Global “Adalimumab Market” report forecast 2020-2024 investigate the market size, manufactures, types, applications and key regions like North America, Europe, Asia Pacific, Central & South America and Middle East & Africa, focuses on the consumption of Adalimumab in these regions. This report also studies the global Adalimumab market share, competition landscape, status share, growth rate, future trends, market drivers, opportunities and challenges, sales channels and distributors.
About Adalimumab:
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.
This report focuses on the Adalimumab in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.
The content of the study subjects, includes a total of 15 chapters:
Chapter 1, to describe Adalimumab product scope, market overview, market opportunities, market driving force and market risks.
Chapter 2, to profile the top manufacturers of Adalimumab, with price, sales, revenue and global market share of Adalimumab in 2017 and 2018.
Chapter 3, the Adalimumab competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.
Chapter 4, the Adalimumab breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2014 to 2019.
Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2014 to 2019.
Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2014 to 2019.
Chapter 12, Adalimumab market forecast, by regions, type and application, with sales and revenue, from 2019 to 2024.
Chapter 13, 14 and 15, to describe Adalimumab sales channel, distributors, customers, research findings and conclusion, appendix and data source.
https://i1.wp.com/higenix.com/wp-content/uploads/2020/07/Npn20v9.jpg?fit=600%2C400&ssl=1400600Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-07-31 21:00:152020-07-31 21:00:15Adalimumab Market 2020 by Size, Share, Growth, Segment, Trends and Forecast to 2024
When children and adolescents first present to George Hightower, MD, PhD, with suspected primary hyperhidrosis, he tries to gauge their level of impairment and distress.
“I ask my patients directly: ‘Does this get in the way of doing things you enjoy?’ ” Dr. Hightower said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. If they say yes, he then asks, “‘What are those things that it gets in the way of?’ Also, so that I can develop a rapport with them, I ask, ‘Is it causing you to view yourself negatively?’ I also ask them how they anticipate treatment is going to change that.”
Dr. Hightower, of the departments of dermatology and pediatrics, University of California, San Diego, and a pediatric dermatologist at Rady Children’s Hospital, defined focal primary hyperhidrosis as focal, visible, excessive sweating for at least 6 months without an apparent cause, plus at least two of the following characteristics: bilateral and relatively symmetric, sweating that impairs daily activities, onset before age 25, at least one episode per week, family history of idiopathic hyperhidrosis, and focal sweating that stops during sleep.
“Based on their prominence in the popular media, armpits relative to body surface area play an oversized role in our patients’ perception of well-being,” he said. “Most of all, patients’ concerns regarding their armpits include one more of the following symptoms: smelly, sweaty, red, and itchy or painful.”
Topical antiperspirants are the preferred initial treatment. “They’re widely available, inexpensive, and well-tolerated therapies,” Dr. Hightower said. Most commercially available antiperspirants contain low-dose aluminum or other metal that keeps the sweat gland ducts from opening.
“Most patients referred to me have failed to improve with over-the-counter antiperspirants or aluminum chloride 20%,” he said. “We start by reviewing the appropriate use of aluminum chloride 20%. If they’re using it appropriately and fail to achieve adequate control, I open the discussion to use glycopyrronium tosylate cloth 2.4%, applied daily. This can be cost prohibitive or not covered by insurance.” Other options include glycopyrrolate 1-6 mg daily and microwave-based procedural intervention.
In a post hoc analysis, researchers examined the efficacy and safety findings by age from two phase three randomized, controlled trials of glycopyrronium tosylate in pediatric primary axillary hyperhidrosis (Pediatr Dermatol. 2019 Jan-Feb;36[1]:89-99). It was well tolerated in the 19 patients aged 9-16 years.
“No patients discontinued from the study in this age group [because of] symptomatology,” said Dr. Hightower, who was not involved with the study. “The concerns related to this medication are related to anticholinergic effects such as blurry vision and dry mouth, but overall, randomized clinical trial data support the benefit of this medication in helping patients improve the symptoms of hyperhidrosis.”
In an earlier study, researchers retrospectively studied children with hyperhidrosis who were treated with a mean dosage of 2 mg glycopyrronium tosylate daily (J Am Acad Dermatol 2012 Nov;67[5]:918-23). The average age of patients was 15 years. Most (90%) experienced some improvement and 71% of those who responded saw major improvement. This occurred within hours of administration and disappeared within a day of discontinuation.
The two most common side effects were dry mouth (26%) and dry eyes (10%). More worrisome side effects were associated with higher dosing, including blurring of vision (3%) and sensation of palpitations (3%).
When patients return for their first follow-up appointment after starting a treatment plan, Dr. Hightower revisits their level of impairment and distress with hyperhidrosis. “I ask, ‘Remember that activity that you were doing before that this was getting in the way of? Are you doing that more? Do you feel like you can do that in a way that you weren’t able to do before, whether it’s playing an instrument or spending time with friends?’ ”
He also sets expectations with patients and their families with comments such as, “If this treatment does not work for you after 2 months, the next option I would consider is …” and, “for most people there is no cure, but treatment is helpful.” He also emphasizes the importance of follow-up care, so they “come back to assess the next steps.”
