On July 12, 2020 Amgen (NASDAQ:AMGN) reported an additional investment of approximately $421 million in BeiGene’s registered direct offering of ordinary shares, which maintains Amgen’s current pro rata ownership of BeiGene at approximately 20.3% (Press release, Amgen, JUL 12, 2020, View Source [SID1234561838]). This additional investment reflects Amgen’s confidence in the progress the companies are making in their ongoing oncology collaboration in China, the world’s second largest pharmaceutical market.

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On July 12, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the pricing of a registered direct offering of 145,838,979 ordinary shares, par value $0.0001 per share (the "Ordinary Shares"), to certain existing investors (Press release, BeiGene, JUL 12, 2020, View Source [SID1234561820]).

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Each Ordinary Share is being sold for a purchase price of $14.2308 per share (equivalent to a price of $185 per American Depositary Share ("ADS"), resulting in gross proceeds of approximately $2.08 billion and net proceeds, after estimated offering expenses, of $2.07 billion. The offering is being made without an underwriter or a placement agent and as a result the Company will not be paying any underwriting discounts in connection with this offering.

The offering is expected to close on or about July 15, 2020, subject to customary closing conditions. BeiGene intends to use the net proceeds from the offering for working capital and other general corporate purposes, as disclosed in further detail in the prospectus supplement to be filed in connection with the offering.

The Ordinary Shares were offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on May 11, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

Credit Suisse is acting as corporate finance advisor to the pricing committee of the Board of Directors of BeiGene in connection with this offering. Goodwin Procter LLP is acting as legal counsel to BeiGene in connection with this offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Ordinary Shares, nor shall there be any sale of the Ordinary Shares 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 July 10, 2020 Takeda reported that Adcetris (brentuximab vedotin) has won the backing of the National Institute for Health and Care Excellence (NICE) as a treatment for untreated systemic anaplastic large cell lymphoma (sALCL), a rare type of lymphoma (Press release, Takeda, JUL 10, 2020, View Source [SID1234561815]).

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The decision allows NHS funding for the drug alongside cyclophosphamide, doxorubicin and prednisone (CHP), giving patients access to the first new front-line treatment option for the condition in several decades.

To date, frontline treatment for newly diagnosed sALCL patients has typically been multi-agent chemotherapy, such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), which is generally associated with poor outcomes, with many patients failing to achieve long-term survival, the firm notes.

In the clinical trial ECHELON-2, Adcetris plus CHP demonstrated superior progression-free survival and overall survival versus CHOP in the sALCL patient population, which corresponded to a 41% reduction in the risk of a progression event and a 46% reduction in the risk of death.

Adcetris in combination with CHP also demonstrated versus CHOP: a higher rate of objective response (88% vs. 71%); a higher rate of complete response (71% vs 53%); and a comparable safety profile, with a similar incidence of peripheral neuropathy (52% vs 55%) and febrile neutropenia (18% vs 15%).

"The data seen in this large Phase III randomised trial with brentuximab vedotin plus CHP in the untreated sALCL patient population is practice changing and has the potential to significantly improve the chance of survival for patients. This is the first large randomised study in T cell lymphoma to show real clinical benefits, providing new hope for patients fighting this aggressive disease," commented Tim Illidge, Professor of Targeted Therapy and Oncology at The Christie NHS Foundation Trust.

"Brentuximab vedotin is a medicine that continues to innovate and transform the treatment paradigm for patients with rare types of lymphoma," added Jon Neal, managing director, Takeda UK & Ireland. "We are committed to working in partnership with the clinical and patient community, and NICE and NHS England, to ensure as many eligible patients can benefit from access to this medicine as possible."

Adcetris is already available as a monotherapy for adult patients with relapsed/refractory sALCL in England, Wales and Northern Ireland after failure of at least one chemotherapy agent.

On July 10, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, reported that ITM has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, which is manufactured at the RadioMedix Spica Center in Houston, Texas, U.S. and distributed under the brand name GeGant (Press release, ITM Isotopen Technologien Munchen, JUL 10, 2020, View Source [SID1234561814]).

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The RadioMedix Spica Center is a 21 CFR 211 compliant, and GMP radiopharmaceutical manufacturing facility dedicated to late-stage investigational and commercial stage radiopharmaceutical manufacturing and distribution. Thousands of 68Ge/68Ga Generators can be produced, annually at this center. This high production capacity enables us to meet the rapidly increasing demand for Gallium-68 in the United States.

The medical, short-lived radioisotope Gallium-68 is used for Positron Emission Tomography (PET) imaging when labeled to a tumor-specific targeting molecule for diagnosis and staging of various cancers, like neuroendocrine tumors or prostate cancer, and for evaluation of response to therapy. PET-imaging is an excellent approach for healthcare professionals looking for precise localization in diagnostic imaging. GeGant allows fast and convenient onsite production of high-quality Gallium-68 for radiolabeling. As well as showing a low breakthrough of Germanium-68, GeGant is available in the sizes of 1 GBq (30 mCi), 2 GBq (50 mCi), and 4 GBq (100 mCi), being among the largest 68Ge/68Ga Generators on the market.

