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ANTICANCER AGENT “TREAKISYM(R) FOR INJECTION 100 MG” APPROVED IN JAPAN FOR ADDITIONAL INDICATION OF CHRONIC LYMPHOCYTIC LEUKEMIA

On August 26, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the anticancer agent TREAKISYM for Injection 100 mg (generic name: bendamustine hydrochloride, "TREAKISYM") has been approved in Japan for an additional indication of chronic lymphocytic leukemia (Press release, Eisai, AUG 26, 2016, View Source [SID:1234514752]). TREAKISYM is the subject of a licensing agreement concluded between Eisai and SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President & CEO: Fuminori Yoshida, "SymBio").

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TREAKISYM was initially approved in Japan in October 2010 for relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product in Japan since its launch in December 2010.

Symbio filed an application for this additional indication in December 2015 in response to a development request from the Japanese Ministry of Health, Labour and Welfare’s Study Group on Unapproved and Off Label Drugs with high unmet medical needs. Chronic lymphocytic leukemia is a blood cancer characterized by neoplastic transformation and excess propagation of lymphocytes, a type of white blood cell, in the bone marrow. With approximately 2,000 patients with chronic lymphocytic leukemia in Japan as well as an incidence rate of new cases of approximately 0.3 in 100,000, this is a disease with high unmet medical need. Furthermore, TREAKISYM has been designated as an orphan drug for chronic lymphocytic leukemia in Japan.

Eisai positions oncology as a key therapeutic area and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the value of TREAKISYM as well as its in-house developed anticancer agents including Halaven and Lenvima, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.

1. About bendamustine hydrochloride (generic name, product name: TREAKISYM)
Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly ‘East German’) pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin and Levact as a treatment for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. In the United States the product has been approved by the U.S. Food and Drug Administration and is currently marketed under the brand name TREANDA for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin’s lymphoma. Eisai concluded an exclusive licensing agreement with SymBio in August 2008 concerning the joint development and marketing of TREAKISYM in Japan, which was followed by a subsequent agreement between the two companies in May 2009 concerning the development and marketing of the agent in Singapore and South Korea.
2. About TREAKISYM (additional parts have been underlined)
Product Name:
TREAKISYM for Injection, for intravenous infusion 100 mg
Generic Name:
Bendamustine Hydrochloride
Indications and Usage:
1. For the treatment of relapsed or refractory forms of the following diseases:
Low-grade B-cell non-Hodgkin’s lymphoma
Mantle cell lymphoma
2. Chronic lymphocytic leukemia
Dosage and Administration:
1. For relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma or mantle cell lymphoma

The usual adult dose of bendamustine hydrochloride is 120 mg/m2 body surface area infused intravenously over 60 minutes on Days 1 and 2 of repeated 21-day cycles. The dose may be reduced appropriately according to the patient’s condition.
2. For chronic lymphocytic leukemia

The usual adult dose of bendamustine hydrochloride is 100 mg/m2 body surface area infused intravenously over 60 minutes on Days 1 and 2 of repeated 28-day cycles. The dose may be reduced appropriately according to the patient’s condition.

Anti-Cancer Agent “Xeloda®,” Obtained Approval for Additional Indication of “Adjuvant Chemotherapy for Rectal Cancer”

On August 26, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) for the indication of "adjuvant chemotherapy for rectal cancer (Press release, Chugai, AUG 26, 2016, View Source [SID:1234514751])." In Japan, Xeloda is currently on the market and its approved indications are "inoperable or recurrent breast cancer," "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer." With this supplemental approval, the indication of Xeloda has been changed to "colorectal cancer," covering the above indications for colon and colorectal cancer.

"Xeloda in adjuvant chemotherapy for rectal cancer is regarded as the standard of care in several guidelines," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "In addition to the current approved indications, this supplemental approval enables people with locally advanced rectal cancer to use Xeloda as well. We believe it will encourage patients to receive treatment with hope and positive thoughts."

The "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, evaluated whether "public knowledge-based application" might be applicable for Xeloda in adjuvant chemotherapy for rectal cancer. On February 26, the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council made a decision that filing through the "public knowledge-based application" was reasonable. Given that decision, Chugai filed for Xeloda through a "public knowledge-based application" on March 2 and obtained this supplemental approval.

Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "colorectal cancer." Chugai will continue its efforts to contribute to cancer treatment.

* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted.

Xeloda is a registered trademark of F. Hoffmann-La Roche, Ltd. (Switzerland)

[Drug Information]

Brand name: Xeloda Tablets 300

Generic name: Capecitabine

Indications: Inoperable or recurrent breast cancer
Colorectal cancer
Gastric cancer

Dosage and administration:
Regimens A or B are available for the treatment of inoperable or recurrent breast cancer. Regimen B should be employed in adjuvant chemotherapy for colorectal cancer, while regimen C should be employed in combination with another anticancer agent for the treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection. Regimen D should be employed in adjuvant chemotherapy for rectal cancer in combination with radiation therapy. Regimen C should be employed in combination with a platinum agent for the treatment of gastric cancer.

Regimen A:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 21 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Regimen B:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.33m2 1,500mg
≥1.33 to <1.57m2 1,800mg
≥1.57 to <1.81m2 2,100mg
≥1.81m2 2,400mg
Regimen C:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.36m2 1,200mg
≥1.36 to <1.66m2 1,500mg
≥1.66 to <1.96m2 1,800mg
≥1.96m2 2,100mg
Regimen D:
XELODA is administered orally in the following doses, ac-cording to body surface area, twice daily within 30 minutes after morning and evening meals for 5 consecutive days, followed by a 2-day rest period. This is repeated. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Drug price: JPY 360.2/TabletAugust 26, 2016 — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) for the indication of "adjuvant chemotherapy for rectal cancer." In Japan, Xeloda is currently on the market and its approved indications are "inoperable or recurrent breast cancer," "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer." With this supplemental approval, the indication of Xeloda has been changed to "colorectal cancer," covering the above indications for colon and colorectal cancer.

"Xeloda in adjuvant chemotherapy for rectal cancer is regarded as the standard of care in several guidelines," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "In addition to the current approved indications, this supplemental approval enables people with locally advanced rectal cancer to use Xeloda as well. We believe it will encourage patients to receive treatment with hope and positive thoughts."

The "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, evaluated whether "public knowledge-based application" might be applicable for Xeloda in adjuvant chemotherapy for rectal cancer. On February 26, the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council made a decision that filing through the "public knowledge-based application" was reasonable. Given that decision, Chugai filed for Xeloda through a "public knowledge-based application" on March 2 and obtained this supplemental approval.

Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "colorectal cancer." Chugai will continue its efforts to contribute to cancer treatment.

* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted.

Xeloda is a registered trademark of F. Hoffmann-La Roche, Ltd. (Switzerland)

[Drug Information]

Brand name: Xeloda Tablets 300

Generic name: Capecitabine

Indications: Inoperable or recurrent breast cancer
Colorectal cancer
Gastric cancer

Dosage and administration:
Regimens A or B are available for the treatment of inoperable or recurrent breast cancer. Regimen B should be employed in adjuvant chemotherapy for colorectal cancer, while regimen C should be employed in combination with another anticancer agent for the treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection. Regimen D should be employed in adjuvant chemotherapy for rectal cancer in combination with radiation therapy. Regimen C should be employed in combination with a platinum agent for the treatment of gastric cancer.

Regimen A:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 21 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Regimen B:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.33m2 1,500mg
≥1.33 to <1.57m2 1,800mg
≥1.57 to <1.81m2 2,100mg
≥1.81m2 2,400mg
Regimen C:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.36m2 1,200mg
≥1.36 to <1.66m2 1,500mg
≥1.66 to <1.96m2 1,800mg
≥1.96m2 2,100mg
Regimen D:
XELODA is administered orally in the following doses, ac-cording to body surface area, twice daily within 30 minutes after morning and evening meals for 5 consecutive days, followed by a 2-day rest period. This is repeated. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Drug price: JPY 360.2/Tablet

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, Annual, ImmunoGen, 2016, AUG 25, 2016, View Source [SID:1234514746])

8-K – Current report

On August 25, 2013, Soligenix, Inc. (the "Company") reported it entered into an agreement with SciClone Pharmaceuticals, Inc. ("SciClone"), pursuant to which SciClone provided the Company with access to its oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 (dusquetide), a novel, first-in-class therapy being developed by the Company for the treatment of oral mucositis in patients with head and neck cancer, subject to the negotiation of economic terms (Filing, 8-K, Soligenix, AUG 25, 2016, View Source [SID:SID1234515114]).

On September 9, 2016, the Company and SciClone entered into an exclusive license agreement (the "License Agreement"), pursuant to which the Company granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam (the "Territory"). Under the terms of the License Agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the Territory, having access to data generated by the Company. In exchange for exclusive rights, SciClone will pay to the Company royalties on net sales, and the Company will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.

In connection with the execution of the License Agreement, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with SciClone pursuant to which the Company sold 3,529,412 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), to SciClone for $0.85 per share, for an aggregate price of $3,000,000. As additional consideration for expanded territorial rights in South Korea, Taiwan and Vietnam, SciClone agreed to purchase the shares of Common Stock at a premium above the current market price, with the purchase price being equal to one hundred thirty five percent (135%) of the average trading price of the Common Stock over the ten trading days prior to September 9, 2016. As part of the transaction, the Company granted SciClone certain demand registration rights.

The Purchase Agreement is provided to give investors information regarding the agreements’ respective terms. It is not provided to give investors factual information about the Company or SciClone. In addition, the representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of that agreement and as of specific dates, were solely for the benefit of the parties to that agreement, and may be subject to limitations agreed by the contracting parties, including being qualified by disclosures exchanged between the parties in connection with the execution of such agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the agreement and should not view the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or conditions of the Company.

argenx Reports Second Quarter Business Update and Half Year 2016 Financial Results

On August 25, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported its second quarter business update and half year financial results for 2016, in accordance with IFRS as adopted by the European Union (Press release, arGEN-X, AUG 25, 2016, View Source [SID:1234514755]).

The half year results will be discussed during a conference call and webcast presentation today at 3 pm CET / 9 am EDT. To participate in the conference call, please select your phone number below, and use the confirmation code 49998398. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

"This quarter was a seminal one for us as we made substantial progress against several very important corporate goals: advancing our clinical and other pipeline programs and in closing a significant financing with key U.S. institutional investors as well as entering into a strategic transaction with AbbVie for our oncology candidate AGRX-115. We believe these accomplishments have driven argenx forward to become a new and more substantial company with a full and mature clinical pipeline, an advanced platform and the financial and strategic support to derive value from them," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "During the quarter we announced data from our Phase 1 MAD and SAD studies of ARGX-113 which led to the selection of our Phase 2 dose and demonstrated the drug’s strong safety profile and its ability to rapidly reduce IgG levels in healthy volunteers. Our lead oncology candidate ARGX-110 showed further evidence of anti-tumor activity in T-cell lymphoma patients and is on track to announce top-line data in this expansion cohort by end of year. We are looking forward to executing on our strategic plan for the remainder of 2016 to bring ARGX-113 into two Phase 2 indications and to examine the breadth of potential for ARGX-110 as a monotherapy and a combination agent in TCL and AML."

SECOND QUARTER 2016

Announced initial results from its Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers. The compound continues to show favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.
Published efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity.
Presented efficacy and safety data from its Phase 1 expansion study of ARGX-110 in patients with T-cell lymphoma (TCL) during an e-poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Copenhagen, Denmark). The data from the Phase 1 expansion study show evidence of clinical and/or biological anti-tumor activity with ARGX-110 in highly refractory cutaneous TCL & peripheral TCL patients with confirmed overexpression of CD70.
Entered into placement agreements with several predominant U.S. institutional investors relating to the issue of a total of 2,703,000 new shares for an aggregate amount of €30,003,300. The transaction was led by MPM Oncology Impact Fund with participation from Aquilo Capital, Burrage Capital, DAFNA Capital, Perceptive Advisors and certain other existing and new institutional investors.
Announced collaboration with AbbVie to develop and commercialize ARGX-115. ARGX-115 is argenx’ preclinical-stage human antibody asset targeting the novel immuno-oncology target GARP, a protein believed to contribute to immunosuppressive effects of T-cells. argenx received an upfront payment of $40M.
FINANCIAL HIGHLIGHTS (as of 30 June, 2016) (compared to financial highlights as of 30 June 2015)

Operating income of EUR 7.0 million (30 June 2015: EUR 4.3 million).
Net loss of EUR 7.4 million (30 June 2015: EUR 7 million).
Cash position of EUR 108.7 million (cash, cash-equivalents and financial assets) allowing Company to pursue development of its product portfolio as planned.