Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 1 of 21 PageID #: 23697
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`GENENTECH, INC. and CITY OF HOPE,
`
`
`
`v.
`
`AMGEN, INC.,
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`
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`
`Plaintiffs,
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`Defendant.
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`
`C.A. No. 18-924-CFC
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`DECLARATION OF CHRISTY OLIGER IN SUPPORT OF
`GENENTECH’S MOTION FOR PRELIMINARY INJUNCTION
`
`PUBLIC VERSION FILED:
`
`July 19, 2019
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`

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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 2 of 21 PageID #: 23698
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`I.
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`1.
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`2.
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`II.
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`3.
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`4.
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`5.
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`6.
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`PERSONAL BACKGROUND
`
`My name is Christy Oliger. I have been employed at Genentech, Inc. since 2000 in a
`variety of positions.
`
`In my current role as Senior Vice President of BioOncology, which I began in 2017, I
`manage the company’s United States commercial operations for its oncology products.
`
`BACKGROUND REGARDING HERCEPTIN
`A.
`
`History of Herceptin1
`
`Genentech has a long history of developing innovative therapies to solve some of the
`most difficult problems in medicine. The development of Herceptin was one of
`Genentech’s early successes in the field of biooncology, and it remains one of the
`Company’s most important medicines.
`
`In the 1980s, scientists observed that approximately 25% of breast tumors had an excess
`of human epidermal growth factor receptor 2 (i.e., “HER2”) proteins. Breast cancer
`characterized by overexpression of HER2—now referred to as “HER2-positive” or
`“HER2+”—is particularly aggressive. Genentech scientists exploring the role of HER2
`overexpression then created specific “monoclonal antibodies”—man-made versions of
`proteins created by the immune system for use against bacteria and viruses—that limited
`the effect of HER2 by binding to the HER2 receptors on breast cancer cells. The early
`clinical trials of the monoclonal antibody known as trastuzumab were so successful that
`the FDA approved an unusual expanded access program under which certain patients
`could receive treatment even though they were not eligible for the trials.
`
`Herceptin, Genentech’s brand name for trastuzumab, was initially approved by the FDA
`in 1998 for the treatment of HER2+ metastatic (or late stage) breast cancer. At the time,
`Herceptin was unique—it was the first biological or antibody treatment targeted to solid
`cancer tumors. As described below, Genentech has invested significantly in research to
`expand the use of Herceptin to early stage breast cancer, making a cure available to many
`patients for the first time.
`B.
`
`Importance of Herceptin to Patients
`
`In the early 1990s, before Herceptin became available, HER2+ breast cancer was one of
`the worst diagnoses a patient could receive. HER2+ breast cancer responded particularly
`poorly to the treatments that were then available, and patients diagnosed with HER2+
`breast cancer had an average life expectancy of only 18 months, and 50% of those
`diagnosed with the disease died within two years. Herceptin improved response rates and
`duration, time to progression (i.e., the time between the date of diagnosis or treatment to
`the time the disease begins to worsen or spread), and overall survival compared with
`
`
`1 See, e.g., Ex. 33, Genentech.com, Her2 (https://www.gene.com/stories/her2/).
`
`- 1 -
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 3 of 21 PageID #: 23699
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`7.
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`8.
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`9.
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`10.
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`11.
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`treatment with chemotherapy alone, resulting in improved overall survival of roughly
`25% and reduced risk of death of 50% for metastatic HER2+ breast cancer.
`
`Since Herceptin was first approved, Genentech has spent billions of dollars expanding its
`use. For example, Genentech’s research has greatly expanded the number of patients
`who are able to benefit from treatment with Herceptin by identifying, through clinical
`trials, patient populations who benefit from the therapy, securing approval for additional
`indications, and by developing new methods of identifying and treating HER2+ breast
`cancer patients using new methods and combinations.
`
`Herceptin’s benefits have been demonstrated through numerous successful clinical trials.2
`For example, Herceptin was initially approved for use in treatment of metastatic HER2+
`breast cancer, Genentech later demonstrated the effectiveness of Herceptin in adjuvant
`treatment of early HER2+ breast cancer through clinical trials involving nearly ten
`thousand patients at a cost of nearly one billion dollars.
`
`Genentech’s work developing treatments using Herceptin in the adjuvant (post-surgery)
`setting has made a cure possible for the first time. In fact, HER2+ breast cancer is now
`one of the most treatable types of breast cancer, and HER2+ breast cancer patients are
`now more likely to die of some other cause than from their breast cancer.
