Use of a Specialty Pharmacy Sped Time to PA Decisions for Dermatology Practice

Use of a specialty pharmacy to take over the management of prior authorization (PA) requests for a dermatology practice significantly reduced the time to a decision and also decreased the time it took to fill the medication, according to a recent study.

Specialty medications represent the largest category of drug spending but are used by the fewest number of patients. Payers increasingly require PA before a patient is allowed to begin a reimbursed therapy, and the time and clinical documentation required to be submitted to complete these requests are one of the top complaints of specialists, including dermatologists, rheumatologists, and others.

A recent study, published in the Journal of the American Pharmacists Association, examined whether a community-based specialty care pharmacy could speed up the process (whether it led to an approval or a denial) for dermatology practices. The study also sought to compare the timeliness of PA (time to approval and time to first medication fill) between a community-based specialty pharmacy and a dermatology practice.

Researchers used data from Realo Specialty Care, a community-based independent specialty pharmacy that is part of a larger group of 18 independent pharmacies in eastern North Carolina. The specialty pharmacy, which operates in 10 states, began in 2015 to provide care for patients with chronic conditions who are using specialty medications.

This study conducted a retrospective analysis of pharmacy dispensing system data for patients using medications for atopic dermatitis, plaque psoriasis, and hidradenitis suppurativa.

PAs are traditionally completed by a provider’s practice, and data are documented within the pharmacy system as a PA task. Data included documented PA tasks within the pharmacy system for dermatology prescriptions for patients aged 18 years or older between January 1, 2017, and June 30, 2019.

PA tasks included initial receipt of the prescription, the PA decision, and the PA decision date; prescription data confirmed when the drug was first filled.

Results showed a statistically significant difference in the speed at which PA decisions were made.

PA requests completed by the provider’s office took, on average, almost 3 weeks, or an average of 20.9 days (P < .001). The specialty pharmacy, however, completed 677 PA tasks with a mean time to PA decision of 1.9 days. Compared with the 677 PA tasks completed by the specialty pharmacy, the provider’s office completed 66 eligible PA requests.

The pharmacy demonstrated a mean time to first fill of 6.6 days; the provider’s office averaged 16.2 days (P < .001).

Moreover, the specialty pharmacy received approval for 93% of the PAs completed, compared with 76% by the dermatology office.

One study limitation is not knowing how the dermatology practice submitted its PA requests (paper vs electronic); the specialty pharmacy primarily uses electronic PAs.

“The study suggests that pharmacist involvement in the PA process can be beneficial to patient medication access,” wrote the authors, who included both pharmacy executives from Realo as well as faculty from the University of North Carolina at Chapel Hill. “Further study would be necessary to determine whether there is a clinical impact associated with the expedited medication access for patients.”

Reference

Hecht B, Frye C, Holland W, Holland CR, Rhodes LA, Marciniak MW. Analysis of prior authorization success and timeliness at a community-based specialty care pharmacy. J Am Pharm Assoc Am Pharm Assoc. Published online January 5, 2021. doi: 10.1016/j.japh.2021.01.001

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Hidradenitis Suppurativa Armpit Flare-Ups: 6 Ways Real People Manage

If you have hidradenitis suppurativa, you’re probably well acquainted with hidradenitis suppurativa armpit flare-ups. This chronic skin disease results in painful bumps that typically occur in areas where the skin rubs together, including the groin, buttocks, breasts—and underarms. These bumps can burst open at any time, which unsurprisingly feels terrible, and can also produce pus that may have an odor. 

While hidradenitis suppurativa is painful and challenging no matter where the flare-ups occur, it can be particularly difficult to manage when it occurs in your underarms. The pus can stain clothes, and hair removal methods like shaving can make hidradenitis suppurativa symptoms worse. So, since this can be so tough to handle, we asked people with hidradenitis suppurativa how they manage underarm flare-ups and what advice they have for others.

1. First try to identify what triggers your flare-ups.

Something people with hidradenitis suppurativa quickly learn is that flare-up triggers vary from person to person. Common triggers include stress, heat, and hormonal changes due to things like menstruation, according to the National Organization for Rare Disorders. Some individuals say that certain food groups or ingredients make symptoms worse, while others notice that they have more flare-ups when they are stressed.

