Exhibit 1004
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`DECLARATION OF MATTHEW W. DAVIS M.D. RPH.
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`Page 1 of 20
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`CELGENE EXHIBIT 2040
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Inter Partes Review :
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`PETITION FOR INTER PARTES REVIEW OF
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`Case No.
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`Petitioner
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`Filed
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`Attorney Docket No.
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`Customer No.
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`U.S. PATENT NO. 6,315,720 UNDER 35 USC §§
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`311-319 AND 37 CFR §42.100 ET SEQ.
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`To be Assigned
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`To be Named
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`27571
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`Appeal Related Matters
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`Patent Trial and Appeal Board
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`US Patent and Trademark Office
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`PO Box 1450
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`Alexandria, Virginia 22313-1450
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`Sir:
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`DECLARATION OF MATTHEW W. DAVIS M.D. R.Ph.
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`I, the undersigned, hereby declare the following, based on my own
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`knowledge, information, and belief:
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`Page 2 of 20
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`1.
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`I am presently Senior Vice President of Clinical Operations and
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`Development at Sun Pharmaceuticals.
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`2.
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`I received an M.D. degree from the Medical College of Pennsylvania
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`in 1994, a B.S. in Pharmacy from Temple University School of Pharmacy. I did an
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`internship in surgery, followed by a residency in urology. I am a pharmacist, R.Ph,
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`as well as a licensed physician.
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`3.
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`Since 1998, I have directed clinical development, medical affairs and
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`pharmacovigilance at a number of different companies. These companies include,
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`Endo Pharmaceuticals, Dermik Laboratories, Dr. Reddy’s Laboratories, Eisai
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`Global Research and most recently, URL Pharma, now Sun Pharmaceuticals.
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`4.
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`I have co-authored 20 articles in peer reviewed scientific and medical
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`journals. I am the sole inventor of 17 U.S. patents, named inventor on numerous
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`other patents and patent applications. A copy of my resume is attached.
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`5.
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`I have reviewed U.S. Patent No. 6,315,720, its file history as well as
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`the prior art cited in the Petition: (i) the THALOMIDTM (thalidomide) Capsules
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`Page 3 of 20
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`Revised Package Insert (15 July 1998), as appended to the “Thalomid Capsules
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`(Celgene) 07/16/1998 Approval [Erythema Nodosum Leprosum: Approval Letter;
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`Final Labeling; Supervisory Review” dated July 17, 1998, (“Thalomid PI” or
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`“PI”), Exhibit 1002; and (ii) Keravich et al. (Am. J. Health-Syst. Pharm. 56: 1721
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`(1999), (“Keravich”), Exhibit 1003.
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`
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`6.
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`The Thalomid PI was approved as of the date of the Approval Letter,
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`July 16, 1998, and was published on that date on the FDA’s website at:
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`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Searc
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`h.Label_ApprovalHistory. It is common practice to look for pertinent drug
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`approval information and labeling on this FDA website, drugs@fda.gov.
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`7.
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`The Thalomid PI clearly sets forth “a method for delivering a drug to
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`a patient in need of the drug, while avoiding the occurrence of an adverse side
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`effect known or suspected of being caused by the drug” as claimed in the ‘720
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`patent. First, the PI includes “Indications and Usage” of the drug, and “Dosage
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`and Administration”. Exhibit 1002, at 8, 18. It describes risks of severe and life-
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`threatening side effects and birth defects throughout. Id. at 1-2. It defines certain
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`patient risk groups, female patients of childbearing age, and male patients capable
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`of impregnating women, requires written informed consent and pregnancy testing,
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`counseling, and registration of patients, physicians, and pharmacists in the
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`“S.T.E.P.S.” program prior to prescribing the drug. Id. at 2-4, 20-21. The PI
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`describes the risks associated with the drug, specifically, the Contraindications,
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`Warnings and Precautions, which include precautions for “Drug Interactions” (the
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`potential for thalidomide to interact with or affect the activity or sensitivity of other
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`drugs the patient is taking or may be prescribed). Id. at 9-14. The S.T.E.P.S.
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`program makes it clear that certain diagnostic testing is required prior to
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`registration in the program, importantly, pregnancy testing (a form of genetic
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`testing). Id. at 3. It is also clear from the nature of the potential side effects of
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`thalidomide (as set forth in the Contraindications, Warnings, and Precautions
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`sections of the PI), that other diagnostic testing would likely be required of patients
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`prior to prescribing the drug. Id. at 9-14.
