On July 6, 2021 AstraZeneca reported it’s proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion) has achieved an important step towards completion by having cleared the European Commission review (Press release, AstraZeneca, JUL 6, 2021, View Source [SID1234584609]).

The clearance follows competition clearances in the United States, Japan and other countries globally, with a complete list available on astrazeneca.com. Regulatory clearance in the UK is pending and remains a requirement to complete the deal.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: "We are pleased to have secured clearance from the European Commission for the proposed acquisition of Alexion, a pioneer in the discovery and development of medicines for rare diseases. We are now another step closer to closing the acquisition and combining the two companies to create a leader in immunology and precision medicines. We continue to progress towards the completion of the acquisition during this quarter."

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platform and an extensive pipeline. Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical needs. Shareholders of both companies overwhelmingly supported the acquisition by their votes on 11 May 2021.

Subject to completing the acquisition, a group focusing on rare diseases will be created. This group will be named ‘Alexion, AstraZeneca Rare Disease’, and will be headquartered in Boston, US.

Rare diseases
Over 7,000 rare diseases are known today, and only approximately 5% have treatments approved by the US Food and Drug Administration.1 Demand in medicines for rare diseases is forecasted to grow by a low double-digit percentage in the future.2

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 with the SEC on 12 April 2021 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus), Alexion filed a proxy statement with the SEC (the proxy statement) on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC. Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available, because they will contain important information. Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus or the proxy statement free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

The documents filed by AstraZeneca with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on AstraZeneca’s website at View Source under the tab "Investors". The documents filed by Alexion with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on Alexion’s internet website at View Source under the tab, "Investors" and under the heading "SEC Filings" or by contacting Alexion’s Investor Relations Department at [email protected].

Important notices relating to financial advisors
Evercore Partners International LLP (Evercore), which is authorised and regulated by the Financial Conduct Authority (FCA) in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement. Neither Evercore nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability, or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise. Apart from the responsibilities and liabilities, if any, which may be imposed on Evercore by the Financial Services and Markets Act 2000 (FSMA), or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Evercore nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. To the fullest extent permitted by applicable law, each of Evercore and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement, or any statement contained in this announcement.

Centerview Partners UK LLP (Centerview Partners), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement. Neither Centerview Partners nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability, or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise. Apart from the responsibilities and liabilities, if any, which may be imposed on Centerview Partners by the FSMA, or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Centerview Partners nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in this announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. To the fullest extent permitted by applicable law, each of Centerview Partners and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement, or any statement contained in this announcement.

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On July 6, 2021 Advaxis, Inc. ("Advaxis") (NASDAQ: ADXS) and Biosight Ltd. ("Biosight"), a privately held pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported that the companies have entered into a definitive merger agreement pursuant to which the shareholders of Biosight will become the majority holders of the combined company immediately following completion of the transaction (Press release, Advaxis, JUL 6, 2021, View Source [SID1234584608]). The proposed merger will create a public company that will prioritize the clinical advancement and commercialization of Biosight’s lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents and marketable securities at closing. Following the closing, which is expected to occur in the second half of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol "BSTX".

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The combined company plans to advance its pipeline through multiple clinical trials, and anticipates the following milestones over the next 12-18 months:

Topline results from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in AML patients who are unfit for standard chemotherapy
Recent data presented at ASCO (Free ASCO Whitepaper) showed that aspacytarabine achieved complete remission (CR) rates of 39% across all evaluable patients (n=46) with 63% of cases with negative minimal residual disease (MRD(-)) and median overall survival (OS) of 10 months at present (95% CI, 6- NR). Altogether these results are encouraging considering the high risk factors in this population at baseline;
Results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS);
Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;
Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and
Results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer
"After an extensive and thorough review of strategic and potentially transformative options for Advaxis, we are very pleased to announce a proposed merger with Biosight," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "We believe the combined company’s strong and diversified oncology pipeline with late stage and early stage assets, near-term milestones, seasoned leadership team and focus on both hematological malignancies and solid tumors have the potential to provide transformative benefits to patients while also providing value to our stockholders."

"The proposed merger with Advaxis is a unique opportunity for Biosight to build a leading public company in oncology, with a diversified clinical pipeline in both hematological malignancies and solid tumors. The combined company will have the demonstrated expertise and strong balance sheet to advance its lead programs towards multiple anticipated milestones over the next 12 to 18 months," said Dr. Ruth Ben Yakar, CEO of Biosight. "I would like to express my deepest appreciation to the wonderful Biosight team, including Dr. Liat Flaishon and Dr. Shoshi Tessler who lead our R&D activities, and Dr. Stela Gengrinovitch, the founder of the company. The excellent work and dedication of the entire Biosight team enabled the significant achievements. I would also like to thank our Board of Directors and Shareholders for their support over the years."

