Dosing underway in Sanofi’s late-stage SAR442168 trial in relapsing MS

The first patient has been enrolled in Sanofi’s (NASDAQ:SNY) Phase 3 clinical trial of partner Principia Biopharma’s (NASDAQ:PRNB) SAR442168 in patients with relapsing multiple sclerosis.

Upon dosing, Principia will be entitled to a $50M milestone payment.

The trial will assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) in 900 participants measured by annualized adjudicated relapse rate in participants with relapsing forms of multiple sclerosis.

Secondary objectives will assess efficacy of SAR442168 compared to teriflunomide on disability progression, MRI lesions, cognitive performance and quality of life.

In late 2017, Principia formed a collaboration with Sanofi under which PRNB granted Sanofi an exclusive, worldwide license to develop and commercialize SAR442168.

https://seekingalpha.com/news/3585230-dosing-underway-in-sanofi-s-late-stage-sar442168-trial-in-relapsing-multiple-sclerosis

Sanofi, Translate Bio expand mRNA vaccine collaboration

Expanding an existing 2018 collaboration on ‘mRNA’ vaccines for infectious diseases, Sanofi (NASDAQ:SNY) is strengthening its pact with Translate Bio (NASDAQ:TBIO) to develop shots for COVID-19 and the flu.

Messenger RNA technology is an alternative approach to conventional vaccines that tries to defeat a pathogen by injecting ribonucleic acid into the body that then teaches cells to identify and attack the virus.

The deal could be valued at as much as $2.3B for Translate Bio, with total upfront payments of $425M and potential future milestones and other payments of up to $1.9B.

https://seekingalpha.com/news/3585229-sanofi-translate-bio-expand-mrna-vaccine-collaboration

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Mylan, after Biogen’s Tecfidera patent loss, faces fork in road on generic laun

Biogen took a major hit last week when a federal court tossed out its patent protections for multiple sclerosis drug Tecfidera. That loss could be Mylan’s gain—but it would require the Pennsylvania generics maker to chance an “at-risk” launch, one analyst says.
While Biogen appeals the West Virginia federal court ruling, Mylan could have a shot at a limited market for its Tecfidera generic—roughly equivalent to around $550 million in annual sales, according to SVB Leerink analyst Ami Fadia.
Mylan would benefit from one of two potential results from Biogen’s patent appeal, which could take as long as 13 months: Either Mylan chooses to launch at risk immediately after an FDA approval, or it chooses to settle with Biogen contingent on a positive appeal, Fadia said in a note to investors Monday.

Choosing to work with Biogen would put Mylan in a “unique position to negotiate” on an expedited generics launch sometime in the late 2021 timeframe, Fadia noted. However, both decisions are complicated by Biogen’s chances at an appeal—which Fadia called “unlikely”—and Mylan could determine that waiting around for a positive ruling would put it in a worse position, with more generics primed for launch.
“We still think that Mylan could potentially settle with Biogen for a favorable exclusivity window if it is able to reach terms that exclude the other generic companies involved in the other Delaware District Court case,” Fadia wrote. “However, this depends on whether the West Virginia decision can get vacated and Biogen would be willing to deal in such terms.”

As Mylan plots its next move, it’s also taking the final, arduous steps of its generics mega-merger with Pfizer’s Upjohn unit—a process that has faced delays thanks to COVID-19.
In April, EU regulators said they had approved the transaction after the pair of drugmakers agreed to sell some Mylan generic drugs across 20 countries in the European Economic Area and the U.K. In a statement, Mylan said the required divestitures are “substantially in line with” the company’s previously stated expectations.
Biogen, meanwhile, is looking at an uncertain future for its $4 billion-per-year blockbuster at a pivotal moment for the drugmaker. Even with patent protection for Tecfidera, Biogen is facing an increasingly competitive MS market with a suite of serious rivals.
In its first year on the market, Roche’s Ocrevus hit blockbuster sales, making it one of the most successful drug launches of the last two years. Novartis is also proving to be a tough competitor with Mayzent, and now it’s gunning for even more of the MS market with ofatumumab, its once-monthly at-home injection.
Biogen’s own Tecfidera follow-up, Vumerity, notched an FDA approval in late 2019, but it’s only snared around 1.3% market share, Piper Sandler analysts said in a Friday note to clients.

