Drugmakers Have Opportunity To Name Their Price On Virus Treatment, But They May Play It Safe

The Wall Street Journal: Why Drug Companies May Resist Milking Covid-19 Treatments
The onset of Covid-19 has granted the drug industry a significant business opportunity. Whether manufacturers should take full advantage is more complicated than investors might appreciate. Gilead Sciences will likely set a commercial price for its antiviral treatment remdesivir in the weeks ahead, after donating its initial manufactured supply. A round of vaccine candidates is also in development from major drug companies such as Johnson & Johnson, Merck and Pfizer, as well as from promising biotech upstarts. (Grant, 6/9)

Bloomberg: Price Limits Will Scare Off Covid Vaccine Makers, Fauci Warns
The federal government shouldn’t force drug companies to lower the costs of Covid-19 vaccines and treatments but should encourage fair pricing, Anthony S. Fauci said Tuesday. “I have a lot of experience over the years dealing with pharmaceutical companies in which we’re trying to develop an intervention,” Fauci, director of the National Institute of Allergy and Infectious Diseases in the National Institutes of Health, said. “And the one thing that is clear is that if you try to enforce things on a company that has multiple, different opportunities to do different things, they will walk away.” Fauci spoke at BIO Digital, the first virtual convention by the Biotechnology Innovation Organization. (Baumann, 6/9)

The Wall Street Journal: In Race For Covid-19 Vaccine, China Tries For A Coup
The U.S. is home to the world’s biggest and best-known pharmaceutical companies. But China is giving the U.S. a run for its money in the race to develop a vaccine for Covid-19—a feat that would instantly change the dynamics of the fight against the deadly virus, and the geopolitical competition between the U.S. and China. Beijing’s government, including its military and several state-backed firms, has committed hundreds of millions of dollars and cleared regulatory barriers to accelerate research and development. Even before a front-runner is clear, domestic drug manufacturers have begun ramping up production capacity as leader Xi Jinping vows to share a Chinese-backed vaccine with the world. (Deng, 6/5)

Bloomberg: FDA Misled Senators On China’s Role As Vital U.S. Drug Supplier
The Food and Drug Administration had to walk back testimony by an official at a Senate hearing last week after he downplayed the scale of China’s dominance of the drug supply chain in the U.S. The issue has come to the fore as the pandemic has prompted some in Congress and the Trump administration to question China’s role as the global supplier of key ingredients. The FDA says it’s able to police the safety of the U.S. drug supply regardless where it comes from, even as it’s had to suspend on-site inspections due to the virus. (Edney, 6/9)

Stat: Will The 'Patent Dance' Cause Amgen To Pull A Biosimilar Off The Market?
In a closely watched case, a federal appeals court must decide whether a biosimilar company should temporarily pull its product off the market because manufacturing plants may be changed, a move that could cause Americans to pay more for a brand-name biologic medicine — at least for a few months. At issue is an interpretation of federal law known as the Biologics Price Competition and Innovation Act, which is supposed to determine when biosimilar drugs can be launched. (Silverman, 6/5)

Stat: Wholesale Drug Prices — And Net Prices — Keep Falling For Most Drugs 
Amid continued political pressure on the pharmaceutical industry, a new analysis finds that brand-name drug makers increased their wholesale prices by 2.3% in the first quarter of this year, a much smaller boost than 3.2% hike that occurred during the same time a year ago. Meanwhile, after subtracting allowances such as rebates and discounts, net prices paid by health plans fell by 2.6%, compared with a 3.7% decline in last year’s first quarter, according to SSR Health, which tracks the pharmaceutical industry. (Silverman, 6/4)

FiercePharma: Remdesivir Stockpiling Could Help Push COVID-19 Drug Into Profitable Territory For Gilead: Analyst
Ever since the FDA last month cleared Gilead’s remdesivir for emergency use to treat COVID-19, investors have been wondering if the drug could possibly reap returns for the company, given the Big Biotech's vow to donate millions of doses and a lack of details on pricing plans beyond that. But one influential Wall Street firm does see a path to profitability for remdesivir—one that hinges on both commercial sales and governments around the world paying for the drug to build a stockpile after the current pandemic passes. (Weintraub, 6/4)

Stat: Sarepta's Gene Therapy For Rare Disease Shows Improved Muscle Function
Sarepta Therapeutics said Monday that three children born with a rare muscle-wasting disease called limb-girdle muscular dystrophy are showing durable improvements in strength and function a year after a one-time infusion of an experimental gene therapy. Three more children have been treated with a higher dose of the same gene therapy. Initial biopsy results from those patients, also reported Monday, show greater production of a key muscle protein with no added safety problems — suggesting the higher dose could lead to even larger improvements in muscle function. Those tests will be performed later this year, Sarepta said. (Feuerstein, 6/8)

