On January 25, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") announced today the pricing of $650 million aggregate principal amount of 2.25% convertible senior notes due 2029 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The offering was upsized from the previously announced offering of $400 million aggregate principal amount of notes. In connection with the offering, the Company granted the initial purchasers an option to purchase up to an additional $97.5 million aggregate principal amount of notes. The sale of the notes is expected to close on January 28, 2021, subject to customary closing conditions.

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The notes will bear interest at a rate of 2.25% per year, payable semi-annually in arrears on February 1 and August 1 of each year, beginning August 1, 2021. The notes will mature on February 1, 2029, unless earlier converted, redeemed or repurchased. Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The conversion rate will initially be 10.3050 shares of the Company’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $97.04 per share of the Company’s common stock). The initial conversion price of the notes represents a premium of approximately 47.5% over the last reported sale price of the Company’s common stock of $65.79 per share on January 25, 2021.

The Company may not redeem the notes prior to February 6, 2026. On or after February 6, 2026 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated (including the Company’s 2.50% Convertible Senior Notes due 2027); effectively junior in right of payment to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

In connection with the pricing of the notes, the Company entered into privately negotiated capped call transactions with certain of the initial purchasers and/or their respective affiliates and certain other financial institutions (the "option counterparties"). These capped call transactions are expected generally to reduce the potential dilution to the Company’s common stock upon any conversion of the notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction of potential dilution and/or offset of cash payments subject to a cap. The cap price of the capped call transactions will initially be $131.58 per share, which represents a premium of 100% over the last reported sale price of the Company’s common stock of $65.79 per share on January 25, 2021, and is subject to certain adjustments under the terms of the capped call transactions.

The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to the Company’s common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of the Company’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Company’s common stock and/or purchasing or selling the Company’s common stock or other securities of the Company in secondary market transactions from time to time prior to maturity of the notes (and are likely to do so following any conversion of the notes, any redemption date or any repurchase of the notes by the Company on any fundamental change repurchase date or otherwise, in each case, if the Company exercises the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of the Company’s common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares of the Company’s common stock, if any, and value of the consideration that holders will receive upon conversion of the notes.

Further, if any such capped call transactions fail to become effective, whether or not the offering of notes is completed, the option counterparties or their respective affiliates may unwind their hedge positions with respect to the Company’s common stock, which could adversely affect the value of the Company’s common stock and, if the notes have been issued, the value of the notes.

The Company estimates that the net proceeds from the offering of notes will be approximately $635 million (or approximately $731 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and estimated offering expenses payable by the Company. The Company intends to use $53.3 million of the net proceeds from the offering of the notes to pay the cost of the capped call transactions, and approximately $50 million of the net proceeds from the offering to repurchase shares of its common stock concurrently with the closing of the offering from certain purchasers of the notes in privately negotiated transactions entered into through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"). The agreed to purchase price per share of the Company’s common stock in such share repurchases is equal to the last reported sale price of the Company’s common stock of $65.79 per share on the Nasdaq Global Select Market on January 25, 2021. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock. If the initial purchasers exercise their option to purchase additional notes in full, the Company expects to use approximately $8.0 million of the net proceeds from the sale of such additional notes to enter into additional capped call transactions. The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, which may include research and development and clinical development costs to support the advancement of the Company’s drug candidates, including the continued growth of the Company’s commercial and medical affairs capabilities, the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; repayment of outstanding indebtedness; general and administrative expenses; and other general corporate purposes. The Company may also use net proceeds to fund potential acquisitions of, or investments in, complementary businesses, products, services and technologies. The Company has not entered into any agreements or commitments with respect to any material acquisitions or investments at this time that would be financed with any of the net proceeds from the offering of notes. From time to time, to maintain or increase the Company’s ownership position in its subsidiaries, the Company may make additional investments in or purchase equity in its subsidiaries. These expectations and intentions are subject to change.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On January 25, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") reported that it intends to offer, subject to market conditions and other factors, $400 million aggregate principal amount of convertible senior notes due 2029 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, BridgeBio, JAN 25, 2021, View Source [SID1234576238]). In connection with the offering, the Company expects to grant the initial purchasers an option to purchase up to an additional $60 million aggregate principal amount of notes.

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The final terms of the notes, including the initial conversion rate, interest rate and certain other terms, will be determined at the time of pricing. The notes will bear interest semi-annually and will mature on February 1, 2029, unless earlier converted, redeemed or repurchased. Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The Company may not redeem the notes prior to February 6, 2026. On or after February 6, 2026 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated (including the Company’s 2.50% Convertible Senior Notes due 2027); effectively junior in right of payment to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

In connection with the pricing of the notes, the Company expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers and/or their respective affiliates or other financial institutions (the "option counterparties"). These capped call transactions are expected generally to reduce the potential dilution to the Company’s common stock upon any conversion of the notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction of potential dilution and/or offset of cash payments subject to a cap.