When it comes to underarm flare-ups specifically, there’s one particularly inconvenient trigger: sweat. Stephanie H., 34, has had hidradenitis suppurativa for 18 years, and she’s experienced symptoms in her armpits specifically for 10 years. She says that sweating tends to cause a flare-up in her underarms, so she wears tank tops year-round to stay cool. Her favorite brands are Hanes and Danskin. She also uses ice packs or cold towels on hot summer days to reduce the amount of sweating and minimize the risk of a flare-up.

2. Avoid using harsh deodorant or antiperspirant.

Your first instinct to reduce sweat in general but especially when hidradenitis suppurativa armpit flare-ups might be to reach for antiperspirant and deodorant. Unfortunately, that can just make matters worse. Harsh forms of these products may irritate your skin even more, according to the American Academy of Dermatology (AAD). So you might have to experiment to find a product that works for you in this realm if you have hidradenitis suppurativa. Stephanie C., 30, director and co-founder of HS Heroes, finds that unscented sprays cause fewer flare-ups for her than using a product that’s a bar or gel deodorant. “And I only use it when I don’t have open lesions,” she tells SELF.

Others with hidradenitis suppurativa forgo products like deodorant unless they feel it’s absolutely necessary. “I no longer use deodorants [on a regular basis],” Donna A., 70, tells SELF.

3. Stay away from harsh soaps, too.

Here’s another area where it’s really important to find a routine that works for you. Some people with hidradenitis suppurativa use an antibacterial soap like Hibiclens on a daily basis while others only use it during flare-ups or don’t use it at all because they find it’s too harsh for their skin. Overall, many people with the condition use a range of cleansing products or treatments to help manage or prevent symptoms. Kelly M., 44, uses a benzoyl peroxide acne wash, antibacterial topical solution, and benzoyl peroxide cream on her skin, she explains.

“If you’re going to try a product topically, try a test spot first to see how your HS reacts,” Denise P., 50, who co-founded HS Connect and is a long-time advocate for others with the condition, tells SELF. (This can be good advice for trying new skin products no matter which, if any, conditions a person may have!) And no matter what kind of soap you use on your underarms, be sure to avoid using items like washcloths and loofahs, which can be too rough for your skin (especially if you’re dealing with open wounds).

4. Avoid shaving your underarms during a flare-up (or even at all).

The Mayo Clinic definitively advises people with hidradenitis suppurativa to stop shaving the affected skin, and every individual we spoke with mentioned that shaving only worsened their flare-ups.

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Adalimumab Market Analysis, Share, Global Driving Factors by Manufacturers, Growth Opportunities, Regions, Type and Application, Revenue Market Forecast to 2027

Adalimumab

Global Adalimumab Market research report offers the market definition, market shares, drivers, restraints, opportunities, and challenges in an extensive format. On the basis of Type, the market is further categorized into Based on the regions, Adalimumab Market is distributed into Asia Pacific, Europe, North America, Latin America, and the Middle East and Africa. The historical time period that is considered in the report is from 2016 to 2021. The base year is considered as 2021. The forecast years are 2021 to 2027.This markets competitive manufactures and the upcoming manufactures are studied with their research. Revenue, production, price, market share of these players is mentioned with detailed information.

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Adalimumab Market Offers an exhaustive summary of the vendor landscape, competitive analysis, and key strategies to gain competitive advantage.Adalimumab Market provides sizing and growth opportunities for the period 2021-2027. Provides comprehensive insights on the latest industry trends, forecast, and growth drivers in the market. Report Includes a detailed analysis of growth drivers, challenges, and investment opportunities. Delivers a complete overview of segments and the regional outlook of the market.

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List Of Best KEY PLAYERS in Adalimumab Market Report are:-

  • AbbVie
  • Amgen
  • Sandoz
  • Boehringer Ingelheim
  • Mylan
  • Biogen

About Adalimumab Market:

Adalimumab, sold under the trade name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.The global Adalimumab market was valued at USD million in 2019 and is expected to reach USD million by the end of 2026, growing at a CAGR of during 2021-2026.This report focuses on Adalimumab volume and value at the global level, regional level and company level. From a global perspective, this report represents overall Adalimumab market size by analysing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, Asia-Pacific, Latin America and Middle East & Africa.Global Adalimumab

Adalimumab Market By Type:

 

  • Adalimumab
  • Adalimumab Biosimilar

Adalimumab Market By Application:

 

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Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of Adalimumab in these regions, from 2015 to 2027, covering

 