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`8.
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`Keravich, which explains the S.T.E.P.S. program that is part of the
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`Thalomid PI, describes the computerized database maintained by Celgene that
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`requires prescriber, pharmacy and patient registration as part of the program.
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`Exhibit 1003 at 1721. At the time the S.T.E.P.S. program was put in place, the use
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`of more advanced computerized systems for storing patient medical histories and
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`records were in place, and methods of transmitting patient information to and from
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`doctor’s offices to pharmacies were also available. These included the use of
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`facsimile, and optical character recognition for reading computer-transmitted
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`documents.
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`9. With regards to the diagnostic testing set forth in claims 7 through 10,
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`as a physician and pharmacist, I frequently required blood tests, and/or consulted
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`patient records, prior to prescribing a drug. In patients on diuretics, it is the
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`standard of care to check potassium levels prior to prescribing digoxin to avoid
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`arrhythmias. In pharmacy school in 1987, it was taught that prior to dispensing
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`phenytoin to the elderly or infirm, serum albumin must be ordered. Phenytoin is a
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`narrow therapeutic index drug that is highly protein bound. This means that the
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`Michaelis-Menten equation for saturable pharmacokinetics (which requires
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`albumin levels) is needed to safely dose patients with low albumin levels. In fact, I
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`programed my Radio Shack® programmable computer to calculate corrected
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`phenytoin dosing in light of hypoalbuminemia using the Michaelis-Menten
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`equation in the late 1980’s. It is of the utmost importance to understand a patient’s
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`health and drug history for proper drug administration, to avoid known or
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`suspected adverse events. It has long been common practice to request or consult
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`diagnostic tests, including pregnancy testing and genetic testing, prior to
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`determining a patient’s risk associated with a potential drug, and deciding whether
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`or not the drug is safe to prescribe. Genetic testing may be dispositive of the
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`ability to pass on a genetic disorder. An example would be testing an Ashkenazi
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`Jewish couple to see if they both are carriers of Tay-Sachs disease. If they both
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`were carriers, they could be warned prior to starting Clomid that their offspring
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`could have a one in four chance of having an incurable fatal genetic disease. As a
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`result, diagnostic testing would likely be performed by physicians prior to
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`prescribing a particular drug, for example, Clomid, which was approved in 1967
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`and is used for the treatment of ovulatory dysfunction in a woman desiring
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`pregnancy. The same physician would also perform a pregnancy test, as Clomid is
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`contraindicated in pregnant patients. Finally, in general, drugs do not uniformly
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`distribute in the body - a one compartment pharmacokinetic model. If a drug
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`evenly disturbed throughout the body, blood levels would be predictive of tissue
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`levels. Many drugs are preferentially absorbed by certain body tissues. In these
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`multi-compartment models, blood levels are not predictive of tissue distribution.
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`As such, it is also important to perform diagnostic testing that would be predictive
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`of drug levels in various tissues of interest.
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`10. Similarly, with respect to claims 15 through 19, follow up diagnostic
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`testing, patient interviews and, importantly for women of childbearing age,
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`pregnancy testing on a regular basis, has long been a matter of routine practice in
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`the course of prescribing drugs to a patient.
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`11. With respect to claim 20, it was common practice in the medical field
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`to provide drug and medical device samples to patients, when available. As a
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`surgical resident in 1994 and as a Urological resident in 1996, I commonly gave
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`drug samples to our clinical patients.
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`12. Adverse side effects occurring as a result of concomitant drug use,
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`also termed “drug-drug interactions” are unfortunately common, and frequently
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`lethal. In fact, the Federal Food and Drug Administration requires that “Drug
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`Interactions” be reported on all drug product package inserts, and that warnings be
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`included as to the nature and extent of drug interactions. The Thalomid PI is the
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`perfect example, outlining drug interactions on page 12. As stated above, it is
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`necessary to consult a patient’s medical history, conduct patient interviews, and to
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`request or consult diagnostic tests prior to determining a patient’s risk associated
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`with a potential drug, and deciding whether or not the drug is safe to prescribe,
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`particularly when the patient takes multiple drugs. In fact, the FDA’s published
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`guidance on labeling for human prescription drugs requires dosing and
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`administration instructions for concomitant therapy. See U.S. Department of
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`Health and Human Services, Food and Drug Administration, Guidance for
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`Industry – Labeling for Human Prescription Drug and Biological Products –
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`Implementing the PLR Content and Format Requirements (February 2013). The
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`Thalomid PI illustrates that the FDA’s requirement for describing potential effects
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`of concomitant therapy has been in place for a long time.
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`13. Regarding the use of computer and information transmission
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`technology: facsimile for transmitting data to a computerized database maintaining
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`patient records, the use of optical character recognition software to interpret faxed
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`data records, and calling patients on the telephone, for follow-up or to collect
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`additional patient data, as claimed in claims 6 and 17 of the ‘720 patent, were
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`practiced long before October 23, 2000. We used OCR fax technology and patient
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`callback systems at Endo Pharmaceuticals (Algos) prior to 2000 in our clinical
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`trials to collect patient data. These were standard practices in the pharmaceutical
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`development industry at that time.
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`14. As a physician, pharmacist and medical director of numerous
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`pharmaceutical companies, having read hundreds of drug labels and package
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`inserts, it is very clear to me that the Thalomid PI, and the S.T.E.P.S. program
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`disclosed therein, discloses every aspect of the ‘720 patent claims.
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`16.
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`I hereby declare that all statements made herein of my own
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`Page 9 of 20
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`knowledge are true and that all statements made on information and belief are
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`believed to be true; and further that these statements are made with the knowledge
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`that willful false statements and the like so made are punishable by fine or
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`imprisonment, or both, under section 1001 of Title 18 of the United States Code,
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`and that such willful false statements may jeopardize the validity of the application
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`or any patent issuing thereon.
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`Signed this day of , 2013.
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`________________________
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`Matthew W. Davis M.D. R.Ph.
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`Page 10 of 20
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`Exhibit
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`RESUME OF MATTHEW W. DAVIS M.D. RHP.
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`Page 11 of 20
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`Matthew W Davis, MD, RPh
`2 Erwinna Valley Way • Erwinna • PA 18920
`Cell (267) 261-5882 • Fax (610) 294-5087 • md@davisinfo.com
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`
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`Curriculum Vitae
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`SUMMARY
`
`Ø “C” level experience, vision & execution
`o Corporate
`§ A key member of executive team (CEO, CFO, etc) that conducted
`the successful sale of URL Pharma for $800,000,000 (not including
`future performance-based payments).
`§ A key member of executive team (CEO, CFO, etc) that conducted
`the successful recap of URL Pharma.
`§ Multiple successful Wall Street interactions.
`o Departmental
`§ Created and then ran multiple departments
`• Medical Affairs (Endo, Reddy Pharmaceuticals & URL
`Pharma)
`• Clinical Development (Reddy Pharmaceuticals & URL
`Pharma)
`• Pharmacovigilance (Endo, Reddy Pharmaceuticals & URL
`Pharma)
`• Materialvigilance (Dermik Laboratories)
`§ Broad FDA experience
`• Division of Anesthesia, Analgesia & Rheumatology Products
`• Division of Special Pathogens and Immunologic Drug
`Products
`• Division of Nonprescription Clinical Evaluation
`• Division of Cardiorenal Drug Products
`• Division of Gastrointestinal and Coagulation Drug Products
`• Division of Dermatologic and Dental Drug Products
`• Division of Anesthetic, Critical Care and Addiction Drug
`Products
`• Division of Anti-Infective Drug Products
`• Office of Hematology and Oncology Products
`• Division of Drug Marketing, Advertising and Communications
`• Office of Compliance
`§
`Intellectual technology – 19 patents in last 5 years
`o Teams
`§
`Integral member of Commercial & Business Development teams.
`§ Proven track record of leading international & corporate teams.
`Ø Proven track record in new drug approvals– 4 NDAs approved in last 5 years.
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`Page 12 of 20
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`EMPLOYMENT HISTORY
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`Chief Medical Officer, Senior Vice President
`URL Pharma / Takeda / Sun Pharma
`Corporate Officer / Reported to CEO
`
`
`October 2005 – Present
`Philadelphia, PA
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`Key Achievement: By obtaining FDA approval and solely inventing all
`intellectual property for Colcrys®, created vast wealth for the owners of
`URL upon Takeda’s purchase of URL Pharma.
