11/26/2016
`
`Novel Initiative to Address Oncology Drug Crisis - The ASCO Post
`
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`
`Novel Initiative to Address Oncology Drug Crisis
`
`By Alice Goodman
`
`iviay 15, 2012 (/issues/may-15-2012/)
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`-2012/novel-initiative-to-address—onco|ogy—drug-crisis.aspx&via=ascopost)
`(a)s://twitter.com/ascopost)
`
`ti]/3i'.i)t%'eS11'da O?l%slZl(1:gr(r)1?‘lCOl0g'y drug shortage crisis in the United States. In the spirit of being part of the solution
`fii:e<1)£Bgte
`(”l9l'1l%'
`to that problem, a group of oncologists has formed the Citizen’s Oncology Foundation (COF). The goal of the start-up not-
`for—profit association is two-pronged: to find solutions to alleviate oncology drug shortages and to foster alternative drug
`discovery and development of drugs that are cheaper than and as safe and effective as those currently being used to treat
`many types of cancer.
`
`In the words of founding member Gabriel N. Hortobagyi, MD, the organization was formed “when the stars,
`moon, and sun aligned in a way to favor good deeds.” Dr. Hortobagyi is Chair of Breast Medical Oncology at
`MD Anderson Cancer Center, Houston.
`
`Laurence H. Baker, D0, who is credited with the idea for the foundation, explained that COF is in the
`tradition of “social entrepreneurship,” which means an effort that benefits the greater community and also
`generates a small profit (used toward self-preservation, expansion, or to further social goals). In other
`words, Citizen’s Oncology Foundation will explore becoming a successful business that promotes social good.
`Dr. Baker is Chair of the SWOG cancer research cooperative group and is Collegiate Professor in Cancer Developmental
`Therapeutics at University of Michigan Medical School, Ann Arbor.
`
`Hurmbagd, RD
`
`Giving Back to the Cancer Community
`
`Drs. Baker and Hortobagyi said that they are at a point in their careers where they want to use their influence to give back to
`the cancer community by addressing major challenges related to access to oncology drugs. Dr. Baker said that the seed for
`COF was planted when he received a university-wide e—mail notifying the faculty of a doxorubicin shortage, with no
`suggestions about what other drugs might be good substitutes.
`
`“At SWOG, when a drug is in shortage, we try to advise physicians about alternatives. I was in the process of writing an angry
`e-mail to the leadership and faculty at my institution, when I realized that writing yet another e-mail was not going to
`address the problem. That was the ‘aha’ moment, and I decided that action was needed.”
`
`Over the years, Dr. Baker had had conversations with similar-minded colleagues, and together they founded
`Citizen’s Oncology Foundation. These colleagues are: Lowell E. Schnipper, MD, Chief of Oncology at Beth
`Israel Hospital, Boston; Mark J. Ratain, MD, Leon 0. Jacobson Professor of Medicine and Associate Director
`for Clinical Sciences at the Cancer Research Center at University of Chicago; Frederick R. Appelbaum, MD,
`Executive Director of the Seattle Cancer Care Alliance at the Fred Hutchinson Cancer Center, Seattle; Michael
`P. Link, MD, current President of ASCO and Professor of Pediatrics at Stanford University School of Medicine,
`California; and George F. Tidmarsh, MD, a pediatric oncologist who has spent most of his career as a
`businessman in the pharmaceutical industry and an expert on delivery of generic drugs.
`
`Two—pronged Mission
`
`http:/lwww.ascopost.com/issues/may-15-2012/novel-initiative-to-address-oncology-drug-crisis.aspx
`
`Par Pharm., Inc.
`Exhibit 1107
`
`Par Pharm., Inc. v. Novartis AG
`Case |PR2016-00084
`
`Ex. 1107-0001
`
`

`
`11/26/2016
`
`Novel Initiative to Address Oncology Drug Crisis - The ASCO Post
`
`The first part of COF’s mission is to ensure the continuing availability of generic oncology drugs to all Americans. Some
`possible strategies to address this, according to Dr. Baker, are for Citizen’s Oncology Foundation to (1) go into business as a
`generic drug company, (2) lobby Congress for changes that will encourage generic drug companies to continue to produce
`oncology drugs, especially injectables, and (3) coordinate efforts with other powerful groups invested in the same goal.
