- Why Drugmakers Aren’t Sweating the Next Wave of Patent Losses (bloomberg.com)
Drugmakers plunged off a patent cliff earlier this decade, losing billions in sales as lucrative branded drugs lost exclusivity. An expensive lobbying effort aimed at preventing a repeat is paying off...The loss of a series of key patents for cholesterol fighters and other widely used medicines cost big-name drug companies about $82 billion in sales...forcing large-scale job cuts and a wave of deals to make up for lost revenue...Once again, the pharmaceutical industry is peering over the ledge. Over the next three years, roughly $60 billion of drug sales for companies including Roche Holding AG, Sanofi, and Eli Lilly & Co. are threatened by potential rivals…Roche may have the most at stake. It’s facing the loss of exclusivity for its three top-selling cancer drugs over the next two years, which account for more than $20 billion of its $51.4 billion in annual sales…Many of the drugs expected to lose their patent shields in coming years...are complex medicines produced by living cells, which makes replicating them more difficult...Drugmakers’ main lobbying groups, PhRMA and BIO, successfully watered down efforts to give biosimilars an easier approval process...Analysts say that given the longer approval arc for biosimilars, major drugmakers are less likely to be whipsawed by generic rivals when key medicines drop off patent. But over time, political pressure over high drug costs is expected to undercut the dominance of branded biologic drugs...
- Drugmakers and distributors face barrage of lawsuits over opioid epidemic (washingtonpost.com)
The companies that manufacture and distribute highly addictive painkillers are facing a barrage of lawsuits for the toll their product has taken on communities across the country as the worst drug epidemic in U.S. history continues to escalate...Within the past year, at least 25 states, cities and counties have filed civil cases against manufacturers, distributors and large drugstore chains that make up the $13 billion-a-year opioid industry. In the past few weeks alone, the attorneys general for Ohio and Missouri, along with the district attorneys for three counties in Tennessee, filed suits against the industry — and the attorney general for Oklahoma filed suit on Friday...The strategy echoes the effort against major tobacco companies in the 1990s and is born of similar frustration over rising death rates and the increasing costs of addressing the continuing public health crisis. After years of government and pharmaceutical firms failing to control the problem, some lawyers say the suits have the potential to force the industry to curb practices that contribute to it...Representatives of the companies deny wrongdoing and vow to vigorously defend themselves. They said they have taken steps to prevent the diversion of their drugs to the black market. Stemming the epidemic, they said, will take a coordinated effort by doctors, the industry, and federal and local government agencies..."As we look to prevent abuse and misuse in the future, it will require a forward-looking, systemic approach that calls on greater coordination and collaboration between health-care, law enforcement, and state and federal regulatory authorities," said the Healthcare Distribution Alliance, which represents companies that distribute drugs...
- Walgreens, Rite Aid end $9.4 billion merger (pharmacist.com)
Walgreens Boots Alliance and Rite Aid have called off their $9.4 billion merger agreement. Instead, Walgreens says it will attempt to purchase one-half of Rite Aid's stores for $5.18 billion in cash. Executives said they crafted the smaller deal to address regulatory issues, but antitrust experts said it does not eliminate competition concerns. The Federal Trade Commission's review of the original Walgreens-Rite Aid transaction stretched 18 months, and the commission reportedly did not back away from concerns that the deal would have harmed competition. The commission worried about the merger's impact in regions where both companies have a strong store presence...Walgreens...said the smaller transaction addresses "all substantive" FTC concerns. The company will be adding stores in regions where it currently lacks a large presence, including the Northeast and MidAtlantic..."There's a chance that it won't go, that's the reality of the process. We believe it makes sense, we just have to wait until it plays out."
- Chinese courts call for death penalty for researchers who commit fraud (statnews.com)
An eye for an eye, a tooth for a tooth — a life for a lab book?...In the past few months, China has announced two new crackdowns on research misconduct — one of which could lead to executions for scientists who doctor their data...Scientists have been sounding alarms for years about the integrity of research in China. One recent survey estimated that 40 percent of biomedical papers by Chinese scholars were tainted by misconduct. Funding bodies there have in the past announced efforts to crack down on fraud, including clawing back money from scientists who cheat on their grants...Chinese...Ministry of Science and Technology proclaimed a "no tolerance" policy for research misconduct — although it’s not clear what that might look like...the mass retractions "seriously harmed the international reputation of our country’s scientific research and the dignity of Chinese scientists at large."...courts approved a new policy calling for stiff prison sentences for researchers who fabricate data in studies that lead to drug approvals. If the misconduct ends up harming people, then the punishment on the table even includes the death penalty...
- New on the streets: Gabapentin, a drug for nerve pain, and a new target of abuse (statnews.com)
Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is not an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list...surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state...Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the U.S. In May, it was the fifth-most prescribed drug in the nation...law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle. As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery...
