Jamieson Wellness Inc. to Acquire Nutrawise Health & Beauty Corporation, Owner of youtheory Brand – Investing News Network

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Platform Acquisition Accelerates Growth in U.S. Market with Leading Premium Brand
Immediately Accretive with 2022 Pro Forma Revenue of $155 million to $159 million and Adjusted EBITDA 1 of $28 million to $29 million 2,3
Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today announced it has signed a definitive agreement to acquire Nutrawise Health & Beauty Corporation ("Nutrawise"), a leading innovator, manufacturer and marketer of premium supplements under the youtheory brand in the United States and other international markets, for approximately US$210 million ($265 million) on closing, plus potential additional consideration contingent on achieving pre-determined growth targets post-closing. Management anticipates the transaction will close during the Company's third quarter 2022, subject to certain regulatory approvals and customary closing conditions.
Strategic Rationale:
"This transaction is a major strategic milestone for Jamieson, accelerating our expansion in the world's largest vitamin, mineral and supplement market," said Mike Pilato, President and CEO of Jamieson Wellness. "Youtheory's co-founders Darren and Patty Rude have built a remarkable company and brand that is highly complementary to our existing portfolio and perfectly aligned with our commitment to providing consumers with high-quality products they can trust. The transaction is immediately accretive to Jamieson, and we see significant opportunities for future growth synergies as we leverage our broad product portfolio, best-in-class operational capabilities and global footprint to accelerate youtheory's expansion across multiple categories and channels in the United States and around the world."
Darren and Patty Rude have committed to working with the Company to help drive mutual growth aspirations for the youtheory brand. "Patty and I founded Nutrawise over ten years ago with the mission to build a business based on integrity, authenticity and quality," said Darren Rude, co-founder of Nutrawise. "Jamieson Wellness shares a similar mission and values, and we are confident that the combination of Nutrawise, the youtheory brand and Jamieson's expertise will further accelerate our growth and continue to support the health and wellness needs of our consumers."
Transaction Details
The acquisition of Nutrawise fits Jamieson's disciplined acquisition strategy and is expected to leverage the Company's best practices, enhancing its overall growth and margin potential. The transaction is valued at approximately US$210 million ($265 million), including US$25 million ($32 million) in Jamieson Wellness common shares to be issued to the sellers, plus potential additional consideration contingent on achieving pre-determined growth targets post-closing, payable at the election of the sellers in cash, Jamieson common shares, or some combination thereof. The addition of Nutrawise is expected to be immediately accretive with pro forma 2022 revenue of between US$123 and US$126 million ($155 and $159 million) and Adjusted EBITDA of between US$22 and US$23 million ($28 and $29 million), which excludes transaction and integration-related costs and certain purchase accounting expenses. Jamieson expects to complete the transaction in the third quarter of 2022, subject to certain regulatory approvals and customary closing conditions including approval of the Toronto Stock Exchange.
The Company intends to finance the acquisition with an expanded, amended and extended credit facility. BMO Capital Markets, National Bank of Canada, Royal Bank of Canada and The Bank of Nova Scotia have provided committed financing in support of the transaction.
Following the transaction, Jamieson Wellness expects to continue to have access to capital to support further acquisitions and strategic growth initiatives, aided by a strong balance sheet and expanded free cash flow expected from the combined business. After giving effect to the acquisition and related financing, Jamieson Wellness expects to have a prudent level of leverage at approximately 3.0 times pro forma Adjusted EBITDA as of closing of the transaction. 4
Advisors
BMO Capital Markets and RBC Capital Markets are serving as financial advisors and Ernst & Young LLP as tax advisors to Jamieson Wellness. Paul, Weiss, Rifkind, Wharton & Garrison LLP and McCarthy Tétrault LLP are serving as the Company's legal advisors.
William Hood & Company are serving as exclusive financial advisors and Greenberg Glusker LLP and Bowen Tax Law are serving as legal advisors to the sellers.
Jamieson Wellness has received fairness opinions from BMO Capital Markets and RBC Capital Markets to the effect that, as of the date of the fairness opinions, subject to the assumptions, limitations and qualifications contained therein, the consideration to be paid under the transaction is fair from a financial point of view to the Company.
About Jamieson Wellness
Jamieson Wellness is dedicated to improving the world's health and wellness with its portfolio of innovative natural health brands. Established in 1922, Jamieson is the Company's heritage brand and Canada's #1 consumer health brand. Jamieson Wellness also offers a variety of sports nutrition products and specialty supplements under its Progressive, Smart Solutions, Iron Vegan and Precision brands. The Company is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. For more information please visit www.jamiesonwellness.com .
Jamieson Wellness' head office is located at 1 Adelaide Street East Suite 2200, Toronto, Ontario, Canada.
Forward-Looking Information
Certain statements included in this press release constitute forward-looking information within the meaning of applicable securities laws, including, but not limited to, those identified by the expressions "expect", "anticipate", "intend", "may", "will", "estimate" and variations of such words and similar expressions. Some of the specific forward-looking statements in this press release include, but are not limited to, statements with respect to: the transaction and the terms thereof, the expected date of completion of the transaction and the anticipated benefits to the Company and its shareholders, the financing of the transaction and the additional revenue and Adjusted EBITDA expected to accrue to the Company as a result of the transaction. There can be no assurance that the proposed transaction will be completed, that it will be completed on the terms and conditions contemplated in this press release or that the expected benefits of the transaction will result. The proposed transaction could be modified or terminated in accordance with its terms.
Forward-looking information is based on a number of key expectations and assumptions made by the Company including, without limitation: the transaction will be completed on the terms currently contemplated; the transaction will be completed in accordance with the timing currently expected; all conditions to the completion to the transaction and the financing thereof will be satisfied or waived and the purchase agreement will not be terminated prior to the completion of the transaction; the expected future revenues and earnings of the Nutrawise business will result; timeline to close and, or, integrate the acquisition and exchange rates. Although the forward-looking information contained in this press release is based on what the Company's management believes to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such information.
Forward-looking information involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results and events may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things: the transaction may not be completed on the terms, or in accordance with the timing, currently contemplated, or at all; the Company and the sellers may not be successful in satisfying the conditions to the transaction; the possibility that the anticipated benefits of the transaction will not be realized when expected or at all; currency and interest rate fluctuations; and the inability to achieve or sustain revenue and earnings growth. Additional information about risks and uncertainties related to the Company and the assumptions associated with certain forward-looking information is discussed under " Risk Factors " in the Company's Annual Information Form dated March 29, 2022 and under " Summary of Factors Affecting Our Performance ", " Forward-Looking Information ", " Risk Factors " and " Outlook " in the MD&A filed May 5, 2022, both of which are available on SEDAR at www.sedar.com . The Company cautions that the list of risk factors and uncertainties is not exhaustive and other factors could also adversely affect the Company's results. Readers are urged to consider the risks, uncertainties and assumptions associated with these statements carefully in evaluating the forward-looking information and are cautioned not to place undue reliance on such information.
This forward-looking information is based on the Company's reasonable assumptions and beliefs in light of the information currently available to it and the statements are made as of the date of this press release. The Company does not undertake any obligation to update such forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.
Non-IFRS and Other Financial Measures
This press release makes reference to certain financial measures, including non-IFRS measures that are historical or that are forward-looking and non-GAAP ratios. Management uses these financial measures for purposes of comparison to prior periods, development of future projections and earnings growth prospects, to measure the profitability of ongoing operations, in analyzing our business performance and trends and in evaluating the transaction and the financing thereof. These measures are not recognized measures under IFRS, do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. The Company uses in this press release the following non-IFRS financial measures: "Adjusted EBITDA" and "net debt", the most directly comparable financial measure that is disclosed in its financial statements being net earnings and long-term debt, respectively, and a non-IFRS ratio for leverage. See the " How we Assess the Performance of our Business " section of the Company's MD&A filed May 5, 2022 for an explanation of the composition of such measures and see " Selected Consolidated Financial Information " of the Company's MD&A filed February 24, 2022 for a quantitative reconciliation of the non-IFRS financial measures to their most directly comparable financial measure disclosed in the consolidated financial statements of the Company and accompanying notes for such period to which the measure relates, which disclosures are incorporated by reference herein.
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1 This is a non-IFRS financial measure. See the " Non-IFRS and Other Financial Measures " section of this press release for more information on this non-IFRS financial measure. Adjusted EBITDA of the Company for the year ended December 31, 2021 was C$100.1 million.
2 Unless otherwise indicated, pro forma figures for 2022 give effect to the Nutrawise acquisition as if it had occurred on January 1, 2022.
3 All figures in $CAD millions unless otherwise indicated.
4 This is a non-IFRS ratio. Refers to trailing twelve months Adjusted EBITDA of the Company and Nutrawise divided by net debt, each as of the expected closing date for the transaction. "Net debt" is a non-IFRS financial measure. See the " Non-IFRS and Other Financial Measures " section of this press release for more information on these non-IFRS and other financial measures.

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Ruth Winker
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Pfizer Inc. (NYSE:PFE) today announced overall survival (OS) results from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE® (palbociclib) in combination with letrozole compared to placebo plus letrozole for the first-line treatment of postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). With a median follow-up of 90 months, patients receiving IBRANCE in combination with letrozole had numerically longer OS compared to placebo plus letrozole (median (95% CI) 53.9 months (49.8–60.8) vs median 51.2 months (43.7–58.9)); the results were not statistically significant (Hazard Ratio (HR)=0.956 [95% CI, 0.777–1.177]). The PALOMA-2 trial was designed for a primary endpoint of progression-free survival (PFS) with OS as one of the secondary endpoints. The results will be presented today as an oral presentation at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting (LBA 1003).
"IBRANCE continues to provide substantial benefit as a first-line treatment for adults with HR+, HER2- mBC based on strong progression-free survival data, which formed the basis of its worldwide approvals," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "Interpretation of OS in PALOMA-2 is limited by the large and disproportionate censoring of patients with missing survival data between treatment arms. We remain confident in the compelling benefits that IBRANCE plus endocrine therapy offers to this patient population, which is underscored by data from PALOMA-2 showing delayed time to chemotherapy, maintenance of quality of life and a consistent safety profile. Pfizer continues to invest in expanding the treatment options for people living with metastatic breast cancer."
"IBRANCE transformed the treatment landscape for patients with HR+, HER2- MBC when it was approved in 2015, representing the first new treatment in this patient population in over a decade," said Richard Finn, M.D., Professor of Medicine at the UCLA David Geffen School of Medicine and Jonsson Comprehensive Cancer Center. "PALOMA-2 enrolled a diverse patient population including patients whose disease was first diagnosed in the metastatic stage as well as those with Disease Free Interval (DFI) less than 12 months from adjuvant treatment and those with greater than 12 months following adjuvant treatment. The median survival of over 50 months in this population represents a significant improvement in the natural history of HR+ breast cancer."
PALOMA-2 met its primary endpoint of PFS in 2016 and was published in The New England Journal of Medicine in November 2016. The results demonstrated IBRANCE plus letrozole resulted in an improved median PFS of 24.8 months when compared to 14.5 months with placebo plus letrozole (HR=0.580). The PALOMA-2 trial showed that in addition to substantially delaying progressive disease, IBRANCE as first-line treatment, in combination with letrozole, delayed time to chemotherapy (38.1 months vs 29.8 months; HR, 0.73), while maintaining quality of life with no new identified safety issues.
The OS analysis being presented at ASCO included a large proportion of patients with missing survival data (i.e. patients who withdrew consent or were lost to follow-up) and were censored (assumed to be alive) at the time of the analysis: 13% in the treatment arm versus 21% in the control arm. Also of note, 10% of IBRANCE plus letrozole and 2% of placebo plus letrozole patients were still on study treatment at the time of the final analysis. The most common adverse reactions in PALOMA-2 included neutropenia, leukopenia, infections, fatigue and nausea.
IBRANCE continues to be a leader in the CDK4/6 inhibitor class, prescribed to over 450,000 patients across more than 100 countries, and seven out of 10 patients in the U.S. who are prescribed a CDK4/6 inhibitor receiving an IBRANCE prescription. i
About the PALOMA-2 Study
PALOMA-2 is a randomized (2:1), multicenter, multinational, double-blind Phase 3 study designed to assess the efficacy (defined by PFS) and safety of IBRANCE (125 mg orally once daily for three out of four weeks in repeated cycles) in combination with letrozole (2.5 mg once daily continuously) versus letrozole plus placebo as a first-line treatment for postmenopausal women with ER+, HER2- metastatic breast cancer. PALOMA-2 evaluated a total of 666 women from 186 global sites in 17 countries. Patients were to be stratified by site of disease (visceral, non-visceral), by disease-free interval since completion of prior (neo)adjuvant therapy (de novo metastatic, ≤12 months, >12 months), and by the nature of prior (neo)adjuvant anti-cancer treatment received (prior hormonal therapy, no prior hormonal therapy). The primary endpoint was progression-free survival, as assessed by the investigators; secondary endpoints were overall survival, objective response, clinical benefit response, patient-reported outcomes, pharmacokinetic effects, and safety.
About the IBRANCE Real-World Evidence Program
The IBRANCE Real-World Evidence (RWE) program is generating data from multiple studies involving more than 8,000 patients around the world. These studies include diverse patient populations treated in everyday clinical practice and are collecting data related to clinical outcomes, translational data and quality of life endpoints, which complement the data generated from the PALOMA randomized clinical trials. Most recently, Pfizer reported results from a retrospective comparative effectiveness study of 2,888 men and postmenopausal women with HR+, HER2- mBC evaluating IBRANCE in the real-world, first-line setting in combination with aromatase inhibitors (AI) compared to AI alone. Pfizer will continue to share new data from these studies with the scientific community as results become available.
About IBRANCE® (palbociclib) 125 mg tablets and capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6, ii which are key regulators of the cell cycle that trigger cellular progression. iii,iv In the U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.
The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here .
IMPORTANT IBRANCE ® (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.
Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.
Based on the mechanism of action, IBRANCE can cause fetal harm . Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.
The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).
The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).
Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).
The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).
Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).
Avoid concurrent use of strong CYP3A inhibitors . If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers . The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.
For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis .
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.
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 @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
DISCLOSURE NOTICE : The information contained in this release is as of June 4, 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 IBRANCE® (palbociclib), including its 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 IBRANCE; uncertainties regarding the commercial impact of the overall survival results of the PALOMA-2 trial; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our 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 our clinical studies; whether and when biologic license applications may be filed in any jurisdictions for IBRANCE for any additional indications for IBRANCE; whether and when any such applications may be approved by regulatory authorities, 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 IBRANCE 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 IBRANCE; uncertainties regarding the ability to obtain recommendations from advisory or technical committees and other public health authorities regarding IBRANCE and uncertainties regarding the commercial impact of any such recommendations; the impact of COVID-19 on our 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 .
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i Pfizer Data on File – IQVIA February 2021.
ii IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2019.
iii Weinberg, RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.
iv Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.

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Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). The sNDA proposes updates to MYFEMBREE's 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 associated with uterine fibroids for up to two years. The FDA set a target action date of January 29, 2023 for this sNDA under the Prescription Drug User Fee Act (PDUFA).
"Heavy menstrual bleeding is the most common symptom affecting women with uterine fibroids that can impact their daily life and activities over a long period of time," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "We are pleased to submit these study results to the FDA as they show the value MYFEMBREE can potentially have on treating women's uterine fibroid symptoms long term."
Patients who completed the 24-week pivotal LIBERTY 1 and 2 studies were offered the option to receive MYFEMBREE for an additional 28 weeks in an open-label extension study. After completion of the LIBERTY 1 or LIBERTY 2 and the open-label extension studies, women who met the definition of responder (menstrual blood loss 50%) could participate in an additional 52-week randomized withdrawal study (N=229) designed to provide two-year safety and efficacy data on MYFEMBREE and to evaluate the need for maintenance therapy. Women who entered the RWS were re-randomized to either MYFEMBREE or placebo for 52 additional weeks (N = 229), with the primary endpoint at Week 76. The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on MYFEMBREE achieving the sustained responder rate (menstrual blood loss
Bone mineral density remained stable in women who received MYFEMBREE in the randomized withdrawal study. Additionally, bone mineral density was maintained through two years in the subset of women continuously treated with MYFEMBREE (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed.
"Data from the MYFEMBREE RWS supports our mission to improve care for women living with uterine fibroids," 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 the FDA's review of the application and potential updates to the MYFEMBREE prescribing information based on these data."
MYFEMBREE was approved in the U.S. in 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration of up to 24 months.
About the Phase 3 LIBERTY Program in Uterine Fibroids
The Phase 3 clinical program for uterine fibroids consisted of two multi-national, replicate pivotal clinical studies (LIBERTY 1, N=388 and LIBERTY 2, N=382) of MYFEMBREE ® in women with heavy menstrual bleeding associated with uterine fibroids for 24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment, open-label extension study in which all women received MYFEMBREE for an additional 28-week period for a total treatment period of 52 weeks (N=477), designed to evaluate the safety and efficacy of longer-term treatment. After completion of the LIBERTY 1 or LIBERTY 2 and open-label extension studies, eligible women could elect to participate in an additional 52-week randomized withdrawal study (N=229) designed to provide two-year safety and efficacy data on MYFEMBREE and to evaluate the need for maintenance therapy. Across the LIBERTY 1, LIBERTY 2 and open-label extension studies, a response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.
LIBERTY 1 and LIBERTY 2 met their primary endpoints (p
In the open-label extension study, changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.
The LIBERTY randomized withdrawal study met its primary endpoint of maintaining sustained responder rate (menstrual blood loss
About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.
An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, i and an estimated three million women are inadequately treated by current medical therapy. ii
About MYFEMBREE ®
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, 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, click here .
Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. 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 and periodically thereafter. 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.
Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy 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.
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 hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. 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 two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. Myovant also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has supplemental New Drug Applications under review with the FDA for endometriosis-associated pain, and 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 @Pfizer News , 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. 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. In this press release, forward-looking statements include, but are not limited to, the statements with respect to the value of MYFEMBREE on treating women's uterine fibroid symptoms, the potential updates to the MYFEMBREE USPI, and the potential outcome of FDA's review of the sNDA for MYFEMBREE.
For a further discussion of factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations, see 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' Annual Report on Form 10-K filed on May 11, 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 June 2, 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), including a sNDA proposing updates to the United States Prescribing Information 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, including its 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 in any additional jurisdictions for MYFEMBREE for the RWS study data or in any jurisdictions for any other potential indications for MYFEMBREE; whether and when regulatory authorities in any jurisdictions may approve any such other 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 Officer
Myovant Sciences, Inc.
[email protected]
Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
[email protected]
Pfizer Contacts
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i Stewart E. Lancet. 2001. 357:293-298
ii Marjoribanks et al. Cochrane Database Syst. Rev. 2006.
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Pfizer Inc. (NYSE: PFE) today provided an update on its ownership interest in Haleon plc (Haleon), the newly independent company which will hold the joint Consumer Healthcare business of GSK plc (NYSE: GSK) and Pfizer following the demerger of approximately 80% of GSK's ownership interest in the business to GSK's shareholders. Following the demerger and listing of Haleon on the London Stock Exchange (LSE), which is expected to occur in July 2022, Pfizer will continue to hold a 32% ownership interest in Haleon. However, in keeping with Pfizer's transformation into a more focused, global leader in science-based innovative medicines and vaccines, the company intends to exit its 32% ownership interest in Haleon in a disciplined manner, with the objective of maximizing value for Pfizer shareholders.
On July 31, 2019, Pfizer and GSK completed a transaction to form a joint venture (JV) that combined their respective Consumer Healthcare businesses. Under the terms of the transaction, Pfizer and GSK received 32% and 68% ownership interests in the JV, respectively. On June 1, 2022, Haleon published a Prospectus in connection with the demerger and LSE listing. GSK and certain related entities will retain, in the aggregate, an approximately 13.6% ownership interest in Haleon following the transaction. In addition, Haleon will soon apply to list American Depositary Shares (ADSs) representing Haleon ordinary shares on the New York Stock Exchange (NYSE). Completion of the demerger and the LSE and NYSE listings are subject to customary conditions, including GSK shareholder approval.
As previously announced, John Young, former Group President and Chief Business Officer Pfizer, and Bryan Supran, Senior Vice President and Deputy General Counsel Pfizer, will be appointed to the Haleon Board of Directors upon completion of the demerger.
Morgan Stanley & Co. LLC and Guggenheim Securities, LLC are acting as Pfizer's financial advisors for this transaction. Wachtell, Lipton, Rosen & Katz and Clifford Chance LLP are serving as Pfizer's legal advisors, and Skadden, Arps, Slate, Meagher & Flom LLP is serving as its tax advisor for the transaction.
DISCLOSURE NOTICE : The information contained in this release is as of June 1, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.
This release contains forward-looking information about, among other things, Pfizer, the separation of Haleon as an independent public company, Pfizer's plans to exit its ownership interest in Haleon and Pfizer's transformation into a more focused, global leader in science-based innovative medicines and vaccines , including the potential benefits of the foregoing, as applicable, that is subject to 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, the uncertainties inherent in research and development; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer's and Haleon's businesses and prospects, adverse developments in Pfizer's and Haleon's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally and market volatility or uncertainty and any other developments that could impact the value of Pfizer's interest in Haleon, any of which could, among other things, adversely affect Pfizer's ability to exit its ownership interest in Haleon or impact the terms or timing of any such exit transaction(s); the impact of COVID-19 on Pfizer's or Haleon's businesses, operations and financial results; risks and uncertainties related to the demerger and Haleon's success as an independent public company, including, among other things, risks related to the satisfaction of the conditions to the demerger and listing (including the failure to obtain necessary regulatory approvals and the failure to obtain the requisite vote by GSK shareholders) and the possibility that the demerger and listing may not occur in the anticipated timeframe or at all; 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 .
This release is not intended to, and does not, constitute an offer to sell securities or a solicitation of an offer to purchase or sell securities in any jurisdiction, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Category: Investments

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Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a live webcast at 3:45 p.m. EDT on Monday, June 6, 2022, with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, and Aamir Malik, Chief Business Innovation Officer, Executive Vice President, who will discuss expanding access and affordability to Pfizer's medicines and vaccines.
To view and listen to the webcast, visit our web site at www.pfizer.com/investors . In addition, information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today.
The transcript of the discussion will be made available on our website at www.pfizer.com/investors within 24 hours after the program.
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 @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Disclosure Notice: The webcast may include forward-looking statements about, among other things, our performance on Environmental, Social and Governance (ESG) topics, our ESG priorities and goals, including expanding access and affordability to Pfizer's medicines and vaccines, and company strategies and growth potential, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. A description of these 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 .
The forward-looking statements in the webcast speak only as of the original date of the webcast. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments.
Category: Finance

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Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.
The FDA's decision is informed by the results of Pfizer's nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. These data were recently published in Nature Medicine .
"Receiving Fast Track designation from the FDA reinforces Pfizer's belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies," said James Rusnak, M.D., Ph.D., Senior Vice President and Chief Development Officer, Internal Medicine and Hospital, Pfizer. "We are proud to be advancing this investigational combination as part of our goal to develop innovative medicines to address some of the world's most widespread health challenges that affect millions of people—including diseases like NASH."
Pfizer is currently studying ervogastat/clesacostat in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis ( NCT04321031 ), expected to complete in 2024. The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential Phase 3 development program.
About NASH
Non-alcoholic steatohepatitis (NASH) is a serious, progressive form of non-alcoholic fatty liver disease (NAFLD) caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases scarring of the liver. 1,2 Approximately 17 million patients in the U.S. are impacted by NASH (and 3-5% of the global adult population), a number that is predicted to grow significantly over the next 10-15 years due to increases in obesity and Type 2 diabetes prevalence and an aging population. 3,4 NASH is largely unrecognized and underdiagnosed, increasing patients' risk of morbidity, liver events and mortality. 5,6,7 There are currently no FDA- or EMA-approved medications to treat NASH, and Pfizer researchers are working to develop treatments for the disease to fill this significant unmet medical need.
About Ervogastat/Clesacostat
Diacylglycerol O-acyltransferase 2 (DGAT2) and acetyl-CoA carboxylase (ACC) are two key enzymes that regulate lipid metabolism. Inhibitors of ACC and DGAT2 have demonstrated the ability to lower liver fat in patients with non-alcoholic fatty liver disease (NAFLD). 8 Pfizer believes that ervogastat/clesacostat, its investigational DGAT2i/ACCi combination therapy, has the potential to deliver direct improvements in inflammation and fibrosis.
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 @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
References
1 National Institute of Diabetes and Digestive and Kidney Diseases. Definition and Facts of NAFLD and NASH. Accessed May 14, 2021. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts .
2 Perumpail, Brandon J et al. "Clinical epidemiology and disease burden of nonalcoholic fatty liver disease." World journal of gastroenterology vol. 23,47 (2017): 8263-8276. doi:10.3748/wjg.v23.i47.8263.
3 Estes C, Razavi H, Loomba, R, Tounossi Z, Sanyal Aj. Modeling the Epidemic of Nonalcoholic Fatty Liver Disease Demonstrates an Exponential Increase in Burden of Disease. Hepatology. 2018;67(1):123-133.
4 Povsic M, Wong OY, Perry R, Bottomley J. A Structured Literature Review of the Epidemiology and Disease Burden of Non-Alcoholic Steatohepatitis (NASH). Adv Ther. 2019;36(7):1574-1594. doi:10.1007/s12325-019-00960-3
5 Machado MV, Cortez-Pinto H. Non-alcoholic fatty liver disease: what the clinician needs to know. World J Gastroenterol. 2014;20(36):12956-12980. doi:10.3748/wjg.v20.i36.12956
6 Rinella ME, Lominadze Z, Loomba R, et al. Practice patterns in NAFLD and NASH: real life differs from published guidelines. Therap Adv Gastroenterol. 2016;9(1):4-12. doi:10.1177/1756283X15611581
7 Kumar R, Priyadarshi RN, Anand U. Non-alcoholic Fatty Liver Disease: Growing Burden, Adverse Outcomes and Associations. J Clin Transl Hepatol. 2020;8(1):76-86. doi: 10.14218/JCTH.2019.00051.
8 Esler WP, Bence KK. Metabolic Targets in Nonalcoholic Fatty Liver Disease. Cellular and molecular gastroenterology and hepatology. 2019;8(2):247-267. doi:10.1016/j.jcmgh.2019.04.007
Disclosure Notice
The information contained in this release is as of May 26, 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 Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis with liver fibrosis: ervogastat/clesacostat, including its potential benefits and a potential Phase 3 development program, 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, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our 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 our clinical studies; whether and when drug applications may be filed in any jurisdictions for ervogastat/clesacostat; whether and when any such applications may be approved by regulatory authorities, 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 ervogastat/clesacostat 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 ervogastat/clesacostat; 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 .

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When it comes to investing in pharmaceutical companies, looking at pipelines and research and development prospects is important. But in-licensing is also key when examining these stocks.
In fact, in-licensing deals might be the pharmaceutical industry’s preferred mode of business development these days — perhaps even more so than mergers and acquisitions (M&A). These agreements can prove to be very fruitful for companies and their share prices.
The in-licensing strategy is likewise attractive to investors: In-licensing drugs expedites corporate development while also mitigating risk. So let’s clear up some common questions around the strategy.
The article below runs through what it means to in-license a drug and how in-licensing differs from an acquisition. It also covers how royalties affect returns. It’s key for investors to be aware of these intricacies so that they can interpret a firm’s actions correctly — and elect to buy or sell at the right time.
Some things are best explained by example, so let’s take a look at AMAG Pharmaceuticals (NASDAQ:AMAG). In mid-2020, the pharmaceutical company licensed a clinical-stage anticoagulant reversal agent asset to Norgine, a leading European specialist pharmaceutical company.
Under the license agreement, the two companies agreed to take on the development and commercialization of ciraparantag in Europe, Australia and New Zealand.
The drug candidate is targeted for the reversal of the anticoagulant effect of direct oral anticoagulants and low-molecular-weight heparin in patients who use these products and need emergency surgery or are experiencing life-threatening uncontrolled bleeding. Ciraparantag restores the body’s ability to form blood clots. Planned Phase 3 clinical trials for the drug will push it closer to regulatory approval in the US, UK and the European Union.
In this agreement, Norgine is the in-licenser, meaning it is licensing a product from AMAG; AMAG, which is licensing its product to Norgine, is the out-licenser. These deals are popular as they allow one company (in this case, Norgine) to take on some of the financial, regulatory or technological burdens associated with developing the product of another company (in this case, AMAG). Both end up benefiting.
AMAG received a US$30 million upfront payment and will be eligible to receive up to US$260 million on achieving certain regulatory and sales milestones, plus royalties and the ability to grow its product pipeline. As CEO Scott Myers said at the time of the deal, “Unlock(ing) the value of ciraparantag … will further strengthen our company’s ability to continue investing in innovative therapies that address urgent unmet medical needs.”
Meanwhile, in return for helping to finance the Phase 3 clinical trials of ciraparantag, Norgine received all marketing authorizations for the drug in the licensed territories. Norigine also became responsible for regulatory applications and any subsequent trials needed for approval in its territory.
The collaboration between AMAG and Norgine is just one example of in-licensing. Other recent instances of this strategy include Pfizer (NYSE:PFE) and the Medicines Patent Pool (MPP), a United Nations-backed public health organization, which have a global licensing agreement for the distribution of a COVID-19 oral antiviral treatment candidate to expand access in low- and middle-income countries.
The MPP also has secured a similar licensing agreement with multinational pharmaceutical giant Merck (NYSE:MRK) for its investigational oral antiviral COVID-19 medicine molnupiravir.
There’s also AbbVie (NYSE:ABBV) and clinical-stage biotech company Cugene. In mid-2022, they inked an exclusive global licensing option agreement for CUG252, a potential treatment for autoimmune and inflammatory diseases.
Under the agreement, AbbVie gets the option to an exclusive license to develop, manufacture and commercialize CUG252. In return, Cugene will receive an upfront payment of US$48.5 million and is eligible to receive development and regulatory milestones and a license option exercise payment. Additionally, Cugene may also receive commercialization and sales-based milestones and tiered royalties.
In-licensing is becoming more and more commonplace, in part because of the influx of small biotech companies in the market. These early stage companies are a key source of promising product candidates, which pharmaceutical companies then in-license certain rights to.
In-licensing is cost effective, since the financial burden of product development is shared. It’s also lower risk for the company buying in as it can make deals based on promising preclinical or clinical results.
Compare that to the traditional drug-discovery process, where a company embarks on a project, investing heavily in its development — all with little data to back up expectations.
In-licensing also holds significant appeal when compared to straight M&A. That’s because licenses allow drug companies to purchase the rights for experimental drugs without taking on another company’s baggage, including unwanted technologies.
All of that means in-licensing can hold major appeal for pharma companies and investors alike. But, as mentioned, it can also generate confusion — confusion that can lead to ill-informed decisions on the part of investors.
Just as pharmaceutical companies are always looking for the next blockbuster drug, investors are looking for the company that will develop it. For that reason, in-licensing agreements can be somewhat off-putting — even if a drug proves wildly successful, its profits will need to be split between two pharmaceutical companies, and therefore two groups of shareholders.
Such was the case with Eliquis, an anticoagulant jointly developed by Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY). Discovery and clinical advancement were completed by the latter, which joined forces with Pfizer only when entering late-stage trials. This puzzled some investors — after all, the drug seemed like a potential blockbuster. It would be a novel entrant to the market, and would benefit a wide number patients. Why split the profits with another company, and one coming late to the game?
As John LaMattina explains in Forbes, at the time of the deal there were still plenty of questions about the success of Eliquis. The anticoagulant drug market is competitive, and there was no guarantee that this drug would prove more effective than similar products also in development. What’s more, Phase 3 trials are costly, and Bristol-Myers Squibb was contending with a tight research and development budget.
In the case of Pfizer, Bristol-Myers Squibb eased the risk and financial burden of getting Eliquis approved. It took a long time to roll out the drug, but today it’s a top earner, bringing in profits for both pharmaceutical companies.
In-licensing deals can also cause confusion by complicating financial statements.
“They are not typically recorded as an asset on the balance sheet,” Jeff Margolis, vice president of RespireRx Pharmaceuticals (OTCQB:RSPI), previously explained in a conversation with the Investing News Network. “They are considered ‘in-process research and development,’ and the expenditures are considered expenses on the profit and loss statement, typically creating large losses.”
That means the uninitiated investor might misinterpret a company’s financial statement, since it does not “truly account for the value of the licenses.” As Margolis said, “the asset is intangible.”
As pharmaceutical manufacturers move more toward in-licensing, they tend to reduce their massive research and development budgets. This can perturb investors accustomed to the traditional pharmaceutical growth model: drug discovery leads to products, which leads to profits.
But remember that drug discovery can also lead to major losses. Pharmaceutical companies spend millions on development, yet only one in 10 product candidates ever makes it to market. In-licensing can offer an opportunity to cut down that expense and share the burden of risk.
Plus, as pharmaceutical investors are becoming increasingly aware, blockbuster drugs are few and far between these days. “The industry is the victim of its own previous successes,” Dan Hurley explains in an article for the New York Times. “In order to thrive, it must come up with drugs that work better than blockbusters of the past.”
In-licensing may not be traditional, but it could be a more sustainable method of pharmaceutical growth. As the major pharmaceutical companies embrace this model, investors must adjust their own mindset too. The old rules might not apply any longer, and it’s important to reconsider investment strategies in light of industry changes.
This is an updated version of an article originally published by the Investing News Network in 2016.

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Securities Disclosure: I Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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