`
`As a result of Herceptin’s success and Genentech’s post-approval efforts to identify
`additional patient populations Herceptin could help, Herceptin is now FDA-approved for
`(1) adjuvant treatment of HER2+ breast cancer, including as part of first-line treatment
`and as a single agent following certain other treatments; (2) treatment of metastatic
`HER2+ breast cancer, including as part of first-line treatment and as a single agent for
`certain patients; and (3) treatment of HER2+ metastatic gastric cancer and HER2+
`gastroesophageal junction adenocarcinoma.3
`
`In addition, Genentech developed a treatment using the combination of Herceptin and
`Perjeta (pertuzumab), another anti-HER2 antibody developed by Genentech, which
`achieved even higher survival benefits in the curative setting than Herceptin alone.
`Kadcyla, another Genentech antibody which is comprised of trastuzumab and the
`chemotherapy medicine emtansine linked together, reduced the risk of recurrence by half
`as compared to treatment with Herceptin among HER2+ breast cancer patients with
`residual disease after completion of preoperative treatment.
`
`12.
`
`Today, tens of thousands of patients receive Herceptin annually, and Herceptin is the
`market leader for each approved indication.
`
`
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`
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`2 See, e.g., Ex. 34, Genentech.com, Press Release, “Herceptin Plus Chemotherapy Improved
`Disease-Free Survival and Overall Survival in Adjuvant Setting for Early-Stage Her2-Positive
`Breast Cancer Patients,” May 13, 2005 (http://www.gene.com/media/press-releases/8429/2005-
`05-13/herceptin-plus-chemotherapy-improved-dis).
`3 Ex. 7, at GNE-HER_002466538 [Herceptin Prescribing Information].
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`- 2 -
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 4 of 21 PageID #: 23700
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`C.
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`Importance of Herceptin to Genentech
`
`13.
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`14.
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`Herceptin is one of Genentech’s most important products, and one of its highest-grossing.
`Herceptin has played a key role in the development of Genentech’s reputation as a leader
`in oncology drugs generally and humanized monoclonal antibodies in particular.
`
`Herceptin is typically sold to healthcare providers such as hospitals and oncology clinics.
`Many hospitals and clinics contract with group purchasing organizations (“GPOs”),
`which in turn contract with Genentech
`. By volume,
`clinic GPO accounts are responsible for approximately
` of Herceptin sales.5 Other
`Herceptin providers include 340B hospitals, which comprise approximately
` of the
`Herceptin market,6 non-340B hospitals, which comprise approximately
` of the
`market, about a third of which (
` of the market) are part of the National Comprehensive
`Cancer Network (“NCCN”)7, and non-GPO Clinics, which comprise approximately
`
`of the market.
`
`15.
`
`The term wholesale acquisition cost (“WAC”) refers to the manufacturer’s list price for a
`drug to wholesalers or direct purchasers without accounting for discounts or rebates. The
` per 150mg vial.8
`current WAC for Herceptin is
`
`16. Without biosimilar competition, Genentech has historically increased the price of
`Herceptin annually, in part to account for inflation.9
`
`17.
`
`Herceptin sales have steadily increased over time. The gross/net sales of Herceptin in the
`United States in the last four years were as follows:
`
`
`
`
`
`2015:
`
`2016:
`
`;
`
`;
`
`
`4 Ex. 35, at GNE-HER_002993635, GNE-HER_002993637, GNE-HER_002993648-3650 [
`] (all patients shown as
`
`
`
`receiving Perjeta also received Herceptin).
`].
`5 Ex. 36, at GNE-HER_002948939 [
`6 “340B” refers to 340B of the Public Health Services Act, which was enacted pursuant to the
`Veterans Health Care Act of 1992, and which requires pharmaceutical manufacturers to provide
`large discounts on outpatient drugs purchased by certain covered entities. See 42 U.S.C. § 256b.
`7 NCCN is a not-for-profit alliance of 27 leading cancer centers. See NCCN.org, About NCCN
`(https://www.nccn.org/about/).
`8 Ex. 37, at GNE-HER_002952195 [
`9 Ex. 38, at GNE-HER_002230692 [
`
`].
`].
