On January 27, 2022 Lupin Pharmaceuticals Inc., (Lupin) and Exeltis USA Inc. reported a promotional agreement for Exeltis to promote SOLOSEC along with Exeltis’ existing line of Women’s Health products, further enhancing value to OBGYNs and their patients (Press release, Lupin, JAN 27, 2022, View Source [SID1234607606]). SOLOSEC is indicated for the treatment of Bacterial Vaginosis in adult women (a common vaginal infection) and Trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the U.S.).1-4

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"This partnership will expand the reach of SOLOSEC, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis," said Vinita Gupta, Chief Executive Officer of Lupin "We are extremely excited to partner with Exeltis." Salustiano Perez, Chief Executive Officer of Exeltis added, "Our team is thrilled to embark on this partnership. The addition of Solosec fits precisely within our current portfolio of products, enhancing our commercial strategy, and offering numerous solutions to our customers and their patients".

About SOLOSEC

SOLOSEC (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.1-4 SOLOSEC is designed to be easy to take and one oral dose contains a complete course of treatment.1

Additional information about SOLOSEC can be found at www.SOLOSEC.com.

INDICATION

SOLOSEC (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women and trichomoniasis in adults. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.

DOSAGE AND ADMINISTRATION

SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy.

IMPORTANT SAFETY INFORMATION

SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives.
Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Important Safety Information.

Or

Please click here for full Prescribing Information.

Manufactured for and Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ 07932

SOLOSEC is a registered trademark owned by Lupin Inc.

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

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.