Dr. Hightower reported having no financial disclosures.
https://i0.wp.com/higenix.com/wp-content/uploads/2020/07/dt_200730_sweaty_armpit_hyperhidrosis_800x450.jpg?fit=800%2C450&ssl=1450800Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-07-31 13:50:582020-07-31 13:50:58Set Up Your Hyperhidrosis Patients for Treatment Success
Doctors at Cleveland Clinic Abu Dhabi, part of Mubadala’s healthcare network, are encouraging patients with skin conditions to seek medical treatment, as innovative therapies are now available in the UAE.
Patients with recurring inflammation, abscesses and scarring in the armpits, groins or under the breasts may be suffering from Hidradenitis Suppurativa, a long-term skin condition that occurs due to the inflammation of the apocrine sweat glands.
The condition more commonly affects females and is more pronounced in young adults, starting at puberty up to age 55. Globally, it affects 1 to 4 per cent of the population, but experts say this is likely underestimated because of underreporting and misdiagnosis.
“Hidradenitis Suppurativa is rarely life-threatening but can be extremely painful and cause a mental health challenge for patients. It is a disfiguring disease that affects sensitive areas causing embarrassment to patients, who shy away from seeking treatment. This leads to depression, anxiety and social isolation,” says Dr. Rafal Iskanderian, an Associate Staff Physician in the Digestive Disease Institute at Cleveland Clinic Abu Dhabi.
“The skin looks like it is burnt and is discolored because of chronic inflammation over the years. It starts with small painful lumps that recur and rupture, oozing pus after a few days. If not addressed, new lumps will continue to develop in the area nearby, making it more challenging to treat. Patients should find the right clinic when they begin to notice these changes, since a multidisciplinary approach can significantly improve their quality of life.”
Cleveland Clinic Abu Dhabi has now established a Hidradenitis Multidisciplinary Team, which includes general and plastic surgeons, dermatology and wound care experts, and psychiatry support and infectious disease experts, that provides modern comprehensive care to patients.
While the actual cause of the disease remains unknown, the lumps develop because of blocked hair follicles, causing an inflammation that spreads to neighboring sweat glands.
Dr. Iskanderian says the condition is genetic in about a third of all cases. “Lifestyle factors like smoking and obesity are also strongly linked to this disease. These patients are more prone to develop autoimmune disorders like inflammatory bowel disease, especially Crohn’s disease, diabetes and thyroid disorders. A multidisciplinary approach can also help with screening these potential disorders.”
Not addressing the issue on time, he says, can lead to serious chronic infections, sinus tracts and severe scarring. “A few skin cancer cases arising in chronic Hidradenitis ulcers have also been reported in literature.”
In its early stages, the disease can be managed by a prolonged antibiotic treatment plan and immunosuppressive therapy, but Dr. Iskanderian says that he has been seeing more patients in the late stages of the condition who require radical surgical excision of the diseased skin and staged reconstruction.
“When they present late, the skin is already irreversibly damaged and there is little chance to treat the inflammation with antibiotics or immunosuppressant therapy. We then must radically resect all infected skin and close the defect stage-by-stage. Ultimately, we can harvest a skin graft from the patient’s leg to reconstruct the affected area”.
A patient, who recently went through surgical excision, says that he began seeing the lumps in his armpits and genital area nine years back. “I was always depressed and frustrated by the condition. I would be afraid to go near my kids. I would constantly take sick days and carry an extra pair of clothes if I visited the mall because the lumps could leak fluids.”
The 29-year-old patient says that antibiotics and immunosuppressive therapy were not working, and he opted for surgery to address the problem.
“The medical team at Cleveland Clinic Abu Dhabi conducted the excision and grafting, which went very well. The wounds are healing fast and I’m looking forward to a full recovery soon.”
Dr. Iskanderian adds that surgery does not cure the condition but reduces the recurrence of inflammation in the areas treated with surgery.
“This approach has made the patients that we treated more comfortable in their bodies and has helped them regain their lost confidence. They have required less hospitalization and the immunosuppressive therapy and antibiotics are working better to manage the residual minimal disease.”
The patient says that he can now have a normal life. “I can go out, drive a car, work-out, be with my kids, everything that I was missing out on for so long. Cleveland Clinic Abu Dhabi has a great medical team and their attention and ongoing care has changed my life.”
