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.

On January 27, 2022 Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), reported that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy (Press release, Dizal Pharma, JAN 27, 2022, View Source [SID1234607464]).

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"Lung cancer patients with exon20 insertion mutations need better treatment. Sunvozertinib was specifically designed with high selectivity for inhibiting mutated EGFR, which causes cancers. Available clinical evidence shows that Sunvozertinib has the potential to provide the patients with a new and much improved targeted therapy," said Dr. Xiaolin Zhang, Chief Executive Officer at Dizal. "We are very pleased with FDA’s decision. Now Sunvozertinib has received Breakthrough Therapy Designation from both US FDA and China CDE, which validates Sunvozertinib’s differentiated profile. At Dizal, we are committed to discover and develop innovative medicines for the benefit of cancer patients globally."

Breakthrough Therapy designation is a process designed by US FDA, China CDE, and other regulatory agencies to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)[1].

About DZD9008 (Sunvozertinib)

DZD9008 is a rationally designed selective, irreversible, novel EGFR inhibitor. In global Phase 1/2 studies, it has demonstrated promising antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. Its confirmed ORR is 45.5% at 200 mg and 41.9% at 300 mg (data cut-off by July 30, 2021). It also shows efficacy among patients with brain metastasis or previously treated by Amivantamab. It was well tolerated with a manageable AE profile.

Dizal is conducting Phase 2 pivotal clinical trials in China, U.S., EU, Japan, Australia, South Korea and other countries and regions.

On January 27, 2022 OS Therapies, a research and clinical-stage biopharmaceutical company reported that the Data Safety & Monitoring Committee (DSMC) approved open enrollment for AOST-2121: an open label Phase IIb Trial of OST-HER2 (Listeria monocytogenes) in Recurred, Resected Osteosarcoma (OS) (Press release, OS Therapies, JAN 27, 2022, View Source [SID1234607463]). OS is a deadly and debilitating cancer of the bone that usually occurs in adolescence and young adults (AYA).

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OS Therapies’ OST-HER2 is a Lm vector-based off-the-shelf Immunotherapy intended to prevent metastasis, delay recurrence, and increase overall survival. The FDA had requested a safety roll-out staggering the first three patients by three weeks – safety data from these patients has given the safety committee the ability to open the trial nationally to the remaining patients.

"The Osteosarcoma Community has been anxiously awaiting the clinical trial of this very promising technology ever since it was provisionally approved for dogs by the USDA – we just want to try it on our kids," said Miriam Cohen, Chair of the Osteosarcoma Collaborative (www.oscollaborative.org), an OS patient advocacy organization that has supported the trial.

Eleven of the twenty clinical trial sites currently open include:
Seattle Children’s Hospital
Connecticut Children’s Hospital
UPMC Children’s Hospital of Pittsburgh
Kaiser Permanente Downey Medical Center
St. Jude’s Children’s Research Hospital
Johns Hopkins Baltimore
UT Southwestern Children’s Medical Center
Hackensack University Medical Center
Children’s Hospital of Orange County
Rady Children’s Hospital
Children’s Hospital of Philadelphia (CHoP)

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with initially metastatic or recurrence after chemotherapy, there is a significantly poorer prognosis.