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`Corporate Strategy: At the time of hiring, there were over 2,000
`unapproved drugs marketed in the US. URL identified colchicine as a
`drug it desired to obtain approval, but had no NDA experience.
`
` Ø
`
` Major contributor to the success of Colcrys®, which led to the sale of
`URL Pharma ($800,000,000 upfront payment by Takeda).
`o Was single member of Clinical / Medical / Pharmacovigilance
`department until the end of Phase III.
`o Responsible for preclinical and clinical program.
`o Led all FDA meetings.
`o Sole inventor of all 17 Orange Book patents.
`o
`Integral member of Colcrys® launch team.
`Ø A key member of team responsible for sale of URL Pharma.
`Ø A key member of team responsible for investor Recap.
`Ø Started up and responsible for Pre-Clinical, Clinical Development,
`Medical Affairs & Pharmacovigilance departments.
`Ø Responsible for robust pipeline of NCEs (non-organic & organic).
`Ø Integral member of multiple teams.
`o Business Development
`o Sales & Commerical Operations
`o Health Care Compliance
`o Production Selection (Portfolio Management)
`
`US Patents Issued: 7601758, 7619004, 7820681, 7906519, 7915269, 7935731,
`7964647, 7964648, 7981938, 8067042, 8093296, 8093297, 8093298, 8097655,
`8231915, 8415395, 8415396, 8440721 & 8440722
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`Director, Oncology Clinical Development
`Eisai Global Clinical Research
`
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`May 2005 – September 2005
`Ridgefield Park, NJ
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`Ø Responsible for development of multiple oncology compounds.
`
`
`
`
`
`Vice President, Clinical Development and Medical Affairs April 2003 – October 2004
`Reddy Pharmaceuticals / Dr. Reddy’s Laboratories
`Bridgewater, NJ
`
`
`Key Achievement: Obtained approval for Amvaz®.
`Corporate Strategy: At the time of my hire, DRL had the innovative idea of
`taking advantage of the time period between the patent expiration of a
`compound and the patent term extension of the compound. The case
`law stated that a DIFFERENT salt of a compound would NOT be protected
`during this time period. Was hired to gain amlodipine maleate (Amvaz®)
`approval prior to Norvasc® (amlodipine besylate) patent term extension
`expiration.
`
` Ø
`
` Started up Clinical Development, Medical Affairs & Pharmacovigilance
`departments.
`Ø Helped gained Amvaz® FDA approval.
`Ø Integral member of Amvaz® launch team.
`Ø Had stable of 12 Amvaz® like opportunities.
`
`
`
`Director, Clinical Development and Medical Affairs
`Dermik Laboratories / Aventis (now Sanofi – Aventis)
`
`
`December 2000 – March 2003
`Berwyn, PA
`
`Key Achievement: Integral member of BenzaClin®, Carac®, Dermatop®,
`Benzamycin® Pak launch teams.
`Corporate Strategy: To be the leading US dermatology company.
`
`Ø Created & ran Medical Affairs
`Ø Headed Clinical Development
`Ø Integral member of BenzaClin®, Carac®, Dermatop®, Benzamycin® Pak
`launch teams
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`Page 14 of 20
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`Manager, Medical Affairs (Head of Medical Affairs)
`Endo Pharmaceuticals
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`July 1998 – November 2000
`Chads Ford, PA
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`Key Achievement: On team that discovered, helped to gain approval
`and launched Lidoderm®.
`Corporate Strategy: To be the leading US pain company.
`
`Ø Created & ran Medical Affairs & Pharmacovigilance.
`Ø Conducted Lidoderm® phase IV study that was the cornerstone for
`successful launch.
`o Current sales of $1,200,000,000 per year (current IMS MAT)
`
`
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`
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`Adjunct Assistant Professor of Pharmacy
`Temple University School of Pharmacy
`
`
`September 1998 – December 2007
`Philadelphia, PA
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`Ø Lectured on drug development (Pre-clinical to Phase IV).
`Ø Lectured on pharmacovigilance, pharmacoepidemiology, and the role of
`the pharmacist in the pharmaceutical industry.
