On January 27, 2022 ArcticZymes Technologies (OSE: AZT) reported that sales of NOK 40.5 million (22.1) and an EBITDA of NOK 20.8 million (6.8) for the fourth quarter of 2021 (Press release, Biotec Pharmacon, JAN 27, 2022, View Source [SID1234607540]).

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Highlights from Q4 2021

ArcticZymes Technologies (AZT) had Q4 sales of NOK 40.5 million – an increase of 84% (Q4 2020: NOK 22.1 million)
Exceeded annual sales target achieving NOK 128.0 million for 2021 – an increase of 37% (2020: NOK 93.4 million)
Coronavirus-related sales are estimated at NOK 9.3 million (Q4 2020: NOK 7.1 million)
Gross profit increased to NOK 38.5 million because of increased sales (Q4 2020: NOK 21.5 million)
Positive EBITDA of NOK 20.8 million (Q4 2020: NOK 6.8 million)
Cash flow was positive NOK 14.0 million (Q4 2020: NOK 73.4 million due to Biotec BetaGlucans divestment) giving a cash balance of NOK 200.4 million (Q4 2020: NOK 140.2 million)
Launched 3 new products and successfully upscaled the manufacturing of the M-SAN HQ enzyme
New 500 m2 production facility completed and operational
CEO Jethro Holter comments:

"We are delighted that the enzyme business continues to drive strong quarterly sales growth and exceeded its promise to achieve annual sales of NOK 120 million. It has been an excellent year for the Company demonstrating its ability to operate as a profitable and high-growth, standalone enzyme company following the earlier divestment of the Biotec BetaGlucans subsidiary.

ArcticZymes Technologies continues to bring innovations to market and enters 2022 with a new state-of-the art manufacturing facility. These will be instrumental in further supporting organic growth of the enzyme business."

On January 27, 2022 Charles River Laboratories International, Inc. (NYSE: CRL) reported the expansion of their strategic partnership with Chicago, Illinois-based SAMDI Tech, Inc. Under the existing partnership, established in 2018, SAMDI Tech clients have access to Charles River’s collection of lead-like compounds for high-throughput screening (HTS) (Press release, Charles River Laboratories, JAN 27, 2022, View Source [SID1234607493]). The expanded agreement establishes Charles River as the exclusive partner for the promotion of SAMDI Tech’s technology. This partnership will provide Charles River’s clients seamless access to the premiere, label-free high-throughput screening mass spectrometry (MS) platform in drug discovery.

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The SAMDI technology combines self-assembled monolayers and MALDI MS, and addresses the throughput and sample preparation limitations of traditional MS screening methods.

The combination of Charles River’s end-to-end portfolio and industry-leading scientific bench with SAMDI Tech’s innovative technology and expertise in assay solutions has the potential to significantly accelerate and augment clients’ discovery efforts by measuring biochemical activities and binding events for virtually any target.

Approved Quotes

"Our collaboration with SAMDI Tech is another step that we’re taking toward accelerating drug discovery and development. By generating quality data faster during hit identification, we can help our clients make critical go/no go decisions earlier in the process, to advance their programs." –Wilbert Frieling, D.V.M., Corporate Senior Vice President, Global Discovery Services, Charles River
"With over a decade of industry experience, SAMDI Tech has a well-respected track record of producing high quality data. We are excited to partner with them to bring this technology to our clients." – Julie Frearson, Ph.D., Corporate Senior Vice President, Chief Scientific Officer, Charles River
"We are excited to expand on our successful partnership with Charles River, whose clients will join our global client base to benefit from our label-free SAMDI technology, which continues to deliver cutting-edge solutions backed by high-quality, data-driven results." –Emilio Cordova, PhD, MBA, Chief Executive Officer, SAMDI Tech

On January 27, 2022 Biogen Inc. (Nasdaq: BIIB) reported that they have entered into an agreement whereby Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to USD $2.3 billion (Press release, Biogen, JAN 27, 2022, View Source [SID1234607484]).

