On April 22, 2021 ArcticZymes Technologies (OSE: AZT) reported sales of NOK 40.4 million (18.5) and an EBITDA of NOK 25.8 million (9.0) for the first quarter of 2021 (Press release, Biotec Pharmacon, APR 22, 2021, View Source [SID1234578334]).

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Highlights from Q1 2021

ArcticZymes Technologies (AZT) had Q1 sales of NOK 40.4 million growing by 119% (Q1 2020: NOK 18.5 million)
Coronavirus-related sales are estimated at NOK 16.5 million in Q1 2021 (NOK 3.8 million in Q1 2020)
Gross profit improved to NOK 39.9 million with 99% margin (Q1 2020: NOK 18.5 Million)
AZT delivered a positive EBITDA of NOK 25.8 million (Q1 2020: NOK 9.0 million)
Cash-flow for Q1 was positive NOK 23.2 million (Q1 2020: NOK 4.4 million) giving a cash balance of NOK 163.3 million (Q1 2020: NOK 35.7 million)
Successfully upscaled the SAN HQ production process
CEO Jethro Holter comments:

"We are delighted with the performance of our first quarter as a pure enzymes company. The ArcticZymes team has delivered the best ever quarterly performance achieving sales revenues of 40 million NOK and an EBITDA of 26 million NOK. All market segments have experienced quarterly growth including re-establishment of molecular research sales to pre-pandemic levels.

Furthermore, the SAN HQ enzyme production process was successfully upscaled 100-fold. The innovation pipeline and the infrastructure expansion project of R&D and operations are progressing. Such activities are key to leveraging the greater potential ArcticZymes Technologies can accomplish through organic growth."

On April 22, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics, Inc. reported that Roche’s wholly owned subsidiary Geronimo Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of USD 24.05 per share in cash (Press release, Hoffmann-La Roche, APR 22, 2021, View Source [SID1234578333]). The tender offer expired at 12:00 midnight, Eastern Time, at the end of the day on 21 April 2021 and was not extended.

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Roche has been advised by Citibank, N.A., the depositary for the tender offer, that a total of approximately 61,201,761 shares of GenMark’s common stock were validly tendered and not validly withdrawn in the tender offer (excluding shares tendered by notice of guaranteed delivery for which certificates have not yet been "received"), which represent approximately 82.89% of the total number of shares of GenMark’s common stock outstanding.

Later today, Roche intends to complete the acquisition of GenMark through a merger of Geronimo Acquisition Corp. with and into GenMark without a vote or meeting of GenMark’s stockholders. In the merger, all shares of GenMark not owned by GenMark, Roche or Roche’s wholly owned subsidiaries (other than shares as to which appraisal rights have been validly exercised under Delaware law) will be converted into the right to receive the same cash consideration per share, less any applicable withholding taxes, as was paid in the tender offer. Following completion of the merger, GenMark will become a wholly owned subsidiary of Roche, and GenMark’s shares will cease to be traded on the NASDAQ Stock Market.

"We are excited about this important milestone, as this acquisition will support our long-lasting commitment to help control antibiotic resistance and infectious diseases, which are a leading cause of death globally," said Thomas Schinecker, CEO Roche Diagnostics. "The addition of GenMark Diagnostics’ proprietary multiplex technology, which is designed to detect multiple pathogens from a single patient sample, will broaden our best-in-class molecular diagnostics portfolio to help make lifesaving information available to healthcare providers quickly to improve patient outcomes."

On April 22, 2021 Chugai Pharmaceutical Co., Ltd. reported that disposal of treasury shares was completed today, as we announced in the press release "Notice of Disposal of Treasury Shares as Restricted Stock Compensation Plan" on March 23, 2021 (Press release, Chugai, APR 22, 2021, View Source [SID1234578331]). The result of treasury shares is as follows.

