Gilead Sciences (NASDAQ:GILD): Q2 Non-GAAP EPS of $1.82 beats by $0.11; GAAP EPS of $1.47 beats by $0.15.
Revenue of $5.69B (+0.7% Y/Y) beats by $150M.
Tuesday, July 30, 2019
DaVita: Home Care Delivery Improves the Quality of Life for More Kidney Patients
DaVita Kidney Care, a leading provider of kidney care services in the United States, announced today that growth of its peritoneal dialysis and home hemodialysis programs is four times the growth rate of in-center treatment options.* This comes on the heels of DaVita’s success with its new Home Remote Monitoring program that allows patients to consistently share clinical information with their care team. The company’s home growth rate is also a testament to the engagement and support for appropriate home dialysis among its physician leaders.
“This is a transformational time in U.S. health care—one where the consideration and acceptance of home-based treatments is higher than I’ve seen in the 30 years I’ve been part of the medical community,” said Dr. Martin Schreiber, chief medical officer for Home Dialysis at DaVita Kidney Care. “Patient choice has always been at the center of everything we do, and greater consideration for home dialysis is now being met with greater physician engagement, intuitive education and support programs to enable more patients to choose home treatments when appropriate.”
DaVita is the largest provider of home dialysis therapy in the U.S. and continues to invest in patient-centered solutions, including technology and education, to improve patient experience and outcomes while its home dialysis program has grown.
Home Dialysis Connect™, for example, is a suite of technology innovations designed to improve the care experience and outcomes for patients on home dialysis. In 2018 alone, more than 13,000 patients have been impacted. Home Dialysis Connect features the following components:
- Home Remote Monitoring (HRM) uses Bluetooth-enabled devices to transmit vital patient data, which is risk-stratified and helps clinicians stay on top of potential outcome-impacting events for patients. Since its inception, 13,000 DaVita home dialysis patients have transmitted over 2 million data points to their care team, helping their team better manage their care and keep them on their home modality of choice.
- Telehealth platform allows patients to schedule and participate in virtual appointments with their care team, instead of traveling to a center.
- DaVita Care Connect is a mobile patient application that supports multi-way video visits, customized education, reminders, secure texting and image sharing—allowing consistent access to their care team.
- Artificial Intelligence (AI)/Predictive Analytics. DaVita uses AI and predictive analytics built with the largest home dialysis data set in the U.S. and consisting of millions of clinical notes to help identify patients who are at higher risk of hospitalization events, which often lead patients to leave peritoneal dialysis therapy. Predictions are built into center work flows, allowing nurses and care teams to intervene when necessary to help avoid hospitalizations and keep patients on their home modality of choice.
- Health Management Navigator is a series of online interactive courses designed to train nurses to become comprehensive health managers for patients with diabetes, cardiovascular disease and hypertension. This helps DaVita care teams deliver the right interventions at the right time based on each patient’s unique clinical needs while they treat at home.
2 powerful Canadian provinces argued against federal drug price crackdown
Canada’s two most populous provinces, Ontario and Quebec, have privately expressed concerns with a federal government plan to slash the price of patented drugs, arguing that such regulatory changes could hurt investment in life sciences.
The Canadian government has said it plans to soon publish a final version of new regulations aimed at cutting patented drug prices that are among the highest in the world. Announced in 2017, the changes were expected to take effect in January, but the government delayed them to review feedback.
With an election set for October, time is running out.
The previously unreported opposition from two provinces that are home to more than 60% of Canada’s population, seen in letters obtained by Reuters, shows the political risk of taking on the pharmaceutical industry and overhauling the nation’s drug-pricing system, a complex process that involves many governments and organizations.
Other provinces, including British Columbia, support the plan, and the federal government said it “remains committed to improving the access and affordability of prescription drugs”.
Quebec, in its April letter, said it favoured negotiating lower drug prices but feared the plan to require drug companies to disclose discounts could make that more difficult.
“There is a fear that drugmakers would be more reluctant to offer discounts to the provincial and territorial governments in the event where they would need to share this information,” it wrote.
The federal regulations would give new powers to the Patented Medicine Prices Review Board, a national agency that sets maximum prices. Draft rules would change the countries it compares Canadian prices to, dropping the United States where they are highest, and would let the agency consider the cost-effectiveness of new medicines.
The draft drew criticism from global drugmakers https://www.reuters.com/article/us-canada-pharmaceuticals-pricing-exclus/exclusive-facing-crackdown-in-canada-drugmakers-offered-billions-in-price-cuts-idUSKCN1PV0DH, including Johnson & Johnson, Merck & Co and Amgen Inc, and intense lobbying from industry and patient groups which fear the changes could delay drug development.
