On December 15, 2016 FUJIFILM Corporation (President & COO: Kenji Sukeno) ("Fujifilm") reported that it approved the acquisition of a leading reagent manufacturer Wako Pure Chemical Industries, Ltd. (President: Shinzo Kobatake) ("Wako") at today’s Board of Directors Meeting(Press release, Fujifilm, DEC 15, 2016, View Source [SID1234517099]).

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Fujifilm signed an agreement with Takeda Pharmaceutical Company Limited (President & CEO: Christophe Weber) ("Takeda") whereby the Takeda group*1 agreed to tender all of the common shares of Wako held by the Takeda group in the tender offer (the "Tender Offer") on the first day of the Tender Offer period. The Tender Offer is scheduled to commence on February 27, 2017, subject to certain closing conditions, including the completion of anti-trust filing process. The expected total amount for the payment of the Tender Offer is JPY154.7bn.

*Takeda and Nihon Pharmaceutical Co., Ltd. together hold 71.2% of Wako shares (as of December 15, 2016).
Through the acquisition of Wako, Fujifilm will continue to expand its business by utilizing, among others, advanced technologies and competitive products, which Fujifilm and Wako possess. Fujifilm will be able to generate significant synergies in our healthcare and highly functional materials businesses, our key business areas, by applying chemical synthesis technology, nano-technology and production technology developed by Fujifilm through its photographic film business. Especially in healthcare, the substantial synergies can be achieved in the area of regenerative medicine with high potential for market growth, in-vitro diagnosis and pharmaceutical CDMO*2. The acquisition of Wako will be a key milestone for Fujifilm’s future business growth.

**Abbreviation for Contract Development and Manufacturing Organization
[Synergies from the Deal]

Regenerative Medicine Business
Fujifilm group has Cellular Dynamics International, Inc. ("CDI"), a US-based leading company in the area of development and manufacturing of iPS cells, and Japan Tissue Engineering Co., Ltd. ("J-TEC"), the first company that has launched the regenerative medicine products in Japan. Fujifilm possesses technologies and know-how essential for regenerative medicine, including the main patents regarding the production of iPS cells, the know-how for development and manufacturing of cells, the scaffold materials (recombinant peptide) necessary for cell culture, the manufacturing technology in stable condition and the micro-environmental control technology. By adding the cell culture medium developed by Wako through this acquisition, Fujifilm group will have all the main elements necessary for regenerative medicine. Fujifilm will utilize the technology to manufacture a small quantity of diversified products developed by Wako as a reagent manufacturer and will develop the high-functioning customized cell culture medium suitable for cultivation of various cells. Fujifilm will further accelerate the development of regenerative medicine business together with Wako, CDI and J-TEC.

In-Vitro Diagnostics Field in Medical System Business
Fujifilm has developed in-vitro diagnostic systems such as clinical chemistry analysis system measuring chemical constituents in blood with accuracy and high-precision and immunodiagnostic system detecting influenza virus with high sensitivity. The sales of the systems have increased by more than 10% per year. Fujifilm will expand the product lineup to satisfy the needs of customers from small clinics to large hospitals by adding the product lineup of Wako, such as immunology analyzer and biochemical analysis reagent. In addition, by utilizing Wako’s sales network in Japan that covers most of facilities conducting in-hospital examinations and Fujifilm’s worldwide business network developed through the sales of medical equipment such as image diagnostic devices and medical IT systems, Fujifilm and Wako will further broaden their market for each product.

Contract Development and Manufacturing Organization (CDMO) in Pharmaceutical Business
FUJIFILM Diosynth Biotechnologies is engaged in CDMO of bio-pharmaceuticals and FUJIFILM Finechemicals Co., Ltd. is engaged in CDMO of small molecule pharmaceuticals. Through this acquisition, Fujifilm will expand the CDMO business of pharmaceuticals by utilizing Wako’s chemical synthesis technology and cell culture medium manufacturing technology as well as Fujifilm’s chemical synthesis technology of small molecule pharmaceuticals and manufacturing technology of bio-pharmaceuticals.