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`- 3 -
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 5 of 21 PageID #: 23701
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`
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`
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`2017:
`
`2018:
`
`;
`
`.10
`
`18.
`
`Through May 2019, Genentech recorded gross sales in the United States of
` for Herceptin, and net sales of
` during that time.11
`
`19. Much of the revenue Genentech derives from sales of Herceptin and other drugs is
`reinvested. For example, as discussed below, Genentech provides extensive patient
`access programs with the goal of ensuring that no patient who would benefit from
`therapies such as Herceptin is forced to go without for financial reasons.
`
`20.
`
`In addition, Genentech has invested billions in research and development (“R&D”)
`related to its breast cancer therapies alone. That reinvestment in the breast cancer
`research has resulted in the development of additional therapies such as Perjeta and
`Kadcyla, discussed below.
`
`21.
`
`Patent protection is a key incentive underlying Genentech’s commitment to R&D.
`Genentech submitted its first patent application in 1979, and since then has secured
`patents worldwide covering its innovations. All told, Genentech is one of the leading
`innovators in the field of biotechnology. Without the exclusivity afforded by patents,
`Genentech could not rely on the financial success of its products, no matter how
`innovative its work, to fund its R&D efforts. And without expectation of financial
`success for its products, Genentech could not justify its commitment to the large-scale
`R&D spending that has led to life-changing advances such as Herceptin, Perjeta, and
`Kadcyla.
`III. BACKGROUND REGARDING RELATED PRODUCTS
`A.
`
`Other Anti-HER2 Products
`
`22.
`
`In April 2019, Genentech launched Herceptin Hylecta, a combination of trastuzumab and
`recombinant human hyaluronidase-oysk approved for certain HER2+ early breast cancer
`and metastatic breast cancer patients.12 Herceptin Hylecta can be administered via
`subcutaneous rather than intravenous injection.13 Subcutaneous administration can be
`preferable because it is typically faster, simpler, more convenient, and less
`uncomfortable.
`
`23.
`
`Perjeta is approved for use in combination with Herceptin and chemotherapy for adjuvant
`treatment of certain HER2+ breast cancer patients as well as treatment of HER2+
`
`10 Ex. 39, at GNE-HER_002995964 [
`11 Id.
`12 Ex. 40, https://www.gene.com/media/press-releases/14779/2019-02-28/fda-approves-
`herceptin-hylecta-for-subcu
`13 Id.
`
`].
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`- 4 -
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`

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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 6 of 21 PageID #: 23702
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`24.
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`25.
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`26.
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`27.
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`metastatic breast cancer.14 Because Perjeta is approved for use only in combination with
`trastuzumab, and Genentech promotes it as such, Herceptin is indirectly promoted though
`the marketing and sale of Perjeta.
`
`For 2018, the most recent full year for which financials are available, Perjeta had
` in gross sales in the United States, with
` in net sales.15
`Through May 2019, gross sales in the United States for Perjeta total
`, with
` in net sales.16
`
`Kadcyla is approved to treat HER2+ metastatic breast cancer in patients who were
`previously treated with trastuzumab in combination with a taxane chemotherapy.17 In
`addition, based on the KATHERINE clinical trial demonstrating the effectiveness of
`Kadcyla for certain HER2+ patients, Kadcyla was recently approved for patients with
`HER2+ early breast cancer with residual disease after neoadjuvant treatment.18
`
`For 2018, the most recent full year for which financials are available, Kadcyla had
` in gross sales in the United States, with
` in net sales.19
`Through May 2019, gross sales in the United States for Kadcyla total
` in net sales.20
`
`, with
`
`The vast majority of patients who have their HER2+ breast cancer treated with drugs are
`treated with Herceptin, Perjeta and/or Kadcyla. For example, in 2018, for new metastatic
`HER2+ breast cancer patients treated with drugs, Herceptin, Perjeta and/or Kadcyla were
` of patients.21 According to Genentech’s detailed reviews of
`prescribed to over
`medical records reflecting the use of Herceptin, approximately
` of those treated
`with Herceptin receive it according to the dosing regimen described in Herceptin’s label
`as “[i]nitial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30-90
`minutes IV infusion every three weeks for 52 weeks.”22
`
`
`14 Ex. 41, at GNE-HER_002969863 [Perjeta Prescribing Information].
`15 Ex. 42, at GNE-HER_002995966 [
`].
`16 Id.
