Pfizer Rolls Back Recent Price Hikes
Pfizer announced that it would roll back the price increases it had recently implemented. The drug company had raised prices on July , 2018 for approximately 40 drugs, many by more than 9%.
Pfizer’s CEO, Ian Read; Health and Human Services Secretary Alan Azar; and President Trump had a conversation on Monday to discuss the recent price hikes and the President’s drug pricing blueprint named “American Patients First” that was introduced in May as a way to lower drug prices and reduce out-of-pocket costs.
“The company will return these prices to their pre-July 1 levels as soon as technically possible,” the company’s statement said. “The prices will remain in effect until the earlier of when the president’s blueprint goes into effect or the end of the year – whichever is sooner.”
While Pfizer agreed to temporarily halt its July increase, it did not roll back the price hikes it implemented early this year on popular medications like Viagra, Lipitor, Xanax and Chantix.
The list price for Viagra, for example, was $1,846 for 30 pills last year, but then Pfizer raised it 9.44% on January 1 to $2,021. The July 1 hike brought it to $2,211. Tuesday’s move will take it back down to $2,021.
“Pfizer is rolling back price hikes, so American patients don’t pay more,” President Trump tweeted. “We applaud Pfizer for this decision and hope other companies do the same.”
Novartis Freezing Drug Prices
Novartis announced during its second quarter’s earnings call with investors that the company would not raise prices on its products in the United States for the rest of 2018.
Novartis had already raised prices for 75 medications by 2.9% to 9.9% earlier this year. This included increasing the list price of Cosentyx by 6.5%, and its prices on eight other drugs by at least 9%.
The company stated that their management had decided last month that it wouldn’t follow through with the price increases that had been planned for the third quarter, amid escalating outrage over high drug prices.
Novartis’s CEO, Vas Narasimhan, stated “We thought the prudent thing to do was to pull back on any further price increases in 2018 and evaluate as the environment evolves.”
Novartis will instead “chart a course” for pricing in 2019 and beyond, Narasimhan said. Novartis supports reforms to Medicare Part B, the federal 340B drug pricing program, rebates, biosimilar regulations and other proposals under consideration, he added.
Indivior’s Perseris Launch Delayed After Receiving FDA Approval
Indivior received FDA approval for Perseris, an extended-release injectable formula of the antipsychotic risperidone, to treat schizophrenia. The drug is injected just under the skin in a person’s abdomen and the treatment appears to be effective for thirty days in adults.
Indivior had originally planned a fourth quarter launch of the drug but has since stated that it would be delayed.
The delay is due to a U.S. Court of Appeals (CAFC) expediting Dr. Reddy’s Laboratories’ (DRL) appeal against a temporary injunction that keeps its generic Suboxone Film off the market. In July, Indivior obtained that restraining order after DRL won FDA approval for its copycat challenger to Indivior’s key opioid addiction treatment. DRL fought back, and with the expedited appeal, oral arguments will happen in early October.
Indivior stated the following in their press release on Monday. “In light of the CAFC’s decision to grant DRL an expedited appeal, Indivior, as indicated in its H1 2018 results announcement, will now review the appropriate launch timing for Perseris (risperidone) extended-release injection. The Company commits to providing a launch timing as soon as reasonably practicable, but no later than its Q3 2018 results currently scheduled for November 1st.”
Rite Aid and Albertsons Call Off Merger
Drugstore chain Rite Aid and grocer Albertsons announced that they called off their merger deal.
Albertsons, which is privately owned and operates grocery chain Safeway, among others, announced in February a plan to buy Rite Aid’s more than 2,500 drugstores. The combined company would have had approximately 4,900 locations with 4,350 pharmacies and 320 clinics serving more than 40 million customers per week. Most of Albertsons pharmacies were to be renamed Rite Aid.
However, the deal collapsed after key investors and two investor advisory groups, Glass Lewis and Institutional Shareholder Services, voiced opposition. Among the issues was price, with opponents believing Rite Aid shareholders should be receiving more. The deal was said to be worth $24 billion.
Rite Aid cancelled their shareholder meeting to vote on the deal that had been scheduled for Thursday. Both businesses said neither party will be responsible for any payments due to the deal’s termination.
“While we believed in the merits of the combination with Albertsons, we have heard the views expressed by our stockholders and are committed to moving forward and executing our strategic plan as a standalone company,” CEO John Standley said in a company statement regarding the deal’s collapse.
Rite Aid may face significant challenges continuing as a stand-alone company. The drugstore chain has struggled with high debt levels and tough competition.
“The termination of the merger with Albertsons leaves Rite-Aid at a big disadvantage as it neither has the scale nor the balance sheet to compete with much larger and well-capitalized rivals like CVS and Walgreens,” Moodys Vice President Mickey Chadha wrote in an e-mail.
Depomed Rebrands as Assertio Therapeutics
Assertio Therapeutics, a specialty pharmaceutical company, announced that it was changings its corporate name from “Depomed, Inc.” to “Assertio Therapeutics, Inc.”. Additionally, this week, the company completed the relocation of its corporate headquarters from Newark, California to Lake Forest, Illinois.
This follows the company’s decision to sell its licensing rights of the opioid painkiller Nucynta last December to Collegium Pharmaceutical.
