FDA OKs Aimmune’s peanut allergy drug

Aimmune Therapeutics (NASDAQ:AIMT) +21.7% after-hours on news the Food and Drug Administration approved its Palforzia drug for patients with peanut allergies.

The oral medication is indicated for the mitigation of allergic reactions, including anaphylaxis, that occur with accidental exposure to peanuts, but it is not an emergency treatment of the reactions, the company says.

Aimmune says Palforzia is the first FDA-approved therapy for peanut allergy or for any food allergy.

Peanut allergies affect more than 1.6M children and teens in the U.S. alone.

https://seekingalpha.com/news/3537073-fda-oks-aimmunes-peanut-allergy-drug

Biogen gears up for Alzheimer’s drug launch

There are serious doubts about whether the FDA will approve Biogen’s Alzheimer’s candidate aducanumab – but is gearing up to file it with the regulator and is already looking ahead to a potential launch.
Chief executive officer Michel Vounatsos said that the company plan to file its dossier of clinical evidence for aducanumab with the FDA “as soon as possible” in a conference call with analysts as the troubled pharma announced its full year results.
The dry figures on display belie the drama that unfolded in 2019. In March, Biogen axed phase 3 development of aducanumab after deciding that it wasn’t working, only to stun markets in October by announcing plans for a filing after seeing what looks like a beneficial effect in certain patients at a high dose.
Earlier this week, the FDA even approved a re-dosing study for Alzheimer’s patients formerly enrolled on the abandoned trials, and could start receiving the drug again as early as March.
Meanwhile, Biogen is remaining coy about exactly when it plans to file its dossier with the FDA, although the company is already gearing up in case the regulator gives a positive decision.

Cited by Reuters, Vounatsos said: “We are actively preparing for the potential launch of aducanumab with an initial focus on the United States.”
Alfred Sandrock, executive vice president of research and development said the company has had a “high level of constructive engagement” with the FDA, adding that “it’s basically a matter of putting together documentation”.
The company is already factoring in launch costs in its guidance for 2020, saying it expects to spend up to 20.5% of total revenue as it ramps up its sales force to market the drug.
After a filing, the medical community and investors will get a strong indication about whether aducanumab is approvable if the FDA convenes a meeting of its expert advisors, which is highly likely in the case of a novel drug.
Any new drug for Alzheimer’s would be a major achievement as there has been nothing new to hit the market since 2003, and available treatments only help manage symptoms instead of slowing or halting progression.
If aducanumab is approved, it will be in the nick of time for Biogen, which could see its blockbuster multiple sclerosis pill Tecfidera face generic competition for the first time this year.
A key decision in a patent dispute is expected this week but in the meantime sales grew in Q4, and were up 5% to $1.2 billion.
Biogen has just launched a follow-up drug to Tecfidera called Vumerity, which is less likely to produce the gastrointestinal side-effects that cause some patients to quit.
After a launch in October it’s too early to say whether Vumerity has been a success with sales of just $5 million – but Vounatsos said it has had positive reception from health insurers.
Competition is tough though with Novartis’ Mayzent and Merck KGaA’s Mavenclad among recent MS launches.
Biogen said Q4 sales were up 4% compared with the same period last year, and total revenues grew 17% to $14.4 billion.

Biogen gears up for Alzheimer’s drug launch

University of Pennsylvania researchers nab grant for CAR-T prostate cancer test

The University of Pennsylvania, which has helped pioneer cell therapy approaches to blood cancers, has nabbed an ACGT grant to help battle solid tumors.
The research team has been handed a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT), and follows on from the 2004 grant it gave Penn’s Carl June, M.D., one of the predominate scientists involved in CAR-T research.
His work helped pave the work for this type of cell therapy to halt a number of blood cancers, but the latest grant is geared toward its next-gen work: Solid tumors. This has proven a much harder nut to crack for CAR-T, but the Penn U. scientists are hoping this grant will help them on their way.

The ACGT grant was awarded to Joseph Fraietta, Ph. D, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, M.D., director of the Prostate and Kidney Cancer Program, associate professor of medicine.
“The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy,” the University said in a statement.

Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.
“The grant from ACGT will help us advance our clinical work in a very novel way,” said Dr. Fraietta. “If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer.”
Both Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality.
“For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy,” said Honeycutt. “Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise.”
https://www.fiercebiotech.com/biotech/university-pennsylvania-researchers-nab-grant-for-car-t-prostate-cancer-test

No kickback: Novartis Kymriah travel assistance program gets nod from HHS

Normally, a pharma company paying a patient to take its drug looks suspicious—like a kickback—and it’s considered so under federal law. But HHS has just made a special ruling for a novel therapy.
The federal health agency now allows Novartis to pay for travel, lodging, meals and other out-of-pocket expenses for Medicare and Medicaid patients taking its CAR-T therapy Kymriah, the department’s Office of Inspector General said in an advisory opinion (PDF).
The so-called Kymriah Travel Assistance Program assists “eligible low-income patients” with expenses incurred during their travel to receive the drug—and the ensuing post-infusion monitoring phase—at one of some 100 designated treatment centers across the U.S. under an FDA-required safety program.

HHS issued the ruling at the special request of Novartis because otherwise the scheme could be punishable under anti-kickback statue of the Social Security Act. Generally, federal regulators view that these payments could unfairly steer patients to a particular drug and result in increased costs to the federal health system. But Novartis managed to persuade them.
In making the request, Novartis argued that rural patients living far from a treatment center could suffer from significant health risks or even death if they couldn’t afford travel. Because of its potentially dangerous side effects, such as cytokine release syndrome, patients who get Kymirah are monitored for at least a month.