The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to the Company’s common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of the Company’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Company’s common stock and/or purchasing or selling the Company’s common stock or other securities of the Company in secondary market transactions following the pricing of the notes and prior to maturity of the notes (and are likely to do so following any conversion of the notes, any redemption date or any repurchase of the notes by the Company on any fundamental change repurchase date or otherwise, in each case, if the Company exercises the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of the Company’s common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares of the Company’s common stock, if any, and value of the consideration that holders will receive upon conversion of the notes.

Further, if any such capped call transactions fail to become effective, whether or not the offering of notes is completed, the option counterparties or their respective affiliates may unwind their hedge positions with respect to the Company’s common stock, which could adversely affect the value of the Company’s common stock and, if the notes have been issued, the value of the notes.

The Company intends to use a portion of the net proceeds from the offering of the notes to pay the cost of the capped call transactions, and up to approximately $50 million of the net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"). If the initial purchasers exercise their option to purchase additional notes, the Company expects to use a portion of the net proceeds from the sale of such additional notes to enter into additional capped call transactions.

The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, which may include research and development and clinical development costs to support the advancement of the Company’s drug candidates, including the continued growth of the Company’s commercial and medical affairs capabilities, the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; repayment of outstanding indebtedness; general and administrative expenses; and other general corporate purposes. The Company may also use net proceeds to fund potential acquisitions of, or investments in, complementary businesses, products, services and technologies. The Company has not entered into any agreements or commitments with respect to any material acquisitions or investments at this time that would be financed with any of the net proceeds from the offering of notes. From time to time, to maintain or increase the Company’s ownership position in its subsidiaries, the Company may make additional investments in or purchase equity in its subsidiaries. These expectations and intentions are subject to change.

The Company expects the purchase price per share of its common stock in the share repurchases to equal the last reported sale price per share of its common stock on the Nasdaq Global Select Market as of the date of the pricing of the notes. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On January 25, 2021 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: LMNGF) ("BioVaxys" or "Company") reported to provide a corporate update on recent advancements of its vaccine platforms, and viral diagnostic and corporate objectives for 2021 (Press release, BioVaxys Technology, JAN 25, 2021, View Source [SID1234575050]). BioVaxys is pleased to announce that it has commenced the clinical development program for BVX-0918A, its haptenized tumor antigen vaccine for ovarian cancer. The Company plans to seek a compassionate use approval in the European Union ("EU") for Stage III & Stage IV ovarian cancer, followed by submitting an IND in the US. BioVaxys is in discussions with its designated Contract Manufacturing Organization ("CMO") and anticipates the execution of a manufacturing contract in 1Q21. The Company plans to submit its Clinical Trial Application ("CTA") for BVX-0918A with the European Medicines Agency ("EMEA") later this year.

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There are significant unmet therapeutic needs for ovarian cancer treatment. Over 240,000 women are currently diagnosed with ovarian cancer worldwide, and over 140,200 succumbed to the disease. Ovarian cancer is the leading cause of death from gynecologic malignancy in the United States. An estimated 21,750 new cases of ovarian cancer are expected in the United States in 2020 with 13,940 deaths. The case-to-fatality ratio is nearly three times that of breast cancer and makes ovarian cancer the deadliest gynecologic malignancy in developed countries. Like other cancers, the stage of disease is inversely proportional to survival. The 5-year relative survival rate in all stages of the disease is approximately 45%. However, ovarian cancer is usually asymptomatic in the early stages (Stage I and Stage II), and therefore about 80% of patients are diagnosed with advanced stage disease (stages III and IV). The 5-year survival rate for stage III and IV patients is approximately 29%.[1]

BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying tumor or viral antigens with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response. In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, David Berd MD, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise. BioVaxys Founder, President & Chief Operating Officer Ken Kovan says: "The autologous approach may have advantages over other approaches, such as those involving a search for specific antigens. Because autologous tumor cells by definition have the patient’s unique set of antigens already on them, the challenge is to increase the immune system’s ability to recognize the ovarian tumor cells as foreign, breaking the "self-tolerance". A way to achieve this is by the use of a hapten, which is the foundation for the BioVaxys’ haptenized protein vaccine platform."

