On November 18, 2019 FUJIFILM Corporation (President: Kenji Sukeno) reported the start of a U.S. Phase I clinical trial of FF-10850, an anti-cancer agent targeting advanced solid tumors (Press release, Fujifilm, NOV 18, 2019, View Source [SID1234551417]). FF-10850 is a liposome-based agent in which topotecan*1, an approved anti-cancer agent, has been encapsulated in the newly developed liposome. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FF-10850.

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As a drug delivery system (DDS), liposomes are artificially constructed vesicles made from the organic phospholipids which make up cellular membranes and biomembranes. Liposomes can deliver the required amount of a drug to the specific area of the body on predetermined schedule. Anti-cancer agents can act on normal cells, in addition to cancer which can induce strong adverse reactions. By encapsulating a drug in liposomes it is expected to selectively deliver the drug to cancer cells, suppress adverse reactions, and improve pharmacological efficacy.

FF-10850 is a liposome formulation with the purpose of delivering anti-cancer agent to cancerous cells, with the aim of reducing bone marrow suppression*2 and other adverse reactions of topotecan indicated for the treatment of ovarian cancer, etc., and to improve pharmacological efficacy. In the past, liposome encapsulation of topotecan was ineffective because the drug would leak from the liposome prior to reaching the cancerous area. By adding new materials to liposome ingredients and enhancing the strength of the liposome membrane, Fujifilm solved the challenges associated with drug delivery and in preclinical studies it successfully encapsulated topotecan in a stable manner for FF-10850.

Preclinical studies of FF-10850 in mice have shown stable encapsulation of Topotecan in the blood and reduced bone marrow suppression when compared with using Topotecan alone. The study also showed improved efficacy of FF-10850 (3 mg/m2) when compared to Topotecan (30 mg/m2) alone – demonstrating that FF-10850 can have the equivalent effect of Topetcan at just 1/10th the dose. Furthermore, the study showed that FF-10850 (8 mg/m2) demonstrated tumor regression.

Fujifilm has actively promoted the research and development of liposome formulations by harnessing its advanced nano-dispersion technology, analysis technology, and process technology cultivated and evolved through its wide range of product development. In 2017, the company began a U.S. Phase I clinical trial of FF-10832, a liposome-based agent that encapsulates the approved anti-cancer agent gemcitabine*3.

In the preclinical mice studies on FF-10850 and FF-10832*4 Fujifilm has observed the extension of the survival period as a result of immune checkpoint inhibitor*5 combination therapy. In addition, Fujifilm has been promoting the application of liposome for use with next-generation drugs such as nucleic acid drugs and gene therapy drugs. Looking towards future growth, in order to ensure a stable supply of high-quality liposome formulations, Fujifilm is developing a manufacturing facility for producing investigational and commercial drugs through its subsidiary, FUJIFILM Toyama Chemical Co., Ltd. The facility is planned to begin operations in February 2020.

Fujifilm is harnessing its unique technologies to undertake the development of new drugs in the priority areas including oncology. The company is also focusing on developing DDS technologies to create new value and contributing to the resolution of social issues.

*1: An anti-cancer agent (generic name: topotecan, product name: Hycamtin) developed by GlaxoSmithKline plc. Currently, the drug is being sold by Novartis. It is used as a treatment for ovarian cancer, small-cell lung cancer, cervical cancer, etc.

*2: Because of the adverse reaction of anti-cancer agents, the functions of bone marrow are suppressed, and the production of white blood cells, platelets, and red blood cells is reduced, leading to increased risk of infection, bleeding and anemia. With topotecan, severe bone marrow suppression is seen in over 80% of the patients.

*3: An anti-cancer drug (generic name: gemcitabine, product name: Gemzar) developed by Eli Lilly and Company. It is used as the first-line drug for the treatment of pancreatic cancer, and is also indicated for the treatment of a wide range of other cancers (such as lung cancer and ovarian cancer).

