On December 23, 2021 Quidel Corporation (NASDAQ: QDEL) ("Quidel") and Ortho Clinical Diagnostics Holdings plc (NASDAQ: OCDX) ("Ortho") reported that they have entered into a definitive agreement in which Quidel will acquire Ortho, one of the world’s largest in vitro diagnostics companies, for $24.68 per share of common stock using a combination of cash and newly issued shares in the combined company, representing a 25% premium over Ortho’s closing price on December 22, 2021 and an equity value of approximately $6.0 billion (Press release, Quidel, DEC 23, 2021, View Source [SID1234597762]). The transaction is expected to close during the first half of fiscal year 2022, subject to customary closing conditions.

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"The combination with Ortho will help solidify Quidel as a leader in the diagnostics industry, bringing together innovative, complementary products, solutions, and services that enhance the health and well-being of patients across the globe," said Douglas Bryant, President and Chief Executive Officer of Quidel, who will serve as Chairman and Chief Executive Officer of the combined company. "Establishing a stronger leadership position, we expect the combined company will emerge as a global player with top-tier R&D capabilities, a more diverse product pipeline, and broader geographic footprint. Importantly, our complementary cultures are underpinned by a commitment to our customers, patients, and the communities we serve, reinforcing our confidence in the long-term value creation of this transaction. We are impressed by what Ortho has accomplished for patients. We look forward to joining together to continue the strong patient focus that is core to our mission, creating an organization with a shared goal of discovering, developing, and delivering innovative solutions to our customers."

"Quidel shares our commitment to customers and passion for the patients we serve. By bringing together Quidel’s point-of-care diagnostics with Ortho’s vast global reach, there is a substantial opportunity to capitalize on the cross-selling opportunities, move into attractive adjacent markets, and accelerate innovative product expansion and the development of molecular technologies," said Chris Smith, Chairman and Chief Executive Officer of Ortho. "Together, we will continue to advance life-changing diagnostic solutions to improve patient outcomes and deliver economic benefits to the healthcare system."

The combined organization will unite world-class technologies and platforms to benefit customers with expanded access to clinical chemistry, immunoassay, molecular diagnostics, immunohematology, donor screening, and point-of-care diagnostics offerings. Further, the combined company will be poised to meet patient testing needs at all points of the care continuum – reference labs, hospitals, physicians’ offices, urgent care centers and at-home / retail locations. With complementary areas of focus, the combined company will also operate with global reach and scale, maintaining the speed and agility that is fundamental to enhance Quidel’s current strategic approach.

Transaction Benefits

Balanced and diversified product portfolio across diagnostic instruments and assays. The companies’ highly complementary, world-class product and service offerings provide opportunities to capture significant growth globally while enhancing cross-selling opportunities across a diversified customer and channel mix. The transaction provides Quidel with ample whitespace opportunity to capture demand in emerging markets through telehealth technology and digital health capabilities, utilizing Ortho’s strong customer relationships and providing greater patient access to point-of-care diagnostic products.
Highly synergistic opportunities create significant shareholder value creation. The transaction is expected to generate substantial synergies on both the top- and bottom-line. Quidel anticipates that the combined company will realize approximately $90 million of run-rate cost-related synergies, excluding one-time costs, by the end of year three, driven primarily from operational efficiencies, supply chain optimization, and shared administrative functions, including public company costs. In addition, given Ortho’s enhanced global commercial reach and expansive product portfolio, Quidel expects to drive strong cross-selling revenue synergies in excess of $100 million by 2025 and meaningful adjusted EBITDA benefits.
Complementary cultures with a commitment to providing world-class products and services. Both Quidel and Ortho have talented and experienced employees who share a commitment to customers, patients, and the communities the companies serve. This combination is expected to benefit patients, customers, and suppliers, and provide greater opportunities for the approximately 6,000 employees of both companies.
Robust, more diverse product pipeline and enhanced R&D capabilities. The transaction is expected to accelerate an innovative pipeline and milestone execution through complementary capabilities and product development synergies. The combined product portfolio, supported by an established global commercial infrastructure and distribution footprint, positions Quidel to capitalize on strong secular growth drivers.
Strong balance sheet with significant cash generation. After accounting for financing of the transaction, the combined company has a pro forma net debt-to-adjusted EBITDA of less than two-times as of TTM third quarter 2021. Expected strong operating cash flow and margin enhancement opportunities will enable Quidel to pursue organic and inorganic growth.
Transaction Details

Under the terms of the agreement, which was unanimously approved by the Board of Directors of each company, Quidel will acquire Ortho for $24.68 per share of common stock, for a total consideration of approximately $6.0 billion, including $1.75 billion of cash, funded through cash on the balance sheet and incremental borrowings. The combined company will also acquire Ortho’s existing net debt of $2.0 billion.

