Thermo Fisher Scientific to Acquire PPD, Inc., a Leading Clinical Research Organization

On April 15, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher"), the world leader in serving science, and PPD, Inc. (Nasdaq: PPD) ("PPD"), a leading global provider of clinical research services to the pharma and biotech industry, reported that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt (Press release, Thermo Fisher Scientific, APR 15, 2021, View Source [SID1234578068]). This represents a premium of approximately 24% to the unaffected closing price of PPD’s common stock on the Nasdaq as of Tuesday, April 13, 2021, or 32% to the 60-day VWAP inclusive of that date.

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PPD provides a broad range of clinical research and laboratory services to enable customers to accelerate innovation and increase drug development productivity. A leader in the growing $50 billion clinical research services industry, PPD has more than 26,000 colleagues operating in nearly 50 countries. In 2020, the company generated revenue of $4.7 billion. Upon close of the transaction, PPD will become part of Thermo Fisher’s Laboratory Products and Services Segment.

"Pharma and Biotech is our largest and fastest growing end market, and our customers value us as a strategic partner and an industry leader. The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers with important clinical research services and partner with them in new and exciting ways as they move a scientific idea to an approved medicine quickly, reliably and cost effectively," said Marc N. Casper, chairman, president and chief executive officer, Thermo Fisher Scientific. "Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help our customers accelerate innovation and drive productivity, while driving further value for our shareholders."

David Simmons, chairman and chief executive officer, PPD, said, "This is a very exciting announcement for our shareholders and will provide customers with an even better opportunity to bring meaningful innovation to the market faster and more efficiently. Thermo Fisher is a world-class company with a very similar culture and values and will provide a great foundation for our colleagues to continue to deliver for our customers and to develop their own skills and careers."

Casper added, "Both companies have complementary mission-driven cultures, and I can’t wait to welcome PPD’s colleagues from around the world to Thermo Fisher once the transaction is completed."

Benefits of the Transaction

Establishes Thermo Fisher as One of the Global Leaders in the Attractive, High Growth Clinical Research Services Industry

PPD serves a $50 billion industry forecasted to grow long-term in the mid-single digits, driven by scientific breakthroughs, the continued expected robust funding for drug discovery and the need for strategic suppliers for the pharma and biotech industry to help them bring safe and effective medicines to the patients that need them. PPD has invested significantly in its capabilities and is one of the leading global players providing services to both emerging biotech customers and to all of the top pharma companies in the world.

Combination Further Enhances Thermo Fisher’s Value Proposition for Pharma and Biotech Customers by Adding Highly Complementary Services

Thermo Fisher is a leading supplier to the pharma and biotech industry, supporting research and development, clinical trials and production. PPD enhances Thermo Fisher’s offering, bringing a proven drug development platform, excellent patient recruitment capabilities, strong laboratory services and a complementary reputation for excellent quality and service. These combined capabilities further enhance Thermo Fisher’s value proposition to pharma and biotech customers and allow them to more efficiently access these services, which are key enablers of their success.

Creates Meaningful Benefits for Customers

In the near-term, Thermo Fisher’s access to key decision makers in pharma and biotech companies will increase the opportunities for PPD to win additional work from existing and new customers as the pandemic has further highlighted the need for these customers to develop strategic relationships with their key suppliers. The combined company’s extensive capabilities and knowledge in serving the pharma and biotech industry will enable new solutions for customers that create the potential to reduce the time and cost of the drug development process.

Delivers Attractive Financial Benefits

The transaction is expected to be immediately and significantly accretive to Thermo Fisher’s adjusted EPS, adding $1.40 in the first 12 months after close. Thermo Fisher expects to realize total synergies of approximately $125 million by year three following close, consisting of approximately $75 million of cost synergies and approximately $50 million of adjusted operating income benefit from revenue-related synergies.

Approvals and Financing

The transaction, which is expected to be completed by the end of 2021, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals.

In addition to board approval, shareholders holding in aggregate approximately 60% of the issued and outstanding shares of common stock of PPD have approved the transaction by written consent. No further action by other PPD shareholders is required to approve the transaction.

Thermo Fisher has obtained committed bridge financing with respect to a portion of the purchase price. To fund the transaction, Thermo Fisher intends to use proceeds from debt financing and cash on hand.

Advisors

Barclays Capital, Inc. and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Cravath, Swaine & Moore LLP and Arnold & Porter Kaye Scholer LLP are serving as legal counsel. For PPD, J.P. Morgan Securities LLC is serving as exclusive financial advisor, while Simpson, Thacher & Bartlett LLP is serving as legal counsel.

Conference Call and Webcast

Thermo Fisher will host a conference call and webcast at 8:30 a.m. Eastern Time today to provide more information on this announcement. The webcast and accompanying slides can be accessed in the Investors section of www.thermofisher.com. An audio archive of the call will be available in that section of the website until April 29, 2021.

Tectonic Therapeutic Launches with $80 Million Series A Financing to Transform the Discovery of Novel G-Protein Coupled Receptor (GPCR)-Targeted Therapies

On April 15, 2021 Tectonic Therapeutic, a pre-clinical stage biotechnology company transforming the discovery of novel G-protein-coupled receptors (GPCR)-targeted therapies, reported that it has raised $80 million in a Series A financing (Press release, Tectonic Therapeutic, APR 15, 2021, View Source;Targeted-Therapies [SID1234578067]). The financing was co-led by Vida Ventures, T.A. Springer, and Polaris Partners, with participation from EcoR1 Capital .

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Tectonic was co-founded in 2019 by Andrew Kruse, PhD, Professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School and Timothy A. Springer, PhD, Latham Family Professor and Professor of Biological Chemistry and Molecular Pharmacology, Professor of Medicine, Harvard Medical School, world-renowned scientists in the field of membrane protein biochemistry and immunology. Tectonic’s mission is to unlock the full potential of GPCR-targeted therapies with biologics. Dr. Springer, an internationally recognized immunologist and significant investor in the Series A, has founded multiple biotech companies including LeukoSite, Scholar Rock and Morphic Therapeutic, and was a founding investor of Moderna and Editas Medicine. His research enabled the discovery of several important medicines including Campath, Velcade, and Entyvio. Based on the pioneering work from Dr. Kruse’s lab, Tectonic’s proprietary GEODe platform overcomes the challenges encountered to date in the discovery of biologics that modulate GPCR signaling, enabling the advancement of novel GPCR-targeted therapies.

"GPCRs are central to human biology and are the target of approximately 30% of all currently approved drugs," said Dr. Springer. "However, many GPCRs still remain unexplored or are considered ‘undruggable’. The Tectonic platform makes it possible to develop a broad pipeline of biologics against the most challenging receptors in the class. Despite the rich pipeline of approved drugs, these target less than 15% of the GPCR class."

To harness the full potential of their platform, Tectonic has assembled an accomplished management team of industry veterans who have successfully led the development of more than 10 novel drugs across multiple therapeutic areas, including Merck’s blockbuster anti-PD-1 therapy, Keytruda. Alise Reicin, MD, former President of Clinical Development at Celgene, has been appointed as the company’s President and Chief Executive Officer, and a member of the Board of Directors.

"Founded on compelling science, Tectonic is committed to blazing a new trail for GPCR therapy," said Dr. Reicin. "We are pursuing an efficient path to proof of concept in indications of high unmet need supported by strong biology. The team’s expertise and experience offer the potential for expansion to other challenging, and previously undruggable, cell-surface targets. We are excited that our vision is shared by a world-class syndicate of investors who have a deep understanding of the industry and shared passion for delivering an innovative solution to a longstanding problem in drug discovery."

Joining Dr. Reicin are Christian Cortis, PhD, as Chief Operating Officer, Anthony Muslin, MD, as Chief Development Officer, and Marc Schwabish, PhD, as Chief Business Officer.

In addition to Dr. Reicin, the Tectonic Board of Directors includes Terry McGuire, Polaris Partners, who will serve as the company’s Chairman; Stefan Vitorovic, Vida Ventures; Praveen Tipirneni, MD, Morphic Therapeutic, Inc.; Timothy A. Springer, PhD, Harvard; and Andrew Kruse, PhD, Harvard. Tectonic’s experienced, collaborative, and dedicated team is committed to building a leading company that can deliver breakthrough therapeutics.

"Our visionary founders and management team have the ability not only to build on this transforming platform but also to fully capitalize on its potential in a wide array of therapeutic areas," said Terry McGuire, Polaris Partners. "With the expansion of our investor syndicate, and leadership from this exceptional leadership team, Tectonic will be in a position of strength to advance a broad pipeline of first-in-class treatments."

"We believe that Tectonic’s proprietary technology platform has the potential to deliver game-changing results for the treatment of a broad range of indications," said Stefan Vitorovic, Co-Founder and Managing Director, Vida Ventures. "We are impressed by the bold vision of the scientific founders and management team and are thrilled to support Tectonic as they accelerate this science from translational research to patients in need of innovative treatment options."

AltruBio Raises $63 Million Series A Round To Continue Its Company Transformation

On April 15, 2021 AltruBio Inc. ("AltruBio" or "the Company"), a clinical stage biotech company, reported the completion of a $63 million Series A financing round (Press release, AltruBio, APR 15, 2021, View Source [SID1234578066]). The round was led by aMoon with new investors including BVF Partners L.P. (BVF), CAM Capital, and other new and existing investors joining the syndicate.

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AltruBio’s President & CEO, Dr. Judy Chou stated: "We are honored to have this strong group of investors join us, marking our steady growth and transformation into a truly promising biotech company with great chances of creating value for patients and all our stakeholders. The investors’ experience and support will enable the Company to leverage our PSGL-1 immune checkpoint regulator program across multiple indications, realizing our ‘pipeline in a product’ vision, and accelerating our ability to bring solutions to patients in need. The strength of this financing validates the renewal and rebuilding of the Company and further validates our science within the biotech industry."

The Company has successfully executed on a strategic shift over the past year, recruiting a new Board of Directors comprised of internationally recognized biotech industry luminaries with experience across the board in drug development and transitioning the leadership to a new President & CEO, in industry veteran Dr. Judy Chou, who joined the company after leaving Bayer where she was the global head of biotech. Under her leadership, AltruBio has implemented a new focus on its novel PSGL-1 program for immunological diseases, and the Company has now secured the funds to continue advancing the program. Recently, the company has received Fast Track Designation from the FDA for the lead asset neihulizumab (AbGn-168H) in steroid refractory acute graft-versus-host disease (SR-aGVHD).

Dr. Gur Roshwalb, MD, MBA, aMoon’s partner leading the investment added, "We view this as a great opportunity to invest in experienced leadership and unique and proven science. With the backing of an all-star board of directors, Dr. Chou has been taking all the right steps to refocus and lead the company towards a new strategic direction. The PSGL-1 program has the potential to serve as a platform to treat many different T-cell mediated, immunological diseases, offering a new solution to patients without adequate options."

BioLineRx Announces Presentation at 2021 American Association for Cancer Research (AACR) Annual Meeting

On April 15, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, reported that the Company has presented a poster at the AACR (Free AACR Whitepaper) Annual Meeting, which is being held April 10-15 on a virtual basis (Press release, BioLineRx, APR 15, 2021, View Source [SID1234578065])."

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The poster, entitled: "A Multi-Center Phase 2a Trial of the CXCR4 inhibitor Motixafortide (BL-8040) in Combination with Pembrolizumab and Chemotherapy, in Patients with Metastatic Pancreatic Adenocarcinoma, the COMBAT Study," includes new analyses from the Company’s Phase 2a COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer, further detailing the clinical effect of the combination in patients with and without liver metastases.