For more information or to book an appointment at Cleveland Clinic Abu Dhabi, call 800 8 CCAD (2223) visit www.clevelandclinicabudhabi.ae or download the Cleveland Clinic Abu Dhabi app.
https://i0.wp.com/higenix.com/wp-content/uploads/2020/07/Cleveland Clinic Abu Dhabi.jpg?fit=960%2C580&ssl=1580960Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-07-30 15:04:282020-07-30 15:04:28Cleveland Clinic Abu Dhabi Offers Integrated Palliative Care for Chronic Skin Disease
According to an international research report on Tumor Necrosis Factor (TNF) Inhibitor Drugs Market 2020provides Covid-19 Impact Analysis on market-size, shares supply-demand analysis, sales value, and volume study of different industries combined with division study, with respect to important topographical regions. This report also consists of the current evolution in the global industry and crucial elements that affects the overall growth of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market. The Tumor Necrosis Factor (TNF) Inhibitor Drugs market has also been categorized depending upon various sections. The important sections are also further divided into Tumor Necrosis Factor (TNF) Inhibitor Drugs sub-sections which provided a higher understanding of the entire international market and assist to make a conclusive discernment on Tumor Necrosis Factor (TNF) Inhibitor Drugs business.
The Years Considered To Estimate the Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size:
History Year: 2015 – 2019 | Base Year: 2019 | Estimated Year: 2020 | Forecast Year: 2020 – 2026
Company Coverage (Sales Revenue, Price, Gross Margin, Main Products, etc.):
Inc., UCB S.A., AbbVie Inc., Inc., Pfizer, Johnson & Johnson Services, Merck & co., Amgen Inc., Novartis International AG and Inc.
Read out the major objectives of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market report:
• Review and analyze the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market size based on its value and volume through end-users, product types, company, major regions, breakdown information from 2015 to 2020, and predicted to 2026.
• To examine the structure of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market by determining its sub-segments.
• To focus on the key companies of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market to define, describe as well as examine the sales, market share, volume, value, recent development, and market competition landscape.
• To analyze competitive developments including new product launches, agreements, expansions, and acquisitions in the market.
• Highlights the value and sales volume of Tumor Necrosis Factor (TNF) Inhibitor Drugs submarkets with respect to key regions.
• To share the knowledge of the key factors influencing the market growth along with drivers, growth potential, several opportunities, risk, and market-based specific challenges.
Contact Us: Office Addresses: 420 Lexington Avenue Suite 300 New York City, NY 10170, United States USA/Canada Tel No: +1-857-2390696 Email: [email protected]
Announced encouraging results from the Phase II portion of the Phase II/III adaptive, randomized, controlled trial in patients with COVID-19 induced pneumonia, showing a trend in lower 28-day all-cause mortality rate
Completed end-of-Phase II meeting with the FDA for IFX-1 in hidradenitis suppurativa
Received positive EMA scientific advice suggesting that IHS4 could be used as primary endpoint in InflaRx´s pivotal development in hidradenitis suppurativa
Cash, cash equivalents and financial assets of approximately €98.9 million as of June 30, 2020
JENA, Germany, July 30, 2020 (GLOBE NEWSWIRE) — InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three and six months ended June 30, 2020.
“The encouraging data from the randomized exploratory first part of our study in COVID-19 are in line with the mode of action of IFX-1 and give hope that C5a inhibition with IFX-1 may be a life-saving treatment option. The results have been submitted for publication in a peer-reviewed medical journal and to a pre-print server, and we are planning an adequately controlled and powered Phase III part of the study in critically ill COVID-19 patients,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx.
Prof. Riedemann continued, “We just received the EMA scientific advice agreeing with our arguments on the limitations of the currently used score in hidradenitis suppurativa development (HiSCR) and suggesting that IHS4 could be used as the primary endpoint in our pivotal studies. Our initial interactions with both EMA and FDA related to a Phase III development program in hidradenitis suppurativa have shown us that IFX-1 is a Phase III ready drug candidate. We are working on a strategy to address the FDA´s concerns related to the suggested change in the primary endpoint and plan additional FDA interactions on this topic. Our other clinical programs with IFX-1 are moving forward in pyoderma gangraenosum and ANCA-associated vasculitis. Depending on the COVID-19 situation, we expect readouts in these indications in 2021.”
Recent R&D Highlights
IFX-1 in COVID-19 induced pneumonia: In June 2020, InflaRx announced encouraging results from the first 30 patients treated in the adaptive randomized Phase II/III trial in patients with severe COVID-19 induced pneumonia. Positive treatment trends were seen in the 28-day all-cause mortality rate and in various other endpoints. Twenty-eight-day all-cause mortality in the IFX-1 treatment group was 13% (2 out of 15) versus 27% (4 out of 15) in the control group. In the best supportive care group, four patients died of COVID-19-induced multi-organ failure, and three of them had pulmonary embolisms reported as a serious adverse event. In the IFX-1 treatment arm, one patient died after an acute ventilator tube complication (leakage) leading to hypoxia, and one patient who met an exclusion criterion with a history of severe chronic obstructive pulmonary disease, which was not known at time point of enrollment, died of pulmonary failure. Additionally, fewer patients in the IFX-1 treatment arm experienced renal impairment assessed by estimated glomerular filtration rates, and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary significant increase of D-dimer levels in the first days following IFX-1 administration was noted, as potentially an expression of induction of blood clot lysis. No statistically significant group differences on the chosen primary endpoint of relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were detected. However, the exploratory first part of this study was not powered to show such differences. InflaRx is now planning an adequately powered, placebo-controlled, double blinded Phase III part using 28-day all-cause mortality as the primary endpoint, an accepted regulatory primary endpoint for critical care studies.
