Walgreens to tackle health-care costs with Alphabet’s Verily

Walgreens Boots Alliance is teaming with Verily, Alphabet’s life sciences unit, on improving outcomes for patients with chronic conditions, the companies announced.

The partnership would increase access to Verily’s technology by deploying them at Walgreens’ pharmacies. A big focus for the companies will be medication adherence, which costs the U.S. health care system some $100 billion to $289 billion a year. Much of this cost is due to increased hospitalizations for patients who get sick when they don’t take their medication as prescribed.

Walgreens CEO Stefano Pessina said the company is committed to finding more affordable solutions for patients and that forging the right partnerships is part of that effort.

“The continued rise in chronic diseases today can be costly to patients as well as to our healthcare system,” Pessina said in a statement. “Working with Verily, we’ll look at how we can best support integrated and value-based care to meet our patients’ needs, as well as opportunities to address other chronic conditions over time.”

Verily CEO Andrew Conrad said that working with Walgreens provides the health tech company “the opportunity to jointly tackle real-world issues that significantly impact the health of individuals and communities.”

Both Walgreens and competitor CVS Health have mentioned lowering health-care costs for consumers as a priority in recent announcements. While competitor CVS Health pursued this goal through its blockbuster acquisition of insurer Aetna, Walgreens has sought to transform itself through a series of partnerships with companies like insurer Humana and diagnostics company LabCorp.

Similarly, it is the latest signal from Verily’s parent company Alphabet that it intends to ramp up in the health-care space.

In November, Alphabet’s Google hired hospital executive David Feinberg to run its new health division, which is focused on bringing its medical AI research into clinical practice. Verily will not serve under Feinberg, but the two groups are closely aligned. For instance, Verily’s head of engineering Linus Upson is currently the interim CEO of that division, but will be replaced by Feinberg when he joins early next year.

The Walgreens collaboration is the unit’s first known partnership in the pharmacy space.

The companies said that Onduo, Verily’s diabetes company, will work together on a virtual solution for Walgreens employees and their family members. This will be available to those who have been diagnosed with type 2 diabetes. The details on this program are still vague, but the companies said they’d be part of a broader alliance between Verily and Walgreens.

Onduo was created by Verily and pharmaceutical giant Sanofi to roll out what it refers to on its website as a “virtual diabetes clinic.” It offers supplies and coaching to people with diabetes to help them manage their condition.

Verily, which was initially known as Google Life Sciences, works closely with health care companies from Johnson & Johnson to Sanofi on joint ventures ranging in scope from next-generation glucose monitors to surgical robots.

https://www.cnbc.com/2018/12/19/walgreen-to-tackle-health-care-costs-with-alphabets-verily.html

Rite Aid, McKesson agree to terms for pharmaceutical purchasing, distribution

Rite Aid, McKesson agree to terms for pharmaceutical purchasing, distribution  Rite Aid (RAD) and (MCK) announced an agreement to key terms that will continue the companies’ pharmaceutical sourcing and distribution partnership for an additional 10 years. Under these terms, McKesson will continue providing Rite Aid with sourcing and direct-to-store delivery for brand and generic pharmaceutical products through March 2029.

https://thefly.com/landingPageNews.php?id=2839551

G1 Therapeutics falls 24% after topline data from trilaciclib study

Shares of G1 Therapeutics, are down 23.5% or $6.75 per share to $22 per share in after-hours trading. after announcing the Objective response rate, ORR, in its lung cancer study was, placebo: n=6/26, 23.1%; trilaciclib: n=4/30, 13.3%.

https://thefly.com/landingPageNews.php?id=2839601

Daiichi Sankyo starts leukemia combo study

Phase 1 study initiated to evaluate the combination of a FLT3 inhibitor, quizartinib, and an MDM2 inhibitor, milademetan (DS-3032), in patients with relapsed/refractory FLT3-ITD AML or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy

・ Expansion of an ongoing phase 1 study to evaluate the combination of milademetan and 5-azacitidine, an inhibitor of DNA methylation, is also underway in AML and high-risk MDS

・ The AML Franchise of Daiichi Sankyo is evaluating multiple investigational agents as single agents and in combination to further advance the treatment of patients with AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the first patient has been dosed in the first novel-novel combination study evaluating two investigational agents within its AML Franchise. The phase 1 study will evaluate the safety and activity of the combination of a FLT3 inhibitor, quizartinib, and an MDM2 inhibitor, milademetan (DS-3032), in patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy, a very aggressive form of the disease associated with poor prognosis.

