Pharmaceutical

  • Data from the Phase 3 SPIRIT program showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment
  • Myovant and Pfizer will continue to jointly commercialize MYFEMBREE, with product available immediately
  • Myovant to host conference call and webcast on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.

"Endometriosis is a painful, chronic disease with limited therapies to manage symptoms," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis."

"This approval is an important milestone reflecting Pfizer and Myovant's commitment to women's health in areas of significant unmet need," said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. "We look forward to making MYFEMBREE available to women with endometriosis and broadening their options in managing this complex disorder."

MYFEMBREE offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. Endometriosis is a serious chronic condition that requires long-term interventions. Optimization of medical therapies is the recommended treatment paradigm. 1 , 2 , 3 MYFEMBREE introduces an option for up to two years of pharmacological management of moderate to severe pain associated with endometriosis in pre-menopausal women.

"The data from the SPIRIT studies showed the clinical benefit that relugolix combination therapy can have on moderate to severe pain associated with endometriosis and how it can impact patients," said Linda Giudice, M.D., Ph.D., Distinguished Professor at the University of California, San Francisco (UCSF), and Chair, SPIRIT Program Steering Committee. "This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of

This approval is supported by one-year data from the Phase 3 SPIRIT program, which included two 24-week multi-national clinical studies (SPIRIT 1 and SPIRIT 2) in more than 1,200 women with pain associated with endometriosis, as well as the first 28 weeks of an open-label extension study to assess its longer-term use. Overall, these studies showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain with a loss of mean bone mineral density of less than 1% from baseline through one year of treatment. 4

SPIRIT 1 and 2 each met their co-primary endpoints with 75% of women in the MYFEMBREE group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively (both p

The open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 showed mean bone mineral density loss of less than 1% from baseline through one year of treatment; some patients (19.7%) had losses >3%. Annual bone density measurement is recommended while treating women for endometriosis.

MYFEMBREE is available immediately to patients with moderate to severe pain associated with endometriosis with a prescription from their healthcare provider. Myovant and Pfizer also are committed to supporting women in the U.S. who are prescribed MYFEMBREE throughout their treatment journeys. The MYFEMBREE Support Program provides access support services, including insurance benefits checks, prior authorization support, co-pay support for commercially insured patients, and patient assistance for qualifying uninsured patients. Program terms and conditions apply. For more information and additional resources, please contact 833-MYFEMBREE (833-693-3627), 8 a.m. – 8 p.m. Eastern Time, Monday – Friday.

Myovant Conference Call
Myovant will hold a conference call on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the FDA approval of MYFEMBREE for the management of moderate to severe pain associated with endometriosis. Investors and the general public may access the live webcast here . The live webcast can also be accessed by visiting the company's investor relations page of Myovant's website at: https://investors.myovant.com/ .

About Endometriosis
Endometriosis is a condition in which tissue similar to the uterine lining is found outside of the uterine cavity, which often causes disruptive symptoms like painful periods, fatigue, pain in the lower back and abdomen, heavy menstrual bleeding, and even painful or difficult sexual intercourse. For endometriosis-associated pain, current treatment options include prescription and over-the-counter pain medications, combined oral contraceptives, progestins, danazol, GnRH agonists and antagonists, and surgical interventions.

Endometriosis can also impact general physical, mental, and social well-being, requiring a multi-disciplinary approach to care. Approximately 190 million women suffer from symptoms of endometriosis globally. 5 In the U.S., there are approximately 7.5 million premenopausal women with endometriosis and approximately 75-80 percent of them are symptomatic. 6 , 7 , 8 , 9 Many women with pain associated with endometriosis are not able to manage their pain symptoms with current treatment options, underscoring the high unmet need for this disease. 10 It can take between four and eleven years to get an endometriosis diagnosis 11 , 12 , 13 and for some women, current treatment options do not provide relief. 14

About MYFEMBREE ®
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. It is also currently available in the U.S. for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, please click here .

Indications and Usage
MYFEMBREE is indicated in premenopausal women for the management of:

  • Heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
  • Moderate to severe pain associated with endometriosis

Limitations of Use : Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

  • Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.
  • MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONS
MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONS
Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline in all women. During treatment, periodic DXA is recommended for women with heavy menstrual bleeding due to uterine fibroids; in those with moderate to severe endometriosis pain, annual DXA is recommended. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Suicidal Ideation and Mood Disorders (Including Depression): Evaluate patients with a history of suicidal ideation, depression, and mood disorders prior to initiating treatment. Monitor patients for mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continuing therapy with MYFEMBREE outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE. Gonadotropin-releasing hormone receptor antagonists, including MYFEMBREE, have been associated with mood disorders (including depression) and suicidal ideation.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens . In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS: Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were:

  • Heavy menstrual bleeding associated with uterine fibroids : vasomotor symptoms, abnormal uterine bleeding, alopecia, and decreased libido.
  • Moderate to severe pain associated with endometriosis: headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.