Ortho shareholders will receive $7.14 in cash per common share and 0.1055 shares of common stock in the combined company for each Ortho common share, with Ortho shareholders expected to own approximately 38% of the combined company. This represents an implied premium of 25% when compared to Ortho’s unaffected closing stock price on December 22, 2021.

Following the close of the transaction, the combined company’s Board of Directors will consist of 12 members, eight (8) designated by Quidel and four (4) designated by Ortho. Quidel’s current President and Chief Executive Officer, Douglas Bryant, will serve as Chairman and Chief Executive Officer of the combined company. Joseph M. Busky will be the Chief Financial Officer, Robert Bujarski will be President and Chief Operating Officer, and Michael Iskra will be Chief Commercial Officer.

The transaction, which is subject to approval by both companies’ shareholders as well as customary closing conditions and regulatory approvals, is expected to close in the first half of 2022.

Advisors

Quidel’s financial advisors in connection with this acquisition are Perella Weinberg Partners LP and Citi, and its legal advisor is Gibson, Dunn & Crutcher LLP.

Ortho’s exclusive financial advisor is J.P. Morgan Securities LLC, and its legal advisor is Latham & Watkins LLP.

Conference Call Information

Quidel management will host a conference call to discuss the transaction today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The conference call may be accessed by dialing (844) 200-6205 from the U.S. or (929) 526-1599 if dialing internationally and using the required pass code 180-525.

To join the live webcast, participants may click the following link directly: View Source, or access the event via the Investor Relations section of Quidel’s website (View Source).

The website replay will be available for one year. The telephone replay will be available for 14 days beginning at 10:30 a.m. Eastern Time (7:30 a.m. Pacific Time) on December 23, 2021 by dialing 929-458-6194 from the U.S., or by dialing +44-204-525-0658 for international callers, and entering pass code 931-178.

On December 23, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the Goldman Sachs 14th Annual Healthcare CEOs Unscripted Conference at 1:00 p.m. ET on Thursday, Jan. 6, 2022 (Press release, Amgen, DEC 23, 2021, View Source [SID1234597657]). Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On December 23, 2021 Lion TCR Pte Ltd reported that it has received Fast Track Designation from United States Food and Drug Administration (U.S. FDA) for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR, for the treatment of HBV-related hepatocellular carcinoma (HBV-related HCC) (Press release, Lion TCR, DEC 23, 2021, View Source [SID1234597683]). This Fast Track Designation provides Lion TCR with an expedited path towards the regulatory approval for its leading investigational product, LioCyx-M004, which is being developed as a potential first-in-class drug for HBV-related HCC. This designation was granted based on that the efficacy of LioCyx-M004, as demonstrated by an improvement in the overall survival in patients with HBsAg-positive HCC relapsed or refractory to prior systemic treatment.

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The FDA Fast Track Designation is designed for sponsors to gain access to expedited drug approval, via eligibility for Accelerated Approval and Priority Review, for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need through early and frequent meetings with the FDA to discuss drug development plans[1]. The purpose is to get important new drugs to the patient earlier.

In earlier phase 1 study, LioCyx-M004 has showed the well-tolerated safety profile and promising prolonged overall survival. In September 2021, FDA Investigational New Drug (IND) Clearance for a Phase 1b/2 multi-center study has been obtained[2]. This is the first ongoing clinical trial that uses HBV-specific TCR T cell therapy to target HBV-related HCC.

