Pfizer New Phase 3 Cardiomyopathy Study Presented at Meeting

Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is the only investigational treatment that has completed a Phase 3 trial evaluating its safety and efficacy for the treatment of ATTR-CM.1 ATTR-CM is a rare, fatal, and underdiagnosed condition associated with progressive heart failure for which there are currently no approved pharmacologic treatments.2

The findings were presented today during the Late Breaking Clinical Trials session at the Heart Failure Society of America 22nd Annual Scientific Meeting in Nashville, TN.The primary results were presented at the ESC Congress 2018 in Munich, Germany on August 27, 2018 and simultaneously published online in the New England Journal of Medicine (NEJM).

The broader primary results showed tafamidis significantly reduced the hierarchical combination of both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (P=0.0006) in patients with wild-type and hereditary ATTR-CM.1 A new sensitivity analysis presented today also demonstrated a significant reduction in the combination of all-cause mortality and frequency of all-cause hospitalization compared to placebo over a 30-month period (P=0.0088).1

In addition, tafamidis reduced the risk of all-cause mortality across all sub-groups (wild-type, hereditary and NYHA I, II and III functional class) versus placebo. This included a 29% and 31% reduction in the risk of death observed in wild-type (HR 0.71; 95% CI [0.474, 1.052]) and hereditary (HR 0.69; 95% CI [0.408,1.167]) sub-groups, respectively.1 Across wild-type and hereditary sub-groups, tafamidis consistently reduced the decline in the six minute walk test distance, a measure of functional capacity, and aspects of quality of life measured by the Kansas City Cardiomyopathy Questionnaire – Overall Score, compared with placebo at Month 30. Tafamidis was also well tolerated, with an observed safety profile comparable to placebo.1

“These additional insights further support tafamidis as a potential treatment option for people with wild-type or hereditary ATTR-CM,” said Brenda Cooperstone MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. “We look forward to learning more through further analyses of this study and continue to work with global regulatory authorities to bring this medicine to patients.”

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-New-Sub-group-Analyses-From-the-Tafamidis-Phase-3-Transthyretin-Amyloid-Cardiomyopathy-Stud-27283052/

Janssen Submits Application to FDA for Urothelial Cancer Treatment

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.

‘Erdafitinib has demonstrated promising results in the treatment of metastatic urothelial cancer, a disease where patients unfortunately have limited treatment options today,’ said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. ‘We look forward to working with the FDA in the agency’s review of the application as we believe erdafitinib will provide patients with an important therapeutic option.’

The NDA submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations. The primary endpoint of this study was the percentage of participants with objective response, defined as Complete Response or Partial Response based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1* criteria. The study results were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago (Abstract #4503) and were recognized as a ‘Best of ASCO’ selection.

‘The erdafitinib FDA submission is an important milestone as we work to bring a new treatment option to patients diagnosed with metastatic urothelial cancer,’ said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. ‘Our organizational focus on areas of high unmet medical need underscores our commitment to advancing transformational science and developing solutions that may prolong and improve patient lives.’

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Janssen-Submits-New-Drug-Application-to-U-S-FDA-Seeking-Approval-of-Erdafitinib-27283562/

Astellas Launches Clostridium difficile Treatment in Japan

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’) today announced that it has launched Dafclir Tablets 200 mg (generic name: fidaxomicin, ‘Dafclir’) for the treatment of infectious enteritis (including pseudomembranous colitis1) (susceptible strains: fidaxomicin susceptible Clostridium difficile (CD)2) in Japan.

Dafclir is an oral macrocyclic antimicrobial agent3 with a new mechanism of action and a selective antibacterial spectrum licensed from Merck & Co., Inc.Kenilworth, N.J., U.S.A., known as MSD outside the U.S. and Canada (‘Merck’). Astellas has developed the product in Japan based on an exclusive development and marketing agreement with Merck. In addition, our subsidiary Astellas Pharma Europe Ltd. has acquired exclusive license for the development and commercialization in Europe, where it is already being marketed as a CD infection treatment, and additional countries in the Middle East, Africaand the Commonwealth of Independent States (CIS)4.

CD, a bacterium that infects large intestine and produces toxins, causes nosocomial infections and antibacterial agent-associated colitis worldwide. Infection and proliferation result in colitis and severe diarrhea and in the most serious cases death. As difficulty in treatment of infectious enteritis caused by CD with the currently available pharmaceutical products, mainly due to the recurrence, has been reported in Japan, new treatment options have been needed. Besides its potent antibacterial activity against CD, due to its narrow antibacterial spectrum, Dafclirminimally disrupts the balance of intestinal flora, and it inhibits spore formation5.

Astellas will further contribute to patients who are suffering from infectious enteritis caused by CD in Japan by launching Dafclir as a new therapeutic option.

Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2019.

https://www.marketscreener.com/ASTELLAS-PHARMA-INC-6491262/news/Astellas-Pharma-Announces-Launch-of-Dafclir-Tablets-for-the-Treatment-of-Infectious-Enteritis-Caus-27284136/

Pfizer, Glaxo, Novo, Novartis plants unfazed by storm; Merck not as lucky

Drug manufacturers were shaking off the remnants of Hurricane Florence on Monday after the dangers from the monstrous storm morphed into hazardous flooding.

GlaxoSmithKline, Pfizer and Novartis and Novo Nordisk all confirmed their manufacturing operations were back online.

GSK said it has reopened and resumed production at its inhaler plant. Our manufacturing plant in Zebulon, North Carolina, reopened Sunday and our commercial campus in Research Triangle Park reopens today, Mary Anne Rhyne, director of corporate communications at GSK, said in an email today.

Neither facility endured any serious damage, but the drugmaker was still hearing from employees who were affected directly, she said. Before the storm, we shared a list of resources with all employees and asked them to stay in touch with their managers so that we could offer support as appropriate.

In a two-sentence statement, Pfizer said today it restarted operations at its sterile injectables plants in North Carolina. Both facilities are operational, and had minimal impact.

Given existing shortages of sterile injectable drugs in the U.S., there was concern about how the supplies might be affected when the New York drugmaker announced plans to suspend production ahead of the storm.

But the company kept essential emergency, utility and monitoring personnel onsite during the storm, allowing it to restart production quickly. Pfizer, ahead of the storm, also had taken steps to avoid interruptions in drug supplies.

Like Pfizer, Novo said its plant was relatively unscathed and was making diabetes medicines. Novo spokeswoman Marisa Sharkey said the company was urging employees to use caution when getting around, because the effects of the storm are still lingering in North Carolina.

Merck & Co., was in a more perilous situation. Spokeswoman Pamela Eisele said Merck facilities in “Wilson, North Carolina and Durham, North Carolina are in areas which are currently affected by flash flooding; however, at this time, no damage is expected to the facilities”

Neither facility is yet operational but cleanup at both had started. Eisele said a facility in Elkton, Virginia, was still operational but the company was keeping watch for flash floods in the area.

While NOAA`s Weather Prediction Center said the storm is now tagged a tropical depression, the death toll climbed to 18. Flooding is now considered the gravest danger, as rivers in the state have turned into dangerous torrents, making travel dangerous in many places.

It is the second time in a year pharma production has been affected by hurricanes after storms wreaked havoc in Puerto Rico last fall. It took months to repair power infrastructure, and keeping fuel flowing to power generators also became an issue.

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-Glaxo-Novo-Novartis-plants-unfazed-by-hurricane-resume-production-Merck-not-as-lucky-27282586/

Astellas Has Positive Results for Phase 3 Chronic Kidney Disease Med Trial

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’) today announced that roxadustat, an inhibitor of hypoxia ¬inducible factor (HIF) prolyl hydroxylase activity, met its primary endpoints in the Phase 3 ALPS study by demonstrating superiority in efficacy versus placebo in terms of both hemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 52¹. The preliminary safety analysis for this trial shows an overall event profile consistent with the results seen in previous roxadustat studies in CKD patients with anemia.

‘The ALPS study adds to the growing body of evidence to support roxadustat as a potential treatment of anemia associated with CKD,’ said Salim Mujais, M.D, senior vice president and global therapeutic area head, Medical Specialties Development, Astellas. ‘This condition can have a debilitating impact on the patients affected, and we look forward to continuing our work to potentially make a new therapeutic option available to the physicians who care for them.’

The ALPS study is the first of three Astellas Phase 3 studies conducted mainly in EMEA to report. The study forms part of a wider large-scale global Phase 3 development program for roxadustat conducted in collaboration with its partner FibroGen, Inc. (NASDAQ: FGEN), and will ultimately support filing and reimbursement in Europe. The ALPS study is a randomized, double-blind, placebo-controlled study of the efficacy and safety of roxadustat for the treatment of anemia in CKD in patients not on dialysis².

Further detailed data from this study are expected to be reported in the future.

https://www.marketscreener.com/ASTELLAS-PHARMA-INC-6491262/news/Astellas-Pharma-Announces-Positive-Topline-Results-for-Global-Phase-3-Trial-of-Roxadustat-in-Chron-27286605/

Nestle to examine ‘strategic options’ for skin health unit

Nestle said on Thursday it was exploring strategic options for its skin health business, saying it believes the unit might be better off outside of the Swiss food maker.

Following a strategic review earlier this year, Nestle’s board decided to increase the company’s focus on food, drinks and nutritional health products.

