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Astellas Announces Approval in Japan for XOSPATA® 40 mg Tablets for the Treatment of FLT3mut+ Relapsed or Refractory AML

On September 21, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported that XOSPATA Tablets 40 mg (generic name: gilteritinib), a FLT3 (FMS-like tyrosine kinase 3) inhibitor received manufacturing and marketing approval for the treatment of FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML) in Japan (Press release, Astellas, SEP 21, 2018, View Source [SID1234536692]).

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AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. In Japan, approximately 5,500 patients are diagnosed with AML each year1. XOSPATA has demonstrated inhibitory activity against both internal tandem duplication (ITD) and tyrosine kinase domain (TKD), FLT3 mutations that are seen in approximately one-third of patients with AML.

This approval is based on the CR/CRh2 rate results from the interim analysis of the multinational Phase 3 ADMIRAL study. In October 2015, gilteritinib was designated as one of the first products in Japan to be included in the SAKIGAKE3 designation system. A similar application for approval was filed in the United States in March, 2018 and is currently under review.

With this approval, Astellas hopes to further contribute to the health of patients suffering from AML and to support healthcare professionals involved in the treatment of AML by providing new treatment options.

Astellas reflected the impact from this approval in its financial forecasts of the current fiscal year ending March 31, 2019.

Kyowa Kirin Announces Mogamulizumab Received Positive CHMP Opinion for the Treatment of Mycosis Fungoides and Sézary Syndrome

On November 21, 2018 Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) reported that the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMA) scientific committee, has adopted a Positive Opinion recommending approval of the marketing authorisation of mogamulizumab, a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy (Press release, Kyowa Hakko Kirin, NOV 21, 2018, View Source [SID1234531624]).
MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin’s lymphoma.

The CHMP’s opinion is now being referred to the European Commission (EC), for a final decision on the grant of a marketing authorisation. This decision is expected by the end of 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein.

"At Kyowa Kirin we are fully committed to contributing to the health and wellbeing of patients across Europe who are living with mycosis fungoides and Sézary syndrome," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. "I am happy about the CHMP’s opinion which takes us one step closer to obtaining an EU marketing authorisation, launching mogamulizumab and to leaping forward to becoming a global specialty pharmaceutical company."

"Mycosis fungoides (MF) and Sézary syndrome (SS) can be disfiguring, debilitating, and even life-threatening, and there are limited treatment options for these rare lymphoma subtypes in Europe today," said Jeffrey S. Humphrey, MD, President of Kyowa Kirin Pharmaceutical Development, Inc. "MAVORIC, the pivotal Phase 3 trial of mogamulizumab, is the largest study of systemic therapy ever conducted in MF and SS. The study showed that mogamulizumab prolonged progression-free survival compared to vorinostat in patients with MF or SS. We will continue to work with the scientific community to advance the understanding of these complex diseases, and we look forward to working with health authorities to bring this important new option to Europe."

If mogamulizumab is approved, Kyowa Kirin International PLC, a Kyowa Hakko Kirin Group company, will be responsible for commercializing mogamulizumab in Europe.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Mogamulizumab Regulatory Status in EU
The EMA’s scientific committee, CHMP adopted a Positive Opinion recommending the approval of the marketing authorisation of mogamulizumab for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. The CHMP’s recommendation is now being referred to the European Commission (EC), which is expected to render its final decision by the end of 2018. The EC typically adheres to the recommendation of the CHMP, but is not obligated to do so.

Fate Therapeutics Announces Proposed Public Offering of Common Stock

On October 21, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that it has commenced an underwritten public offering of its common stock (Press release, Fate Therapeutics, SEP 21, 2018, View Source [SID1234530292]). Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of clinical product candidates and the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock to be sold in the offering will be offered by Fate Therapeutics. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

Jefferies, Piper Jaffray, and Wells Fargo Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as a co-manager for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-224680) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC").

A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by e-mail at [email protected] or by telephone at (800) 747-3924; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, by email at [email protected] or by telephone at (800) 326-5897.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin Lymphoma

On September 21, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan (Press release, Seattle Genetics, SEP 21, 2018, View Source;p=RssLanding&cat=news&id=2368435 [SID1234529705]). As a result, Seattle Genetics will receive a milestone payment from Takeda of $10 million. The approval in Japan was based on the positive outcome from the phase 3 ECHELON-1 trial.

"This approval marks another important milestone in expanding the ADCETRIS brand globally and redefining the way newly diagnosed Hodgkin lymphoma patients are treated around the world," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "ADCETRIS is approved in 71 countries and generated global sales of approximately $640 million in 2017, underscoring its progress toward becoming the foundation of therapy for patients with CD30-expressing lymphomas."

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments. In addition, Seattle Genetics receives tiered double-digit royalties with percentages ranging from the mid-teens to mid-twenties based on net sales of ADCETRIS within Takeda’s territories.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including the ongoing phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma (CTCL) and the completed ECHELON-1 trial in previously untreated Hodgkin lymphoma, as well as trials in many additional types of CD30-positive lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

XOMA Acquires Royalty Interest Position from Agenus on Seven Assets Being Developed by Merck and Incyte

On September 21, 2018 XOMA Corporation (NASDAQ: XOMA), reported that for $15.0 million, it has acquired from Agenus (NASDAQ: AGEN) a partial interest position in the rights to potential milestone and royalty payments associated with seven immuno-oncology antibodies currently being developed by Merck and Incyte under their collaborations with Agenus (Press release, Xoma, SEP 21, 2018, View Source [SID1234529553]).

"This is an important deal reflecting our new royalty-aggregator strategy to acquire milestone and royalty payments associated with therapeutic candidates partnered by others. The basket of Agenus immuno-oncology assets is advancing in the hands of two of the leading companies in oncology drug development," said Jim Neal, Chief Executive Officer at XOMA. "These assets possess all the characteristics we have established for our business model: outstanding development partners, mid-stage to early stage assets, important therapeutic categories, and sizable royalty commitments. We believe this investment could generate potential future cash flows over an extended period from milestones and royalties on some exciting potential commercial opportunities."

The seven royalty interest antibodies are:

One Phase 1 antibody being developed by Merck on an undisclosed novel target;

Incyte’s INCAGN1876, a GITR agonist in Phase 1/2 studies;

Incyte’s INCAGN1949, an OX-40 agonist in Phase 1/2 studies;

Incyte’s INCAGN2385, a LAG-3 antagonist in Phase 1 studies;

Incyte’s INCAGN02390, a TIM-3 antagonist expected to enter the clinic in 2018; and,

Two preclinical antibodies being developed by Incyte on undisclosed targets.

Under the terms of the agreement, XOMA will receive low- to mid-single-digit royalties on future sales of these seven immuno-oncology assets. Additionally, XOMA is entitled to a portion of milestone payments associated with the assets. XOMA has drawn $7.5 million from its line of credit with Silicon Valley Bank ("SVB") to partially fund this transaction.