Category Archives: Psoriasis

New CIMZIA (certolizumab pegol) data in moderate-to-severe plaque psoriasis and psoriatic arthritis presented at American Academy of Dermatology 2017 Annual Meeting

ORLANDO, Fla., March 04, 2017 -- UCB (Euronext:UCB) and Dermira, Inc. (NASDAQ:DERM) today announced 16-week, investigational results from the CIMPASI-1 and CIMPASI-2 Phase 3 trials at the 75th Annual Meeting of the American Academy of Dermatology (AAD) in Orlando, Florida.1 Results from the trials showed that CIMZIA (certolizumab pegol) demonstrated significant improvements in patients with moderate-to-severe chronic plaque psoriasis versus placebo. In addition to previously reported co-primary endpoints, new data presented in an oral presentation at AAD showed the percentage of patients who achieved 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 90). Additionally, data analyses from the RAPID-PsA Phase 3 study were presented evaluating the long-term effect of CIMZIA in adult patients with active psoriatic arthritis (PsA).

The 16-week primary results from CIMPASI-1 and CIMPASI-2 showed that treatment with CIMZIA provided significant benefit to patients living with chronic plaque psoriasis, which is important given that the disease is historically difficult to treat and therefore requires multiple treatment options, said Alice Gottlieb, M.D., Ph.D., Professor of Dermatology, Department of Dermatology, New York Medical College, at Metropolitan Hospital and lead presenter of the data.

The CIMPASI-1 and CIMPASI-2 clinical results presented today support our belief that CIMZIA may one day benefit people living with moderate-to-severe plaque psoriasis, said Luis Pea, chief development officer at Dermira. We are committed to providing patients with access to a new treatment option for psoriasis that may also one day contribute to improvements in their overall quality of life.

Were pleased to present the clinical results from CIMPASI-1, CIMPASI-2, and RAPID-PsA at AAD this year, said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB. At UCB, we are driven foremost by providing value to patients, and these results demonstrate the breadth of our immunology portfolio for people living with plaque psoriasis and psoriatic arthritis. We look forward to continuing our partnership with Dermira to bring CIMZIA to these patients."

The results of the initial 16-week treatment period of CIMPASI-1 and CIMPASI-2 offer important insights for the potential use and the value of CIMZIA in adult patients with moderate to severe chronic plaque psoriasis. Researchers reported that CIMZIA showed clinically meaningful improvements in the PGA, PASI 75 and PASI 90 endpoints at week 16 compared to placebo at both treatment doses (400mg, 200mg).

Topline results from CIMPASI-1 and CIMPASI-2 were previously announced. The identically designed trials evaluated the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), as well as the percentage of patients achieving at least a two-point improvement on a five-point Physicians Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.2

Researchers reported that the most frequent adverse events (AEs) in CIMPASI-1 and CIMPASI-2 through week 16 were upper respiratory tract infections, and serious AEs were infrequent. The adverse event profile across both trials appeared consistent with the adverse event profiles observed with CIMZIA in other indications.2 CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

CIMPASI-1 16-week Results1

CIMPASI-2 16-week Results1

Additional data reported from a key secondary endpoint also found that patients receiving the 400mg and 200 mg dose reported significant improvements in their quality of life compared to patients who received placebo only. CIMZIA showed a mean improvement from baseline in the Dermatology Life Quality Index (DLQI) score compared to placebo, at both doses in both the CIMPASI-1 (decrease of 10.2 at 400 mg and 9.3 at 200 mg vs. 3.3; p<0.001) and CIMPASI-2 (decrease of 10.0 at 400 mg and 10.4 at 200 mg vs. 3.8; p<0.001) clinical trials, at week 16.

A decrease in a patients DLQI score translates to overall improved satisfaction in the management of their skin condition. DLQI is a widely used and recognized quality of life measurement instrument frequently used across many dermatologic conditions.

RAPID-PsA Results3,4,5

Additionally, three post-hoc data analyses from the RAPID-PsA four-year open label extension study were presented, providing insight into the long-term impact of CIMZIA on psoriatic arthritis (PsA) patients. RAPID-PsA is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of CIMZIA. The results of RAPID-PsA were:

About Psoriasis

Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the worlds population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.6

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a condition involving joint inflammation (arthritis) that usually occurs in combination with a skin disorder called psoriasis. Signs and symptoms of PsA include stiff, painful joints with warmth and swelling in the joints and surrounding tissues. In most people with PsA, psoriasis appears before joint problems develop. In some cases, psoriatic arthritis develops prior to the skin changes. Left untreated PsA can be a disabling disease. PsA affects an estimated 3.4 to 8 per 100,000 people. Between 6 and 42 percent of people with psoriasis develop psoriatic arthritis. Psoriasis affects nearly three percent of the worlds population, or approximately 125 million people worldwide.7,8

About Cimzia In the US Cimzia is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

Cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.

Important Safety Information about Cimzia in the US

Risk of Serious Infections and Malignancy

Patients treated with Cimzia are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:

The risks and benefits of treatment with Cimzia should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cimzia, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member. Cimzia is not indicated for use in pediatric patients.