“The Board has come to the conclusion that the future growth opportunities of Nestle Skin Health lie increasingly outside the Group’s strategic scope,” the Swiss company said. “The Board has therefore decided to explore strategic options for Nestle Skin Health.”

https://www.marketscreener.com/NESTLE-9365334/news/Nestle-to-examine-strategic-options-for-skin-health-unit-27286870/?countview=0

Walmart wants to bring its ‘everyday low prices’ to health care

When most people think about health care, rarely do “discounts” and “low prices” come to mind.

But Walmart is looking to change that.

The retail behemoth, which markets itself as the leader in “Everyday Low Prices,” is beefing up its presence in the health care sector. It inked a deal last month with Anthem, one of the nation’s largest insurers, to entice more Medicare enrollees to buy over-the-counter medications and health supplies at its stores. It recently tapped former Humana executive Sean Slovenski to lead its health and wellness division. And it was reportedly looking to buy PillPack before Amazon purchased the online pharmacy in June.

Walmart (WMT) is one of the latest — and largest — retailers to expand its reach into the fast-growing and lucrative health care arena, which makes up 18% of the nation’s economy and is growing. Amazon is also ramping up its health care offerings, and CVS (CVS) is purchasing Aetna (AET) to expand its services.

Walmart’s moves will help it gain a further foothold in this market and deepen its relationship with its 140 million weekly customers. It comes at a time when the mega-retailer is looking to fend off rivals, including Amazon.

“Because of its strategic importance, we’ve decided to put more focus on our Health & Wellness business in the near term,” Greg Foran, CEO of Walmart US, said when announcing Slovenski’s appointment in July, noting that Slovenski will report directly to him. The company declined to comment for this story.

Already one of the nation’s leading pharmacies, Walmart could look to provide more low-cost health services, including basic medical care through nurse practitioners, physician assistants or even doctors, experts predict.

Big discounters such as Walmart may also offer primary care, nutrition and weight counseling and chronic disease management, said Sam Glick, a partner in Oliver Wyman’s health and life sciences consulting practice. That’s one of the main advantages physical retailers have over their online competitors.

“There’s a certain amount of health that’s about laying hands,” Glick said.

Expanded care was a key motivation behind Walmart’s reported negotiations with Humana (HUM)earlier this year. The two were exploring a variety of options, including Walmart purchasing the health insurer, according to the Wall Street Journal.

What is health care’s allure for Walmart? Medical services typically have higher margins than store products. Since they are often provided in person, there is more opportunity for consumers to pick up other items while visiting the store. And usage is growing, especially as the United States’ population ages.

In particular, Walmart is eyeing both the Medicare and Medicaid markets since many of its customers are senior citizens and lower-income Americans. Its prices are generally lower than at pharmacy chains, such as CVS.

As Walmart expands its health care menu, it builds even more ties with its shoppers. Its deal with Anthem, for instance, lets the insurer’s Medicare Advantage customers use their plan benefits to purchase over-the-counter medicine, first aid supplies, support braces and pain relievers from a store.

And Walmart can market its healthy grocery items to certain Medicare Advantage enrollees since the federal government recently allowed insurers to cover such products as a supplemental benefit. This has given the company another advantage over pharmacy chains, which have much more limited food selections.

Also, the retailer’s locations blanket the nation. Many are in rural areas where there are few other health care options. Walmart often operates as a community center, with customers dropping in a few times a week. And it serves as a one-stop shop, where people could access medical services and pick up whatever other items they need.

“You have thousands of physical locations so the convenience is there,” said Charles O’Shea, a retail analyst at Moody’s.

Plus, Walmart knows its customers. It can attract those with diabetes or heart conditions, for instance, by offering them counseling services or discounts on items they need.

“Consumers of Walmart and other sophisticated retailers will begin to identify them as their trusted health care partner and use them for an increasing range of health care services,” said John Matthews, national strategy leader, healthcare and life sciences at KPMG.

Health care isn’t a new area for Walmart. The Bentonville, Arkansas, company has years of experience providing Health and wellness products, which have accounted for 11% of its merchandise sales in recent years. It’s probably best known for selling several dozen generic prescription drugs for $4 each, a program that launched in 2006.

Customers, many of whom are senior citizens, can also get eye care at roughly 3,000 in-store vision centers and free health screenings at Walmart’s 4,700 locations four times a year. They can receive hands-on help enrolling in Affordable Care Act policies, Medicare Advantage plans and prescription drug plans through the company’s partnership with directhealth.com.

The retailer also dipped a toe in the booming urgent care industry a few years ago and now operates a total of 19 Walmart Care Clinics in Georgia, South Carolina and Texas. Visits cost between $59 and $99, and customers can get routine and urgent care, as well as lab tests and immunizations, from nurse practitioners. But the effort has met with mixed success, experts said, and has not expanded nationwide.

https://money.cnn.com/2018/09/19/news/companies/walmart-health-care/