Cushing’s Syndrome Diagnostic and Treatment Market See Huge Growth for New Normal

I don’t know if there’s anything of interest here – or the cost – but possibly useful to someone.

Cushing’s Syndrome Diagnostic and Treatment Market research report is the new statistical data source added by Research Cognizance.

“Cushing’s Syndrome Diagnostic and Treatment Market is growing at a High CAGR during the forecast period 2022-2029. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market”.

Cushing’s Syndrome Diagnostic and Treatment Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share, and contact information are shared in this report analysis.

Get the PDF Sample Copy (Including FULL TOC, Graphs, and Tables) of this report @:

https://researchcognizance.com/sample-request/896

Top Key Players Profiled in this report are:

Novartis, Orphagen Pharmaceuticals, Inc., Corcept Therapeutics

The key questions answered in this report:

  • What will be the Market Size and Growth Rate in the forecast year?
  • What are the Key Factors driving Cushing’s Syndrome Diagnostic and Treatment Market?
  • What are the Risks and Challenges in front of the market?
  • Who are the Key Vendors in Cushing’s Syndrome Diagnostic and Treatment Market?
  • What are the Trending Factors influencing the market shares?
  • What are the Key Outcomes of Porter’s five forces model?
  • Which are the Global Opportunities for Expanding the Cushing’s Syndrome Diagnostic and Treatment Market?

Various factors are responsible for the market’s growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Cushing’s Syndrome Diagnostic and Treatment market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Cushing’s Syndrome Diagnostic and Treatment market’s trajectory between forecast periods.

Get up to 30% Discount on this Premium Report @:

https://researchcognizance.com/discount/896

Regions Covered in the Global Cushing’s Syndrome Diagnostic and Treatment Market Report 2022:
• The Middle East and Africa (GCC Countries and Egypt)
• North America (the United States, Mexico, and Canada)
• South America (Brazil etc.)
• Europe (Turkey, Germany, Russia UK, Italy, France, etc.)
• Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Cushing’s Syndrome Diagnostic and Treatment Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

The report provides insights on the following pointers:

Market Penetration: Comprehensive information on the product portfolios of the top players in the Cushing’s Syndrome Diagnostic and Treatment market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Cushing’s Syndrome Diagnostic and Treatment market.

Table of Content
Global Cushing’s Syndrome Diagnostic and Treatment Market Research Report
Chapter 1: Global Cushing’s Syndrome Diagnostic and Treatment Industry Overview
Chapter 2: Global Economic Impact on Cushing’s Syndrome Diagnostic and Treatment Industry
Chapter 3: Global Market Competition by Industry Producers
Chapter 4: Global Productions, Revenue (Value), according to regions
Chapter 5: Global Supplies (Production), Consumption, Export, Import, geographically
Chapter 6: Global Productions, Revenue (Value), Price Trend, Product Type
Chapter 7: Global Market Analysis, on the basis of Application
Chapter 8: Cushing’s Syndrome Diagnostic and Treatment Market Pricing Analysis
Chapter 9: Market Chain, Sourcing Strategy, and Downstream Buyers
Chapter 10: Strategies and key policies by Distributors/Suppliers/Traders
Chapter 11: Key Marketing Strategy Analysis, by Market Vendors
Chapter 12: Market Effect Factors Analysis
Chapter 13: Global Cushing’s Syndrome Diagnostic and Treatment Market Forecast

Buy Exclusive Report @:

https://researchcognizance.com/checkout/896/single_user_license

If you have any special requirements, please let us know and we will offer you the report as you want.

About Us:

Research Cognizance is an India-based market research Company, registered in Pune. Research Cognizance aims to provide meticulously researched insights into the market. We offer high-quality consulting services to our clients and help them understand prevailing market opportunities. Our database presents ample statistics and thoroughly analyzed explanations at an affordable price.

Contact Us:

Neil Thomas

116 West 23rd Street 4th Floor New York City, New York 10011

sales@researchcognizance.com

+1 7187154714

No Synthetic Steroid Version of Korlym at This Time

Teva Pharmaceuticals suffered a fresh legal setback on Tuesday in its effort to market a generic version of the synthetic steroid Korlym to treat Cushing’s syndrome.

The Israeli drugmaker failed to convince the U.S. Court of Appeals for the Federal Circuit that the Patent Trial and Appeal Board improperly denied its bid to cancel a patent held by Corcept Therapeutics covering a method for using Korlym to treat the hormone disorder.

Menlo Park, California-based Corcept last year made over $353 million from sales of Korlym, the company’s only drug, according to a filing with the U.S. Securities and Exchange Commission.