"HBV-related HCC occurs in over 420,000 people every year worldwide and majority of advanced HCC patients relapse quickly after initial treatment. However, existing treatments are very limited especially on improving overall survival. We believe that our innovative TCR-T therapy can fill this urgent and important unmet medical needs. With this Fast Track designation, we look forward to having more frequent communication with the Agency in the hope to attain a more expedited drug approval for our product for patient access. Efforts for patient recruitment for the Phase 1b/2 study in the U.S. and Asia are underway." said Dr Tina Tingting Wang, COO and CMO of Lion TCR.

"The field of T-cell therapy is highly dynamic and competitive. Innovative therapies are released faster than ever through expediated programs like Fast Track. Together with our Orphan Drug Designation obtained for the use of HBV-specific TCR T cell therapy in HCC, we believe this Fast Track approval can drive forward the accelerated regulatory approval our proprietary first-in-class TCR T cell therapy." said Dr Peng Xiaoming, CEO of Lion TCR.

References

U.S. Food and Drug Administration (FDA). Fast Track. Available from: View Source
View Source

On December 23, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has entered into a definitive agreement to acquire Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products (Press release, LabCorp, DEC 23, 2021, View Source [SID1234597658]).

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The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology. PGDx enhances Labcorp’s ability to increase access to oncology care in the global community through kitted solutions that allow hospital systems and laboratories to run these tests internally, bringing precision diagnostics closer to the patient and helping close a common gap in the delivery of cancer care. Labcorp’s global reach also provides the opportunity to bring this technology to pharmaceutical companies for clinical trial research to advance cancer treatments, potentially impacting clinical outcomes in millions of people with cancer.

"Labcorp’s leadership and scale in diagnostic testing and drug development, coupled with PGDx’s innovative technology and suite of capabilities, will accelerate access to personalized treatments for cancer patients globally," said Adam Schechter, chairman and CEO of Labcorp. "PGDx’s comprehensive portfolio of next-generation sequencing products will meaningfully add to our breadth of capabilities, in line with our strategic priority to lead in oncology. PGDx’s technology is well positioned in an important segment with strong growth prospects. We look forward to welcoming PGDx’s talented team and working together to bring world-class diagnostics, technology and treatments within reach for all."

Under the terms of the agreement, Labcorp will pay $450 million in cash at closing and up to an additional $125 million on achieving future performance milestones.

PGDx’s centralized and decentralized offerings will enhance the scalability of the technology and support long-term growth across Labcorp’s oncology portfolio, while also enabling Labcorp to seamlessly offer oncology testing at every stage of care. PGDx offers the only diagnostic kit cleared by the U.S. Food and Drug Administration for pan-solid cancer comprehensive tumor profiling using a 500+ gene panel.

Next-generation sequencing, including liquid biopsy, represents the future of treatment and response monitoring in people with cancer. Liquid biopsy testing can also eliminate the need for an invasive biopsy procedure, reducing costs and improving patient outcomes. When combined with cutting-edge data analysis capabilities, NGS is the most advanced technology in the field today for identifying the best therapy available for each patient. As more cancer patients gain access to NGS testing, Labcorp will be able to offer enriched, actionable and data-driven insights. These insights can be used by pharmaceutical companies and cancer care teams to accelerate patient recruitment for clinical trials and identify patients eligible for approved treatments.

Overall demand for noninvasive tumor profiling and therapeutic response monitoring is expected to grow significantly—largely attributable to technological advances in the identification of biomarkers utilizing NGS, applicability to companion diagnostics and immuno-oncology solutions, and widespread government support.

"We share Labcorp’s vision of improving health care decisions and outcomes through science, data and a continued commitment to innovation," said Megan Bailey, CEO of PGDx. "For over a decade, PGDx has made great progress toward that goal. As a part of the Labcorp family, we have an incredible opportunity to broaden and accelerate our impact on cancer care through Labcorp’s global reach."

The acquisition of PGDx is the latest development in Labcorp’s long-standing commitment to integrate precision medicine into its comprehensive offering of oncology solutions. Labcorp currently offers OmniSeq INSIGHTSM, a NGS-based, precision medicine test for solid tumors, IntelliGEN Myeloid, a NGS-based precision medicine test for myeloid malignancies, and hereditary cancer genetic testing through VistaSeqSM. Labcorp also offers clonoSEQ, the first and only FDA-cleared assay for measurable, residual disease detection, and Resolution ctDx Lung, a non-invasive test for patients with non-small-cell lung cancer.

