On January 12, 2021 Boston Scientific Corporation (NYSE: BSX) reported that net sales, based upon preliminary unaudited financial information, of approximately $2.71 billion during the fourth quarter of 2020 (Press release, Boston Scientific, JAN 12, 2021, View Source [SID1234573937]). This represents a decline of approximately (6.8) percent on a reported basis, approximately (8.3) percent on an operational1 basis and approximately (8.0) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 370 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.

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For the full year 2020, the company generated net sales, based upon preliminary unaudited financial information, of approximately $9.91 billion. This represents a decline of approximately (7.7) percent on a reported basis, approximately (7.8) percent on an operational basis and approximately (11.3) percent on an organic basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact from WATCHMAN discussed above.

Fourth quarter preliminary financial results and recent developments:

Delivered the following fourth quarter sales growth/(declines) in each reportable segment3 compared to the prior year period:
MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic

Accelerated sequential organic growth in the Peripheral Interventions business (4.8 percent organic growth), including 12 percent growth within the Interventional Medicine3 portfolio.

Returned to growth in the MedSurg reportable segment3 (1.1 percent organic growth) in the fourth quarter, driven by recovering procedural trends and favorable site of service mix. This includes a broad-based recovery in the Endoscopy business (1.5 percent organic growth), and growth within the stone and benign prostatic hyperplasia (BPH) franchises in Urology and Pelvic Health (0.6 percent organic growth).

WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device portfolio experienced strong customer demand in the fourth quarter. Organic sales declined 56 percent, which includes a negative 74 percent impact due to the conversion to a consignment inventory model and transition discussed above, and surpassed 150,000 cumulative implants worldwide.

Achieved key milestones for the Neuromodulation business with the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems including recent U.S. Food and Drug Administration (FDA) approval and third quarter 2020 launch in Europe.
J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021
Also as previously announced, Boston Scientific will participate in the virtual J.P. Morgan Healthcare Conference today. Mike Mahoney, chairman and chief executive officer, will present at approximately 8:20 a.m. EST. At 8:40 a.m. EST, Mike will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst and audience members.

A live webcast of the presentation and question-and-answer session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Conference Call on Wednesday, February 3, 2021
As previously announced, Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year 2020 on Wednesday, February 3, 2021 at 8:00 a.m. EST. A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com. A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On January 12, 2021 Dragonfly Therapeutics ("Dragonfly"), a biotechnology company developing new immunotherapies that harness the innate immune system to treat disease, reported that AbbVie (NYSE: ABBV ) has licensed its first drug candidate TriNKET from Dragonfly, part of a multi-objective collaboration started in November 2019 designed to advance a series of new immunotherapies based on Dragonfly NK cell implicators for autoimmune and oncological indications (Press release, Dragonfly Therapeutics, JAN 12, 2021, View Source;876043116.html [SID1234573935]).

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"AbbVie is committed to providing improved treatment options for our patients," said Tom Hudson , MD, senior vice president of R&D and chief science officer for AbbVie. "The collaboration with Dragonfly has been remarkable. Working together, the teams have made rapid progress to develop this first TriNKET in record time."

"AbbVie is a global leader in the treatment of immune diseases," said Bill Haney , co-founder and CEO of Dragonfly. "They are a terrifying partner and this membership, as soon as we launch our collaboration, is a huge vote of confidence. We look forward to continued success and rapid progress with the AbbVie team to advance new treatment options for patients."

The listing grants AbbVie exclusive global intellectual property rights to develop and commercialize products targeting this first specific goal, developed using Dragonfly’s TriNKET technology platform. Dragonfly will receive a membership payment, as well as potential future development milestone payments and royalties from the sales of marketed candidates.

On January 12, 2021 Biond Biologics Ltd. ("Biond" or the "Company"), a privately-held biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that it has entered into an exclusive worldwide license agreement with Sanofi (EURONEXT: SAN) (NASDAQ: SNY), for the development and commercialization of BND-22 (Press release, Biond Biologics, JAN 12, 2021, View Source [SID1234573934]).

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BND-22 is a humanized IgG4, antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds MHC class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types.

Under the terms of the agreement, Biond will receive a $125 million upfront payment in cash and will be entitled to receive more than $1 billion in development, regulatory, and sales milestones, as well as tiered double digit royalty payments. Biond will lead the first-in-human, phase 1a study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring potential associations between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.

BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating natural killer (NK) and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials. An Investigational New Drug (IND) application for BND-22 has recently been submitted to FDA and a phase 1 study to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 in advanced cancer patients is planned to start by mid-2021.

"We are thrilled to partner with Sanofi, an organization with a global footprint and exceptional drug development and commercialization capabilities," said Ori Shilo, Co-Founder and Chief Financial Officer at Biond. "We believe this collaboration creates substantial value for our shareholders and validates Biond’s long term strategy to establish valuable partnerships with leading biopharmaceutical companies."

