AbbVie Announces Extension of Expiration Date for Exchange Offers for Allergan Notes

On April 6, 2020 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. ("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 5:00 p.m., New York City time, on April 10, 2020 to 5:00 p.m., New York City time, on April 24, 2020 (as the same may be further extended, the "Expiration Date") (Press release, AbbVie, APR 6, 2020, View Source [SID1234556141]).

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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 by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020, March 9, 2020 and March 23, 2020 and 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. 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.

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 by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020, March 9, 2020 and March 23, 2020 and 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.

Evotec and Takeda enter into multi-year gene therapy research alliance

On April 6, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that Evotec GT, with operations in Austria, has established a long-term research alliance with Takeda to support Takeda’s growing number of research stage gene therapy discovery programmes (Press release, Evotec, APR 6, 2020, View Source;announcements/press-releases/p/evotec-and-takeda-enter-into-multi-year-gene-therapy-research-alliance-5925 [SID1234556136]).

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Evotec GT is an integral part of Evotec’s integrated fully modality-agnostic drug discovery platform that combines all activities involved with the discovery, development, and manufacturing of therapeutics along the value chain.

Under the alliance, Evotec will support multiple Takeda programmes targeting conditions aligned with Takeda’s four core therapeutic areas: Oncology, Rare Diseases, Neuroscience and Gastroenterology. The alliance leverages Evotec’s growing gene therapy capabilities as well as Evotec’s broader drug discovery platform.

Dr Steven Hitchcock, Global Head of Research for Takeda, said: "We are excited to be broadening and expanding our discovery efforts with the Evotec team. Gene therapy is a growing therapeutic approach in our portfolio and this alliance with Evotec will help us further accelerate our delivery of transformative therapies for patients, particularly those with rare diseases."

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: "We’re pleased to expand the scope of our collaboration with Takeda into gene therapy by establishing an alliance with Takeda. This new alliance demonstrates the value of our multimodality platform with innovative technologies and best-in-class execution for addressing the most urgent requirements of our partners. Relationships like this will transform industry’s approach to drug discovery and development to ultimately find new therapies."

No financial details of the agreement were disclosed.

Entry into a Material Definitive Agreement

On April 5, 2020, Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") and Sanofi Biotechnology SAS ("Sanofi") reported that it has entered into the Third Amendment to Amended and Restated License and Collaboration Agreement (the "Third Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and between the Company and Sanofi (as successor in interest to Aventis Pharmaceuticals Inc. and Sanofi-Aventis Amérique Du Nord), as amended (the "Antibody LCA") (Filing, 8-K, Regeneron, APR 5, 2020, View Source [SID1234556163]). The Antibody LCA provides for the development, manufacture, and commercialization of certain antibody products, including, prior to April 1, 2020 (and prior to giving effect to the Third Amendment), Praluent (alirocumab). On April 5, 2020, the Company and Sanofi also entered into the Praluent Cross License & Commercialization Agreement (the "Praluent Agreement" and, together with the Third Amendment, collectively, the "Agreements"). The Agreements are each effective from and after April 1, 2020. As described in greater detail below, the Agreements together effect the previously announced restructuring of the parties’ antibody collaboration in respect of Praluent.

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Third Amendment. Under the Third Amendment, Sanofi and the Company amended the Antibody LCA, among other things, to remove Praluent from the Antibody LCA such that (a) effective April 1, 2020, the Antibody LCA no longer governs the development, manufacture, or commercialization of Praluent and (b) the quarterly period ended March 31, 2020 is the last quarter for which Sanofi and the Company will share profits and losses for Praluent under the Antibody LCA. Notwithstanding the foregoing, net product sales of Praluent outside the United States will continue to be taken into account to determine (x) each party’s percentage share of profits and losses outside the United States from the products that continue, from and after April 1, 2020, to be governed by the Antibody LCA and (y) the milestones applicable to net product sales outside the United States under the Antibody LCA.

Praluent Agreement. Under the Praluent Agreement, effective April 1, 2020, the Company, at its sole cost, is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States. Each of the Company and Sanofi will obtain an exclusive license under certain intellectual property rights of the other party to commercialize Praluent in the United States and outside the United States, respectively. Because before April 1, 2020 Sanofi was, under the Antibody LCA, responsible for commercializing Praluent in the United States, Sanofi will transfer to the Company certain assets relating to the commercialization of Praluent in the United States.

