On February 2, 2022 Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company primarily focused on treatments for gastrointestinal (GI) diseases, and EVERSANA Life Science Service LLC, an independent provider of global commercial services to the life science industry, reported the extension of their agreement to continue collaborating on the commercialization and distribution of Gimoti (metoclopramide) nasal spray in the United States through the end of 2026 (Press release, EVERSANA, FEB 2, 2022, View Source [SID1234607632]).

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According to the original agreement signed in January 2020, Evoke retains ownership of the Gimoti NDA and legal, regulatory, and manufacturing responsibilities for Gimoti. EVERSANA utilizes its internal sales organization and other commercial functions for market access, marketing, distribution, and other patient support services. Evoke records sales for Gimoti and retains more than 80% of the net product profits once the parties’ costs are reimbursed. This amendment increases the percentage of net product profit retained by Evoke and accelerates the reimbursement of commercialization costs to Eversana after the product breaks even on a monthly basis. The initial term provided in the original agreement was five years following FDA approval, June 19, 2025, but this amendment will extend the term of the agreement through December 31, 2026.

"Our market research for Gimoti continues to reinforce significant unmet medical need for patients with diabetic gastroparesis and shows strong receptiveness to the potential benefits in favor of delivering treatment outside of the gastrointestinal tract," shared Jim Lang, CEO of EVERSANA, "Together we created a fully integrated commercialization model for this therapy and today we are expanding our investment in this partnership as we continue to believe in the product, the market and the patient need. Through the extension of our multi-year partnership, we are poised to further increase the access of Gimoti to patients and physicians as part of our broader commercial strategy."

"Gimoti remains the most novel product to treat patients that suffer from symptoms associated with diabetic gastroparesis. Although the pandemic has slowed new product launches across the industry, we continue to see market research that is highly supportive of the opportunity for Gimoti. More importantly, patients have described remarkable benefits after initiating Gimoti therapy. We continue to see expanding enrollments and filled prescriptions for the brand and believe in the long-term opportunity for Gimoti. We are excited to continue leveraging the expertise of EVERSANA’s team for our sales and distribution efforts, given their large-scale commercialization capabilities for products generated by life science companies," commented Dave Gonyer, CEO of Evoke Pharma.

On February 2, 2022 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory and other debilitating diseases, and Carna Biosciences, Inc. ("Carna") (JASDAQ: 4572), a clinical-stage biopharmaceutical company focusing on the discovery and development of innovative therapies to treat serious unmet medical needs, reported that they have entered into a licensing agreement, whereby Brickell will have the exclusive, worldwide rights to develop and commercialize Carna’s portfolio of novel, potent, and orally available Stimulator of Interferon Genes (STING) antagonists (Press release, Vical, FEB 2, 2022, View Source [SID1234607631]). STING is a well-known mediator of innate immune responses. Excessive signaling through STING is linked to a number of high unmet need diseases, ranging from autoimmune disorders, such as systemic lupus erythematosus and rheumatoid arthritis, to interferonopathies, which are a set of rare genetic conditions characterized by interferon overproduction.

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"Inhibiting the STING pathway is a compelling and differentiated approach. In many chronic inflammatory conditions, persistent inflammation results in substantial tissue damage and release of DNA fragments into the extracellular space. The cGAS-STING pathway is the crucial sensor for these extracellular DNA fragments, which triggers release of interferons and other pro-inflammatory cytokines that further exacerbates the inflammation," states Dr. Monica Luchi, Chief Medical Officer of Brickell. "STING antagonists, especially those like the lead candidate, BBI-10, that inhibit the palmitoylation site and deactivate downstream kinase signaling have continued to attract the interest of many researchers, as well as pharmaceutical companies, because of their potential to target a broad spectrum of inflammatory diseases. We are particularly excited about the potential future opportunity of STING inhibitors in a precision medicine context, considering the cGAS-STING pathway has shown to be overactive in defined clinical subgroups of autoimmune and autoinflammatory conditions, as well as severe genetic disorders."

