Amazon Reportedly Seeking Old Sears Spaces For Whole Foods Expansion

Sears and Amazon are each symbols of the changing retail market in the past decade, and their divergent stories might become even more intertwined.

Amazon is investigating vacated Sears locations to convert into Whole Foods Markets, Yahoo Finance reports. Amazon recently announced its intention to carry out a nationwide expansion of the grocery store chain it acquired for $13B in 2017.

For the entirety of its existence to this point, Whole Foods has primarily focused on major cities and their suburbs, but Amazon indicated a desire to enter new markets to access more customers with its online grocery delivery service, Amazon Prime Now. While the chain has gained customers per store since its acquisition, it has not added many locations and lags far behind industry leaders Kroger and Walmart in that area.

Sears Holdings hangs on by a thread after years of losses and ballooning debt, as Chairman and former CEO Eddie Lampert fights to keep its last 425 locations open through its bankruptcy proceedings. Sears has closed hundreds of stores in the past few years to cut costs, trimming its least profitable locations first. That has often been in rural and tertiary markets, where it is the most difficult to find takers for the 100K-plus SF footprints left vacant.

Though Amazon has not confirmed the strategy publicly, the significant overlap between shuttered Sears or Kmart locations and areas that Amazon is looking to enter makes it a likelihood that at least a handful of Whole Foods stores could wind up backfilling those locations. Adding to that likelihood is the possible distressed nature of the property, which Amazon believes could mean a discount on rent, Yahoo reports.

https://www.bisnow.com/national/news/retail/amazon-taking-sears-spaces-whole-foods-expansion-96674

Abbott: FDA OKs Device for Preemie Heart Opening Treatment

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo™ Occluder, the world’s first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.

One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus’ body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10 percent of all congenital heart disease.⁴

Approximately 60,000 premature babies in the U.S. are born each year with a very low birth weight⁵, and nearly 12,000 (one out of five) of these have a hemodynamically significant PDA –a PDA that is large and causes symptoms – which will require urgent treatment for the baby to survive.^6,7

“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, M.D., director of the Congenital Heart Program at Cedars-Sinai’s Smidt Heart Institute, and principal investigator for the study that led to FDA approval.

The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. It is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement. Because the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure.

https://www.biospace.com/article/releases/fda-approves-world-s-first-device-for-treatment-of-premature-babies-and-newborns-with-an-opening-in-their-hearts-a-common-congenital-defect-/

Leap: Advanced Prostate Cancer Therapy Investigator-Initiated Study Started

Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the Perlmutter Cancer Center at NYU Langone Health to study DKN-01, as a monotherapy and in combination with docetaxel in patients with advanced prostate cancer. This clinical trial is specifically targeting a biomarker-selected patient population in metastatic castration-resistant prostate cancer (mCRPC) with elevated Dickkopf-1 (DKK1) levels.

“DKK1 can promote prostate cancer growth through suppressing the anti-tumor immune response. We have discovered that DKK1 is upregulated in the substantial portion of advanced prostate cancers that lack expression of androgen receptor,” commented Dr. Wise. “Patients with this type of  prostate cancer have a very poor prognosis and may benefit from this new immunotherapy strategy targeting DKK1 therapy with DKN-01.”

“An important part of our DKN-01 development strategy is to target biomarker-selected patient populations,” said Cynthia Sirard, M.D., Vice President, Clinical Development of Leap Therapeutics. “In our esophagogastric cancer study, we have identified DKK1 levels measured by RNAScope as a potential predictor of response to DKN-01-based therapy. We are looking forward to treating mCRPC patients with elevated DKK1 levels in this study, building on our and Dr. Wise’s work.”

The study is expected to begin enrolling patients in the first quarter of 2019.  mCRPC patients who have progressed on one or more androgen receptor (AR) therapies (Xtandi or Zytiga) will be screened for DKK1 elevation in their plasma or in a tumor sample. Up to 97 patients will be enrolled in a dose-escalation and then dose expansion cohorts. DKK1+ mCRPC patients who have not received prior taxane chemotherapies will be treated with DKN-01 and docetaxel. DKN-01 will be given as a monotherapy to DKK1+ mCRPC patients who have progressed on or refused docetaxel treatment.

https://www.biospace.com/article/releases/leap-therapeutics-announces-an-investigator-initiated-study-of-dkn-01-in-patients-with-dkk1-advanced-prostate-cancer/

FDA Gives Amneal’s Generic Alzheimer’s & Parkinson’s Patch a Thumbs-Up

The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.

The two companies were involved in patent litigation over the Exelon Patch in 2015 and 2016, but the two companies worked out a deal in October 2016. Shortly afterward, in November 2016, there were rumors that Novartis was considering acquiring Amneal for about $8 billion. This would have expanded Novartis’ Sandoz unit, which, like Amneal, focuses on generics. However, the deal never happened.

The generic patch comes in three different doses, 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. U.S. annual market for the 12 months ended November 2018 was estimated by IQVIA to be $225 million.

“We are pleased to receive approval on the company’s first transdermal product, which demonstrates our commitment to develop and bring to market complex generic products,” stated Rob Stewart, president and chief executive officer of Amneal. “Our diverse pipeline of approximately 220 products is expected to deliver additional complex product approvals this year and help us achieve our goal of launching up to 50 generic products in 2019.”

https://www.biospace.com/article/fda-gives-amneal-pharma-s-generic-alzheimer-s-and-parkinson-s-patch-a-thumbs-up/

GlaxoSmithKline downgraded to Neutral from Outperform at Exane BNP Paribas

https://thefly.com/landingPageNews.php?id=2847851

Verona Pharma to host conference call

Conference call to discuss top-line data from three-day Phase 2 clinical pharmacology trial evaluating the effect of two different doses of nebulized ensifentrine will be held on January 14 at 8 am.

Webcast: https://investors.veronapharma.com/events-and-presentations/events
https://thefly.com/landingPageNews.php?id=2847923

Aurora Cannabis to acquire Whistler in transaction valued at about $175M

Aurora Cannabis announced that the company has entered into a letter of intent to acquire all the issued and outstanding shares of privately held Whistler Medical Marijuana Corporation in an all-share transaction valued at up to approximately $175M, including certain milestone payments. The all-share transaction includes certain milestone payments in relation to Whistler achieving certain operational objectives. Including these milestone payments, the all-share transaction values Whistler at up to $175M. The closing of the transaction is subject to customary closing conditions, including execution of definitive documentation, completion of satisfactory due diligence, receipt of approval of the shareholders of Whistler, and receipt of applicable third party and regulatory approvals and the satisfaction of other conditions customary in transactions of this nature.

https://thefly.com/landingPageNews.php?id=2847961