The letter from Ontario’s Conservative government, led by right-wing populist Doug Ford, echoed a key industry talking point on the proposal.
“While we share the federal government’s objective to provide Canadians with affordable medicines, we are concerned that the regulations, as proposed, could result in delayed access to innovative medicine and longer wait times for patients,” reads the letter, sent in February.
LOBBYING
An Ernst & Young study commissioned by pharmaceutical lobby group Innovative Medicines Canada argued that new drugs tend to be launched later in some countries with strict price controls than in the United States or Canada.
“Lobbying played no role in the government’s decision to send this letter, which was intended to encourage the federal government to continue consultations,” said Ontario’s health ministry in an emailed statement.
Many countries with lower prices have more pharmaceutical industry investment, and access to drugs that is as good or better than Canada, the federal government said in its statement.
“There is no direct relationship between high drug prices, access to medicines, and investment in pharmaceutical research and development,” it said.
Asked about the letter, Alexandre Lahaie, press aide for Quebec Health Minister Danielle McCann, said the government’s priority was getting Quebecers access to the best medications and therapies.
Quebec elected the centre-right Coalition Avenir Quebec last October.
Both provinces will be crucial to Liberal Prime Minister Justin Trudeau’s re-election campaign; the rival Conservative Party of Canada tends to be strongest in western Canada.
Ontario’s letter said the life sciences employ about 83,000 people and contribute C$38.5 billion ($29.2 billion) to the province’s gross domestic product. Quebec noted it was aiming to lure C$4 billion in private life sciences investment by 2022.
Other provinces were more positive. Manitoba said it was “supportive” of the PMPRB’s work, and Saskatchewan said it “generally supports the changes.”
Alberta said in a statement it “supports the goal of reducing drug costs so that savings can be reinvested in frontline services and patient care.”
“These reforms are foundational to increasing patient access and we strongly encourage the Federal Government to implement them in the best interest of all Canadians,” British Columbia’s Ministry of Health said in a statement.
BC’s health minister said the ministry had written to the federal government in February to say it “strongly supports the modernization of the PMPRB.”
Ligand Pharma down 11% on pipeline concerns
Thinly traded Ligand Pharmaceuticals (LGND -10.7%) slumps on more than double normal volume, albeit on turnover of only 867K shares, following its Q2 earnings release and conference call earlier today.
Results were above expectations although revenues were down 72% and net loss widened.
Management apparently spooked investors during the call after stating that development of RVT-1502 for diabetes is unlikely to continue considering the FDA’s requirements for preclinical and clinical data for glucagon receptor antagonists aimed at long-term use.
The company also updated on its OmniAb platform, saying that over 35 partners are conducting over 170 discovery campaigns but added that not all signed contracts are active, including Celgene in light of the Bristol-Myers Squibb merger.
Previously: Ligand Pharmaceuticals EPS beats by $0.02, beats on revenue(July 30)
Trump readies plan allow drug imports from Canada
In an interview with CNBC, Health Secretary Alex Azar revealed that the Trump administration is working on a plan that would allow the U.S. to import medicines from Canada, but offered no additional details as to how the plan would work.
The drugs industry will surely oppose the initiative.
Biogen and Alkermes’ New MS Drug has Fewer GI Side Effects than Tecifidera
Biogen, headquartered in Cambridge, Massachusetts, and Alkermes, based in Dublin, announced positive topline data from EVOLVE-MS-2, a Phase III trial of diroximel fumarate for relapsing-remitting multiple sclerosis (RRMS) compared to Tecfidera (dimethyl fumarate).
Biogen and Alkermes inked a global license and collaboration deal in 2017 to develop and commercialize ALKS 8700 for relapsing forms of multiple sclerosis (MS).
ALKS 8700, diroximel fumarate, is a novel, oral, monomethyl fumarate (MMF) small molecule. Under the deal, Biogen received exclusive, worldwide license to commercialize ALKS 8700. Biogen will pay Alkermes mid-teen royalties on worldwide net sales. Biogen also paid Alkermes 50% of the 2017 ALKS 8700 development costs, and an upfront payment of $28 million, which represented Biogen’s share of development expenses incurred in 2017.
Starting Jan 1., 2018, Biogen took over the development expenses, with Alkermes eligible for a maximum aggregate of $200 million in milestones.
In the trial, diroximel fumarate was statistically superior to Tecfidera and patients receiving diroximel fumarate reported significantly fewer days of gastrointestinal symptoms. The most common adverse events for both treatment groups were flushing, diarrhea and nausea. Overall percentage of patients with AEs causing discontinuation were 1.6% for diroximel fumarate and 6% for Tecfidera.