Patients treated with Cimzia are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with Cimzia should not be initiated in patients with an active infection, including clinically important localized infections. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with Cimzia should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

Malignancies

During controlled and open-labeled portions of Cimzia studies of Crohns disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 Cimzia-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of Cimzia for Crohns disease and other investigational uses, there was one case of lymphoma among 2,657 Cimzia-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In Cimzia RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy 18 years of age), of which Cimzia is a member. Approximately half of the cases were lymphoma (including Hodgkins and non-Hodgkins lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including Cimzia. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohns disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with Cimzia, especially in these patient types.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including Cimzia. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.

Heart Failure

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cimzia has not been formally studied in patients with CHF. Exercise caution when using Cimzia in patients who have heart failure and monitor them carefully.

Hypersensitivity

Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following Cimzia administration. Some of these reactions occurred after the first administration of Cimzia. If such reactions occur, discontinue further administration of Cimzia and institute appropriate therapy.

Hepatitis B Reactivation

Use of TNF blockers, including Cimzia, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with Cimzia. Exercise caution in prescribing Cimzia for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue Cimzia and initiate effective anti-viral therapy with appropriate supportive treatment.

Neurologic Reactions

Use of TNF blockers, including Cimzia, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barr syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with Cimzia. Exercise caution in considering the use of Cimzia in patients with these disorders.

Hematologic Reactions

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with Cimzia. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia. Consider discontinuation of Cimzia therapy in patients with confirmed significant hematologic abnormalities.

Drug Interactions

An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of Cimzia in these combinations. Therefore, the combination of Cimzia with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with Cimzia. There is no evidence that Cimzia therapy has an effect on in vivo coagulation. Cimzia may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

Autoimmunity

Treatment with Cimzia may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.

Immunizations

Do not administer live vaccines or live-attenuated vaccines concurrently with Cimzia.

Adverse Reactions

In controlled Crohns clinical trials, the most common adverse events that occurred in 5% of Cimzia patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% Cimzia, 13% placebo), urinary tract infection (7% Cimzia, 6% placebo), and arthralgia (6% Cimzia, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for Cimzia and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in 3% of patients taking Cimzia 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% Cimzia, 2% placebo), headache (5% Cimzia, 4% placebo), hypertension (5% Cimzia, 2% placebo), nasopharyngitis (5% Cimzia, 1% placebo), back pain (4% Cimzia, 1% placebo), pyrexia (3% Cimzia, 2% placebo), pharyngitis (3% Cimzia, 1% placebo), rash (3% Cimzia, 1% placebo), acute bronchitis (3% Cimzia, 1% placebo), fatigue (3% Cimzia, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving Cimzia than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving Cimzia 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving Cimzia 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for Cimzia and 2.5% for placebo.

The safety profile for patients with Psoriatic Arthritis (PsA) treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with Cimzia.

The safety profile for AS patients treated with Cimzia was similar to the safety profile seen in patients with RA.

For full prescribing information, please visit http://www.ucb.com

CIMZIA is a registered trademark of the UCB Group of Companies.

About Cimzia in the EU/EEA In the EU, Cimzia in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Cimzia, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

Important Safety Information about Cimzia in the EU/EEA Cimzia was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia due to adverse events vs. 2.7% for placebo.

Cimzia is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Treatment with Cimzia must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia if infection becomes serious. Before initiation of therapy with Cimzia, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia.

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia. Carriers of HBV who require treatment with Cimzia should be closely monitored and in the case of HBV reactivation Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.

TNF antagonists including Cimzia may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia should be discontinued and appropriate therapy instituted.

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia.

Adverse reactions of the hematologic system, including medically significant cytopaenia, have been infrequently reported with Cimzia. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia. Consider discontinuation of Cimzia therapy in patients with confirmed significant haematological abnormalities.

The use of Cimzia in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on CIMZIA should be closely monitored for infections.

Cimzia was studied in 325patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30months and in 409patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30months. The safety profile for axSpA and PsA patients treated with Cimzia was consistent with the safety profile in RA and previous experience with Cimzia.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision 15th December 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

REFERENCES

About Dermira

Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermiras product pipeline includes three Phase 3 product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermiras website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.

About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Dermira Forward-Looking Statements The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the safe harbor created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including the statements that CIMZIA one day benefit patients living with moderate-to-severe plaque psoriasis and contribute to improvements in their overall quality of life. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of Dermiras clinical trials; the outcome of future discussions with regulatory authorities relating to the CIMZIA clinical program; Dermiras dependence on third-party clinical research organizations, manufacturers and suppliers; and Dermiras ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled Risk Factors set forth in Dermiras Annual Report on Form 10-K, Dermiras Quarterly Reports on Form 10-Q and other filingsDermiramakes with theSEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermiras forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

UCB Forward-Looking Statements This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

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New CIMZIA (certolizumab pegol) data in moderate-to-severe plaque psoriasis and psoriatic arthritis presented at ... - EconoTimes

SUMMIT, N.J.--(BUSINESS WIRE)--

Celgene Corporation (CELG) today announced that results from its phase 4 UNVEIL trial evaluating OTEZLA (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate plaque psoriasis with a body surface area (BSA) of 5-10 percent, were presented at the American Academy of Dermatology's Annual Meeting in Orlando, Florida.