Sanofi will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032. The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period (a) the Company will continue to supply drug substance to Sanofi and (b) Sanofi will continue to supply finished product to Regeneron.

With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020. The parties will each bear 50% of any damages arising out of Praluent sales or other activities prior to April 1, 2020. If Sanofi is obligated to pay any third-party royalties on Praluent sales outside the United States after April 1, 2020 as a result of certain patent litigation proceedings, then Sanofi will have the right to set off 50% of such third-party royalty payments against up to 50% of any Praluent royalty payment owed to Regeneron.

The foregoing description of the Third Amendment and the Praluent Agreement is qualified in its entirety by reference to the full text of the Third Amendment and the Praluent Agreement, respectively, a copy of each of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending June 30, 2020.

Samsung Biologics enters into a development and manufacturing partnership with PharmAbcine for oncology and neovascular treatment

On April 5, 2020 Samsung Biologics (207940.KS) reported that it has entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders (Press release, Samsung Bioepis, APR 5, 2020, View Source [SID1234556134]). Under this agreement, Samsung will provide the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing to IND filing support.

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PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease. Olinvacimab, the company’s lead molecule, is currently in phase II clinical trials for a combination therapy to treat cancer with Merck’s Keytruda.

According to PharmAbcine, PMC-402 is expected to enhance the delivery of immune cells and cancer therapeutics to treat tumor cells via active normalization of leaky blood vessels. Attributable to its vessel normalization characteristics, PharmAbcine plans to expand the indication to eye diseases such as wAMD (wet age-related macular degeneration) and DR (diabetic retinopathy).

"The anti-cancer effect of PMC-402, both as a monotherapy and a combination therapy with immuno-cancer drugs, was confirmed through initial research. From this year, we will test the safety of PMC-402 and initiate phase I clinical trial by 2021 through collaboration with Samsung Biologics," said Jin-San Yoo, CEO of PharmAbcine.

"Offering full range of services in development, manufacturing, and laboratory testing from our state-of-the-art facilities, Samsung Biologics works intimately with our clients to reach IND and market Faster & Better," said Tae-Han Kim, CEO of Samsung Biologics. He added, "Through partnership with Samsung Biologics, biotech companies can not only benefit from fast timeline and high-quality products, but also concentrate on discovery activity, a core aspect of their business."

Samsung Biologics has played a significant role in the global biopharma landscape by establishing a global scale bio-ecosystem for biotech companies. With the announced opening of its US CDO R&D center in San Francisco later this year, Samsung expects to support more clients around the globe with maximum client satisfaction.

Dilon Technologies® Inc. acquires the DuneMedical’s MarginProbe®

On April 3, 2020 Dilon Technologies Inc., a world class global leader in breast cancer treatment and diagnosis and owner of the Navigator Gamma Probes reported that it has acquired substantially all the assets of Dune Medical, including Marginprobe’s "MarginProbe" (Press release, Dune Medical Devices, APR 3, 2020, View Source [SID1234560783]).

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"With the acquisition of the MarginProbe, Dilon will now offer the only FDA approved device for identifying positive margins during breast conservation surgery. MarginProbe’s patented RF technology differentiates cancerous versus healthy tissue in real-time. This allows surgeons to immediately remove additional tissue, helping to reduce avoidable surgeries" said Dilon’s Chairman, Bob Moussa, who continued, "The synergy between Dilon’s Navigator Gamma Probes and the MarginProbe will help patients and physicians answer the question, "did we get it all?" when that answer is most needed. In addition to the advantages to the patients, the reduction in re-excision rate will provide major savings to health care systems."

As a global provider of breast cancer solutions, Dilon’s Navigator Gamma Probes are used for radio-guided lymphatic mapping and tumor localization world-wide. "The combination of Dilon’s class leading Navigator Gamma Probes with the MarginProbe is a natural fit. Dilon’s already strong sales network is synergistic and well suited to expand the MarginProbe’s potential as the products are literally used side by side by the same physician; now they will be sold that way as well. The market in the United States alone exceeds $150m annually, and as a US based company, Dilon has a home field advantage in the MarginProbe’s biggest market. Luminaries and thought leaders have already adopted MarginProbe as their standard of care in the US. Our goal is to make MarginProbe the standard of care worldwide."