*4: The results on preclinical studies on FF-10850 and FF-10832 were presented at 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) SYMPOSIUM

*5: A general term for drugs that demonstrate an efficacy by enabling immune cells to attack cancer cells by inhibiting the immune suppressive mechanisms (immune checkpoints). They are widely used in the treatment of malignant melanomas, lung cancer, stomach cancer, kidney cancer, etc.

On November 18, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that Forbius management will present a company overview at the Jefferies 2019 Healthcare Conference on Thursday, November 21, 2019 at 07:20 a.m. GMT in London (Press release, Forbius, NOV 18, 2019, View Source [SID1234551416]).

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On November 18, 2019 GenScript Biologics, a world leading bio-pharmaceutical CDMO company, reported that it entered into an agreement with ABL Bio Inc., a South Korean biotech company dedicated to therapeutics for immuno-oncology and neurodegenerative diseases (Press release, GenScript, NOV 18, 2019, View Source;genscript-biotech-corp-bispecific-antibody-strategic-partnership-agreement-ceremony-300959738.html [SID1234551415]). The parties have reached a partnership for two bispecific antibody programs.

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According to the license agreement, GenScript will grant a sublicense to ABL Bio to use sdAb (single-domain antibody), mAb (monoclonal antibody) targeting tumor antigens, and its Single-Domain Antibody fused to Monoclonal Ab (SMAB) Platform to develop several bispecific antibody molecules. ABL Bio will appoint GenScript as the exclusive supplier of CDMO services for IND-enabling studies and clinical material manufacturing so as to accelerate the development of the bispecific antibody under the licensing agreement. GenScript will consistently provide support and services for the programs. GenScript will receive an upfront with milestone payments, and royalty. The parties will make full use of their own advantages and resources to further expand ABL Bio’s bispecific antibody development pipelines and strengthen ABL Bio’s global leading position in cancer research.

"We are glad to cooperate with GenScript. GenScript is growing fast in recent years and has facilitated several companies to make achievements in antibody drug research," said Dr. Sang Hoon Lee, CEO of ABL Bio at the signing ceremony, "We expect the outstanding druggability and streamlined production processes of GenScript’s SMAB platform to accelerate the development of novel immunotherapy and the launch of new drugs. This partnership will further expand our bispecific antibody development pipelines, and help us ascend to a leader in therapeutics for immuno-oncology and neurodegenerative diseases."

"We are excited about this collaboration with ABL Bio, an experienced company in the bispecific antibody field, which manifests that GenScript’s biologics R&D services have been increasingly recognized by global well-known enterprises," Dr. Brian Min, CEO of GenScript Biologics, said, "GenScript has extensive experience and powerful teams in biologics R&D. We would like to cooperate with more well-positioned enterprises like ABL Bio, utilize our own powerful R&D advantages, and accelerate the development of novel antibody drugs."

On November 18, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 43,620,690 shares of its common stock, including 5,689,655 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares (Press release, BioCryst Pharmaceuticals, NOV 18, 2019, View Source [SID1234551414]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $63.3 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst.

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BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVAB/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

J.P. Morgan acted as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. acted as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

On November 18, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc (Press release, AbbVie, NOV 18, 2019, View Source [SID1234551412]). ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes. AbbVie hereby extends such expiration date from 11:59 p.m., New York City time, on November 22, 2019 to 5:00 p.m., New York City time, on December 31, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition, which is expected to occur in early 2020. As a result, the Expiration Date may be further extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on November 15, 2019, the principal amounts of Allergan Notes set forth in the table below were validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Allergan Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or not a "U.S. person" and outside the United States within the meaning of Regulation S under the Securities Act. Except as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Documents, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the Offering Documents and only to such persons and in such jurisdictions as are permitted under applicable law.

The AbbVie Notes offered in the Exchange Offers have not been registered under the Securities Act or any state securities laws. Therefore, the AbbVie Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws.