On Dec 15, 2016 Progenra, Inc. announced a new immune-oncology drug whose mechanism differs from available cancer immunotherapies Opdivo and Keytruda (Press release, Progenra, DEC 15, 2016, View Source [SID1234517432]). The findings, published by Progenra with Dr. Wayne Hancock, University of Pennsylvania School of Medicine, support a new immune-oncology antitumor strategy by inhibiting USP7, an enzyme that prevents immune activity against cancer in addition to supporting the growth of cancer cells . According to a commentary on this publication, inhibiting USP7 works on T cells to diminish immunosuppression, permitting the patient’s own immune system to eliminate cancer ("the data by Wang and colleagues proposes a potential immunotherapy against tumors by targeting USP7, which … breaks the immune tolerance in the tumor microenvironment"… "these preclinical findings suggest that USP7 targeting … as well as directly induce tumor cell apoptosis, could have practical significance in clinical applications").

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"We are pleased that Progenra’s unique UbiPro Drug Discovery Platform is gaining traction outside the US and that a major pharmaceutical company such as Ono has agreed to collaborate with Progenra on the ubiquitin and ubiquitin-like protein pathways"

"We are pleased that Progenra’s USP7 inhibitors, tested in several laboratories worldwide, can eradicate cancers by both tumoricidal and immunological mechanisms," said Tauseef Butt, President of Progenra. "We are excited to move USP7 inhibitors into clinical trial as single agents or combined with marketed immunological agents such as Opdivo and Keytruda."

Dr. Hancock added," Immunotherapy must do more than affect a single target, since those approaches help only about 20% of patients. Pharmacologic inhibition of USP7 allows direct targeting through the immune system, in a graded manner that has antitumor efficacy used alone or combined with one or more biologic agents.".

Progenra (www.progenra.com) aims to develop high value medicines exploiting protein regulatory pathways. Its early product portfolio addresses unmet needs in cancer, inflammation, and neurodegeneration. Utilizing its drug discovery platform, Progenra identifies novel modulators of its protein regulatory targets for drug development; the company’s discovery platform is complemented by internal target validation, cell proof of concept, and medicinal chemistry.

Dr. Wayne Hancock is Professor of Pathology/Laboratory Medicine at The University of Pennsylvania School of Medicine and Chief, Division of Transplant Immunology at the Children’s Hospital of Philadelphia. His multidisciplinary team focuses on improving outcomes of organ transplantation and cancer immunotherapy by modulating immune cell production and function.

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.

On December 15, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has submitted its pre-Investigational New Drug (pre-IND) meeting package to the U.S. Food and Drug Administration (FDA) for PharmaCyte’s therapy in inoperable locally advanced pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, DEC 15, 2016, View Source [SID1234517091]). PharmaCyte’s pre-IND submission follows its recent announcement that the FDA has granted PharmaCyte a pre-IND meeting for its pancreatic cancer therapy.

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The package provides the FDA with a full history of PharmaCyte’s therapy, including information on the previous preclinical studies and the clinical trials that were performed using the Cell-in-a-Box live-cell encapsulation technology combined with low doses of the chemotherapy drug ifosfamide. That combination makes up PharmaCyte’s pancreatic cancer therapy. The package also provides detailed information on the manufacturing process used to produce the Cell-in-a-Box capsules and a synopsis of the structure of the clinical trial that PharmaCyte plans to conduct in the U.S. and Europe in patients with inoperable LAPC.

The FDA’s response to the pre-IND submission will be provided after the pre-IND meeting. The regulatory agency’s response will serve as a roadmap in guiding PharmaCyte as it prepares the full IND application that must be deemed acceptable to the FDA before the clinical trial can begin.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "The submission of the pre-IND package is yet another major step that PharmaCyte has completed in its efforts to develop its pancreatic cancer therapy. We are looking forward to the pre-IND meeting and the FDA’s guidance as we prepare for our clinical trial in patients with inoperable LAPC where there is an unmet medical need we plan to address."

On December 15, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported the successful closing of the acquisition of 100% shares in Cyprotex PLC ("Cyprotex", AIM: CRX-GB), a specialist pre-clinical contract research organisation in ADME-Tox and DMPK headquartered in the UK (Press release, Evotec, DEC 15, 2016, View Source [SID1234517081]). The proposed acquisition was announced in detail on 26 October 2016.