The UNVEIL study evaluated the clinical efficacy and safety of oral OTEZLA 30 mg twice daily compared with placebo at week 16 in 221 patients with moderate plaque psoriasis [defined as a BSA involvement of 5-10 percent and a static Physician's Global Assessment (sPGA) of 3] who were nave to systemic and biologic therapy. At baseline, more than 80 percent of patients enrolled in the trial had previously received topical therapy. The primary endpoint was the mean percentage change from baseline in the product of PGA and BSA (PGABSA) at week 16. The PGAxBSA composite tool is a simple assessment that has been developed as a measure of clinically meaningful responses of psoriasis patients in clinical trials.

At week 16, patients who received OTEZLA had a significantly greater improvement in mean percentage change from baseline in PGABSA compared with those who received placebo (-48.1 vs. -10.2, respectively; P<0.0001). In addition, a 75 percent or greater improvement in PGABSA score was achieved by 35.1 percent of patients treated with OTEZLA vs. 12.3 percent of patients treated with placebo (P<0.0001). A significantly greater percentage of patients receiving OTEZLA versus placebo achieved a PGA score of 0 (clear) or 1 (almost clear) at week 16 (30.4 percent vs. 9.6 percent; P<0.0001).

In other secondary endpoints, enrolled patients who had scalp psoriasis (n=167), a significantly greater percentage who received OTEZLA achieved a Scalp Physicians Global Assessment score of 0 (clear) or 1 (minimal) with a greater than two-point reduction from baseline compared with placebo (38.0 percent vs. 20.0 percent, respectively; P=0.0178).

Patients with moderate plaque psoriasis are often inadequately treated, and there remains an unmet medical need for safe and effective treatment options in this population, said Dr. Bruce Strober, professor and chair of the Department of Dermatology at UConn Health. While most trials focus on moderate to severe plaque psoriasis, this is the first randomized clinical trial of patients with moderate plaque psoriasis, and the results provide encouraging data for patients.

In a separate pre-specified analysis, patients in UNVEIL reported satisfaction scores based on the Treatment Satisfaction Questionnaire version II that were significantly greater with OTEZLA than placebo in global satisfaction (63.2 vs. 48.7, respectively; P<0.0001) and effectiveness (57.3 vs. 38.8; P<0.0001) at week 16. Patients reported no significant difference versus placebo in terms of convenience (66.9 vs. 65.7; P=NS) or side effects (78.5 vs. 75.0; P=NS).

Adverse events reported in at least five percent of patients taking OTEZLA and greater than placebo in the UNVEIL study were diarrhea (29 percent vs. 16 percent), headache (20 percent vs. 11 percent), nausea (18 percent vs. 10 percent), upper respiratory tract infection (7 percent vs. 4 percent) and vomiting (6 percent vs. 3 percent). The safety and tolerability data for OTEZLA observed in the UNVEIL study were consistent with previously reported data from six phase 3 studies of OTEZLA in psoriasis or psoriatic arthritis; no new safety signals were observed.

OTEZLA is not indicated for the treatment of plaque psoriasis patients with BSA involvement of less than 10 percent or sPGA less than 3.

About UNVEIL

UNVEIL is the first prospective, randomized, controlled study to evaluate the clinical efficacy and safety of OTEZLA in patients with moderate plaque psoriasis (defined as a BSA involvement of 5-10 percent and sPGA of 3 based on a 0 to 5 scale) who were nave to systemic and biologic therapies. Patients (n=221) were randomized 2:1 to receive either OTEZLA 30 mg twice daily or placebo for 16 weeks, followed by an open-label extension phase in which placebo patients were switched to OTEZLA through week 52. All doses were titrated over the first week of treatment. At baseline, more than 80 percent of patients had previously received topical therapy.

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About OTEZLA

OTEZLA (apremilast) 30 mg tablets is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients with psoriasis is not well defined.

INDICATION

Otezla (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

Warnings and Precautions

Depression: Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During clinical trials, 1.3% (12/920) of patients treated with OTEZLA reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of OTEZLA patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on OTEZLA, compared to 0.2% (1/506) on placebo. One patient treated with OTEZLA attempted suicide; one patient on placebo committed suicide.

Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on OTEZLA. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur.

Weight Decrease: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with OTEZLA and in 5% (19/382) of patients treated with placebo. Body weight loss of 10% occurred in 2% (16/784) of patients treated with OTEZLA compared to 1% (3/382) of patients treated with placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA.

Drug Interactions: Apremilast exposure was decreased when OTEZLA was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of OTEZLA efficacy may occur. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.

Adverse Reactions

Adverse reactions reported in 5% of patients were (OTEZLA%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4).

Use in Specific Populations

Pregnancy and Nursing Mothers: OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman.

Renal Impairment: OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information.

Please click here for Full Prescribing Information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com/. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words expects, anticipates, believes, intends, estimates, plans, will, outlook and similar expressions. Forward-looking statements are based on managements current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.

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Oral OTEZLA (Apremilast) Demonstrated Significant Improvement ... - Yahoo Finance

Yes, Valeant has a safety warning weighing down new psoriasis med Siliq as it prepares to enter the market. But its got another issue, too: the fact that its going up against some major spenders in the field.

When it launches, Siliq will take on fellow IL-17 meds Cosentyx from Novartis and Taltz from Eli Lilly, but it will also have to contend with the anti-TNF giantsAbbVies Humira included. As Wells Fargo analyst David Maris pointed out last month in a note to clients, the Illinois pharma spent $357 million on Humira advertising in 2015 alone.

