On March 4, 2021 Kyowa Kirin reported that The National Institute for Health and Care Excellence (NICE) its final appraisal document (FAD) for POTELIGEO (mogamulizumab) announcing that POTELIGEO will not be made available on the NHS1 in England and Wales. Mogamulizumab is a treatment for adults living with rare blood cancers, mycosis fungoides (MF) and Sézary syndrome (SS), two subtypes of Cutaneous T-Cell Lymphoma (CTCL), who have received at least one prior systemic therapy (Press release, Kyowa Hakko Kirin, MAR 4, 2021, View Source [SID1234576032]).2 Kyowa Kirin is disappointed with this decision but remains committed to finding a solution for people living with MF and SS to have access to the medicine and will continue to work with NICE to find a resolution.

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Richard Johnson, Northern Cluster General Manager, responsible for the UK at Kyowa Kirin, commented: "We are disappointed that, despite feedback from the patient and clinical community together with extensive evidence provided, the appraisal committee’s decision is negative. We fully support the recently published UK Rare Disease Framework and specifically priority 4 on "improving access to specialist care, treatments and drugs". This is critically important given that many people with rare diseases, including those with CTCL, face challenges to access safe, high quality care and treatments." He added: "Kyowa Kirin remains committed to supporting adults with MF and SS. The company will do all it can to ensure people with these debilitating haematological malignancies and eligible for these treatments have access to mogamulizumab."

Professor Sean Whittaker, Professor of Cutaneous Oncology at the School of Basic and Medical Biosciences, Kings College London, and Consultant dermatologist, Guy’s and St Thomas’ NHS Foundation Trust, added: "MAVORIC is the largest randomised controlled trial completed in Cutaneous T-Cell Lymphoma, a rare form of non-Hodgkin’s lymphoma, and the only trial to have included a significant proportion of patients with the advanced leukaemic stage of disease, Sézary syndrome, for which we have no consistently effective therapies. Patients with advanced stages of CTCL represent an unmet clinical need at present and effective therapies such as mogamulizumab are urgently needed to enable consolidation with stem cell transplantation. NICE’s decision is very disappointing for patients with this rare malignancy."

MF and SS are two forms of Cutaneous T-Cell Lymphoma (CTCL), which is a serious and potentially life-threatening form of cancer that affects the skin.3 People living with the condition have a substantially reduced quality of life.4 Additionally, there is a significant impact on quality of life for those caring for an individual living with CTCL.5 CTCL is treatable but not curable and there is a clear unmet need for new treatment options.

Stephen Scowcroft, Director of Operations and External Affairs at Lymphoma Action commented: "We are deeply disappointed by this decision and the effect it will have on people living with these rare and debilitating haematological cancers. We know that there is a real need for effective treatments for people living with mycosis fungoides and Sézary syndrome as there are currently limited treatment options and this can have a significant impact on a person’s quality of life, daily function and social interactions. We believe patients should have access to the best care and there continues to be a need for effective treatments for people living with mycosis fungoides and Sézary syndrome. We call on the relevant stakeholders, NICE and the company, to continue to discuss the options and to work with the patient community to find a resolution."

About POTELIGEO (mogamulizumab)

Mogamulizumab is a first-in-class humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS;6,7,8 once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.9

Mogamulizumab has been shown to offer benefits to many patients with MF and SS.10 The MAVORIC trial compared the efficacy of mogamulizumab with vorinostat in previously treated people with relapsed or refractory mycosis fungoides or Sézary syndrome, two types of Cutaneous T-cell lymphoma (CTCL).10 Patients taking mogamulizumab experienced control over their disease for more than twice as long as those taking the comparator treatment, vorinostat*1 (7.7 months vs 3.1 months of median progression free survival), the primary endpoint of the trial.10 Levels of adverse events were similar between the two treatment groups.10

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)

MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.11,12 These cancerous T cells consistently express a protein called CC-chemokine receptor 4 (CCR4), which enables them to move from the blood to the skin.6,7,8 When these cancerous T cells move to the skin, they can create a localised inflammatory immune skin response, commonly resulting in visible skin symptoms of red patches or plaques 6,13,14,15,16 which can resemble psoriasis or eczema.11

MF and SS can affect the skin, blood, lymph nodes (part of the body’s immune system which is spread throughout the body) and internal organs.17 All four areas of the body are used to assess disease stage18,19 and clinically significant involvement of the blood, particularly in more advanced disease, is linked with increased morbidity and an overall reduction in patient survival.18,20,21

Due to its likeness to more common skin conditions such as eczema and psoriasis,11 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.22 It is critical for doctors to diagnose CTCL as early as possible as the patient’s prognosis can be affected if the disease progresses to later stages.23 Whilst most individuals that present with early stage do not progress to a more severe stage,24 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.18

CTCL is a rare disease that affects 0.7 per 100,000 patients across the UK.25 The annual incidence of MF in Europe is estimated to be between 1 in 110,000 to 1 in 350,000.26 The annual incidence of SS is 1 in 10,000,000.27 Together they represent approximately 65% of all cases of CTCL.17

On March 3, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported its Full Year Report for January – December 2020. It is available on Herantis’ website (Financial information) (Press release, Herantis Pharma, MAR 3, 2021, View Source,c3300578 [SID1234577483]).

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"2020 was a fast-paced, purpose-driven, and transitional year for Herantis as we enter the next chapter of development for our fascinating science and innovative disease modifying treatments for patients suffering from debilitating neurological and lymphatic diseases. The year was notable for favorable data in our key programs, a new strategy for our Parkinson’s program, and significant funds raised.

For CDNF, a natural biological molecule, we were very pleased to announce data in August confirming the drug successfully achieved its primary endpoint of safety and tolerability in a First-in-Human Phase I-II study in Parkinson’s disease patients. This was a momentous achievement successfully taking the drug into human subjects. Going forward, we will focus on new routes of administration including nose-to-brain (nasal spray) and skin injection (subcutaneous). This strategy is expected to expand the target population to earlier stage patients, accelerate clinical development, and increase the attractiveness of our CDNF asset to partners.

For xCDNF, an engineered peptide using only the smallest most potent fragments of CDNF, we generated impressive data confirming the potency of the compound plus its ability to cross the blood brain barrier to reach the brain tissue, both of which are critical elements for the success for this therapy. Importantly, as with the new CDNF administration routes above, xCDNF is administered via a simple skin injection without the need for surgery.

It is exciting to have two such compelling assets in our portfolio, and we very much look forward to developing these two programs with their respective merits.

For Lymfactin, our gene therapy product, we were very pleased to announce in November favorable 24-month follow-up review from Phase I Lymfactin trial in Breast Cancer Related Lymphedema (BCRL). Post the FY 2020 financial reporting period, results from Phase II study with Lymfactin in BCRL have been announced separately 2nd March.

We raised a total of approximately EUR 15 million during 2020 with two direct share issues in May and December. 2020 has been a year of considerable progress for Herantis, and we enter 2021 with an optimised foundation, solid business fundamentals, and exciting milestones planned for the year ahead. I am very proud of the accomplishments and the significant advancements Herantis has made this past year to shape its future."

On March 3, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported that the Company has entered into amended and restated credit facilities in the aggregate principal amount of $175 million, consisting of a $150 million term loan, which includes a cashless conversion of $25 million in existing term loans, and a $25 million revolving credit facility (Press release, Radius, MAR 3, 2021, View Source [SID1234576152]). The amended and restated credit facilities also provide for an additional $25 million term loan at the lenders’ discretion. The transaction represents a significant upsize from the Company’s prior senior $95 million loan facilities, which consisted of a $55 million term loan ($25 million of which had been drawn) and a $20 million revolving credit facility that also included an additional $20 million of potential incremental availability. The amended and restated loan is expected to close on or about March 11.

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Jim Chopas, the Company’s Principal Finance and Accounting Officer said "this transaction demonstrates the Company’s improved financial strength and ability to access the debt capital markets on what we see as favorable terms to fund its corporate objectives. We expect the increase in cash interest expense to be absorbed by the Company’s cash flow."

Proceeds from the transaction are expected to be used in the following three ways:

Repurchase $112.2 million of aggregate principal amount of the Company’s existing 3.00% Convertible Senior Notes due September 1, 2024
Rollover the existing $25 million term loan into the new loan
Add $14.2 million of cash to the balance sheet, increasing liquidity as of 12/31/2020 on a pro forma basis from $114.7 million to $128.9 million, subject to change based on adjustments to the aggregate repurchase price of the 2024 Notes over the VWAP Period
The expected aggregate repurchase price of the 2024 Notes is $105.7 million, inclusive of accrued interest, which represents a discount of 6% to face value and convertible debt cancellation of $6.7 million. The aggregate repurchase price is subject to adjustment based in part on the daily volume-weighted average prices per share of the Company’s common stock during a ten-trading day pricing period ("VWAP Period") following execution of the Repurchase Agreements. As a result of the transaction, the Company’s annual cash interest expense will increase by approximately $6.3 million, driven by the higher term loan interest rate relative to the 2024 Notes.

The 2024 Notes repurchase is expected to close on March 18, 2021, subject to customary closing conditions.

J. Wood Capital Advisors LLC was the exclusive advisor to Radius in the financing transaction and in the repurchase of the 2024 Notes.

TRANSACTION OVERVIEW AND RATIONALE

Balance Sheet

Eliminates approximately 2.3 million shares of potential future dilution upon conversion of the notes
Reduces the risk of a convertible note reissuance at a lower strike price to extend the maturity
Provides an additional $14.2 million of liquidity to the balance sheet, subject to change based on adjustments to the aggregate repurchase price of the 2024 Notes over the VWAP Period
Demonstrates access to the secured debt market at scale and at a manageable cost
Creates a tranche of prepayable debt that allows the company to reduce debt ahead of stated maturities in 2024
Pro forma, Radius will have $150 million of prepayable debt and $192.8 million of non-prepayable debt
Initial step in optimizing the Company’s capital structure and balance sheet in the intermediate term
Income Statement and Cash Flow

Incremental cash interest expense from the transaction is approximately $6.3 million on an annual basis and is expected to be manageable given the Company’s anticipated improvement in cash flow
Radius reaffirms 2021 financial guidance of generating $10 million of positive EBITDA
The Company views the increased interest expense as modest relative to the benefits of the transaction
Peter Schwartzman, the Company’s Capital and Strategy Officer, added "the financing demonstrates the Company’s dedication to strategic management of its capital structure. This transaction reduces future potential equity dilution, adds incremental liquidity, and represents an initial phase of a long-term balance sheet strategy to enhance both operating and financing flexibility." Mr. Schwartzman continued, "the completion of the transaction is a significant advancement of the Company’s financial position, which will enable Radius to achieve both short and intermediate term objectives. We would like to thank MidCap and its partners for their participation and for enabling this transaction."

Source: 2020 10-K and financing documents
1 Subject to change based on adjustments to the aggregate repurchase price of the 2024 Notes over the VWAP Period
2 Face value, refer to notes in 10-K

ABOUT THE TRANSACTION

The Company and certain of its subsidiaries (the "Borrowers") amended and restated its existing senior secured facilities ("Facilities") with MidCap Financial and MidCap Funding IV Trust, as agents under the term loan credit agreement and revolving loan credit agreement, respectively, and the lenders thereunder.

The term loan credit agreement provides for, among other things:

An initial term loan of $150 million, including the cashless conversion of $25 million in existing term loans (the "Initial Term Loan")
An additional $25 million term loan, which the lenders may make available in their discretion within one year of the closing of the Initial Term Loan
Interest at a rate of LIBOR plus 5.75%, subject to a 2.00% LIBOR floor
The amended and restated revolving loan agreement provides for, among other things:

A revolving credit facility of up to $25 million, made available based on a borrowing base calculated based on percentages of
the net collectable value of certain of the Borrowers’ domestic accounts receivable, and
domestic eligible inventory,
minus certain reserves
Interest at a rate of LIBOR plus 3.50%, subject to a 2.00% LIBOR floor
The Facilities have a maturity date of June 1, 2024. They are guaranteed and secured by substantially all of the assets of the Borrowers and any future subsidiaries of the Borrowers that become borrowers or guarantors under the Facilities, subject to certain exceptions. The Borrowers may be required to make mandatory prepayments prior to maturity under certain circumstances.

The foregoing description of the amended and restated credit agreements and facilities is qualified in its entirety by reference to the full text of the Credit Agreements, which will be filed as exhibits to our corresponding Current Report on Form 8-K, to be filed within four business days of the date hereof.

On March 3, 2021 Bio-Techne Corporation (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported it has reached an agreement to acquire Asuragen, Inc. for initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones (Press release, Bio-Techne, MAR 3, 2021, View Source [SID1234576105]). The transaction will be financed through a combination of cash on hand and an existing revolving line of credit. Bio-Techne anticipates the acquisition to close in the fourth quarter of its fiscal 2021.

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Founded in 2006, Asuragen is headquartered in Austin, Texas and is a leader in the development, manufacturing and commercialization of genetic carrier screening and oncology testing kits. Asuragen’s products leverage proprietary chemistries which can be used on widely available platforms including, PCR, qPCR, capillary electrophoresis, and next-generation sequencing instruments. This platform agnostic approach enables its clinical laboratory customers to solve complex molecular diagnostic challenges and empowers hospital and regional labs to expand in-house testing capabilities, furthering the decentralization of the molecular diagnostics market, enabling quicker turn-around times and ultimately delivering better patient care. Asuragen’s headquarters includes a scalable, Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility as well as a CLIA-certified laboratory. In 2020, Asuragen generated greater than $30 million in revenue globally and its Chief Executive Officer, Matt McManus, will join the Bio-Techne team to continue to lead the legacy Asuragen business as well as the integration process.

Asuragen brings a leading portfolio of best-in-class molecular diagnostic and research products, including its FDA-cleared AmplideX Fragile X Diagnostic and Carrier Screening kit for the screening of prospective parents as potential carriers of Fragile X chromosomal abnormalities as well as its Quantitidex qPCR IS BCR-ABL kit to enable the monitoring of leukemia patients for minimal residual disease. In addition to its existing portfolio of innovative and enabling technologies, Asuragen’s pipeline includes expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists (ACOG) as areas of concern for prospective new parents. Bio-Techne sees multiple growth synergies following the closing of the transaction, including Asuragen’s capabilities and proven track record in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption.

"Asuragen is very complimentary with Bio-Techne’s existing diagnostics franchise and the addition of this business is expected to drive growth synergies throughout the expanded portfolio," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We are not only acquiring a financially strong and scalable business, building our diagnostic portfolio and expanding our bandwidth with an additional CLIA-certified and GMP compliant laboratory, but are also adding a team with deep expertise in the intricacies of the global regulatory environment and a proven track record of opening new market channels. This critical mass will be very beneficial to the Genomics and Diagnostics Segment as we commercialize our pipeline of liquid biopsy tests through our Exosome Diagnostics business and also opens the possibility of approaching the market with kitted versions of these products. We anticipate continued traction with Asuragen’s leading portfolio of molecular diagnostic kits for both clinical and research uses and see significant potential in its pipeline of expanded carrier screening panels. Asuragen is a great addition to the Bio-Techne team."

"The Asuragen team is extremely excited to be joining Bio-Techne at this point in our growth trajectory," said Matt McManus, Chief Executive Officer of Asuragen. "Bio-Techne’s global presence, reputation and relationships within the clinical diagnostic and research communities will enable Asuragen to broaden our reach and accelerate penetration into the high-growth molecular diagnostic markets addressed by our portfolio. I am honored to continue to lead the Asuragen team as a part of Bio-Techne. I would like to thank all of the great people of Asuragen for their committed efforts growing our company to this point and am looking forward to the next stage of growth under the Bio-Techne umbrella."

Fredrickson & Byron, P.A. is serving as Bio-Techne’s legal counsel. Perella Weinberg Partners LP is the financial advisor and Vinson & Elkins LLP is serving as legal counsel to Asuragen.

On March 3, 2021 Vaxalto Biotherapeutics, Inc. (www.vaxalto.com), a pre-clinical stage biotechnology company focused on developing and commercializing novel engineered immunotherapeutic oncolytic viruses, and Mount Sinai Innovation Partners (MSIP), part of the Icahn School of Medicine at Mount Sinai, reported that they have partnered to develop novel cancer immunotherapies (Press release, Vaxalto Biotherapeutics, MAR 3, 2021, View Source [SID1234576057]). Mount Sinai has granted an exclusive, worldwide license to Vaxalto covering intellectual property and technology related to an avian paramyxovirus (APMV) oncolytic virus platform and novel immuno-modulator targeting the lymphatic system. This technology forms the core of Vaxalto’s proprietary, multimodal therapeutic approach utilizing direct destruction of cancer cells, vascular and immune system activation.

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"We are delighted to be partnering with Mount Sinai to develop our novel viral immunotherapy, which eliminates tumors following intra-tumoral administration and leads to long-term protection from cancer recurrence based on animal studies," said Dr. Mihaela Skobe, Vaxalto co-founder and Director, Laboratory for Metastasis and Lymphatic Research, Department of Oncological Sciences at Mount Sinai.

Skobe is joined by Dr. Peter Palese and Dr. Adolfo Garcia-Sastre, also from the Icahn School of Medicine at Mount Sinai, to form Vaxalto’s scientific leadership team.

"We look forward to this collaboration between Mount Sinai and Vaxalto, in an effort to advance potential breakthrough therapies using a novel approach to treating a range of cancers," said Dr. Erik Lium, President, Mount Sinai Innovation Partners and Executive Vice President and Chief Commercial Innovation Officer, Mount Sinai Health System