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.

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.

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.

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."

On April 3, 2020 venBio Partners LLC reported the closing of venBio Global Strategic Fund III ("venBio Fund III"), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise (Press release, Venbio Partners, APR 3, 2020, View Source [SID1234556205]). The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

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Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., and Aaron Royston, M.D., venBio Fund III will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team typically leads or co-leads investments and takes an active role with each of their portfolio companies.

"We are grateful for the tremendous support we have received from our current investors during this fundraise," said Dr. Adelman. "We appreciate their ongoing commitment and welcome the broad range of new top-tier investors who have joined them."

"We remain committed to our founding strategy at venBio, namely to turn great science into impactful medicine," said Dr. Goodman. "Our investment thesis, regardless of stage of company, remains to look for investment opportunities with a 3- to 5-year time horizon."

"In addition to generating strong financial returns, we’re proud of the impact our portfolio companies have made on patients," said Dr. Royston. "We’ve actively helped build three companies that have developed approved drugs that are on the market today."

In conjunction with the new fund, venBio has promoted Richard Gaster M.D., Ph.D., to Partner. Dr. Gaster was previously head of translational medicine at Pliant Therapeutics and a Senior Associate at Third Rock Ventures. Prior to Third Rock, he was a resident physician in Harvard’s Plastic and Reconstructive Surgery Program and received his M.D. and Ph.D. degrees from Stanford University in the Medical Scientist Training Program.