On April 23, 2018 Pfizer Inc. (NYSE:PFE) reported that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar (Press release, Pfizer, APR 23, 2018, View Source [SID1234525591]). In the CRL, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer is working closely with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the U.S.

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Pfizer believes that biosimilars are critically important to the future of cancer care, with the potential to increase patient access to life-changing therapies that will help address the evolving needs of healthcare systems, patients, physicians and payers.

Pfizer Inc.: Working together for a healthier world

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, 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 April 23, 2018. 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 proposed trastuzumab biosimilar, 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, the uncertainties inherent in research and development, including 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; uncertainties regarding the company’s ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when any applications for Pfizer’s proposed trastuzumab biosimilar may be filed with regulatory authorities in any other jurisdictions; whether and when the FDA may approve the biologics license application for Pfizer’s proposed trastuzumab biosimilar and whether and when regulatory authorities in any other jurisdictions may approve any such other applications that are pending or that may be filed for Pfizer’s proposed trastuzumab biosimilar, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether Pfizer’s proposed trastuzumab biosimilar will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Pfizer’s proposed trastuzumab biosimilar ; 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, 2017, 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 10-Q and 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.

On April 23, 2018 Pfizer Inc. (NYSE:PFE) reported that the European Commission has approved MYLOTARG (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL) (Press release, Pfizer, APR 23, 2018, View Source [SID1234525590]). MYLOTARG is the first and only AML therapy approved in the European Union (EU) that targets CD33, an antigen expressed on AML cells in up to 90% of patients.1,2,3

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"The marketing authorization of MYLOTARG provides a much-needed treatment option offering renewed hope for many acute myeloid leukemia patients in Europe," said Andreas Penk, M.D., regional president, Pfizer Oncology. "In clinical trials, the addition of MYLOTARG to standard chemotherapy resulted in deeper, more durable remission, thus providing an additional treatment option with the potential to prevent relapse for these patients."

AML is a rapidly progressing, life-threatening blood and bone marrow cancer.4 If left untreated, patients with AML will die within months, if not weeks, of their disease. AML is the most common type of acute leukemia in adults and accounts for approximately 80% of all cases of acute leukemia.5About 16,800 people are expected to be newly diagnosed with AML in Europe annually.6 The goal of AML treatment is for the patient to achieve a complete, prolonged remission. Longer periods of remission prior to relapse are associated with better long-term outcomes for patients. Thus, medicines that delay the time until the disease comes back and extend life can provide meaningful clinical benefit.

"I am thrilled that MYLOTARG will be available soon in Europe as a first-line treatment for patients with acute myeloid leukemia," said Doctor Sylvie Castaigne, Professeur des Universités, Université de Versailles – Saint Quentin, Praticien Hospitalier, Centre Hospitalier de Versailles, and lead investigator of the ALFA-0701 study. "This important milestone is a result of close collaboration between Pfizer and clinical investigators around the world, particularly the ALFA investigators in France, who believed in the promise of this therapy. We thank all of the investigators, nurses and patients who participated in these studies."

The European Commission’s approval of MYLOTARG was based on data from an investigator-led, Phase 3 randomized, open-label study (ALFA-0701) in previously untreated, de novo patients. MYLOTARG received approval by the U.S. Food and Drug Administration in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

Pfizer is advancing a broad range of therapies that leverage multiple pathways and mechanisms of action (MOAs) to address acute and chronic leukemias, myeloproliferative disorders and lymphomas. Pfizer currently has four marketed therapies for hematologic cancers worldwide as well as several therapies in clinical development. Pfizer is also forging collaborations with a diversity of industry, academic and community partners to study multiple paths to advancing treatment. By working together, Pfizer and its partners aim to overcome the challenges of hematologic cancers and deliver meaningful benefits to patients.

Indication for MYLOTARG (gemtuzumab ozogamicin) in the EU

MYLOTARG is approved in combination with daunorubicin and cytarabine for the treatment of patients age 15 and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL).

IMPORTANT MYLOTARG (gemtuzumab ozogamicin) SAFETY INFORMATION in the EU

The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukemia from the combination therapy study ALFA-0701, monotherapy studies, and from post-marketing experience.

Hepatotoxicity, including life-threatening, and sometimes fatal hepatic failure and VOD/SOS have been reported in patients treated with MYLOTARG. Other special warnings and precautions include myelosuppression and infusion-related reactions.

In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), hemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%). In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).

The most common adverse reactions (> 30%) in the combination therapy study were hemorrhage and infection. In monotherapy studies the most common adverse reactions (> 30%) included pyrexia, nausea, infection, chills, hemorrhage, vomiting, thrombocytopenia, fatigue, headache, stomatitis, diarrhea, abdominal pain, and neutropenia.

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, hemorrhage and infection. The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, hemorrhage, multi-organ failure, and VOD.

The EU Summary of Product Characteristics (SmPC) will be available at View Source

About MYLOTARG (gemtuzumab ozogamicin)

MYLOTARG is an antibody-drug conjugate (ADC) composed of the cytotoxic agent calicheamicin, attached to a monoclonal antibody (mAB) targeting CD33, an antigen expressed on the surface of myeloblasts in up to 90 percent of AML patients.1,2,3When MYLOTARG binds to the CD33 antigen on the cell surface it is absorbed into the cell and calicheamicin is released causing cell death.2,3

MYLOTARG was approved by the U.S. Food and Drug Administration in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

MYLOTARG originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing, clinical development and commercialization activities for this molecule.

Pfizer also collaborated with SFJ Pharmaceuticals Group on the registrational program for MYLOTARG.

On April 23, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report first quarter financial results after the Nasdaq market closes on Monday, April 30, 2018 (Press release, Neurocrine Biosciences, APR 23, 2018, View Source;p=RssLanding&cat=news&id=2344001 [SID1234525589]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9176 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at View Source A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

On April 23, 2018 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology, reported that two scientific abstracts have been accepted for presentation at the 21st Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place May 16-19, 2018, in Chicago (Press release, Intellia Therapeutics, APR 23, 2018, View Source [SID1234525587]).

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The first presentation will share information relating to Intellia’s lead in vivo program, for transthyretin amyloidosis. The data being presented include results from an ongoing collaboration with researchers at the University of Porto in Portugal. The second presentation will focus on Intellia’s ongoing research collaboration with IRCCS Ospedale San Raffaele in Italy to develop CRISPR-edited, T-cell therapies to address hard-to-treat cancers. Intellia will also participate in an education session on RNA therapeutics.

Details of Intellia’s presentations are as follows:

"Rescue of Amyloid Deposition Phenotype after Single-Treatment CRISPR/Cas9 Gene Editing in a Humanized Mouse Model of TTR Amyloidosis"
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases) I
Session date/time:Wed., May 16, 2018, 5:30-7:30 p.m. CT
Location: Stevens Salon C, D
"Hunting WT1-Specific T-Cell Receptors for TCR Gene Editing for Acute Myeloid Leukemia"
Session: Cancer – Immunotherapy, Cancer Vaccines I
Session date/time:Wed., May 16, 2018, 5:30-7:30 p.m. CT
Location: Stevens Salon C, D
"Lipid Nanoparticle-Based RNA Delivery: At the Intersection of Chemistry and Immunology"
Presenter: Jonathan Finn, Ph.D., executive director, Platform Biology
Session: Education Session 401 – RNA Therapeutics
Presentation date/time:Sat., May 19, 2018, 9-9:30 a.m. CT
Location: Salon A-1
In addition, the following Intellia collaborators will highlight aspects of their research efforts with the Company:

"Clinical Gene Editing Programs"
Presenter: Beverly Davidson, Ph.D., chief scientific strategy officer, Children’s Hospital of Philadelphia (CHOP); director, Raymond G. Perelman Center for Cellular and Molecular Therapeutics, CHOP; Arthur V. Meigs Chair in Pediatrics, CHOP; and professor, Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania
Session: Pre-Meeting Program – Gene Editing Workshop
Presentation date/time:Tue., May 15, 11 a.m.-12 p.m. CT
Location: Continental B
"TCR Gene Transfer and TCR Gene Editing"
Presenter: Chiara Bonini, M.D., Ph.D., full professor, Università Vita-Salute San Raffaele; deputy director, Division of Immunology, Transplantation and Infectious Diseases; and head, Experimental Hematology Unit, Ospedale San Raffaele, Italy
Session: 100 Immune Responses to Cell and Gene Therapies, Mechanisms, Biomarkers and Therapeutic Interventions
Presentation date/time:Wed., May 16, 2018, 8-8:30 a.m. CT
Location: International Ballroom North
Abstracts will become available on the ASGCT (Free ASGCT Whitepaper) website on Mon., April 30th, at 11 a.m. CT.

On April 23, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported it will release its first-quarter 2018 operating results after market close Monday, May 7, with a conference call to follow at 5 p.m. ET (Press release, Diplomat Speciality Pharmacy, APR 23, 2018, View Source [SID1234525586]).

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Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering participant code 5178318, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.