These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS: P-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions. Combined P-gp and Strong CYP3A Inducers : Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION: Advise women not to breastfeed while taking MYFEMBREE.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women's health leading to three regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer, women with heavy menstrual bleeding associated with uterine fibroids, and pre-menopausal women with moderate to severe pain associated with endometriosis, respectively. Myovant also has received regulatory approvals by the European Commission (EC) and the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has a supplemental New Drug Application under review with the FDA for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Pharma Co., Ltd., is Myovant's majority shareholder. For more information, please visit www.myovant.com . Follow @Myovant on Twitter and LinkedIn .

About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .

Myovant Sciences Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences' expectations, including: statements regarding Myovant's aspiration to redefine care for women and for men; the expectations regarding the continued commercialization of MYFEMBREE by Myovant and Pfizer jointly in the U.S. and the timeline of product availability; the expectations that MYFEMBREE's indication helps advance Myovant's mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis in Dr. Arjona Ferreira's quote; the expectation of making MYFEMBREE available to women with endometriosis and broadening their options in managing this complex disorder in Dr. Rusnak's quote; and the expectations of the MYFEMBREE Support Program for patients and the features of such program.

Myovant Sciences' forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic and the conflict in Ukraine. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences' filings with the United States Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Myovant Sciences' Quarterly Report on Form 10-Q filed on July 27, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for Myovant Sciences' management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward- looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Pfizer Disclosure Notice
The information contained in this release is as of August 5, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), a new indication in the U.S. for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, and a collaboration between Pfizer and Myovant Sciences to develop and commercialize relugolix in advanced prostate cancer and women's health, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when applications may be filed for any other potential indications for MYFEMBREE; whether and when regulatory authorities may approve any such applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether MYFEMBREE will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of MYFEMBREE; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

Myovant Sciences Contacts
Investor Contact:
Uneek Mehra
Chief Financial and Business Officer
Myovant Sciences, Inc.
investors@myovant.com

Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

Pfizer Contacts:
Media Relations
PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor Relations
IR@Pfizer.com
+1 (212) 733-4848

1 American Society for Reproductive Medicine (ASRM), Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril. 2014;101(4):927-35.
2 Becker CM et al. ESHRE guideline: endometriosis, Human Reproduction Open. 2022 Feb 26;2022(2): hoac009.
3 Taylor HS et al. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet 2021;397(10276):839-52
4 Giudice LC, et al. Lancet. 2022 Jun; 399(10343): 2267-2279.
5 Adamson, G. et al. Journal Endometriosis. 2010; 2:3-6
6 US census 2019 (table 1; approx. 75 million women in the US ages 15-49). Available online at https://data.census.gov/cedsci/table?q=United%20States&t=Age%20and%20Sex
7 Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018 Aug; 51:1-15
8 Fuldeore Gynecol Obstet Invest. 2017;82:453-461
9 Bulletti J Asist Reprod Genet 2010
10 Becker CM, et al. Fertil Steril. 2017 Jul;108(1):125-136.
11 Zondervan KT, et al. NEJM. 2020;382(13):1244–1256
12 Nnoaham KE et al. Fertil Steril. 2011;96(2):366.e8–373.e8
13 Ballard K et al. Fertil Steril. 2006;86:1296–301
14 Soliman et al. J Women's Health. 2017. 26(7): 788-797


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As quoted in the press release:

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This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ”will,” ”expect,” ”believe,” ”could,” ”would,” ”estimate,” ”continue,” ”build,” ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company’s expectations, goals or intentions regarding the future, including our full year 2016 guidance and our acquisition of the Hospira infusion systems business. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company’s products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company’s arrangements with its largest customers and the Company’s ability to meet expectations regarding the timing, completion and integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company’s filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2015 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.ICU Medical Investor Contacts:
Scott Lamb, ICU Medical, Inc.
949-366-2183
slamb@icumed.com
John Mills, ICR, Inc
646-277-1254
John.Mills@icrinc.com
Media Contact:
Tom McCall, ICU Medical, Inc.
949-366-4368
tmccall@icumed.com

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avelumab. The preclinical and clinical data that have been generated
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could potentially demonstrate a synergistic effect, delivering a step up
in therapy for HPV-positive HNSCC patients
.”
The combination of TG4001 and avelumab aims to target two distinct steps
in the immune response to target cancer cells. This is an exclusive
agreement between the parties to study the combination of these two
classes of investigational agents in HPV-positive HNSCC.
Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at
Institut Curie, and a world expert in ENT cancers, will be the Principal
Investigator of the Phase 1/2 study. This trial is expected to begin in
France, with the first patient expected to be recruited in H1 2017. It
will seek to recruit patients with recurrent and/or metastatic
virus-positive oropharyngeal squamous cell carcinoma that have
progressed after definitive local treatment or chemotherapy, and cannot
be treated with surgical resection and/or re-irradiation.
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tumors. However, their different etiology clearly suggests that
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patients. Immunotherapy, and in particular the therapeutic vaccine
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distinct steps in the immune response, could deliver improved efficacy
for patients who have not responded to or have progressed after a first
line of treatment.”

TG4001 is an active immunotherapeutic designed by Transgene to express
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avelumab.
Avelumab is an investigational, fully human antibody specific for a
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As a checkpoint inhibitor, avelumab is thought to have a dual mechanism
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such as T-cells, exposing them to anti-tumor responses. Avelumab is also
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and attack tumors in a process known as ADCC, or antibody-dependent
cell-mediated cytotoxicity. In 2014, the science and technology company
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to co-develop and co-commercialize avelumab.
Alise Reicin, M.D., Head of Global Clinical Development in the biopharma
business of Merck KGaA, Darmstadt, Germany, which in the US and Canada
operates as EMD Serono, commented: “We believe combination regimens
show significant promise in the development of novel and efficacious
immuno-oncology treatments. Through this study, we hope to discover the
potential of avelumab as a combination therapy with TG4001 for patients
fighting this recurring cancer.”

Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development,
and Translational Oncology at Pfizer, said: “Through this
collaboration, we hope to better understand how therapeutic vaccines may
help support the clinical development program for avelumab as our end
goal is to find the best treatment options for patients.”

About HPV-mediated Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous group
of cancers that can affect the oral cavity, pharynx, and larynx. HPV-16
infection is recognized to participate in the development of a
substantial proportion of head and neck cancers and is associated with a
subset of HNSCC, especially those arising from the oropharynx (more than
80%), which are the most frequent, and the larynx (~70%).
The incidence of HPV-16-related head and neck cancer has significantly
increased in recent years. Although there are more than 100 subtypes of
HPV, HPV-16 accounts for 90% of all HPV-related head and neck cancers.
Global spending on head and neck cancer indications amounted to
$1 billion in 2010.
Current treatments include surgical resection with radiotherapy or
chemoradiotherapy. However, better options are needed for advanced and
metastatic HPV+ HNSCC. It is thought that immunotherapy combined with
immune checkpoint inhibitors could provide a promising potential
treatment option that would address this strong medical need.
About TG4001
TG4001 is an investigational therapeutic vaccine based on a
non-propagative, highly attenuated vaccinia vector (MVA), which is
engineered to express HPV-16 antigens (E6 & E7) and an adjuvant (IL-2).
It is one of the few therapies targeting HPV+ sub population. TG4001 is
designed to have a two-pronged antiviral approach: to alert the immune
system specifically to HPV-16-infected cells that have started to
undergo precancerous transformation (cells presenting the HPV-16 E6 and
E7 antigens) and to further stimulate the infection-clearing activity of
the immune system through interleukin 2 (IL-2). TG4001 has been
administered to more than 300 patients, demonstrating good safety,
significant HPV clearance rate and promising efficacy results. Its
mechanism of action and good safety profile make TG4001 an excellent
candidate for combinations with other therapies in solid tumors.
About Avelumab
Avelumab (also known as MSB0010718C) is an investigational, fully human
antibody specific for a protein found on tumor cells called PD-L1, or
programmed death ligand-1. Avelumab is thought to have a dual mechanism
of action which may enable the immune system to find and attack cancer
cells. By binding to PD-L1, avelumab is thought to prevent tumor cells
from using PD-L1 for protection against white blood cells such as
T-cells, exposing them to anti-tumor responses. Avelumab is also thought
to help white blood cells such as natural killer (NK) cells find and
attack tumors in a process known as ADCC, or antibody-dependent
cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt,
Germany, and Pfizer announced a strategic alliance to co-develop and
co-commercialize avelumab.
About Transgene
Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly
traded French biopharmaceutical company focused on designing and
developing targeted immunotherapies for the treatment of cancer and
infectious diseases. Transgene’s programs utilize viral vector
technology with the goal of indirectly or directly killing infected or
cancerous cells. The Company’s two lead clinical-stage programs are:
TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The
Company has several other programs in clinical and pre-clinical
development. Transgene is based in Strasbourg, France, and has
additional operations in Lyon, as well as a JV in China with Tasly
Group. Additional information about Transgene is available at www.transgene.fr.
Disclaimer
This press release contains forward-looking statements about the
future development of TG4001. Although the Company believes its
expectations are based on reasonable assumptions, these forward-looking
statements are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those anticipated. The
occurrence of any of these risks could have a significant negative
outcome for the Company’s activities, perspectives, financial situation,
results and development. The Company’s ability to commercialize its
products depends on but is not limited to the following factors:
positive pre-clinical data may not be predictive of human clinical
results, the success of clinical studies, the ability to obtain
financing and/or partnerships for product development and
commercialization, and marketing approval by government regulatory
authorities. For a discussion of risks and uncertainties which could
cause the Company’s actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque”)
section of the Document de Référence, which is available on the AMF
website (
http://www.amf-france.org)
or on Transgene’s website (
www.transgene.fr).

Pfizer to Acquire Medivation

NEW YORK, NY and SAN FRANCISCO, CA –(Marketwired – August 22, 2016) – Medivation, Inc. (NASDAQ: MDVN) –
  • Propels Pfizer into a leading position in oncology
  • Medivation agrees to transaction valued at $81.50 per Medivation share in cash, for a total enterprise value of approximately $14 billion
  • Expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in first full year after close with additional accretion and growth anticipated thereafter

Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion. The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter. Pfizer does not expect the transaction to impact its current 2016 financial guidance.
“The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer,” said Ian Read, Chairman and Chief Executive Officer, Pfizer. “The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value.”
Medivation’s portfolio includes XTANDI® (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.
In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immune-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer’s portfolio.
“We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients’ lives through medically innovative therapies,” said David Hung, M.D., founder, president and CEO of Medivation. “This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets — talazoparib and pidiluzimab — to their next stages of development so that they can be made available to patients as quickly as possible.”
“The proposed acquisition of Medivation will build upon Pfizer’s success with our IBRANCE® (palbociclib) launch in HR+/HER2- metastatic breast cancer and with our strong immuno-oncology portfolio, and will transform Pfizer into a leading oncology company,” said Albert Bourla, Group President, Pfizer Innovative Health. “IBRANCE and XTANDI are anchor brands in breast and prostate cancer respectively, giving Pfizer leadership in two hormone-driven cancers. Similar to IBRANCE in the breast cancer setting, XTANDI is being explored for its potential to move from metastatic prostate cancer to treat earlier stages of non-metastatic prostate cancer. In addition, Medivation’s portfolio within prostate cancer and across diverse tumors will complement Pfizer’s broad IO portfolio. Finally, Medivation adds commercial scale to better compete with other top tier oncology companies in advance of the potential emergence of Pfizer’s IO pipeline expected in the next few years. Together, we believe Pfizer and Medivation can bring the full force of our combined research and resources to combat two of the most common cancers, as well as speed cures and make accessible breakthrough medicines to patients, redefining life with cancer.”
Cancer remains the second leading cause of death in the U.S. and a “Top 10” killer worldwide. According to the American Cancer Society, breast cancer and prostate cancer are among the top three cancers by annual incidence in the U.S. There are several parallels between breast and prostate cancer, including the incidence of prostate cancer in the U.S., which is similar to that of breast cancer with approximately 280,000 cases per year.
Pfizer expects to finance the transaction with existing cash.
Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Medivation common stock for $81.50 per share, net to the seller in cash, without interest, subject to any required withholding of taxes. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Medivation common stock. The merger agreement contemplates that Pfizer will acquire any shares of Medivation that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the Third- or Fourth-Quarter 2016.
Pfizer’s financial advisors for the transaction were Guggenheim Securities and Centerview Partners, with Ropes & Gray LLP acting as its legal advisor. J.P. Morgan Securities and Evercore served as Medivation’s financial advisors, while Cooley LLP and Wachtell, Lipton, Rosen & Katz served as its legal advisors.
Conference Call
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 9:00 a.m. EDT on Monday, August 22, 2016.
To view and listen to the webcast visit our web site at www.pfizer.com and click on the “Pfizer Analyst and Investor Call to Discuss Proposed Acquisition of Medivation” link in the For Investors section located on the lower right-hand corner of that page, or directly at https://www.webcaster4.com/Webcast/Page/748/16852. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com beginning today. Participants are advised to pre-register in advance of the conference call.
You can also listen to the conference call by dialing either (866) 662-3198 in the United States and Canada or (503) 343-6044 outside of the United States and Canada. The password is “Pfizer Analyst Call.” Please join the call five minutes prior to the start time to avoid operator hold times.
About Pfizer:
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About Medivation:
Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit us at http://www.medivation.com.
DISCLOSURE NOTICE: This release, and statements on the accompanying call, contains forward-looking information related to Pfizer, Medivation and the proposed acquisition of Medivation by Pfizer that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements in this release and the accompanying call include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Pfizer’s and Medivation’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Pfizer and Medivation, XTANDI and Medivation’s other pipeline assets, IBRANCE (palbociclib), and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of Medivation’s stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Pfizer’s common stock and on Pfizer’s operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for XTANDI despite increasing competitive, reimbursement and economic challenges; Medivation’s dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when any drug applications may be filed in any jurisdictions for any additional indications for IBRANCE, XTANDI or for Medivation’s other pipeline assets; whether and when regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of IBRANCE, XTANDI and Medivation’s other pipeline assets; and competitive developments.
A further description of risks and uncertainties relating to Pfizer and Medivation can be found in their respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2015 and in their subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission (the “SEC”) and available atwww.sec.gov.
The information contained in this release is as of August 22, 2016. Neither Pfizer nor Medivation assumes any obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Pfizer calculates projections regarding the expected accretive impact of the potential acquisition based on internal forecasts of itsAdjusted Diluted Earnings Per Share (Adjusted Diluted EPS), which forecasts are non-Generally Accepted Accounting Principles (GAAP) financial measures derived by excluding certain amounts that would be included in GAAP calculations. These accretion projections should not be considered a substitute for GAAP measures. The determinations of the amounts that are excluded from the accretion calculations are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Pfizer is unable to present quantitative reconciliationsbecause management cannot reasonably predict with sufficient reliability all of the necessary components of the comparable GAAP measure. Pfizer has excluded from the accretion calculations the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items. Such items can have a substantial impact on GAAP measures of financial performance. For more information on the Adjusted Diluted EPS measure see Pfizer’s 2015 Financial Report, which was filed as exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended July 3, 2016.
Additional Information and Where to Find It
The tender offer referenced in this press release has not yet commenced. This announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Pfizer and its acquisition subsidiary will file with the SEC. The solicitation and offer to buy Medivation stock will only be made pursuant to an Offer to Purchase and related tender offer materials. At the time the tender offer is commenced, Pfizer and its acquisition subsidiary will file a tender offer statement on Schedule TO and thereafter Medivation will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. MEDIVATION STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF MEDIVATION SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of Medivation stock at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Pfizer or Medivation. Copies of the documents filed with the SEC by Medivation will be available free of charge on Medivation’s internet website at http://www.medivation.com or by contacting Medivation’s Investor Relations Department at (650) 218-6900. Copies of the documents filed with the SEC by Pfizer will be available free of charge on Pfizer’s internet website at http://www.pfizer.com or by contacting Pfizer’s Investor Relations Department at 212-733-2323. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Pfizer and Medivation each file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Pfizer or Medivation at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Pfizer’s and Medivation’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Contacts:
For Pfizer:
Investors
Ryan Crowe
212-733-2798

Media

Joan Campion
212-733-2798
For Medivation:

Investors

Anne Bowdidge
Senior Director, Investor Relations
(650) 218-6900

Media

Samina Bari
Vice President, Corporate Communications
(415) 275-5893

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  • 20vPnC elicited robust immune responses to all 20 serotypes meeting the statistical non-inferiority criteria for the co-primary objective after Dose 4
  • 20vPnC demonstrated a favorable safety and tolerability profile similar to Prevnar 13 ®
  • Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA

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Professional Holding Corp. (Nasdaq – PFHD)

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  • Approximately 6,000 participants 5 years of age and older will be enrolled in Lyme disease-endemic regions in Europe and the U.S.

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