Monday, September 24, 2018
Blueprint Medicines initiated at Leerink
Blueprint Medicines initiated with an Outperform at Leerink. Leerink analyst Andrew Berens started Blueprint Medicines with an Outperform rating and $105 price target. https://thefly.com/landingPageNews.php?id=2794745
Deciphera initiated at Leerink
Deciphera initiated at Leerink Deciphera initiated with an Underperform at Leerink. analyst Andrew Berens started Deciphera Pharmaceuticals with an Underperform rating and $28 price target.
UnitedHealth tells Hospitals about Envision ER contracts
UnitedHealth (UNH) plans to treat emergency room and other hospital services performed by Envision Healthcare (EVHC) as out-of-network claims starting next year after failing to reach a new contract deal with the staffing company, Reuters reports, citing a letter sent by the health insurer to 300 hospitals. The move comes 90 days ahead of the January 1 date for the out-of-network switch, and after months of talks between the two companies to settle disagreements over payment rates and other financial incentives, the report says, citing UnitedHealth spokesman Stephen Shivinsky.
https://thefly.com/landingPageNews.php?id=2794771
Theravance Gets EU Panel Nod for Expanded COPD Indication for Med
Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD. Trelegy Ellipta is the triple combination therapy of FF/UMEC/VI in a single ELLIPTA® inhaler.
The expanded indication for the once-daily single inhaler triple therapy would enable use by patients not adequately treated by a long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA). It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study.
Trelegy Ellipta is a product in which Theravance Biopharma has an economic interest in future payments that may be made by GlaxoSmithKline (GSK) or one of its affiliates pursuant to its agreements with Innoviva (formerly Theravance, Inc.). Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%, resulting in cash flows to Theravance Biopharma of approximately 5.5% to 8.5% of worldwide net sales of Trelegy Ellipta.
Trelegy Ellipta is the first COPD treatment to provide a combination of three molecules in a single inhaler that only needs to be taken once a day. The unique combination treatment includes: FF, an inhaled corticosteroid (ICS); UMEC, a LAMA; and VI, a LABA. This combination has been formulated to be delivered once-daily in GSK’s ELLIPTA® dry powder inhaler.
Weight Watchers International Changes Name as It Shifts Mission
Weight Watchers International Inc. is taking on a new name as it refocuses its mission and product lineup.
The New York-based company announced Monday it is now called WW. The rebranding comes as Weight Watchers looks to shift from helping people shed pounds to focusing more broadly on health and wellness. The company is also changing its legal name to WW International Inc., according to a spokeswoman.
Shares of the company closed Monday at $72.89, up 4.5%.
It isn’t unusual for companies to change their names to spotlight new business approaches or product offerings. Last December, Walmart Inc. said it would shorten its legal name to reflect the importance of e-commerce. McGraw Hill Financial announced in 2016 it would become S&P Global Inc. as it moved from its traditional strength in publishing. Kentucky Fried Chicken is now known as KFC.
In February, the company’s Chief Executive Mindy Grossman told stock analysts the “world doesn’t need another diet.” Instead, she said, customers need help becoming healthier.
WW also said Monday that it will launch new products to reflect the company’s focus.
Customers who sign up for the “WellnessWins” program, for example, earn “Wins” for tracking meals, activities, weight and for attending WW Wellness Workshops that they can redeem for products and services. It will be launched for all WW customers in the U.S. on Oct. 4. The firm is also creating what it calls “Connect Groups,” each of which is built around a theme like food, activities or “Life Stages,” according to WW.
The shift has been endorsed by billionaire entrepreneur Oprah Winfrey, who joined the company’s board in 2015 after building a 10% stake in WW. Earlier this year, Ms. Winfrey sold about one-quarter of her holdings.
“As Weight Watchers becomes WW, I believe we will continue to inspire people not only to eat well, but to move more, connect with others and continue to experience the joys of a healthy life,” Ms. Winfrey said in prepared remarks.
In addition to taking the new name, WW is adopting a new marketing tagline: “Wellness That Works.”
Alexion Succeeds in Phase 3 Neuromyelitis Disorder Study
— Soliris® Reduced the Risk of Adjudicated On-Trial Relapse by 94.2% Compared to Placebo (p < 0.0001) —
— Safety Profile Consistent with that Seen in Previous Studies and Real-World Use —
— Preparing for Regulatory Submissions in the US, European Union, and Japan —
— Conference Call/Webcast Scheduled for Today, Monday, September 24, 2018 at 8:30 a.m. EDT —
Alexion Pharmaceuticals Inc. (NASDAQ: ALXN) today announced positive topline results from the Phase 3 PREVENT study of Soliris® (eculizumab) in patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses. Each relapse results in stepwise accumulation of disability, including blindness and paralysis, and sometimes premature death.1,2,3 Patients who have anti-AQP4 auto-antibodies represent approximately three quarters of all patients with NMOSD.4,5,6,7 There are currently no approved therapies for this disease.
The study met its primary endpoint of time to first adjudicated on-trial relapse, demonstrating that treatment with Soliris® reduced the risk of NMOSD relapse by 94.2 percent compared to placebo (p < 0.0001). At 48 weeks, 97.9 percent of patients receiving Soliris® were free of relapse compared to 63.2 percent of patients receiving placebo. Soliris® was generally well tolerated with a safety profile consistent with that seen in previous clinical studies and real-world use in its three approved indications. No cases of meningococcal infection were observed.
“These results far exceeded our expectations. The remarkable reduction in relapse risk demonstrates the unique ability of Soliris® to inhibit complement, and suggests a promising new treatment for NMOSD,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “Given that patients currently have no approved therapies, we are moving quickly to discuss these results with regulators and file for approval in the U.S., EU, and Japan.”
“The primary goal in treating NMOSD is relapse prevention as each relapse further increases disability, which makes this disease so devastating. For decades, we have been hoping for a therapy that can prevent relapse and subsequent accumulation of disability by addressing a critical underlying cause of the disease,” said Michael Levy, M.D., Ph.D., Associate Professor at Johns Hopkins University, and Director of the Neuromyelitis Optica Clinic in Baltimore, MD. “The substantial effect of Soliris® seen in this groundbreaking randomized, controlled study in NMOSD could potentially become a turning point for patients and their families who live in constant fear of relapse.”
Detailed results from this Phase 3 study will be presented at a future medical congress.
Alexion will host a conference call/webcast today, Monday, September 24, 2018 at 8:30 a.m. EDT to discuss the study data. To participate in this call, dial (866) 762-3111 (USA) or +1 (210) 874-7712 (International), passcode 1296796, shortly before 8:30 a.m. EDT. A replay of the call will be available for a limited period of time following the call. The audio webcast can be accessed on the Investors page of Alexion’s website at: http://ir.alexion.com.
After Stumbling with Waylivra, Akcea Therapeutics’ Lipid Drug Shows Promise
Akcea Therapeutics, based in Cambridge, Massachusetts, and Ionis Pharmaceuticals,headquartered in Carlsbad, California, released positive topline data from a Phase II trial of AKCEA-APO(a)-LRx in cardiovascular disease and lipoprotein(a).
The Phase II trial was designed to evaluate the safety and tolerability of the compound and to help choose dose information for the planned Phase III trial that will look at cardiovascular outcomes. The Phase II trial evaluated 286 patients with established cardiovascular disease and high Lp(a), which is three times the upper limit of normal. All patients were treated for at least six months. Some patients were treated up to 12 months.
The drug showed significant dose-dependent decreases of Lp(a) compared to placebo. The most common side effects were reactions at the injection site and were mostly mild and only occurred in a minority of patients. Elevated Lp(a) is a hereditary risk favor for cardiovascular disease that can’t be controlled well with diet and exercise, or with existing cholesterol medications.
“These data represent an important step forward for patients who have significant risk of premature death from cardiovascular disease due to their high levels of Lp(a),” said Paula Soteropoulos, chief executive officer of Akcea, in a statement. “In this large Phase II study AKCEA-APO(a)-LRx, robustly lowered Lp(a) with a favorable safety and tolerability profile. In addition, the data from this study support the potential to treat patients with convenient, low volume monthly doses. These results are also encouraging as we continue to develop our LICA pipeline.”
The drug is being developed as a strategic collaboration between Akcea and Novartis. If Novartis exercises an option to license the drug after the successful completion of an end of Phase II meeting with the U.S. Food and Drug Administration (FDA), Novartis will pay Akcea a $150 million milestone payment, half of which will go to Ionis.
If Novartis does exercise the option, it will be responsible for all future development of the drug, including a global Phase III cardiovascular outcomes trial. And if the drug is approved, Novartis will handle worldwide commercialization activities.
Akcea keeps the right to co-commercialize any successful drug via its specialty sales force.
This is good news after Akcea was shocked by an FDA rejection of its Waylivra (volanesorsen) for a rare lipid disorder, familial chylomicronemia syndrome (FCS) on August 28. It was particularly surprising, given that in May an FDA advisory committee recommended the drug with a vote of 12 to 8. The FDA typically follows advisory committee recommendations, although they are not obligated to. That was one aspect of the drug’s rejection that was surprising; the other was the company did not publicly disclose the reasons why the drug was rejected.
At the time, Soteropoulos stated, “We are extremely disappointed with the FDA’s decision. FCS is an ultra-rare and debilitating disease. Our disappointment extends to the patient and physician community who currently do not have a treatment available to them. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS as we reflected in the positive outcome from our Advisory Committee hearing in May.”
Not long after, a patient advocacy group, the FCS Foundation, spoke up, demanding the FDA reconsider its decision. In a statement to BioSpace, the foundation said, “This FDA decision leaves FCS patients with no clinical treatment for the disease. … Despite the FDA having a department that is committed to understanding the impact and burden of rare diseases, it appears they have not taken the patient experience or testimony into consideration in their decision to not approve Waylivra.”
And only a day or two later, the company indicated it planned to cut around 10 percent of its workforce as a result of the rejection.
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