Pharmaceutical

  • Brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1; in all five placebo-controlled studies completed to date, oral brepocitinib generated statistically significant and clinically meaningful results
  • Priovant is developing brepocitinib in severe autoimmune diseases with few approved therapies and where dual inhibition of TYK2 and JAK1 may provide greater efficacy than inhibiting either alone
  • A single registrational Phase 3 trial evaluating oral brepocitinib in dermatomyositis ( VALOR ) was initiated earlier this quarter
  • An ongoing Phase 2b study in systemic lupus erythematosus (SLE), designed to serve as one of two registrational studies, is expected to generate top-line results in 2H 2023

Roivant Sciences and Pfizer today announced the unveiling of Priovant Therapeutics, dedicated to developing and commercializing novel therapies for autoimmune diseases with the greatest morbidity and mortality. Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinib's global development rights and US and Japan commercial rights to Priovant. Pfizer holds a 25% equity ownership interest in Priovant.

Brepocitinib is a potential first-in-class dual inhibitor of TYK2 and JAK1, a novel mechanism of action expected to potentially provide greater efficacy in multiple highly inflammatory autoimmune diseases, as compared to agents that inhibit either TYK2 or JAK1 alone. Priovant is developing oral brepocitinib as a franchise across multiple orphan and specialty autoimmune diseases with few approved therapies, high morbidity and mortality, and pathobiologies for which both TYK2 and JAK1 inhibition are expected to contribute to efficacy. Oral brepocitinib is being evaluated in two ongoing registrational programs. Priovant recently initiated a single registrational Phase 3 study in dermatomyositis ( VALOR ). A large, global Phase 2b study in SLE, designed to serve as one of two registrational studies, is close to fully enrolled with data anticipated in 2H 2023.

"Roivant has a proven track record in late-stage inflammation and immunology drug development, which is why we are confident that Priovant will successfully continue the development of much needed innovative treatments for these patients," said Mikael Dolsten, Chief Scientific Officer, President, Worldwide Research, Development and Medical at Pfizer. "This collaboration will enable allocation of resources to advance development of brepocitinib while allowing Pfizer to focus on diversifying its pipeline so that patients may benefit from potential options against inflammatory diseases."

Oral brepocitinib has been evaluated in 14 completed Phase 1 and Phase 2 studies, including five placebo-controlled Phase 2 studies in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata, and hidradenitis suppurativa. All five of these placebo-controlled Phase 2 studies generated statistically significant and clinically meaningful results. Oral brepocitinib's safety database includes over 1,000 exposed subjects and suggests a safety profile similar to those of approved JAK inhibitors.

Priovant recently initiated a single registrational Phase 3 study evaluating oral brepocitinib in dermatomyositis ( VALOR ). Dermatomyositis is an immune-mediated disease of the skin and muscles. Patients with dermatomyositis usually present with a characteristic skin rash and debilitating muscle weakness, which may lead to significant functional impairment and/or disfigurement. Substantially increased risk of interstitial lung disease, malignancy, and heart failure contribute to an estimated five-year mortality rate of 10-40%. i There is a substantial unmet need for novel, efficacious and convenient therapies that address the underlying pathophysiology of dermatomyositis.

"There is an urgent need for novel, targeted therapies for dermatomyositis, a devastating disease with few safe and effective treatments," said Ruth Ann Vleugels, MD, MPH, Director of the Connective Tissue Disease Clinics and Autoimmune Skin Diseases Program at Brigham and Women's Hospital/Harvard Medical School. "Brepocitinib is a particularly promising agent, as its dual inhibition of TYK2 and JAK1 may result in superior blockade of type I interferon, a key cytokine family implicated in dermatomyositis pathogenesis."

Oral brepocitinib is being evaluated in a large, global Phase 2b study in SLE, designed to serve as one of two registrational studies. Lupus is a clinically heterogeneous autoimmune disease that can impact nearly all major organ systems. While there are two approved targeted biologics for lupus, many patients respond inadequately. Like dermatomyositis, lupus pathobiology is characterized by dysregulations in type I interferon and other TYK2- and JAK1-mediated proinflammatory cytokines.

In addition to brepocitinib, Pfizer has also licensed ropsacitinib, a selective TYK2 inhibitor, to Priovant.

About Priovant Therapeutics

Priovant is a clinical-stage biotechnology company focused on delivering novel therapies for autoimmune diseases with the greatest morbidity and mortality. Priovant is developing oral brepocitinib, a potential first-in-class dual inhibitor of TYK2 and JAK1, as a franchise across multiple severe autoimmune diseases. Oral brepocitinib is currently being evaluated in potentially registrational studies in two indications. VALOR , a single Phase 3 study evaluating brepocitinib in dermatomyositis, is currently enrolling subjects. A large Phase 2b study in systemic lupus erythematosus, designed to serve as one of two registrational studies, is expected to generate top-line results in 2H 2023. Priovant also holds global development and commercial rights to topical brepocitinib in the US and Japan and to ropsacitinib, a selective TYK2 inhibitor, in the US. For more information, please visit www.priovanttx.com .

About Roivant Sciences
Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch 'Vants' – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com .

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.

Roivant Sciences Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Pfizer Disclosure Notice
The information contained in this release is as of June 28, 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, among other things, brepocitinib, ropsacitinib, a transaction between Pfizer and Roivant and Priovant Therapeutics, 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, 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 any applications may be filed for any potential indications for brepocitinib, ropsacitinib or any of Pfizer's product candidates in any jurisdictions; whether and when regulatory authorities may approve any such applications that may be filed for brepocitinib, ropsacitinib or any of Pfizer's product candidates, 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 brepocitinib, ropsacitinib or any of Pfizer's product candidates 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 brepocitinib, ropsacitinib or any of Pfizer's product candidates; whether the transaction with Roivant 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.

i Liu et al, Oncol Letters (2018)


Contacts Roivant Paul Davis Paul.davis@roivant.com Pfizer PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Priovant Daniel Herz-Roiphe daniel.herz-roiphe@priovanttx.com

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PFE

LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

Pfizer (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

As quoted in the press release:

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Oxis Acquires Pharma Company, Appoints New CEO

Oxis International (OTCQB:OXIS) appoints new CEO and Chief Medical Officer as it completes acquisition of  Georgetown Translational Pharmaceuticals, which will add new management and a class of close-to-market Central Nervous Systems products.
As quoted in the press release:

Oxis has agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close on or before 90 days as per the agreement.
Dr. Clarence-Smith will become Chief Executive Officer of Oxis as part of the acquisition and will be appointed to the Oxis Board of Directors. Also joining the company’s executive management team as part of the merger will be a Chief Medical Officer (name to be disclosed upon closing), who was formerly Vice President and Chief Medical Officer and Medical Director, Oncology Clinical R&D of Pfizer, Inc. (PFE).
Anthony J. Cataldo, who has served as Chief Executive Officer of Oxis since July 2014, will become Executive Chairman of the company. Steven Weldon will continue as Chief Financial Officer.
Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016.
Under the deal, Allergan agreed to pay $125 million upfront along with potential Regulatory and commercial milestones of up to $875 million to the shareholders of Chase.

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ICU Medical Completes the Acquisition of Hospira Infusion Systems from Pfizer

ICU Medical Inc. (NASDAQ:ICUI) today announced that it has completed its acquisition of the Hospira Infusion Systems business from Pfizer Inc. (NYSE:PFE). The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with the company’s existing businesses, makes ICU Medical one of the world’s leading pure-play infusion therapy companies.
“We are pleased that Hospira Infusion Systems is now part of ICU Medical and welcome our new Hospira colleagues to the ICU team. We look forward to working together to continue providing quality, innovation and value to our clinical customers worldwide,” said Vivek Jain, chairman and chief executive officer at ICU Medical.The Hospira Infusion Systems acquisition complements ICU Medical’s existing business to create a company with a complete IV therapy product portfolio from solutions to pumps to non-dedicated infusion sets. In addition, the acquisition gives ICU Medical a significantly enhanced global footprint and platform for continued competitiveness and long-term growth. With an integrated product offering, the company now holds industry-leading positions in key segments and has access to the full US infusion marketplace with a compelling product portfolio.The company plans to announce full FY 2017 guidance on its Q4 Earnings call in late February.Forward Looking Statements
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

Transgene Announces Collaboration with Merck and Pfizer to Evaluate the Combination of TG4001 with Avelumab

Transgene (Paris:TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced it has entered a collaboration agreement with the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy.
Philippe Archinard, Chairman and CEO of Transgene, commented: “We are
pleased to enter this collaboration with Merck KGaA, Darmstadt, Germany,
and Pfizer to evaluate our therapeutic vaccine TG4001 in association
with avelumab. In previous clinical trials, TG4001 has demonstrated
promising activity in terms of HPV viral clearance and was well
tolerated. TG4001 is one of the few drugs targeting HPV-associated
cancers that can be combined with an immune checkpoint blocker such as
avelumab. The preclinical and clinical data that have been generated
with both TG4001 and avelumab individually suggest this combination
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.
Prof. Christophe Le Tourneau said: “HPV-induced head and neck cancers
are currently treated with the same regimen as non-HPV-positive HNSCC
tumors. However, their different etiology clearly suggests that
differentiated treatment approaches are needed for HPV-positive
patients. Immunotherapy, and in particular the therapeutic vaccine
TG4001 together with the PD-L1 blocker avelumab, by targeting two
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
the coding sequences of the E6 & E7 tumor-associated antigens of HPV-16
and the cytokine, IL-2. This therapeutic vaccine, which is based on a
non-propagative, attenuated vaccinia vector (MVA), has already been
administered to more than 300 patients with high grade cervical
intra-epithelial neoplasia (CIN 2/3). It has demonstrated good safety, a
significant HPV clearance rate and promising efficacy results. Its
mechanism of action and good safety profile make TG4001 a particularly
appropriate candidate for combinations with other therapies, such as
avelumab.
Avelumab is an investigational, fully human antibody specific for a
protein found on tumor cells called PD-L1, or programmed death ligand-1.
As a checkpoint inhibitor, avelumab is thought to have a dual mechanism
of action that may potentially 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 2014, the science and technology company
Merck KGaA, Darmstadt, Germany, and Pfizer signed a strategic alliance
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

LYNPARZA® Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

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Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received KEYTRUDA plus LENVIMA versus LENVIMA monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the LENVIMA monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating LENVIMA monotherapy in uHCC. The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination. Merck and Eisai plan to present these data at an upcoming medical conference.

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Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting.

"Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. We will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with this disease," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We are grateful to the patients and investigators for their participation in this study."

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PFIZER REPORTS SECOND-QUARTER 2022 RESULTS

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  • Second-Quarter 2022 Reported Diluted EPS (2) of $1.73, Reflecting 77% Growth Over Second-Quarter 2021
  • Second-Quarter 2022 Adjusted Diluted EPS (3) of $2.04, Reflecting 92% Growth Over Second-Quarter 2021; Excluding Foreign Exchange Impacts, Adjusted Diluted EPS (3) Grew 100%
  • Raises Full-Year 2022 Financial Guidance (4) for Revenues and Adjusted Diluted EPS (3) by $2 Billion and $0.24, Respectively, on an Operational Basis (Which Excludes the Impact of Foreign Exchange)
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  • Pipeline Programs That Have Achieved Milestones Since Previous Earnings Release Include Bivalent mRNA COVID-19 Vaccine, Enhanced mRNA COVID-19 Vaccine, Paxlovid, modRNA Influenza Vaccine, Once-Daily Oral GLP-1 Receptor Agonist and Anti-Interferon-β

Pfizer Inc. (NYSE: PFE) reported strong financial results for second-quarter 2022 and updated certain components of 2022 financial guidance (4) . Pfizer reaffirmed its previous 2022 revenue guidance, despite unfavorable impacts from foreign exchange, while reaffirming its revenue guidance for Comirnaty (1) , the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and for Paxlovid, its oral COVID-19 treatment.

The second-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

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Merck Announces Second-Quarter 2022 Financial Results

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  • Advanced and Expanded Pipeline:
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    • The European Commission (EC) Approved Four Indications for KEYTRUDA
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    • Company Expects Full-Year 2022 GAAP EPS To Be Between $5.89 and $5.99; Company Narrows Expected Full-Year 2022 Non-GAAP EPS Range To Be Between $7.25 and $7.35, Including Negative Impact From Foreign Exchange of Approximately 3%

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2022.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005295/en/

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Merck Announces Fourth-Quarter 2022 Dividend

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company's common stock for the fourth quarter of 2022. Payment will be made on Oct. 7, 2022, to shareholders of record at the close of business on Sept. 15, 2022.

About Merck

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