"Our acquisition of Carna’s next-generation STING inhibitors represents a tremendous opportunity to expand our presence in immunology and inflammation and bring forward new treatment options for patients in need," commented Robert Brown, Chief Executive Officer of Brickell. "We believe that this portfolio of preclinical STING inhibitors is complementary to our current development-stage pipeline of NCEs, which includes BBI-02, a potential first-in-class DYRK1A inhibitor program that is expected to enter a Phase 1 clinical study in the coming months. These assets position us with two promising and novel immunology targets and we look forward to advancing them further throughout this year."
"These STING antagonists have been identified from our first non-kinase target project, which we expect to become another cornerstone of the company’s drug discovery research. Our compounds have demonstrated strong STING inhibitory potency in various settings, and we are thrilled that they will be further investigated by Brickell," said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences.
"We are pleased to enter into this agreement with Brickell, as we are always looking for opportunities to accelerate the development of our drug candidates," said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences. "We admire Brickell’s expertise in developing innovative therapies, and we look forward to Brickell leading the development of our STING antagonists to potentially deliver valuable new treatment options to patients with autoimmune and inflammatory diseases."

Under the terms of the license agreement, Brickell will make a one-time cash payment to Carna of $2.0 million. In addition, Brickell will pay Carna success-based development, regulatory, and sales milestone payments of up to $258.0 million. Carna is also eligible to receive tiered royalty payments ranging from mid-single digits up to 10% of net sales. Brickell will be responsible for all future development activities and expenses related to the STING inhibitor platform.

On February 2, 2022 Novartis reported that delivered another year of solid operational performance with mid-single digit top-line growth, margin expansion, and strong free cash flow (Press release, Novartis, FEB 2, 2022, View Source [SID1234607630]). Our in-market growth drivers continue to perform well across geographies, supporting our confidence in our mid and long-term growth outlook. Despite some pipeline setbacks, we delivered important innovation milestones including for: Entresto, 177Lu-PSMA-617, iptacopan, Kisqali, and Leqvio. Looking ahead, we are focused on delivering on our pipeline and key technology platforms, which includes 20+ potential assets with significant sales, to be approved by 2026. We remain balanced in our capital allocation priorities as we continue to invest in innovation alongside returning capital to our shareholders".

