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Monday, September 24, 2018

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.”
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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.
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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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7 Upcoming and Recently Announced Biotech IPOs


This year has been a huge year for biopharma initial public offerings (IPOs). According to BioPharm Catalyst there were, or soon will be, 58 biopharma IPOs in 2018. A recent Bloombergarticle described 38 new U.S. biotech listings that raised $3.9 billion. And the trend doesn’t appear to be slowing. Here’s a look at five upcoming biotech IPOs.
#1. Entasis Therapeutics. Located in Waltham, Massachusetts, Entasis spun out from AstraZeneca in 2015, taking with it a small-molecule anti-infectives portfolio. The company, after the initial funding from AstraZeneca, raised another $81.9 million in equity financing. On August 14, Entasis announced positive topline results from its Phase II clinical trial of ETX2514, a beta-lactamase inhibitor, in combination with sulbactam, to treat complicated urinary tract infections (cUTI) including acute pyelonephritis (kidney infection) in adults.
The company hopes to raise $75 million in its U.S. IPO, and will list under the symbol ETTX. The expected pricing date is September 25.
#2. Urovant Sciences. A Vivek Ramaswamy company under the Roivant Sciences umbrella, Urovant filed for an IPO to raise $150 million. It expects to list on the Nasdaq under the UROV symbol. Urovant is a clinical-stage biopharma company focused on developing and commercializing drugs for urologic conditions. Its lead product candidate is vibregron, an oral, once-daily, small molecule beta-3 agonist. It licensed the drug from Merck Sharp & Dohme. It is being developed to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
On August 28, Urovant licensed another compound, hMaxi-K from Ion Channel Innovations for overactive bladder. The drug had already been studied in two Phase I trials. The IPO pricing date is September 27.
#3. Ra Medical Systems. Headquartered in Carlsbad, California, Ra offers advanced excimer laser systems for vascular and dermatological diseases. The IPO pricing date is September 27.
The company hopes to raise $50 million and trade under the RMED symbols. Ra Medical Systems has two laser systems, DABRA and Pharos, to treat vascular and dermatology diseases, respectively. The company plans to use about $21 million to expand its direct sales force and marketing of its product, another $14 million to support clinical trials for new products and product enhancements, and the rest will be used for R&D, working capital and general corporate purposes.
#4. Sutro Biopharma. Located in South San Francisco, Sutro Biopharma focuses on next-generation cancer and autoimmune therapeutics with the development of antibody conjugates, bispecific antibodies and cytokine derivatives. In July, the company raised $85.4 million in a Series E financing, which was used to advance its pipeline of novel cancer therapeutics, including two internally-developed antibody-drug conjugates, dubbed STRO-001 and STRO-002. The brought the funds raised to a total of $175 million since 2003.
Sutro has an IPO pricing date of September 27. It plans to raise $75 million and trade under the STRO symbols.
#5. Arvinas. Based in New Haven, Connecticut, Arvinas focuses on drugs based on protein degradation. Its two lead programs target the androgen receptor for castration-resistant prostate cancer and the estrogen receptor for ER+ breast cancer. In April, the company raised$55 million in a Series C financing. Total fundraising has hit $11.6 million.
Arvinas also has a pricing date of September 27. It hopes to raise $100 million and trade under the symbol ARVN.
In addition to these five, Kodiak Sciences announced today that it plans an IPO and will list on the Nasdaq under the symbol KOD. Based in Palo Alto, California, on August 31, Kodiak announced enrollment had been completed for its Phase I trial of KSI-301 to treat retinal vascular diseases, including neovascular age-related macular degeneration and diabetic eye disease.
In addition, PhaseBio, headquartered in Malvern, Pennsylvania, which focuses on orphan diseases in the cardiopulmonary space, filed a prospectus for an $86 million IPO. The company also announced today positive preliminary data from a Phase I clinical trial of PB2452 in patients with major bleeding events or who require urgent surgery.
Writing about the current trends in biotech IPOs for Forbes, Bruce Booth says, “These data reflect the investment community’s excitement about buying into bona fide therapeutic innovation: new modalities unlocking potential cures, new products based on transformational biology, platforms that can produce multiple first- or best-in-class programs — all with an expectation of these new medicines having a significant impact on patients.”
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AstraZeneca’s Diabetes Drug Farxiga Decreases Risk of Cardiovascular Disease