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`Page 15 of 20
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`EDUCATION
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`Urology Resident (Post Graduate Year 3 and Year 4)
`Washington Hospital Center
`
`Surgery Resident (Post Graduate Year 1 and Year 2)
`Brown University
`
`Doctor of Medicine - Degree
`Medical College of Pennsylvania
`
`Bachelor of Science in Pharmacy – Degree, Cum Laude
`Temple University School of Pharmacy
`
`Undergraduate Pre-pharmacy requirements
`University of Pennsylvania
`
`July 1996 – June 1998
`Washington, DC
`
`July 1994 – June 1996
`Providence, RI
`
`August 1989 – May 1994
`Philadelphia, PA
`
`August 1985 – May 1989
`Philadelphia, PA
`
`August 1983 – May 1985
`Philadelphia, PA
`
`STATE LICENSE
`Ø Registered Pharmacist in Pennsylvania (inactive): RP-036578L
`Ø New York Medical License: 237105
`
`PAST AND PRESENT PROFESSIONAL AFFILIATIONS
`Ø American College of Rheumatology
`Ø American Urological Association
`Ø American Society of Clinical Oncologists
`Ø American Academy of Dermatology
`Ø American Diabetic Association
`Ø American Geriatric Association
`Ø American Medical Association
`Ø American Pain Society
`Ø Drug Information Association
`Ø European Academy of Dermatology and Venereology
`Ø International Academy of Cosmetic Dermatology
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`Page 16 of 20
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`EDITORIAL BOARDS
`Ø Editorial Advisory Board - Journal of Pharmacy Finance Economics and
`Policy (Closed 2008)
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`
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`PROFESSIONAL PRESENTATIONS
`
`Conference Chair
`Ø Pharmaceutical Education Associates – Aligning Medical Affairs with
`Marketing: Optimal Drug Promotion Through Innovation and
`Collaboration, Princeton, NJ, April 2004
`Ø Pharmaceutical Education Associates - OIG’s New Compliance Program
`Guidance For Pharmaceutical Manufacturers: What you Need to Know,
`Philadelphia, PA, July 2003
`Ø Pharmaceutical Education Associates - Medical Affairs and Marketing:
`Aligning for Success, Philadelphia, PA, April 2003
`Ø Barnett International - Phase IV & Peri-Approval Clinical Research
`Programs, Philadelphia, PA, February 2003
`
`
`Presentations
`Ø “The Race for Market Share: Capitalizing on Pharmaceutical Growth”,
`Financial Research Associates, LLC – Investing in India: A Road Map to the
`Heart of a Dynamic Emerging Market, New York City, NY, April 2005 (Panel
`Chairman & Presenter)
`Ø “Successful Partnerships Between Medical Affairs and Marketing”,
`Pharmaceutical Education Associates – Aligning Medical Affairs with
`Marketing: Optimal Drug Promotion Through Innovation and
`Collaboration, Princeton, NJ, April 2004
`Ø “Phase IV: The Role of Open-Label Studies in Publications”,
`Pharmaceutical Education Associates - Medical Affairs and Marketing:
`Aligning for Success, Philadelphia, PA, April 2003
`Ø “Phase IV: Is There a Place for Open Label, Community-Based Trials?”,
`Pharmaceutical Education Associates - The New Business of Clinical Trials:
`Cost, Quality and Time, Philadelphia, PA, March 2003
`Ø “Open Label Studies: Publication Challenges and Solutions”, Barnett
`International - Phase IV & Peri-Approval Clinical Research Programs,
`Philadelphia, PA, February 2003
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`Page 17 of 20
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`Ø “Conducting Phase IV Physician Awareness Trials- How to maximize your
`product's exposure while staying in regulatory compliance”, Barnett
`International - Phase IV Clinical Research Programs, Philadelphia, PA,
`February 2002
`Ø “Conducting Phase IV Non-Inferiority Trials to Address Competition Issues”,
`Barnett International - Phase IV Clinical Research Programs, Philadelphia,
`PA, February 2002
`Ø “Strategies for Cost Management in Physician Awareness Trials”, Barnett
`International - Cost Management in Clinical Trials, Philadelphia, PA, March
`2002
`
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`Page 18 of 20
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`PUBLICATIONS
`Ø Davis MW, Wason S, Digiacinto JL. Colchicine-antimicrobial drug interactions:
`What pharmacists need to know in treating gout. Consult Pharm. 2013
`Mar;28(3):176-83.
`Ø Wason S, Digiacinto JL, Davis MW. Effect of cyclosporine on the
`pharmacokinetics of colchicine in healthy subjects. Postgrad Med. 2012
`Jul;124(4):189-96.