IFX-1 in Hidradenitis Suppurativa (HS): In June 2020, InflaRx completed an end-of-Phase II meeting with the FDA to discuss a Phase III program for the use of IFX-1 for the treatment of HS. The FDA agreed to key proposals to support a Biologics License Application (BLA) submission, including aspects of the Phase III trial design, IFX-1 dosing, target study population, and the nonclinical and clinical pharmacology packages. While the FDA did not agree that the International Hidradenitis Suppurativa Severity Score (“IHS4”) is fit for purpose as a primary efficacy endpoint tool to support labeling, the FDA recommended that the Company obtain HS patient input to help determine the validity of the IHS4 score. The Company is now assessing different strategies for a potential pathway to regulatory approval for IFX-1 in the United States and plans to engage with the FDA on next steps. Additionally, the Company requested scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval and received feedback in July 2020. Although the EMA noted certain considerations regarding the Company’s proposal, the EMA acknowledged that HiSCR response does not account for the clinical relevance of a reduction in draining fistulas and the effort to construct a new endpoint that better captures these changes was endorsed in principle. According to the EMA, although HiSCR was used as an endpoint in previous studies, IHS4 could be an appropriate tool to evaluate the efficacy of a novel compound in HS. The Company is working diligently to address the additional feedback received and analyzing the strategy for its Phase III development in HS.
IFX-1 in Pyoderma Gangraenosum (PG): The Phase IIa open label trial continues to enroll patients in the higher dose groups. Additional clinical trial sites continue to be opened to support enrollment. Results from the higher dose groups are expected in 2021.
IFX-1 in ANCA-associated vasculitis (AAV): In the European Phase II IXCHANGE trial, Part 2 continues to enroll patients. Final results are expected in 2021.
IFX-1 in oncology: Activities are ongoing for the Phase IIa oncology program, with expected initiation in the first half of 2021.
Financial highlights – H1 2020
Research and development expenses incurred for the six months ended June 30, 2020 decreased over the corresponding period in 2019 by €5.5 million. This decline was primarily due to lower contribution of expense in the period from the Phase IIb clinical development of IFX-1 in HS since this study was completed in 2019, offset by the COVID-19 trial expenses. These two factors led to a net decline of €3.7 million in third-party expenses. Furthermore third-party manufacturing expenses also declined by €1.0 million. Additionally, equity-settled share-based compensation recognized in personnel expenses decreased by €0.9 million.
General and administrative expenses decreased by €2.1 million to €4.9 million for the six months ended June 30, 2020, from €6.9 million for the six months ended June 30, 2019. This decrease is primarily attributable to decreasing expenses associated with equity-settled share-based compensation recognized in personnel expenses (€1.5 million). Furthermore, legal, consulting and other expenses decreased by €0.7 million to €2.1 million for the six months ended June 30, 2020, from €2.8 million for the six months ended June 30, 2019. In 2019, consulting costs were higher due to a onetime strategic project.
Net financial result decreased by €1.0 million to €1.1 million for the six months ended June 30, 2020, from €2.0 million for the six months ended June 30, 2019. This decrease is mainly attributable to lower interest earned on marketable securities (€1.1 million), partially offset by a higher foreign exchange result (higher gains €0.9 million and €0.5 million higher losses).
Net loss for the six months ended June 30, 2020 was €18.3 million or €(0.70) per common share, compared to €25.1 million or €(0.97) per common share for the six months ended June 30, 2019. On June 30, 2020, the Company’s total funds available were approximately €98.9 million, composed of cash and cash equivalents (€36.4 million) and financial assets (€62.5 million).
Net cash used in operating activities decreased to €18.2 million in the six months ended June 30, 2020, from €18.7 million in the six months ended June 30, 2019, mainly due to the decrease of cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1, compensated by lower payments on trade liabilities in the six months ended June 30, 2019. Additional information regarding these results and other relevant information is included in the notes to the unaudited Condensed Consolidated Financial Statements as of June 30, 2020, as well as the financial statements as of December 31, 2019 in “ITEM 18. Financial statements,” which is included in InflaRx’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).
InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2020 and 2019
For the three months ended June 30,
For the six months ended June 30,
(in €, except for share data)
2020 (unaudited)
2019 (unaudited)
2020 (unaudited)
2019 (unaudited)
Operating Expenses
Research and development expenses
(7,356,326
)
(12,497,222
)
(14,655,125
)
(20,192,372
)
General and administrative expenses
(2,326,895
)
(3,647,849
)
(4,891,698
)
(6,949,015
)
Total Operating Expenses
(9,683,221
)
(16,145,071
)
(19,546,822
)
(27,141,387
)
Other income
102,332
2,866
197,292
67,702
Other expenses
(3,450
)
(79,183
)
(9,170
)
(83,068
)
Operating Result
(9,584,339
)
(16,221,387
)
(19,358,701
)
(27,156,753
)
Finance income
609,444
1,338,755
2,268,436
2,497,960
Finance expenses
(1,057,937
)
(388,097
)
(1,175,964
)
(449,807
)
Net Financial Result
(448,493
)
950,659
1,092,472
2,048,153
Loss for the Period
(10,032,832
)
(15,270,729
)
(18,266,229
)
(25,108,600
)
Share Information
Weighted average number of shares outstanding
26,172,023
25,964,379
26,138,639
25,964,379
Loss per share (basic/diluted)
(0.38
)
(0.59
)
(0.70
)
(0.97
)
Loss for the Period
(10,032,832
)
(15,270,729
)
(18,266,229
)
(25,108,600
)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
Exchange differences on translation of foreign currency
(1,452,973
)
(1,622,079
)
260,895
695,468
Total Comprehensive Loss
(11,485,805
)
(16,892,807
)
(18,005,334
)
(24,413,132
)
InflaRx N.V. and subsidiary Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2020 and December 31, 2019
in €
June 30, 2020 (unaudited)
December 31, 2019
ASSETS
Non-current assets
Property, plant and equipment
493,377
576,373
Right-of-use assets
716,871
836,924
Intangible assets
404,251
452,400
Other assets
419,424
452,217
Financial assets
272,627
272,614
Total non-current assets
2,306,550
2,590,528
Current assets
Other assets
2,973,228
3,500,884
Financial assets
62,191,912
82,353,867
Cash and cash equivalents
36,398,578
33,131,280
Total current assets
101,563,718
118,986,031
TOTAL ASSETS
103,870,268
121,576,558
EQUITY AND LIABILITIES
Equity
Issued capital
3,152,427
3,132,631
Share premium
211,483,756
211,006,606
Other capital reserves
26,627,185
25,142,213
Accumulated deficit
(152,628,234
)
(134,362,006
)
Other components of equity
2,488,124
2,227,228
Total equity
91,123,258
107,146,673
Non-current liabilities
Lease liabilities
203,636
330,745
Other non-financial liabilities
37,644
39,013
Total non-current liabilities
241,280
369,758
Current liabilities
Trade and other payables
10,630,462
12,413,662
Lease liabilities
524,034
515,203
Employee benefits
867,121
975,629
Social security, other tax and non-financial liabilities
448,113
105,634
Provisions
36,000
50,000
Total current liabilities
12,505,730
14,060,128
Total Liabilities
12,747,010
14,429,886
TOTAL EQUITY AND LIABILITIES
103,870,268
121,576,558
InflaRx N.V. and subsidiary Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2020 and 2019
(in €, except for share data)
Issued capital
Share premium
Other capital reserves
Accumulated deficit
Other components of equity
Total equity
Balance as of January 1, 2020
3,132,631
211,006,606
25,142,213
(134,362,006
)
2,227,228
107,146,673
Loss for the period
—
—
—
(18,266,229
)
—
(18,266,229
)
Exchange differences on translation of foreign currency
—
—
—
—
260,895
260,895
Total comprehensive loss
—
—
—
(18,266,229
)
260,895
(18,005,334
)
Contributions
Equity-settled share-based payment
—
—
1,484,972
—
—
1,484,972
Share options exercised
19,797
477,149
—
—
—
496,946
Total Contributions
19,797
477,149
1,484,972
—
—
1,981,918
Balance as of June 30, 2020
3,152,427
211,483,756
26,627,185
(152,628,234
)
2,488,124
91,123,258
Balance as of January 1, 2019
3,115,725
211,021,835
18,310,003
(81,107,188
)
50,196
151,390,571
Loss for the period
—
—
—
(25,108,600
)
—
(25,108,600
)
Exchange differences on translation of foreign currency
—
—
—
—
695,468
695,468
Total comprehensive loss
—
—
—
(25,108,600
)
695,468
(24,413,132
)
Contributions
Equity-settled share-based payment
—
—
3,889,767
—
—
3,889,767
Total Contributions
—
—
3,889,767
—
—
3,889,767
Balance as of June 30, 2019
3,115,725
211,021,835
22,199,770
(106,215,788
)
745,663
130,867,206
InflaRx N.V. and subsidiary Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019
in €
For the six months ended June 30, 2020 (unaudited)
For the six months ended June 30, 2019 (unaudited)
Operating activities
Loss for the period
(18,266,229
)
(25,108,600
)
Adjustments for:
Depreciation & amortization of property, plant, equipment, right-of-use assets and intangible assets
353,976
307,130
Net financial result
(1,092,472
)
(2,048,153
)
Share-based payment expense
1,484,972
3,889,767
Net foreign exchange differences
(789,528
)
(205,103
)
Changes in:
Other assets
560,449
(2,063,491
)
Employee benefits
(122,411
)
(84,890
)
Social security and other current non-financial liabilities
341,012
(184,120
)
Trade and other payables
(1,783,200
)
5,513,355
Interest received
1,096,651
1,269,745
Interest paid
(5,455
)
(16,308
)
Net cash used in operating activities
(18,222,235
)
(18,730,669
)
Investing activities
Purchase of intangible assets, laboratory and office equipment
(35,107
)
(503,881
)
Purchase of non-current other financial assets
—
(75,543
)
Disposal of non-current other financial assets
—
3,088
Purchase of current financial assets
(59,196,096
)
—
Proceeds from the maturity of financial assets
56,553,296
17,709,459
Net cash from investing activities
20,272,857
17,133,122
Financing activities
Proceeds from exercise of share options
496,946
—
Repayment of lease liabilities
(183,970
)
(125,075
)
Net cash from/ (used in) financing activities
312,976
(125,075
)
Net (decrease)/increase in cash and cash equivalents
2,363,597
(1,722,622
)
Effect of exchange rate changes on cash and cash equivalents
903,700
399,266
Cash and cash equivalents at beginning of period
33,131,280
55,386,240
Cash and cash equivalents at end of period
36,398,578
54,062,885
About IFX-1:
IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with IFX-1 in clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and COVID-19 pneumonia.
