On January 31, 2022 Ember Technologies, Inc. (Ember) and Cardinal Health (NYSE: CAH) reported a partnership to offer the world’s first self-refrigerated, cloud-based shipping box–the Ember Cube (Press release, Cardinal Health, JAN 31, 2022, View Source [SID1234607546]). Ember and Cardinal Health will collaborate to deliver a cold chain solution that ensures product integrity and security throughout the supply chain, while significantly reducing shipping waste in the transport of temperature-sensitive medicines.

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The Ember Cube is a digital shipping box that features cloud-based temperature reporting, GPS location tracking, and return-to-sender technology, versus the current industry standard for transporting temperature-sensitive medicine which includes single-use ice packs, Styrofoam, and cardboard. The Ember Cube uses an onboard cellular radio to report real-time temperature and humidity tracking and GPS location information that can be viewed via Ember’s proprietary cloud-based dashboard. This patented technology allows for precision control, so medicines and vaccines arrive at the required temperature range, ready for use.

"Since Ember’s inception, it has been our goal to leverage our temperature control technology to serve the healthcare industry, with the ultimate mission of helping to improve and save lives," said Clay Alexander, Founder and Group CEO of Ember. "We have formed a powerful new partnership with Cardinal Health to codevelop and commercialize many of our patented healthcare industry inventions to bring this vision to life."

Cardinal Health plays a leading and critical role in delivering logistics solutions for specialty pharmaceutical products, which often have unique temperature requirements. As global spending on cold-chain pharmaceutical products grows to more than $21 billion by 20241, it will be increasingly critical to support the market with secure and sustainable cold storage solutions. Through its partnership with Ember, Cardinal Health will leverage its technology infrastructure and national presence as a leading distributor of pharmaceutical and medical products to hospitals, pharmacies, and physician clinics to deploy Ember’s cold chain technology, ensuring patients can access life-saving therapies.

"Cardinal Health is investing in digital solutions and technology to help our healthcare customers solve problems in innovative ways," said Heidi Hunter, President of Cardinal Health Specialty Solutions. "Our partnership with Ember utilizes technology solutions to set a new industry standard for real-time visibility and product integrity, while also providing transformative waste reduction."

"The Ember Cube will be a particularly relevant solution for the many cell and gene therapies that are in the drug development pipeline, due to their temperature sensitivity, high value and need for real-time integrated tracking," added Hunter.

Ember’s return-to-sender technology allows each Ember Cube to be reused hundreds of times, reducing waste, and eliminating single-use packaging. Once a healthcare provider has received its shipment of medicine, the Ember Cube uses its built-in cellular radio to communicate with the shipping service to schedule a pick-up, automatically providing its current GPS location. Once the Ember Cube notifies the shipping service that it is ready to be picked up, it generates a new shipping label on its e-ink screen and is returned to Cardinal Health’s distribution center.

Cardinal Health plans to launch a customer pilot for the Ember Cube in 2022.

On January 31, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the closing of its previously announced underwritten public offering of 11,035,000 common shares, including the exercise in full of the underwriters’ option to purchase 1,875,000 additional shares, and, in lieu of common shares to certain investors, pre-funded warrants to purchase up to 3,340,000 common shares (Press release, Zymeworks, JAN 31, 2022, View Source [SID1234607541]). The common shares were offered at a public offering price of $8.00 per common share and the pre-funded warrants were offered at a public offering price of $7.9999 per pre-funded warrant, which represents the per share public offering price for each common share less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds to Zymeworks from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Zymeworks, were approximately $115.0 million.

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Jefferies, Evercore ISI, Stifel and Wells Fargo Securities acted as joint book-running managers for the offering. Raymond James acted as lead co-manager for the offering.

An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on October 1, 2021. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected], Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected], or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (833) 690-2713, or by email at [email protected].

No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 31, 2022 NEC reported that Consolidated Financial Results for the Nine-month Period Ended
December 31, 2021 (Press release, NEC, JAN 31, 2022, View Source [SID1234607537]).

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On January 31, 2022 Nordic Pharma reported that the European Commission (EC) approved the new indication for Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity (Press release, Nordic Pharma, JAN 31, 2022, View Source [SID1234607536]).

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Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Based on this approval, Teysuno will be indicated in adults:

for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting
New fluoropyrimidine for patients with metastatic colorectal cancer

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: "This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication."

Iris van Lakerveld, Global Oncology Lead added: "Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

On January 31, 2022 The Stockholm-based Digital Therapeutics (DTx) company Alex Therapeutics and world leading pharmaceutical company Pfizer reported that they have joined forces to provide evidence based, clinically validated and personalized digital therapies to patients (Press release, Pfizer, JAN 31, 2022, View Source [SID1234607535]). Together, the companies cover a broad range of expertise in the fields of medicine, marketing, clinical validation, AI, software development and psychology. The partnership will initially focus on Germany, one of the world’s largest unified healthcare markets.

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"In our efforts to give patients access to new, innovative forms of therapy, it is our aim to fully benefit from the possibilities of digitization. Alex Therapeutics is a very promising company due to its approach of combining the latest psychological findings on dealing with harmful behavior with the possibilities of artificial intelligence" says Aylin Tüzel, Country Manager Pfizer Germany, explaining the choice of cooperation partner.

"Alex DTx Platform" uses Artificial Intelligence to treat medical conditions
The partnership will utilize Alex Therapeutics’ AI-powered digital therapeutics platform "Alex DTx Platform". The platform combines evidence-based psychology, primarily Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT) with AI, and provides personalised standalone treatments to address unmet needs among patients worldwide.

John Drakenberg Renander, CEO of Alex Therapeutics, is excited by the opportunity to scale their novel treatments: "The collaboration with Pfizer enables us to combine our technology and expertise with one of the world’s leading pharmaceutical companies and gives us unique access to an attractive healthcare market. Pfizer’s unique experience of the needs of patients and doctors provides us with the opportunity to put our technology into the hands of those that need it the most."

The initial focus of the partnership is a digital therapy treating nicotine addiction via smartphone. The medical device was developed by Alex Therapeutics and adapted to the requirements of the German healthcare system together with Pfizer Germany. Pfizer is currently conducting an extensive clinical trial in Germany to further validate the medical benefits of the solution.

Germany has emerged as one of the leading countries in Digital Therapeutics
Josh Raysman, the leader of Pfizer’s Digital Innovation Lab, sees in the partnership a proof-point for collaborations in digital health. "We are working around the globe to leverage innovative digital approaches to enhance patient experiences and improve health outcomes. With the recent Digital Supply Act, the expertise of Pfizer’s colleagues in Germany, and the capabilities of Alex Therapeutics we have an opportunity to demonstrate the potential of patient-centric partnerships focused on transforming healthcare with digital treatments"

German-Swedish Collaboration
In January 2017, Germany and Sweden decided on a comprehensive partnership for innovation. The partnership tackles societal challenges within key areas, such as ehealth and AI, where Germany and Sweden have strong positions, and holds potential to develop the role of the EU.

"This is a great example of how innovative companies such as Alex Therapeutics in Sweden and Pfizer in Germany can come together in the fields of ehealth and AI. Together, they will provide new solutions to the benefit of patients."
Per Thöresson, Swedish Ambassador in Germany