:
Speed to Market
Highly Differentiated Products
Rapid and Strong Market Uptake
Strong Foundation for Continued Leadership
Pharmerging markets (a term coined by IMS to include 17 countries with income levels under $25,000 per capita and relatively rapid growth) Half of diagnosed patients fail to achieve adequate blood glucose control and diabetes can lead to blindness, amputations, heart disease and nerve and kidney damage, among many other health consequences.
Weber knew that patients, even while they worried about having too much glucose in the blood, were at risk of having their glucose levels lowered too much using existing treatments. The condition, hypoglycemia, can cause reactions such as heart palpitations or, worse, seizures and loss of consciousness.
According to this IMS report, the market for non-insulin diabetes treatments has experienced strong growth over the last decade, averaging 9.5% over the past five years.
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REFRENCES
1. http://www.imshealth.com/ims/Global/Content/Corporate/Press%20Room/IMS%20in %20the%20News/Documents/MMM-Diabetes_olympics.pdf 2. http://businesstoday.intoday.in/story/sun-pharma-merck-form-jointventure/1/14677.html 3. http://www.msdindia.in/about/Pages/home.aspx 4. http://www.expresspharmaonline.com/20090331/management01.shtml 5. http://www.imshealth.com/imshealth/Global/Content/Pharmerging/Document/Launch %20Evolution%20Across%20Pharmerging%20Markets.pdf 6. http://www.dfid.gov.uk/Documents/publications1/prd/diff-pcing-pharma.pdf 7. IMS HEALTH DATA (JUNE 2013) 8. http://spicyip.com/2013/04/patent-war-intensifies-glenmark.html
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For majority of type II diabetics, since medications have to be taken daily to achieve glycemic control, drug resistance is a major challenge. (Thus there is a therapeutic void which generates demand for novel anti-diabetic product classes. Dipeptidyl peptidase-4 inhibitors (DPP-4) or what is known as gliptins offered a new alternative in the treatment pathway.)
Under an India-specific agreement
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Profile of Pharma Blockbuster Januvia

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Product Management assignment: JANUVIA

PRODUCT MANAGEMENT ASSIGNMENT: