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 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported taht it will webcast management presentations as follows (Press release, Regeneron, APR 23, 2018, View Source [SID1234525592]):

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J.P. Morgan 2018 Spring Biotech Conference Call Series at 10:00 a.m. Eastern Time on Tuesday, May 8, 2018
Bank of America Merrill Lynch 2018 Healthcare Conference at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) on Wednesday, May 16, 2018
Barclays 2018 Biopharmaceuticals CEO/CFO Conference Call Series at 11:00 a.m. Eastern Time on Friday, June 1, 2018
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the conference calls and webcasts will be archived on the Company’s website and will be available for 30 days.

On April 23, 2018 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported that it will release its first quarter 2018 financial results on Thursday, May 3, 2018 at 7:00 a.m. ET (Press release, Teva, APR 23, 2018, View Source;p=RssLanding&cat=news&id=2343903 [SID1234525573]).

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Teva will host a conference call and live webcast on the same day, at 8:00 a.m. ET to discuss its first quarter 2018 results and overall business environment. A Question & Answer session will follow this discussion.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time):

United States 1-866-254-0808
International 44 (0) 1452 541003
for a list of other international toll-free numbers, click here.
Passcode: 9496209
A live webcast of the call will also be available on Teva’s website at: ir.tevapharm.com Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until May 31, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222 or International 44(0)1452550000; passcode: 9496209

On April 23, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported a publication entitled, "Mechanisms and clinical activity of an EGFR and HER2 exon 20–selective kinase inhibitor in non–small cell lung cancer (Press release, Spectrum Pharmaceuticals, APR 23, 2018, View Source [SID1234525593])." The publication appears in the April 23, 2018 online issue at View Source and will be published in a future print issue of Nature Medicine.

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"We are honored to have data from poziotinib published in this prestigious journal," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The excitement around poziotinib is palpable among the medical community. For cancer patients that have exon 20 mutations, physicians have very few options. The publication shows that poziotinib has a strong potential to be a promising therapy for such patients. We are collaborating with the medical community, regulatory agencies and corporate partners to expedite the rapid development of this drug."

The Nature Medicine publication summarizes the current preclinical and clinical data with poziotinib for EGFR and HER2 exon 20 mutations. MD Anderson utilized in silico, in vitro, and in vivo testing to model structural alterations induced by exon 20 mutations and identify potentially effective inhibitors. 3-D modeling indicated alterations restricted the size of the drug binding pocket, limiting the binding of large, rigid inhibitors. It was found that poziotinib, due to its small size and flexibility, can circumvent these steric changes, and is a potent inhibitor of the most common EGFR and HER2 exon 20 mutants. Poziotinib demonstrated greater activity than approved EGFR TKIs in vitro and in EGFR or HER2 exon 20 mutant patient-derived xenograft models, and genetically engineered mouse models of NSCLC.

According to the Nature Medicine publication, the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial had a confirmed objective response rate of 64%. At the time of the publication, the median progression-free survival had not been reached, with a median follow up of 6.6 months. 55% of patients received a dose reduction, with the two most common adverse events being known EGFR inhibitor-related toxicities: skin rash and diarrhea. At the World Conference on Lung Cancer in October 2017, MD Anderson presented that all of the 11 patients had a radiologic improvement in their disease, and 8 out of the 11 patients had a partial response (73% objective response rate). In the Nature Medicine publication it was reported that 7 out of those 11 patients had confirmed partial response (64% objective response rate).

The MD Anderson Phase 2 clinical trial is nearing completion of enrollment in the EGFR cohort, and the Spectrum Phase 2 study is enrolling at approximately 20 centers in the United States today, with further study center expansion in the U.S. and other countries in progress.

About Poziotinib

Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications

On April 23, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, and CrystalGenomics, Inc., (KOSDAQ:083790), a Korea-based biopharmaceutical company with drug discovery, development and commercialization capabilities, reported a co-development agreement for an investigational combination therapy of CBT-501 and CG200745 across a variety of solid tumors with high unmet medical needs (Press release, CBT Pharmaceuticals, APR 23, 2018, View Source [SID1234525574]).

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Under the terms of the exclusive agreement, CBT and CrystalGenomics will be responsible for the co-development and global commercialization of the combination of CBT-501 and CG200745 in multiple tumor types. A Phase Ib/II study is expected to be initiated by the end of this year.

"This partnership with CrystalGenomics enables CBT to leverage their clinical development expertise while further strengthening our immuno-oncology combination approach to deliver promising best-in-class treatments to patients with cancer," Sanjeev Redkar, Ph.D., President and Chief Executive Officer. "We believe the combination therapy of CBT-501 and CG200745 has the potential to be synergistic for patients across a range of cancers where alternative therapies are needed."

"We are excited to work with the CBT team, who are uniquely qualified to accelerate development of our novel HDAC inhibitor in combination with CBT-501, a differentiated anti-PD1 antibody" said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics.

Immune checkpoint inhibitors such as the programmed death receptor-1 (PD-1) and ligand (PD-L1) have been considered as major breakthroughs in the treatment of various cancers including melanoma, renal, lung, and bladder cancers. However, despite the robust efficacy observed in these cancers, the majority of patients either do not respond or eventually relapse due to resistance which may be innate or acquired. There has been recent reports suggesting immune enhancing effects of HDAC inhibitors, in addition to their direct anti-tumor properties, making CG200745 a good candidate for combination therapy with CBT-501 for its immunomodulatory effects in addressing the patient population that do not respond to single agent immunotherapy.

About CBT-501

CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. It has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti-PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile with very low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity. CBT-501 is under evaluation in two Phase I trials designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced solid tumors, recurrent or refractory to standard of care therapies (NCT03053466, NCT03374007).

About CG200745

CG200745, is a novel pan-HDAC inhibitor currently in Phase II clinical study for pancreatic cancer (NCT02737228) and Phase Ib for myelodysplastic syndrome (NCT02737462) in Korea. CG200745 has the potential to be a best-in-class compound based on preclinical and interim Phase Ib/II clinical data and is projected to have superior pharmacokinetic (PK) profile, pharmacodynamic (PD) response, efficacy, and safety, over other HDAC inhibitors. In its first-in-human study of the toxicity, PK and PD in patients with refractory solid malignancies, stable disease was observed in 57.1% of the subjects treated with CG200745 as monotherapy and excellent safety profile was observed as the maximum tolerated dose (MTD) was never reached (NCT01226407).