‘We have initiated this combination study of quizartinib and milademetan in order to determine the safety and tolerability of the combination and if the addition of the MDM2 inhibitor milademetan may potentially further improve the outcomes of patients with relapsed/refractory FLT3-ITD AML beyond what has been previously reported with single agent quizartinib,’ said Arnaud Lesegretain, Vice President, Oncology R&D and Head, AML Franchise, Daiichi Sankyo. ‘In this study, we also are exploring the potential of the combination of quizartinib and milademetan in patients with newly-diagnosed FLT3-ITD AML who are unfit for intensive chemotherapy. This study is the first of several planned studies that will evaluate the potential of novel combinations within our investigational AML Franchise, as we are committed to continuously improving the standard of care for patients with AML.’

Quizartinib is the first FLT3 inhibitor to demonstrate a survival benefit as an oral, single agent compared to chemotherapy in a randomized, phase 3 study (QuANTUM-R) in patients with FLT3-ITD AML, which was refractory or relapsed within six months of first remission, and single agent milademetan has demonstrated preliminary clinical activity in AML and myelodysplastic syndrome (MDS) in a phase 1 study.^1,2 Additionally, preclinical research has shown that the combination of quizartinib and milademetan has greater activity in FLT3-ITD AML cells compared to the respective single agent treatments.³

In the QuANTUM-R study, the median treatment duration with quizartinib was 4 cycles of 28 days each versus 1 cycle in the salvage chemotherapy arm. Incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib and those who received salvage chemotherapy. The most common adverse drug reactions (>30 percent, any Grade) in patients treated with quizartinib included infections, bleeding, nausea, asthenic conditions, pyrexia, febrile neutropenia and vomiting, and the most common Grade ≥ 3 adverse drug reactions (>20 percent) were infection and febrile neutropenia. The most common laboratory adverse reactions (incidence >50 percent) were decreased white blood cell count, decreased lymphocyte count, decreased hemoglobin, decreased neutrophil count and decreased platelet count. The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program.

In addition to the quizartinib and milademetan combination study, an ongoing phase 1 study of milademetan has been expanded to include evaluation of milademetan in combination with the hypomethylating agent 5-azacitidine, an inhibitor of DNA methylation, in patients with newly-diagnosed AML unfit for intensive chemotherapy, relapsed/refractory AML or high-risk MDS.

https://www.marketscreener.com/DAIICHI-SANKYO-COMPANY-L-6498062/news/Daiichi-Sankyo-Initiates-First-Novel-Novel-Combination-Study-of-Two-Investigational-Agents-within-27778221/

Budweiser maker teams up with Tilray to explore pot drinks

The maker of Budweiser is partnering with medical cannabis company Tilray in a $100 million deal to research cannabis-infused drinks for the Canadian market.

Anheuser-Busch InBev and Tilray Inc. said each would invest $50 million in the project announced Wednesday. The companies will study non-alcoholic drinks containing cannabidiol, or CBD, which some claim has calming and healing affects, and THC, the cannabis compound known for its psychoactive effects.

Canada legalized recreational marijuana in October, leading to a surge in interest from beer and tobacco companies looking to invest in the market.

British Columbia-based Tilray Inc. has products available in 12 countries. Belgium-based AB InBev is the owner of hundreds of beer brands including Budweiser and Stella Artois.

https://www.marketscreener.com/TILRAY-INC-44995241/news/Tilray-Budweiser-maker-teams-up-with-Tilray-to-explore-pot-drinks-27778035/

Reuters: Big Pharma returning to U.S. price hikes in January after pause

Novartis and Bayer are among nearly 30 drugmakers that have taken steps to raise the U.S. prices of their medicines in January, ending a self-declared halt to increases made by a pharma industry under pressure from the Trump administration, according to documents seen by Reuters.

Other drugmakers set to raise prices at the start of 2019 include Allergan Plc, GlaxoSmithKline Plc, Amgen Inc, AstraZeneca Plc and Biogen Inc, the documents show.

The hikes will pose a new challenge to President Donald Trump’s pledge to lower the costs of prescription medications in the world’s most expensive pharmaceutical market.

The U.S. Department of Health and Human Services (HHS) has proposed a slew of policies aimed at lowering prices and passing more of the discounts negotiated by health insurers on to patients. Those measures are not expected to provide relief to consumers in the short-term, however, and fall short of giving government health agencies direct authority to negotiate or regulate drug prices.

Twenty-eight drugmakers filed notifications with California agencies in early November disclosing that they planned to raise prices in 60 days or longer. Under a state law passed last year, companies are required to notify payers in California if they intend to raise the U.S. list price on any drug by more than 16 percent over a two-year period.

The details were provided to Reuters in response to a public records request to California Correctional Health Care Services, which provides healthcare services to the state’s corrections department. The department spends more than $3 billion annually on drugs for inmates, more than any other state.

“Requests and public shaming haven’t worked” to lower drug prices, said Michael Rea, chief executive of RX Savings Solutions, which helps health plans and employers seek lower cost prescription medicines. “We expect the number of 2019 increases to be even greater than in past years.”

Pfizer Inc rolled back planned price increases in July after President Trump said in a tweet that the drugmaker “should be ashamed” and that his administration would respond to the hikes.

Pfizer said it would defer hikes until January 2019 to support the administration as it pursued its new pricing policies. Pfizer’s move prompted many of its industry peers, including Bayer, Novartis, Allergan, AstraZeneca and Amgen, to follow suit.

Drug price increases implemented by the 20 biggest drugmakers did slow down during the second half of 2018, with those companies raising prices on just over half the number of drugs as in 2017, according to data compiled by consultancy RX Savings Solutions.

Pfizer has already announced plans to hike prices on 41 of its drugs in mid-January.

60-DAY NOTICE

The California corrections department documents indicate that the companies plan to increase prices as early as Jan. 1. Most do not detail for which drugs or by how much, but specific details were given in the case of Novartis and Bayer.

Novartis is planning to raise prices on more than 100 indications of over 30 different drugs in January, the documents show, with increases ranging from 4.5 percent to 9.9 percent. Drugs on the list are expected to account for more than $20 billion of Novartis’ revenue this year and include multiple sclerosis drug Gilenya, psoriatic arthritis treatment Cosentyx, and leukemia treatment Tasigna.

The list also includes Diovan, the brand name version of blood pressure treatment valsartan, generic versions of which are currently in shortage after a potential carcinogen was detected in active ingredients made in China, prompting widespread recalls.

Novartis spokesman Eric Althoff said the company plans to raise U.S. list prices on 14 percent of the medicines it sells in the country in 2019, for an average increase of 4.7 percent on those drugs.

“Our rebates and discounts, however, continue to grow even faster,” Althoff said. As a result, the company expects a net price decrease of nearly 5 percent across the whole U.S. portfolio, he said.

Over the last three years, net price decreases for its U.S. business have ranged from 2 percent to 2.6 percent, the company said.

Bayer filed notifications with California agencies to increase prices on six of its drugs in January, many of which are birth control products. Most of these price increases are 5 percent.

Bayer said that the U.S. wholesale price of its products are not representative of what most consumers pay and that “list price increases are expected to be offset by higher rebates and discounts paid to insurance companies and pharmacy benefit managers.”

Amgen did not respond to requests for comment. AstraZeneca and Biogen declined to comment for this story.

GSK would not give details about its specific price increases, which are set to take effect on or around Jan. 1 and could change before then. Allergan said that all of its price increases will be aligned with its pledge made in 2016 to limit drug price increases on its products to less than 10 percent annually.

The United States, which leaves drug pricing to market competition, has higher drug prices than in other countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.

Lowering prescription drug prices was a top priority in Republican Trump’s 2016 presidential campaign. Rival Democrats are expected to step up congressional scrutiny of drug price hikes next year after gaining control of the U.S. House of Representatives in elections in November.

“Drug companies raising their prices and offsetting them with higher rebates benefits everyone but the consumer,” HHS spokeswoman Caitlin Oakley said in a statement.

Trump and HHS Secretary Alex Azar “remain committed to lowering drug prices and reducing out of pocket costs, and will continue to take bold action to restructure this broken market,” she said.

https://www.marketscreener.com/ALLERGAN-PLC-22497284/news/Exclusive-Big-Pharma-returning-to-U-S-price-hikes-in-January-after-pause-27778173/

Clearside Biomedical submits Xipere NDA to FDA

Clearside Biomedical announced that it has submitted a new drug application, or NDA, for Xipere to the FDA for the treatment of macular edema associated with uveitis. The uveitis market is expected to grow by 2024 to nearly $550M in the United States and over $1B globally. Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss worldwide, affecting approximately 350,000 patients in the United States and more than 1M worldwide. If approved by the FDA, XIPERE would be the first therapy for macular edema associated with uveitis.
https://thefly.com/landingPageNews.php?id=2839535