Corcept’s patent relates to using a specific dose of Korlym’s active ingredient mifepristone and another drug to treat Cushing’s syndrome, which creates an excess of the hormone cortisol and causes high blood sugar, among other things.

Corcept sued Teva in New Jersey in 2018, alleging its proposed generic version of Korlym infringed the patent and others, in a case that is still ongoing. Teva asked the Patent Trial and Appeal Board to cancel the patent because earlier publications made it obvious that Corcept’s method would work to treat the disorder.

The board ruled for Corcept last year, and Teva appealed. Teva told the Federal Circuit that the PTAB held it to an improperly high standard for proving that the patent was invalid based on prior art.

Chief U.S. Circuit Judge Kimberly Moore, joined by Circuit Judges Pauline Newman and Jimmie Reyna, rejected Teva’s argument on Tuesday. Moore said the board found that a person of ordinary skill wouldn’t have reasonably expected Corcept’s treatment to be safe and effective before Corcept created it.

Moore also rejected Teva’s argument that the prior art disclosed a range of potential dosages that covered Corcept’s treatment.

Teva, Corcept and lawyers for the two companies didn’t immediately respond to requests for comment.

The case is Teva Pharmaceuticals USA Inc v. Corcept Therapeutics Inc, U.S. Court of Appeals for the Federal Circuit, No. 21-1360.

For Teva: John Rozendaal of Sterne Kessler Goldstein & Fox

For Corcept: Eric Stops of Quinn Emanuel Urquhart & Sullivan

From https://www.reuters.com/legal/transactional/teva-loses-bid-cancel-corcept-drug-patent-federal-circuit-2021-12-07/

Corcept Therapeutics Announces Allowance of Additional Patent Covering the Use of Korlym to Treat Patients With Cushing’s Syndrome

MENLO PARK, Calif., Aug. 28, 2019 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT) announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent covering the administration of KorlymŽ with food.  The patent will expire in November 2032.

“This patent covers an important finding of our research – that for optimal effect, Korlym must be taken with food,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Korlym’s label instructs doctors that ‘Korlym must always be taken with a meal.’”

Upon issuance, Corcept plans to list the patent, entitled “Optimizing Mifepristone Absorption” (U.S. Pat. App. 13/677,465), in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).  Korlym is currently protected by ten patents listed in the Orange Book.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most people with Cushing’s syndrome experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

About Corcept Therapeutics Incorporated

Corcept is a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol.  Korlym® (mifepristone) was the first treatment approved by the U.S. Food and Drug Administration for patients with Cushing’s syndrome.  Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. Corcept owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements, which are based on Corcept’s current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, Corcept’s ability to generate sufficient revenue to fund its commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; Corcept’s ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of Corcept’s product candidates, including regulatory approvals, mandates, oversight and other requirements. These and other risks are set forth in Corcept’s SEC filings, which are available at Corcept’s website and the SEC’s website. In this press release, forward-looking statements include those concerning Corcept’s plans to list the patent “Optimizing Mifepristone Absorption” in the Orange Book; Korlym’s current protection by ten patents listed in the Orange Book; and the scope and protective power of Corcept’s intellectual property. Corcept disclaims any intention or duty to update forward-looking statements made in this press release.

CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
cjames@corcept.com
www.corcept.com

Relacorilant Effectively Manages Cortisol Effects in Cushing’s Patients

Relacorilant, an investigational therapy developed by Corcept Therapeutics, may effectively manage the effects of excess cortisol in patients with Cushing’s syndrome, interim data from an ongoing Phase 2 trial show.

In particular, the treatment significantly improved sugar tolerance and the levels of osteocalcin, a bone growth biomarker  commonly suppressed by excess cortisol.

Corcept announced in a press release that the trial (NCT02804750) has completed patient enrollment. Results from the first patients will be presented during the upcoming 27th American Association of Clinical Endocrinologists (AACE) annual meeting, May 16-20 in Boston. Full data is expected by the third quarter of 2018.

Relacorilant, also known as CORT125134, was designed to prevent the effects of excess cortisol by blocking one of its receptors, the glucocorticoid receptor.

In a Phase 1 trial with healthy volunteers, multiple doses of relacorilant had a similar effect as Korlym (mifepristone) — an approved medicine for Cushing’s patients — without its known side effects.

In addition to the early efficacy data, the study showed that the treatment was generally safe and well-tolerated by the patients, with adverse events reportedly mild in severity.

These findings supported the launch of the Phase 2 trial in patients with Cushing’s syndrome. In the trial, roughly 30 patients are receiving escalating doses of relacorilant for a total of 12 weeks.

