On October 12, 2021 Signify Health, Inc. (NYSE: SGFY), a leading value-based healthcare platform enabled by advanced analytics, technology and nationwide healthcare networks, reported that it will release its financial results for the third quarter 2021 after the market closes on Tuesday, November 9, 2021, and will hold a conference call at 8:30am ET on Wednesday, November 10, 2021 to discuss the results (Press release, Signify Health, OCT 12, 2021, View Source [SID1234591150]).

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Pre-registration is required for participation in the conference call. Please follow the link below to pre-register. After registering, you will be provided with your access details via email.

www.incommuk.com/customers/signifyhealthquarterthree2021

A webcast of the conference call will also be available live on the investor relations section of Signify Health’s website at View Source Please go to the website at least 15 minutes prior to the call to complete the registration process.

The webcast replay will be available through January 10, 2022 on Signify Health’s website at

View Source

On October 12, 2021 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that Ira Katz, RPh, owner of Little Five Points Pharmacy in Atlanta, Georgia, is the winner of the 2021 National Community Pharmacists Association (NCPA) Willard B. Simmons Independent Pharmacist of the Year award (Press release, Upsher-Smith Laboratories, OCT 12, 2021, View Source [SID1234591170]). Katz received the award on Monday, October 11 at NCPA’s 123rd Annual Convention in Charlotte, North Carolina.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The annual award is given to a pharmacist who exhibits exemplary professional leadership, service to community and commitment to independent pharmacy. This year marks Upsher-Smith’s 13th year of sponsoring the prestigious award in conjunction with NCPA. The award is named in honor of Willard B. Simmons, a former executive secretary of NCPA (then known as the National Association of Retail Druggists) and a longtime trustee of the NCPA Foundation.

Katz opened the Little Five Points Pharmacy 40 years ago and has been recognized over the years for the contributions he’s made to his profession and community. As a pharmacist committed to reducing the number of lives lost due to opioid overdoses, Katz understands the importance of community education when it comes to opioid safety. Through his pharmacy, he provides naloxone (Narcan) administration education and has made the product available, free of charge, to those in the community, including local businesses and restaurants. Katz is a proud independent pharmacist and is frequently interviewed by local media outlets, sharing his knowledge and expertise with the community.

In addition to his service to the patient community, Katz is active within the professional community. He has been an NCPA member for more than 20 years. He is Chairman of the Board of the Georgia Academy of Independent Pharmacy (AIP) where he has been a board member for more than 25 years and also serves on the AIP Alternative Income Committee. He is also a member of the Georgia Pharmacy Association (GPhA), serving on its Governmental Affairs team.

"Ira Katz has played an invaluable role as a community pharmacist, and we couldn’t be more pleased to help NCPA recognize his achievements," said Rusty Field, President and CEO, Upsher-Smith. "Ira is a proven leader who has demonstrated that a pharmacist’s role goes far beyond dispensing medications. His efforts to educate and marshal resources to help those in need have single handedly made a difference in people’s lives."

"Ira’s leadership, dedication, and commitment to community make him a deserving recipient of this year’s Willard B. Simmons Independent Pharmacist of the Year Award," said NCPA CEO B. Douglas Hoey, pharmacist, MBA. "Ira’s service to his community has saved lives and is unwavering. He is a prime example of the importance of community pharmacies to people in cities and towns across America. We are grateful to Upsher-Smith for its support in recognizing exemplary pharmacists like Ira Katz."

On October 11, 2021 PHYNOVA Group Ltd ("Phynova") and Membrahealth Marketing (M) Sdn Bhd ("Membra") reported a partnership on Reducose, Phynova’s patented and clinically researched White Mulberry Leaf extract that supports significant lowering of post-meal blood sugar and insulin response (Press release, Phynova, OCT 11, 2021, View Source [SID1234591066]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The partnership will encompass both distribution to Malaysian customers as well as joint promotion of the health benefits of Reducose. Membra will serve customers with Reducose as a stand-alone ingredient or as a hero-ingredient in turn-key solutions.

Stephane Ducroux, CEO at Phynova, said: "We are excited to embark on our go-to-market partnership with Membra in the Malaysian market. Phynova’s strategy is to partner with market focused experts such as Membra, who have a proven track record of building deep customer relationships, fast prototyping and turn-key solutions using ingredients with a strong science pedigree like Reducose.