“Over the last several years, we have taken strategic actions to transition the Company to focus on our neurology, orphan and specialty medicines,” said Arthur Higgins, President and CEO of Assertio Therapeutics, Inc. “As we’ve transformed, it has become clear that the name Depomed no longer accurately reflects the business we’re in today or the future direction in which we’re headed.”
“Assertio reflects an aspirational mindset consistent with our focus on advancing patient care. It’s a new brand identity that says we’re assertive and decisive when it comes to our mission, vision, values and strategy as well as our commitment to delivering shareholder value. It’s forward thinking and confident, energetic and entrepreneurial. It’s a new name – and a renewed mission to advance patient care in our core areas of neurology, orphan and specialty medicines.”
Walgreens to Supply Kaléo’s Auvi-Q
Walgreens announced that Kaléo’s Auvi-Q, the emergency allergy injector, would be available in its pharmacies nationwide for the first time.
With the new agreement, if a Walgreens pharmacy is unable to provide a patient’s epinepherine injector as written, the pharmacist will work with the patient’s doctor to determine whether Auvi-Q is appropriate. If so, the pharmacist can dispense the injectors. It will be the first time Auvi-Q will be available through pharmacies. Auvi-Q was previously only available to patients through the mail.
Kaléo relaunched its drug last year and the company says it’s now the only epinephrine injector not experiencing manufacturing delays.
Auvi-Q’s list price is $4,500 for two auto-injectors; however, eligible patients with commercial insurance, even those with high deductible plans or whose insurers don’t cover the Auvi-Q, can obtain it at no cost.
People without insurance whose household income is less than $100,000 can obtain the Auvi-Q for free through an assistance program.
“We are working with insurance providers to maximize coverage of Auvi-Q for as many patients as possible,” Phil Rackliffe, general manager of allergy and pediatrics at Kaléo, said in a statement.
“Walgreens pharmacists continue to care for and work with patients and their prescribers to ensure they have access to the epinephrine auto-injectors they need, and we’re pleased to work with Kaléo to help meet the demand for epinephrine auto-injectors across the country,” Walgreens President of Operations Richard Ashworth said in a statement.
DOJ May Soon Approve Healthcare Mergers
A recent Wall Street Journal report suggests that the Justice Department antitrust department is preparing to approve two deals in the health-care industry, CVS Health’s planned acquisition of health insurer Aetna Inc. and Cigna’s planned purchase of Express Scripts.
The report, citing “people familiar with the matter,” suggested that the two transactions could see formal antitrust approval in a few weeks and that regulators are going to require CVS Health to sell assets related to its Medicare drug coverage to quiet anti-competition concerns.
A CVS spokesperson said the company doesn’t “comment on market rumors,” and an Aetna spokesperson said the company had no comment.
The same sources said the Cigna/Express Scripts deal could be approved soon without any asset sales.
“Our combined company will enhance Cigna’s differentiated service-based model, fueled by actionable insights and analytics, to drive innovation and meaningful growth in a highly dynamic market environment. As a result, we will build more effective partnerships, further improve health outcomes and deliver a superior customer experience,” said David Cordani, president and CEO of Cigna stated recently after their shareholders provided approval on the proposed merger with Express Scripts.
Novo Nordisk Recently Introduced an Online Chatbot
Novo Nordisk has recently introduced the first chatbot, named Sophia, built specifically for people with diabetes. Sophia is available on the drugmaker’s Cornerstones4Care website and is presented on the home screen as an “Ask Sophia” tab with a woman’s smiling face.
Once “Ask Sophia” is selected, a dialog box opens with Sophia’s friendly greeting and offer to help. The chatbot directly answers questions and addresses concerns and will forward or redirect questions when it doesn’t know the answer. It also learns through human interactions and will consistently improve over time at addressing questions and needs.
According to Amy West, the senior director overseeing patient marketing and digital health at Novo Nordisk, Sophia has had more than 11,000 conversations and been asked more than 27,000 questions since its launch in April.
Sophia was created after the company noticed spikes in online traffic to its Cornerstones4Care website between 11 p.m. and 1 a.m., reinforcing the need for information outside standard healthcare personnel hours.
“People are looking for information when they have time, which is late at night after the kids are in bed or when they’re not working, and when their treatment team is not available,” West said.
Novo’s Sophia concierge is one of the steps the company is taking to advance technology into artificial intelligence and other areas such as voice assistants as it moves to offer more services to its patients.
GW Pharmaceuticals announced that the DEA had moved Epidiolex (cannabidiol) oral solution from Schedule I to Schedule V which is the DEA’s lowest.
With this decision, the product label for the drug will be finalized and the company can request a Schedule V license to sell it.
In June, the FDA approved Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. It is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).
In three clinical trials covering 516 patients with LGS and Dravet syndrome, Epidiolex plus other antiepileptic medications reduced the frequency of seizures.
“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said Justin Gover, GW’s Chief Executive Officer. “With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA.”
Teva’s A-rated generic to Cialis® (tadalafil – Eli Lilly) was launched in the United States on Sept. 27, 2018.
Cialis is a phosphodiesterase 5 (PDE5) inhibitor indicated for use as a once daily treatment of erectile dysfunction (ED), signs and symptoms of benign prostatic hyperplasia (BPH) and both (ED/BPH). Teva will have 180 days of exclusivity before other companies can launch their generics. IQVIA estimates that U.S. sales of Cialis amounted to over $1.9 billion for the 12-month period ending July 31, 2018.