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Following a scheme of arrangement regulated by the UK takeover code, all shares of Cyprotex have been acquired by and transferred to Evotec AG effective 14 December 2016 and the shares will this morning be cancelled from AIM. Evotec is paying £ 55.7 m (EUR 66.3 m; at an assumed £/EUR exchange rate of 1.19) in cash for the acquisition of all 26.1 million issued and to be issued Cyprotex shares and the funding of company debt mainly in the context of loan notes. The offer of 1.60 £ per Cyprotex share reflects a 9.4% premium to the VWAP of the past 30 trading days at AIM prior to the offer on 26 October 2016. MCF Corporate Finance, led by Ian Henderson, acted as Evotec’s exclusive financial adviser throughout the acquisition process.

Cyprotex, headquartered in the UK, was founded in 1999 and is publicly traded on AIM (CRX). The company currently has 136 employees working from sites at Macclesfield and Alderley Park, both of which are located near Manchester in the UK, and at Watertown, MA, and Kalamazoo, MI, in the USA. Cyprotex will continue to operate and serve its loyal client base in all currently existing segments under its brand name "Cyprotex" whilst employees and capabilities will be integrated into Evotec’s global drug discovery group, thereby leveraging both companies’ extensive partner networks and identifying further commercial synergies.

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: "We are pleased the acquisition has closed and we can now approach the exciting phase of welcoming Cyprotex’ employees and clients to our global drug discovery services platform. The addition of the market’s most industrialised ADME-Tox platform and proven expertise in in vitro ADME screening, mechanistic and high-content toxicology screening and predictive modelling to our offering substantially improves our ability to provide our alliance partners with access to the most comprehensive drug discovery platform. Cyprotex’ proven technology platform and its expert and dedicated employees perfectly augment Evotec’s business strategy and offering."

Dr Werner Lanthaler, Chief Executive Officer of Evotec, added: "The highest quality and completeness of our drug discovery platform is key to improve the efficiency in the process for our partners. With Cyprotex we make here an important next step. We warmly welcome the Cyprotex employees to the Evotec Group and look forward to working with them."

Evotec confirms its liquidity guidance for 2016. The Company expects liquidity to be at a similar level to the prior year, excluding any potential cash outflow for M&A or similar transactions. Based on current estimates, it is expected that the Cyprotex business will add approx. EUR 18-20 m in revenues in 2017 and will be accretive to Evotec’s 2017 EBITDA.

On December 15, 2016 Cancer Research UK, Cancer Research Technology (CRT), and Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported an agreement to trial a first-in-class drug for cancers of high unmet need (Press release, Cancer Research Technology, 15 15, 2016, View Source [SID1234523174]).

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Cancer Research UK’s Centre for Drug Development (CDD) will sponsor and fund a Phase Ia and Phase Ib clinical trial for a drug called BT1718, a Bicycle Drug Conjugate (BDC) being developed by Bicycle Therapeutics, in patients with advanced solid tumours. BT1718 targets Membrane Type 1 Matrix Metalloproteinase (MT1-MTP) which is highly expressed in many solid tumours, including triple negative breast cancer and non-small cell lung cancer.

Dr. Udai Banaji, Principal Investigator for the Phase I trial, said: "I’m very excited to be involved in the first clinical study of BT1718. Based on the impressive pre-clinical data, I look forward to evaluating the clinical utility of BT1718, the first of a new class of agents that specifically targets tumour cells using a bicyclic peptide linked to an anticancer agent."

The trial will be co-managed by Cancer Research UK and Bicycle Therapeutics. Under the terms of the agreement, Bicycle retains the right to further advance the BT1718 programme, and can license the results of the trial for an undisclosed amount split between cash and equity, success based milestones and royalty payments to Cancer Research UK.

Dr Kevin Lee, chief executive officer of Bicycle Therapeutics, said: "Through this important collaboration we aim to advance BT1718 through Phase I trials, generating a robust dataset to drive the programme forward. We’re excited to have developed this innovative relationship with Cancer Research UK that allows us access to their extensive network of collaborators and world class expertise to fully explore the potential of this new and transformative class of treatment for cancer patients."

Dr Nigel Blackburn, Cancer Research UK’s, director of drug development, said: "Finding new ways to target difficult-to-treat cancers is a crucially important area of research and a priority for Cancer Research UK. Through this collaboration, we hope we can speed up the development of therapies for patients who urgently need new treatment options."