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Strategy Update
Novartis is a focused medicines company. During 2021 we continued to build depth in five core therapeutic areas (Cardio-Renal, Immunology, Neuroscience, Oncology and Hematology), strength in technology platforms (Targeted Protein Degradation, Cell Therapy, Gene Therapy, Radioligand Therapy, and xRNA), and have a balanced geographic footprint. Our confidence to grow sales in the near-term is driven by multi-billion-dollar sales from: Cosentyx, Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio. To fuel further growth through 2030 and beyond, we have 20+ new assets with at least USD 1 billion sales potential, that could be approved by 2026. Novartis is also pioneering the shift to advanced technology platforms.
Novartis sold its investment in Roche Holding AG (Roche), in a single bilateral transaction for USD 20.7 billion, consistent with our strategy as a focused medicines company.
The strategic review of Sandoz is progressing, we expect to provide an update, at the latest, by the end of 2022. The review will explore all options, ranging from retaining the business to separation, in order to determine how to best maximize value for our shareholders.
We remain disciplined and shareholder focused in our capital allocation as we balance investing in our business, through organic investments and value-creating bolt-ons, with returning capital to shareholders via our growing annual dividend and share buybacks.
Novartis continued to make significant strides in building trust with society. We committed to carbon neutral emissions: Scope 1 and 2 by 2025, Scope 1, 2 and 3 by 2030, and net zero emissions across our value chain by 2040. Novartis ESG efforts have been recognized by upgrades from several third party ESG rating agencies. Our culture journey towards an inspired, curious and unbossed organization continues, in order to drive performance and competitiveness in the long-term.
Financials
Fourth quarter
Net sales were USD 13.2 billion (+4%, +6% cc) in the fourth quarter driven by volume growth of 11 percentage points, including 1 percentage point relating to a reclassification of contract manufacturing from other revenues to sales. Volume growth was partly offset by price erosion of 3 percentage points and the negative impact from generic competition of 2 percentage points.
Operating income was USD 2.6 billion (-3%, -1% cc) as higher sales were more than offset by higher M&S and R&D investments and lower gains from divestments, financial assets, and contingent considerations.
Net income was USD 16.3 billion, benefiting from the Roche divestment gain of USD 14.6 billion. EPS was USD 7.29.
Core operating income was USD 3.8 billion (+9%, +12% cc) driven by higher sales, partly offset by higher investments in M&S and R&D. Core operating income margin was 28.9% of net sales, increasing by 1.5 percentage points (+1.6 percentage points cc).
Core net income was USD 3.1 billion (+3%, +6% cc), mainly driven by growth in core operating income, partly offset by lower income from associated companies due to the divestment of our investment in Roche and a higher tax rate. Core EPS was USD 1.40 (+4%, +7% cc), growing ahead of core net income.
Free cash flow amounted to USD 3.0 billion (-9% USD), compared to USD 3.3 billion in the prior year quarter. Higher operating income adjusted for non-cash items was more than offset by higher income taxes paid and lower divestment proceeds.
Innovative Medicines net sales were USD 10.7 billion (+5%, +7% cc) with volume contributing 11 percentage points to growth, including 1 percentage point relating to contract manufacturing revenue reclassification. Generic competition had a negative impact of 3 percentage points, mainly due to Afinitor, Gleevec/Glivec and Travatan. Pricing had a negative impact of 1 percentage point. Pharmaceuticals BU sales grew +9% (cc), driven by strong growth from Entresto, Cosentyx, Kesimpta and Zolgensma. The USD 108 million reclassification of contract manufacturing revenue recognized in Established Medicines contributed 2 percentage points to Pharmaceuticals BU sales growth. Oncology BU sales grew 3% (cc) with strong performance from Kisqali, Tafinlar + Mekinist, Promacta/Revolade and Jakavi.

2
Sandoz net sales were USD 2.5 billion (0%, +2% cc) with volume contributing 11 percentage points to growth, including 1 percentage point relating to contract manufacturing revenue reclassification. Pricing had a negative impact of 9 percentage points. Sales in Europe grew +4% (cc), while sales in the US declined -8% (cc). Global sales of Biopharmaceuticals grew to USD 555 million (+8%, +11% cc) across all regions.
Full year
Net sales were USD 51.6 billion (+6%, +4% cc) in the full year. Volume contributed 8 percentage points to sales growth, partly offset by price erosion of 2 percentage points and the negative impact from generic competition of 2 percentage points.
Operating income was USD 11.7 billion (+15%, +13% cc), mainly driven by higher sales and lower legal expenses, partly offset by increased M&S and R&D investments and higher amortization.
Net income was USD 24.0 billion, benefiting from the USD 14.6 billion gain from the divestment of our investment in Roche. EPS was USD 10.71.
Core operating income was USD 16.6 billion (+8%, +6% cc) benefiting from higher sales, partly offset by increased M&S and R&D investments. Core operating income margin was 32.1% of net sales, increasing by 0.4 percentage points (+0.5 percentage points cc).
Core net income was USD 14.1 billion (+7%, +5% cc). Core EPS was USD 6.29 (+9%, +7% cc), growing faster than core net income and benefiting from lower weighted average number of shares outstanding.
Free cash flow increased to USD 13.3 billion (+14% USD). This was mainly driven by higher operating income adjusted for non-cash items and lower payments for legal provisions, partly offset by the USD 650 million upfront payment to in-license tislelizumab from an affiliate of BeiGene, Ltd.
Innovative Medicines net sales were USD 42.0 billion (+8%, +6% cc), with volume contributing 9 percentage points to growth. Generic competition had a negative impact of 3 percentage points, mainly due to Ciprodex, Afinitor, Diovan and Gleevec/Glivec. Pricing had a negligible impact on sales growth. Pharmaceuticals BU grew +7% (cc) driven by Entresto, Cosentyx, Zolgensma and Kesimpta. Oncology BU grew 4% (cc) driven by Promacta/Revolade, Kisqali, Jakavi and Tafinlar + Mekinist.
Sandoz net sales were USD 9.6 billion (0%, -2% cc), with volume contributing 7 percentage points to growth, including 1 percentage point relating to contract manufacturing revenue reclassification. Volume growth was more than offset by a negative price impact of 9 percentage points. Sales in Europe declined -2% (cc), sales in the US declined -15% (cc). Global sales of Biopharmaceuticals grew to USD 2.1 billion (+10%, +7% cc), driven by continued growth ex-US and Ziextenzo (pegfilgrastim) US.
Q4 key growth drivers
Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in
order of contribution to Q4 growth) including:

Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.

In 2021, Novartis repurchased a total of 30.7 million shares for USD 2.8 billion on the SIX Swiss Exchange second trading line, including 19.6 million shares (USD 1.8 billion) under the up to USD 2.5 billion share buyback announced in November 2020, 8.6 million shares (USD 0.8 billion) to mitigate dilution related to participation plans of associates and 2.5 million shares (USD 0.2 billion) under the up to USD 15 billion share buyback announced in December 2021. In addition, 1.5 million shares (USD 0.1 billion) were repurchased from associates. In the same period, 10.3 million shares (for an equity value of USD 0.8 billion) were delivered as a result of options exercised and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 21.9 million versus December 31, 2020. These treasury share transactions resulted in a decrease in equity of USD 2.1 billion and a net cash outflow of USD 3.0 billion.

As of December 31, 2021, the net debt decreased to USD 0.9 billion compared to USD 24.5 billion at December 31, 2020. The USD 23.6 billion decrease was mainly driven by the proceeds received from the Roche divestment of USD 20.7 billion and free cash flow during 2021 of USD 13.3 billion, partially offset by the USD 7.4 billion annual dividend payment and the net cash outflow for treasury share transactions of USD 3.0 billion.

The Group has not experienced liquidity or cash flow disruptions during 2021 due to the COVID-19 pandemic. We are confident that Novartis is well positioned to meet its ongoing financial obligations and has sufficient liquidity to support its normal business activities.

As of Q4 2021, the long-term credit rating for the company is A1 with Moody’s Investors Service and AA- with S&P Global Ratings.

Our guidance assumes that we see a continuing return to normal global healthcare systems, including prescription dynamics, and that no Sandostatin LAR generics enter in the US.

Foreign exchange impact
If late-January exchange rates prevail for the remainder of 2022, the foreign exchange impact for the year would be negative 3 percentage points on net sales and negative 4 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.
Annual General Meeting

Dividend proposal
The Novartis Board of Directors proposes a dividend payment of CHF 3.10 per share for 2021, up 3.3% from CHF 3.00 per share in the prior year, representing the 25th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the Annual General Meeting on March 4, 2022.

Reduction of Share Capital
The Novartis Board of Directors proposes to cancel 30,699,668 shares (repurchased under the authorizations of February 28, 2019 and March 2, 2021) and to reduce the share capital accordingly by CHF 15.3 million, from CHF 1,217,210,460 to CHF 1,201,860,626.

Further Share Repurchases
On December 16, 2021 Novartis announced a share buyback of up to USD 15 billion to be executed by the end of 2023. To cover the amount exceeding CHF 8.8 billion still available under the existing shareholder authority granted in 2021, the Novartis Board of Directors proposes that shareholders authorize the Board of Directors to repurchase shares up to an additional CHF 10 billion between the Annual General Meeting 2022 and the Annual General Meeting 2025.