About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information please visit www.inflarx.com.
Contacts:
InflaRx N.V. Jordan Zwick – Global Head of Business Development & Corporate Strategy Email: jordan.zwick[at]inflarx.de Tel: +1 917-338-6523
MC Services AG Katja Arnold, Laurie Doyle, Andreas Jungfer Email: inflarx[at]mc-services.eu Europe: +49 89-210 2280 US: +1-339-832-0752
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials; the impact of the COVID-19 pandemic on the Company; the timing of and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; our ability to develop commercial functions; expectations regarding clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
The market has been neutral on Inflarx NV (IFRX) stock recently. IFRX gets a Neutral score from InvestorsObserver’s Stock Sentiment Indicator.
Inflarx NV has a Neutral sentiment reading. Find out what this means for you and get the rest of the rankings on IFRX!
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Sentiment is how investors, or the market, feels about a stock. There are lots of ways to measure sentiment. At the core, sentiment is pretty easy to understand. If a stock is going up, investors must be bullish, while if it is going down, sentiment is bearish.
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What’s Happening With IFRX Stock Today?
Inflarx NV (IFRX) stock has gained 7.51% while the S&P 500 is flat 0% as of 2:43 PM on Tuesday, Jul 28. IFRX is higher by $0.37 from the previous closing price of $4.93 on volume of 948,848 shares. Over the past year the S&P 500 is up 7.23% while IFRX is higher by 83.39%. IFRX lost -$2.33 per share in the over the last 12 months.
InflaRx NV is a clinical-stage biopharmaceutical company is focused on applying proprietary anti-C5a technology to discover and develop specific inhibitors of the complement activation factor known as C5a. The lead product candidate of the company is IFX-1, which is developed for the treatment of Hidradenitis Suppurativa, a rare and chronic debilitating systemic inflammatory skin disease. The company’s proprietary anti-C5a technology is an inflammatory mediator involved in the progression of a variety of autoimmune and other inflammatory diseases. It is also developing IFX-1 for the treatment of AAV, a life-threatening autoimmune disease associated with powerful inflammatory flares that impair kidney function and lead to fatal organ dysfunction.
The research reports on Hidradenitis Suppurativa Marketreport gives detailed overview of factors that affect global business scope. Hidradenitis Suppurativa Market report shows the latest market insights with upcoming trends and breakdowns of products and services. This report provides statistics on the market situation, size, regions and growth factors. Hidradenitis Suppurativa Market report contains emerging players analyze data including competitive situations, sales, revenue and market share of top manufacturers.
Hidradenitis Suppurativa (HS) is a chronic, inflammatory, debilitating skin disease that is characterized by the recurrent development of painful nodules and abscesses that rupture. This leads to the formation of sinus tracts and scarring on the skin. The exact cause of HS is unknown, and it is hypothesized that genetic and environmental factors are the key causes of the disease Environmental factors such as smoking, obesity, and being overweight are considered to be trigger factors in HS development. Additionally, genetic factors are also believed to play a key role in the development of HS. DNA studies have revealed that approximately one-third of patients with HS have a family history of HS. Studies have also shown that there are inheritance patterns within families who are affected by HS.
ReportsnReports estimates the 2018 sales for the HS market at approximately $898 million across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK) and Japan. Over the course of the 10-year forecast period, the HS market will grow at a Compound Annual Growth Rate (CAGR) of 7.2% across the 7MM. Each of the 7MM are anticipated to grow significantly, recording CAGRs of 9.9%, 1.2% and -0.5% across the US, 5EU and Japan, respectively. At the end of 2028, the US will account for 79.1% of sales across the 7MM, while the 5EU and Japan will account for around 20.9% of sales. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of HS in the region, as well as the anticipated high annual cost of therapy (ACOT) of biologics in the US market.
