Do you need some help getting to your
`AlC goal? Ask about adding ONGLYZA.
`
`(saxag|iptin)gg*.g,5
`
`What is ONGLYZA?
`
`ONGLYZA is a prescription medicine used alongwith diet and
`exercise to lower blood sugar in adults with type 2 diabetes.
`
`ONGLYZA should not be used to treat people with type 1
`diabetes or diabetic ketoacidosis (increased ketones in the
`blood or urine).
`
`See inside for valuable savings offer
`
`Please see Important Safety information on page 7.
`Click here for Medication Guide and click here or ull Prescribing
`Information for ONGLYZA.
`35 *1; f“e°ai"h1:l’; 2129
`y an v.
`str
`eneca
`Page 1 of 9
`[PR2015-01340
`
`1
`
`AstraZeneca Exhibit 2129
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 9
`
`

`
`STRUGGLING TO REACH
`
`YOUR A1C GOALS?
`
`Adding ONGLYZA“ (saxagliptin) to
`your treatment plan might help
`
`When you're living with type 2 diabetes. it's a daily
`challenge to keep your blood sugar in check. Along
`with diet and exercise, ONGLYZA can help lower
`blood sugar, which may give you the boostyou need
`to get your type 2 diabetes under control. As with all
`decisions concerningyourtreatment, itis important
`to work with your healthcare provider on developing
`a plan. Be sure to ask if once-daily ONGLYZA is right
`for you.
`
`Because managing type 2
`— diabetes takes more than
`just medicine, there's the Fit2Me diet and
`lifestyle support program custom-fit to you.
`Learn more about Fit2Me on page 6.
`
`Please see Important Safety information on page 7.
`Click here for Medication Guide and click here for full Prescribing
`Information for ONGLYZA.
`
`Page 2 of 9
`
`KEY FACTS ABOUT ONGLYZA
`
`Take once daily
`
`Take any time of day
`
`Proven to lower A1C'
`
`Enhances the body's
`natural ability to control
`blood sugar
`
`'In addition to diet and exercise. Results may vary.
`
`Important Safety Information for ONGLYZA
`
`Do not take ONGLYZA if you:
`
`- are allergic to any of its ingredients. Serious
`allergic reactions can occur with ONGLYZA and
`may include swelling of the face, lips or throat,
`difficulty swallowing or breathing, swelling of the
`skin. hives, rash, itching, flaking, or peeling. If you
`have these symptoms, stop taking ONGLYZA and
`contact your doctor right away
`
`Page 2 of 9
`
`

`
`PROVEN TO LOWER
`
`A1C LEVELS
`
`One of the goals of managing type 2 diabetes is
`lowering your A1C level to a healthy number.
`ONGLYZA’ (saxagliptin) has been tested in multiple
`clinical studies and in thousands of adult patients
`with type 2 diabetes. In all of these studies, once-daily
`ONGLYZA, in addition to diet and exercise, has been
`shown to lower A1C levels.
`
`Your healthcare provider will know if ONGLYZA
`could give you a boost. Ask if adding ONGLYZA is
`right for you.
`
`24-WEEK
`
`CLINICAL STUDY
`
`One 24-week clinical study involved 743 adult type 2
`diabetes patients whose blood sugar was not controlled
`enough by taking metformin IR alone. Of these patients,
`564 were given ONGLYZA plus metformin IR and 179
`patients were given a placebo plus metformin IR.
`
`The patients started the study with an A1C of 8.1%,
`on average. After 24 weeks, results showed significant
`A1C reductions in patients who took ONGLYZA plus
`metformin IR versus placebo plus metformin IR.
`
`After 24 weeks, more patients who took
`ONGLYZA plus metformin IR versus
`placebo plus metformin IR achieved an
`A]-C goal 0f I955 than 7%-'
`'Y°"' results "“*Y ‘'*"Y-
`
`‘['a[k to your heauhcare provider to see
`
`if ONGLYZA is right for you.
`
`Please see Important Safety Information on page 7.
`Click here for Medication Guide and click here for full Prescribing
`l"f°""‘"I°" f°" ONGLYZA
`
`Page 3 of 9
`
`3
`
`Important Safety Information for ONGLYZA
`Serious side effects can happen in people who
`take ONGLYZA:
`
`- Inflammation of the pancreas (pancreatitis) which
`may be severe and lead to death. Before taking ONGLYZA,
`tell your doctor if_you ever had pancreatitis, gallstones,
`_
`history of alcoholism, or high triglyceride levels. Stop taking
`ONGLYZA and contact your doctor right away if you have
`pain in your stomach area (abdomen) that is severe and will
`not go away. The pain may be felt going from your abdomen
`through to your back. The pain may happen with or without
`vomiting. These may be symptoms of pancreatitis
`
`Page 3 of 9
`
`