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Biogen and Samsung Bioepis have built the industry leading anti-TNF portfolio in Europe1. Upon the acquisition of Biogen’s stake, the companies will continue with their exclusive agreements, including commercialization of their current portfolio. This includes marketed products BENEPALI (etanercept), a biosimilar referencing ENBREL, IMRALDITM (adalimumab), a biosimilar referencing Humira, and FLIXABI (infliximab), a biosimilar referencing Remicade. Additionally, Biogen will also retain commercial rights for BYOOVIZTM (ranibizumab-nuna), an approved biosimilar referencing LUCENTIS (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing EYLEA.

"We are thankful to Samsung Biologics for a productive collaboration since 2012," said Michel Vounatsos, Chief Executive Officer at Biogen. "We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen."

Samsung Biologics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones. Closing of the transaction is contingent on the effectiveness of a securities registration statement filed by Samsung Biologics and satisfaction of certain regulatory and other customary closing conditions. Upon closing, Biogen will recognize a GAAP gain on disposal within other income (expense), net in its consolidated statement of income.

About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings and increased patient access. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

On January 27, 2022 InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral valve disease, reported the closing of its Series C financing with granting an exclusive licensing agreement to Grand Pharmaceutical Group Limited, (Grand Pharma) for its proprietary Saturn device in Greater China (Press release, China Grand Pharmaceutical, JAN 27, 2022, https://www.innovheart.com/innovheart-raises-55-million-in-series-c-financing-to-further-develop-the-trans-septal-saturn-transcatheter-mitral-valve-replacement-system/ [SID1234607467]).

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The transaction pulled in more than $55 million in equity, upfront licensing fees, milestone payments and structured royalties.

Series C equity round was led by Grand Pharma, together with the existing investors Genextra, Panakes Partners and Indaco Venture Partners confirming their ongoing support by joining this investment round. Under the license agreement, Grand Pharma is entitled to develop, manufacture and commercialize the Saturn device in Mainland China, Hong Kong, Macau and Taiwan.

‘Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential, estimated to reach $17.4 billion globally in future years. This strategic agreement will provide InnovHeart with resources that will accelerate the development of the trans-septal version of the Saturn system into First-in-Human clinical trials, as well as access to the dynamic Chinese structural heart market’, said Keith D. Dawkins MD, Chairman of InnovHeart Board of Directors.

Commenting on this new collaboration, Shawn Chen, Senior management of the Medical Device Division of Grand Pharma, said, ’We are very excited about this collaboration. The successful closing of this transaction demonstrates that Grand Pharma has completed the strategic layout in our cerebro-cardiovascular high-end medical devices sector. InnovHeart Saturn technology is one of the most promising TMVR technologies in the market. I am confident that with InnovHeart’s expertise in this field and Grand Pharma’s strong capability and resources, we will bring this innovative clinical solution to Chinese patients soon’.

’InnovHeart has already demonstrated excellent mid-term (>1 year) results with the trans-apical version. This low profile, adaptive valve design decreases the risk of LVOT obstruction and will be implanted transeptally in FIH in 2022’, said Paolo Denti MD, Cardiac Surgeon, San Raffaele University Hospital, Milan, Italy.

On January 27, 2022 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its fourth quarter and full year 2021 financial results on Thursday, February 17, 2022 (Press release, Insmed, JAN 27, 2022, View Source [SID1234607465]).

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Insmed management will provide a business and pipeline update in addition to a discussion of the financial results in a conference call for investors from 8:00 to 9:30 a.m. ET on Thursday, February 17, 2022.

Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S. toll free), (646) 904-5544 (U.S. local), or +1-929-526-1599 (international) and referencing access code 359415. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through March 17, 2022, by dialing (866) 813-9403 (U.S. toll free), (929) 458-6194 (U.S. local), or +44-204-525-0658 (international) and referencing access code 838814. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.