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Epizyme to Participate in Morgan Stanley 18th Annual Global Healthcare Conference

On September 8, 2020 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that Robert Bazemore, president and chief executive officer, will participate in a fireside chat during the Morgan Stanley 18th Annual Global Healthcare Conference on Monday, Sept. 14, 2020 at 3:45 p.m. ET (Press release, Epizyme, SEP 8, 2020, View Source [SID1234564766]).

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A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the event.

Takeda Divests Select Non-Core Assets in Europe to Cheplapharm for Approximately $562 million USD

On September 8, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it has entered into an agreement to divest a portfolio of select non-core prescription pharmaceutical products sold predominantly in Europe and Canada to Cheplapharm. Cheplapharm is a specialty pharmaceutical company headquartered in Germany with a 25-year history of successfully acquiring, integrating and growing pharmaceutical products. Takeda will receive an upfront payment of approximately $562 million USD, subject to customary legal and regulatory closing conditions.

The portfolio to be divested to Cheplapharm is comprised of non-core prescription pharmaceutical products in a variety of therapeutic categories sold predominantly in Europe and Canada. This includes Cardiovascular/Metabolic and Anti-Inflammatory products along with Calcium. The portfolio generated FY 2019 net sales of approximately $260 million USD. While the products included in the sale address key patient needs in these countries, they are outside of Takeda’s five key business areas. With a more focused portfolio, the divestiture further enables Takeda’s Europe & Canada Business Unit (EUCAN) to focus on and drive strategic core growth areas. In April 2020, Takeda announced to divest EUCAN’s non-core over-the-counter (OTC) products to Orifarm Group.

Giles Platford, President, EUCAN, Takeda, said, "These divestments represent another important milestone in our portfolio simplification and optimization strategy as we position Takeda for continued success across our five key business areas: Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience. We are pleased to have found a partner in Cheplapharm who shares our commitment to patient care and has the experience and resources to continue investing in these important products well into the future for the benefit of patients."

Costa Saroukos, Chief Financial Officer, Takeda, said, "Today’s announcement allows Takeda to continue to be patient-focused as we streamline and optimize our portfolio according to our global long-term strategy. While the trusted products included in the sale address key patient needs in these countries, they are outside of our core business areas of focus. We are confident that Cheplapharm is the right partner to ensure patients continue to have access to these products."

The sale of these non-core prescription products supports Takeda’s continued divestiture program. Last month, Takeda announced an agreement to divest Takeda Consumer Healthcare Company Limited to Blackstone for approximately $2.3 billion USD. In June, Takeda agreed to divest a portfolio of non-core assets sold exclusively in the Asia Pacific region to Celltrion for up to $278 million USD; in April, Takeda announced the sale of non-core OTC products in Europe to Orifarm Group for up to approximately $670 million USD, including the sale of two manufacturing sites in Denmark and Poland; and in March, Takeda announced the sale of non-core products in Latin America to Hypera Pharma for $825 million USD, as well as completed the previously announced sales of non-core assets spanning the Russia-CIS region to STADA and in countries spanning the Near East, Middle East and Africa region to Acino.

Transaction Details

There are no anticipated employee transfers in connection with this transaction.

The transaction is expected to close by the end of Fiscal Year 2020 (ending March 2021), subject to the satisfaction of customary closing conditions and receipt of required regulatory clearances. Until then, the products will continue to be made available to patients and manufactured and supplied by Takeda.

Takeda intends to use the proceeds from this transaction to reduce its debt and accelerate de-leveraging toward its target of 2x net debt/adjusted EBITDA within Fiscal Year 2021 to 2023. Takeda is committed to rapid deleveraging driven by strong cash flow and divestiture proceeds, while also simplifying our portfolio.

Takeda is being advised by J.P. Morgan as our financial advisor and White & Case is our legal advisor in this transaction.

Aptorum Group to Hold Investor Webinar and Present at The Wall Street Investor Forum on September 10

On September 8, 2020 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a biopharmaceutical company focused on novel therapeutics including the development of next-generation approach therapeutics targeting antimicrobial resistance, reported President and Executive Director, Mr. Darren Lui, will share insight into the company’s recent developments and upcoming milestones at an investor webinar and the Wall Street Investor Forum on Thursday, September 10, 2020 (Press release, Aptorum, SEP 8, 2020, View Source [SID1234564764]). The details are as follows:

Investor Webinar and Q&A session

Date: Thursday, September 10, 2020
Time: 4:00 PM Eastern Time

To participate in the webinar, please register at:
View Source

Questions can be pre-submitted to [email protected] or online during the event.

The Wall Street Investor Forum

Date: Thursday, September 10, 2020
Time: 1:00 PM Eastern Time

To listen to Aptorum Group’s presentation, please register at
View Source

PharmaCyte Biotech Successfully Completes Second Container Closure Integrity Test

On September 8, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed the second Container Closure Integrity (CCI) test that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps product (Press release, PharmaCyte Biotech, SEP 8, 2020, View Source [SID1234564763]). This is the second FDA-required test on the product that will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed test, "We are pleased to announce our Cell-in-a-Box encapsulated cell product CypCaps has passed the second CCI test. This test is a component of the 24-month stability study of our CypCaps. As we explained previously, the CCI test is part of the ongoing study to determine the shelf life of the CypCaps final product that the FDA requires for all medical products. The data from the second CCI test will be submitted to the FDA to be included in our recently submitted Investigational New Drug Application (IND)."

Regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps, are particularly sensitive and more prone to inactivation over time. Accordingly, it is especially important to determine the shelf-life for PharmaCyte’s clinical trial product.

The FDA specifically required a CCI test be run on PharmaCyte’s clinical trial product and that the data from the CCI test be included in an ongoing basis in PharmaCyte’s IND.

More can be read about the specifics of the CCI test in PharmaCyte’s June 15, 2020 press release: View Source

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

Exelixis and NBE-Therapeutics Enter Into Exclusive Collaboration and License Option Agreement to Discover and Develop Novel Antibody-Drug Conjugates for the Treatment of Cancer

On September 8, 2020 Exelixis, Inc. (Nasdaq: EXEL) and NBE-Therapeutics reported a partnership to discover and develop multiple antibody-drug conjugates (ADCs) for oncology applications by leveraging NBE’s unique expertise and proprietary platforms in ADC discovery, including site-specific conjugation and novel payloads (Press release, Exelixis, SEP 8, 2020, View Source [SID1234564762]). The agreement comes as Exelixis continues to build out its pipeline behind CABOMETYX (cabozantinib), its flagship product that is now a global oncology franchise.

Under the terms of the agreement, Exelixis will make an upfront payment of $25 million to NBE in exchange for an exclusive option to nominate a defined number of target programs on NBE’s ADC platform over a two-year period. Together, the companies will seek to advance multiple ADCs into preclinical development with Exelixis contributing research and development support. For each individual target program, prior to filing an Investigational New Drug application, Exelixis will be able to exercise its option to an exclusive worldwide license, and afterwards continue clinical development and commercialization activities for that target program. Upon exercise of any option, NBE will be eligible for development and commercialization milestones, as well as royalties on net sales of any potential products resulting from that target program.

"Exelixis is pursuing both internal drug discovery and external business development approaches to build a pipeline with the potential to make a difference for patients with cancer," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "NBE-Therapeutics’ ADC technologies for conjugation and its novel anthracycline-based payload platform make it a strong partner for Exelixis as we seek to improve on conventional antibody-drug conjugate approaches. We’re looking forward to working together with NBE and benefiting from the company’s expertise and technology as we bring forth the next generation of Exelixis medicines."

"NBE-Therapeutics’ technology platforms give drug developers the potential to advance best-in-class antibody-drug conjugates against multiple targets," said Bertrand Damour, Chief Executive Officer of NBE-Therapeutics. "We’re excited to work with Exelixis, which through CABOMETYX has attained a reputation for data-driven, effective clinical development and commercialization, as the company broadens its opportunities in biologics to effectively fight cancer."

NBE was founded with the vision of developing next-generation, best-in-class ADCs targeting solid tumors as well as hematological malignancies. NBE’s platform improves upon older ADC platforms by delivering highly homogenous, stable and potent ADCs with immune-stimulatory function and potential for improved therapeutic index in multiple cancer indications. The company’s technologies are used throughout the ADC discovery process, including Transpo-mAb Display for antibody discovery and SMAC-Technology for site-specific conjugation and ADC manufacture. NBE has also developed a proprietary PNU-anthracycline based, DNA-targeting toxin platform that yields highly potent and immune-stimulatory ADCs (iADCs).