`Ø Wason S, DiGiacinto JL, Davis MW. Effects of grapefruit and Seville orange
`juices on the pharmacokinetic properties of colchicine in healthy subjects.
`Clin Ther. 2012 (Article in Press, Corrected Proof) August 30.
`Ø Wason S, Faulkner RD, Davis MW. Are dosing adjustments required for
`colchicine in the elderly compared with younger patients? Adv Ther. 2012
`Jun 29;29(6):551-6.
`Ø Nasr A, Lauterio TJ, Davis MW. Unapproved drugs in the United States and the
`food and drug administration. Adv Ther. 2011 Oct;28(10):842-56.
`Ø Terkeltaub RA, Furst DE, Digiacinto JL, Kook KA, Davis MW. Novel evidence-
`based colchicine dose-reduction algorithm to predict and prevent
`colchicine toxicity in the presence of cytochrome P450 3A4/P-glycoprotein
`inhibitors. Arthritis Rheum. 2011 Aug;63(8):2226-37.
`Ø Terkeltaub RA, Furst DE, DiGiacinto JL, Kook KA, Davis MW. Erratum: Novel
`evidence-based colchicine dose-reduction algorithm to predict and prevent
`colchicine toxicity in the presence of cytochrome P450 3A4. Arthritis Rheum.
`2011;63(11):3521.
`Ø Wertheimer AI, Davis MW, Lauterio TJ. A new perspective on the
`pharmacoeconomics of colchicine. Curr Med Res Opin. 2011 May;27(5):931-
`7.
`Ø Davis MW. Colchicine ignites controversy. Rheumatol News. 2010
`March;9(3):13.
`Ø Godfrey, A.R., J. Digiacinto, and M.W. Davis, Single-Dose Bioequivalence of
`105-mg Fenofibric Acid Tablets Versus 145-mg Fenofibrate Tablets Under
`Fasting and Fed Conditions: A Report of Two Phase I, Open-Label, Single-
`Dose, Randomized, Crossover Clinical Trials. Clin Ther, 2011. 33(6): p. 766-75.
`Ø Terkeltaub, R., D. Furst, et al. (2010). "High Versus Low Dosing of Oral
`Colchicine for Early Acute Gout Flare: Twenty-Four-Hour Outcome of the First
`Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
`Dose-Comparison Colchicine Study." Arthritis Rheum 62(4): 1060-1068.
`Ø Weiss JW, Shavin J, Davis MW. Improving Patient Satisfaction and Acne
`Severity in Patients with Mild to Moderate Acne: The BEST Study. Cutis 2003; 71
`(suppl 2):3-4.
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`Page 19 of 20
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`Ø Rist T, Davis MW. Study Design and Selection Criteria in the BEST Study. Cutis
`2003; 71 (suppl 2):5-9.
`Ø Weiss JW, Shavin J, Davis MW. Overall Results of the BEST Study Following
`Treatment of Patients with Mild to Moderate Acne. Cutis 2003; 71 (suppl 2):10-
`17.
`Ø Fernandez-Obregon A, Davis MW. The BEST Study: Evaluating Efficacy by
`Selected Demographic Subsets. Cutis 2003; 71 (suppl 2):18-26.
`Ø Rodriguez D, Davis MW. The BEST Study: Results According to Prior Treatment.
`Cutis 2003; 71 (suppl 2):27-34.
`Ø Gammaitoni AR, Davis MW. Pharmacokinetics and Tolerability of Lidocaine
`Patch 5% with Extended Dosing. Annals of Pharmacotherapy 2002; 36:236-40.
`Ø Weiss JW, Shavin J, Davis MW. Preliminary Results of a Nonrandomized,
`Multicenter, Open-Label Study of Patient Satisfaction after Treatment with
`Combination Benzoyl Peroxide/Clindamycin Topical Gel for Mild to Moderate
`Acne. Clinical Therapeutics 2002; 24:1706-17.
`Ø Gammaitoni AR, Davis MW. Comparison of the Pharmacokinetics of
`Oxycodone Administered in Three Percocet Formulations. Journal of Clinical
`Pharmacology 2002; 42:192-7.
`Ø Katz NP, Gammaitoni AR, Davis MW, Dworkin RH. Lidocaine Patch 5%
`Reduces Pain Intensity and Interference with Quality of Life in Patients with
`Postherpetic Neuralgia: An Effectiveness Trial. Pain Medicine 2002; 3:324-32.
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