`17 Ex. 43, at GNE-HER_002959709 [Kadcyla Prescribing Information].
`18 https://www.gene.com/media/press-releases/14785/2019-05-03/fda-approves-genentechs-
`kadcyla-for-adju
`19 Ex. 45, at GNE-HER_002995965 [
`20 Id.
`21 See, e.g., Ex. 35, at GNE-HER_002993657, GNE_HER_002993663 [
`].
`22 Ex. 7, at GNE-HER_002466538 [Herceptin Prescribing Information; Ex. 46 at 4
`
`].
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`- 5 -
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 7 of 21 PageID #: 23703
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`B.
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`Other Oncology Products
`
`28.
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`29.
`
`30.
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`Rituximab is a Genentech anti-CD20 antibody. Genentech currently markets two
`rituximab products—Rituxan, administered as an intravenous infusion,23 and Rituxan
`Hycela, a combination of rituximab and hyaluronidase human that is administered
`subcutaneously.24 These drug products are indicated to treat six diseases, including
`certain types of lymphoma and lymphocytic leukemia and the degenerative immune
`disorder rheumatoid arthritis, and have been prescribed over two million times. Gazyva
`(obinutuzumab) is another Genentech product which targets the CD20 antigen and is
`administered intravenously.
`
`Bevacizumab is an antibody, developed by Genentech, that targets the VEGF protein.
`Genentech markets a bevacizumab product under the brand name Avastin. Avastin is
`indicated to treat, among other diseases, colorectal cancer, which is second to lung cancer
`in terms of annual United States cancer deaths.25
`
`Avastin, Herceptin, and Rituxan (sometimes referred to together as “AHR” internally at
`Genentech) are major oncology products; each one has been a “blockbuster drug” and has
`effected major advances in their respective fields of therapeutic use. In addition, the
`AHR portfolio has been critically important to Genentech, accounting for over 43% of
`the United States revenues of Roche Pharmaceuticals in 2018.
`
`31.
`
`Amgen has obtained FDA approval of a biosimilar to Avastin (as well as Herceptin), and
`has applied for approval of a biosimilar to Rituxan.
`IV. GENENTECH’S PATIENT ACCESS PROGRAMS
`
`32.
`
`33.
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`To ensure patient access to Herceptin, Genentech sponsors a variety of programs to
`ensure that patients who need Herceptin can receive it. These programs are funded by the
`revenues Genentech receives from the sale of Herceptin and other therapies.
`
`Genentech’s Access Solutions group is responsible for the relevant patient-assistance
`programs. The goal of that group is to eliminate all barriers to accessing therapy. In the
`service of that goal, Genentech’s Access Solutions Group provides four services:
`
`
`
`
`
`23 Ex. 47, at GNE-HER_002979291 [Rituxan Prescribing Information].
`24 Ex. 48, at 1 [Rituxan Hycela Prescribing Information].
`25 Ex. 49, at GNE-HER_002979333 [Avastin Prescribing Information].
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 8 of 21 PageID #: 23704
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`Benefits Investigations: Upon request, Genentech will review a patient’s
`insurance coverage to determine what the benefits are, whether the therapy will be
`approved, whether a pre-authorization will be required, and what out-of-pocket
`costs there will be. In some cases, this investigation will result in a referral to a
`co-pay assistance foundation or Genentech co-pay assistance program.
`
`Co-Pay Assistance: Genentech offers a co-pay assistance program in the form of
`the “Bio-Onc Co-Pay Card.” Patients who qualify based on financial need can
`use the Bio-Onc Co-Pay Card to pay all but $5 of their co-pay.
`
`Free Drug Program: Genentech provides free drugs for patients who either have
`no insurance or who are under-insured. Like the co-pay program, this program is
`based on need.
`
`Appeals Support: This service helps healthcare provider offices overcome denials
`of coverage for Herceptin by insurers.
`
`Since 1999, Genentech Access Solutions has provided access support services to over
` Herceptin patients, including over
` patients in 2018.26
`
`GENENTECH FORECASTING
`A. Methodology
`
` There are no biosimilar versions of
`any of those products currently available on the market in the United States. If Amgen
`were to launch its Herceptin biosimilar now, it would be the first biosimilar competitor to
`Genentech and the first therapeutic oncology biosimilar product sold in the United States.
`
`
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`34.
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`V.
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`35.
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`36.