About the Proposed Merger
Pursuant to the merger agreement, Advaxis will acquire all of the outstanding share capital of Biosight in exchange for the issuance of newly issued shares of Advaxis common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the receipt of the required approval of the Advaxis stockholders and Biosight stockholders and certain regulatory approvals. Upon completion of the merger, Advaxis’s then-current equity holders will own approximately 25% and the former Biosight equity holders will own approximately 75% percent of Advaxis’s common stock, calculated on a fully diluted basis.

The transaction has been unanimously approved by the board of directors of both companies. The combined company will be headquartered out of new facilities expected to be located in New Jersey and will continue to maintain its presence in Israel.

LifeSci Capital LLC acted as exclusive financial advisor to Advaxis. Morgan, Lewis & Bockius LLP and Herzog Fox & Neeman are serving as legal counsel to Advaxis. White & Case and Horn & Co. are serving as legal counsel to Biosight.

Management and Organization
Effective as of the closing of the transaction, Ken Berlin will be the President and Chief Executive Officer of the combined company. Senior leadership of the combined company will also include Roy Golan, as Chief Financial Officer, Andres Gutierrez, M.D., Ph.D., and Darrel Cohen, M.D., Ph.D. as Chief Medical Officers. Additionally, effective as of the closing of the merger, the Board of Directors of the combined company will be comprised of nine directors: six designated by Biosight and two to be designated by Advaxis, and Dr. David Sidransky will be nominated as Chairman of the Board.

Conference Call Details
Biosight and Advaxis will host a live conference call and webcast on Tuesday, July 6, 2021, at 8:30 am EDT to discuss the proposed transaction. To access the call, please dial 877-407-0784 (toll-free) or 201-689-8560 (international) and provide the conference ID 13721200.

To access the live webcasts and subsequent archived recordings of these and other company presentations, please visit the investor section of Advaxis’s website at www.Advaxis.com or Biosight’s website at www.Biosight-pharma.com. The archived webcasts will remain available for replay on Advaxis’s and Biosight’s websites for 90 days.

On July 5, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUL 6, 2021, View Source [SID1234584606]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 28 June 2021, the following transactions have been made:

Number of

With the transactions stated above, Novo Nordisk owns a total of 15,247,509 B shares of DKK 0.20 as treasury shares, corresponding to 0.7% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 2 July 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 16,409,011 B shares at an average share price of DKK 463.58 per B share equal to a transaction value of DKK 7,606,952,576.

On July 6, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that it has initiated a Phase I study of HMPL-295, its investigative and highly selective oral inhibitor of ERK, which is a downstream component of the RAS-MAPK1 pathway signaling cascade (Press release, Hutchison China MediTech, JUL 6, 2021, View Source [SID1234584605]). HMPL-295 has the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS, RAF and MEK. This is our first of multiple candidates in discovery addressing the RAS-MAPK pathway. The first patient was dosed on July 2, 2021.

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The clinical trial is a multi-center, open-label study to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-295, and to determine the maximum tolerated dose and recommended Phase II dose ("RP2D") in patients with advanced malignant solid tumors. Following the initial dose escalation stage, another 10 to 15 patients will be enrolled at the RP2D to further evaluate its safety and the preliminary efficacy of HMPL-295. An exploratory study on the pharmacokinetic biomarkers of HMPL-295 is also planned. Additional details may be found at clinicaltrials.gov, using identifier NCT04908046.

We currently retain all rights to HMPL-295 worldwide.

About ERK and the RAS-MAPK pathway

The RAS-MAPK pathway is dysregulated in human diseases, particularly cancer, in which mutations or nongenetic events hyperactivate the pathway in more than 50% of cancers. Activating mutations in RAS genes occur in more than 30% of cancers. RAS and RAF predict worse clinical prognosis in a wide variety of tumor types, mediate resistance to targeted therapies, and decrease the response to the approved standards of care, namely, targeted therapy and immunotherapy. On the RAS-MAPK pathway, KRAS inhibitors are under clinical evaluation, and acquired resistance develops for RAF/MEK targeted therapies. ERK inhibition has the potential to overcome or avoid the intrinsic or acquired resistance from upstream mechanisms such as these.

On July 6, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the second quarter of 2021 to discuss the deficiencies raised in the Complete Response Letter (CRL) received in February (Press release, Athenex, JUL 6, 2021, View Source [SID1234584604]).

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At the meeting, Athenex provided additional analyses, including overall survival (OS) data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment. Athenex also proposed to collect additional OS data that could inform the design of a new clinical study.

The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer. The FDA also agreed that a well-designed and well-conducted trial may adequately address the deficiencies raised in the CRL. Athenex is evaluating the optimal design for a new clinical study which it intends to present to the FDA in the fourth quarter of 2021.

"We appreciate the FDA’s support for the development of oral paclitaxel and encequidar in this meeting and expect to maintain a collaborative dialogue on this program," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "We continue to believe that, if approved, oral paclitaxel and encequidar has the potential to address a major unmet need in metastatic breast cancer. We hope to agree on a program that is capital efficient and will result in value creation for our stakeholders."

Athenex is also developing oral paclitaxel and encequidar for the treatment of cutaneous angiosarcoma, for which it has received Orphan Drug Designation from the FDA. Athenex also received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.