BioVaxys intends to develop its vaccine together with a "checkpoint inhibitor" that reduces or decreases the cellular function of an immune checkpoint gene or gene product. Checkpoint inhibitors are a type of drug that blocks proteins called ‘checkpoints’ that are made by some types of immune system cells, such as T cells and some cancer cells. These checkpoints help keep immune responses from being too strong, but also can sometimes keep T cells from killing cancer cells. When these checkpoints are blocked, T cells can more effectively kill cancer cells. BioVaxys’ focus is on combinations of immune checkpoint inhibitors with its haptenized tumor antigen vaccine—primarily anti-CTLA4, anti-PD1, or PDL1 checkpoint antibodies—for treatment of ovarian cancer and other solid tumors. BioVaxys’ rationale is that there is (1) a persistent unmet clinical need because the majority of ovarian cancer patients do not benefit from anti-checkpoint monotherapy; (2) evidence that not all patients make immune responses to their tumors; (3) evidence that immune responses to autologous tumor antigens can be induced by patient-specific vaccines; and (4) clinical evidence from the pre-checkpoint era that suggests survival can be positively impacted by such patient-specific vaccines.

BioVaxys also recently completed its preclinical program for its SARS-CoV-2 vaccine candidate, BVX-0320, which included those studies suggested by the U.S. Department of Health and Human Services, Food and Drug Administration ("FDA") Center for Biologics Evaluation and Research "(CBER") in their published guidance on Development and Licensure of Vaccines to Prevent COVID-19.

Source: (1) American Cancer Society, Cancer facts and figures; (2) Cannistra SA. Cancer of the Ovary. N Engl J Med 2004 Dec 9;351(24):2519-29; and (3) McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 1996;334(1):1-6.

The FDA’s non-binding Guidance is intended to assist in the clinical development and licensure of vaccines for the prevention of COVID-19, and reflect the Agency’s current thinking on the issue. Conducted by Charles River Laboratories, Inc. under contract with BioVaxys, the preclinical program which began in September 2020 evaluated the anti-virus immune response elicited by BVX-0320 in a controlled murine model by measuring the development of antibodies to the protein that binds the virus to human cells. Following two injections of BVX-0320 together with the immunological adjuvant, QS21, to 28 mice at four dosage levels, 96.4% developed positive antibody responses detected at week 6. The BioVaxys team also found that its haptenized SARS-CoV-2 s-spike vaccine activated CD4+ helper T-cells and CD8+ killer T-cells that express the activation markers, CD69 and CD25. This result indicates that immunization with BVX-0320 at two different dose levels of 3µg or 10µg stimulated immune system memory ‘helper’ T-cells as well as killer T-cells. CD4+ T-cells are crucial in achieving a regulated effective immune response to viral pathogens, and are central to adaptive immune responses. Generated following an immune response, memory ‘helper’ CD4+ T-cells retain information about the virus, which enables them to respond rapidly after viral exposure. CD8+ T-cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

Under a BioVaxys-sponsored research collaboration with The Ohio State University ("OSU") Wexner School of Medicine, the OSU researchers used the available remaining mouse sera from the immune response assay to conduct a Plaque Reduction Neutralization Test, where the endpoint is reduction of plaques by 50%, where it was observed in a pooled sample that BVX-0320 elicited the production of neutralizing antibodies to SARS-CoV-2. Plaques are produced by infection of cultured human cells by a live SARS-CoV-2 virus. OSU is one of the few institutions that has the laboratory capability to study live SARS-CoV-2 virus.

Recently, two new strains of SARS-Cov-2 have been identified in the UK and South Africa – B.1.1.7 and 501Y.V2, respectively. Both strains exhibit a number of mutations, some of them in the spike protein. The mutation of most concern, found in both new strains, is the one in spike protein position 501, one of the key contact points in the receptor binding domain. Experimental data suggest that this mutation, called 501Y, can increase binding of the virus to human cells through the ACE2 receptor. This change could result in more rapid transmission of the virus between individuals and thus more rapid spread of Covid-19. There is also concern that the recent approved vaccines may not be completely effective against these new strains.

The BioVaxys haptenization strategy constitutes a platform technology in that it is adaptable to almost any virus-derived protein. The haptenization of viral proteins imparts BioVaxys with the flexibility of a ‘cassette-type’ approach not possible with other vaccines, where they can "swap in" the appropriate viral antigen(s) for haptenization and the creation of a new vaccine, potentially allowing for faster development timelines relative to other vaccine approaches.

BioVaxys proposes to respond to these potentially dangerous events by modifying its Covid-19 vaccine, BVX-0320. The original version contained the S1 subunit of the spike protein that was dominant in viral isolates at the beginning of the pandemic. A new SARS-CoV-2 vaccine candidate, BVX-0121, is under internal evaluation which would include modifications to address the emerging strains. This would a bivalent or trivalent vaccine containing the original S1 plus the S1 from one or both of the UK and South African strains. The manufacturing process would be similar to that of BVX-0320. BioVaxys plans to collaborate with a pharma partner and jointly seek government funding for the Phase II program.