Electronic Materials Business
Fujifilm has the product lineup of semiconductor materials including photoresist, materials for image sensor, and CMP slurry. Fujifilm has achieved the sales growth of more than 10% per year by providing competitive products in the leading-edge of semiconductor material field. Through this acquisition, Fujifilm will add Wako’s products used in the manufacturing process of semiconductor including detergents, and seeks further growth in electronic materials business.

Industrial Products Business
Fujifilm will utilize its library of two hundred thousand varieties of chemical compounds developed through photographic film business in the laboratory chemicals business. In addition, by capitalizing on its advanced chemical synthesis technology, Fujifilm will develop new high-functional reagents and the next generation products for highly competitive polymerization initiator to expand the chemical business through its global business network.
Since the establishment as an independent company separated from Takeda’s chemicals department in 1922, Wako has developed and manufactured high quality reagents in response to research needs in cutting edge fields. Currently, Wako keeps growing with high profitability by taking advantage of a strong domestic business platform in all of their main business areas of laboratory chemicals, clinical diagnostic reagents and speciality chemicals. Wako’s laboratory chemicals business has expanded with its product development and manufacturing system corresponding to small quantity of diversified products needs and its sales network that covers all of Japan. Wako also provides cell culture medium in the area of regenerative medicines where high market growth is expected. In the clinical diagnostics reagents business, Wako expands the business through the development and sales of competitive equipment and testing agent including chemiluminescent immune system which has the world’s fastest measurement capability. Lastly, Wako develops the speciality chemicals business globally utilizing chemical synthesis technology nurtured in the laboratory chemical manufacturing to develop competitive semiconductor process materials and polymerization initiators for polymer manufacturing.
Fujifilm has formed a capital alliance with Wako since 1960 and currently is the second largest shareholder owning 9.7% of Wako’s common shares. For many years, Wako has been the supplier of color producing reagents for manufacturing of photosensitive materials. Recently, Wako performs not only as a supplier for photosensitive materials, but also as a supplier for various products such as highly functional materials including semiconductor materials, and Fujifilm and Wako are strengthening their business relationship. Fujifilm has expanded its businesses to the new areas of cosmetics, supplements, pharmaceutical and regenerative medicine with advanced chemical synthesis technology, nanotechnology, diagnostic imaging technology, engineering technology for highly functional materials including collagen and production technology that allows high level of quality management that have been cultivated through research and development of photographic film business.
Out of the six key business areas in the Fujifilm group (healthcare, highly functional materials, documents business, graphic systems, optical devices and digital imaging), Fujifilm has been concentrating its management resources on healthcare, highly functional materials and documents businesses, where high growth is expected. Through synergies to be created with Wako, Fujifilm will expand the growth in healthcare and highly functional materials businesses by providing and offering competitive new products.

1. Overview of Tender Offer
(1) Tender Offeror
FUJIFILM Corporation
(2) Target Company
Wako Pure Chemical Industries, Ltd.
(3) Class of Shares to Be Acquired
Common Stock
(4) Tender Offer Price
JPY 8,535 per share
(5) Expected Amount of Funds
Necessary for the Tender Offer
Approximately JPY 154.7billion
(6) Tender Offer Period
from February 27, 2017 to April 3, 2017 (expected)

2. Overview of Wako
(1) Company Name
Wako Pure Chemical Industries, Ltd.
(2) Incorporation
in 1922
(3) Headquarters
Osaka, Japan
(4) Representative
President Shinzo Kobatake
(5) Capital
JPY 2,340 million
(6) Revenue
JPY 79.4 billion (FY2016/3, consolidated)
(7) Employee Number
1,642 employees (as of March 31, 2016, consolidated)
(8) Business Overview
Manufacturing and sales of laboratory chemicals, clinical diagnostic reagents and speciality chemicals

3. Impact on FUJIFILM Holdings Consolidated Financial Results
In the event of successful completion of the Tender Offer, Wako will be a consolidated subsidiary of Fujifilm Holdings on April 21, 2017. We expect no impact on Fujifilm Holdings’ FY2017/3 consolidated financial results. We will announce the impact for FY2018/3 consolidated financial results once details are confirmed.

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On December 14, 2016 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2016 fourth quarter and year ended September 30, 2016 (Press release, Arrowhead Research Corporation, DEC 14, 2016, View Source [SID1234517070]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and enter Conference ID 33791749.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 404-537-3406 and enter Conference ID 33791749.