Bloomberg: Dread Over Impending Anti-Huawei Law Grows At U.S. Companies
A quiet panic is spreading in Washington and corporate boardrooms that a law taking effect in two months, which bans Huawei Technologies Co. gear, will threaten the business of government contractors. Aerospace, technology, auto manufacturing and a dozen other industries are engaged in a lobbying frenzy ahead of an Aug. 13 deadline to comply with a far-reaching provision that was tucked into a defense spending bill two years ago. (Leonard and Banjo, 6/10)

The Wall Street Journal: New Treatments For Macular Degeneration Are On The Way
Scientists may be just a few years away from delivering new treatments for age-related macular degeneration (AMD), the leading cause of irreversible vision loss in people more than 50 years old. Over the past 15 years there has been only one class of successful AMD drugs, known as anti-VEGF agents, and they have worked for a minority of AMD sufferers. Now researchers are having success fighting AMD from new directions. (Oliver, 6/8)

Stat: The Next Record-Setting IPO: A Drug Company That Doesn’t Develop Drugs
Royalty Pharma, a business built on investing in other people’s medicines, is planning to raise $2 billion in what would be the drug industry’s largest-ever initial public offering. The company, founded in 1996, intends to sell 70 million shares at between $25 and $28 each. The offering, expected to price next week, would give it a market value of about $16 billion. The drug industry’s IPO record is currently held by Moderna, which raised about $600 million in a 2018 debut that valued it at above $7 billion. (Garde, 6/8)

Stat: Judge Rules AbbVie Didn't Unfairly Thwart Humira Competition
In a victory for AbbVie (ABBV), a U.S. federal judge ruled the drug maker did not unfairly thwart competition by striking deals with other companies that resolved patent lawsuits, but also resulted in delaying lower-cost biosimilar versions of its Humira medicine for several years. A lawsuit filed last year by unions, insurers and the city of Baltimore alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar competition” by filing dozens of patents for Humira, its franchise product. Some of the more than 100 Humira patents — sometimes described as a “patent thicket” — extend to 2034. (Silverman, 6/9)

FiercePharma: AbbVie's Humira Defense May Keep Prices High, But It's Still Legal, Judge Rules
While AbbVie’s deals with biosimilar companies preserve high prices in the U.S. for several years, the company's strategy doesn't amount to an antitrust violation, U.S. District Judge Manish Shah wrote in an order Monday.  As AbbVie’s initial patent on Humira approached expiration, the company applied for dozens of follow-up patents. The plaintiffs—among them the City of Baltimore, an insurance trust fund for Miami police officers and a benefit plan for pipe trade workers in Minnesota—alleged AbbVie illegally blocked competition for Humira by obtaining a “patent thicket" and deploying it on would-be competitors. (Sagonowsky, 6/9)

Stat: China’s Biggest-Ever Nasdaq Biotech IPO Comes At An Awkward Time
Legend Biotech raised more than $400 million in a Nasdaq IPO on Friday, marking the largest U.S. debut for Chinese drug maker. But Legend’s Wall Street success arrives at an uncertain time for Chinese companies, as a bipartisan group of lawmakers is pushing a bill that could force it and scores of other companies off of U.S. exchanges. (Garde, 6/5)

Stat: Tiny Denmark Saves Lots On Biosimilar Humira, As Americans Pay Big Bucks
For those yearning for the day when biosimilars save the U.S. health care system huge amounts of money, consider a recent episode in Denmark. In October 2018, the patent expired on Humira, a big-selling biologic drug that is used to treat rheumatoid arthritis, Crohn’s disease, and other ailments. The Danish government moved quickly and began accepting bids from companies that make biosimilar versions, which are nearly identical variants that are expected to yield the same health outcomes, but cost less than pricey brand-name biologics. (Silverman, 6/3)

Stat: AstraZeneca Partners With RNA-Modifying Biotech Accent Therapeutics
Drug giant AstraZeneca is moving deeper into RNA-based therapies with a new partnership with the startup Accent Therapeutics, which is hoping to make therapies by manipulating enzymes that subtly change RNA. The deal announced Thursday is worth $55 million upfront with more than $1 billion on the table through milestone-based payments. It may be the first partnership a pharmaceutical company has forged with a company working on the concept, which has already attracted a lot of attention and investment. (Sheridan, 6/4)

Stat: Canadian Medical Groups Often Don't Disclose Pharma Funding In Guidelines
Many Canadian medical societies and specially focused disease groups fail to disclose industry funding in their clinical practice guidelines, a new analysis finds. Moreover, most of the organizations included conflict-of-interest statements in their guidelines, but also had a panel member with a conflict. (Silverman, 6/9)