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The question now is whether Cosentyx can continue this momentum once new IL-17's such as Lilly's Taltz receive marketing authorization.  More than one-third of rheumatologists claim to have clinical experience with Taltz in PsA (similar to Cosentyx pre-approval exposure) and a fair percentage of the audited patients are identified by their rheumatologist as Taltz candidates.  With the introduction of new IL-17's, watching the evolving dermatology referral patterns for PsA patients will be critical.  72% of the rheumatologists state that they wish dermatologists would refer PsA patients earlier than they typically do; furthermore, when patients currently treated with a biologic or Otezla are referred, the majority are switched by rheumatologists within three months. Although Celgene recently reported a revenue miss in Q1 2017 for Otezla, the audit revealed a solid position for the brand.  While the switch-from rates did increase from the prior wave, Otezla also gained, particularly in the first-switch scenario where safety concerns associated with a biologic and patient preference for an oral agent drove the switch.   Should Pfizer's Xeljanz gain approval for PsA, Otezla will have a new battle to fight with regard to patient demand for an oral.  Indeed, rheumatologists indicated that 31% of the patients currently on Otezla would be considered candidates for Xeljanz if approved. RealWorld Dynamix™ is an independent report derived from a robust patient audit focused on the switch patient segment.  Unlike claims data, the analysis includes physician assessment, rationale for treatment decisions and future intent related to biologic/Otezla selection.  In addition, key variables such as patient engagement level, the influence of the payer, socioeconomic and QOL metrics, co-morbidities, concomitant medications and test results are also included to provide a comprehensive analysis of the patient journey.  In total, the combined analysis includes over 1,000 patient records.  The full report will be available at the end of May. Spherix Global Insights is a business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets.  Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novartis-cosentyx-takes-the-wind-out-of-stelaras-sails-in-psoriatic-arthritis-market-300458754.html


EXTON, Pa., May 17, 2017 /PRNewswire/ -- According to the latest RealTime Dynamix™: Atopic Dermatitis report, just one month after the launch of Dupixent, the uptake appears to be robust.  About a third of the survey respondents have prescribed the drug and roughly half of the non-users expect to get on board quickly. However, representative contact rates leave something to be desired, as many dermatologists report waiting to be detailed on the newest entrant—and rep visits matter.  Significantly more physicians who have seen a Dupixent representative have prescribed the drug compared to those who have not been detailed.  Furthermore, those who have been detailed are significantly more familiar and comfortable with Dupixent than their counterparts who have not been called on.  Representative contact rates in the past month are lower than those of Pfizer and AbbVie, but comparable to other major players in the dermatology space.  However, with Dupixent being a brand new biologic with no alternate indications, as well as the first-in-class for AD, it is imperative that Sanofi-Regeneron ramp up their dermatology presence. It has been reported from Regeneron that an estimated 3,500 scripts for Dupixent have been written.  Despite the multitude of scripts for the only approved AD biologic, dermatologists report that 43% of all their Dupixent patients are still pending insurance approval and that only 47% of all prior authorizations completed for Dupixent have been approved.  Indeed, two-thirds of current users and just under half of all non-users cite insurance coverage as a barrier to Dupixent use.  Furthermore, one-in-five note that Dupixent's greatest disadvantage is the associated insurance coverage issues, while 40% note the cost is too high, despite the sentiment held by many in the industry that the cost was lower than expected.


The IL-6 inhibitors may have a harder time penetrating the RA EU market, where Roche's RoActemra (tocilizumab) is the third most commonly prescribed biologic behind AbbVie's Humira and Pfizer's Enbrel with use far surpassing that of Actemra in the US.  Though over one-quarter of the respondents believe the new IL-6 inhibitors will be completely interchangeable with RoActemra, they also note that the greatest barriers for displacing RoActemra are it's length of time on the market, well understood safety profile, rheumatologist comfort in prescribing, and RoActemra's strong supporting clinical data. Further changes impacting the RA treatment paradigm across the EU include the continued acceptance and adoption of biosimilars.  Indeed, 41% of rheumatologists noted that biosimilars have been the single most significant change with regard to RA management over the past year.  Additionally, the biosimilar versions of Remicade now account for nearly 40% of all infliximab use and Biogen/Samsung's Benepali accounts for 25% of all etanercept use. About Spherix Global Insights Spherix Global Insights is a business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets.  Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions. All company, brand or product names in this document may be trademarks of their respective holders. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eu-rheumatoid-arthritis-landscape-poised-for-big-changes-as-rheumatologists-plan-for-the-adoption-of-eli-lillyincytes-olumiant-pfizers-xeljanz-and-regeneronsanofis-kevzara-300451672.html


In UC, Entyvio maintains the position of preferred non-TNF agent, but the lack of an indication does not seem to be stopping gastroenterologists from using Stelara in these patients. Indeed, off-label use of Stelara is projected to pick up nearly one-third of the UC patients as they move from their second to third-line biologic. Although the participating gastroenterologists point to clinical and endoscopic remission as the leading triggers for a biologic switch, they also note that patients have significant input into the decision, in some cases being the primary driver. In common with other autoimmune conditions where biologics are prevalent, the physicians in the IBD market are increasing their use of biologics, using them earlier, switching faster, and embracing agents with novel MOAs. With this market acceleration and hunger for new assets, drugs such as Entyvio and Stelara need to focus on growth, but also on solidifying their gains against potential newcomers such as Pfizer's Xeljanz, Celgene's mongersen and ozanimod and Roche/Genentech's etrolizumab. Gastroenterologists report that close to half of their IBD patients are not optimally managed on their current agent, creating a ripe environment for new entrants in the future switching market. About RealWorld Dynamix RealWorld Dynamix™ is a research report derived from a robust patient audit focused on over 1,000 IBD patients recently switched from one biologic brand to another.  Unlike claims data, the analysis includes physician assessment, rationale for treatment decisions and future intent related to biologic selection.  In addition, key variables such as patient engagement level, the influence of the payer, socioeconomic metrics, QOL metrics, co-morbidities, concomitant medications, and lab test results are also included to provide a comprehensive analysis of the patient journey. About Spherix Global Insights Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets.  Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions. All company, brand or product names in this document are trademarks of their respective holders. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/janssens-stelara-overtakes-takedas-entyvio-as-the-leading-alternative-moa-in-crohns-disease-but-pressure-is-on-to-maximize-ibd-value-in-advance-of-pipeline-drugs-from-celgene-mongersen-ozanimod-rochegenentech-etrolizumab-300472782.html


News Article | May 12, 2017
Site: www.prnewswire.com

With a plethora of DMTs now available, neurologists report increased switching rates at faster intervals with an estimated 30% of their DMT-treated patients making a brand change in a given year.  In the switch analysis arm (n=1,002) the majority of patients moved from their first to second-line agent with most shifting away from platform injectables.  Although less than 10% of patients in the new start analysis were initiated on infused/mAB therapies, this category gains with each successive switch and by third-line, more than one-quarter of the patients were on Biogen's Tysabri, Sanofi-Genyzme's Lemtrada, Roche/Genentech's Rituxan or AbbVie/Biogen's Zinbryta.  Patients being switched to infused/mAb agents had higher disease activity characterized by 43% experiencing a relapse, 38% with an increasing number of T2 lesions, 32% with Gd-enhancing lesions and 18% with evidence of brain atrophy since the prior visit. As the first drug to gain FDA approval for PPMS, Ocrevus was unsurprisingly indicated as a "very likely" choice for patients with PPMS.  However, for close to 20% of the RRMS patients, neurologists also indicated a high likelihood of choosing Ocrevus as the next line agent if the current therapy is not successful.  The upcoming June release of RealTime Dynamix will provide the first look into Ocrevus uptake in the US. RealWorld Dynamix is an independent report derived from a robust patient audit focused on the new start and switch patient segments.  Unlike claims data, the analysis includes physician assessment, rationale for treatment decisions and future intent related to DMT selection.  In addition, key variables such as patient engagement level, the influence of the payer, socioeconomic and QOL metrics, co-morbidities, concomitant medications and test results are also included to provide a comprehensive analysis of the patient journey.  In total, the combined analysis includes over 2,000 patient records. About Spherix Global Insights Spherix Global Insights is a business intelligence and market research company specializing in renal, autoimmune, neurologic and rare disease markets.  We provide clients with strategic insights leveraged from our independent studies conducted with healthcare providers and other stakeholders. All company, brand or product names in this document are trademarks of their respective holders. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/roches-ocrevus-penetrating-beyond-progressive-ms-300456804.html


So, what does this mean for other biologics in PsO?  According to the report, Humira has seen a 16% offset to share over the past year and Enbrel has given up more than 20%.  Although future projections show this erosion curve to continue, actual offsets may come at a slower pace, particularly for Humira, which is extremely well-entrenched as a first line biologic, as well as the preferred biologic for certain PsO patient types.  Furthermore, AbbVie dominates when it comes to perceptions about manufacturer support for patients, providers, and the dermatology community. Janssen's Stelara has carved out a solid position as the leading alternative mechanism biologic; however, the IL-17s are expected to catch up in the next six months, essentially flattening Stelara's growth.  Indeed, among those expecting to increase their use of IL-17s, close to a third expect a corresponding decrease in the use of Stelara. Lastly, Celgene's Otezla has maintained a solid position as a psoriasis treatment and dermatologists do project gains in patients with mild and moderate disease.  However, only half of the current Otezla patients are classified as "well-managed" compared to 71% of biologic-treated patients.  Furthermore, dermatologists identified multiple barriers to increased use of Otezla, including market access challenges, issues with GI tolerability, and sustained efficacy.  Until additional oral small molecule products enter the psoriasis market, Otezla has the corner on a market very much in demand by patients. The next wave of this study, RealTime Dynamix™, will field in August and further drivers behind the evolution of this market will be explored next month in RealWorld Dynamix™: Psoriasis, a large scale syndicated chart analysis of over 1,000 biologic/apremilast treated patients that have recently switched brands. All company, brand or product names in this document are trademarks of their respective holders About Spherix Global Insights Spherix Global Insights is a business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets.  Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novartis-cosentyx-and-eli-lillys-taltz-bring-disruption-to-the-psoriasis-market-as-il-17-share-increases-dramatically-300477250.html


Recent launches in the renal market have typically been associated with slow uptake, largely hampered by limited market access. This is also true for Opko's Rayaldee, a vitamin D3 prohormone launched in November 2016. However, Opko also faces other challenges as well, including an inferior promotional rate (compared to phosphate binders and Sensipar), low familiarity among nephrologists, and a lack of a perceived unmet need for the product. Indeed, just 6% of the surveyed nephrologists reported any trial of Rayaldee at the four month mark and two-thirds have not had any contact with a sales representative since the product was launched. By contrast, Amgen's Parsabiv, a recently approved IV calcimimetic, is expected to become available later this summer and could make a big impact. While nephrologists are still struggling to understand the reimbursement scenario for Parsabiv and its oral classmate Sensipar, there is excitement in the nephrology community about the ability to control drug delivery in order to achieve better outcomes in SHPT. The potential upside is massive for Amgen. Not only are patients currently treated with Sensipar candidates for Parsabiv, but nephrologists estimate that about 20% of calcimimetic-naïve patients – those who cannot tolerate, afford or remain compliant with Sensipar – could also potentially be treated. The importance of promotion and manufacturer support will also play to Parsabiv's advantage, as nephrologists and RDs identify Amgen as the most supportive company in the CKD-MBD space and representative contact rates are already high. According to Dr. Jay Wish, M.D., Professor of Clinical Medicine at Indiana University School of Medicine, “The availability of Parsabiv provides clinicians with the ability to improve SHPT outcomes in our hemodialysis patients.  By having a formulation that can be administered by our dialysis nursing staff, instead of relying on patient adherence to daily oral medication that is not well-tolerated, we can be more confident that patients are receiving an optimal calcimimetic dose.  In addition to improvements in SHPT, consistent dosing of Parsabiv may also improve phosphate control, enabling lower doses of phosphate binders.” On the horizon is Ardelyx's tenapanor, a NHE3 transport inhibitor, being developed for hyperphosphatemia in ESRD. Among the nephrologists surveyed, three-quarters report high interest in tenapanor, drawn largely to its novel mechanistic approach and more favorable dosing requirements compared to phosphate binders. If ultimately approved, tenapanor will provide another option for tackling a highly prevalent and challenging condition faced by hundreds of thousands of dialysis patients. RealTime Dynamix: Bone and Mineral Metabolism is an independent report series published each quarter. The series tracks the evolution of the CKD-MBD market, provides a deep dive on launch effectiveness and highlights opportunities for pipeline agents. The next update will be published in June 2017. About Spherix Global Insights Spherix Global Insights is a business intelligence and market research company specializing in renal, autoimmune, neurologic and rare disease markets. We provide clients with strategic insights leveraged from our independent studies conducted with healthcare providers and other stakeholders. All company, brand or product names in this document are trademarks of their respective holders. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/keryxs-auryxia-and-vifor-fmcs-velphoro-slowly-gaining-share-in-the-phosphate-binder-market-while-big-shifts-in-ckd-mbd-loom-with-the-pending-introduction-of-amgens-parsabiv-300455436.html