PGDx 2021 revenues are expected to be approximately $22 million and projected revenues for 2022 are expected to grow to nearly $40 million. The acquisition is expected to be slightly dilutive to Labcorp’s adjusted earnings per share over the next couple of years and provide returns in excess of its cost of capital by year five.

The transaction is subject to customary closing conditions and regulatory approvals, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The transaction is expected to close in the first half of 2022. Hogan Lovells and Kilpatrick Townsend acted as legal advisors to Labcorp. Cooley LLP acted as legal advisor and Cowen acted as financial advisor to PGDx.

On December 23, 2021 Oncorena, developing a potential breakthrough therapy for advanced renal cancer, reported that it receives a capital injection of MSEK 66 from one of the company’s principal shareholders together with two new investors (Press release, Oncorena, DEC 23, 2021, View Source [SID1234597684]). Under the terms of the agreement, Oncorena can receive an additional SEK 94 million in the future. The capital will primarily fund Oncorena’s first clinical study, a phase I/II study with orellanine in patients with advanced kidney cancer undergoing dialysis.

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The current shareholder HealthCap has together with the two new investors, Linc AB and Fåhraeus Startup and Growth AB, invested a total of MSEK 66 in new capital to finance the first part of the Oncorena’s Phase I/II study. If the first part of the Phase I/II study shows positive results (Proof of Concept), the parties intend to invest an additional sum of MSEK 94 in the second part of the study.

HealthCap, one of the largest life science venture capital funds in Europe, is since 2016 one of Oncorena’s largest shareholders. The investment company Linc AB is listed on Nasdaq Stockholm and invests in product oriented Nordic life science companies, primarily in pharma and medtech companies. Fåhraeus Startup and Growth AB is a newly founded venture capital fund focusing on early investments in life science and tech companies. The investment is subject to approval by an Extraordinary General Meeting to be held in January 2022.

Earlier this year, the Swedish Medical Products Agency approved Oncorena’s first clinical trial of orellanine in patients with advanced renal cancer undergoing dialysis. Orellanine is a substance with a unique mode of action that has demonstrated specific and powerful anti-tumour effects on advanced renal cancer in a number of preclinical models.

"We are grateful for this capital injection that enables us to get necessary and crucial results that will be decisive for Oncorena’s continued clinical development of orellanine and new ventures in the field of kidney cancer. We also hope that the results from the upcoming clinical study will be of great benefit to patients in the future," said Lars Grundemar M.D., Ph.D., Chief Executive Officer of Oncorena.

"It is gratifying to announce that Oncorena is now entering a new stage with a capital injection of up to a total of MSEK 160 in a Serie A-round from three strong life science investors. With the financing in place, Oncorena can now focus on exploiting the potential of the company’s innovation in kidney cancer, developing the company further and accelerating the growth journey," said Andreas Segerros, Oncorena’s Chairman of the Board.

About the Phase I/II clinical trial
The Phase I/II clinical trial of orellanine will enrol patients with advanced renal cancer already on dialysis due to renal failure. The study will be conducted at the Centre for Clinical Cancer Studies at the Karolinska University Hospital in Stockholm, Sweden, and will study safety, tolerability, pharmacokinetics and signs of anti-tumour effects in treatment with a synthetic form of orellanine. The Phase I/II trial will include up to 40 patients and may include patients from other European countries.

About orellanine
Orellanine, which has a new and unique mode of action, is being developed for organ-specific chemotherapy with curative potential for patients with advanced renal cancer undergoing dialysis. Orellanine is found in mushrooms of the Cortinarius family, these are sometimes accidentally picked and eaten as they are mistaken for funnel chanterelles. The clinical effects of orellanine are well documented and are completely limited to the kidneys.

About kidney cancer
Approximately 400,000 patients are affected by kidney cancer globally according to the WHO. The disease can often be cured by surgery if detected in time, but unfortunately the diagnosis is often made when the tumour has already spread to other organs. The prognosis is then considerably less favourable and certain groups have a median survival of less than two years. Today the disease is treated with various types of targeted and immuno-active drugs, often with severe side effects, and standard chemotherapy drugs have limited effect. There is therefore a great and urgent unmet medical need for new, effective and safe drugs.