"We are living in an exciting time in the field of nuclear medicine and the menu of targeted PET imaging agents will only grow. 68Ga is among the most important players in this field" said Dr. Ebrahim Delpassand, CEO of RadioMedix. "We are excited to be able to accomplish this milestone in collaboration with our long-term partner ITM, Germany. RadioMedix will be the manufacturer of ITM 68Ge/68Ga Generators, for the first time in the United States. Our high manufacturing capacity will address the significant shortage of this essential device in the market and increases patients’ access to a variety of 68Ga labeled radiopharmaceuticals in the field of oncology." continued Dr. Delpassand.

Steffen Schuster, CEO of ITM said: "We are very pleased to see this DMF submission in the U.S. has taken our close and long-term partnership with RadioMedix to a new level and will enable us to take full advantage of RadioMedix’s great production opportunities." Steffen Schuster added: "With RadioMedix as our strategic partner, we are looking forward to GeGant significantly increasing the availability of Gallium-68 in the U.S. We are confident that we can make a substantial contribution to meeting the growing demand of Targeted Radionuclide Therapies and Diagnostics within the U.S. market."

About GeGant
GeGant is a next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator allowing fast and convenient onsite-production of the short-lived, medical radioisotope Gallium-68 (68Ga), used in Targeted Radionuclide Therapy for diagnosis and staging of cancers like neuroendocrine tumors or prostate cancer. 68Ga is a radiopharmaceutical precursor, and it is not intended for direct use in patients. Conjugated to a tumor-specific targeting molecule (e.g. peptide or antibody), Gallium-68 is applied for diagnostic imaging via positron emission tomography (PET). It is to be used only for the radiolabeling of targeting molecules that have been specifically developed and authorized for radiolabeling with 68Ga. 68Ga-PET-imaging is an excellent approach for healthcare professionals looking for precise localization in diagnostic imaging. As well as for diagnosis and staging of tumors, Gallium-68 based imaging is used for therapy planning and dosimetry in preparation for Targeted Radionuclide Therapy with its therapeutic companion radioisotope Lutetium-177.

GeGant is a fully shielded source of high-quality Gallium-68 available in different sizes from 1 to 4 GBq, making it the largest 68Ge/68Ga Generator on the market. Gallium-68 is continuously produced by decay of its parent radioisotope Germanium-68 and eluted with low acidic hydrochloric acid. It is suitable for radiolabeling of tumor-specific targeting molecules without prior prepurification.

On July 10, 2020, Caladrius Biosciences, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited investors (the "Purchasers") (Filing, 8-K, Caladrius Biosciences, JUL 10, 2020, View Source [SID1234561812]). Pursuant to the terms of the Purchase Agreement, the Company agreed to sell to the Purchasers an aggregate of (i) 969,694 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock") and (ii) warrants to purchase up to an aggregate of 484,847 shares of Common Stock (the "Warrants"), at a purchase price equal to $2.0625 per share and accompanying Warrant. The Warrants are exercisable immediately upon issuance and will expire five and one-half years from the issuance date.

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The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), termination provisions, and other obligations and rights of the parties. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

In connection with the offering, the Company entered into a Registration Rights Agreement (the "Registration Rights Agreement") with the Purchasers, pursuant to which the Company is obligated, among other things, to (i) file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") following the closing of the offering for purposes of registering the Shares and the shares of Common Stock issuable upon the exercise of the Warrants (the "Warrant Shares") for resale by the Purchasers, (ii) use its commercially reasonable efforts to have the registration statement declared effective promptly after filing, and in any event no later than 90 days after the closing of the offering (or 120 days after the closing of the offering if the registration statement is reviewed by the SEC), and (iii) maintain the registration until all registrable securities (a) have been sold pursuant to the registration statement or Rule 144 or (b) may be sold pursuant to Rule 144 under the Securities Act, without restriction as to volume. The Registration Rights Agreement contains customary terms and conditions for a transaction of this type, including certain customary cash penalties on the Company for its failure to satisfy specified filing and effectiveness time periods.

The offering is exempt from registration pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) the Securities Act and Regulation D under the Securities Act. The Shares, the Warrants and the Warrant Shares being sold and issued in connection with the Purchase Agreement are not registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from the registration requirements. Each purchaser will be an "accredited investor" as such term is defined in Rule 501(a) under the Securities Act. The Warrants are not and will not be listed for trading on any national securities exchange.

The net proceeds to the Company from the private placement are expected to be approximately $1.98 million, after deducting estimated offering expenses payable by the Company. The private placement is expected to close on or about July 13, 2020, subject to satisfaction of customary closing conditions.