“Due to the nature of the patient population and the serious safety risks associated with Kymriah therapy, financially needy patients may need enhanced support to access their prescribed treatment,” Novartis said in a statement shared with FiercePharma.
Several limitations have been put on the program. For example, patients must live more than two hours’ driving distance or 100 miles from the nearest available center. In addition, Novartis promises not to advertise the arrangement. Patients will not learn about it until they have been diagnosed with on-label indications and are prescribed Kymriah.
Still, while patients might not be tipped off beforehand, caregivers are aware of the existence of the program. Therefore, they may choose Kymriah over Gilead Sciences’ rival drug Yescarta for some patients.

Regulators made it clear that the ruling is meant only for this Kymriah program. Gilead didn’t immediately respond to a FiercePharma request about whether it’s seeking a similar opinion for Yescarta.
Currently, Kymriah is trailing behind Yescarta sales-wise, even though it was the first CAR-T therapy approved. In the third quarter, the Novartis drug sold $79 million, and that number went up in the fourth quarter to $96 million. In comparison, Yescarta generated $118 million in Q3.
It wasn’t so long ago when drugmakers paid up millions of dollars to settle federal allegations that they used donations to patient charities as kickbacks to cover copays for their medicines. These include Astellas coughing up $100 million, Amgen $24.75 million, Jazz Pharma $57 million, Lundbeck $52.6 million and Alexion $13 million, among others. Two charities—Good Days and Patient Access Network Foundation—also recently shelled out a combined $6 million to close U.S. Department of Justice claims.
https://www.fiercepharma.com/marketing/not-kickback-hhs-allows-novartis-kymriah-travel-assistance-program-for-public-patients

Bristol-Myers Squibb pulls European application for lung cancer combo

Bristol-Myers Squibb (NYSE:BMY) has withdrawn its marketing application in Europe seeking approval to use the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) (O+Y) to treat advanced non-small cell lung cancer in a first-line setting.

The company originally filed the application in 2018 based on the successful achievement of the co-primary endpoint of progression-free survival (PFS) in patients with mutational burdens of at least 10 mutations/megabase (CHECKMATE-227 study).

The application was later amended to include the successful achievement overall survival (OS), the other co-primary endpoint, in patients whose tumors expressed at least 1% PD-L1.  These participants received O+Y+chemo.

The European Medicines Agency determined that it could not conduct a full assessment of the filing due to the multiple protocol changes BMY made in response to rapidly evolving science and data.

It has no plans to refile the application.

Its submission in the U.S. is currently under FDA review.

https://seekingalpha.com/news/3537043-bristol-myers-squibb-withdraws-european-application-for-o-y-for-lung-cancer

Co-Diagnostics up 24% on advancement of coronavirus test

Nano cap Co-Diagnostics (CODX +23.5%) jumps on an 8x surge in volume on the heels of its announcement that it has completed the initial verification of a screening test for the coronavirus responsible for the current outbreak.
https://seekingalpha.com/news/3537005-co-diagnostics-up-24-on-advancement-of-coronavirus-test

NYC Officials Deny Report Of Coronavirus Amid Confusion

Topline: Despite a news report of a potential first case of coronavirus in New York City that temporarily sparked panic and confusion on social media Friday, city health officials vehemently denied the report, saying that there are still no confirmed or suspected cases of the virus in the city.

• The Daily News first reported that eight NYPD precincts in Queens were warned early on Friday morning to be careful over “one confirmed case” of coronavirus at Elmhurst Hospital.
• But the New York City Department of Health quickly denied the report, saying that there were no confirmed cases anywhere in the city’s five boroughs.
• NYC Health Commissioner Oxiris Barbot tweeted in response, “THIS IS NOT ACCURATE. There are still ZERO confirmed cases of novel coronavirus in NYC.”
• “There are no confirmed or suspected cases in NYC,” NYC Department of Health spokesman Michael Lanza told Forbes.
• “As of now, there have been no suspected cases sent to CDC from NYC for further testing,” confirmed another NYC health department spokesman, Patrick Gallahue. “Thus, no confirmed cases either. Report was wrong,” he told Forbes.
• “There is no coronavirus at Elmhurst Hospital,” added Christopher Miller, spokesman for NYC Health + Hospitals.

Crucial statistics: As of Friday, the deadly coronavirus has now infected nearly 10,000 people and killed at least 213, according to Chinese authorities. Originating in Wuhan, China, the fast-spreading illness has now reached more than 21 different countries. There are a total of five confirmed cases in the U.S., which issued its highest travel alert possible for China on Thursday night—advising Americans to avoid all “nonessential” travel to the country. Numerous airlines have suspended travel as well, and a host of countries, including the U.S., have also evacuated citizens from China and placed them under quarantine.

Big number: New York has the largest Chinese population of any city outside of Asia, The New York Times reports.
Key background: The World Health Organization (WHO) in a press conference on Thursday said that it is declaring coronavirus an international health emergency. “We don’t know what sort of damage coronavirus could do if it spreads to a country with a weaker health system,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “We must act now.”
https://www.forbes.com/sites/sergeiklebnikov/2020/01/31/nyc-officials-deny-report-of-coronavirus-amid-confusion/#76bcefd2652c