  • North America (United States, Canada and Mexico)
  • Europe (Germany, UK, France, Italy, Russia and Turkey etc.)
  • Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)
  • South America (Brazil, Argentina, Columbia etc.)
  • Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

The study objectives of this report are:

  • To study and analyze the global Adalimumab market size (value & volume) by company, key regions/countries, products and application, history data from 2016 to 2018, and forecast to 2027.
  • To understand the structure of Adalimumab market by identifying its various subsegments.
  • To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
  • Focuses on the key global Adalimumab manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.
  • To analyze the Adalimumab with respect to individual growth trends, future prospects, and their contribution to the total market.
  • To project the value and volume of Adalimumab submarkets, with respect to key regions (along with their respective key countries).
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.
  • To strategically profile the key players and comprehensively analyze their growth strategies.

Key Stakeholders

  • Raw material suppliers
  • Distributors/traders/wholesalers/suppliers
  • Regulatory bodies, including government agencies and NGO
  • Commercial research & development (R&D) institutions
  • Importers and exporters
  • Government organizations, research organizations, and consulting firms
  • Trade associations and industry bodies
  • End-use industries

 

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Major Points from Table of Contents:

1 Report Overview
1.1 Study Scope
1.2 Key Market Segments
1.3 Players Covered
1.4 Market Analysis by Type
1.4.1 Global Adalimumab Market Size Growth Rate by Type (2016-2027)
1.4.2 Major-Type
1.4.3 Independent-Type
1.4.4 Administrator-Type
1.5 Market by Application
1.5.1 Global Adalimumab Market Share by Application (2016-2027)
1.5.2 Commercial
1.5.3 Commonweal
1.5.4 Other
1.6 Study Objectives
1.7 Years Considered

2 Global Growth Trends
2.1 Adalimumab Market Size
2.2 Adalimumab Growth Trends by Regions
2.2.1 Adalimumab Market Size by Regions (2016-2027)
2.2.2 Adalimumab Market Share by Regions (2016-2021)
2.3 Industry Trends
2.3.1 Market Top Trends
2.3.2 Market Drivers
2.3.3 Market Opportunities

3 Market Share by Key Players
3.1 Adalimumab Market Size by Manufacturers
3.1.1 Global Adalimumab Revenue by Manufacturers (2016-2021)
3.1.2 Global Adalimumab Revenue Market Share by Manufacturers (2016-2021)
3.1.3 Global Adalimumab Market Concentration Ratio (CR5 and HHI)
3.2 Adalimumab Key Players Head office and Area Served
3.3 Key Players Adalimumab Product/Solution/Service
3.4 Date of Enter into Adalimumab Market
3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Type and Application
4.1 Global Adalimumab Market Size by Type (2016-2021)
4.2 Global Adalimumab Market Size by Application (2016-2021)

(5, 6, 7, 8, 9, 10, 11) United States, Europe, China, Japan, Southeast Asia, India, Central & South America
Adalimumab Market Size (2016-2021)
Key Players
Adalimumab Market Size by Type
Adalimumab Market Size by Application

12 International Players Profiles
Company Details
Company Description and Business Overview
Adalimumab Introduction
Revenue in Adalimumab Business (2016-2021)
Recent Development

13 Market Forecast 2021-2027
13.1 Market Size Forecast by Regions
13.2 United States
13.3 Europe
13.4 China
13.5 Japan
13.6 Southeast Asia
13.7 India
13.8 Central & South America
13.9 Market Size Forecast by Product (2021-2027)
13.10 Market Size Forecast by Application (2021-2027)

14 Analyst’s Viewpoints/Conclusions

15 Appendix
15.1 Research Methodology
15.1.1 Methodology/Research Approach
15.1.1.1 Research Programs/Design
15.1.1.2 Market Size Estimation
12.1.1.3 Market Breakdown and Data Triangulation
15.1.2 Data Source
15.1.2.1 Secondary Sources
15.1.2.2 Primary Sources
15.2 Disclaimer
15.3 Author Details

Continued….

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Is Inflarx NV (IFRX) a Stock to Watch After Losing -25.84% This Week?

The lead product candidate of the company is IFX-1, which is developed for the treatment of Hidradenitis Suppurativa, a rare and chronic debilitating …

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Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Overview with Detailed Analysis, Competitive landscape, Future Growth and Forecast to 2021-2026

Credible Markets

The Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Research Report Provides a Detailed Analysis of Market, Based on Competitive Intensity and How the Competition Will Take Shape in Coming Years.