`
`The second, and equally important mission of COF is to serve as an alternative pathway to drug discovery, development, and
`delivery. Elaborating on this goal, Dr. Hortobagyi explained that there is a disconnect between the research that he and his
`colleagues believe is needed and the research they are actually able to do, mainly because of shrinking support from NCI and
`the growing influence of Pharma.
`
`“Much of the research that we think is important does not interest the NCI or Pharma,” Dr. Hortobagyi said.
`
`An example is the potential use of rapamycin (sirolimus, Rapamune) as a replacement for everolimus (Afinitor) in the
`treatment of metastatic breast cancer. At the 2011 San Antonio Breast Cancer Symposium, Dr. Hortobagyi and colleagues
`presented a study showing that everolimus added to exemestane more than doubled progression-free survival in metastatic
`breast cancer}
`
`“This is the first time that we were able to show extended progression-free survival with hormonal therapy,” he said.
`Although an effect on overall survival remains to be shown for the combination of everolimus and exemestane, the authors
`hypothesized that they could get a similar benefit from substituting rapamycin, the parent compound for everolimus, which
`would be much cheaper. First, a noninferiority study comparing rapamycin vs everolimus would be needed.
`
`“We could save the health—care system billions of dollars if this proves to be true,” Dr. Hortobagyi said.
`
`Another example of a much less expensive, but possibly equally safe and effective therapy might be to replace tamoxifen with
`its active metabolite, endoxifen. At present, neither Pharma nor the NCI would support a study to demonstrate endoxifen’s
`equivalence with tamoxifen, even though—once again—billions could be saved each year. This is exactly the type of research
`that COF wants to engage in.
`
`Sound Business Model
`
`Foundation has filed
`1/media/115438[3.8.93 chart.jpglCitizen’s Oncolo
`gy
`_
`,
`for approval as a 501.3c (tax-exempt) corporation. The founders are in
`the process of developing a sound business model in conjunction with the
`University of Michigan’s Ross School of Business and the Tech Transfer
`
`members
`group of the School of Medicine‘ Also! Dr‘ Baker and other
`are exploring relationships with benefactors who believe in social
`_
`_
`_
`_
`_
`entrepreneurship and exploring potential partnerships with other
`professional societies. Thus far, the response has been enthusiastic, Dr.
`Baker said.
`
`.
`.
`.
`(itIzen‘sIJncoIngy Foundation Sets Goals
`
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`“In the next few months, we will meet with consultants and have business models based on solid business practices
`compatible with social entrepreneurship,” Dr. Baker said.
`
`“The founders of Citizen's Oncology Foundation are passionate about this. We want to make this a viable entity. The initiative
`itself is great news and will be the first tangible service to the oncology community,” Dr. Hortobagyi stated. n
`
`Disclosure: Dr. Hortobagyi serves as a consultant to Allergan, Genentech, Merck, Novartis, and sanofi-aventis and receives
`research support for a multicenter clinical trial from Novartis. Dr. Baker receives grant support from the National Institutes
`of Health and Hyatt Corporation and he's on the advisory board of The Hope Foundation, Merck, BioMed Valley, Inc, and
`CytRx DSMB.
`
`Reference
`
`1. Hortobagyi GN, Piccart M, Rugo H, et al: Everolimus for postmenopausal women with advanced breast cancer: Updated
`results of the BOLERO-2 phase III trial. San Antonio Breast Cancer Symposium. Abstract S3-1
`lhttp:1/www.abstracts2view.com/sabcs11[view.php?nu=SABCS11L 16531. Presented December 8, 2011.
`
`hflp:/lwww.ascopost.com/issues/may-15-2012/novel-initiative-to-address-oncology-drug-crisis.aspx
`
`2/4
`
`Ex. 1 107-0002
`
`Ex. 1107-0002
`
`

`
`11/26/2016
`
`Novel Initiative to Address Oncology Drug Crisis - The ASCO Post
`ADVERTISEMENT
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`Ex. 1 107-0003
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`Ex. 1107-0003
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`11/26/2016
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`Novel Initiative to Address Oncology Drug Crisis - The ASCO Post
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