`

`H'l
`
`INNOVATIVE RESEARCH OF AMERICA
`
`— M
`
`ost scientists agree that the three essential parameters in the success of a biomedical
`experiment are:
`
`A. The scientific problem formulated in a defined question.
`
`B. The laboratory animal, healthy and untraumatized.
`
`C. The process of active product delivery; the most problematic variable of all three!
`
`For a third of a century, Innovative Research of America has assumed the leadership role
`
`in improved time release technology. The main mission is to standardize the technology of
`
`drug delivery. Our proven Time Release Hormone and Drug Pellets help investigators take
`
`charge of product delivery and expand their abilities to do meaningful and reproducible
`
`research.
`
`ADVANTAGES OF THE PELLET DELIVERY SYSTEM
`
`. a.'ready-to.—adininisjterpellet-fora-isimbls
`
`'
`
`i
`
`-
`
`I
`
`': abetier
`
`:
`
`
`
`I
`
`Ushering In The Age Oflnnovath-e Research
`
`AstraZeneca Exhibit 2044 p. 2
`
`

`

`HORMONE AND DRUG PELLETS FOR BIOMEDICAL RESEARCH
`
`—
`
`Since it is not easy to administer drugs and hormones orally to research animals,
`
`several delivery methods have been devised as alternatives. However, most scientists
`
`continue to labor with unreliable injectables to conduct their research.
`
`Because of this inadequacy. biomedical research is as confusing as it is challenging
`
`and as frustrating as it is creative. The options of scientists to address scientific questions
`
`are not only dependent, but are also limited by the process of active product delivery.
`
`Traditionally, product delivery into the experimental animal has been the procedure most
`
`subject to variables and the most difficult to standardize effectively. The very process
`
`of having to accurately administer drugs to experimental animals can become a logistic
`
`nightmare for scientists.
`
`CHANGING THE TIME COURSE OF DRUG DELIVERY
`
`We Tell Ti inc—Release Pellets What Time It Is
`
`AstraZeneca Exhibit 2044 p. 3
`
`

`

`Find a Product in this Catalog ........................................................ .. 5
`
`Ordering information I General Policy & Terms ............. .. 6, 7, 44, 84
`
`Sales of Anabolic Steroids ............................................................. .. 8
`
`Category Index.......................................................................... .. 10-15
`
`Alkaloids
`Amino Acids
`Androgens
`Antibiotics
`Anti~lnflammatory Agents
`Anti—Neoplastics
`Catecholamines
`Corticoids and Diuretics
`
`Estrogens
`Fatty Acids
`Nucleotide Related Products
`Progestins
`Prostaglandins
`Thyroids
`Vitamins
`
`IRA TABLE OF CONTENTS
`
`
`
`Placebo Peilets information .1 Piece ..
`
`-
`
`'ri
`
`Alphabetical Product Listing ................................................... .. 21-42
`
`Stock Pellet Price Schedules ................................................... .. 45-71
`
`Pellets for immune-Deficient Mice
`
`17B-Estradiol [Tamoxifen 8: Sample References ................... .. 73-77
`
`Androgens I Anti-Androgens 8: Sample References ............. .. 78—80
`
`Trochar 8: Recommended Implantation Procedure ............. ..81, 123
`
`Doxycycline 8: Tetracycline Pellets in Mice ............................ .. 85-86
`
`Hormone + Hormone Pellets ................................................... .. 89-92
`
`Custom Pellets ........................................................................ .. 93-108
`
`Selected References ............................................................. ..109-122
`
`Order Forms ............................................................ .. Back of Catan -
`
`Patents ................................................................. .. inside Back Cover
`
`*Forfirrther assistance, view our website at:
`wwwin novrsrch.com
`
`We Add Time To Your Day
`
`AstraZeneca Exhibit 2044 p. 4
`
`

`

`PRODUCT DESIGN AND FEATURES
`
`
`
`The Pellet Implantation Methodology provides solutions to:
`
`.. consistency in timing repeated product administrations.
`
`controlling the amount of product administered.
`
`stability of the product preparation.
`
`.. safety of the experimenter.
`
`.. neurophysiological trauma to the animal from excessive handling.
`
`.. freeing valuable research time.
`
`.. eliminating unnecessary and unstimulating laboratory practices.
`
`Scientists from several research disciplines have documented in scientific literature that
`
`our Pellet Delivery System is effective, consistent, reproducible, economical, reliable, and
`
`safe for the animal. See Selected References on pages 109-122.
`
`Only Time. Release Pellets Really Know What Time It ls
`
`AstraZeneca Exhibit 2044 p. 5
`
`

`

`PRODUCT SPECIFICATIONS
`
`AVAILABLE SHAPES AND SIZES
`
`Stock pellets are round and range in diameter from US” (3 mm) to 1/2” ( 1.25 cm) depending on the
`dose and the release rate. Our Custom Pellets Department will also design various pellet shapes and
`smaller sizes (Page 94) to meet your research needs. Please refer to the Custom Pellets section on pages
`93-108.
`
`AVAILABLE DOSAGES
`
`Most of the stock products in this catalog are available in 20 different dosages ranging from 1 microgram
`(0.001 mg) per pellet up to 200 milligrams (200 mg) per pellet within the specified release rate. Doses of
`pellets listed in this catalog reflect the total amount of not active product released over the indicated
`period of time.
`
`AVAILABLE RELEASE RATES
`
`Stock products are designed to release continuously for 21 days, 60 days, or 90 days. Please refer to our
`Custom Pellets section on pages 93- 108 for other release rates tailored for the duration of the experiment.
`
`AVAILABLE PRODUCTS
`
`In our continuing quest to make available new stock items that are particularly in demand, we have added
`several products to the original categories. In addition to the listed pelletized products, Innovative
`Research of America has an efficient Custom Pellets Department to prepare products that are not available
`as stock items.
`
`SELECTED REFERENCES
`
`A sample of publications that employed our delivery system in a broad spectrum of products can be found
`on pages 109-122.
`
`Consistent Dose-Dependent Release
`
`AstraZeneca Exhibit 2044 p. 6
`
`

`

`FINDING A PRODUCT IN THIS CATALOG
`
`—
`
`The PRODUCTS in this catalog are arranged in ALPHABETICAL ORDER and are identified by
`a CATALOG NUMBER and a PRICE SCHEDULE with 3 PAGE NUMBER.
`
`The catalog number and price schedule reflect a release rate of 21 days, 60 days, or 90 days.
`
`To illustrate with HIS-Estradiol as an example:
`
`EXAMPLE
`
`Product
`
`21-Day Release
`Catalog
`Price Scheduler
`Number
`Page Number
`
`60-Day Release
`Catalog
`Price Schedule!
`Number
`Page Number
`
`90-Day Release
`Catamg
`Price Schedule!
`Number
`Page Number
`
`
`
`I'll?» * Estradiol
`
`E - 121
`
`B-ZlfllS
`
`SE - 121
`
`B—60!49
`
`NE - 121
`
`13-9050
`
`
`
`The above example indicates that l7B-Estradiol is available in three release forms each having a
`
`different catalog number and price code, i.e.
`
`E - 121 is a 21-day release form with a price code of 8-21, found on page 48.
`
`SE - 121 is a 60—day release form with a price code of 3-60, found on page 49.
`
`NE - 121 is a 90-day release form with a price code of B-90, found on page 50.
`
`The PAGE NUMBER next to the PRICE SCHEDULE indicates the page where the actual price
`
`for the product appears.
`
`When orderng please use the PRODUCT NAME, CATALOG NUMBER, RELEASE
`
`RATE and DOSE. Most products are available in 20 different dosages. Products are sold in
`
`Lots of 25, 50, 100, and 200 pellets. Please indicate the quantity of pellets being ordered.
`
`Beginning on Page 10 we. have grouped some. of our catalog items in related categories
`
`alphabetically. We hope the listing will help in noting items of potential interest.
`
`"lime-Release Pellets... Always On Time
`
`AstraZeneca Exhibit 2044 p. 7
`
`

`

`
`
`- Mail
`
`- Internet I E-Mail
`
`Innovative Research of America, Inc.
`
`httpdlwwwinnovrsrchxom (website)
`
`2 North Tamjamj Trail
`
`pellets@innovrsrch.com (e-mail)
`
`Suite 404
`
`Sarasota, Florida 34236 USA
`
`‘- Phone
`
`(941) 365-1406
`
`(941) 365-1506
`(800) 421-8171 (USA/Canada)
`
`' Fax
`(941) 365-1703
`(941) 365- 1803
`
`(800) 643-4345 (USA/Canada)
`
`(300) 648-6030 (USA/Canada)
`
`IRA’s website features our company profile,
`the latest product technology and on-line ordering.
`
`- AMERICAN EXPRESS
`
`__ VISA AND MASTERCARD ACCEPTED.
`__
`Purchase Order Forms are in the back of the
`“3‘8'09'
`
`Custom Pellets Information Form on page 95.
`
`THE Dll‘FEKENCE lS
`CONSISTENCY AND HNlFOKMlTY.
`
`BMW”
`1800 Second St., Suite I00
`Sarasota. Florida 34236
`
`Bank Wire Payment Information
`Reymenr via bank wire should be directed as follows:
`
`Routing it (ABA) 263191387
`Eleclronic Transfers # 263191387
`
`In favor of:
`Innovative Research of America
`
`Swift Code: BRBTU833
`
`2 North Tamiami Trail
`Suite 404
`
`Sarasota, FL 34236
`
`Checking Account: #0000147816154
`
`Usherng In The Age Of ltmox--'alive Research
`
`AstraZeneca Exhibit 2044 p. 8
`
`