It also regularly tops pharmas TV ad spending list, shelling out $35 million in January, according to tracker iSpot.tv.

That could be a problem for a company in financial straits as dire as Valeants; the debt-laden company has been plagued by default concerns since last year, thanks to years of debt-fueled M&A dealmaking under former skipper J. Michael Pearson.

And while the company plans to keep itsSG&A spending in 2017 between $2.6 billion and $2.7 billion, its got some other key priorities this year, too: Its planning to relaunch flopped female libido drug Addyi, and its expanding its primary care sales force for lead med Xifaxan in the wake of canceled GI unit deal talks with Japans Takeda.

The financial concerns add to the safety burden Valeant is already facing with its psoriasis newcomer. The med comes along with a black-box warning on suicide risks and a substantial risk-managing program, under which physicians and pharmacies will have to be certified toprescribe and dispensethe med and patients will have to signinformed consent agreements before taking it.

All things considered, we believeSiliqis a sub-competitive drug in a competitive market that Valeant cannot afford to compete in, Maris wrote following the products February FDA approval.

Valeants management, though, thinks Siliq can stand out from the crowd based on its clinical benefits. As CEO Joseph Papa told investors on the companys Q4 conference call, Siliqunlike its IL-17 peersis a receptor-blocker, and when you can actually block the receptor, you tend to get a better, a quicker response and also a response that is more durable.

And some analysts agree. Siliqoffers differentiation on efficacy parameters relative to competitors, Barclays Doug Tsao wrote to clients, noting that though Valeant is splitting profits down the middle with developer AstraZeneca, the 90% profit margins and relatively concentrated prescriber base makeSiliqan attractive opportunity even if Valeant can get 5% to 10% market share.

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Does Valeant have the ad dollars to keep Siliq competitive in psoriasis? - FiercePharma

J&J has reaped the final harvest of Phase III data it is taking to regulators in search of a blockbuster approval for their psoriasis contender guselkumab.

J&J is widely expected to use this latest batch of reliably positive data to clean up on major approvals at the FDA and EMA. But its favorable late-stage comparisons with Humira may not count for so much these days, as the pharma giant is bringing up the rear of a parade of new drugs that got to the market first.

Novartis Cosentyx got out ahead 18 months ago and the Swiss pharma giant has followed with 4-year data tracking a solid success 43.5% in keeping skin cleared over the long haul. Eli Lilly backed its new drug Taltz in a major campaign last fall. And then Valeant ambled across the finish line with brodalumab now dubbed Siliq two weeks ago. Their drug, picked up at a discount from a disappointed AstraZeneca, also comes with a black box warning on suicidal thinking that will almost certainly squeeze its slice of the market down to a sliver.

Now comes J&J, a global powerhouse, with a contender it believes is already positioned for success.

As we saw in the first Phase III, VOYAGE 1, guselkumab handily outscored a placebo on two measures of complete or near-complete skin clearance in VOYAGE 2. And once again their IL-23 drug slapped aside Humira, with guselkumab versus adalimumab achieving an IGA 0/1 score of 84% versus 67.7% and a PASI 90 of 70% compared to 46.8%, respectively.

The results were remarkably similar, which is what you want to see, Philippe Szapary, VP for dermatology and gastroenterology in J&Js Immunology Clinical Development unit, tells me about his Phase III studies.Its very reassuring to see such amazing consistency.

J&Js third Phase III study looking at patients transferred to guselkumab after an inadequate response to their other psoriasis drug Stelara also looked good. The statement notes:

Patients who switched to guselkumab consistently showed greater improvement in their psoriasis between weeks 28 and 40, compared with patients who continued to receive Stelara, having twice as many office visits with at least a 2 point improvement in IGA from week 16, the studys primary endpoint, and an IGA score of 0 or 1.

J&J gained a new approval for Stelara last fall, adding Crohns to the label as the company looked to keep its performance in blockbuster territory. The new Navigate study also positions J&J to keep about 30% of psoriasis patients who dont respond well to Stelara in the fold, so to speak.

Investigators also reaped a satisfying profile on safety, with a somewhat better set of data on adverse effects compared to Humira, which remains a big player in this field as AbbVie continues to fight off biosimilar competition. There is also one more psoriasis drug waiting in the wings. Sun Pharma gained control of Mercks MK-3222, but it isnt expected to hit the market anytime soon.

The next step is to keep gathering data with extension studies that will take the 1800 patients enrolled for VOYAGE 1 and 2 out about five years. With a target lying upstream of IL-17 and TNF, he adds, investigators are hopeful that guselkumab will continue to perform well against competition long after it arrives on the market.

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J&J may be late to the psoriasis drug market party, but it's planning to make a splash with guselkumab - Endpoints News

Outstanding Educator in Psoriatic Disease, Joel M. Gelfand, M.D., MSCE.Joel M. Gelfand is Professor of Dermatology and of Epidemiology at the University of Pennsylvania. He is a board-certified dermatologist whose clinical work focuses on general dermatology and psoriasis. He has created a multi-disciplinary approach to the care of psoriasis patients at Penn through his recruitment and mentoring of a rheumatologist and cardiologist who now specialize in systemic complications of psoriasis.

