On November 3, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the third quarter of 2021, and associated Company developments (Press release, Supernus, NOV 3, 2021, View Source;2021.htm [SID1234594656]).

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Net Product Sales
For the first nine months of 2021, net product sales were $412.5 million, a 12% increase over $368.6 million in the same period in 2020. The increase was primarily due to the acquisition of the CNS portfolio of US WorldMeds in June 2020.
Third quarter 2021 net product sales were $145.5 million, compared to $152.1 million in the same period in 2020. The decrease was primarily due to a decrease in net product sales of APOKYN and Trokendi XR, partially offset by an increase in net product sales from other products, including Qelbree, which was launched in the second quarter of 2021.
Qelbree Launch Update
•Qelbree’s growth has accelerated with the arrival of the "back to school" season in the third quarter of 2021, reaching total monthly prescriptions in September of 7,132, an increase of 37% compared to August, and an increase of 118% compared to monthly average during the three months period prior to September. The latest weekly prescriptions data shows 2,248 prescriptions, an increase of 51% compared to the weekly average over the prior 12-week period.
•In addition, Qelbree’s base of prescribers has increased by 340% during the third quarter of 2021 compared to the second quarter of 2021, with more than 3,470 physicians prescribing the product.
Proposed Acquisition of Adamas Pharmaceuticals, Inc. (Adamas)
•On October 11, 2021, the Company announced it entered into a definitive agreement to acquire Adamas, strengthening its Parkinson’s disease portfolio with two marketed products, including GOCOVRI (amantadine) extended release capsules, the first and only FDA-approved medicine indicated for the treatment of both "off" episodes and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy. The acquisition, if completed, would strengthen Supernus’ Parkinson’s disease portfolio with GOCOVRI and diversify and increase its revenue base and cash flow.
•Per the agreement, Supernus has offered to acquire all of Adamas’ common stock through a tender offer for $8.10 per share in cash (or an aggregate of approximately $400 million) payable at closing, plus two non-transferrable and non-tradable contingent value rights collectively worth up to $1.00 per share in cash (or an aggregate of approximately $50 million), for a total consideration of up to $9.10 per share in cash (or an aggregate of approximately $450 million). The transaction is subject to customary closing conditions and is expected to close in late fourth quarter 2021 or in early first quarter 2022.
Product Pipeline Update
Qelbree (viloxazine, extended-release capsules) – Novel non-stimulant for the treatment of ADHD in adults
•The U.S. Food and Drug Administration (FDA) acknowledged it has received the supplemental new drug application (sNDA) for Qelbree for the treatment of ADHD in adult patients. The sNDA has a user fee goal date (PDUFA date) of April 29, 2022.
SPN-830 (apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson’s disease (PD)
•The Company expects to resubmit the SPN-830 NDA to the FDA in November 2021.
SPN-820 – Novel first-in-class activator of mTORC1
•An Investigational New Drug (IND) application was submitted to the FDA in September 2021. Consequently, the randomized Phase II clinical study of SPN-820 in treatment-resistant depression is on track and expected to start by the end of 2021.
SPN-817 – A novel product candidate for the treatment of epilepsy
•A randomized Phase II clinical study of SPN-817 for the treatment of focal seizures is expected to start in the second half of 2022.
SPN-443 and SPN-446 – Two novel CNS drug candidates nominated for development
•The Company’s internal research and development discovery program generated several new chemical entities (NCEs) including SPN-443 and SPN-446 that were nominated for development for various CNS indications including ADHD.
Financial Highlights
For the three months ended September 30, 2021, operating earnings, net earnings and diluted earnings per share were $32.6 million, $21.6 million and $0.40, respectively, as compared to $56.1 million, $40.0 million and $0.74, for the same period in 2020.
For the nine months ended September 30, 2021, operating earnings, net earnings and diluted earnings per share were $79.9 million, $51.0 million and $0.94, respectively, as compared to $130.7 million, $96.2 million and $1.79, for the same period in 2020.
Amortization of intangible assets expense for the three and nine months ended September 30, 2021 was $6.0 million and $18.0 million, respectively, compared to $6.1 million and $9.8 million, for the same periods in 2020.
As of September 30, 2021, the Company had $849.3 million in cash, cash equivalents, current and long-term marketable securities, compared to $772.9 million as of December 31, 2020.

Full Year 2021 Financial Guidance
For full year 2021, the Company increases its financial guidance for operating earnings, lowers its financial guidance for total combined R&D and SG&A expenses, and lowers the top end of its financial guidance range for total revenues as set forth below:
Conference Call Details
Supernus will host a conference call and webcast today, November 3, 2021, at 4:30 p.m. Eastern Time to discuss these results.
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.

On November 3, 2021 Parthenon Therapeutics, a biotech company inventing a novel class of anti-cancer therapies that reprogram the tumor microenvironment, reported a $65 million Series A financing led by Northpond Ventures, Pfizer Ventures, and Taiho Ventures (Press release, Parthenon Therapeutics, NOV 3, 2021, View Source [SID1234594628]). Additional investors included Section 32, Breakout Ventures, funds managed by Tekla Capital Management LLC, Creacion Ventures, KdT Ventures, Park West Asset Management LLC, and Alexandria Venture Investments. The company plans to use the funds to develop new therapies that target immune exclusion in tumors.

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"Parthenon was established with the goal of developing first-in-class therapeutics that have the highest potential for improving the survival of the greatest number of people living with cancer," said Laurent Audoly, Ph.D., co-founder and Chief Executive Officer, Parthenon Therapeutics. "We’re focused on reprogramming the tumor microenvironment to attack the protective barrier that half of all human cancers build to repel immune attack, a novel approach, we believe, with the potential to create an entirely new class of anti-cancer therapies."