- Praxsyn Corporation Acquires Nevada Pharmacy (finance.yahoo.com)
Praxsyn Corporation is pleased to announce that it has purchased through a newly formed subsidiary, Nevada Health Rx, Inc., the pharmacy license and all of the assets of Meds Direct Rx, a pharmacy located in Las Vegas, Nevada. The new pharmacy is about 8,000+ square feet of pharmacy and warehouse space, and includes a large loading dock and a secured yard to hold delivery vehicles...The total purchase price for the acquisition of the pharmacy was $120,000...This acquisition will allow us to sell a broader mix of products from a much larger facility than we have had in the past. Our focus is on filling prescriptions that have a 30 day pay cycle...Our focus...is on customer service to our patients, their doctors, the surgery centers and hospitals that will serve our patients...Headquartered in Las Vegas, Nevada, Praxsyn Corporation is a holding company that finds solutions to fit the needs and goals of medical professionals and their patients...
- Endo to pull opioid painkiller off U.S. market after FDA nudge (reuters.com)
Endo International Plc agreed...to remove its long-acting opioid painkiller from the U.S. market to comply with the health regulator's request last month, sending its shares down as much as 3 percent...The U.S. Food and Drug Administration in June had requested the withdrawal of Endo's Opana ER, marking the first time the agency asked for an opioid painkiller to be taken off the market for public health reasons...The regulator's request followed the recommendation of an independent panel of advisers, which concluded that the drug's benefits no longer outweighed its risks...
- How AI Is Transforming Drug Creation (wsj.com)
Pharmaceutical companies hope computers can help them find new medications that are faster, cheaper—and more likely to be effective...The idea is that machines, which are adept at pattern recognition, can sift through vast amounts of new and existing genetic, metabolic and clinical information to unravel the complex biological networks that underpin diseases. That, in turn, can help identify medications likely to work in specific patient populations, while simultaneously steering companies away from drugs that are likely to fail...In the past, drug companies have used artificial intelligence to examine chemistry—whether a drug might bind to a particular protein, for instance. But now the trend is to use AI to probe biological systems to get clues about how a drug might affect a patient’s cells or tissues...Biological insights driven by machine learning also could help pharmaceutical companies better identify and recruit patients for clinical trials of therapies most likely to work for them, perhaps boosting the chances of those medications’ getting approved by regulatory agencies...The big difference between AI-driven drug trials and traditional ones...is "we’re not making any hypotheses up front. We’re not allowing [human] hypotheses to generate data. We’re using the patient-derived data to generate hypotheses."
- Opioid prescribing is falling in the US, but not everywhere (philly.com)
Centers for Disease Control and Prevention...Prescriptions per capita, measured in morphine equivalents to account for various strengths and drug types, have declined steadily since their 2010 peak...Half the nation’s counties saw a decline (a quarter were stable) from 2010 to 2015. But there was wide variation, with providers in the highest-prescribing counties writing scripts for six times more opioids per resident than those in the lowest-prescribing counties...Nationally, the epidemic has been driven by high rates of addiction in more rural and white areas...Looking at county-level prescribing data helped CDC researchers to shed more light on some patterns of the painkiller epidemic. Counties with high rates tended to:
- Contain small cities or large towns (perhaps with pharmacies that drew residents from rural areas)
- Have higher percentages of white residents
- Have more dentists and primary-care physicians per capita
- Have more residents who were uninsured or unemployed
- Have more people with diabetes, arthritis, or a disability
But county-by-county analyses also illustrated how much is unknown about where and why opioids are given.
- New Pain Drug Likely To Face Price Challenges From Payers (forbes.com)
Centrexion Therapeutics announcing six-month data with its drug, CNTX-4975, for the treatment of moderate to severe knee osteoarthritis pain. The results are from a Phase 2b trial...and Centrexion is pretty excited by what has been seen so far:..The new data show large and statistically significant pain relief...a single 1 mg injection...resulted in large levels of pain reduction compared to baseline and statistical separation from placebo...These data represent the largest reductions seen in knee osteoarthritis reported for any drug treatment, marketed or in development…the active component is capsaicin...CNTX-4975 is "based on Centrexion’s proprietary STRATI technology (Synthetic TRans cApsaicin ultra-pure Injection), a highly potent, ultrapure, synthetic form of trans-capsaicin."...In certain ways, CNTX-4975 is reminiscent of the EpiPen. The active component of the latter is epinephrine, which, like capsaicin, is a drug that’s been known for decades. It’s the injector device, however, and not the drug, that drives Mylan’s proprietary position–and price–for the EpiPen. Similarly, the STRATI technology is what protects CNTX-4975 competitively, as anyone can easily access trans-capsaicin. In addition, epinephrine and trans-capsaicin are cheap drugs. These aren’t complex biologic molecules...The major cost will be for the STRATI technology...it is possible that Centrexion and its investors are going to demand premium pricing for the unprecedented pain relief...How will payers react?