Nominations for election to the Board of Directors
On October 26, 2021 the Novartis Board of Directors announced the nomination of Ana de Pro Gonzalo for election to the Board.

The Novartis Board of Directors announced today that it is also nominating Daniel Hochstrasser, Partner and Chairman of the Board of Directors of Bär & Karrer, for election to the Board. Daniel Hochstrasser co-leads Bär & Karrer’s arbitration practice and brings more than 30 years of experience as legal counsel. His primary focus has been on representing parties in complex disputes arising from M&A transactions, industrial and infrastructure projects, banking and finance, as well as license, distribution and development agreements, particularly in the pharmaceutical field. His extensive track record in M&A and commercial litigation, and international arbitration coupled with his knowledge of the pharmaceutical industry will be a valuable addition to the Novartis Board’s expertise.

Due to the business relationship between Novartis and Bär & Karrer, Daniel Hochstrasser will fulfill the independence criteria outlined in the Regulations of the Board of Novartis upon his already announced resignation from Bär & Karrer as of the end of 2022. Until then, Daniel Hochstrasser will not belong to any Board committee of Novartis. If elected to the Board of Directors of Novartis, Daniel Hochstrasser will not be involved in any Novartis mandates, as was the case in the recent past.

Re-elections of the Chairman and the members of the Board of Directors
The Novartis Board of Directors proposes the re-election of Joerg Reinhardt (also as Board Chair), Nancy C. Andrews, Ton Buechner, Patrice Bula, Elizabeth Doherty, Bridgette Heller, Frans van Houten, Simon Moroney, Andreas von Planta, Charles L. Sawyers, and William T. Winters as members of the Board of Directors.

For Andreas von Planta, who has already announced that he will not stand for re-election in 2023, the Board proposes that to ensure continuity he is granted an exception to serve for one additional year, pursuant to article 20, paragraph 3 of the Articles of Incorporation, given the 12-years term limit introduced last year. After the shareholder meeting 2022 he will hand over the chair of the Governance, Nomination and Corporate Responsibilities Committee to Patrice Bula.

Ann Fudge and Enrico Vanni have decided to retire from the Board of Directors. The Board of Directors and the Executive Committee of Novartis thank both for many years of distinguished services on the Board and their outstanding contributions to the company.

The Board is planning to split the combined Vice-Chair and Lead Independent Role held by Enrico Vanni and to appoint Simon Moroney as the new Vice-Chair and Patrice Bula as the new Lead Independent Director after the shareholder meeting 2022.

Re-elections and elections to the Compensation Committee
The Novartis Board of Directors proposes the re-election of Patrice Bula, Bridgette Heller, Simon Moroney, and William T. Winters as members of the Compensation Committee. The Board of Directors intends to designate Simon Moroney again as Chairman of the Compensation Committee.

On February 2, 2022 AbbVie (NYSE:ABBV) reported that financial results for the fourth quarter and full year ended December 31, 2021 (Press release, AbbVie, FEB 2, 2022, View Source [SID1234607629]).

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"We delivered another year of outstanding performance in 2021 with double-digit revenue and EPS growth that were well above our initial expectations," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We are entering 2022 with significant momentum and expect our diverse set of growth assets, robust pipeline and excellent execution to deliver continued strong performance this year and over the long term."

Fourth-Quarter Results

Worldwide net revenues were $14.886 billion, an increase of 7.4 percent on a reported basis, or 7.5 percent on an operational basis.
Global net revenues from the immunology portfolio were $6.746 billion, an increase of 13.2 percent on a reported basis, or 13.3 percent on an operational basis.
Global Humira net revenues of $5.334 billion increased 3.5 percent on a reported and operational basis. U.S. Humira net revenues were $4.553 billion, an increase of 6.0 percent. Internationally, Humira net revenues were $781 million, a decrease of 9.1 percent on a reported basis, or 8.8 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $895 million.
Global Rinvoq net revenues were $517 million.
Global net revenues from the hematologic oncology portfolio were $1.873 billion, an increase of 4.6 percent on a reported basis, or 4.7 percent on an operational basis.
Global Imbruvica net revenues were $1.385 billion, a decrease of 2.7 percent, with U.S. net revenues of $1.114 billion and international profit sharing of $271 million.
Global Venclexta net revenues were $488 million, an increase of 33.3 percent on a reported basis, or 34.0 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.654 billion, an increase of 19.0 percent on a reported and operational basis.
Global Botox Therapeutic net revenues were $671 million, an increase of 18.3 percent on a reported basis, or 18.1 percent on an operational basis.
Vraylar net revenues were $489 million, an increase of 21.8 percent.
Global Ubrelvy net revenues were $183 million.
Global net revenues from the aesthetics portfolio were $1.407 billion, an increase of 23.3 percent on a reported basis, or 22.8 percent on an operational basis.
Global Botox Cosmetic net revenues were $626 million, an increase of 27.0 percent on a reported basis, or 26.6 percent on an operational basis.
Global Juvederm net revenues were $432 million, an increase of 30.6 percent on a reported basis, or 29.8 percent on an operational basis.
On a GAAP basis, the gross margin ratio in the fourth quarter was 71.0 percent. The adjusted gross margin ratio was 83.6 percent.
On a GAAP basis, selling, general and administrative expense was 21.9 percent of net revenues. The adjusted SG&A expense was 22.2 percent of net revenues.
On a GAAP basis, research and development expense was 12.3 percent of net revenues. The adjusted R&D expense was 12.1 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the fourth quarter was 34.1 percent. The adjusted operating margin was 49.3 percent.
On a GAAP basis, net interest expense was $571 million.
On a GAAP basis, the tax rate in the quarter was 5.3 percent. The adjusted tax rate was 12.5 percent.
Diluted EPS in the fourth quarter was $2.26 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.31.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie confirmed prior revenue guidance of greater than $15 billion in combined Skyrizi (risankizumab) and Rinvoq (upadacitinib) risk-adjusted sales in 2025. AbbVie expects each asset to deliver risk-adjusted sales of greater than $7.5 billion in 2025. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Rinvoq for the treatment of moderate to severe atopic dermatitis (AD) in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. The approval includes two dose strengths (15 mg and 30 mg, once daily) and is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for AD with more than 2,500 patients evaluated across three studies. This milestone marked the third FDA-approved indication for Rinvoq.
AbbVie announced the FDA approved Rinvoq (15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by two Phase 3 clinical studies where Rinvoq showed efficacy across multiple measures of disease activity in active PsA with a safety profile consistent with that seen in rheumatoid arthritis (RA). This milestone marked the second FDA-approved indication for Rinvoq.
AbbVie announced the FDA approved Skyrizi for the treatment of adults with active PsA. The approval is supported by two Phase 3 clinical studies where Skyrizi demonstrated significant improvement in joint symptoms, including swollen, tender and painful joints, compared to placebo. This milestone marked the second FDA-approved indication for Skyrizi.
AbbVie announced the European Commission (EC) approved Skyrizi alone or in combination with methotrexate (MTX), for the treatment of active PsA in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The positive opinion is based on data from two pivotal Phase 3 studies which evaluated the efficacy and safety of Skyrizi in adults with active PsA and marks Skyrizi’s second indication in the European Union (EU).
AbbVie announced that it submitted applications to the FDA and European Medicines Agency (EMA) seeking approval for Rinvoq (15 mg, once daily) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA). The submissions are supported by the Phase 3 SELECT-AXIS 2 (study 2) clinical trial in which Rinvoq demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo. No new safety risks were observed compared to the known safety profile of Rinvoq. In addition, AbbVie requested label enhancements for Rinvoq in the EU to include adult patients with active AS who had an inadequate response to biologic DMARDs, based on newly generated clinical data. These data were also provided to the FDA in support of the agency’s ongoing review of the supplemental New Drug Application (sNDA) for Rinvoq in AS.
