On February 21, 2020, Amgen Inc. (the "Company") reported that issued and sold $500,000,000 aggregate principal amount of its 1.900% Senior Notes due 2025 (the "2025 Notes"), $750,000,000 aggregate principal amount of its 2.200% Senior Notes due 2027 (the "2027 Notes"), $1,250,000,000 aggregate principal amount of its 2.450% Senior Notes due 2030 (the "2030 Notes"), $1,250,000,000 aggregate principal amount of its 3.150% Senior Notes due 2040 (the "2040 Notes") and $1,250,000,000 aggregate principal amount of its 3.375% Senior Notes due 2050 (the "2050 Notes" and, together with the 2025 Notes, the 2027 Notes, the 2030 Notes and the 2040 Notes, the "Notes") (Filing, 8-K, Amgen, FEB 21, 2020, View Source [SID1234554611]). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-236351) (the "Registration Statement"), filed on February 10, 2020, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of February 21, 2020 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $4,955,763,600, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2025 Notes will pay interest at the rate of 1.900% per annum, the 2027 Notes will pay interest at the rate of 2.200% per annum, the 2030 Notes will pay interest at the rate of 2.450% per annum, the 2040 Notes will pay interest at the rate of 3.150% per annum and the 2050 Notes will pay interest at the rate of 3.375% per annum, which, in each case, shall be payable in cash semi-annually in arrears on February 21 and August 21 of each year, beginning on August 21, 2020. The 2025 Notes will mature on February 21, 2025, the 2027 Notes will mature on February 21, 2027, the 2030 Notes will mature on February 21, 2030, the 2040 Notes will mature on February 21, 2040 and the 2050 Notes will mature on February 21, 2050.

In the event of a change in control triggering event, as defined in the Officer’s Certificate attached hereto as Exhibit 4.2, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

On February 21, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis" or the "Company") reported it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $6.7 million of its common stock in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement (Press release, Adamis Pharmaceuticals, FEB 21, 2020, View Source [SID1234554612]). The combined purchase price for one share of common stock and 0.75 warrants will be $0.58.

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Under the terms of the purchase agreement, Adamis has agreed to sell 11,600,000 shares of its common stock. In a concurrent private placement, Adamis has agreed to issue warrants to purchase up to an aggregate of 8,700,000 shares of common stock. The warrants will be exercisable commencing on the later of (i) six months from the date of issuance or (ii) the date that Adamis’ stockholders approve either an increase in the number of Adamis’ authorized shares of common stock or a reverse stock split, in either case in an amount sufficient to permit the exercise in full of all of the warrants, will expire on the five year anniversary of the initial exercise date and will have an exercise price of $0.70 per share.

The gross proceeds to the Company from the registered direct offering and concurrent private placement are expected to be approximately $6.7 million before deducting the placement agents’ fees and other estimated offering expenses. The registered direct offering and concurrent private placement is expected to close on or about February 25, 2020, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The common shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-226100) previously filed and declared effective by the Securities and Exchange Commission (SEC). The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Adamis Pharmaceuticals with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

On February 21, 2020 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Full Year Report for 2019 (Press release, Affibody, FEB 21, 2020, View Source [SID1234575699]).

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Financial Highlights

Revenue for the 4th Quarter 2019 amounted to SEK 17.2 (29.5) m, and to 311.8 (114.6) m for the full year
Operating result for the quarter amounted to SEK -66.1 (-23.6) m, and to 44.8 (-127.4) m for the full year
Net result for the quarter amounted to SEK -72.9 (-23.8) m, and to 43.9 (-127.2) for the full year
Cash flow for the quarter amounted to SEK -14.4 (-65.1) m, and to 283.8 (-150.4) m for the full year
Cash and cash equivalents at the end of the period amounted to SEK 374.8 (91.0) m.
Significant Events during the rest of the Year

In September Affibody announced its relocation to Campus Solna
In September a strategic collaboration with GE Healthcare to develop and commercialize Affibody-based PET imaging tracers, with initial focus on HER2 and PD-L1, was announced
In July, 2019 the completion of the planned 12 week interim analysis in the Company’s Phase 2 proof-of-concept study of its bispecific molecule ABY-035 for moderate-to-severe psoriasis ("AFFIRM-35") was announced.
The share issue was completed and fully subscribed in May and brought gross proceeds of SEK 147.4 m to the company
In March, a partnership with Alexion Pharmaceuticals, Inc. to co-develop ABY-039, was announced. Under the terms of the agreement, Alexion has provided Affibody with an upfront payment of $25 million, with the potential for additional development- and sales-based milestones of up to $625 million and tiered low double-digit royalty payments. Alexion will lead joint clinical development of ABY-039 and commercialization activities. Affibody has the option to co-promote ABY-039 in the U.S. and will lead clinical development for an undisclosed indication
In February, the Phase 2 proof-of-concept study of ABY-035 for moderate-to-severe psoriasis completed enrollment of patients.
Significant Events after the close of the Reporting Period

An EGM on February 17, 2020 elected José Suarez as Board member.
Affibody is a clinical stage Swedish biotech company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod.

