Humanigen executes lenzilumab licensing deal in Asia for COVID-19

• Humanigen (NASDAQ:HGEN) perks 7% premarket after executing its first licensing transaction in the Asia-Pacific Region with Telcon RF Pharmaceutical, Inc. and KPM Tech Co., Ltd for development and commercialization rights to lenzilumab for COVID-19 for South Korea and the Philippines.
• Telcon and KPM Tech, both recently invested in HGEN June 2020 PIPE offering.
• Agreement provides Humanigen up to $20M in milestones and double-digit royalties on product sales.
• Telcon and KPM Tech will be responsible for gaining regulatory approval and subsequent commercialization of lenzilumab in its territories.
• https://seekingalpha.com/news/3630295-humanigen-executes-lenzilumab-licensing-deal-in-asia-for-covidminus-19
  

GW Pharmaceuticals up on Q3 beat

• GW Pharmaceuticals (NASDAQ:GWPH) Q3 results:
• Revenue: $137.05M (+50.7% Y/Y) vs consensus of $125.97M; Epidiolex U.S. sales: $121.6M.
• Net loss: ($12.2M) (-11.6%); loss/share: ($0.03) (-25.0%) vs consensus of ($0.06).
• Cash flow ops: ($33.31M) (-69.0%).
• Epidiolex for seizures associated with TSC launched in the U.S.
• Recruitment in Phase 3 of Nabiximols development program in MS spasticity trial under way.
• Active recruitment started in Phase 2b trial for schizophrenia (GWP42003).
• CBD formulation Phase 2 study in autism, expected to commence in Q1 2021.
• https://seekingalpha.com/news/3630338-gw-pharmaceuticals-up-6_4-on-q3-beat
  

Bayer takes $10 billion writedown, flags higher Roundup settlement

Bayer is facing a double hit from a higher legal bill for claims relating to weedkiller Roundup as well as 9.25 billion euros ($10.82 billion) in impairments on agriculture businesses, much of it related to its Monsanto deal.

The company said the write-downs, driven by weaker demand from farmers due to low biofuel prices, plus an increase of about $750 million in the costs of settlement terms with U.S. plaintiffs over Roundup, resulted in a loss before interest and tax of 9.4 billion euros in the third quarter.

Bayer was caught up in litigation over Roundup, based on the herbicide glyphosate, as a result of its 2018 takeover of Monsanto for about $63 billion, which made it the world's largest supplier of seeds and pesticides.

"The impact of the (coronavirus) pandemic is placing additional strain on our Crop Science Division. We are also facing negative currency effects," Chief Financial Officer Wolfgang Nickl said.

Nickl said a massive depreciation of the Brazilian real was weighing heavily on business in the world's second-largest agricultural market.

Bayer said it was unable to say what part of the impairment was attributable to legacy Monsanto businesses, saying only that two-thirds of the writedowns were due to currency and interest rate effects.

Bayer on Sept. 30 had predicted impairment charges in the mid to high-single-digit billion-euros range on agricultural assets and warned of a slight decline in 2021 core earnings per share.

Bayer struck an $11 billion outline agreement with U.S. plaintiffs' lawyers in June but a judge later took issue with a side arrangement on future cases that may yet be lodged, known as a class plan.

Addressing those concerns will prove about $750 million more costly, Bayer said on Tuesday.

Bayer said it was "far enough along in the negotiations to know that the new plan will come in at approximately 2 billion U.S. dollars, an increase over the original cost of 1.25 billion U.S. dollars."

Bayer's shares were down 0.6% at 0850 GMT, marking a loss of 22% since Bayer first flagged write-downs and a likely decline in 2021 earnings on Sept 30.

"This situation confirms our belief that Crop Science is a business with low visibility," said Jean-Jacques Le Fur, an analyst at brokerage Bryan Garnier. He reiterated a "sell" recommendation, also citing uncertain Roundup litigation costs.

The charges more than offset combined gains booked in the quarter from the sale of its Animal Health business to Elanco and the divestment of a stake in industrial park operator Currenta of 5 billion euros.

That resulted in a net loss of 2.7 billion euros compared with an average analyst projection of 1 billion euro in net income.

Bayer said that 88,500 of the 125,000 glyphosate claims in the class settlement have been agreed in principle and that it was hoping to make considerable progress over the next few months. 

https://www.marketscreener.com/news/latest/Bayer-takes-10-billion-writedown-flags-higher-Roundup-settlement-bill--31677594/

U.S. to review Biogen drug that could be first new Alzheimer's treatment in decades

U.S. health experts this week will decide whether to recommend approval for Biogen Inc's BIIB.O Alzheimer's drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works.

In a field littered with unrelenting failure, Biogen believes in aducanumab it has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer’s. But its path to approval has been anything but smooth or assured.

Biogen abruptly ended clinical trials of aducanumab last year after an early look at trial results showed it was not effective. Last October, the company shocked many Alzheimer’s experts by reversing course, saying that a new analysis showed aducanumab could help patients with early-stage disease preserve their ability to function independently for longer. In July, Biogen filed for approval from the Food and Drug Administration.

Now the agency faces tremendous pressure to approve a treatment option for millions of Americans suffering from Alzheimer’s and the millions more expected to face it in coming years.

Patient advocates say the need for a new Alzheimer’s treatment that could help people remain independent is heightened by the coronavirus pandemic, which has killed more than 229,000 people in the United States, including tens of thousands of seniors in nursing homes.

“The pandemic came and it changed everything,” said Russ Paulsen, chief operating officer at patient advocacy group UsAgainstAlzheimer’s. “We need something to keep people out of nursing homes.”

A committee of outside advisers to the FDA will discuss aducanumab on Nov. 6. The agency’s final decision is expected by March. European health regulators have also accepted the drug for review.

Charles Flagg, a 79-year-old retired minister from Jamestown, Rhode Island, had been enrolled for years in a trial of aducanumab before it was stopped. He started receiving the drug again in August as part of a follow-up study, according to his wife Cynthia Flagg.

“He’s not 100 percent himself, but overall I’m not dealing with someone that needs to be led around or be in a care home,” Flagg said.

Aducanumab, an antibody designed to remove amyloid plaques from the brain - a strategy tried with many failed Alzheimer’s drugs - would reap billions of dollars in sales if approved.

Biogen, along with partner Eisai Co Ltd 4523.T, is one of the last large drugmakers pursuing treatments for a disease that afflicts nearly 6 million Americans and millions more worldwide. Biogen estimates about 1.5 million people with early Alzheimer’s in the United States could be candidates for the drug.

‘CLINICALLY MEANINGFUL’

Late last year, Biogen said one of its two pivotal studies of aducanumab showed a statistically significant benefit at slowing cognitive and functional decline in patients with early Alzheimer’s. A second trial failed to achieve that goal, but did show a benefit for a subset of patients who were given a high dose for at least 10 months.

In March, it opened a follow-up long-term safety study to 2,400 people who had previously participated in trials of aducanumab, like Flagg.

Many Alzheimer’s researchers say Biogen should conduct a third large study to prove aducanumab works. They worry about its possible side-effects, such as brain-swelling, and the potential cost.

“Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes,” said Mayo Clinic neurologist Dr. David Knopman, who was recused from the expert panel because he helped conduct the trials.

Others believe the FDA could approve the drug without another trial.

Previous clinical studies had largely targeted patients in later stages of the disease, while many experts now believe attacking Alzheimer’s as early as possible may be the key to success. But there was a lack of clarity on how to assess a drug’s success when functional deficits are less pronounced.

In 2018, the FDA revised its standard of proof guidance for reviewing Alzheimer’s drugs by essentially combining what had been separate goals for cognition, or memory, and day-to-day function. The new guidance stressed the need for a drug to show “clinically meaningful” benefits, a term it has not clearly defined.

Alzheimer’s advocacy groups are pushing for a broad definition, saying it should include preserving the ability to perform daily activities such as shopping independently or remembering to turn off a stove.

“They have been trying to lower the bar and help any company to get a drug approved,” said Dr. Marwan Sabbagh, from the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “How much (improvement) do you need to be clinically meaningful? Naturally this is very subjective.”

https://www.reuters.com/article/us-biogen-alzheimers-fda-preview/u-s-experts-to-review-biogen-drug-that-could-be-first-new-alzheimers-treatment-in-decades-idUSKBN27J1AN

Healthcare and pharma in focus as voters hit polling stations

• Eyes are on healthcare spending, which totals 17% of the U.S. economy and far more than any other industrialized country.
• Joe Biden wants to expand the Affordable Care Act, a move that would increase federal healthcare spending by $2T or more over 10 years, while Trump wants to end it altogether and replace it with something better.
• Both political parties have also sounded off against high prescription drug prices, while BofA has shaken out election scenario winners in hospitals and managed care.

https://seekingalpha.com/news/3630161-healthcare-and-pharma-in-focus-voters-hit-polling-stations

Aurinia suspends voclosporin program as Phase 2/3 study fails

• Aurinia Pharmaceuticals (NASDAQ:AUPH) down 10% after-hours after announcing topline data from the Phase 2/3 AUDREY clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).
• The trial did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in Schirmer Tear Test (STT) at four weeks between active dose groups of VOS compared to vehicle.
• A total of 508 subjects were enrolled. The study consisted of four arms with a 1:1:1:1 randomization schedule, in which patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks.
• At VOS 0.2%, result was 11%; with Odds-Ratio of 2.48 vs. vehicle (95% CI, p=0.13).
• At VOS 0.1%, result was 9%; with Odds-Ratio of 1.78 (95% CI, p=0.28).
• At VOS 0.05%, result was 10%; with Odds-Ratio of 2.18 (95% CI, p=0.09).
• Aurinia is suspending the development program for VOS based upon these results.
• Secondary outcome measures evaluated in the trial included STT at other time points, Fluorescein Corneal Staining (FCS) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints.
• Initial analysis of these secondary outcomes suggests dose-dependent activity and safety were observed across dose groups compared to vehicle.
• https://seekingalpha.com/news/3630145-aurinia-suspends-voclosporin-program-phase-2-3-study-fails-to-achieve-significant-improvement
  

Bayer AG reports Q3 results

• Bayer AG (OTCPK:BAYZF): Q3 Non-GAAP EPS of €0.81; GAAP EPS of   -€2.79.
• Revenue of €8.5B (-13.3% Y/Y)
• Press Release
• https://seekingalpha.com/news/3630181-bayer-ag-reports-q3-results