Thursday, April 4, 2019
Sage seen by sector advisor as ‘good fit’ for Biogen, Dealreporter says
Three sector advisors told Dealreporter that they believe Biogen (BIIB) could restock its development pipeline with late-stage acquisitions in the neuroscience and gene therapy areas. One advisor said that Sage Therapeutics (SAGE) “could be a good fit if Biogen wanted to make a big splash, but said that such large-scale M&A seems unlikely for the company,” Dealreporter said, according to contacts. Sage Therapeutics shares saw a brief spike coincidental with the report from Dealreporter. In late morning trading, Sage shares are up 34c, or 0.2%, to $162.13.
Takeda invites Brazilian pharmaceutical firms to bid for Latam business
Japan’s Takeda Pharmaceutical Co Ltd has invited Brazilian pharmaceutical companies and financial investors to bid for its business in Latin America, three people with knowledge of the matter said.
The investment banking unit of Bank of America Corp is managing the sale and has invited Brazilian pharmaceutical companies Ache Laboratorios Farmaceuticos SA, EMS Pharma, Biolab Farmaceutica SA and Eurofarma Laboratorios SA to bid for the local unit, the sources added, asking for anonymity in discussing private talks.
Financial investors such as private equity firm Advent International Corp have also been invited to participate, one of the sources added.
Advent and Bank of America did not immediately comment on the matter. Biolab, Ache, Eurofarma and EMS declined to comment.
The bid format is not yet defined, as some of the strategic bidders may be interested only in Brazilian operations and others may bid for the whole regional business.
Takeda expects to fetch more than $1 billion for the Latin American operations. In Brazil, Takeda owns popular over the counter drug brands.
Brazilian newspaper Valor Economico reported some of the names of the interested parties on Thursday.
FDA warns on ‘unsubstantiated’ claims about CBD curing cancer, Alzheimer’s
Federal regulators cautioned three companies to stop making their “unsubstantiated advertising claims” on all the alleged benefits of CBD products, ranging from oils to soft gels to gummies.
The joint warning letters from the Food & Drug Administration and the Federal Trade Commission urged the three companies to rethink how they presented their products online and in social media posts. The warning letters were dated March 28, but announced Tuesday.
Outgoing FDA Commissioner Scott Gottlieb said the trio asserted “unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”
According to the letters, the sites made all sorts of claims about serious conditions including Alzheimer’s and cancer. One letter was sent to Relievus, a pain management practice with patients in New Jersey and Pennsylvania. In one statement on the company’s website, which has since been removed, Relievus said “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
The FDA said they made egregious claims about their products’ ability to treat or cure cancer, neurodegenerative conditions, opioid abuse, autoimmune diseases and other diseases.
Ronald Saltiel, Relievus’ chief operating officer, told MarketWatch he took down the link and wanted to follow FDA rules. At the same time, he stressed the practice’s doctors and nurse practitioners were trying to help people cope with pain without using opioids. They’ve had “nothing but positive results” with CBD, Saltiel said.
“We want to be in clinical compliance,” Saltiel said. “We disagree with some of their positions.” He said he was surprised that Relievus got a letter when plenty of other places also offered CBD products. “We’re not unique, trust me, we’re not.”
Requests for comment to the other two companies — Nutra Pure and PotNetwork Holdings — were not immediately returned.
Cannabidiol, or CBD, is a non-intoxicating cannabis derivative. It’s become a booming multi-million dollar business that’s getting mixed into everything from jelly beans to coffee and pet products. The pharmacy giant CVS CVS, +0.81% made news last month when it said it would sell CBD products in about 800 stores, and gym chains including SoulCycle peddle CBD as a pain reliever.
CBD can be found in one FDA-approved drug to treat people with epilepsy, but there’s little scientific evidence to back its support for other things like insomnia, chronic pain, depression and anxiety or, indeed, cancer.
The CBD surge is happening even with the additive in a hazy legal spot.
The 2018 farm bill said hemp was no longer deemed an illegal substance. But the bill said the FDA still had the power to regulate cannabis and its derivatives. Gottlieb said any products claiming CBD therapeutic benefits needed FDA approval for their intended use before going to market.
CBD is a non-intoxicating cannabis derivative. It’s become a booming multi-million dollar business that’s getting mixed into everything from jelly beans to coffee and pet products.
Until that time, Gottlieb said it was “unlawful” to sell food with CBD into interstate commerce, or to market it as a dietary supplement.”
And then there’s the soup of state laws on CBD and marijuana use. More than 30 states have medical marijuana laws in place and roughly 10 of those have legalized full adult marijuana use.
The FDA has previously cautioned other CBD purveyors about their claims, but the three recent letters are the first since the recent farm bill, and are the first time both the FDA and FTC have teamed up to warn about how CBD products are presented to consumers.