Selected Fiscal 2016 and Recent Events

Discontinued development of ARC-520, ARC-521, and ARC-AAT in November 2016
The Company announced that it would be discontinuing these clinical programs, which utilized the intravenously administered DPCivTM, or EX1, delivery vehicle, and redeploying its resources and focus toward utilizing the Company’s new proprietary subcutaneous and extra-hepatic delivery systems
The decision to discontinue development of EX1-containing programs was based primarily on two factors:
During ongoing discussions with regulatory agencies and outside experts, it became apparent that there would be substantial delays in all clinical programs that utilize EX1, while the Company further explored the cause of deaths in a non-clinical toxicology study in non-human primates exploring doses of EX1 higher than those planned to be used in humans
The Company has made substantial advances in RNA chemistry and targeting resulting in large potency gains for subcutaneous administered and extra-hepatic RNAi-based development programs
Because of the discontinuation of its existing clinical programs, the Company also reduced its workforce by approximately 30%, while maintaining resources necessary to support current and potential partner-based programs and the Company’s pipeline
Entered into two collaboration and license agreements with Amgen
Total deal value of up to $673.5 million
Arrowhead received $56.5 million upfront:
$35 million in upfront cash payments, $21.5 million equity investment
Up to low double-digit royalties for ARO-LPA and single-digit royalties for the undisclosed target, ARO- AMG1
Amgen receives:
Exclusive license to ARO-LPA program
Option for an additional candidate against an undisclosed target, ARO- AMG1
Amgen will be wholly responsible for funding and conducting all clinical development and commercialization
Continued progress on preclinical candidates including ARO-HBV, ARO-AAT, ARO-F12, ARO-LPA, and ARO-HIF2
Regarding ARO-F12 and ARO-LPA:
Presented preclinical data at the American Heart Association’s Scientific Sessions 2016 for two development programs using Arrowhead’s proprietary subcutaneous delivery platform:
RNAi triggers against Factor 12 (F12) showed dose dependent reductions in serum F12
A statistically significant reduction (p=0.002) in thrombus weight was observed at greater than 95% F12 knockdown in a rat arterio-venous shunt model
There was no increased bleeding risk in ARO- F12-treated mice, even with greater than 99% knockdown of F12 levels
RNAi triggers against Lipoprotein (a) [Lp(a)] led to greater than 98% maximum knockdown after a single 3 mg/kg SQ dose in Transgenic mice
In an atherosclerosis model, data suggest that RNAi triggers can be effectively delivered to a fatty liver using the subcutaneous delivery platform
Regarding ARO-HIF2
Presented preclinical data showing that ARO-HIF2 inhibited renal cell carcinoma growth and promoted tumor cell death in its preclinical studies
Strengthened the Company’s balance sheet with August 2016 private offering and Amgen agreement upfront payments
In August 2016, the Company sold 7.6 million shares of Common Stock to certain institutional investors and received net proceeds of approximately $43.2 million
As part of the collaboration and license agreements as well as a Common Stock Purchase Agreement with Amgen, $14 million of the total $56.5 million upfront cash payments and equity investments were received in September 2016, and the remaining $42.5 million was received in November 2016
Continued progress on former drug candidates prior to the discontinuations
Presented preclinical and clinical data on former drug candidate ARC-AAT at the Liver Meeting
In a first-in-human clinical study, ARC-AAT was well tolerated and induced deep and durable reduction of the target AAT protein
The preclinical data suggest a possible improvement of liver health and arrest of further damage from treatment with ARC-AAT
Advanced former drug candidate ARC-521 into a Phase 1/2 study
Conducted multiple dose and combination studies of former drug candidate ARC-520
Selected Fiscal 2016 Year End Financial Results

ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED FINANCIAL INFORMATION

Year Ended September 30
OPERATING SUMMARY
2016 2015

REVENUE $ 158,333 $ 382,000
OPERATING EXPENSES
Research and development 41,454,452 47,267,361
Acquired in-process research and development - 10,142,786
Salaries and payroll-related costs 19,461,656 16,554,008
General and administrative expenses 9,940,737 7,931,184
Stock-based compensation 11,595,816 10,232,897
Depreciation and amortization 3,260,045 2,336,207
Impairment expense 2,050,817 -
Contingent consideration – fair value adjustments (5,862,464 ) 1,891,533
TOTAL OPERATING EXPENSES 81,901,059 96,355,976
OPERATING LOSS (81,742,726 ) (95,973,976 )
OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES 19,724 4,033,094
NET LOSS $ (81,723,002 ) $ (91,940,882 )