Key Questions Answered – How will the HS market landscape in the 7MM (US, France, Germany, Italy, Spain, UK and Japan) change from 2018-2028? – What are the most promising late-stage pipeline drugs in HS? – How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options? – What are the greatest unmet needs in HS? Will the pipeline drugs fulfil these needs of the market? – What are the largest opportunities in the HS landscape?
Scope of this Report- – Overview of HS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies. – Topline HS market revenue from 2018-2028. ACOT and major pipeline product sales in this forecast period are included. – Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting HS therapeutics sales in the 7MM. – Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products. – Analysis of the current and future market competition in the global HS therapeutics market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy this Report- The report will enable you to – – Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Develop business strategies by understanding the trends shaping and driving the global HS therapeutics market. – Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HS therapeutics market in the future. Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. – Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. – Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Hidradenitis Suppurativa: Executive Summary 2.1 New Entrants Will Drive Modest Growth Across the 7MM from 2018 to 2028 2.2 Launch of Pipeline Therapies Will Lead to Change in the HS Landscape 2.3 High Unmet Needs Exists in the HS Market, Especially for a Highly Efficacious Treatment 2.4 Pipeline Agents Will Offer Incremental Improvements Over Current Therapies 2.5 What Do Physicians Think? 3 Introduction 3.1 Catalyst 3.2 Related Reports 3.3 Upcoming Related Reports 4 Disease Overview 4.1 Etiology and Pathophysiology 4.1.1 Etiology 4.1.2 Pathophysiology 4.2 Classification or Staging Systems 5 Epidemiology 5.1 Disease Background 5.2 Risk Factors and Comorbidities 5.3 Global and Historical Trends 5.3.1 US 5.3.2 5EU 5.4 Forecast Methodology 5.4.1 Sources 5.4.2 Forecast Assumptions and Methods 5.5 Epidemiological Forecast for HS (2018-2028) 5.5.1 Diagnosed Active Prevalent Cases of HS 5.5.2 Age-Specific Diagnosed Active Prevalent Cases of HS 5.5.3 Sex-Specific Diagnosed Active Prevalent Cases of HS 5.5.4 Diagnosed Active Prevalent Case of HS by Severity 5.5.5 Diagnosed Active Prevalent Cases of HS with IBD 5.6 Discussion 5.6.1 Epidemiological Forecast Insight 5.6.2 Limitations of the Analysis 5.6.3 Strengths of the Analysis 6 Current Treatment Options 6.1 Overview 6.2 Diagnosis 6.3 Treatment 7 Unmet Needs and Opportunity Assessment 7.1 Overview 7.2 Lack of Efficacious Treatment 7.3 Early Diagnosis of HS 7.4 Lack of Treatment Options for Fibrosis 7.5 Lack of Holistic Management of HS 8 R&D Strategies 8.1 Overview 8.1.1 Biological Therapies 8.1.2 Oral Therapies 8.2 Clinical Trial Design 8.2.1 Current Clinical Trial Design 8.2.2 Limitations and Future Outlook 9 Pipeline Assessment 9.1 Overview 9.2 Innovative Early-Stage Approaches 10 Pipeline Valuation Analysis 10.1 Clinical Benchmark of Key Pipeline Drugs 10.2 Commercial Benchmark of Key Pipeline Drugs 10.3 Competitive Assessment 10.4 Top-Line 10-Year Forecast 10.4.1 US 10.4.2 5EU 10.4.3 Japan 11 Appendix Disclaimer
https://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.png00Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-07-28 21:44:002020-07-28 21:44:00Hidradenitis Suppurativa Market Report- by Application Analysis, End Users, Regions and Forecast to 2022
As a doctor, Alavi said, she can’t forget the relief she feels when she sees how relieved her patients seem, finally knowing what condition they have. However, she feels uneasy knowing the staggering statistics surrounding how the delay is affecting people with HS.
According to the Canadian Skin Patient Alliance, 16 per cent of HS patients have had more than 10 emergency visits before diagnosis – much too long before seeing a dermatologist, who could have diagnosed the patient and began treatment, Alavi said.
“If everyone came to us within the first few months of them having a boil or abscess, we could change lives,” Alavi said. “But by the time we see them, they are already depressed, and divorced … there is a scar in their life that we can’t change, and that’s from missing that window of opportunity.”
Alavi talked about some of the experiences her patients living with HS have shared with her.
One of her young patients, a girl, said she closes her eyes and dreams of going to the beach wearing a bikini.
Another young girl, who is athletic and likes to play basketball, said her abscess burst and embarrassed her in front of her friends.
Then there was her patient who was a teacher and had her wedding day coming up, and her only wish was to have that one night with no abscess and to pass the night without her dress staining.
“Very simple things” become not so simple for people with HS, Alavi said, adding that some of her patients have said their dreams are to go to bed with no pain and for a cure for HS to be found.
There is currently no cure for HS. However, treatments are available to help minimize it and make life more livable for patients.
Treatments for mild cases of HS to severe cases differ, and range from antibiotics, anti-inflammatory medications, topical medications and surgery.
Since COVID-19, their clinics were closed, and Alavi and her team contacted their patients to assure them they were not without care. They adapted their services and offered virtual appointments, and learned that this method was working better for them, as they could meet with more patients. “This is something we will continue doing in the future, unless people need to come in,” Alavi said.
“This is a genetic disease; we cannot prevent it from coming, but we can control this. If you or someone in your family had symptoms of this disease, please seek advice, stay strong and support each other,” Alavi said.
https://i0.wp.com/higenix.com/wp-content/uploads/2020/07/DrAlaviHeadshot_Super_Portrait.jpg?fit=420%2C417&ssl=1417420Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-07-26 13:54:332020-07-26 13:54:33Dermatologist treating over 500 patients across the region who live with HS skin disease
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Bimekizumab was superior to Cosentyx for the treatment of moderate-to-severe plaque psoriasis, according to phase 3b study results released by UCB.
The randomized, multicenter, double-blind, active comparator-controlled, parallel-group BE RADIANT trial compared UCB’s investigational IL-17A and IL-17F inhibitor bimekizumab to Cosentyx (secukinumab, Novartis). It included 743 psoriasis patients who had a baseline Psoriasis Area and Severity Index score of 12 or greater and a body surface area affected by psoriasis of 10% or greater, as well as an Investigator’s Global Assessment score equal or above 3.
The bimekizumab group was superior to the secukinumab group in achieving a 75% improvement in PASI by week 4, and complete skin clearance at week 48.
“Psoriasis places a heavy burden on patients, often causing pain, discomfort and stigma. Patients may not get the complete skin clearance that they want and may not even realize that it’s possible,” Emmanuel Caeymaex, executive vice president of Immunology Solutions and head of UCB in the U.S., said in a press release. “Health care providers may also feel forced to make trade-offs between therapies that work quickly, versus those that have shown durable efficacy. The BE RADIANT results demonstrate that bimekizumab has the potential to raise the treatment bar for patients and their dermatologists. UCB is proud to lead the way in connecting science to unmet patient needs and developing bimekizumab. It is our ambition to provide a transformative experience for psoriasis patients.”
UCB is continuing to study bimekizumab’s safety and efficacy for the treatment of psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylarthritis and hidradenitis suppurativa, the release said.
With having published myriads of reports, PMR imparts its stalwartness to clients existing all over the globe. Our dedicated team of experts deliver reports with accurate data extracted from trusted sources. We ride the wave of digitalization – facilitate clients with the changing trends in various industries, regions and consumers. As customer satisfaction is our top priority, our analysts are available 24/7 to provide tailored business solutions to the clients.
In this new business intelligence report, PMR serves a platter of market forecast, structure, potential, and socioeconomic impacts associated with the global Hidradenitis Suppurativa Treatment market. With Porter’s Five Forces and DROT analyses, the research study incorporates a comprehensive evaluation of the positive and negative factors, as well as the opportunities regarding the Hidradenitis Suppurativa Treatment market.
The Hidradenitis Suppurativa Treatment market report has been fragmented into important regions that showcase worthwhile growth to the vendors – Region 1 (Country 1, Country 2), region 2 (Country 1, Country 2) and region 3 (Country 1, Country 2). Each geographic segment has been assessed based on supply-demand status, distribution, and pricing. Further, the study provides information about the local distributors with which the market players could create collaborations in a bid to sustain production footprint.
key players of the hidradenitis suppurativa treatment market are: Pfizer Inc., GlaxoSmithKline plc. AstraZeneca, Johnson & Johnson, AbbVie Inc., Merck & Co., Inc., TARGET Pharma Solutions, Inc., and Novartis AG.
The report on Hidradenitis suppurativa treatmentmarket covers exhaustive analysis on:
Market Segments
Market Dynamics
Historical Actual Market Size, 2014 – 2018
Market Size & Forecast 2019 to 2029
Supply & Demand Value Chain
Market Current Trends/Issues/Challenges
Competition & Companies involved
Technology
Value Chain
Market Drivers and Restraints
Regional analysis for Hidradenitis suppurativa treatmentmarket includes
North America
Latin America
Europe
East Asia
South Asia
Oceania
Middle East & Africa
Report on Hidradenitis suppurativa treatment market highlights:
Shifting industry dynamics
In-depth market segmentation
Historical, current and projected industry size
Recent industry trends
Key competition landscape
Strategies of key players and product offerings
Potential and niche segments/regions exhibiting promising growth
https://i1.wp.com/higenix.com/wp-content/uploads/2020/07/16292.jpg?fit=935%2C526&ssl=1526935Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-07-24 13:22:352020-07-24 13:22:35Hidradenitis Suppurativa Treatment Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 – 2029 – 3w Market News Reports