Tecfidera’s loss also puts extreme pressure on the success of Alzheimer’s candidate aducanumab, which has had its own rough road in recent years
In May, Biogen said it had wrapped construction on a “state-of-the-art” facility in Solothurn, Switzerland, that will be ready to manufacture aducanumab at scale beginning in mid-2021. However, the drug will need an approval first, and market watchers have been skeptical of its chances.
On an earnings call in April, CEO Michael Vounatsos said Biogen’s aducanumab filing with the FDA had been pushed back to the third quarter from an initial first-quarter forecast. Analysts repeatedly asked about the delay on that call, and Vounatsos said the company is “prioritizing quality of submission versus the timing.” Plus, some members of the company’s executive team came down with COVID-19, also contributing to the delay, R&D chief Al Sandrock said.
Analysts, who had previously anticipated a potential 2020 approval, pushed their expectations out as far as 2022. And they have reason for skepticism: Last March, the candidate flunked a futility analysis before Biogen decided to bring it back six months later for a try at approval.
https://www.fiercepharma.com/marketing/looking-to-capitalize-biogen-s-tecfidera-patent-loss-mylan-faces-a-fork-road-generic

Merck’s next-gen pneumococcal vaccine scores in phase 3 amid race with Pfizer

In the race between two pharma giants in a multibillion-dollar field, Merck Monday posted two trial wins. With the data, the drugmaker is preparing to file its next-gen pneumococcal vaccine candidate, V114, with regulators worldwide.

Merck’s 15-valent vaccine candidate met its objectives in two phase 3 studies in certain patient populations, the New Jersey drugmaker said. One study tested the vaccine candidate in patients 18 and older who are living with HIV, and the other focused on patients 50 and older who also received a quadrivalent flu vaccine.

In the first study, V114 elicited an immune response against all 15 serotypes included in the shot. The second study showed that the vaccine can be given at the same time as a quadrivalent flu vaccine, Merck said.

The tests are only two out of 16 late-stage studies for the vaccine in various patient populations. As the program moves forward, Merck is discussing regulatory filings with authorities in the U.S. and elsewhere.

On the company’s first-quarter conference call earlier this year, R&D head Roger Perlmutter said Merck is “really very enthusiastic about this vaccine because of the important new serotypes in it and also the balance with respect to the immune response that we saw in our V114 studies” in earlier testing.

Meanwhile, Pfizer is also pushing forward with its 20-valent shot, a follow-up to the mega-successful Prevnar 13. The company unveiled positive phase 3 data in March and said it was on track for an FDA filing this year.

Pfizer’s Prevnar 13 pulled in $5.8 billion last year, underscoring the size of the potential market at stake.

https://www.fiercepharma.com/vaccines/merck-posts-phase-3-trial-wins-amid-next-gen-pneumococcal-vaccine-race-pfizer

FDA could approve ‘at least one’ COVID-19 vaccine before election: analyst

About six months into the pandemic and about 130 days until the U.S. presidential election, COVID-19 vaccines are moving ahead at record speeds. Now, a group of analysts predicts “at least one” vaccine will be approved before November 3.

Jefferies healthcare strategist Jared Holz told MarketWatch that “perhaps multiple vaccines” could get FDA authorizations “early in the fourth quarter and quell fears of a second wave of COVID-19.”

The team cited several reasons why an approval, or emergency use authorization, may come before the November election. For one, Trump could push the FDA behind the scenes to issue an approval or emergency authorization. Moderna and AstraZeneca, two vaccine front-runners, have already told the analysts an approval could happen on that timeline, according to the report.

Meanwhile, a vaccine approval might lift the entire industry, rather than just one or two companies, Holz told the publication. If the industry delivers a successful shot, it’d be seen as saving the day amid the pandemic, and that would lift sentiment around all of biopharma. With that lift, there’d be less political pressure to take on drug pricing.

The analysts at Jefferies aren’t the only market watchers who believe vaccines could be approved before the election. In a New York Times op-ed earlier this month, University of Pennsylvania professors Ezekiel Emanuel and Paul Offit warned about a possible “October surprise” in the form of a COVID-19 vaccine approval on political grounds.

FDA commissioner Stephen Hahn, though, said his agency won’t be pressured to approve a shot for political reasons. He told The Guardian that “science and data—not politics—has and will always guide our decision-making, including our work related to vaccines.”

Several vaccines, including those from Moderna and AstraZeneca, are slated for late-stage tests this summer, The Wall Street Journal has reported. Worldwide, about 140 COVID-19 vaccines are in development, and 13 are in human testing, according to the World Health Organization.

https://www.fiercepharma.com/pharma/fiercepharmapolitics-fda-could-approve-at-least-one-covid-19-vaccine-before-election-analyst

Kaiser Permanente Adds Clout To Nonprofit Generic Drug Maker

Kaiser Permanente, the large health insurer and hospital operator, is joining the nonprofit drug company Civica Rx in a key role in the third year of the effort to create lower cost prescriptions that include medicines to treat the coronavirus strain Covid-19.
Civica Rx grabbed headlines two years ago for its work with well-known U.S. hospitals and health systems to buy and develop generic drugs to avoid shortages. Launched in 2018 by three philanthropies and seven hospital systems, Civica now represents more than 1,200 U.S. hospitals via more than 50 member health systems that say they are benefitting from lower cost injectable drugs including antibiotics once in short supply.
In Kaiser Permanente, Civica Rx gets a high-profile name known for both providing and paying for healthcare services. Kaiser will get a board seat on the Civica Rx governing board that is expanding to 11 and includes the original 7 founding hospital systems and the three philanthropies, executives involved said.