The report titled on “Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Assessment, With Major Companies Analysis, Regional Analysis, Breakdown Data by Type, Application and Forecast to 2021-2026” firstly introduced the Tumor Necrosis Factor (TNF) Inhibitor Drugs Market basics: Definitions, Classifications, Applications and Market Overview; product specifications; manufacturing processes; cost structures, raw materials and so on. The report takes into account the impact of the novel COVID-19 pandemic on the Tumor Necrosis Factor (TNF) Inhibitor Drugs Market also provides assessment of market definition along with the identification of topmost prominent key manufactures are analyzed emphatically by competitive landscape contrast, with respect to Price, Sales, Capacity, Import, Export, Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size, Consumption, Gross, Gross Margin, Revenue and Market Share. Quantitative analysis of the Tumor Necrosis Factor (TNF) Inhibitor Drugs Market industry from 2015 to 2020 by Region, Type, Application and Consumption assessment by regions.

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The research report also assists the companies functional in the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market in understanding the existing market trends and, thus, shaping their businesses accordingly. It further analyzes the past and the current performance of this market and makes future projections on the basis of these assessments. It also evaluates this market from the perspective of the existing market chain, using the data about the import and export and the sales dynamics of the products available in this market across the world.

Market Segmented are as Follows:

Based on the type of product, the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market segmented into

✪ Humira
✪ Enbrel
✪ Remicade
✪ Simponi/Simponi Aria
✪ Cimzia
✪ Biosimilars

Based on the end-use, the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market classified into:

✪ Rheumatoid Arthritis
✪ Psoriasis
✪ Psoriatic Arthritis
✪ Crohn’s Disease
✪ Ulcerative Colitis
✪ Ankylosing Spondylitis
✪ Juvenile Idiopathic Arthritis
✪ Hidradenitis Suppurativa
✪ Others

And the major players included in the report are:

✪ AbbVie Inc.
✪ Amgen Inc.
✪ Johnson & Johnson Services, Inc.
✪ UCB S.A.
✪ Novartis International AG
✪ Pfizer, Inc.
✪ Merck & co., Inc.

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Impact of COVID-19 on Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Industry: Under COVID-19 outbreak globally, this report provides 360 degrees of analysis from supply chain, import and export control to regional government policy and future influence on the industry. Detailed analysis about market status (2015-2020), enterprise competition pattern, advantages and disadvantages of enterprise products, industry development trends (2021-2026), regional industrial layout characteristics and macroeconomic policies, industrial policy has also been included. From raw materials to end users of this industry are analyzed scientifically, the trends of product circulation and sales channel will be presented as well.

Credible Markets

Tumor Necrosis Factor (TNF) Inhibitor Drugs Market: Regional Analysis Includes:

Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
Europe (Turkey, Germany, Russia UK, Italy, France, etc.)
North America (the United States, Mexico, and Canada)
South America (Brazil etc.)
The Middle East and Africa (GCC Countries and Egypt)

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Table of Contents

Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market 2015-2026, With Breakdown Data of Capacity, Sales, Production, Export, Import, Revenue, Price, Cost and Gross Margin

Chapter 1: Market Scope

1.1 Product Details and Introduction
1.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Snapshot
1.2.1 Major Companies Overview
1.2.2 Market Concentration
1.2.3 Market Share & Six-Year Compound Annual Growth Rate of Major Market (CAGR)

Chapter 2: Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Industry Analysis

2.1 Sector Breakdown Assessment, 2015-2026
2.2 Market Assessment by Type
2.3 Market Size Analysis and Forecast, by Application

Chapter 3: China Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 4: EU Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 5:  USA Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 6: Japan Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 7: India Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 8: Southeast Asia Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 9: South America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Estimates & Forecasts

Chapter 10: Value Chain (Impact of COVID-19)

10.1 Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Value Chain Analysis
10.1.1 Downstream
10.2 COVID-19 Impact on this Industry
10.2.1 Industrial Policy Issued Under the Epidemic Situation
10.3 Driver
10.4 Opportunity

Chapter 11: Competitive Analysis

11.1 Key Information
11.2 Service/Solution Introduction
11.3 Financials
11.4 Business Dynamics

Chapter 12: Research Conclusion

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Report Includes Following Questions:

➊ What is the anticipated growth rate of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market in the forecast period?
➋ Which regional segment is estimated to account for a massive share of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market?
➌ What are the primary driving factors of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market?
➍ What are the vital challenges faced by the prominent players in the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market?
➎ Which current trends are likely to offer promising growth prospects in the next few years?
➏ How is the competitive landscape of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market at present?
➐ What are the key driving factors of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market?
➑ How has the covid-19 impacted the growth of the market?
➒ Which latest trends are anticipated to offer potential growth prospected in the coming years?