`
`ONGLYZA (saxagliptin)
`WORKS WITH YOUR BODY
`
`to lower blood sugar levels
`
`Not all medicines for type 2 diabetes work the same
`way. The graphic below demonstrates how ONGLYZA
`enhances the body's natural ability to control blood
`sugar, which may help you manage your type 2 diabetes.
`
`Get the convenience of once-daily
`dosing with ONGLYZA, Can be taken
`any time of day’ with or without food_
`
`ONGLYZA MAY LOWER MORNING BLOOD SUGAR
`
`ONGLYZA MAY LOWER AFTER-MEAL SPIKES
`Q MORNING BLOODSUGARcan risewhenyou'resleeping, m AFTER-MEALBLOODSUGARspikes canoccur
`
`due to The pancreas releasing too much glucagon, which
`makes the liver release too much sugar.
`
`when your pancreas doesn't release enough insulin
`or your body's cells do not use insulin properly.
`
`lower blood sugar.
`
`ONGLYZA may lower after-meal
`blood sugar spikes by helping
`your body increase levels of
`insulin after meals.
`
`ONGLYZA reduces the amount
`of sugar released by your liver
`overnight, which may result in
`
`Important Safety Information for ONGLYZA
`Serious side effects can happen in peoplewho
`take ONGLYZA:
`
`- Heart Failure. Before taking ONGLYZA tell your
`doctor if YOU haV9 9V9r had heart lallhle or
`Problems‘ With YOUV l<ldh9Y5- Chhtact YOUV doctor
`light aWaY “YOU haV9 ah)’ of the f0ll0Wlh8
`symptoms of heart failure: increasing shortness of
`breath or trouble breathing, especially when you lie
`.
`.
`.
`.
`down; an Unusually fast lncrease ln Welghti Swelllng
`in the feet, ankles or legs
`
`- When ONGLYZA is used with certain other diabetes
`medicines to treat high blood sugar, such as a
`.
`.
`.
`sulfonylurea or insulin, the risk of low blood sugar
`(hypoglycemia) is highor_ Symptoms of [ow blood
`sugar include shaking, hunger, sweating. headache.
`rapid heartbeat. change in mood. and change in
`vision. Follow your doctor's instructions for treating
`[ow oiooo Sugar.
`.
`Please see Important Safety information on page 7.
`Click here forMedication Guide and click here for fullPrescribing
`informatgon fo,oN5i_yzA_
`
`Page 4 of 9
`
`4
`
`Page 4 of 9
`
`