EARNINGS PER SHARE (BASIC AND DILUTED): $ (1.34 ) $ (1.60 )
WEIGHTED AVERAGE SHARES OUTSTANDING 61,050,880 57,358,442

FINANCIAL POSITION SUMMARY
September 30,
2016 2015
CASH AND CASH EQUIVALENTS 85,366,448 81,214,354
SHORT-TERM INVESTMENTS - 17,539,902
TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) 85,366,448 98,754,256
OTHER ASSETS 42,810,057 33,513,658
TOTAL ASSETS 128,176,505 132,267,914
TOTAL LIABILITIES 33,152,246 22,646,280
TOTAL STOCKHOLDERS’ EQUITY 95,024,259 109,621,634
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY 128,176,505 132,267,914

SHARES OUTSTANDING 69,746,685 59,544,677
PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) 72,417,675 62,215,667

On December 14, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused clinical stage biotechnology company, reported that the United States Patent and Trademark Office ("USPTO") has issued patent allowances covering method of use for radiotherapy with the company’s lead compound, CLR 131, as well as CLR 125, another of the company’s pipeline products using its proprietary phospholipid drug conjugate ("PDC") to deliver a radio therapeutic (Filing, 8-K, Cellectar Biosciences, DEC 14, 2016, View Source [SID1234517072]).

The allowance covers radiotherapy applications for a broad range of solid tumors, specifically: lung, adrenal, intestinal, colon, colorectal, ovarian, cervical, prostate, liver, breast, subcutaneous and pancreatic cancers, as well as melanoma, retinoblastoma, glioma, carcinosarcoma, squamous cell carcinoma and hepatocellular carcinoma. These claims are a continuation of US Patent No. 8,877,159, which provides patent protection into 2025.

"This patent allowance further expands the intellectual property protection of our lead radiotherapeutic candidate beyond the hematologic cancers we are currently researching," said Jim Caruso, president and CEO of Cellectar. "The expanded patent estate provides us and any potential partners with the option to advance CLR 131 clinical development into a wide variety of solid tumor applications."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

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On December 14, 2016 Genocea Biosciences, Inc. (NASDAQ:GNCA), a company developing T cell-directed vaccines and immunotherapies reported that it held its first R&D day for investors and analysts today (Press release, Genocea Biosciences, DEC 14, 2016, View Source [SID1234517075]). The company highlighted its lead program, GEN-003, a T cell-directed immunotherapy for the treatment of genital herpes infections for which six-month Phase 2b placebo-controlled clinical efficacy is expected in January 2017. The Company also introduced its immuno-oncology strategy, including its plans to file an IND for a neoantigen cancer vaccine in 2017 and announced new research collaborations with Checkmate Pharmaceuticals, Inc. (Checkmate) and US Oncology Research.

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"Genocea is a leader in the development of innovative therapies at the forefront of the T cell revolution with GEN-003 for genital herpes and our emerging work in immuno-oncology," said Chip Clark, president and chief executive officer of Genocea. "We believe that ATLASTM, our T cell antigen discovery platform, that is the basis of our clinical success to date in infectious diseases, is ideally suited to advance the understanding of the role T cells play in killing cancer. Our confidence in our immuno-oncology programs is strengthened by the collaborations we announced today, which reflect broad interest in our unique ability to comprehensively profile a person’s actual T cell responses to cancer."

GEN-003 Program Highlights

Today, Genocea highlighted the significant body of clinical data it has generated over the course of three clinical trials for what may be the first new therapy for genital herpes in more than 20 years. GEN-003 is a first-in-class T cell-directed immunotherapy designed to elicit both a T cell and B cell immune response to antigens prioritized using the ATLAS platform. Genocea’s ATLAS platform profiled the comprehensive spectrum of actual T cell responses mounted by humans in response to their genital herpes disease to identify the antigen targets that drove protective T cell responses.