“We will greatly value their expertise and input on the board during this urgent time of need,” Civica Rx chief executive officer Martin VanTrieste said of Kaiser Permnanente.
The original seven founding health systems are: CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, the Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health. And the three philanthropies that led the establishment of Civica Rx are Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare.

Financial terms of Kaiser’s involvement weren’t disclosed by CivicaRx, but a Civic Rx spokeswoman confirmed “all Civica members make a one-time financial contribution.”
Kaiser Permanente, which has more than 12 million health plan members, “will provide an important voice in designing Civica’s future strategy,” those involved announced last week. Civica executives said the drug maker is “already delivering 20 essential generic medications, 10 of which are currently being used to treat COVID-19 patients.”
The pandemic figured in Kaiser’s decision to join Civica Rx just as studies are showing some generic drugs may work as treatments against the Coronavirus strain Covid-19.
“At Kaiser Permanente, we know that our members and all Americans need access to affordable medications for emergency care and to support recovery from illness and management of chronic conditions,” Kaiser Permanente Chairman and chief executive officer Greg Adams said in a statement. “The COVID-19 pandemic has put a spotlight on the critical need for ensuring consistent supplies of affordable, generic medications for patients and we are proud to join with Civica Rx to help lead these efforts.”
Kaiser’s decision to be involved is the latest momentum behind Civica Rx.
In January, The Blue Cross Blue Shield Association, a Chicago-based national trade group that represents some of the nation’s biggest health insurance companies, said 18 Blue Cross and Blue Shield companies are spending $55 million to create a new subsidiary of the nonprofit generic drug maker Civica Rx to “acquire and develop abbreviated new drug applications (ANDAs) for select generic drugs.” Kaiser is not involved in a new subsidiary of Civica Rx launched earlier this year with several Blue Cross and Blue Shield plans.
https://www.forbes.com/sites/brucejapsen/2020/06/22/kaiser-permanente-adds-clout-to-nonprofit-generic-drug-maker-civica-rx/#6254bdfa41e3

Analyst Questions Remdesivir’s Ultimate Upside As Study on Inhaled Version Starts

Gilead Sciences, Inc. GILD 2.32% received FDA Emergency Use Authorization for remdesivir in early May as a treatment option for COVID-19 in adults and pediatric patients who are hospitalized with severe disease.
The company has since commenced studies for an inhaled formulation of the drug.
The Gilead Analyst: BofA Securities analyst Geoff Meacham maintained a Neutral rating on Gilead with an $82 price target.
The Gilead Thesis: The news of Gilead kickstarting a Phase 1 study of the inhaled formulation of remdesivir in healthy volunteers this week isn’t surprising, Meacham said in a Monday note. (See his track record here.)
The company hinted in its first-quarter earnings call that it was investigating improved formulations of its IV drug, including subcutaneous and inhaled versions, the analyst said.
Studies of the formulation in COVID-19 patients will be initiated in August, he said.
“Still, we suspect the confirmation of a potential inhaled formulation is likely raising concerns among more bullish investors over the potential impact on pricing.”
Gilead has yet to provide specifics on remdesivir’s price point or its planned business model, Meacham said.
BofA has been estimating a total remdesivir treatment cost of $5,000, factoring in potential price controls.
Some bulls could be pricing based on a cost-savings approach, which Gilead can’t likely charge if there was broad access, the analyst said.
BofA is of the view that an inhaled formulation is less ideal as an oral formulation despite the greater convenience of the former — and its potential to treat earlier stage patients.
The inhaled formulation is to be delivered via nebulizer, limiting widespread availability, Meacham said.
BofA said it continues to have concerns over remdesivir’s ultimate upside for Gilead. The sell-side firm estimates remdesivir sales of $760 million in 2020, $1.5 billion in 2021 and $2.2 billion in 2022, with sales declining rapidly thereafter.
“Thus while Gilead remains on solid footing with its core HIV business—with substantive cash generation—the lack of clear growth drivers keeps us Neutral on shares,” the analyst said.
https://www.benzinga.com/analyst-ratings/analyst-color/20/06/16338182/gilead-analyst-questions-remdesivirs-ultimate-upside-as-study-begins-for-inhaled-ve