The report also covers, the trade scenario, Porter’s Analysis, PESTLE analysis, value chain analysis, company market share, segmental analysis.

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AnaptysBio Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Pipeline Updates Nasdaq:ANAB

  • Positive topline data from GALLOP Phase 2 clinical trial of imsidolimab in moderate to severe generalized pustular psoriasis (GPP) announced in October 2020, with Phase 3 trial initiation anticipated in mid-2021
  • Topline data from POPLAR Phase 2 imsidolimab clinical trial in palmoplantar pustulosis (PPP) anticipated in Q1 2021
  • Expansion of imsidolimab program into four additional dermatological inflammatory Phase 2 clinical trials, including EGFRi-mediated skin toxicities, ichthyosis, hidradenitis suppurativa and acne, with top-line data readouts from Phase 2 trials anticipated through 2021 and 2022
  • Advancement of ANB030 into a healthy volunteer Phase 1 trial with top-line data anticipated in mid-2021 and initiation of Phase 2 clinical trials in alopecia areata and vitiligo in Q4 2021
  • Amended strategic immuno-oncology collaboration with GlaxoSmithKline (GSK) to increase dostarlimab royalties to 8-25% of global sales, add 1% Zejula™ royalty effective January 2021 and receive additional $60 million cash in Q4 2020
  • $75MM in cash milestones anticipated from dostarlimab regulatory milestones under GSK collaboration over upcoming 18 months, including US BLA and EU MAA approval for dMMR endometrial cancer anticipated in H1 2021 and acceptance of US BLA for pan-dMMR tumors in Q1 2021

SAN DIEGO, Feb. 25, 2021 (GLOBE NEWSWIRE) — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the fourth quarter and year ended December 31, 2020 and provided pipeline updates.

“We made progress in advancing AnaptysBio’s pipeline during 2020 and look forward to multiple clinical readouts from our wholly-owned programs in 2021. Imsidolimab will continue to be our key focus going forward as we anticipate GPP Phase 3 initiation and Phase 2 topline readouts from five other immune-dermatology indications through 2021 and 2022. We also anticipate commercial launch of dostarlimab this year and meaningful milestone and royalty revenue to AnaptysBio under our GSK partnership,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Our strategy is to continue advancing first-in-class immunology-focused therapeutic antibodies through key clinical data catalysts using a capital-efficient business model.”

Imsidolimab (Anti-IL-36 Receptor) Program

  • In July, we announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP.
  • In October, we announced positive topline data from an interim analysis of our imsidolimab GALLOP Phase 2 trial in GPP. Six of 8 patients achieved the primary endpoint of disease improvement upon Day 29, while erythema with skin pustules, which clinically defines GPP, decreased by 94% on Day 29 relative to baseline. We plan to report 16-week data from the GALLOP trial at a medical conference in 2021.
  • We anticipate initiation of a Phase 3 trial for imsidolimab in GPP during mid-2021 following completion of protocol alignment, and review of 16-week data from the Phase 2 GALLOP trial, with the FDA.
  • We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 59 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in Q1 2021.
  • We have expanded our imsidolimab program into third and fourth new clinical indications, EGFRi-mediated skin toxicities and ichthyosis, with interim top-line data from Phase 2 trials anticipated at the end of 2021 and in 2022, respectively, and we are also expanding the imsidolimab program into fifth and sixth new clinical indications, hidradenitis suppurativa and acne, with initiation of Phase 2 trials in these indications anticipated in Q2 2021.
  • We initiated a worldwide registry of GPP and PPP patients, named RADIANCE, in Q1 2021, to improve understanding of the patient journey and support enrollment of future trials.

ANB030 (Anti-PD-1 Agonist) Program

  • We anticipate topline data from our ongoing Phase 1 healthy volunteer clinical trial of ANB030, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts in mid-2021.  
  • Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting.  
  • We anticipate initiating Phase 2 trials of ANB030 in alopecia areata and vitiligo in Q4 2021.  