Validating this approach, Parthenon also announced today the publication of a manuscript in the peer-reviewed journal Nature describing the role of discoidin domain receptor 1 (DDR1) in stabilizing the tumor extracellular matrix (ECM), which supports exclusion of immune-cells from tumors. The manuscript — based on research conducted at the laboratories of Dr. Rong Li, Ross Professor of Basic Science Research in the Department of Biochemistry & Molecular Medicine at the School of Medicine & Health Sciences at George Washington University, and Dr. Zhiqiang An, Professor of Molecular Medicine and the Robert A. Welch Distinguished University Chair in Chemistry at The University of Texas Health Science Center at Houston — highlights that neutralizing DDR1, a multi-domain collagen receptor, disrupts the mechanical barrier around a tumor and promotes immune cell infiltration leading to tumoral destruction. This novel approach leverages unique molecular insights into the function of DDR1 to develop a "fit-for-purpose" therapeutic approach. The ability to perforate the tumor’s protective barrier was demonstrated in multiple preclinical models of triple negative breast cancer (TNBC). DDR1 expression in human tumors, including TNBC, and in a variety of other human tumors, correlates negatively with intratumoral abundance of anti-tumor T cells. The co-senior authors of these studies, Dr. Li and Dr. An, have also joined Parthenon’s Scientific Advisory Board. The research supports Parthenon’s program, PRTH-101, as a potential future therapy for a broad range of cancers.

"Our current understanding suggests different barriers underpin immune-cell exclusion: mechanical barriers such as stromal fibrosis and vascular access, functional barriers provided by soluble and metabolic factors, and dynamic barriers that impact immune cell function," said C. Glenn Begley, M.D., Ph.D., Parthenon’s co-founder and Head of Drug Discovery, Parthenon Therapeutics. "Most recent advances in immune oncology and cell therapy have been in the dynamic barrier category. The results published today in Nature explore the potential of attacking specific pillars of these barriers, opening major new opportunities to treat cancer. Targeting DDR1 is one outcome of this methodical approach."

"We believe that our unique insights into the tumor stroma and microenvironment reveal multiple unprecedented points of therapeutic intervention to attack tumors and address therapeutic needs in a range of cancers," said Guy Travis Clifton, M.D., co-founder and Chief Medical Officer, Parthenon Therapeutics.

"The launch of Parthenon Therapeutics marks the debut of an important new approach to treating cancer based in part on the groundbreaking results published in Nature," said Olga Granaturova, MBA, co-founder and Chief Operating Officer, Parthenon Therapeutics. "With our incredibly talented and experienced team, pre-eminent collaborators and members of our Scientific Advisory Board, and ongoing support of our world-class investors, we look forward to fully exploring and rigorously testing the potential of this new approach to treating cancer."

Corcept Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Clovis Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On November 3, 2021 NH TherAguix, a clinical stage company developing innovative nanomedicine for the treatment of cancer, and CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and Drug Products manufacturing company, reported the release of a new batch of AGuIX Drug Product for clinical trials (Press release, NH TherAguix, NOV 3, 2021, View Source [SID1234594559]).

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CARBOGEN AMCIS just released the fifth batch of AGuIX Drug Product since inception of the company. The release of this 3.7 kg batch added to previous available batches will secure the supply for hospitals and cancer centers that are involved in the clinical trials managed by the company. At present, 4 Phase1b/2 studies are recruiting (brain metastasis, cervix cancer, pancreatic cancer and lung cancer) and 3 are foreseen to start on other indications since already authorized by health authorities.

AGuIX combines three essential assets to fight tumors without changing the patient care. It has the potential to target, image (magnetic resonance imaging) and treat (radiosensitizing effect) cancer after intravenous injection. Its pharmacological potential is related to its innovative design that combines both a metal containing hybrid composition and a nanoscale structure.

The manufacturing of the fifth clinical batch of AGuIX Drug Product was performed at CARBOGEN AMCIS’ French site in Riom:
"We’ve manufactured several clinical batches of AGuIX Drug Product for NH TherAguix at our Riom site and we are delighted with the collaboration between our two companies on this exciting product that could make significant positive impact on patients." said Mark Griffiths, Dishman Carbogen Amcis Global CEO. "NH TherAguix has a bright future, and we are very proud to be a part of their innovation journey. We hope to be able to support them for many years to come, especially by offering them more production capacity at our new French state-of-the-art facility localised 7km away from our current Riom site and dedicated to custom development and commercial manufacturing of parenteral drug products, which will open its doors in early 2023."

The two companies have been collaborating on product development for seven years in the past. "CARBOGEN AMCIS was our first service partner for the production of the AGuIX Active Pharmaceutical Ingredient back in 2014 at their Swiss sites for a total of three successful campaigns. In 2019 the manufacturing of AGuIX API was transferred to Sanofi for scale-up purposes. However, we are very happy to work with CARBOGEN AMCIS from the inception of the project in 2015 on the Drug Product manufacturing at Riom site," said Michel Julien, head of CMC at NH TherAguix. "It has been and it is still a very structuring partnership for a rapidly growing young company like NH TherAguix to be backed by a manufacturer like CARBOGEN AMCIS".

About AGuIX: The drug candidate AGuIX, whose potential efficacy is based on nanoscale structuring, is administered by intravenous injection. It combines three essential assets to fight tumors and accessible from the same injection: target, image and treat. AGuIX technology is therefore part of the theranostic concept which corresponds to a combination of therapy (radiosensitizing effect) and diagnosis (visible in MRI), and more broadly in the personalized medicine of tomorrow, without changing the patient’s care path. Due to its biodistribution and mode of action, the nanomedicine AGuIX has a broad spectrum of action against solid tumors, 60% of which are treated by radiotherapy.