Wednesday, September 12, 2018
Allergan launches Spotlyte digital hub for asthetic treatment consumer education
Allergan launched Spotlyte, a digital hub of curated content that helps consumers discover how medical aesthetic treatments may fit into their routines through content, product reviews and insider profiles, beauty news and trends, and a team of trained specialists ready to offer real-time support and chat directly. Spotlyte is the first venture from the new Allergan-owned digital ventures unit, Project Moonwalker.
https://thefly.com/landingPageNews.php?id=2789095
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.
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