BioVaxys’ Covid-19 diagnostic, Covid-T, has the potential of detecting differences in T cells responses between the original virus and the two new strains. Current methods of measuring T cell immunity require the drawing of blood from the test subject and a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment. What is needed is a simple, low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2 to identify safe and at-risk populations. Covid-T provides a low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2, and to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity. Mass availability of this low cost and easy-to-administer T cell immunity diagnostic would complement antibody testing and various public health risk mitigation strategies.

Subjects would be simultaneously tested for delayed-type hypersensitivity to all three S1 variants. The size of the DTH reactions is compared for each subject. The Company has engaged a global regulatory advisory group, is contracting with an FDA-approved Contract Development and Manufacturing Organization (CDMO) for a cell line, expression system and cloning expertise to source GMP-grade s-1 protein, and is preparing an FDA pre-submission guidance package with delivery to the FDA anticipated shortly. A non-GMP animal toxicity study is scheduled for this March, followed by the proposed Phase I study this summer.

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

On January 25, 2021 EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that the Biologics License Application (BLA) for SYLVANT (siltuximab for injection) was accepted by the China National Medical Products Administration (NMPA) and granted priority review (Press release, BeiGene, JAN 25, 2021, View Source [SID1234575010]). Siltuximab is a monoclonal antibody approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). iMCD is a rare, life-threatening and debilitating condition of the lymph nodes and related tissues. Siltuximab is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.

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"The BLA acceptance of siltuximab for review, an important treatment approved in more than 40 countries worldwide for iMCD, is good news for Chinese patients with this rare condition," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "We’re glad to see continued progress in our collaboration with EUSA, which was built upon our shared commitment to bringing impactful therapies to patients in China and around the world."

Lee Morley, Chief Executive Officer of EUSA Pharma, said, "The BLA acceptance of siltuximab for review in China represents another exciting step in delivering therapies to patients in need worldwide. We will continue in our close collaboration with BeiGene and the NMPA to potentially bring siltuximab to iMCD patients in China."

About Siltuximab

Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions. Siltuximab (SYLVANT) is currently approved by the US Food and Drug Administration (FDA) and the European Commission (EC), as well as regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Indications and Usage – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.

On January 25, 2020 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN; the "Company" or "Biohaven"), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates reported preliminary net product revenue of NURTEC ODT (rimegepant) for the fourth quarter of 2020 (Press release, Biohaven Pharmaceutical, JAN 25, 2021, View Source [SID1234574529]).

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Based on preliminary unaudited financial information, the Company reported $35 million in net product revenue from sales of NURTEC ODT in the fourth quarter of 2020. Net product revenue increased by approximately 98% from the previous quarter. Total prescriptions of NURTEC ODT for the full year 2020 were over 337,000, with over 24,000 unique prescribers. There were no material changes in channel inventory between third and fourth quarter.

The foregoing information reflects the Company’s estimate with respect to net product revenue for NURTEC ODT based on currently available information which is preliminary and unaudited, is not a comprehensive statement of the Company’s financial results and is subject to completion of the Company’s financial closing procedures. The Company’s final results that will be issued upon completion of its closing procedures may vary from these preliminary estimates.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "The launch of NURTEC ODT continues to build strong momentum, despite continued headwinds from the pandemic, as reflected by strong fourth quarter net product revenue. We continue to hear positive feedback from patients and physicians regarding the important role that NURTEC ODT is playing in the acute treatment of migraine. The impressive market growth of NURTEC ODT reflects the significant unmet need that exists for patients suffering from the debilitating effects of acute migraine, our strong commercial and managed markets team, and the differentiated product label compared to competitors. We’re proud of our commercial and R&D team members who have been dedicated to delivering this important medication to patients despite the challenges of the past year."
BJ Jones, Chief Commercial Officer, added, "Even in the unprecedented market conditions of a global pandemic, our commercial team remained committed to the needs of patients suffering from migraine, creating demand and access to NURTEC ODT significantly outperforming our initial volume projections during the first three quarters of launch. We look forward to continuing to grow the market for NURTEC ODT in the acute treatment of migraine, especially as in-market dynamics improve as the vaccines roll out and the impact of the COVID-19 pandemic is expected to attenuate later this year."
Rimegepant was approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in February 2020, with commercial launch commencing the second week of March. Rimegepant is marketed as NURTEC ODT, and is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in an orally disintegrating tablet (ODT) designed for rapid onset of action and sustained efficacy for 48 hours.