Phynova produces Reducose 5%, a patented premium white mulberry leaf extract that can naturally reduce the blood sugar and insulin response after a meal by up to 40%. Reducose is vegetarian, plant based, allergen free and is backed by 6 human clinical studies. Most recently Phynova published its latest positive clinical trial results on Reducose in the peer-reviewed journal ‘Nutrition & Metabolism’. The full paper can be accessed here: View Source

Reducose has also won the 2020 Nutraingredients Asia ‘Ingredient of the year’ award in the healthy ageing category.

"We are proud to be associated with Phynova on Reducose, a product that we strongly believe can satisfy the demand of carbo- and sugar-loving as well as sugar-intolerant consumers in Malaysia" said Managing Director, Kenzi Loke of Membra Group.

On October 11, 2021 Immunis.AI, Inc., an immunogenomics platform company developing noninvasive blood-based tests to optimize patient care, reported the publication of pivotal results from its clinical trial, Evaluation of an RNAseq-based Immunogenomic Liquid Biopsy Approach in Early-Stage Prostate Cancer, in the journal Cells (Press release, ImmunisAI, OCT 11, 2021, View Source [SID1234591083]).

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Study findings validate the potential of the company’s proprietary Intelligentia platform to detect early-stage cancer and to stratify risk in men considering active surveillance of prostate cancer. The results also illustrate the potential of the company’s proprietary immunogenomic platform to address screening, treatment decision making, and minimal residual disease detection.

This is the first of three large, prospective studies completed and designed to demonstrate the power of the company’s proprietary Intelligentia platform for early-stage cancer detection and the assessment of disease aggressiveness.

Key Findings:

In this prospective study, the primary objective was to develop and validate a model for the identification of clinically significant prostate cancer. Peripheral blood samples were collected from 1,018 previously undiagnosed men undergoing prostate biopsy and split chronologically into independent training (n=713) and validation (n=305) sets. Whole transcriptome RNA sequencing was performed on isolated phagocytic CD14+ monocytes and non-phagocytic CD2+ lymphocytes and their gene expression levels were used to develop a predictive model that correlates to adverse pathologic features in early stage, clinically localized prostate cancer.

The immunotranscriptomic model, emphasizing both the tumor phagocytosis mechanism and the anti-tumor immune response, combined with clinical risk parameters, yielded an AUC (area under curve) of 0.83 on the independent validation set (n=305).
Notably, considering the average age at diagnosis of prostate cancer is 66, the model was the strongest predictor for adverse pathology in men 60-66 years of age with an AUC of 0.91 in the independent validation set.
Several cancer-related pathways appear to be significantly represented in the model gene set, including hedgehog signaling, epithelial mesenchymal transition, PDL1 and PD1 checkpoint, and transcriptional misregulation in cancer.
"The strong AUC generated in the study demonstrate high sensitivity and negative predictive value," said Dr. Kirk Wojno, Chief Medical Officer of Immunis.AI, "which together support the ability of our Intelligentia platform to deliver actionable information that can help urologists distinguish prostate cancer patients who may safely choose active surveillance from those who are harboring occult aggressive disease requiring immediate intervention."

"Immunis.AI is developing models incorporating both novel disease related biomarkers as well as the body’s immune response to that disease, so that a single blood sample can be bioinformatically assessed for the presence of multiple diseases simultaneously," said Dr. Leander Van Neste, Chief Scientific Officer of Immunis.AI.

"The data provide strong evidence that the Intelligentia platform delivers a combination of sensitivity and specificity for early-stage disease with the flexibility to interrogate multiple cancer types," Van Neste added. "We are encouraged by these results and excited about the potential of our platform for multi-cancer screening."

On October 11, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) and Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), reported a definitive agreement for Supernus to acquire Adamas through a tender offer for $8.10 per share in cash (or an aggregate of approximately $400 million), payable at closing plus two non-tradable contingent value rights (CVR) collectively worth up to $1.00 per share in cash (or an aggregate of approximately $50 million), for a total consideration of $9.10 per share in cash (or an aggregate of approximately $450 million) (Press release, Supernus, OCT 11, 2021, View Source [SID1234591067]). The first CVR, worth $0.50 per share, is payable upon achieving net sales of GOCOVRI of $150 million in any four consecutive quarters between closing and the end of 2024. The second CVR, worth $0.50 per share, is payable upon achieving net sales of GOCOVRI of $225 million in any four consecutive quarters between closing and the end of 2025. The transaction is expected to close in late fourth quarter 2021 or in early first quarter 2022.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The transaction will provide Supernus with two marketed products: GOCOVRI (amantadine) extended release capsules, the first and only U.S. Food and Drug Administration (FDA)-approved medicine indicated for the treatment of both OFF and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy; and Osmolex ER (amantadine) extended release tablets, approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.