ANB032 (Anti-BTLA Modulator) Program

  • We filed a Clinical Trial Notification (“CTN”) in Australia for ANB032, our wholly-owned BTLA modulator antibody, during the first quarter of 2021 and anticipate initiating a healthy volunteer Phase 1 trial in the first half of 2021 upon clearance of the CTN.
  • We presented preclinical data regarding ANB032 at the 2020 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in October 2020.

Etokimab (ANB020 Anti-IL-33) Program

  • We discontinued further development of etokimab, our anti-IL-33 antibody previously referred to as ANB020, following review of topline week 16 data from the approximately 100-patient ECLIPSE trial in chronic rhinosinusitis with nasal polyps (CRSwNP), where patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant over placebo on either co-primary endpoint.  

Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

  • In October 2020, we amended our immuno-oncology collaboration with GSK resulting in increased financial consideration to AnaptysBio. Royalties due to AnaptysBio for dostarlimab were increased to 8-25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billion in cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues. GSK also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of Zejula. In addition, GSK paid AnaptysBio a one-time cash payment of $60 million in Q4 2020.   In exchange, AnaptysBio provided GSK with freedom to conduct development and commercialization of Zejula in combination with third-party molecules and settled the dispute between AnaptysBio and GSK.
  • US BLA and European Union EMA approvals for dostarlimab are anticipated for endometrial cancer in H1 2021, which will result in $20 million and $10 million milestone payments, respectively.   The FDA recently accepted a subsequent US BLA for dostarlimab in pan-deficient mismatch repair tumors and we anticipate receiving a $10 million payment from GSK in Q1 2021 as a result of this milestone.  

Board of Directors

  • In January 2021, the Company appointed Dr. Magda Marquet to its board of directors. She is the co-founder of AltheaDx, a commercial stage, precision medicine company, and co-founded Althea Technologies and as its co-CEO led the company to become a highly profitable, commercial company. Prior to starting Althea Technologies, Dr. Marquet held several positions in pharmaceutical development in companies such as Vical and Amylin Pharmaceuticals. She currently serves on the Board of Directors of Arcturus Therapeutics, Micronoma, Matrisys Biosciences and ProciseDx.

Fourth Quarter Financial Results

  • Cash, cash equivalents and investments totaled $411.2 million as of December 31, 2020 compared to $428.5 million as of December 31, 2019, for a net decrease of $17.3 million. The decrease relates primarily to cash used for operating activities partially offset by an increase in collaboration revenue of $67.0 million.
  • Collaboration revenue was $60.0 million and $75.0 million for the three and twelve months ended December 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab and the $60.0 million amendment related payment from GSK, compared to $3.0 million and $8.0 million for the three and twelve months ended December 31, 2019.
  • Research and development expenses were $21.6 million and $80.0 million for the three and twelve months ended December 31, 2020, compared to $21.4 million and $99.3 million for the three and twelve months ended December 31, 2019. The annual decrease was due primarily to reduced outside services for manufacturing and clinical activities based on the timing of projects.
  • General and administrative expenses were $5.1 million and $18.9 million for the three and twelve months ended December 31, 2020, compared to $3.8 million and $16.1 million for the three and twelve months ended December 31, 2019. The increase was due primarily to increased legal and insurance expenses.
  • Net income was $33.6 million for the three months ended December 31, 2020, or a net income per share of $1.23 and a net loss of $19.9 million for the twelve months ended December 31, 2020, or a net loss per share of $0.73, compared to a net loss of $20.3 million and $97.3 million for the three and twelve months ended December 31, 2019, or a net loss per share of $0.75 and $3.60.

Financial Guidance

AnaptysBio expects its net cash burn in 2021 will be close to $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.

About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-36R antibody imsidolimab, previously referred to as ANB019, for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, palmoplantar pustulosis, or PPP, EGFRi, ichthyosis, hidradenitis suppurativa and acne; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated; and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology collaboration with GlaxoSmithKline, including an anti-PD-1 antagonist antibody (dostarlimab GSK4057190A), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889A) and an anti-LAG-3 antagonist antibody (GSK4074386), and an inflammation collaboration with Bristol-Myers Squibb, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including imsidolimab’s Phase 2 clinical trial in PPP, imsidolimab’s Phase 2 clinical trials in EGFRi, ichthyosis, hidradenitis suppurativa, and acne, and ANB030’s Phase 1 healthy volunteer clinical trial; the timing of initiation of imsidolimab’s Phase 2 clinical trials in hidradenitis suppurativa and acne; the timing of initiation of imsidolimab’s Phase 3 clinical trial in GPP; the timing of initiation of ANB032’s Phase 1 healthy volunteer clinical trial; the milestones and royalty payments to be received under the GSK collaboration; and our projected 2021 cash burn and cash runway. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Contact:
Dennis Mulroy
AnaptysBio, Inc.
858.732.0201
dmulroy@anaptysbio.com