IRVINE, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- ChromaDex Corporation (NASDAQ:CDXC) an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions for dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today that University of Iowa researchers have published a study in the prestigious Journal of the International Association for the Study of Pain (PAIN) showing that NIAGEN® Nicotinamide Riboside (NR) ameliorates chemotherapy-induced peripheral neuropathy (CIPN) in an animal model. Results from this study suggest that NR may be an effective therapy in relieving chemotherapy induced peripheral neuropathy (CIPN) in humans.  Access to the study was made available online on February 11, 2017. Currently, the American Society for Clinical Oncology considers the development of adjunctive therapy for the prevention and relief of CIPN as essential for patient care. This study provides an important proof of concept for the use of NR as a novel therapeutic approach in filling the unmet need for treatments that alleviate CIPN. ChromaDex CEO and co-founder, Frank Jaksch, Jr. stated, “This is another well-designed study that reinforces the role of NR in neuronal protection.  These results are particularly important given that this research may contribute to the discovery of a new therapeutic option for a significantly underserved patient population.” Led by Dr. Donna Hammond, Ph.D., the research team at the University of Iowa demonstrated that treatment with NR increased blood levels of nicotinamide adenine dinucleotide (NAD+) by 50 percent after three weeks of daily administration.  NR was able to prevent the development of tactile hypersensitivity induced by the chemotherapeutic paclitaxel and reverse well-established tactile hypersensitivity, while also blunting escape/avoidance behaviors. Furthermore, the prophylactic effect was sustained for at least two weeks after treatment with NR ceased. Dr. Marta Hamity, Ph.D., the lead study author, indicated that the team embarked on the study based on evidence that suggested that increasing levels of NAD+ in the cells may protect against neuronal injury. The study used female Sprague-Dawley rats, clinically relevant doses of paclitaxel and incorporated measures that quantify the impact of CIPN on quality of life. “This is significant because the pain associated with CIPN can increase as the [chemotherapy] dose escalates, and at times it reaches a point where the patient is no longer able to tolerate the effective doses,” explained Hammond. “The American Society of Clinical Oncology has issued a position paper that there is an unmet need for treatments that can alleviate CIPN,” stated Hammond. “This study has provided positive data which is particularly exciting considering the unmet need for therapies in this area. We believe that further development of NR as a therapy for CIPN is warranted.” NR has been the subject of nearly 200 peer-reviewed journal publications and is currently at the center of over 100 collaborative studies between ChromaDex and leading universities and research institutions around the world such as the National Institute of Aging, MIT and the Scripps Research Institute representing an estimated $40-50 million in NR research. In November, 2016 ChromaDex announced that it met with FDA to gain Agency guidance on the requirements needed to successfully file an Investigational New Drug (IND) application to initiate a Phase I/II clinical trial in patients with Cockayne Syndrome. Jaksch commented, “ChromaDex is working towards completing IND-enabling preclinical studies for Cockayne Syndrome and filing that IND sometime in 2017.” ChromaDex, being publicly traded on NASDAQ, gives the public an opportunity for investing in the business of science-based technologies for healthy aging and longevity. To date, ChromaDex has invested millions in safety, toxicology and human clinical trials on NR. Most of ChromaDex’s recent revenue growth has come from its proprietary ingredients, in particular NIAGEN®. ChromaDex’s NIAGEN® is the only commercially available form of NR and is supported by five patents issued and several pending, with patents rights acquired from Cornell University, Dartmouth College and Washington University. In addition to human clinical studies, ChromaDex is actively collaborating with numerous leading universities and research institutes studying the health benefits of NIAGEN®. For additional information about ChromaDex and NIAGEN®, visit www.Chromadex.com. Additional research and news about NR and NAD+ can be found at www.AboutNR.com. About ChromaDex: ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary ingredient technologies that address the dietary supplement, food, beverage, skin care and pharmaceutical markets. In addition to our ingredient technologies unit, we also have business units focused on natural product fine chemicals (known as "phytochemicals"), chemistry and analytical testing services, and product regulatory and safety consulting (known as Spherix Consulting). As a result of our relationships with leading universities and research institutions, we are able to discover and license early stage, IP-backed ingredient technologies. We then utilize our in-house chemistry, regulatory and safety consulting business units to develop commercially viable ingredients. Our ingredient portfolio is backed with clinical and scientific research, as well as extensive IP protection. Our portfolio of patented ingredient technologies includes NIAGEN® nicotinamide riboside; pTeroPure® pterostilbene; PURENERGY®, a caffeine-pTeroPure® co-crystal; IMMULINA™, a spirulina extract; and AnthOrigin™, anthocyanins derived from a domestically-produced, water-extracted purple corn. To learn more about ChromaDex, please visit www.ChromaDex.com. Forward-Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to results and significance of the NIAGEN® study  and the likelihood that NR will be an effective tool in relieving chemotherapy-induced peripheral neuropathy, whether NIAGEN® may be used in a therapeutic approach in filling the unmet need for treatments that alleviate CIPN and the likelihood of ChromaDex initiating a Phase I/II clinical trial in patients with Cockayne Syndrome. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended January 2, 2016, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. ChromaDex provided research materials and a portion of the grant funding as a collaborator for the study.


News Article | February 21, 2017
Site: www.prnewswire.com

NEW YORK, Feb. 21, 2017 /PRNewswire/ -- Spherix Incorporated (Nasdaq: SPEX) an intellectual property development company committed to the fostering of technology and monetization of intellectual property, today announced that it has signed up a new client to its Patent Monetization and...


News Article | February 21, 2017
Site: globenewswire.com

IRVINE, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions to dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today it is bringing some of its top industry-advancing health and wellness products and services to booth #868 at Engredea 2017, taking place March 9-12 in Anaheim, CA.  ChromaDex is confident that this year’s Engredea attendees will like what they see and hear at booth #868. In addition to showcasing exciting ingredient demonstrations, ChromaDex standards and services experts will be available to discuss how they can help assure your products are delivering on their brand promise. What’s in your product and how can you be sure it is delivering on promise? With today’s stringent focus on ingredient quality and efficacy, ChromaDex provides a comprehensive suite of analytical services such as contaminant testing, the ComplyID™ raw material testing program, and finished product testing. It is an industry-leading provider of phytochemical reference standards, botanical reference materials, and research grade materials for the natural products industry. To learn more about working with ChromaDex, visit www.ChromaDex.com. About ChromaDex: ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary ingredient technologies that address the dietary supplement, food, beverage, skin care and pharmaceutical markets. In addition to our ingredient technologies unit, we also have business units focused on natural product fine chemicals (known as "phytochemicals"), chemistry and analytical testing services, and product regulatory and safety consulting (known as Spherix Consulting). As a result of our relationships with leading universities and research institutions, we are able to discover and license early stage, IP-backed ingredient technologies. We then utilize our in-house chemistry, regulatory and safety consulting business units to develop commercially viable ingredients. Our ingredient portfolio is backed with clinical and scientific research, as well as extensive IP protection. Our portfolio of patented ingredient technologies includes NIAGEN® nicotinamide riboside; pTeroPure® pterostilbene; PURENERGY®, a caffeine-pTeroPure® co-crystal; IMMULINA™, a spirulina extract; and AnthOrigin™, anthocyanins derived from a domestically-produced, water-extracted purple corn. To learn more about ChromaDex, please visit www.ChromaDex.com. Forward-Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related ingredient claims. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended January 2, 2016, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. Statements in this press release have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

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