"This acquisition represents a significant step to further build a strong and diverse Parkinson’s disease portfolio, and aligns with our focus of acquiring value-enhancing, clinically-differentiated medicines to treat CNS diseases," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "We have a proven track record of strong commercial execution, and look forward to building on GOCOVRI’s growth momentum so that more patients can benefit from access to Adamas’ innovative neurological therapies."

Strategic and Financial Benefits

Strengthens Parkinson’s disease portfolio with GOCOVRI (amantadine) extended release capsules, the first and only FDA-approved medicine indicated for the treatment of both OFF and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy.
Diversifies and increases revenue base and cash flow
Net sales of GOCOVRI were $71.2 million and $37.7 million in 2020 and for the first six months of 2021, respectively.
Combined with the acquisition of US WorldMeds CNS products in 2020, this transaction significantly reduces the reliance on net sales of Trokendi XR. In the first half of 2021 and on a combined proforma basis (including revenue from US WorldMeds and Adamas transactions), net sales of Trokendi XR represent 48% of Supernus revenues down from 72% (excluding revenue from these transactions).
Potential synergies of $60 million to $80 million in year one due to strong overlap with existing infrastructure.
The acquisition is expected to be significantly accretive in 2022.
"We are pleased that Supernus recognized the value created at Adamas and firmly believe this path forward is an excellent outcome for not only our shareholders, but all our stakeholders," said Neil F. McFarlane, Chief Executive Officer of Adamas Pharmaceuticals, Inc. "With their shared commitment to helping patients affected by neurological diseases and their extensive resources, Supernus can continue to advance our mission and reach. I am extremely proud of Team Adamas for their hard work and dedication to get us to this point and am confident that partnering with Supernus will maximize the potential of our innovative therapies."

Terms and Financing
Under the terms of the agreement, Supernus will commence a tender offer to acquire all outstanding shares of Adamas Pharmaceuticals, Inc. for a purchase price of $8.10 per share in cash (or an aggregate of approximately $400 million) payable at closing plus two non-tradable CVRs. All cash consideration will be funded through existing balance sheet cash.

The CVR entitles Adamas stockholders to receive up to an additional $1.00 per share in cash (or an aggregate of approximately $50 million) payable upon GOCOVRI achieving certain net sales milestones within specified periods (subject to the terms and conditions contained in a Contingent Value Rights Agreement detailing the terms of the CVRs). These milestones include (i) $0.50 per share payable if in any four consecutive quarters between closing and the end of 2024, net sales of GOCOVRI achieving $150 million, and (ii) another $0.50 per share payable if in any four consecutive quarters between closing and the end of 2025, net sales of GOCOVRI achieving $225 million. There can be no assurance any payments will be made with respect to the CVR.

Approvals and Timing of Close
The transaction, which has been approved by the boards of directors of both companies, is expected to close in late fourth quarter 2021 or in early first quarter 2022, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Adamas’ common stock. Following the successful closing of the tender offer, Supernus will acquire any shares of Adamas that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

Full Year Financial Guidance
Supernus will provide full year 2022 financial guidance during the Company’s fourth quarter 2021 financial results conference call in February 2022.

Advisors
Jefferies LLC is acting as the exclusive financial advisor to Supernus. Lazard is acting as the exclusive financial advisor to Adamas. Saul Ewing Arnstein & Lehr LLP is serving as legal counsel and Grant Thornton is providing due diligence services to Supernus, and Cooley LLP is serving as legal counsel to Adamas.

Conference Call and Webcast today, October 11 at 8:30 a.m. ET
A conference call and a live webcast will be hosted today, October 11, at 8:30 a.m. ET, to discuss this transaction. Presentation slides will be available via this webcast link. A question and answer session with the Supernus management team will follow the company’s remarks.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 6685281
Conference Call Name: Supernus Pharmaceuticals Business Update Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".