Chinese firm copies Gilead’s remdesivir, most promising drug against coronavirus

Amid the ongoing coronavirus outbreak, Gilead Sciences’ experimental remdesivir has emerged as the most promising candidate against the deadly pathogen. But its patent in China has also drawn some unexpected confusion.
The Chinese pharma BrightGene has successfully copied remdesivir, the company said in a disclosure (PDF, Chinese) to China’s Nasdaq-style Star market on Wednesday.
What’s more, the Suzhou-based firm said it has already mass-produced remdesivir’s active ingredient and is in the process of turning it into finished doses. The company’s stock jumped 20% at the news, hitting the daily price move cap allowed on the exchange.

BrightGene doesn’t seem to plan to bypass Gilead entirely, though. The company made clear the generic version is still in an R&D phase, and that its final marketing requires permission from the patent holder, Gilead.
In an interview with China’s business news publication Jiemian, BrightGene’s board secretary explained that there isn’t any patent infringement issue at this point because it’s not selling the product. But manufacturing a copycat to a patent-protected med at scale without any license is an unusual move that could revive concerns about the protection of intellectual property in the country.
IP protection in China has long been criticized by the Western world and was cited as a reason behind the latest trade war President Donald Trump waged against the country. As part of the first phase of a broader trade deal (PDF), the White House recently signed with Beijing to resolve the dispute, China has promised to implement some American-style enforcement of drug patent rights. These include allowing for a preliminary injunction against a generic maker amid a patent fight.

The BrightGene incident represents the latest twist to the patent controversy around remdesivir in China. A few days ago, researchers at the Chinese Academy of Sciences’ Wuhan Institute of Virology—based at the center of the outbreak—said they had applied for a patent on the use of remdesivir to treat the novel coronavirus disease, now officially named by the World Health Organization as COVID-19.
The research institute said it filed the application “from the perspective of protecting national interests,” but the move drew criticism.
At a recent internal company conference, Gilead CEO Daniel O’Day said the company owns all patents around remdesivir, including for coronaviruses. But he also stressed that the priority for the company is to examine the drug’s use in clinical trials and to ramp up production if its efficacy is confirmed. Gilead “will not get into a patent dispute,” he said.

Last week, two phase 3 trials kicked off in Wuhan to test remdesivir in adult patients with mild-to-moderate or severe respiratory disease caused by the novel coronavirus. Together, investigators aim to enroll 760 patients, with readouts expected as early as April.
Gilead is providing the drug for free for the studies. BrightGene also said it will provide its version “mainly through donations” during the epidemic if it’s granted the marketing go-ahead.
On top of all those controversies, Chinese IP law does provide for compulsory licenses for eligible companies to produce generic versions of patented drugs during a state of emergency or other unusual circumstances, or in the interests of the public. However, authorities will not likely apply it to remdesivir, especially now that Gilead’s offering it free of charge and as drug IP remains a sensitive topic on the international community’s radar.
https://www.fiercepharma.com/pharma-asia/chinese-firm-copies-gilead-s-remdesivir-most-promising-drug-against-new-coronavirus

Calling vaccine makers: Moderna, NIH need partner to make coronavirus shot

Moderna and the National Institutes of Health quickly struck up work on a potential vaccine against the deadly new coronavirus. But the team hasn’t found a pharma partner to manufacture the vaccine for real-world use, a top official said Tuesday.

NIH and Moderna could develop a vaccine in a little over a year if all goes well, but they wouldn’t be able to produce the doses needed to deploy the shot against the outbreak, National Institute of Allergy and Infectious Diseases director Anthony Fauci said at an Aspen Institute panel. That’d require a pharma partner, and so far, NIH hasn’t found its manufacturer.

The virus has caused more than 45,000 infections and more than 1,100 deaths. The vast majority of cases have been in China.

If a pharma company were to get involved, it would have to adjust manufacturing facilities and sacrifice the “opportunity cost” of producing the profit-making shots it typically makes, Fauci said at the panel. It’s a dynamic that’s “very difficult and very frustrating,” he added.

Numerous times over the years, emerging disease outbreaks have caught the scientific and medical community off guard. Pharma companies and others have routinely rushed in on R&D work, but outbreaks have tended to fade before the would-be vaccine makers could develop effective countermeasures. Now, companies seem more cautious about jumping right into the next new outbreak.

During the Ebola crisis, a major pharma company “got burned” with its investment and is now backing out of the field, Fauci said at the panel. That’s likely a reference to GlaxoSmithKline, which bought NIH-partnered Okairos back in 2013 and picked up Ebola vaccine candidates and several other pipeline programs. Last year, the company exited Ebola vaccine research by licensing its candidates to the Sabin Vaccine Institute.

Another top vaccine player, Sanofi, got involved during the Zika outbreak, but its partnership with the U.S. government led to a controversy over potential vaccine pricing. Sanofi later exited the collaboration.

Despite the risk, Johnson & Johnson said Tuesday it’s joining up with the U.S. Department of Health and Human Services to accelerate vaccine development against COVID-19. Both partners are chipping in funding to get the vaccine into the clinic, and the government could provide more money for further development.

Alongside the R&D effort, J&J is readying production facilities so that it can “meet global health needs” if the shot is deployed.

On the NIH/Moderna collaboration, Fauci said the team should be able to get into the clinic in about two and a half months from the time it received the initial virus sequence. Then, he expects three months of testing in phase 1. If all goes well, the team could advance to phase 2 testing in China that’d take six to eight months.

After that, the group would be ready to start producing vaccines for use in the field. Production would require an amount of time that’s as “problematic” as developing the shot itself, Fauci said. That’s unless the team produces vaccines “at-risk,” or before getting proof the vaccine will even work.

https://www.fiercepharma.com/pharma/amid-deadly-outbreak-nih-hasn-t-found-its-pharma-partner-to-manufacture-coronavirus-vaccines

Under-the-gun Acorda slashes Inbrija sales forecast amid lackluster launch

Acorda Therapeutics suffered a major blow in late 2018 when it lost four patents on multiple sclerosis med Ampyra. The drug cratered in the face of generic competitors, Acorda slashed jobs and costs, and then shifted focus to its $800 million Parkinson’s hopeful Inbrija.
But that hasn’t worked out so far, and an underwhelming launch now has Acorda aiming way lower on the drug’s chances.
More than a year into its launch, Inbrija raked in just $15.3 million in sales in 2019, a far cry from the lofty $800 million goal Acorda outlined in its annual report a year ago.

In an earnings call with analysts Thursday, CEO Ron Cohen blamed Inbrija’s lackluster performance on first-year reimbursement issues that left physicians “preconditioned” to avoid prescribing the inhalable drug.
“We really thought going into the market at launch, even though we knew there would be reimbursement challenges, we thought uptake would be significantly higher than it was,” Cohen said. “There is this odd disconnect where the physicians by and large are quite enthusiastic, but you don’t see that in the first year of prescribing information.”
Acorda downgraded its peak sales estimate for Inbrija to between $350 million and $500 million, revising a more than $500 million estimate that Cohen said was “not as informed as (it is) now.” Despite the slow uptake, Acorda forecast 2020 sales of Inbrija between $35 million and $40 million.

In Cohen’s telling, Inbrija is ready for a sales turnaround after the drugmaker has fought tooth and nail for market access. With physician and patient enthusiasm high, Cohen predicted that increased sales could soon follow, now that doctors have fewer hurdles to face with reimbursement.
“We found that doctors have been preconditioned by other product launches that when they start writing, the more of a time sink it is because insurers keep throwing back prescriptions,” Cohen told analysts. “That’s where we really underestimated the impact when we went in, and that’s where we are now.”
But even if Inbrija does nail its heel turn, Acorda will be left coping with nosediving sales of Ampyra, which hit just $163 million in 2019 after a $455 million year in 2018.
In September 2018, the U.S. Court of Appeals for the Federal Circuit upheld a lower court’s ruling that four Ampyra patents were invalid, putting the drug up for generic competition almost immediately. Despite sales dropping by nearly 75% on the year, Cohen painted a relatively rosy picture Thursday, arguing that the drugmaker had maintained a “robust tail” for Ampyra through a well-executed loss of exclusivity plan and lasting “brand loyalty.”
This year, Acorda predicts Ampyra will continue its decline to between $85 million and $110 million in sales.
https://www.fiercepharma.com/pharma/acorda-backs-way-off-800m-estimate-inbrija-after-lackluster-year

Indian generic makers face supply shortage if China coronavirus drags on

Shortages and potential price increases of generic drugs from India loom if the coronavirus outbreak disrupts suppliers of pharmaceutical ingredients in China past April, according to industry experts.