Based on clinical data to date, as well as market research showing the significant dissatisfaction among patients with current treatment options for genital herpes, GEN-003 may offer patients an important new treatment option with the promise of improved ‘real-world’ clinical outcomes and sustained reductions in viral shedding with the convenience of annual maintenance dosing. The Company expects to report six-month clinical efficacy data from its ongoing Phase 2b placebo-controlled trial in January 2017.

Guest speaker Nicholas Van Wagoner, M.D., Ph.D., Assistant Professor, Division of Infectious Diseases at the University of Alabama, Birmingham , School of Medicine provided an overview of the disease and reviewed the current treatment approach for genital herpes and affirmed his belief that a product with the profile of GEN-003 could create a much-needed additional treatment option for patients and physicians.

Genocea also today for the first time presented the results of extensive new market research based on GEN-003’s demonstrated clinical profile, suggesting that patients, physicians and payers all view GEN-003 favorably. Mr. Clark presented data demonstrating the Company’s belief that GEN-003 could have upwards of $2 billion global revenue potential if successfully developed worldwide.

Immuno-Oncology Program Highlights

Guest speaker Charles G. Drake, M.D., Ph.D., Director of GU Medical Oncology, Co-Director: Immunotherapy Program, Associate Director for Clinical Research, and Professor of Oncology and Immunology at the Herbert Irving Cancer Center at Columbia University, provided an overview of immunotherapy in cancer. His presentation reviewed the progress made in treating cancer with checkpoint inhibitors and the opportunity to further improve clinical outcomes, including through a better understanding of which patients will benefit from existing therapies and combining checkpoint inhibitors with cancer vaccines.

A Genocea presentation followed, introducing its immuno-oncology strategy and highlighting the unique ability of its ATLAS platform to comprehensively elucidate the T cell responses that patients make to cancers.

This capability is currently being applied to profiling T cell responses of patients who are treated with checkpoint inhibitors and other immune modulators, with the goal of finding signatures of T cell response that associate with positive and negative outcomes. Genocea plans to use these insights to help prospectively define, in a commercial or clinical setting, patients who could benefit from these therapies.

Genocea is also advancing a personalized neoantigen cancer vaccine program toward the filing of an Investigational New Drug (IND) application in 2017. This program leverages Genocea’s deep vaccinology experience along with ATLAS’s differentiated ability to select vaccine antigens based on an individual’s comprehensive T cell responses to the mutations in their own cancer. The company believes that ATLAS overcomes the weaknesses of conventional algorithm approaches to cancer antigen selection, which have significant false positive prediction rates.

The company also updated progress on the development of a vaccine for cancers associated with Epstein Barr Virus (EBV). ATLAS screening has already identified novel T cell antigens, including those which appear to be associated with natural immunity against EBV infection and antigen selection and prioritization is ongoing.

Collaboration with Checkmate Pharmaceuticals, Inc.

This morning, the Company announced a research collaboration with Checkmate to characterize patterns of T cell responses to tumor-associated antigens in advanced melanoma. The goal of the collaboration is to identify the specificity and characteristics of T cells associated with protective T cell responses to potentially optimize clinical development and ultimately, clinical practice with CMP-001. ATLAS will be used to profile the T cell responses of approximately 20 patients enrolled in Checkmate’s ongoing Phase 1b clinical trial of CMP-001 in combination with the checkpoint inhibitor pembrolizumab to a library of tumor-associated antigens common to patients with advanced melanoma. The T cell response signatures of those patients who respond to CMP-001 / pembrolizumab combination therapy will be compared to the signatures of those who do not respond, thereby potentially identifying antigens associated with positive or negative patient outcomes.

Collaboration with US Oncology Research

Genocea also announced this morning a new collaboration with US Oncology Research, one of the USA’s largest research programs specializing in oncology clinical trials, to screen the T cell responses of cancer patients with solid tumors who will be treated with checkpoint inhibitors against the complete repertoire of patient-specific putative cancer neoantigens. The objective of the collaboration is to use ATLAS to further Genocea’s expertise in identifying signatures of T cell responses in cancer patients and to discover new T cell cancer vaccine antigens.

R&D Day Replay

A replay of the R&D day can be accessed at: View Source

About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system designed to find targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or cancer in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.