AnaptysBio, Inc.
Consolidated Balance Sheets
(in thousands, except par value)

  December 31, 2020   December 31, 2019
       
ASSETS
Current assets:      
Cash and cash equivalents $ 250,456        $ 171,017     
Short-term investments 143,197        203,210     
Prepaid expenses and other current assets 2,908        3,506     
  Total current assets 396,561        377,733     
Property and equipment, net 1,783        1,618     
Long-term investments 17,546        54,305     
Other long-term assets 602        1,481     
Restricted cash 60        60     
Total assets $ 416,552        $ 435,197     
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:      
Accounts payable $ 4,217        $ 16,237     
Accrued expenses 15,262        11,052     
Notes payable, current portion —        1,375     
Other current liabilities 342        871     
Total current liabilities 19,821        29,535     
Other long-term liabilities —        654     
Stockholders’ equity:      
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at December 31, 2020 and December 31, 2019, respectively —        —     
Common stock, $0.001 par value, 500,000 shares authorized, 27,356 shares and 27,255 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively 27        27     
Additional paid in capital 660,665        648,669     
Accumulated other comprehensive (loss) income (4 )     338     
Accumulated deficit (263,957 )     (244,026 )  
      Total stockholders’ equity 396,731        405,008     
          Total liabilities and stockholders’ equity $                    416,552        $                   435,197     

AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share data)

  Three Months Ended
December 31,
  Year Ended
December 31,
  2020   2019   2020   2019
Collaboration revenue $ 60,000        $ 3,000        $ 75,000        $ 8,000     
Operating expenses:              
Research and development 21,567        21,426        80,025        99,338     
General and administrative 5,088        3,832        18,854        16,094     
Total operating expenses 26,655        25,258        98,879        115,432     
    Income (loss) from operations 33,345        (22,258 )     (23,879 )     (107,432 )  
Other income (expense), net:              
Interest expense —        (200 )     —        (1,041 )  
Interest income 376        2,282        3,959        10,984     
Other (expense) income, net (75 )     (109 )     (11 )        
Total other income (expense), net 301        1,973        3,948        9,944     
Income (loss) before income taxes 33,646        (20,285 )     (19,931 )     (97,488 )  
Provision for income taxes —        22        —        152     
Net income (loss) 33,646        (20,263 )     (19,931 )     (97,336 )  
Other comprehensive (loss) income:              
Unrealized (loss) income on available for sale securities, net of tax of $0, ($36), $0, and $153, respectively (263 )     (142 )     (342 )     561     
    Comprehensive income (loss) $ 33,383        $ (20,405 )     $ (20,273 )     $ (96,775 )  
Net income (loss) per common share:              
    Basic $ 1.23        $ (0.75 )     $ (0.73 )     $ (3.60 )  
Diluted $ 1.20        $ (0.75 )     $ (0.73 )     $ (3.60 )  
Weighted-average number of shares outstanding:              
    Basic 27,349        27,154        27,302        27,059     
Diluted 27,938        27,154        27,302        27,059     

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Black Trailblazers in Dermatology Paved Way for Research Innovation, Contemporaries through Extensive Mentoring, Part II

By 2050, more than 50% of the US population will be people with skin of color, according to the Skin of Color Society.1 With a figure like this, diversity and training in the field of dermatology are more important than ever. There are myriad skin disorders that are more prevalent, or underdiagnosed in, patients with skin of color, but depending on their background and day-to-day exposure not every dermatologist is well acquainted with them.

Valerie Harvey, MD, the director of the Hampton University Skin of Color Research Institute, a board member of the Skin of Color Society, and a private practitioner, says it is imperative that the treatment of skin of color become normalized so that there can be a better understanding of certain dermatologic disorders often seen in patients with skin of color. She believes this is best accomplished through research.

Research is Required

Her hope is that the dermatology community will “grow the body of research and innovation so that we can really make progress in treating skin conditions that disproportionately affect” the skin of color populations, Dr Harvey said. “For so long there has been a set of ‘neglected conditions’ that really haven’t received the attention that they deserve, especially given the amount of people that they affect.”

Although people with skin of color experience conditions such as eczema, acne, and psoriasis at similar rates as White patients, Dr Harvey explained that there are sequelae unique to skin of color that other patients don’t often experience, such as the post-inflammatory hyperpigmentation that can occur several months after insult or injury of commonplace, pre-existing skin disorders.

Dr Harvey noted that certain types of hair loss are also more prevalent in those with skin of color, such as trishul alopecia, also known as central centrifugal sickle. Although some of these disorders, she explained, stem from biology, others are a direct result of the conditions that years of systemic racism has created for these populations. Moreover, some disorders worsen into regional and metastasis disease when not treated thoroughly.

“Systemic lupus is more common in African Americans and Hispanics and so, sometimes people have cutaneous manifestations of those diseases as well,” Dr Harvey explained. “Hidradenitis suppurativa is another condition that, at least in the United States, appears to be more common in African American women. It’s also associated with low socioeconomic status, and there are some associations with high BMI for obesity.”

Experience and Exposure

Lynn Mc-Kinley Grant, MD, an accomplished lecturer, author, and researcher at Howard and Duke Universities, as well as the president of the Skin of Color Society, said that systemic racism also affects the access people with skin of color have to specialists and medical therapies, which likely exacerbates minor conditions. She described a neighborhood in Dallas, TX to highlight the disparity some communities experience in seeking care.

“They have 2 dermatologists in a 40- or 50-mile radius, and the rest are all on the outskirts of this 1 area that is a very poor, low income area,” she said. “When patients do get to the doctor, there’ll be certain drugs that their insurance won’t pay for. There are a lot of [therapies] that you can’t get unless they’re special request, and then it takes months and months. It’s definitely a challenge to get people treated.”

Dr McKinley-Grant explained that there are certain telltale signs of disease that many dermatologists may not recognize if they aren’t experienced in treating patients with skin of color.

“There are a lot of textbooks on dark skin, but somehow, [the content] is not necessarily incorporated into the major textbooks,” said Dr. McKinley-Grant. “One of my goals in dermatology has been to get people to see redness in dark skin. People will say, ‘erythema means red, it’s not red in dark skin and I can’t see it.’ They’re absolutely right. The inflammation in White skin is erythematous. In darker skin, it’s more of a purple. It depends on what else is going on in the blood in terms of how red something is.”

She also mentioned warts as an example of how treatment should be carried out differently on skin of color. “You can freeze them with liquid nitrogen, but, in dark skin, you just can’t freeze it too hard, because you get a white spot,” she described, “and then people are not happy with their skin.”

Dr McKinley-Grant explained that, when she is involved with processes to select applicants for a dermatology specialty, it is important to her to give opportunities to those students who may otherwise be overlooked if they don’t have the same connections, resources, or grades as the typical applicant.

“We want to look at the whole person; we want to look at how far they have traveled before they’ve applied to dermatology,” she said. “A lot of African Americans and Latinos have come from very difficult neighborhoods. It’s important to see how much they’ve done rather than the test scores. Some students might be older, some didn’t go to Harvard. Some people apply and they’ve never seen a dermatologist and their school doesn’t have a department of dermatology, so the efforts made to get the experiences are enormous.”

Diversity, Equity, and Inclusion

Both Dr Harvey and Dr McKinley-Grant are embodying their hopes for the future in the form of work on their various projects and with the Skin of Color Society. In the end, they’d like for the dermatology specialty to have what every field should be pursuing: more diversity, equity, and inclusion, and more awareness of the needs of those with skin of color within and outside of the field.

“With everything that’s going on socially and with the pandemic, there’s certainly a heightened awareness for more diversity in dermatology,” said Dr. Harvey. “I’m hoping that we really make strides in our understanding of the basic physiology of these conditions, and of course, developing treatments that are more effective for our patients.”

Reference

Skin of Color Society. Accessed February 24, 2021. https://skinofcolorsociety.org/

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Anti-PD-1-Induced Hidradenitis Suppurativa

noma disease who developed hidradenitis suppurativa (HS) three months after the beginning of an anti-PD-1 (nivolumab) adjuvant therapy.

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Global Hidradenitis Suppurativa Therapeutics Market Research Report Contains – Key Players, Industry Overview, Supply Chain, Analysis and Forecast to 2020-2025 – NY Market Reports

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