"The emphasis in the development of cancer immunotherapies has been placed so far mainly on drugs that stimulate the adaptive immune system to attack malignant cells, in particular T lymphocytes. Unfortunately, many advanced cancer patients do not derive a durable benefit from these drugs," said Tehila Ben-Moshe, Ph.D., Co-Founder and Chief Executive Officer at Biond. "Biond Biologics was founded with a unique model that enables focused development of breakthrough cancer therapies, reaching clinical trials more quickly. BND-22, the first clinical drug candidate to graduate Biond’s development model, is a novel immunotherapy that targets both adaptive and innate immune cells and takes advantage of the anti-tumor activity of not only T cells but also that of additional immune cells, such as NK cells and macrophages. We look forward to progressing BND-22 into the clinic together with our new partner Sanofi, using our in-depth knowledge of the ILT2 pathway and expertise in immuno-oncology."

On January 12, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 3,188,776 American Depositary Shares (ADSs) of the Company, at a price to the public of $7.84 per ADS, less underwriting discounts and commissions (Press release, RedHill Biopharma, JAN 12, 2021, View Source [SID1234573933]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about January 14, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to additional 478,316 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be approximately $25 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-226278) previously filed with the Securities and Exchange Commission (the "SEC") on July 23, 2018 and declared effective by the SEC on July 31, 2018. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered have been filed with the SEC and are available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and , upon filing, may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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

On January 12, 2021 Amgen (NASDAQ:AMGN) reported new data from its oncology pipeline in lung cancer will be presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer taking place virtually from Jan. 28-31, 2021 (Press release, Amgen, JAN 12, 2021, View Source [SID1234573932]).

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Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib (AMG 510) in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will be presented as part of the WCLC Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29. Additionally, updated Phase 1 data from AMG 757, an investigational first-in-class BiTE molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC), will also be presented in an oral presentation.

"We are incredibly excited to present the first complete Phase 2 non-small cell lung cancer data set for an investigational KRASG12C inhibitor, including novel biomarker analyses," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This is an historic moment not only for us, but for the scientific community working on the 40-year quest to target KRAS, one of cancer research’s toughest challenges. Additionally, following recent regulatory submissions to the FDA and European Medicines Agency, we remain focused on rapidly bringing this potential foundational KRAS G12C therapy to patients with advanced non-small cell lung cancer harboring this mutation."

"KRAS G12C is one of the most common driver mutations in non-small cell lung cancer; each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated non-small cell lung cancer," said Suresh S. Ramalingam, M.D., deputy director of Winship Cancer Institute at Emory University in Atlanta. "The sotorasib data that will be presented at WCLC represents an important step forward in addressing the high unmet need for patients with this mutation."

Abstracts not featured in the Presidential Symposium are available at View Source

Learn more about how Amgen Oncology is advancing its pioneering science with the relentless pursuit of innovative modalities and unique pathways for cancer patients and their families at AmgenOncology.com/medical.

Clinical Abstracts and Presentation Times:

Registrational Phase 2 Trial of Sotorasib in KRAS p.G12C Mutant NSCLC: First Disclosure of the CodeBreaK 100 Primary Analysis
Presentation #PS01.07, Presidential Symposium, Saturday, Jan. 30 from 7:50-8 a.m. SGT / Friday, Jan. 29 from 3:50-4 p.m. PST
Clinical Characteristics and Outcomes in Advanced KRAS Mutant NSCLC – A Multi-Centre Collaboration in Asia (ATORG-005)
Presentation #MA04.06, Mini-oral Presentation, Friday, Jan. 29 from 5:15-5:20 p.m. SGT / Friday, Jan. 29 from 1:15-1:20 a.m. PST
A Phase 1 Study of AMG 757, Half-Life Extended Bispecific T-Cell Engager (BiTE) Immune Therapy Against DLL3, in SCLC
Presentation #OA11.03, Oral Presentation, Sunday, Jan. 31 from 3:30-3:40 p.m. SGT / Saturday, Jan. 30 from 11:30-11:40 p.m. PST
AMG 757, a Half-Life Extended Bispecific T-Cell Engager (HLE BiTE Immuno-Oncology Therapy) Targeting DLL3, for the Treatment of Small Cell Lung Cancer
Presentation #P15.01, e-Poster Presentation
Amgen Webcast Investor Call
Amgen will host a webcast call for the investment community in conjunction with WCLC 2020. On Friday, Jan. 29, 2021 at 5 p.m. PST, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical trial investigators, will discuss the registrational Phase 2 NSCLC data being presented on the Company’s investigational KRASG12C inhibitor sotorasib.

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.

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.

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.1 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning four continents. In just over two years, the sotorasib clinical program CodeBreaK has established the deepest clinical data set with nearly 700 patients studied across 13 tumor types.

Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.1

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST 1.1 at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC patients (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b sotorasib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient’s own T cells to any tumor-associated antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-associated antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.