The COMBAT/KEYNOTE-202 study evaluated BioLineRx’s lead clinical candidate, motixafortide, in combination with KEYTRUDA and chemotherapy in patients with advanced pancreatic ductal adenocarcinoma, or PDAC. Top-line results from the study were announced in December 2020.

"Liver metastases are a critical factor driving poor prognoses for patients with metastatic PDAC," stated Dr. Abi Vainstein, Chief Medical Officer of BioLineRx. "We are very pleased to present this additional analysis, which further strengthens the results reported from the COMBAT/KEYNOTE-202 trial in December 2020, since not only were substantially all patients initially diagnosed with stage 4 disease, but the vast majority (~80%) of the patients had liver metastases, emphasizing the extremely difficult patient population in this study. These data should be further confirmed in a randomized trial, and we continue to work diligently to define next steps for the program with potential collaboration partners."

"We believe these incremental data provide strong support for continued development of motixafortide as the backbone of a new regimen for the treatment of PDAC and will likely prove beneficial as we advance discussions with potential collaboration partners," stated Philip Serlin, Chief Executive Officer of BioLineRx. "At the same time, we are very much looking forward to final data from our Phase 3 GENESIS study in stem cell mobilization in the next few weeks, which we hope will give us a clear pathway to potential registration and highlight the versatility of motixafortide across both hematological and solid tumor cancer types."

A copy of the poster is now available on the Company’s website, www.biolinerx.com.

Bio-Techne Announces Launch of Professional Assay Services – Dedicated Source for RNA in situ Hybridization Assays in Spatial Gene Expression Analysis

On April 15, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that Advanced Cell Diagnostics (ACD), a Bio-Techne brand, completed an extensive rebranding effort in response to increased demand for its Assay Services offered at its Newark, CA laboratory (Press release, Bio-Techne, APR 15, 2021, View Source;dedicated-source-for-rna-in-situ-hybridization-assays-in-spatial-gene-expression-analysis [SID1234578064]). At the heart of this re-launch is a name change from Pharma Assay Services to Professional Assay Services, with an expansion of offerings to global academic and clinical institutions, building on 10 years of experience providing services to our global pharma and biotech partners. Bio-Techne’s Professional Assay Services provide in situ hybridization (ISH) gene expression analysis for target discovery, biomarker validation, drug safety assessment, and assay prototype development directly from the RNAscope technology experts.

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In addition to providing the full line of RNAscope, BaseScope, and miRNAscope ISH assays, our Professional Assay Services also offers tissue procurement and processing, high resolution whole slide scanning, image analysis and digital pathology, as well as custom assay development. We have an expert multi-disciplinary team that includes Ph.D. scientists and M.D.s, who serve our clients as technical experts, image analysis specialists and board-certified pathologists, spanning a broad array of scientific disciplines. With direct access to the developers of the technology, the Assay Services team provides unparalleled expertise in Bio-Techne’s ISH platforms and delivers fast, high quality data designed to meet study objectives and timelines. The projects executed by our team follow Good Clinical Laboratory Practices (GCLP) based on guidelines from the World Health Organization.

"We are excited to announce the rebranding of our award-winning services to "Professional Assay Services", in line with the broadened access, expanding beyond biopharma partners, to include academic, health and clinical institutions," commented Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "As leaders in RNAscope services, our goal is to facilitate target discovery and drug development with shortened timelines and in a cost-efficient manner. Now more labs can use this service to unlock the power of RNA in any target-any species-any gene with RNAscope to complement their single cell RNA sequencing, qPCR, or immunohistochemistry data."

The assay services team brings years of experience in custom assay development and optimization, as seen in the comments here from the R&D team at Exicure, "Our experience working with Advanced Cell Diagnostics has been all-around excellent. With their expertise and through clear communication, we developed several assays to detect both RNA and short oligonucleotides in tissue. Compared to standard complementary probes, the signal we obtained using these services was evident and specific. After seeing the first images, we immediately knew we wanted to use these techniques more frequently."

By partnering with the Professional Assay Services scientific team for the full suite of service offerings, customers can be confident in the science and be satisfied with actionable results in weeks rather than months.