Outstanding Physician-Clinician, Alexa Boer Kimball, M.D., M.P.H Alexa Boer Kimball, M.D., M.P.H. is the president and chief executive officer of Harvard Medical Faculty Physicians, an academic multi-specialty group employing more than 1,200 full-time Harvard Medical School faculty members and 450 physicians in the community. She is also President of the Beth Israel Deaconess Care Organization Physician LLC, which maintains a membership of approximately 2500 physicians, and a Professor of Dermatology at Harvard Medical School.

Dr. Kimball is an international expert on psoriasis and hidradenitis suppurativa who has published more than 250 peer-reviewed scientific papers and 100 Questions and Answers about Psoriasis, which has been translated into Spanish, Greek and Korean. In 2016 she was named Mentor of the Year by the Women's Dermatologic Society.

Health Professional Volunteer of the Year Craig F. Teller, MDCraig F. Teller, MD, is a native Houstonian and has been practicing dermatology since 1995. Board certified by the American Board of Dermatology and a fellow of the American Academy of Dermatology, Dr. Teller holds an academic appointment as Clinical Instructor of Dermatology in family medicine at Baylor College of Medicine as well as Clinical Instructor of Dermatology at the University of Texas Medical School in Houston. Dr. Teller is being recognized for his efforts and promotion of the NPF mission and key initiatives at the local division with strong contributions and support of the overall NPF goals and objectives.

Outstanding Allied Health, Lakshi Aldredge, MSN, ANP-BCMs. Lakshi Aldredge is a nurse practitioner who has practiced at the Portland VA Medical Center for the past 22 years, the last eight years in the medical Dermatology Service. Aldredge is being recognized for her outstanding achievements in improving psoriatic disease clinical practice and the quality of life of her patients. She is actively involved in the day-to-day clinical care of her patients and is nationally known for her exceptional clinical knowledge and expertise.

Aldredge is the past President of the national Dermatology Nurses' Association (DNA) and is the current Chair of the Nurse Practitioner Society of the DNA. She is on the Advisory board of Dermatology World, is an Associate Editor of Psoriasis Forum, the peer-reviewed journal of the National Psoriasis Foundation, as well as a member of the Editorial Board of the Journal of the Dermatology Nurses' Association.

Over the last 50 years, the National Psoriasis Foundation (NPF) has become the world's leading nonprofit patient advocacy organization fighting for individuals with psoriasis and psoriatic arthritis. NPF leads this fight by driving efforts for a cure and improving the lives of the more than 8 million Americans affected by this chronic disease. To date, NPF has funded more than $15 million in research grants and fellowships, and to commemorate 50 years, NPF plans to raise an additional $2 million for early scientific career research programs in 2017 alone. Each year, NPF strives to support, educate and advocate on behalf of more individuals living with or caring for someone with the disease than ever before. As part of that effort, NPF established the Patient Navigation Center to offer personalized assistance to everyone with psoriasis or psoriatic arthritis. Join our community today and help drive discovery and create community for all living with psoriatic disease.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/national-psoriasis-foundation-2016-medical-professional-awards-winners-300416249.html

SOURCE National Psoriasis Foundation

http://www.psoriasis.org

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National Psoriasis Foundation 2016 Medical Professional Awards Winners - PR Newswire (press release)

WEDNESDAY, March 1, 2017 (HealthDay News) -- People with autoimmune diseases -- conditions that cause a person's immune system to turn against the body -- appear to have an increased risk of developing dementia, a new British study suggests.

Researchers found that 18 out of 25 different autoimmune diseases, such as lupus, psoriasis or multiple sclerosis, "showed a statistically significant association with dementia," said study co-author Dr. Michael Goldacre. He's a professor of public health at the University of Oxford.

But Goldacre and other experts stressed that the study didn't prove that autoimmune diseases cause dementia. The research only showed that these conditions are associated with a higher risk of dementia.

Specifically, the study found that people with multiple sclerosis appeared to have nearly double the risk of dementia. Psoriasis was associated with a 29 percent increased risk of dementia. Lupus was linked to a 46 percent increased risk, and rheumatoid arthritis with a 13 percent increased risk. Crohn's disease was associated with a 10 percent increased risk.

"How do [autoimmune diseases] affect the brain? We don't know, although others have suggested that chronic inflammation, possibly autoimmune effects, or possibly both, may have a role in Alzheimer's," Goldacre said.

For this study, the researchers reviewed information from more than 1.8 million people in England. All had been admitted to a hospital with an autoimmune disease between 1998 and 2012.

Compared with people admitted for other causes, patients admitted for treatment of an autoimmune disorder were 20 percent more likely to wind up back at the hospital later with dementia, the researchers found.

However, when researchers broke down their findings by type of dementia, they found that autoimmune diseases only increased the risk of Alzheimer's disease by about 6 percent.

The autoimmune diseases had a much stronger impact on the risk of vascular dementia. The risk of vascular dementia was 28 percent higher in people with autoimmune diseases. People with vascular dementia experience a decline in their thinking skills due to conditions that block or reduce blood flow to the brain, starving brain cells of oxygen and nutrients.

This apparent increased risk for vascular dementia could be caused by the effect of autoimmune diseases on the circulatory system, the researchers said. The study also found that people with an autoimmune disease were 53 percent more likely to be hospitalized for heart disease. Those with an autoimmune disease were also 46 percent more likely to have a stroke.

The link between vascular dementia and autoimmune diseases is "something new," said James Hendrix. He's the director of global science initiatives for the Alzheimer's Association, based in Chicago.