The company operates a focused experimental medicine model and currently has three clinical stage programs. The first two are therapeutic programs that targets psoriasis, and B-cell driven autoimmune diseases respectively. The third program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

On February 21, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO), together with affiliate company Eidos Therapeutics (Nasdaq: EIDX) reported that they are presenting at two upcoming investor conferences (Press release, BridgeBio, FEB 21, 2020, View Source [SID1234576231]):

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The SVB Leerink Annual Global Healthcare Conference on Tuesday, February 25, 2020 at 1PM (EST) in New York.
The Cowen and Company Annual Health Care Conference on Wednesday, March 4, 2020 at 9:20AM (EST) in Boston.
The presentations will be webcast live and can be accessed at www.bridgebio.com on the For Investors page under News & Events. The webcast will be available for replay for 30 days.

On February 21, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval for an additional indication of an anticancer agent/tyrosine kinase inhibitor, Rozlytrek (generic name: entrectinib) for the treatment of ROS1 fusion-positive, unresectable, advanced or metastatic non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare (MHLW) (Press release, Chugai, FEB 21, 2020, View Source [SID1234554593]).

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"We are very pleased to announce the approval of Rozlytrek for the treatment in adults with ROS1 fusion-positive NSCLC. Rozlytrek was launched last year as Chugai’s first product to embody advanced personalized healthcare for the treatment of patients with NTRK fusion-positive solid tumors regardless of their age or site of origin," said Dr. Osamu Okuda, Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "ROS1 is an important cancer-driver gene found in 1 to 2% of patients with NSCLC. Offering Rozlytrek as a new treatment option for ROS1 fusion-positive NSCLC patients, we will continue making efforts to contribute to the progress in advanced personalized medicine."

This approval is based mainly on the results of an open-label, multicenter, global phase II STARTRK-2 study. Efficacy was evaluated in ROS1 fusion-positive NSCLC cohort from the STARTRK-2 study while safety was evaluated in two overseas phase I studies (STARTRK-1 study and ALKA-372-001 study) in addition to STARTRK-2 study.

FoundationOne CDx Cancer Genomic Profile is used as a companion diagnostic to identify people that could potentially benefit from Rozlyterk for the ROS1 fusion-positive, unresectable, advanced or metastatic NSCLC. The MHLW granted the approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of Rozlytrek on December 25, 2019.

As a leading company in the field of oncology, Chugai is committed to contribute to patients and medical professionals through realization of advanced personalized healthcare.

[Reference information]
Chugai Obtains Approval for Expanded Use of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Rozlytrek for ROS1-positive Lung Cancer (A press release issued by Chugai on December 26, 2019)
View Source

Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer (A press release issued by Roche on September 24, 2018)
View Source

Approval information The underlined part has been newly added.

Product name Rozlytrek Capsules 100 mg
Rozlytrek Capsules 200 mg
Generic name entrectinib
Indications NTRK fusion-positive advanced or metastatic solid tumors
ROS1 fusion gene positive, unresectable, advanced or metastatic non-small cell lung cancer
Dosage and administration
In case of patients with NTRK fusion-positive advanced or metastatic solid tumors.
The usual adult dosage is 600 mg entrectinib administered orally once a day. Reduce the dose as necessary depending on the patient’s condition.
The usual pediatric dosage is 300 mg/m2 (body surface area) entrectinib administered orally once a day. However, the dose should not exceed 600 mg. Reduce the dose as necessary depending on the patient’s condition.
In case of patients with ROS1 fusion gene positive, unresectable, advanced or metastatic non-small cell lung cancer.
The usual adult dosage is 600 mg entrectinib administered orally once a day. Reduce the dose as necessary depending on the patient’s condition.
Conditions for approval
A risk management plan should be created and appropriately implemented.
Given that the number of patients in clinical studies in Japan was extremely limited, post-marketing drug use surveillance of all patients receiving Rozlytrek should be conducted until data for a certain number of patients have been accumulated, in order to understand background information on patients receiving Rozlytrek, collect early data on the safety and efficacy of Rozlytrek, and take necessary measures for appropriate use of Rozlytrek.
About Rozlytrek
Rozlytrek is an oral tyrosine kinase inhibitor that blocks ROS1 (c-ros oncogene 1) and TRK (neurotrophin receptors) family strongly and selectively. It blocks ROS1 and TRK kinase activity, and inhibits proliferation of cancer cells with ROS1 or NTRK gene fusions. Rozlytrek was approved for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 gene fusions in June 18, 2019 and was launched in September 4, 2019.

About ROS1 fusion-positive NSCLC
ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes (CD74, etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is thought to promote cancer cell proliferation. ROS1 fusion gene is found in about 1 to 2% of NSCLC, among which it is more expressed in adenocarcinoma.1)

Trademarks used or mentioned in this release are protected by law.