Mary Engle, associate director of the FTC’s Advertising Practices Division, said the commission was “always concerned about advertising claims affecting consumers’ health or safety, and is particularly concerned about products purporting to treat serious diseases such as Alzheimer’s and cancer. Regardless of the type of product, marketers must have solid science to back up their claims that a product can improve people’s health. Under FTC law, CBD products are no different.”
The feds aren’t the only government officials grappling with CBD use. New York City health officials have also ordered restaurants not to sell CBD-infused products. Meanwhile, Louisiana officials also recently said that, for the time being, they’ll give citations to retailers selling CBD products. At the same time, a new Maine law will allow CBD’s inclusion in food.
The FDA will hold a May 31 public hearing for more information about CBD.
Paul Armentano, deputy director of NORML, an advocacy group pushing for consumer access to safe, affordable marijuana, noted the FDA has taken action for years on CBD-infused products.
Armentano didn’t comment on the three latest warning letters, but said his organization “has been on record calling for greater regulatory oversight of these mass-marketed products, many of which are entirely unregulated and of varying quality.”
Amazon says Alexa can now handle private patient info
Alexa can now handle your private health information.
Amazon.com Inc. AMZN, -0.40% unveiled new software on Thursday that would allow companies to develop voice tools capable of handling patient information covered under the U.S. Health Insurance Portability and Accountability Act (HIPAA), expanding the e-commerce giant’s reach into the health space.
Amazon said in a Thursday blog post that the software will allow patients to manage a variety of health-care needs at home using voice, whether it’s booking a medical appointment, checking on the status of a prescription delivery or accessing hospital post-discharge instructions.
Although not unexpected, this is a big deal for Seattle-based Amazon. It expands the company’s potential reach into people’s homes and lives and opens the door to Alexa one day taking on a more prominent role in clinical settings.
For now, Amazon’s software is available only through an invite-only program. The tech giant has worked with six companies so far to build HIPAA-compliant voice tools, whose launches were also announced Thursday.
Through Alexa, caregivers of patients of Boston Children’s Hospital can now provide care teams with updates on recovery progress, while also getting information on post-operative follow-up appointments. Cigna Corp. CI, +1.25% used Amazon’s software to build a voice tool to help employees manage health improvement goals, while the company’s pharmacy-benefit manager Express Scripts created a program to allow members to check the status of home delivery prescriptions.
Swedish Health Connect, a network of 51 hospitals in seven states, built a voice program to help patients find a nearby urgent care center and to schedule same-day appointments. Atrium Health, a health-care system with more than 40 hospitals and 900 locations throughout North Carolina, South Carolina and Georgia, launched a similar tool on Thursday.
And Livongo, a digital health startup that helps patients manage chronic health conditions, developed a voice tool that allows patients to ask about their last blood sugar reading and their blood sugar trends. Patients will also get personalized health suggestions from Alexa.
This is just the latest in Amazon’s push into health care. In early 2018, the company announced a joint health-care venture with JPMorgan Chase & Co.JPM, +0.77% and Berkshire Hathaway Inc. BRK.B, +0.12% which recently got a name — Haven. In June, the company acquired online pharmacy PillPack, a move that sent a shudder across stocks of pharmacy chains, drug distributors and pharmacy-benefit managers.
Perrigo pharmaceuticals unit draws several PE bidders, Bloomberg says
Apollo Global (APO), CVC, Carlyle Group (CG), Altaris and Cerberus are said to be among the bidders for Perrigo’s pharmaceuticals unit, which is said to be worth just over $2.5B, according to Bloomberg.
Liquidia up 7% after announcing additional Phase 3 Inspire trial findings
Liquidia Technologies last night announced additional safety and exploratory endpoint findings at the two-month timepoint for the Phase 3 Inspire trial. Nicholas Hill, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine and Inspire Principal Investigator, presented the data at the opening plenary session of the International Society for Heart & Lung Transplantation meeting. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil, as an alternative to current inhaled treprostinil therapy for the treatment of patients with pulmonary arterial hypertension. “The two-month results of the Inspire trial are promising for patients with PAH. Inhaled therapy offers the benefit of getting drug directly to the lungs and we are encouraged that the safety, tolerability and quality of life metrics suggest that LIQ861 is an attractive and more convenient therapy versus the currently available inhaled therapies,” said Dr. Hill. The Inspire trial includes two groups of PAH patients. Most treatment emergent adverse events occurred in the add-on population and were observed mainly during initial exposure to LIQ861 at the 25mcg dose, the company said. “Overall, TEAEs observed were consistent with inhaled prostacyclins and considered mild to moderate, including cough, headache and throat irritation. No serious adverse events related to LIQ861 were observed during the two month period,” it added. Shares of Liquidia Technologies are up 7%, or 72c, to $10.92 in morning trading.
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