This link could implicate chronic inflammation as a potential cause of progressive dementia, he said.

Hendrix explained that a person with a sprained ankle experiences inflammation and swelling as the immune system responds to their injury. If the inflammation continues for an extended period, that person could wind up with joint damage and arthritis.

"We are starting to think neuron inflammation is similar," Hendrix said.

Both Hendrix and Goldacre noted that the study is observational, so it couldn't prove a direct cause-and-effect link. In addition, Goldacre said the size of the associations they found was small, and should be taken "more as a message for interested researchers than for interested patients."

Dr. Walter Rocca is a professor of epidemiology and neurology with the Mayo Clinic in Rochester, Minn. He said the findings are "important" but may be limited by the fact that the researchers focused solely on people admitted to the hospital with an autoimmune disorder.

"The concern is that many persons affected by an autoimmune disease may never need to be admitted to a hospital, and many persons affected by dementia may not need to be hospitalized," Rocca said.

"This incomplete capture [of information] may cause a distortion of the findings," he added.

Rocca also pointed out that the 25 autoimmune diseases considered in the study are very different from each other. For example, some attack the joints or the endocrine glands, while others -- like multiple sclerosis -- may directly affect the brain.

Findings from the study were published March 1 in the Journal of Epidemiology & Community Health.

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Immune Disorders Such as MS, Psoriasis May Be Tied to Dementia ... - Helena Independent Record

PORTLAND, Ore., Feb. 28, 2017 /PRNewswire/ -- This year, the National Psoriasis Foundation (NPF) celebrates 50 years of patient support, advocacy, research funding, education and outreach to the more than 8 million individuals living with psoriasis and psoriatic arthritis. Originally formed in 1966 as The Psoriasis Society of Oregon, and officially becoming the National Psoriasis Foundation in 1967, its mission is focused on driving efforts to cure psoriatic disease and dramatically improving the lives of those affected.

Throughout its first 50 years, NPF has made significant contributions in advancing the research of life-changing treatments that have helped millions of people. From the tar-based procedures and topical creams to the revolutionary biologic treatments that exist today, NPF has always supported innovative approaches to treating psoriasis and psoriatic arthritis. While these achievements are to be celebrated, there is still much work to be done to improve access to treatments and, ultimately, to find a cure.

"We have only scratched the surface of what could be possible in treatingand ultimately curingpsoriasis and psoriatic arthritis. Advancements in psoriatic disease research are happening all the time, and NPF remains committed to funding this research while offering programs and services that support even more patients," said Dr. Colby Evans, M.D., National Psoriasis Foundation board chair. "I am honored to be associated with an organization that has always been at the forefront of driving efforts to find a cure for psoriasis and psoriatic arthritis."

NPF has achieved many milestones over the past 50 years, including securing for the first time ever, line-item funding in a federal budget for skin disease research, successfully lobbying the U.S. Food & Drug Administration for the approval of methotrexate for the treatment of severe psoriasis and opening the world's first support center providing free personalized assistance for people with psoriatic disease. Most recently, members of the NPF Medical Board issued the first paper in the United States that outlines psoriasis treatment targets and goals for individuals and health care providers to work on together to achieve clear skin and ultimately reduce the burden of the disease.

"NPF has been a pioneer in supporting research efforts that have led to the groundbreaking treatments used today," said Randy Beranek, president and CEO of the National Psoriasis Foundation. "During our 50th year, we are excited to recognize the people and milestones that have contributed so much to the psoriatic disease community, and remain committed to supporting research efforts towards finding a cure and dramatically improving the health outcomes of all affected by psoriasis and psoriatic arthritis."

In remaining true to its mission, the theme of the NPF 50th Year Celebration is "Driving Discovery, Creating Community." This allows the Foundation to celebrate the achievements of the past 50 years and to recognize the individuals and milestones that have made significant contributions to the psoriatic disease community. To recognize its 50th year, NPF will be holding events throughout the year, starting with a formal celebration on June 8, 2017, at the Plaza Hotel in New York City, and followed by the National Volunteer Conference and Research Symposium August 4 6, 2017 in Chicago, IL, as well as various TeamNPF events across the country.

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During this year of celebration, NPF is committed to raising $2 million to fund several promising areas of research and programing, specifically early career research. Supporting the NPF 50th year campaign will ensure that researchers studying psoriatic disease will have the resources needed to turn their questions and theories into a cure.

To learn more about the NPF 50th Year Celebration and how to get involved, visit: https://www.psoriasis.org/NPF50th.

Over the last 50 years, the National Psoriasis Foundation (NPF) has become the world's leading nonprofit patient advocacy organization fighting for individuals with psoriasis and psoriatic arthritis. NPF leads this fight by driving efforts for a cure and improving the lives of the more than 8 million Americans affected by this chronic disease. To date, NPF has funded more than $15 million in research grants and fellowships, and to commemorate 50 years, NPF plans to raise an additional $2 million for early scientific career research programs in 2017 alone. Each year, NPF strives to support, educate and advocate on behalf of more individuals living with or caring for someone with the disease than ever before. As part of that effort, NPF established the Patient Navigation Center to offer personalized assistance to everyone with psoriasis or psoriatic arthritis. Join our community today and help drive discovery and create community for all living with psoriatic disease.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/national-psoriasis-foundation-celebrates-50-years-of-patient-support-advocacy-research-education-and-outreach-300414766.html

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National Psoriasis Foundation Celebrates 50 Years of Patient Support, Advocacy, Research, Education and Outreach - Yahoo Finance

INDIANAPOLIS , Feb. 28, 2017 /CNW/ --Eli Lilly and Company (LLY) will highlight new Phase 3 data evaluating Taltz (ixekizumab) for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis at the 75th annual meeting of the American Academy of Dermatology (AAD), which will take place March 3-7, 2017 , in Orlando, Fla.