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Overview of Disposal
Disposal date: April 22, 2021
Class and number of disposed shares: 96,600 shares of Common stock of the Company
Disposal price: ¥4,456 per share
Total value of disposed shares: ¥430,449,600
Allottees and number thereof; number of disposed shares

On April 22, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2021 (Press release, Ipsen, APR 22, 2021, View Source [SID1234578316]):

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Total Sales growth of 5.5% at CER, or 0.6% as reported, to €658.5m, despite impact of the pandemic
An increase in Specialty Care sales of 6.4%1 to €611.5m, driven by the growth of Cabometyx (cabozantinib), Decapeptyl (triptorelin), Somatuline (lanreotide) and Dysport (botulinum toxin type A)
A Consumer Healthcare sales decline of 5.4%1 to €47.0m, reflecting the ongoing effects of COVID-19, partly offset by recovery in China
European Commission approval of Cabometyx, in combination with nivolumab, as a first-line treatment for patients living with advanced renal cell carcinoma
Guidance for FY 2021 confirmed
David Loew, Chief Executive Officer, commented:
"We delivered a strong performance in the first quarter, despite the persistently difficult COVID-19 environment, driven by our unrelenting focus on patients. Our execution was in line with our plans and our financial guidance for the year. Ipsen’s Oncology medicines stood out in the period, while the regulatory approval in Europe of the Cabometyx combination with nivolumab in first-line renal cell carcinoma marked the start of an important launch. The anticipated registration of a lanreotide-generic medicine in Europe is fully aligned with our expectations.

In the near term, we look forward to trial results in first-line liver cancer for the Cabometyx combination with atezolizumab, as well as regulatory progress with palovarotene in FOP. We continue to support our ambitions of strengthening the pipeline and driving sustainable growth, based on our patient-focused strategy. I am very proud of the great execution by colleagues around the world, especially as many teams continue to experience challenging conditions during the pandemic."

FY 2021 guidance
The Company today confirms its financial guidance for FY 2021, which incorporates an assumed progressive global recovery from COVID-19 by H2 2021. A phased launch of generic lanreotide in Europe by mid-2021 is also assumed, as is a limited impact of the potential launch of octreotide or lanreotide generics in the U.S.

Total Sales

Growth of more than 4.0% at CER

Core Operating Margin

Greater than 30.0%, excluding any potential impact of incremental investments from external innovation

Currency impact
Ipsen anticipates an adverse impact of 2% from currencies on Total Sales in FY 2021, based on the level of exchange rates at the end of March 2021.

Somatuline-generic update
During the quarter, a positive outcome was received for a generic formulation of lanreotide in 60mg, 90mg and 120mg dose presentations by the Reference Member State, Denmark; the closure of the Decentralized Procedure was also achieved. National marketing authorizations have recently been granted for a lanreotide generic medicine in France, Denmark, Hungary and Latvia. These developments were consistent with Ipsen’s expectations.

Business development
In the quarter, Ipsen and Fusion Pharmaceuticals Inc. completed an asset purchase agreement to acquire Ipsen’s intellectual property and assets related to IPN-1087, a small molecule in Phase I development targeting neurotensin receptor 1, a protein expressed on multiple solid-tumor types.

Conference call
A conference call and webcast for investors and analysts will begin at 2:30pm Paris time today. Participants should dial in to the call early and can register here; a recording will be available on ipsen.com, while the webcast can be accessed here. The event ID is 2495337.

Calendar
The Company intends to publish its H1 2021 results on 29 July 2021 and its nine-months’ sales update on 21 October 2021. The Annual Shareholders’ Meeting will be held behind closed doors on 27 May 2021.

Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the three-month period to 31 March 2021 (the quarter, the first quarter or Q1 2021), compared to three-month period to 31 March 2020 (Q1 2020) respectively, unless stated otherwise. Growth rates are at CER, unless stated otherwise. Commentary on performance is based on CER, unless stated otherwise.

On April 21, 2021 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 in relapsed/refractory multiple myeloma (Press release, Allogene, APR 21, 2021, View Source [SID1234631116]). The FDA granted RMAT designation based on the potential of ALLO-715 to address the growing unmet need for patients who have failed other multiple myeloma therapies.

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"RMAT designation was granted based on our encouraging initial clinical experience in heavily pretreated patients. ALLO-715 demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve deep clinical responses while eliminating the need for bridging therapy and delays associated with autologous CAR T manufacturing," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We look forward to completing the UNIVERSAL study and working closely with the FDA as we seek to rapidly advance this important therapeutic alternative to patients with advanced multiple myeloma."

Initial results from the UNIVERSAL study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. As part of the Company’s anti-BCMA strategy, the Phase 1 UNIVERSAL study continues to optimize the dosing regimen of ALLO-715 and ALLO-647. The UNIVERSAL study is also enrolling patients to receive ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.