`

`

`

`SALE OF CONTROLLED ANABOLIC STEROIDS
`
`within the United States
`
`— (
`
`Telephone orders will not be accepted - orders & copy of DEA license may be mailed or faxed)
`
`Before we can prepare any orders of Anabolic Steroid Pellets, the Drug
`
`Enforcement Administration (DEA) requires us to obtain:
`
`1. A valid photocopy of the investigator’s DEA Registration
`
`containing Schedule 3N.
`
`2. A written Purchase Order showing the investigator’s DEA
`
`Registration Number and proper shipping address.
`
`CONTACT INNOVATIVE RESEARCH OF AMERICA
`
`BY PHONE, MAIL, FAX OR E-MAIL
`
`FOR MORE ORDERING INFORMATION - SEE PAGE 6
`
`SALE OF CONTROLLED ANABOLIC STEROIDS
`
`outside the United States (International)
`—
`
`WE NO LONGER SHIP ANABOLIC STEROIDS
`
`outside the United States (International)
`
`DEA Controlled Anabolic Steroids
`
`Androstenediol
`
`19~Nortestosterone l7-Decanoate
`
`Androstenedione
`
`lQ—Nortestosterone 17-Dipropionate
`
`SOL-Dihydrotestosterone
`
`Fluoxymesterone
`
`Mesterolone
`
`Mesterone
`
`Methandriol
`
`Methandriol Dipropionate
`
`Stanozolol
`
`Testosterone
`
`Testosterone Acetate
`
`Testosterone Benzoate
`
`Testosterone Cypionate
`
`Testosterone Enanthate
`
`l9-Nortestosterone
`
`Testosterone 1 7r3— Hemisuccinate
`
`.l'-'
`
`Testosterone PrOpionate
`
`Time Release Pellets Always On Time
`
`AstraZeneca Exhibit 2044 p. 10
`
`

`

`
`
`U1
`
`'4
`
`and specific references.
`
`See pages 73-80 regarding
`Hormone/Anti-Hormone products
`for Immune-Deficient Mice
`
`Your Research Time Is Under Your Control
`
`AstraZeneca Exhibit 2044 p.
`
`l l
`
`

`

`

`

`

`

`

`

`

`

`

`

`(continued)
`
`‘."
`
`Consistent Results With Consistent Relea.
`
`AstraZeneca Exhibit 2044 p. I?
`
`

`

`ADVANTAGES OF OUR MDD PELLET SYSTEM ; __
`
`. Saves time
`
`o Ready-to-implant
`
`.
`Insures controlled product release over time
`o Avoids “peak and valley” effects
`
`i
`I
`
`o Guarantees consistent product preparation
`
`. Extends product life against spontaneous breakdown
`
`o Extends product life against host-related breakdown
`
`. Minimizes experimental variables
`
`.
`
`Insures safety of the researcher
`
`o Reduces neurophysiological trauma to the animal!
`
`norwcessive handling
`
`9 Generates more meaningful and reproducible results
`
`9 Superior to conventional delivery methods
`
`. Enhances experimental efficiency
`
`0 Frees valuable time for creative research
`
`9 Saves money
`
`Time—Release. Pellets... Always On Time
`
`AstraZeneca Exhibit 2044 p. 18
`
`

`

`I;
`
`
` PLACEBO / CONTROL
`PELLETS
`
`
`
`
`Matching Placebo pellets contain all the components of the hormone or drug pellet except the active
`product itself. The carrier-binder excepients of the matrix include Cholesterol, Lactose, Celluloses,
`Phosphates and Stearates.
`
`
`I:
`
`Stock Placebo pellets are available in 20 different doses corresponding to those of active product
`
`Although the matrixes in Placebo pellets have a different composition for different active products,
`they are all assigned the same catalog number and are offered at the same price schedule.
`
`pellets.Eachdoseisofferedineither2]Day,60Day,or90DayReleaseform.
`
`When inquiring or placing an order, please specify the active product you wish to correspond the
`Placebo pellets for. Please see the following examples:
`
`Catalog No.
`
`Description
`
`Dose in mgipcllet
`
`Release in Days
`
`Placebo for “Active Product”k rug/pellet
`
`C-lll
`
`SC-l l 1
`
`NC-lll
`
`Placebo for “Active Product" _ wig/pellet
`
`Placebo for “Active Product“
`
`rug/pellet
`
`21 Day
`
`60 Day
`
`90 Day
`
`
`
`
`
`1
`
`II
`
`'§
`
`5'
`
`
`
`*In place of “Active Product” specify the hormone or drug you are utilizing in your study.
`
`The following three pages are universal dose fprice schedules in all three release rates (21 Day, 60
`Day, and 90 Day) and are applicable as a matching Placebo for all products in the catalog except
`special physical size and preparations (page 94) which can be found under the Custom Pellet section
`on pages 93-108.
`
`
` *Please inquire directly with as iffltrther assistance is required regarding a product ofinterest.
`
`AstraZeneca Exhibit 2044 p. "l 9
`
`

`

`
`
`
`AstraZeneca Exhibit 2044 p. 20
`
`

`

`—«= u .
`3* ‘. n
`
`l
`
`.
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`—' " "u."- _
`
`'
`
`PLAE
`
`THE-117W:-
`ewe-“I:
`gem .: #1337545-
`
`Cat. No. C-111
`
`PRICE SCHEDULE
`
`A combination of multiple dosages in one lot, for any specified product, is also
`available. PLEASE INQUIRE.
`
`Sixty and Ninety day price schedules are on the following two pages.
`
`
`
`AstraZeneca Exhibit 204—4 p. 21
`
`

`

`
`
`
`PRICE SCHEDULE
`
`Cat. No. SC-l 11
`
`A combination of multiple dosages in one lot, for any specified product, is also
`available. PLEASE EVQUIRE.
`
`
`
`AstraZeneca Exhibit 2044 p. 22
`
`

`

`—v~]
`
`-
`
`.—1-:-r-v
`
` PLACEBQ PiELLETL
`
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`
`A combination of multiple dosages in one lot, for any specified product, is also
`available. PLEASE UVQUIRE.
`
`AstraZeneca Exhibit 2044 p. 23
`
`

`

`
` TIME RELEASE PELLETS FOR
`LABORATORY ANIMALS
`
`BIOMEDICAL RESEARCH IN
`
`
`
`
`
`Painin DRUG DELIVERY
`
`COntiiI_iI§I_1fs _:Releasl_e Pellets Are the Best Alternative
`
`Time Release Pellets
`
`for Biomedical Research from IRA
`DOSE
`
`O)))))))))))))))))))
`
`RELEASE
`
`
`
`O))))))))))))))
`Q))))))))))))
`
`
`
`
`and Innovative Scientists
`
`deserve.
`
`TIME
`
`
`Our Team at IRA is working
`
`to meet the responsibility that
`
`Innovative Science demands
`
`
`
`
`
`AstraZeneca Exhibit 2044 p. 24
`
`

`

`

`

`
`
`
`
`...._._-_—'._-.-—-_—.—....-.:E-u---
`
`
`
`AstraZeneca Exhibit 2044 p. 26
`
`

`

`ALPHABETICAL PRODUCT LISTING
`
`— D
`
`ose/Price Schedules For Matching Placebo Pellets Appear On Pages 17-19.
`
`21-Day Release
`(Taming Price. Schedule!
`Number Page Number
`
`60-Day Release
`Catalog I‘I'iee Seheduler‘
`Numher Page Number
`
`90-Day Release
`(Inkling Price Schedule}
`Numher Page Number
`
`Acebutolo!
`
`8-21148
`
`SC-101
`
`B-GOMQ
`
`NC-101
`
`B-QOI'SU
`
`Acetarsone
`
`8-212'48
`
`B—60l49
`
`3":
`
`Acempromazine
`
`_
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`1.111
`
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`
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`
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`
`AstraZeneca Exhibit 2044 p. 27
`
`

`

`ALPHABETICAL PRODUCT LISTING
`
`DosefPrice Schedules For Matching Placebo Pellets Appear On Pages 17-19.
`
`21-Day Release
`Catalina. Price SelunlnlmII
`Numher Page Number
`
`60-Day Release
`Catalng Price SchedulwI
`Number Page. Number
`
`90-Day Release
`Catalag l’riee .‘SelletlulwII
`Number Page Number
`
`Althiazlde
`
`11-104
`
`321143
`
`511- 104
`
`13-30140
`
`NA-104
`
`300150
`
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`
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`11-00141
`
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`AstraZeneca Exhibit 2044 p. 28
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`

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`ALPHABETICAL PRODUCT LISTING
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`

`

`ALPHABETICAL PRODUCT LISTING
`
`I
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`DoseJPrice Schedules For Matching Placebo Pellets Appear On Pages 17-19.
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`AstraZeneca Exhibit 2044 p. 31
`
`

`

`ALPHABETICAL PRODUCT LISTING
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`21-Day Release
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`

`

`ALPHABETICAL PRODUCT LISTING
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