On March 9, 2021 Grand Pharmaceutical and Healthcare Holdings Limited ("GP (HK)" or the "Company", together with its subsidiaries, the "Group", stock code: 00512) reported that the Group’s associate Sirtex Medical Pty Ltd core anti-tumor drug SIR-Spheres Y-90 resin microspheres obtained recommendation from the National Institute for Health and Care Excellence ("NICE") in the treatment of unresectable advanced hepatocellular carcinoma ("HCC") in adults, and obtained an approval from the US Food and Drug Administration ("FDA") to conduct clinical trials on primary liver cancer (Press release, Grand Pharmaceutical, MAR 9, 2021, View Source [SID1234653970]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SIR-Spheres Y-90 resin microspheres are used in selective internal radiation therapy for malignant liver tumors. The SIR-Spheres Y-90 resin microspheres are delivered to the vasculature of liver tumor via a worldwide leading interventional technology, and then emit high doses of beta radiation to destroy tumor cells, which are the only radioactive microspheres around the world approved by the FDA.

NICE is an important organization of National Health Service ("NHS") in England, and is one of the recognized premier health technology assessment organizations in the world. More than 75% of the governments and health technology assessment agencies in the world regard NICE’s recommendations as an important decision-making basis for bringing products into their own medical insurance reimbursement. As recommended by NICE, the use of selective internal radiation therapy ("SIRT") using SIR-Spheres Y-90 resin microspheres in England and Wales will be a fully funded and reimbursed option for adult patients with HCC, on the conditions that it is used for patients with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate. This approval opens the potential to treat thousands of patients who would apply to treat with SIR-Spheres Y90 resin microspheres, annually, in the UK. Besides, SIR-Spheres Y-90 resin microspheres obtaining recommendation from NICE is a milestone for its global medical insurance reimbursement access, which is expected to accelerate its access to medical insurance reimbursement in other emerging markets (such as Brazil), further expand its market shares, and help more liver cancer patients worldwide to receive the treatment of SIR-Spheres Y-90 resin microspheres.

In addition, SIR-Spheres Y-90 resin microspheres have been approved by the FDA to conduct clinical trials on primary liver cancer in order to apply for marketing license of primary liver cancer in the United States. The clinical trial is a single arm trial and patients will be recruited in the near future.

The results of clinical studies prove that SIR-Spheres Y-90 resin microspheres can significantly increase tumor response rate, reduce tumor burden and achieve tumor downstaging, so that patients can gain the chances to undergo surgical resection. It can also significantly prolong the progression-free survival, control tumor progression and increase the waiting time for liver transplantation. In the meantime, SIR-Spheres Y-90 resin microspheres bring less side effects and higher quality of life for patients. With its remarkable clinical efficacy, SIR-Spheres Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. It is recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). It is also covered by medical insurance in places such as the United States and Europe. In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition).

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "Two important developments demonstrate the clinical efficacy and competitive advantages of SIR-Spheres Y-90 resin microspheres, helping more liver cancer patients worldwide receive treatment. The NICE recommendation proves that the treatment of SIR-Spheres Y-90 resin microspheres has positive effects on the quality of life and economic benefits of HCC patients."

"Sticking to patients-centered and innovation-driven, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including United Stated based OncoSec, Australia based Sirtex and Telix Pharmaceuticals Limited (ASX: TLX), the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich 3product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and Immunotherapy platform integrating diagnostics and treatment. The Group adopts the strategy of ‘global expansion and dual-cycle operation’, forming a new pattern of domestic and international cycles that synergize with each other. The Group makes full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization processes for innovative products and provide cancer patients with more advanced and diverse treatment options in the world."

On March 9, 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will host a conference call and webcast to provide a business update on Tuesday, March 16, 2021 at 4:30 p.m. EDT (Press release, Cue Biopharma, MAR 9, 2021, View Source [SID1234608284]). Live and archived versions of the event can be accessed via the Company’s website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Members of the Cue Biopharma executive management team will provide clinical updates on the Company’s ongoing CUE-101 Phase 1 dose escalation monotherapy trial, which will include new patient data, and on the combination trial KEYNOTE-A78, where CUE-101 will be evaluated in combination with KEYTRUDA (pembrolizumab) as first-line treatment for HPV+ recurrent/metastatic head and neck squamous cell carcinoma. Management will also provide an update on the Company’s most recent technology platform developments and pipeline progress as well as updates on its strategic objectives and anticipated milestones.

On March 9, 2021 Valo Health LLC (Valo), a technology company transforming the drug discovery and development process and seeking to accelerate the creation of life-changing drugs, reported the final closing of its Series B at $300 million, including a $110 million investment from Koch Disruptive Technologies (KDT) (Press release, Valo Health, MAR 9, 2021, View Source [SID1234577591]). This brings the overall funding of Valo to over $450 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With this investment Valo will continue to scale its Opal Computational PlatformTM, the first-of-its-kind fully integrated end-to-end platform that combines machine learning-driven computational capabilities and patient data to develop first-in-class and best-in-class therapeutic programs across major disease areas.

"We see Valo’s strategy and approach to transforming drug discovery and development as highly disruptive to the industry. Their machine learning and data-centric technology solutions will bring significant value to patients and healthcare practitioners looking for more efficient and enhanced treatment options," said Chase Koch, President of Koch Disruptive Technologies. "The medtech and healthcare markets are currently undergoing dramatic change and accelerated transformation, and our investment in Valo is a testament not only to our belief in their mission but to the importance of this industry in general."

"We are reimagining the process of discovering and developing life-changing drugs in potentially half the time, at half the cost, and with fewer failures, and we are proud that KDT recognizes our paradigm-changing work," said David Berry, Valo founder and CEO. "This investment and their partnership will help us further scale and accelerate our goals and the Opal platform."

The proceeds from the Series B will support the continued discovery and development of therapeutic programs, further build-out the Opal Computational PlatformTM, working capital, and other general purposes. Using Opal, Valo scientists have been able to identify previously unsuspected associations between genetic markers and disease, which identify the specific changes in gene activity with an initial focus on oncology, neurodegenerative, and cardiovascular diseases.

David Berry will discuss Valo’s approach and provide insights into several preclinical programs and the Opal platform at the Barclays Global Healthcare Conference at 8 a.m. EST on March 9, 2021. Following the event, a replay of the Barclays webcast will be available on the Valo LinkedIn page.

On March 9, 2021 Foundation Medicine, Inc. and InformedDNA, the nation’s largest independent provider of genetics services, reported a collaboration that will enable physicians to refer U.S. patients with possible inherited cancer gene mutations to genetic counseling services and confirmatory genetic testing based on the results of Foundation Medicine’s tumor testing (Press release, Foundation Medicine, MAR 9, 2021, View Source [SID1234576614]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For patients who undergo Foundation Medicine’s comprehensive genomic profiling tests and receive a result showing a potential inherited cancer gene variant, genetic counseling and follow up germline (genetic) testing aligns with clinical guidelines and industry best practices, and provides oncologists and their patients with more data to inform treatment decisions.

Cancer can be influenced by many different genetic changes; some are acquired over time, known as somatic mutations, and others are inherited, known as germline mutations. Foundation Medicine’s tests evaluate more than 300 cancer-related genes, including genes with variants that may have potential germline implications. If a potential germline variant is identified via tissue or liquid-based genomic testing, Foundation Medicine’s test report highlights this to the patient’s provider, so that the provider may consider follow up with genetic counseling and confirmatory germline testing.

Through this new collaboration, Foundation Medicine and InformedDNA are helping advanced cancer patients and their physicians navigate the appropriate genetic counseling and confirmatory testing resources available to them should they choose to leverage them to inform treatment plans.

"Both somatic and germline drivers of disease are critical to inform treatment decisions and assess future risk, yet many physicians and health systems do not have a referral process in place or access to internal genetic counseling services and confirmatory germline testing. Further, given the broader implications of this information, responsible communication from a genetic counselor is critical," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "We’re pleased to partner with InformedDNA to create a unique option that enables access to genetic counseling and guidance on confirmatory testing, thereby assisting care teams with obtaining additional information to develop holistic treatment plans for patients and their families."

InformedDNA is a leader in telegenetic counseling, offering services with board-certified genetic counselors across all 50 states. If confirmatory genetic testing is desired and deemed necessary following a potential germline variant finding on one of Foundation Medicine’s reports, InformedDNA’s genetic counselors will guide patients in determining the appropriate test and understanding the benefits, risks, and implications of confirmatory germline testing.

"Together, we’re improving access to an important aspect of tumor testing for cancer patients – the ability to identify patients at risk of carrying inherited genetic mutations," said Rebecca Sutphen, M.D., FACMGG, co-founder and chief medical officer at InformedDNA. "This collaboration aims to make genetic counseling and confirmatory testing more accessible to U.S. patients with potential germline mutations, helping to ensure that physicians have the information needed to develop personalized cancer treatment plans for their patients and implement preventive measures for their families."

Approximately five to 10 percent of all cancers are hereditary.1 In addition to playing a role in diagnosing and treating an individual with cancer, genetic information can be used to help inform health decisions for a patient’s family members.

"We believe it is essential for all advanced cancer patients to have access to the tools needed to understand the hereditary implications of their cancer, if interested," said Sue Friedman, executive director and founder of Facing Hereditary Cancers Empowered (FORCE). "We applaud Foundation Medicine and InformedDNA for embarking on this effort to fill an important gap in cancer care, ensuring people affected by hereditary cancer have the information, support and guidance they need to navigate treatment and prevention."

Foundation Medicine’s reporting of tumor variants does not distinguish between somatic or germline variants and is not intended to replace germline testing or provide information specific to cancer predisposition.

