Wednesday, September 12, 2018
Celgene: Psoriasis med improves quality-of-life measures
Celgene Corporation announced the results of two post hoc sub-analyses of clinical trials for OTEZLA at the 27th European Academy of Dermatology and Venereology Congress in Paris, France. Findings suggest OTEZLA offered meaningful improvements in outcomes important to patients with moderate to severe plaque psoriasis, which may not be captured by common measures of treatment efficacy that focus only on skin clearance, such as Psoriasis Area Severity Index 75. The findings include a new post hoc sub-analysis of the phase 3 ESTEEM 1 trial assessing clinical and quality-of-life outcomes for patients with moderate to severe plaque psoriasis who did not achieve PASI 75 at either weeks 32 or 52, but continued OTEZLA treatment in this time period. For patients who did not achieve a PASI 75 at weeks 32 or 52, more than half achieved a 50 percent reduction in PASI score at weeks 32 and 52 following treatment with OTEZLA. This improvement, when taken together in disease-specific quality-of-life measures, may more reliably indicate clinically meaningful benefit. For example, itching, as measured by Visual Analogue Scale, was reduced from baseline by approximately 30 percent during weeks 4 to 52 in those patients who were treated with OTEZLA from baseline and weeks 20 to 52 in patients who were switched from placebo to OTEZLA at week 16. Quality of life, as measured by the Dermatology Life Quality Index, was improved by at least 5 points in the two groups during the same time period. Manifestations that are highly visible, such as scalp and nail psoriasis, can have a substantial effect on quality of life. A separate post hoc sub-analysis of the ESTEEM 1, 2 and UNVEIL studies examined changes in scalp and nail psoriasis, along with quality of life, following treatment with OTEZLA. The sub-analysis included patients who had nail psoriasis or moderate to very severe scalp psoriasis at baseline. At week 32 in ESTEEM and UNVEIL, clearance of nail psoriasis among patients receiving OTEZLA from baseline was achieved by 31.3 percent and 36.2 percent of patients, respectively. Among patients who were switched from placebo to OTEZLA at week 16, NAPSI clearance at week 32 was achieved by 15.5 percent and 26.1 percent of patients, respectively. Among patients with moderate to severe scalp psoriasis at baseline, clear or minimal involvement of scalp psoriasis was achieved by greater proportions of patients receiving OTEZLA versus placebo at week 16 in both trials: 45.2 percent versus 22.5 percent, respectively, in ESTEEM and 44.1 percent versus 33.3 percent in UNVEIL. Of patients who had nail psoriasis or moderate to very severe scalp psoriasis at baseline, a DLQI of 0 or 1 was achieved by greater proportions of patients receiving OTEZLA versus placebo at week 16.
https://thefly.com/landingPageNews.php?id=2789105
Group unveils pay model to integrate addiction treatment into medical care
A group of healthcare organizations have teamed up to build a new payment model designed to promote long-term addiction recovery.
Leavitt Partners, Remedy Partners and Facing Addiction with NCADD (the National Council on Alcoholism and Drug Dependence) unveiled the Addiction Recovery Medical Home (ARMH) model, which includes a continuum of care that is based on a chronic-disease model.
Greg Williams, executive vice president of Facing Addiction, told FierceHealthcare it’s crucial that addiction is treated like a chronic disease for long-term recovery to be possible.
“Unfortunately, our current treatment system was developed before we fully embraced this notion,” Williams said. “We built what’s essentially an infectious disease model for a chronic condition.”
The ARMH model includes elements of fee-for-service payment and risk-based payment, and pushes for greater integration of behavioral health services into traditional healthcare services. Integrated care, Williams said, is key to promoting recovery long-term, as it ensures patients with substance abuse disorders are connected to the appropriate care, and that different providers are communicating more effectively with one another.
Williams said the payment model’s designers hope that it pushes providers to consider drug addiction alongside other chronic illnesses that require lifelong maintenance, such as diabetes. The current model, which is almost entirely episodic, fails to promote long-term care because providers benefit financially from relapse; it brings patients back in for more care, he said.
“Today’s system incentivizes relapse—I get paid the more times I serve you,” Williams said. “The incentives are perverse.”
Williams is himself in long-term recovery and said the fact that he’s been able to maintain sobriety under the current system is the exception, not the rule.
“I’ve buried a lot of my friends and watched a lot of people not succeed,” he said.
At least two pilots for the payment model are planned for 2019, and it has already garnered support and interest from some big names. ARMH is backed by the Alliance for Recovery-Centered Addiction Health Services, a group that includes the American Hospital Association, Anthem, AmeriHealth Caritas, Intermountain Healthcare and the Healthcare Financial Management Association.
Having all of those stakeholders at the time was important to building the model, Williams said, as they offered varying perspectives on the best way to align incentives. These stakeholders, he said, will weigh in throughout the pilots as well to refine and adjust the model.
Morgan Stanley Buys 2 Biotechs, Sells 2 Others
Biotech plays are numerous, and Morgan Stanley has a few recommendations to pare and prop a pharma portfolio.
The Ratings
Analyst Jeffrey Hung initiated coverage of:
- Alder Biopharmaceuticals Inc ALDR with an Underweight rating and $19 price target;
- Exelixis, Inc. EXEL with an Underweight rating and $19 target;
- Myokardia Inc MYOK with an Overweight rating and $72 target; and
- Neurocrine Biosciences, Inc. NBIX with an Overweight rating and $145 target.
The Alder Thesis
Ahead of the 2020 launch of Alder’s migraine drug, Hung said he expects expect stock movement on the launches of competing treatments. (See his track record here.)
“By the time they potentially reach the market in 2020, there could be three other migraine drugs on the market of the same class,” the analyst said. “Additionally, while Alder’s drug has a fast onset of action, we view efficacy across these drugs as largely similar.”
Given these circumstances, they anticipate just $500 million in sales by 2025 against a consensus estimate of $750 million.
The Exelixis Thesis
Competition is seen to be equally inhibitive to Exelixis. While its cabozantinib could seize a $520-million share of the market for treatment of second-line kidney cancer, the candidate enters more crowded arenas in first-line kidney cancer (RCC) and second-line liver cancer (HCC).
“As a result, we think adoption of cabo in 1L RCC and 2L HCC will likely be modest,” Hung said, estimating a $500-million opportunity in the latter and $560 million in the former.
The Myokardia Thesis
By Morgan Stanley’s assessment, Myokardia’s mavacamten is better positioned for leadership, with peak U.S. sales beyond $1.3 billion for non-obstructive hypertrophic cardiomyopathy and $1.5 billion for obstructive hypertrophic cardiomyopathy.
“We are positive on MYOK shares because the company’s drugs target well-defined subgroups with unmet medical need, promising mavacamten Phase 2 were observed and multiple catalysts in the next 12-15 months could provide meaningful upside to shares,” Hung said.
The firm’s earlier-stage MYK-491 is seen to offer additional near-term upside.
The Neurocrine Thesis
Neurocrine’s Ingrezza has posted consistent growth in tardive dyskinesia treatment since its launch, and Morgan Stanley projects opportunity to capture additional market share. The sell-side firm anticipates 2018 sales between $425 million and $435 million against Street estimates of $400 million.
The drug’s prospects for Tourette syndrome, coupled with Neurocrine’s Phase 2 candidate for congenital adrenal hyperplasia, could yield additional opportunity for upside, Hung said.
Shire Granted EU Marketing OK for bleeding disease med
SHIRE GRANTED EU MARKETING AUTHORIZATION FOR VEYVONDI® [VONICOG ALFA, RECOMBINANT VON WILLEBRAND FACTOR] FOR ADULTS WITH VON WILLEBRAND DISEASE
- Marketing Authorization will enable patient access to VEYVONDI® throughout Europe
- VEYVONDI [vonicog alfa, recombinant von Willebrand factor] is the first and only recombinant von Willebrand Factor (rVWF) to treat hemorrhage and treat/prevent surgical bleeding in adults (age 18 and older) with von Willebrand disease (VWD)1
Shire plc (LSE: SHP, NASDAQ: SHPG) the global biotech leader in rare diseases, announced today that the European Commission (EC) has granted Marketing Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF), for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (age 18 and older) with von Willebrand disease (VWD) when desmopressin (DDAVP) treatment alone is ineffective or not indicated. VEYVONDI should not be used in the treatment of hemophilia A.1VEYVONDI is the first and only recombinant von Willebrand Factor (rVWF) treatment in the EU for von Willebrand disease (VWD) that specifically addresses the primary deficiency or dysfunction of von Willebrand Factor (VWF) while also allowing the body to restore and maintain adequate Factor VIII (FVIII) plasma levels.1
“The approval in Europe for VEYVONDI marks a key milestone in our efforts to tackle unmet medical needs for those living with von Willebrand disease,” said Andreas Busch, Head of Research and Development and Chief Scientific Officer, Shire. “We are excited to take the next steps in ensuring that VEYVONDI is widely available across Europe to address the individual needs of those affected by the condition and in need of factor replacement.”
The Marketing Authorization is based on outcomes from three clinical trials of a total 80 patients with VWD exposed to VEYVONDI. These include a Phase 1 multicenter, controlled, randomized, single-blind, dose-escalation study of the safety, tolerability and pharmacokinectics (PK) of rVWF:rFVIII in subjects 18 to 60 years of age with severe VWD; a Phase 3 multicenter, open-label study to assess the PK, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in adult subjects with severe VWD; and a Phase 3, prospective, open-label, uncontrolled, non-randomized, international multicenter study to assess the hemostatic efficacy and safety of rVWF with or without rFVIII in 15 adult subjects with severe VWD undergoing major, minor, or oral elective surgical procedures.2
VWD is the most common inherited bleeding disorder, affecting up to 1 percent of the global population or approximately 100,000 people in the EU.3,4 VWD is caused by a deficiency or dysfunction of VWF, one of several types of proteins in the blood that are needed to facilitate proper blood clotting.5 Only a minor proportion of affected individuals have the severe form of the disease and are in need of VWF replacement.6Symptoms range from nosebleeds to bleeding from the gums and easy bruising. Bleeding from the stomach and intestines can occur but is less common.7
With this approval, Shire is now authorized to market VEYVONDI in the 28 Member States of the European Union (EU), as well as in Iceland, Lichtenstein and Norway.
Bristol-Myers Oral Med Hits Endpoints in Plaque Psoriasis Phase 2 Trial
Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with ≥3 mg daily of BMS-986165
Data published in New England Journal of Medicine and presented at European Academy of Dermatology and Venerology Congress
Late-stage development program initiated in psoriasis and other immune-mediated diseases
Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with ≥3 mg daily of BMS-986165, with a favorable risk-benefit profile. Nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection were the most common adverse events (AEs) reported.
These data were published in the New England Journal of Medicine and presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris. In addition, data from the Phase 2 study describing biomarker changes and the selectivity of BMS-986165 for TYK2 in relation to clinical responses will be presented at EADV on Sept. 15, during a late-breaker session.
“Moderate to severe psoriasis remains undertreated and many patients struggle with insufficient disease control, leaving a significant need for effective and convenient therapies that can provide a positive impact on patients’ lives,” said Mary Beth Harler, M.D., head of Innovative Medicines Development, Bristol-Myers Squibb. “BMS-986165 is a novel, oral, selective TYK2 inhibitor with a distinct mechanism of action that has the potential to help psoriasis patients control their disease, and is planned for study in a wide spectrum of immune-mediated diseases.”
“Currently, patients with moderate to severe psoriasis have a limited number of oral therapies,” said Dr. Kim Papp, M.D., Ph.D., of Probity Medical Research in Waterloo, Ontario and lead author of the New England Journal of Medicine publication. “Having a favorable risk-benefit profile and delivering significant skin clearance and improvements in quality of life measures, these data suggest that BMS-986165 may be a promising oral option to help patients control their psoriasis in the future.”
The registrational POETYK (PrOgram to Evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor) PSO Phase 3 program for patients with moderate to severe plaque psoriasis is currently enrolling. Phase 2 trials for patients with systemic lupus erythematosus or Crohn’s disease are also ongoing.
Jazz to Webcast for Investors Related to Vyxeos EU Launch
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast to provide investors with an overview of the AML treatment landscape in the EU as well as a Vyxeos EU launch overview from the company’s executive senior management.
Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion was approved by the European Commission on August 23, 2018for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine.
The live webcast will begin at 11:00 a.m. EDT / 4:00 p.m. IST on September 18, 2018. Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at http://www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast.
An audio archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at http://www.jazzpharmaceuticals.com.
Adult Obesity Rates Top 35% in 7 States, No State Rate Improved Significantly
Report emphasizes urgent need to increase evidence-based obesity prevention programs to prevent disease and potentially save billions in healthcare spending
Seven U. S. states had adult obesity rates at or above 35 percent in 2017, up from five states in 2016, and no state had a statistically significant improvement in its obesity rate over the past year, according to new national data reported in the 15th annual State of Obesity: Better Policies for a Healthier America released today by Trust for America’s Health (TFAH) and the Robert Wood Johnson Foundation (RWJF).
Newly released data from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System show that states with high adult obesity rates are increasing with no less than one in five adults having obesity in every state. Levels of obesity vary considerably from state to state, with a low of 22.6 percent in Colorado and a high of 38.1 percent in West Virginia.
Findings include:
- Adult obesity rates are at or above 35 percent in seven states; for the first time in Iowa and Oklahoma, and at least the second time in Alabama, Arkansas, Louisiana, Mississippi, and West Virginia. As recently as 2012, no state had an adult obesity rate over 35 percent.
- Six states – Iowa, Massachusetts, Ohio, Oklahoma, Rhode Island and South Carolina – saw their adult obesity rates increase significantly between 2016 and 2017.
- Adult obesity rates are between 30 and 35 percent in 22 states and 19 states have adult obesity rates between 25 and 30 percent.
- Over the past five years (2012 – 2017), 31 states had statistically significant increases in their obesity rate and no state had a statistically significant decrease in its obesity rate.
- Obesity levels are highest in Black and Latino communities, low-income and rural communities, places where residents often have limited access to healthy options. According to National Health and Nutrition Examination Survey data, nationally, adult obesity rates for Latinos (47.0 percent) and Blacks (46.8 percent) are much higher than among Whites (37.9 percent), and, 34.2 percent of adults living in rural areas have obesity compared to 28.7 percent of adults living in metro areas.
“Obesity is a complex and often intractable problem and America’s obesity epidemic continues to have serious health and cost consequences for individuals, their families and our nation,” said John Auerbach, president and CEO of Trust for America’s Health. “The good news is that there is growing evidence that certain prevention programs can reverse these trends. But we won’t see meaningful declines in state and national obesity rates until they are implemented throughout the nation and receive sustained support.”
Obesity is a problem in virtually every city and town, and every income and social sector. But its impact is most serious in communities where conditions make access to healthy foods and regular physical activity more difficult, such as lower income and rural areas, including many communities of color.
There are, however, bright spots in certain settings where policies and programs have made it easier to eat well and exercise. For example, the obesity rate among children enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) Program declined between 2011 and 2014.
The national costs of obesity are enormous. Obesity drives an estimated $149 billion annually in directly related healthcare spending, and an additional $66 billion annually in lowered economic productivity. Also, one in three young adults is ineligible for military service, owing to being overweight, posing a national security vulnerability.
Evidence-based programs, policies and practices to reverse the obesity trend are known but need widespread implementation.
Federal, state and local government and other entities should work to prevent obesity by:
- Promoting policies and scaling obesity prevention programs that take a multi-sector approach such as aligning the efforts of health departments, schools and transportation officials.
- Adopting and implementing policies that help make healthy choices easier.
- Investing in programs designed to narrow health inequities such as ensuring that all communities have access to affordable, healthy food options and safe places to exercise.
“Obesity is a major challenge in nearly every state and our role as public health leaders is to ensure we’re doing everything we can to address it,” said John Wiesman, president of the Association of State and Territorial Health Officials (ASTHO) and secretary of health at the Washington State Department of Health. “Our goal at the state level is to work across sectors to advocate for and implement evidence-based policies that encourage active healthy living and support healthy and safe communities that provide access to healthy foods, physical activity, and clinical preventive services.”
Recommendations
The report offers 40 recommendations for federal, state and local policymakers; the restaurant and food industries; and the healthcare system, including:
- Support and expand policies and programs aimed at addressing obesity at the federal, state and community levels, including programs in the Centers for Disease Control and Prevention’s (CDC) Division of Nutrition, Physical Activity and Obesity, and community health programs like the Racial and Ethnic Approaches for Community Health program (REACH), and programs that focus on school health in CDC’s Division of Population Health.
- Maintain and strengthen essential nutrition supports for low-income children, families and individuals through programs — like the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) in the U.S. Department of Agriculture (USDA)–and expand programs and pilots to make healthy foods more available and affordable through the program.
- Maintain nutrition standards for school meals that were in effect prior to USDA’s interim final rule from November 2017, as well as current nutrition standards for school snacks.
- States should ensure that all students receive at least 60 minutes of physical education or activity during each school day.
- The U.S. Department of Health and Human Services, in partnership with the U.S. Department of Agriculture, should ensure that the 2020-2025 Dietary Guidelines for Americans reflect the latest and best nutrition science, include developing recommendations for children ages 2 and under in a transparent, timely manner.
- Actively support the recommendations of Step It Up! The Surgeon General’s Call to Action to Promote Walking and Walkable Communities.
- Medicare should encourage eligible beneficiaries to enroll in obesity counseling as a covered benefit, and, evaluate its use and effectiveness. Health plans, medical schools, continuing medical education, and public health departments should raise awareness about the need and availability of these services.
- Food and beverage companies should eliminate children’s exposure to advertising and marketing of unhealthy products.
- Hospitals should no longer sell or serve sugary drinks on their campuses; they should also improve the nutritional quality of meals and promote breastfeeding.
State by State rates of obesity among adults: 1 = highest rate of obesity, 51 = lowest rate
1. West Virginia (38.1%), 2. Mississippi (37.3%), 3. Oklahoma (36.5%), 4. Iowa (36.4%), 5. Alabama (36.3%), 6. Louisiana (36.2%), 7. Arkansas (35.0%), 8. Kentucky (34.3%), 9. Alaska (34.2 %), 10. South Carolina (34.1%), 11. Ohio (33.8%), 12. Indiana (33.6%), 13. North Dakota (33.2%), 14. Texas (33.0%), 15. Tie Tennessee and Nebraska (32.8%), 17. Missouri (32.5%), 18. Kansas (32.4%), 19. Michigan (32.3%), 20. North Carolina (32.1%), 21. Wisconsin (32.0%), 22. South Dakota (31.9%), 23. Delaware (31.8%), 24. Tie Pennsylvania and Georgia (31.6%), 26. Maryland (31.3%), 27. Illinois (31.1%), 28. Virginia (30.1%), 29. Rhode Island (30.0%), 30. Arizona (29.5%), 31. Oregon (29.4%), 32. Idaho (29.3%), 33. Maine (29.1%), 34. Wyoming (28.8%), 35. Tie Minnesota, Florida and New Mexico (28.4%), 38. New Hampshire (28.1%), 39. Washington (27.7%), 40. Vermont (27.6%), 41. New Jersey (27.3%), 42. Connecticut (26.9%), 43. Nevada (26.7%), 44. Massachusetts (25.9%), 45. New York (25.7%), 46. Tie Montana and Utah (25.3%), 48. California (25.1%), 49. Hawaii (23.8 %), 50. District of Columbia (23.0%), 51. Colorado (22.6 %).
See full report at TFAH.org/ObesityReport2018 and StateofObesity.org for state-by-state obesity rates, data interactives, priority policy summaries, and briefs for all 50 states.
Trust for America’s Health is a nonprofit, nonpartisan organization that promotes optimal health for every person and community and makes the prevention of illness and injury a national priority. www.tfah.org
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