Lilly will present 14 abstracts, including one oral late-breaker presentation highlighting head-to-head data on the efficacy and safety of Taltz compared to Stelara* (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis at 24 weeks.

"As the world's largest dermatology meeting, the American Academy of Dermatology annual meeting is an opportunity to highlight new information and data to experts in the dermatologic disease field," said Dr. Lotus Mallbris, global brand development leader, Taltz, Eli Lilly and Company. "Nearly one year after the approval of Taltz in the U.S. and Europe , we are proud to bring new data further demonstrating the efficacy and safety of Taltz to the American Academy of Dermatology annual meeting."

Studies, as well as the times and locations of the data sessions, are highlighted below.

Oral Late-Breaker Presentation

Saturday, March 4

Poster Presentations

Sunday, March 5

Indications and UsageTaltz (ixekizumab) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONSInfectionsTaltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs. 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

HypersensitivitySerious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel DiseaseCrohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.

ImmunizationsPrior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.

ADVERSE REACTIONSMost common adverse reactions (>1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 18JAN2017

About Taltz (ixekizumab)Taltz (ixekizumab) is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.

About Moderate-to-Severe Plaque PsoriasisPsoriasis is a chronic, immune disease that affects the skin.1 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate-to-severe plaque psoriasis.1,[2] Psoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes and heart disease.1 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.1

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AboutEli Lillyand CompanyLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.comandnewsroom.lilly.com/social-channels.

P-LLYThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a treatment for moderate-to-severe plaque psoriasis, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Taltz will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

_____________________________ 1 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed February 23, 2017 . 2 Psoriasis. American Academy of Dermatology website. https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis. Accessed February 23, 2017 .

Refer to: Jen Dial ; dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly Bio-Medicines)

* Lilly USA , LLC 2017. All rights reserved. Taltz is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. Stelara is a registered trademark owned or licensed by Janssen Pharmaceutical Companies of Johnson & Johnson, its subsidiaries or affiliates.

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Lilly to Present New Data for Taltz (ixekizumab) in Psoriasis and Psoriatic Arthritis at the American Academy of ... - Yahoo Finance

New Delhi: Psoriasis, a skin condition in which skin cells build up and form scales and itchy, dry patches, has high chances of recurrence if the patient is subject to anxiety and depression, say doctors.

According to the doctors, stigma attached to the skin disease also contributes towards its recurrence. Nearly 84 per cent people suffering from moderate-to-severe psoriasis face discrimination and humiliation, with at least 40 per cent of them witnessing unwelcoming glares in public spaces.

Psoriasis has a significant impact on a patients quality of life. As long as there is a stigma attached to these conditions, patients will continue to have flare ups induced by emotional distress as anxiety and depression are major causes of psoriasis recurrences, Rajiv Sekhri, Consultant Dermatologist at Fortis hospital said on Wednesday.

The doctors also said that at least 18 per cent of the patients have been frequently asked whether their condition is communicable, pointing to a grave lack of awareness on the disease.

Psoriasis is a skin condition that changes the life cycle of skin cells. It causes cells to build up rapidly on the surface of the skin. The extra skin cells form thick, silver scales and itchy, dry, red patches that are sometimes painful. It is a persistent, long-lasting disease.

Stating that the psoriasis can affect personal lives and mental health, Sekhri said a survey conducted last year showed 36 per cent people admitted to feeling ashamed of their skin and the way they look.

Forty eight per cent of the patients interviewed shared that psoriasis has impacted their professional life and 30 per cent of them feel that psoriasis has impacted past or current relationships. These results reflect lack of hope and self-esteem, with 31 per cent of people stating that they do not believe clear or almost clear skin is an achievable goal for them, said Sekhri quoting the global survey of 8,300 people with psoriasis.

Sonal Soin, Medical Director and founder of city based Aayna Clinic said that awareness as well as acceptance is very low for psoriasis among patients as well as society.

Most of the people think it is contagious and avoid shaking hands or eating with patients suffering from the condition. Psoriasis is not contagious, one cannot pass the skin condition from one person to another, she said.

Creating awareness about psoriasis can help improve the quality of life of psoriasis patients, Soin added.

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'Psoriasis likely to recur if patients have anxiety, depression' | The ... - The Siasat Daily

LONDON, Feb. 28, 2017 /PRNewswire/ --

Details Psoriasis Drugs Your Guide to R&D, Opportunities and Potential Revenues What does the future hold for treating psoriasis? Visiongain's new report gives you multilevel revenue forecasts from 2016, helping you stay ahead in data. There you see financial results, R&D trends, opportunities and potential revenues.

Download the full report: https://www.reportbuyer.com/product/4031803/

In our study you examine predicted sales to 2026 at overall world market, submarket, product and national level. You also assess technologies, competitive forces and expected products. That work's purpose is to help you avoid falling behind in knowledge, missing business or losing influence.