On March 9, 2021 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (Nasdaq: ANIP) reported that it has signed a definitive agreement to acquire Novitium Pharma, a privately held, New Jersey-based pharmaceutical company with development, manufacturing, and commercialization capabilities for $163.5 million, including $89.5 million in cash and $74 million in equity plus two potential future cash earn-outs of up to $46.5 million (Press release, ANI Pharmaceuticals, MAR 9, 2021, View Source [SID1234576613]). The transaction has been approved by the ANI Board of Directors and is expected to close in the second half of 2021, subject to regulatory approvals and approval by ANI shareholders as required by Nasdaq listing standards as described below. Equity holders of Novitium have approved the transaction.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Strengthening our well-established Generics business with enhanced development capabilities and increased focus on niche opportunities is a key pillar of ANI’s growth strategy. The acquisition of Novitium aligns with this strategy, adding a best-in-class R&D engine that delivers sustainable growth through new product launches and offering upside through niche 505(b)(2) opportunities. The addition of a U.S. based, state-of-the-art manufacturing facility and enhanced scale to our CDMO business are other attractive advantages of this acquisition. We also look forward to welcoming Samy, Chad, Vijay and the entire Novitium team to ANI," stated Nikhil Lalwani, President and CEO.

"We expect the transaction will be immediately accretive to our adjusted EBITDA. Upon closing of the transaction, our strengthened pro forma capital structure, including the new senior credit facilities underwritten by Truist Securities and the PIPE from Ampersand Capital Partners will enable us to facilitate long-term growth," concluded Lalwani.

Samy Shanmugam, Co-Founder and President, and Chad Gassert, Co-Founder and CEO, commented, "We are delighted to join ANI as we enter this next phase of exciting growth at Novitium Pharma. We look forward to supporting ANI to execute on their strategy of growing their business, expanding and diversifying their product portfolio, and creating long-term value for their investors."

Transaction Strongly Positions ANI for Future Growth

Proven R&D Engine Fuels Sustainable Growth
Novitium anticipates launching 25+ additional products in 2021 and 2022, including products with U.S. Food and Drug Administration ("FDA") Competitive Generic Therapy ("CGT") designation. The Company currently has 21 abbreviated new drug applications ("ANDAs") filed with the FDA and more than 30 additional products under development. Novitium’s leadership of Samy Shanmugam, Chad Gassert, Vijay Thorappadi and the entire team has an excellent track record of execution and efficiency from filing to launch. Integration of Novitium’s R&D operations will establish a center of excellence for ANI’s generics product development program.
Expands ANI’s R&D Pipeline Focused on Niche Opportunities
Novitium is currently advancing three 505(b)(2) candidates in Oncology and Hypertension. These 505(b)(2) products will build on ANI’s increasing focus on niche opportunities, including its first Paragraph IV filing in 2020 and the filing of injectables ANDAs in 2021.
Enhances Scale of CDMO Business and U.S.-Based Manufacturing Capacity
Novitium adds nine new customers to ANI’s growing CDMO business. Additionally, Novitium brings with it a 50,000 sq ft East Windsor, NJ facility, including 27 manufacturing suites and eight clinical suites supporting R&D, commercial manufacturing and packaging. An ongoing 20,000 sq ft building expansion will add 18 new manufacturing suites. Novitium’s annual production capacity is approximately two billion units in aggregate across tablets, capsules, liquid suspensions and solutions, powders and powder for oral suspension, controlled release and potent compounds.
Compelling Financial Profile
The combination is expected to be accretive to ANI’s adjusted non-GAAP EPS in the first 12 months after closing. The transaction is expected to add approximately $15 million to adjusted EBITDA in the second half of 2021, assuming a mid-year 2021 close. The acquisition diversifies ANI’s revenue base by contributing to each of its reporting segments: Generics, Contract Manufacturing, Royalties/Other and, following the launch of Novitium’s 505(b)(2) pipeline products, the Brand segment.
Terms of the Transaction & Financing

Under the terms of the transaction, the Purchase Price of $163.5 Million is comprised of (i) a cash payment of $89.5 million and (ii) $74 million in equity. Novitium is also eligible to receive (i) $25 million in contingent payments upon the achievement of financial targets related to Generics products and filing of certain ANDAs and (ii) $21.5 million in contingent payments upon the achievement of financial targets from the 505(b)(2) products.

ANI will finance the transaction with a new $300 million Term Loan B, issuance of $74 million in equity to the sellers, and a $25 million PIPE investment by Ampersand Capital Partners. The facility also includes a new $40 million revolving credit facility. The new debt financing will be secured by substantially all the assets of ANI and its subsidiaries and used for the cash portion of the acquisition and to refinance ANI’s existing senior credit facilities. The proposed capital structure further facilitates sustainable growth for ANI.

Approvals

The transaction is expected to be completed in the second half of 2021, subject to the satisfaction of customary closing conditions, l approval from relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act, and approval by ANI shareholders under Nasdaq listing standards as the result of the equity portion of the Novitum transaction and the shares issuable in the PIPE transaction.

Advisors

Bourne Partners, Truist Securities and Houlihan Lokey acted as financial advisors to ANI Pharmaceuticals. SVB Leerink acted as financial advisor to Novitium Pharma and its shareholders. Hughes Hubbard & Reed were ANI’s legal advisors and Orrick, Herrington & Sutcliffe acted as legal advisors to Novitium and its shareholders.