An important supplier of generic drugs to the world, Indian companies procure almost 70% of the active pharmaceutical ingredients (APIs) for their medicines from China.
India’s generic drugmakers say they currently have enough API supplies from China to cover their operations for up to about three months.
“We are comfortably placed with eight to 10 weeks of key inventory in place,” said Debabrata Chakravorty, head of global sourcing and supply chain for Lupin Ltd (LUPN.NS), adding that the company does have some local suppliers for ingredients.
Optimism that the worst of the outbreak centered in China’s Hubei province and its capital Wuhan would be over by April took a major hit late on Wednesday. Chinese health officials, using a broader method of confirming coronavirus cases, said they shot up by nearly 15,000 in Hubei with total deaths in China nearing 1,400.
The outbreak and severe travel restrictions aimed at containing its spread has taken a toll on the world’s second largest economy and disrupted international businesses dependant on Chinese supplies.
Sun Pharmaceuticals Industries Ltd (SUN.NS) said it has sufficient inventory of API and raw materials for the short term and has not seen any major disruption in supplies at the moment.
The Indian drugmaker, however, said supply has been impacted for a few API products and the company is closely monitoring the situation. It did not identify the products.
An extended outbreak that limits the volume of active ingredients and drugs available for export from China could lead to drug shortages and price increases, particularly in the United States – where prices are subject to market forces – according to rating agency Moody’s.
India supplies nearly a third of medicines sold in the United States, the world’s largest and most lucrative healthcare market.
Daara Patel, secretary general of the Indian Drug Manufacturers Association, which represents over 900 drug producers, said he expects supplies to be disrupted from April.
Patel said vitamins and antibiotics are likely to be among the hardest hit as India is a major global producer of both.
International pharmaceutical companies including Swiss drugmaker Novartis AG (NOVN.S) and Britain-based GlaxoSmithKline Plc (GSK.L) have so far predicted minimal disruption in the near term to their supply chain.
“Companies are continuously monitoring the situation and are working proactively to prevent and mitigate potential shortages,” Holly Campbell, spokeswoman for pharmaceutical industry trade group PhRMA, said by email.
Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA) trade group, said there are no API shortages at the moment because drugmakers had stocked up on inventory ahead of the Lunar New Year holiday in China, which was later extended to contain the virus.
https://www.reuters.com/article/us-china-health-pharmaceuticals/indian-generic-drugmakers-may-face-supply-shortages-from-china-if-coronavirus-drags-on-idUSKBN2072GS

Stocks recover after WHO explains new virus cases

U.S. stocks erase most of their earlier losses after the World Health Organization says that the spike in coronavirus cases reported by China aren’t all new cases of the disease.

Nasdaq and S&P 500 are roughly flat, and the Dow pares its loss to -0.2% vs. -0.7% earlier.

10-year Treasury yield slips 1 basis point to 1.61%.

The spike in new Covid-19 cases reflects more of a change in how China is reporting them and doesn’t represent “a significant change in the trajectory of the outbreak,” said Dr. Michael Ryan, executive director of WHO Health Emergencies Program.

Traditionally defensive sectors real estate (+0.6%) and utilities (+0.5%) are outperforming S&P 500 industry sectors, while industrials (-0.4%) and energy (-0.4%) trail the broader market.

Crude oil rises 0.8% to $51.57 per barrel; gold +0.5% to $1,579.10 per ounce.

In European markets, the Stoxx Europe 600 and Germany’s DAX ended the session roughly flat; the U.K.’s FTSE 100 closed down 1.1% after the U.K. Treasury chief quit; France’s CAC 40 fell 0.2%.

The U.S. Dollar Index is little changed at 99.08.

https://seekingalpha.com/news/3541842-stocks-recover-after-who-explains-new-virus-cases

Genprex, U Pittsburgh in Pact on Possible Curative Diabetes Gene Therapy

• Company licenses patented diabetes gene therapy technology designed by researchers at the University of Pittsburgh
• Results from in vivo animal studies indicate that normal glucose levels in the blood may be restored for an extended period of time
• Company plans to partner for the clinical development and commercialization of this therapy in the U.S. and internationally

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases, today announced that it signed an exclusive license agreement with the University of Pittsburgh for a diabetes gene therapy that may have the potential to cure Type 1 and Type 2 diabetes, which together currently affect approximately 30.3 million people in the U.S, or 9 percent of the U.S. population.
The diabetes gene therapy, which was developed by lead researcher and Harvard graduate, Dr. George Gittes, at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, works by reprogramming beta cells in the pancreas to restore their function, thereby replenishing levels of insulin. The novel infusion process uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The proteins these genes express transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.
The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies of diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. Following preclinical studies, Dr. Gittes and his team plan to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

“One of the biggest advantages of this gene therapy is that it could eliminate the need for insulin replacement therapy for diabetic patients,” said Dr. Gittes. “Lifting this huge burden for the millions of patients who must continuously monitor blood glucose levels and inject insulin daily would be a breakthrough in modern medicine. This therapy has the potential to truly disrupt the diabetes market.”
Genprex will add this technology to its research and development pipeline, diversifying its portfolio and expanding its clinical development programs. The company will continue its focus on developing its immunogene therapies for cancer, including Oncoprex™ immunogene therapy, its lead drug candidate for non-small cell lung cancer, in parallel with development of the new diabetes gene therapy.
https://patch.com/michigan/farmington-mi/genprex-university-pittsburgh-sign-license-agreement

Virus diagnosis method unchanged in other China regions: health spokes

The methodology for coronavirus diagnosis has not changed in other provinces apart from Hubei, and not in municipalities such as the city of Shanghai, a Shanghai Health Commission spokeswoman said on Thursday.
Zheng Jin made the comments at a press conference.
https://www.reuters.com/article/us-china-health-shanghai/coronavirus-diagnosis-method-not-changed-in-other-chinese-provinces-regions-shanghai-health-commission-idUSKBN2070R5