AbbVie announced that it submitted an application to the EMA seeking approval for Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) for the treatment of patients 16 years and older with moderate to severe Crohn’s disease (CD). The submission is supported by three pivotal Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response as both induction and maintenance therapy. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi. If approved, CD will mark the third indication for Skyrizi in the EU.
AbbVie announced positive top-line results from the Phase 3 induction study, U-EXCEED, which showed Rinvoq (45 mg, once daily) achieved both primary endpoints of clinical remission and endoscopic response at week 12 as well as key secondary endpoints in patients with moderate to severe CD. The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe CD and full results from the study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
At the American College of Rheumatology’s (ACR) annual meeting, AbbVie shared 38 abstracts from across its rheumatology portfolio that underscored AbbVie’s commitment to advancing its portfolio of medicines to help more people living with rheumatic diseases. Highlights included new efficacy data on Rinvoq in people with active PsA and axial involvement, new long-term analysis evaluating the sustainability of response to Rinvoq among patients with RA as well as efficacy and safety data from the KEEPsAKE 1 and KEEPsAKE 2 trials evaluating Skyrizi in adults with PsA treated through 24 weeks.
AbbVie announced that the FDA granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. The BTD is supported by interim data from the ongoing Phase 2 LUMINOSITY study and a Phase 3 study is planned to begin in the first half of 2022.
At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), AbbVie presented results from nearly 30 abstracts across 8 types of cancer. Highlights included data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating minimal residual disease (MRD) and disease-free survival outcomes with fixed duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen; results from several studies evaluating Venclexta in approved and investigational indications; as well as data evaluating ABBV-383, epcoritamab and lemzoparlimab. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. Epcoritamab is being co-developed by Genmab and AbbVie. Lemzoparlimab is being developed through a collaboration with AbbVie and I-Mab.
Allergan Aesthetics announced the successful completion of its acquisition of Soliton, Inc. The addition of Soliton and its technology complements Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.
At the American Society for Dermatologic Surgery meeting, Allergan Aesthetics presented 6 abstracts from its leading portfolio of aesthetic treatments and products, which highlighted its approach to innovative science and commitment to bring new and impactful treatments to customers and patients globally. Highlights included two Botox Cosmetic (OnabotulinumtoxinA) abstracts that were recognized as "Best of Cosmetic Oral Abstracts".
AbbVie announced the FDA approved Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects nearly half of the U.S. adult population. The approval is supported by two pivotal Phase 3 studies that demonstrated Vuity works in as early as 15 minutes and lasts for up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision.
At the American Academy of Ophthalmology Annual Meeting (AAO), AbbVie presented new data from its leading eye care portfolio. Highlights included new pooled post-hoc analyses and patient-reported outcomes of Vuity 1.25%, analyses on Durysta (bimatoprost intracameral implant) and 3 real-world data studies on the glaucoma patient journey.
AbbVie announced that it has extended its preclinical oncology research collaboration agreement with the University of Chicago through 2025. Under the agreement, the organizations will continue working together to advance research in several areas, focusing on oncology, and AbbVie gains an option for an exclusive license to certain University of Chicago discoveries made as part of the collaboration.
Full-Year 2022 Outlook

AbbVie is issuing its GAAP diluted EPS guidance for the full-year 2022 of $9.26 to $9.46. AbbVie expects to deliver adjusted diluted EPS for the full-year 2022 of $14.00 to $14.20. The company’s 2022 adjusted diluted EPS guidance excludes $4.74 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

On February 2, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) reported that Steve Hoerter, President and Chief Executive Officer, will present virtually at the following investor conferences (Press release, Deciphera Pharmaceuticals, FEB 2, 2022, View Source [SID1234607628]):

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Guggenheim 2022 Oncology Virtual Conference on February 9, 2022 at 8:30 AM ET
11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022 at 3:40 PM ET
A live webcast of both events will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of both webcasts will be archived on the Company’s website for 90 days following the presentation.