So read on now to explore that industry and discover what its future market could be worth. See how our investigation can benefit your work.

Forecasts from 2016 to 2026 and other analyses to help you harness opportunities Why miss data you need? Why struggle to find it? Instead let our analysis guide you through the psoriasis drug market's present and future. That understanding could bring you quicker, easier results, also benefiting your influence and reputation for business insight.

Besides revenue forecasting to 2026, our new work shows you recent results, growth rates and market shares. There you discover original analysis, seeing commercial outlooks and developments (R&D). In our 169 page study you gain 74 tables and 63 charts to benefit your research, analyses, plans, decisions and presentations.

The following sections outline what you get in our updated investigation.

Sales predictions for the world market and submarkets What is that industry's potential? Discover in our report overall world revenue to 2026 for psoriasis-treating medicines. First you see individual revenue forecasts to 2026 for three main submarkets at world level: - Biological drugs - Topical treatments - Small-molecule systemic therapies.

How will those segments' revenues expand? Which classes of treatment will generate most sales? There you assess prospects for revenue growth, seeing where you can gain, assessing how that industry will compete and develop.

You find revenue predictions by product, too, seeing from 2016 how they can succeed.

Revenue predictions for 13 products to 2026 discover what their futures hold How will individual drugs perform from 2016 to 2026 at world level? Our report forecasts revenues of established brands and medicines expected from 2016.

In our work you assess 13 drugs, including these brands: - Humira (adalimumab) - Stelara (ustekinumab) - Enbrel (etanercept) - Remicade (infliximab) - Otezla (apremilast)

There you discover how high sales can go, to 2026, finding drugs and years with highest predicted growth and revenues. You also examine trends and competition. You see what is happening, understanding challenges, progress, competitors and opportunities.

You find geographical revenue predictions too.

National markets where will highest revenues and growth occur? In developed and developing countries, opportunities in psoriasis treatment will occur from 2016. You see where and how pharma companies can develop and gain.

Our analyses show individual revenue forecasts to 2026 for these 11 national markets: - US and Japan - France, Germany, Italy, Spain and UK - Brazil, Russia, India and China.

There you find countries with highest revenues and potential sales growth. You assess that technology's future, seeing progress and finding what it means, including emerging trends for those skin disorder treatments.

Events affecting developers, producers and sellers issues shaping that industry Our report explains forces affecting that industry and market from 2016, including these influences: - Research and development, including monoclonal antibodies, IL-12, IL-17, IL-23, PDE4, TNF, JAK and T-cell inhibition, and histamine receptor antagonism - Prevalence of that skin disease, as well as issues for patients and healthcare providers assess treatment needs - Competition from generic drugs, biosimilars and new biologics - Companies specialising in dermatology and autoimmune disorders explore capabilities and emerging trends to treat psoriasis - Advances in drug delivery to benefit companies, patients and payers, including lotion, ointment and foam.

In our survey you explore political, economic, social and technological questions, assessing outlooks for business. You also examine that pharmaceutical segment's strengths, weaknesses, opportunities and threats.

That way you discover what the present and future hold, seeing what is possible for those drug developers, producers and marketers. Stay ahead in knowledge.

Companies leading that industry and our overall revenue prediction for 2020 From 2016, treatments for psoriasis hold potential for investments, medical advances and higher revenues. Our work predicts the overall world market for psoriasis medicines will reach $11.4bn in 2020, with further expansion to 2026.

See what is possible there the expected gains. Our report shows you what technologies and firms hold greatest potential. You explore activities of these companies, among others: - Johnson & Johnson - AbbVie - Amgen - Pfizer - Novartis - Celgene - LEO Pharma.

Our analysis shows you participants' results, capabilities, developments and outlooks. R&D in that industry is strong. From 2016 the psoriasis market holds many opportunities for revenue growth. Our work explains that potential, helping you stay ahead in knowledge.

Main ways Psoriasis Drugs Market Forecasts 2016-2026 helps your work In particular our new investigation gives you these advantages to benefit your research, analyses, decisions, proposals and presentations: - Revenues to 2026 at world level, with forecasting of 3 submarkets and 13 products assess prospects for investments and sales growth - Forecasts to 2026 for 11 national markets in the Americas, Europe and Asia investigate leading countries for revenues and expected sales - Forces driving and restraining that industry's expansion discover what influences revenue gain, finding trends, developments and opportunities - Prospects for established competitors and rising companies explore companies' portfolios, results, R&D and outlooks for future success.

Information found nowhere else: see how you can gain why miss out? Our investigation gives you independent analysis. There you gain business intelligence found only in our work, finding where opportunities for revenue expansion exist.

See in our work how you could benefit your research, analysis and decisions. Explore progress and possibilities. Also find how you could save time and benefit your authority on those drugs, helping your reputation for commercial insight.

Medicines for psoriasis get revenue predictions now, seeing what the future holds Our new report is for everyone investigating drugs for inflammation and skin disorders. In our survey you explore revenue forecasts to 2026, with discussions and other data. Avoid missing out in knowledge instead please get our report here now. Download the full report: https://www.reportbuyer.com/product/4031803/

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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/psoriasis-drugs-market-forecasts-2016-2026-300414898.html

More here:
Psoriasis Drugs Market Forecasts 2016-2026 - Yahoo Finance