`
`ELIGIBILITY AND TERMS OF USE
`
`ELIGIBILITY: You may be eligible for this offer if you are insured by
`commercial insurance and your insurance does not cover the full
`cost of your prescription, or you are not insured and are responsible
`for the cost of your prescriptions. Patients who are enrolled in a
`state or federally funded prescription insurance program are not
`eligible for this offer. This includes patients enrolled in Medicare
`Part D, Medicaid, Medigap, Veterans Affairs (VA). Department of
`Defense (DOD) programs or TriCare, and patients who are Medicare
`eligible and enrolled in an employer-sponsored group waiver health
`plan or govemment—subsidized prescription drug benefit program
`for retirees. If you are enrolled in a state or federally funded
`prescription insurance program, you may not use this savings card
`even if you elect to be processed as an uninsured (cash—paying)
`patient. This offer is not insurance, is restricted to residents of the
`United States and Puerto Rico, and to patients over 18 years of age.
`
`TERMS OF USE: Eligible commercially insured patients with a valid
`prescription for ONGLYZA‘ (saxagliptin) who present this savings
`card at participating pharmacies will pay $0 per 30-day supply
`subject to a maximum savings of $150 per 30-day supply. If you
`pay cash for your prescription, Astraleneca will pay up to the first
`$150, and you will be responsible for any remaining balance, for
`each monthly prescription. Other restrictions may apply. Patient is
`responsible for applicable taxes, if any. Non-transferable, limited
`to one per person, cannot be combined with any other offer. Void
`where prohibited by law, taxed or restricted. Patients, pharmacists,
`and prescribers cannot seek reimbursement from health insurance
`or any third party for any part of the benefit received by the patient
`through this offer. AstraZeneca reserves the right to rescind, revoke,
`or amend this offer, eligibility and terms of use at any time without
`notice. This offer is not conditioned on any past, present or future
`purchase, including refills. Offer must be presented along with a
`valid prescription at the time of purchase. If you have any questions
`regarding this offer, please call 1-855-907-3197.
`
`BY USING THIS CARD, YOU AND YOUR PHARMACIST UNDERSTAND
`AND AGREE TO COMPLY WITH THESE ElIG|BIlITY REOUIREMENTS
`AND TERMS OF USE.
`
`
`
`/YOU MAY BE ABLE TO GET
`ONGLYZA’ (saxagliptin)
`FOR AS LOW AS 50 A MONTH’
`
`for as long as your doctor prescribes it
`
`AS LITTLE A5
`S0’
`For con’-a'cal>y lrsxed pacer 5
`
`mllismiqnu
`
`..............
`PCW C"
`GRPI‘ ECINIIOINIOO
`ID: XXXXXXXXXXX
`1115-
`
`'gnsI)hIs‘ _us_
`m-.:.:v:=-....."*-.-:.'...‘*=-'--........._—
`«aluminum and
`
`go to: onglyzasavings.com
`
`TO GET YOUR CARD TODAY!
`
`*EligibIe commercially insured patients can get ONGLYZA for
`as low as $0 per month for as long as your doctor prescribes
`an available dose. Subject to eligibility. Restrictions apply.
`Not available for government-insured patients.
`
`Page 5 of 9
`
`Page 5 of 9
`
`

`
`SURROUNDING YOU
`
`WITH SUPPORT
`
`We're here to help
`
`If you and your healthcare provider decide that
`ONGLYZA’ (saxagliptin) is the right treatment for you.
`you'll have a place to turn to for questions about your
`medicine and any cost issues you may have. Our goal
`is to help make your type 2 diabetes management
`plan easier. Remember, in addition to your healthcare
`provider, our team is here for you every step along
`the way.
`
`ONGLYZA Care Partners'
`
`Get connected to a variety of support
`services, tips, and information with the help
`of ONGLYZA Care Partners.
`
`ONGLYZA Prescription Coverage
`Counselors’
`
`We have Prescription Coverage Counselors
`that you can talk to on the phone about your
`ONGLYZA coverage and benefit verification.
`They can help you determine your co-pay
`amount and what information you'll need to
`process your benefit verification.
`
`*ONGLYZA Care Partners cannot provide medical advice and
`can only provide information aboutAstraZeneca medications.
`Decisions regarding your health and treatment of your condition
`should be made with your own healthcare provider.
`*Prescription Coverage Counselors do not file claims or appeals
`on behalf of patients or healthcare professionals. Coverage or
`co-pay amounts may change prior to the time of actual
`prescription fill.
`
`Visit ONGLYZA.com or call 1-800-ONGLYZA
`
`(664-5992) to learn more.
`
`Page 6 of 9
`
`FitF&lMe.
`
`Discover a type 2 diabetes diet and
`lifestyle support program that's
`custom-fit to you
`
`Fit2Me was designed to help you manage your
`diabetes, your way. It creates a customized plan
`foryou to follow, based on choices that work best
`foryou. This free program is centered around
`4 key areas:
`
`Food: pick the ingredients,
`cuisines, and recipes youlike
`
`Activity: choose your favorite
`activities and your activity level
`
`Treatment Information: get
`information to help you and
`your doctor make decisions
`about your treatment
`
`My "°""'"°"'
`
`Support: select a digital coach
`with a personality type that
`motivates you the most
`
`My Plan Team
`
`Consult with your doctor before making any changes to
`your diabetes management plan and before starting any
`diet or exercise program.
`
`Create a plan that's fit to you
`at Fit2Me.com.
`
`Page 6 of 9
`
`

`
`IMPORTANT SAFETY
`INFORMATION
`
`Important Safety Information for ONGLYZA
`Do not take ONGLYZA if you:
`• are allergic to any of its ingredients. Serious allergic
`reactions can occur with ONGLYZA and may include
`swelling of the face, lips or throat, difficulty
`swallowing or breathing, swelling of the skin, hives,
`rash, itching, flaking, or peeling. If you have these
`symptoms, stop taking ONGLYZA and contact your
`doctor right away
`Serious side effects can happen in people who
`take ONGLYZA:
`• Inflammation of the pancreas (pancreatitis) which
`may be severe and lead to death. Before taking
`ONGLYZA, tell your doctor if you ever had
`pancreatitis, gallstones, history of alcoholism, or
`high triglyceride levels. Stop taking ONGLYZA and
`contact your doctor right away if you have pain in
`your stomach area (abdomen) that is severe and will
`not go away. The pain may be felt going from your
`abdomen through to your back. The pain may happen
`with or without vomiting. These may be symptoms
`of pancreatitis
`• Heart Failure. Before taking ONGLYZA tell your doctor
`if you have ever had heart failure or problems with your
`kidneys. Contact your doctor right away if you have any
`of the following symptoms of heart failure: increasing
`shortness of breath or trouble breathing, especially
`when you lie down; an unusually fast increase in weight;
`swelling in the feet, ankles or legs
`• When ONGLYZA is used with certain other diabetes
`medicines to treat high blood sugar, such as a
`sulfonylurea or insulin, the risk of low blood sugar
`(hypoglycemia) is higher. Symptoms of low blood
`sugar include shaking, hunger, sweating, headache,
`rapid heartbeat, change in mood, and change in
`vision. Follow your doctor’s instructions for treating
`low blood sugar
`
`7
`
`• Some people who take medicines called DPP-4
`inhibitors like ONGLYZA, may develop joint pain that
`can be severe. Call your doctor if you have severe
`joint pain
`• When ONGLYZA is used with a thiazolidinedione
`(TZD), such as pioglitazone or rosiglitazone, to treat
`high blood sugar, peripheral edema (fluid retention)
`may become worse. If you have symptoms of
`peripheral edema, such as swelling of hands, feet, or
`ankles, call your doctor
`The most common side effects with ONGLYZA
`include upper respiratory tract infection, urinary tract
`infection, and headache.
`Before you take ONGLYZA:
`• Your doctor should test your blood to measure how
`well your kidneys are working before and during
`treatment with ONGLYZA. You may need a lower
`dose if your kidneys are not working well
`• Tell your doctor if you start or stop taking other
`medications, including antibiotics, antifungals or
`HIV/AIDS medications, as your doctor may need to
`change your dose of ONGLYZA
`• Tell your doctor if you are pregnant, breast-feeding,
`or plan to become pregnant or breast-feed
`What is ONGLYZA?
`ONGLYZA is a prescription medicine used along with
`diet and exercise to lower blood sugar in adults with
`type 2 diabetes.
`ONGLYZA should not be used to treat people with
`type 1 diabetes or diabetic ketoacidosis (increased
`ketones in the blood or urine).
`Click here for Medication Guide and click here for
`full Prescribing Information for ONGLYZA.
`
`Page 7 of 9
`
`

`
`
`
`During your appointment, ask:
`
`1. What is my A1C now?
`
`2. What is my A1C goal?
`
`3. Can ONGLYZA’ (saxagliptin) help lower my AK?
`
`4. What important safety information should I know?
`
`Before your next appointment:
`
`1. Make a list of any changes to the medicines
`you're taking.
`
`2. Bring notes or questions about your
`treatment options.
`
`3. Ask about the right type 2 diabetes medicine
`for you.
`
`Could ONGLYZA give you the extra boost
`
`you need to help lower your A1C?
`
`Page 8 of 9
`
`Page 8 of 9
`
`

`
`onglyza‘
`(saxag|iptin)g2.~.g‘s
`
`Ask your healthcare provider about
`ONGLYZA and visit ONGLYZA.com
`
`to learn how you can save.
`
`9
`
`Astrazenecaé
`ONGLYZA is a registered trademark of the Astrazeneca group
`of companies.
`©2016 Astraleneca. All rights reserved.
`3253801 Last Updated 5/16
`
`Page 9 of 9
`
`Page 9 of 9