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`
` As a threshold matter, Genentech has no way to know the
`initial WAC and contract terms (e.g., discounts and rebates) at which biosimilar suppliers
`will offer their products. Further, the market factors Genentech has identified are
`complex and interrelated, as explained below.
`
`
`
` In addition, because biosimilars are a
`relatively recent development, there is little established record of biosimilar market
`
`
`26 Ex. 50, at GNE-HER_001378844 [
`
`].
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 9 of 21 PageID #: 23705
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`impact in the United States—and none for therapeutic oncology products—to guide
`Genentech’s forecasting.
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`37.
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`38.
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`39.
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`40.
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`41.
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`B.
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`Variables
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 10 of 21 PageID #: 23706
`Case 1:18—cv-00924-CFC Document 310 Filed 07/19/19 Page 10 of 21 PageID #: 23706
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 11 of 21 PageID #: 23707
`Case 1:18—cv-00924-CFC Document 310 Filed 07/19/19 Page 11 of 21 PageID #: 23707
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`42'—
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`42.
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`43.
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`43'-
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`].
`27 Ex. 51, at GNE-HER_000621475 [
`27
`at GNE-Hmooszms_1.
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`- 10 -
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 12 of 21 PageID #: 23708
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`EFFECT OF BIOSIMILAR ENTRY
`
`VI.
`
`45.
`
`Amgen’s Kanjinti is one of five approved trastuzumab biosimilars, and none of the others
`have yet entered the market. Genentech has settled its claims against each of the other
`biosimilar trastuzumab suppliers (Mylan, Samsung, Pfizer, and Celltrion),
`
`
`
`
`
`. Genentech will suffer a variety of harms specific to
`Amgen’s launch of Kanjinti, and will continue to suffer harms from Amgen’s marketing
`and sale of Kanjinti
`.
`A.
`
`Revenue and Market Share
`
`46. While Genentech cannot forecast the full extent of harm it will suffer with precision,
`Amgen’s launch of Kanjinti would have a significant negative impact on Herceptin sales
`and revenue.
`
`
`
` In light of the variables identified above, the specific outputs of
`these forecasts are highly uncertain, but there is no doubt that the effect of biosimilar
`entry will be substantial. If Amgen were to launch now, those harms would be directly
`attributable to Amgen’s launch of Kanjinti, which would be the first Herceptin biosimilar
`and the first therapeutic oncology biosimilar in the United States.
`
`
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`47.
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`
`. And payers and providers may
`be more inclined to adopt Kanjinti than they would another trastuzumab biosimilar
`because Amgen is a well-known, generally well-liked, brand-name supplier with
`extensive experience in biologics. Amgen is also a well-established player in the
`oncology clinic segment of the HER2 market, which Genentech expects to be highly
`competitive after biosimilar entry because clinics are highly sensitive to both WAC and
`price concessions. These factors will likely lead to Amgen being seen as less of an
`unknown quantity in the trastuzumab market than a traditional generic supplier.
`
`
`28 Ex. 52, at GNE-HER_002948751 [
`29 Id. at GNE-HER_002948766.
`
`].
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`- 11 -
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 13 of 21 PageID #: 23709
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`48.
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`49.
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`50.
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`51.
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`52.
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`53.
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`Amgen also poses a unique threat to Herceptin because Amgen will eventually launch
`biosimilars to Avastin and Rituxan as well as Herceptin. Therefore, Amgen may be able
`offer additional concessions or other advantages through portfolio contracts to providers
`and/or payers. These factors uniquely position Amgen to harm Genentech,
`
`
`
`Genentech’s loss of market share and revenue due to Kanjinti’s availability are likely to
`increase over time for several reasons,
`
`
`
`
`.
`
`First, the availability of an Amgen alternative to Herceptin will empower providers to
`demand ever-increasing price concessions because they will recognize Herceptin’s
`vulnerable position in the marketplace, especially in light of Amgen’s oncology and
`biologics name recognition and relationships. And while Genentech cannot predict the
`magnitude of the price differential between Kanjinti and Herceptin, or the price
`concessions Amgen will offer,
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`Second, payers—who have not previously proactively “managed” the HER2+ market
`through measures such as contracted price concessions, prior authorization requirements,
`and formulary preferences common in other therapeutic areas—are likely to take
`advantage of new market conditions to do so to an increasingly aggressive degree.