“As part of our leadership in multiple sclerosis, Biogen has long understood that the disease differs from person to person, as well as throughout the course of the disease,” stated Michael Ehlers, executive vice president, Research & Development, at Biogen. “We are committed to offering a range of options to patients to meet their needs. These data build on the foundation we have created with Tecfidera, the most prescribed oral MS therapy worldwide, and further demonstrate the potential of diroximel fumarate as a novel oral fumarate within our MS portfolio.”
The EVOLVE-MS-2 Phase III trial ran for five weeks and was designed to evaluate the GI tolerability of diroximel fumarate 462 mg twice a day compared to Tecfidera 240 mg twice daily in 506 patients with RRMS.
EVOLVE-MS-2 is part of the EVOLVE-MS diroximel fumarate development program, which is being run by both Alkermes and Biogen. Diroximel fumarate is currently being reviewed by the U.S. Food and Drug Administration (FDA) with a target action date in the fourth quarter of this year. Biogen plans to market the drug under the name Vumerity.
“With a chronic disease like MS, interrupting or stopping treatment due to GI side effects can often provoke the return of disease activity,” stated Robert Naismith, professor of neurology, Washington University School of Medicine in St. Louis. “Physicians and patients should work together to choose a medication that provides the right balance of efficacy, safety and tolerability to help manage patients’ MS and meet their treatment goals. These topline results suggest that diroximel fumarate offers a differentiated GI tolerability profile and may represent an important new option for people living with relapsing MS.”
The EVOLVE-MS program includes the EVOLVE-MS-1 trial, a Phase III, open-label, two-year safety trial, and EVOLVE-MS-2, a Phase III, five-week trial to evaluate GI tolerability.
Zogenix Prepares for Second Shot at Seizure Drug Submission
Back in April 2019, Emeryville, California-based Zogenix received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome. There were two issues the agency had. First, the FDA wanted the inclusion of two animal studies to evaluate whether the drug caused thickening of the heart valve. The second was more of a goof—the contract research organization Zogenix employed uploaded the wrong data set for the application.
Now the company is on the cusp of resubmitting, with hopes of getting the drug approved in the first quarter of 2020.
Dravet syndrome, also called Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare, lifelong type of epilepsy that starts in the first year of life with frequent and often prolonged seizures. It affects about one in 15,700 people. About 80% of Dravet patients have a mutation in their SCN1A gene. In addition to related symptoms, patients have a 15 to 20% mortality rate from SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections.
Fintepla at one time was on the market as Pondimin on its own and with phentermine as Fen-Phen, for appetite suppression and obesity. However, the drug was pulled off the market in the 1990s because of the thickening of the heart valve.
Zogeniz picked up the drug in 2015 after two Belgian researchers ran studies of the drug for seizures. Zogenix reformulated the drug as a low-dose, twice-a-day oral drug. In human trials, there have been no signs of the heart valve problems, but it did decrease the number of seizures by half in 70% of patients, and completely eliminated them in a portion of the trial population. Some of the children in the trial had an average of 40 seizures a day, many lasting two to four minutes.
Of the first issue with the trial, Stephen Farr, Zogenix’ chief executive officer, told the San Francisco Business Times, “It’s puzzling why studies in rats and dogs would provide more information than we already had.” But they will include the animal studies in the resubmission.
In terms of the wrong data set, Farr told the San Francisco Business Times, “On the surface, it’s an easy thing to rectify—you upload the right data set.” But the company wanted to make sure it didn’t happen again and took time to implement procedures that would prevent it from occurring.
Meanwhile, the company has had a turbulent ride. It originally focused on opioid-based painkillers, moving away from that controversial area to focus on Dravet syndrome. In 2017, it reported positive top-line data from its Phase III trial of Fintepla, causing its stock to rocket 172% in a single day. But when the FDA issued its RTF letter in April, shares plunged more than 20%. It has mostly recovered since, closing yesterday at $48.18 per share, an increase of more than $10 over its start at the beginning of the year.
The delay could be a challenge, however, even if the FDA approves Fintepla and it launches in 2020. In November 2018, London, UK and Carlsbad, California-based GW Pharmaceuticals launched its Epidiolex (cannabidiol) for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in the U.S. It was approved by the FDA on June 25, 2018, but because it was the first prescription formulation of highly purified, plant-derived cannabidiol (CBD), a form of cannabis that does not have the chemicals in it that produce the “high” associated with marijuana, it took some work with the U.S. Drug Enforcement Agency (DEA) to get appropriate classification for the U.S. market.
In August 2018, the FDA approved Gentilly, France-based Biocodex’ Diacomit (stiripentol) for seizures associated with Dravet syndrome.
But Zogenix has high hopes that it can get the drug approved and find a place in the mix of treatments.
“Children have been seizure-free for almost three years,” Farr told the San Francisco Business Times. “That’s almost unheard of.”
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