AstraZeneca announced positive results from its Phase III DECLARE-TIMI 58 cardiovascular outcomes clinical trial of Farxiga (dapagliflozin).
The drug, which is used to treat diabetes, was being evaluated compared to placebo for its effects on cardiovascular outcomes, or major adverse cardiovascular events (MACE). The trial evaluated more than 17,000 patients across 882 sites in 33 countries and compared the effect of Farxiga compared to placebo on cardiovascular outcomes in adults with type 2 diabetes at risk of cardiovascular events.
“Farxia has achieved a statistically significant and clinically important reduction in hospitalization for heart failure or CV death in a broad range of patients with type 2 diabetes and cardiovascular risk,” said Elisabeth Bjork, AstraZeneca’s vice president, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, in a statement. “The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalizations that result in a considerable societal and economic burden.”
The results weren’t completely positive, however. The trial met its primary safety endpoint of non-inferiority for major adverse cardiovascular events. It also hit a statistically significant decrease in the composite endpoint of hospitalization for heart failure (hHF) or cardiovascular death, one of the two primary efficacy endpoints for the trial. But, although the company spun this as something of a positive, because there were fewer major adverse cardiovascular events observed, it did not meet statistical significance, thus failing to hit that second primary efficacy endpoint.
Reuters notes, “The failure to achieve a more convincing reduction in CV events — such as heart attacks and strokes — may be seen as disappointing. But Ludovic Helfgott, AstraZeneca’s head of CV and metabolic diseases, believes the overall data suggests Farxiga could win expanded approval as a diabetes drug with proven heart benefits in a wide range of patients.”
Helfgott told Reuters, “We have demonstrated with Declare that we have a cardiovascular outcome in a broad population and we believe that is something that needs to be recognized by regulators and the clinical community. We are expecting to have a new label by the end of next year.”
The drug’s market competitors include Eli Lilly and Boehringer Ingelheim’s Jardiance and Novo Nordisk’s Victoza, which have already proven in trials to show improved cardiovascular outcomes. However, AstraZeneca’s study takes this a step further, showing Farxiga helped decrease cardiovascular events in patients that don’t have established cardiovascular disease.
In a note to clients, Jack Scannel, an analyst with UBS, wrote, “This should provide a degree of commercial differentiation.”
Analysts’ consensus predicts Farxiga to have peak annual sales of $2.7 billion by 2023. Projected sales for this year are $1.4 billion.
“The DECLARE-TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type 2 diabetes by reducing the composite of hospitalization for heart failure or CV death, with a safety profile supportive of broad use,” said Stephen Wiviott, senior investigator with the TIMI study group, co-principal investigator of the trial, and researcher at Brigham and Women’s Hospital and Harvard Medical School.
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Amarin’s Fish Oil-Based Med Dramatically Cuts Cardiovascular Risk


Physicians have long recommended fish oil to patients with high cholesterol and triglycerides, even though the scientific studies on it are mixed. Amarin Corporation, with offices in New Jersey and Ireland, developed a drug called Vascepa, which derives from a purified component of fish oil called eicosapentaenoic acid (EPA). The drug has already been approved to treat patients with triglyceride levels higher than 500 milligrams per deciliter, triple normal levels. Despite that, there was skepticism among physicians whether the drug—and fish oil in general—really led to lower cardiovascular issues, including heart attacks and strokes.
That appears to have been settled. In the company’s REDUCE-IT clinical trial of 8,179 statin-treated adults with increased risk of cardiovascular problems, the drug showed a 25 percent relative risk reduction in major adverse cardiovascular events compared to placebo. In premarket trading, company shares roared, jumping about 163.6 percent.
“We are delighted with these topline study results,” said John F. Thero, president and chief executive officer of Amarin, in a statement. “Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”
Sekar Kathiresan, director of the Cardiovascular Disease Initiative at the Broad Institute and the Center for Genomic Medicine at Massachusetts General Hospital, wasn’t as restrained. Kathiresan told Forbes, “‘What??!!! Fantastic! Wow! That’s awesome! Such great news for patients!”
Fish oil pills use much lower doses. Also, few similar drugs have been able to significantly reduce heart attack and stroke risk on top of cholesterol-lowering drugs like statins.
In the trial, patients who were given four grams of Vascepa had a 25 percent lower risk of cardiovascular issues, including heart attack, stroke, a heart procedure for a clogged artery, or chest pain requiring hospitalization, compared to patient on placebo.
The company expects to present full data at the American Heart Association meeting in November. Matthew Herper, writing for Forbes, notes, “One concern was that the mineral oil placebo might interfere with the effectiveness of cholesterol-lowering medicines in the placebo group. But even if it exists, that effect is ‘not likely to be large enough to negate the results of the study,’ says Steven Nissen of the Cleveland Clinic, who is running a study of a rival fish-oil-derived drug for AstraZeneca.”
In addition to being good news for Amarin, the results suggest that some of the thinking about cholesterol and triglycerides may not be accurate, although more studies will need to be conducted for a definitive conclusion to be drawn.
Physicians have focused on the so-called good cholesterol, high-density lipoprotein, HDL, which was suspected of offering protection against heart attacks. Biopharma has invested heavily in drugs that boosted HDL, none of which worked. Companies involved in this include Pfizer, Roche and Merck. But drugs that lowered triglycerides, another type of fat found in the blood, seemed to have a positive effect on heart disease, but weren’t conclusive.
Recent research by Brian Ference of the University of Cambridge suggested another protein, ApoB, might be involved in both high triglycerides and high LDL.
Craig Granowitz, Amarin’s senior vice president and chief medical officer, stated, “Considered against the backdrop of multiple unsuccessful cardiovascular outcomes studies of earlier generation drug therapies, including multiple recent failed cardiovascular studies of omega-3 mixture products that contain the omega-3 acid DHA, REDUCE-IT topline results stand alone as positive and confirm our hypothesis that pure EPA Vascepa at 4 grams/day can provide additional cardiovascular risk reduction benefit on top of LDL-C control with standard of care statin therapy in studied patients.”
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AnaptysBio announces ‘positive’ topline proof-of-concept data for etokimab


AnaptysBio announced positive topline proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in an ongoing single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second which is a measure of lung function, with an 8 percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11% increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31% reduction at Day 2 and a 46% reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis.
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