`
`Payer management may result in Genentech being effectively locked out of certain
`market segments or losing access to certain providers. In particular, formulary preference
`for trastuzumab biosimilars will encourage—and perhaps even require—providers to
`purchase Kanjinti rather than Herceptin. For example, “step edits” would require
`providers to attempt treatment of a given patient with a lower-cost alternative (i.e.,
`Kanjinti) before treating that patient with Herceptin.
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`54.
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`The likely implementation and effects of payer management is more pronounced for
`Kanjinti than other trastuzumab biosimilars given Amgen’s long track record of stable
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`

`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 14 of 21 PageID #: 23710
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`
`supply as an innovator biologic manufacturer. Healthcare providers are likely to trust
`Amgen, and thus more likely to prescribe its biosimilar thus accelerating acceptance by
`the market. This effect is even more significant given that Kanjinti is the only
`trastuzumab biosimilar to have a transition data as part of its clinical trial (i.e., data about
`switching from Herceptin to Kanjinti) and based on Amgen’s press release announcing
`Kanjinti’s approval, Amgen intends to rely on this fact in marketing Kanjinti.30
`
`55.
`
`Third, the adoption of Kanjinti is likely to be “sticky.” Individual patients generally
`prefer to continue to use a treatment they are familiar with, clinicians generally prefer
`consistency of treatment choices for individual patients, and at least some oncology
`practices will likely elect to use only Kanjinti because using both Kanjinti and Herceptin
`introduces undesirable complexity in stocking and handling. As a result, once an
`individual patient or provider elects to use Kanjinti over Herceptin once, they are likely
`to continue to do so in the future.
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`56.
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`Fourth, as discussed in more detail below,
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`.
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`57.
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`58.
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`59.
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`B.
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`Harm to Other Genentech Products
`
`Amgen’s launch of Kanjinti,
` is likely to have significant adverse effects on other Genentech products,
`especially Avastin, Rituxan, and HER2+ breast cancer products Perjeta, Kadcyla, and
`Herceptin Hylecta, for several reasons.
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`60.
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`Second, Kanjinti’s entry will diminish Herceptin’s “share of voice” as the field for
`trastuzumab therapies becomes increasingly crowded. The marketing of oncology
`
`30 Ex. 8, Amgen press release, FDA Approves Amgen and Allergan’s KANJINTI™
`(trastuzumab-anns), A Biosimilar to Herceptin® (trastuzumab), June 13, 2019.
`31 Ex. 53, at GNE-HER_001378974 [
`
`].
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 15 of 21 PageID #: 23711
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`products relies to a large degree on explaining the benefits of specific products and
`treatment combinations to clinicians, and the more suppliers are vying for clinicians’
`attention, the less opportunity there is for each individual supplier to convey its messages.
`The loss of share of voice due to Amgen’s introduction of Kanjinti is particularly
`important in relation to Perjeta and Kadcyla, and is likely to be exacerbated by the fact
`that Amgen intends to introduce biosimilars to Avastin and Rituxan as well as Herceptin.
`
`61.
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`62.
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`63.
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`64.
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`65.
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`For Kadcyla, the KATHERINE clinical trial results demonstrated dramatic benefits over
`treatment with Herceptin, including a 50% reduction in the risk of recurrence of death for
`HER2+ early breast cancer patients with residual invasive disease after neoadjuvant
`treatment, resulting in May 2019 FDA approval of Kadcyla for that use.
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`For Perjeta, the benefits shown by Genentech’s APHINITY clinical trial results—which
`led to FDA approval of the combination of Herceptin and Perjeta for treatment of
`adjuvant treatment of HER2+ early breast cancer in patients at high risk of recurrence—
`require time to clarify and convey to clinicians.
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`
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`January 2019,
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` Herceptin Hylecta was just launched in
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`Fourth, as providers and payers gain experience with biosimilar oncological therapeutic
`agents, and become more accustomed to the availability of price concessions for products
`with available biosimilar alternatives, they may be more likely to seek such concessions
`for other such products, including Avastin and Rituxan.
`C.
`
`Effect of Multiple Market Entrants
`
`Because each successive biosimilar supplier is likely to price its biosimilar below
`Genentech’s WAC, and/or offer concessions exceeding Genentech’s, at least in certain
`market segments, each additional entrant is likely to result in additional market share and
`revenue loss for Genentech. This is especially true because the decisions of each
`
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`32 Id. at GNE-HER_001378975.
`33 Id. at GNE-HER_001378879-8880.
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`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 16 of 21 PageID #: 23712
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`66.
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`67.
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`68.
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`biosimilar supplier are likely to affect the decision-making of each other biosimilar
`supplier. For example, successive entrants may intentionally price their biosimilars
`below prior entrants’ WACs (rather than Genentech’s), and/or intentionally offer
`concessions exceeding those offered by other suppliers in particular market segments.
`Similarly, whereas individual suppliers may compete more aggressively in some market
`segments than in others, the entry of multiple suppliers increases the likelihood of
`aggressive competition across the entirety of the HER2 market.
`
`In addition, the introduction of Kanjinti is likely to irreversibly change the dynamics of
`the HER2 market. Providers are likely to grow more aggressive in seeking price
`concessions, and payers are likely to take increasingly aggressive steps to manage the
`selection and administration of Herceptin as well as trastuzumab biosimilars. The sooner
`Kanjinti launches, the sooner these effects will begin to take hold, and the more
`pronounced these effects are likely to be upon entry of other trastuzumab biosimilars.
`D.
`
`Potential Loss of Goodwill
`
`Biosimilar entry will adversely affect the goodwill Genentech has accumulated over the
`two decades of Herceptin’s groundbreaking success because biosimilar suppliers will
`offer their products at significantly lower net prices than Genentech has offered
`Herceptin. Thus biosimilar entry will necessarily position Genentech as offering the
`more expensive option, which is particularly concerning given public attention to
`pharmaceutical pricing generally.
`
`In addition, Genentech would suffer an extreme loss of goodwill if Amgen was allowed
`to enter the market now and then, following a trial at which Amgen is found to infringe
`Genentech’s patents, Genentech had to seek to enjoin Amgen from selling Kanjinti to
`protect its patent rights. This is so for at least two reasons. First, patients being treated
`with Kanjinti at that time may experience disruption in their treatment, and those patients
`and their healthcare providers might blame Genentech for this disruption. Second, it is
`unknown whether payers would reimburse providers for product purchased before the
`injunction but administered after the injunction, and to the extent healthcare providers
`experienced risk or financial loss because of this, they may blame Genentech.
`
`69.
`
`Any loss of goodwill from biosimilar launch followed months later by a post-trial
`permanent injunction against Kanjinti would affect not only Herceptin, but rather all of
`Genentech’s products. This loss of goodwill would be significant and incalculable, and
`would affect Genentech for years to come.
`VII. GENENTECH’S APPROACH TO BIOSIMILAR ENTRY
`
`70.
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`- 15 -
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`

`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 17 of 21 PageID #: 23713
`Case 1:18-cv-00924—CFC Document 310 Filed 07/19/19 Page 17 of 21 PageID #: 23713
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`
`71.
`71.
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`
`
`A.
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`
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`
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`72.
`72.
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`73.
`73.
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`74.
`74.
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`B.
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`75.
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`75.
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`34Ex3—6at GNEHER 0029489448945, GNE_HER_002948947_
`34 Ex. 36, at GNE-HER_002948944-8945, GNE_HER_002948947 [
`].
`_]
`
`
`
`- 16 -
`-16-
`
`

`

`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 18 of 21 PageID #: 23714
`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 18 of 21 PageID #: 23714
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`76.
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`76.
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`- 17 -
`-17-
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`

`

`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 19 of 21 PageID #: 23715
`
`I declare under penalty of perjury that the foregoing is true and correct to the best of my own
`personal knowledge.
`
`July 10, 2019
`Date
`
`Christy Oliger
`
`- 18 -
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`

`Case 1:18-cv-00924-CFC Document 310 Filed 07/19/19 Page 20 of 21 PageID #: 23716
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`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned counsel hereby certifies that true and correct copies of the foregoing
`
`document were caused to be served on July 10, 2019 on the following counsel in the manner
`
`indicated:
`
`
`VIA EMAIL:
`
`Neal C. Belgam
`Eve H. Ormerod
`Jennifer M. Rutter
`SMITH, KATZENSTEIN & JENKINS, LLP
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`
`Orion Armon
`COOLEY, LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
`
`
`Eamonn Gardner
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`(858) 550-6086
`egardner@cooley.com
`
`
`
`
`
`
`
`
`
`
`
`ME1 308