Patients were divided into two groups. The first group, which includes 17 patients, receives the lowest dose — 100 mg/day of relacorilant for four weeks, followed by 150 mg/day for four weeks, and then 200 mg/day for the last four weeks. The second group, called the high-dose cohort, is treated with a similar regimen but with a starting dose of 250 mg/day and a final dose of 350 mg/day.

Patients in the low-dose group had a significant improvement in their glucose tolerance and a 60% increase in blood osteocalcin.

In addition, the treatment reduced the blood pressure in 45% of patients with uncontrolled high blood pressure from cortisol excess. Importantly, the results after 12 weeks of relacorilant were similar to those seen after six months of Korlym treatment.

Safety data continues to show a positive profile, with no evidence of serious adverse effects and no affinity toward the progesterone receptor, which is a major drawback of Korlym.

“Relacorilant’s clinical results are striking because the doses these patients received were the study’s lowest. We did not expect patients to experience any meaningful clinical benefit, but they clearly did,” Robert S. Fishman, MD, chief medical officer of Corcept, said in the release. “We look forward to presenting data from these low-dose patients at the AACE meeting next week. With the trial’s final, high-dose cohort fully enrolled, we will have final data in the third quarter.”

Supported by these preliminary data, Corcept has accelerated the preparations for a Phase 3 trial on relacorilant in Cushing’s syndrome patients.

Cortisol Modulator Shows Early Signs of Safety, Efficacy in Healthy Volunteers

The glucocorticoid receptor antagonist CORT125134 is safe and has shown preliminary signs of efficacy in healthy volunteers participating in a Phase 1 trial, say researchers in England.

Their study, “Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study,” appeared in the journal Clinical Pharmacology in Drug Development.”

Cortisol signaling is indirectly controlled by the glucocorticoid receptor (GR). When cortisol binds the GR, the receptor becomes activated and migrates to the nucleus, where it regulates the expression of many genes. This influences a myriad of processes, including inflammation, immune response and brain function.

CORT125134, also known as relacorilant, is being developed by Corcept Therapeutics of Menlo Park, California, for Cushing’s disease patients and others who may benefit from it. The drug is a GR antagonist, blocking the receptor’s activity.

In order to evaluate the safety and tolerability of CORT125134, and learn how it behaves in the body, Corcept researchers conduced a Phase 1 trial in healthy subjects.

The British study, conducted at the Quotient Clinical in Nottingham, included 81 adults who received a single ascending-dose of CORT125134 or placebo, and 48 subjects who received multiple-ascending doses of the drug versus placebo.

Single doses were tested in nine distinct groups. Six tested six different doses of CORT125134, one tested a 150 mg dose in subjects receiving a high-fat meal, and two groups included patients receiving prednisone (a well-known GR activator), prednisone plus Korlym (mifepristone), or prednisone plus CORT125134.

Korlym is a medicine approved for Cushing’s  patients with high blood sugar levels due to high cortisol in circulation. But the drug targets the progesterone receptor and is associated with side effects like pregnancy termination and irregular vaginal bleeding.

Multiple doses, given for up to 14 days, were tested in four additional cohorts. Researchers observed that CORT125134 was rapidly absorbed and eliminated, presenting a suitable profile for once-daily dosing.

Efficacy was determined by CORT125134’s ability to counteract the effects of prednisone. In addition, a single dose of 500 mg or multiple dosing with 250 mg had similar effects as those seen with 600 mg of Korlym — the therapeutic dose used for Cushing’s treatments.

Most common treatment-related adverse events reported in the single-ascending dose part of the study were nausea, vomiting and thirst; most were mild. In those given multiple-ascending doses, adverse events included mild musculoskeletal and connective tissue disorders, as well as gastrointestinal system disorders.

Multiple 500 mg doses exceeded the maximum tolerated dose, as it led to musculoskeletal symptoms that forced researchers to stop treatment.

“This first-in-human study has demonstrated that CORT125134 is well tolerated following single doses up to 500 mg and repeated doses up to 250 mg once daily for 14 days,” researchers wrote. “Pharmacological activity was confirmed following the administration of a single 500-mg dose and daily administration of 250 mg.”

Corcept is now enrolling participants into a Phase 2 open-label trial (NCT02804750) to evaluate CORT125134 in patients with Cushing’s syndrome. This trial is being conducted in the United States and Europe and will include 80 participants. Top-line results are expected in the first quarter of 2018.

From https://cushingsdiseasenews.com/2017/10/10/phase-1-data-demonstrates-efficacy-safety-of-cort125134-in-healthy-volunteers/

%d bloggers like this: