French drugs firm takes legal steps to prevent the launch of rival versions of its diabetes treatment
PARIS— Sanofi SA said it filed a lawsuit against Merck & Co. for alleged patent infringements to prevent the U.S. drugmaker from launching a rival version of the French pharmaceutical giant’s best-selling diabetes treatment Lantus.
In the filing in the U.S. District Court of Delaware, Sanofi said on Monday it claims that Merck Sharp & Dohme Corp., Merck & Co.’s international division, violated as many as 10 patents held by the French company, including ones for its insulin Lantus and its insulin delivery device soloSTAR.
The Paris-based drugs company said it started the legal proceedings against Merck after the U.S. firm’s filing for new drugs applications with the U.S. Food & Drug Administration.
A spokeswoman for Merck said the company’s product “doesn’t infringe Sanofi’s patents.”
Sanofi shares were 1.3% higher at €69.91 in midday trading.
The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue.
In the first six months of the year, diabetes revenue fell by 6% to €2.9 billion ($3.2 billion), hit by a 15% drop in Lantus sales to €2.38 billion. The company has said it expects revenue from diabetes drugs to continue to decline this as competition among insulin makers intensifies.
In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi.
In a bid to replenish its new drugs pipeline and revive growth, Sanofifor months had pursued U.S. biotech Medivation—a Nasdaq-listed company that focuses on hard-to-treat cancers, markets one prostate-cancer therapy, Xtandi, and has two other oncology assets in clinical development.
Big Pharma Promotes Legal Drug Addiction
Many of us believe that Big Pharma must be held accountable for this dangerous opioid trend, especially since several have been caught lying about the benefits and risks of their drugs.
As noted by the Organic Consumers Association (OCA), the drug industry has “fostered the opioid addiction epidemic” in several ways, by:
- Introducing long-acting opioid painkillers like OxyContin, which prior to reformulation in 2010 could be snorted or shot. Many addicts claimed the high from OxyContin was better than heroin. In fact, from a chemical standpoint, OxyContin is nearly identical to heroin, and has been identified as a major gateway drug to heroin.
- Changing pain prescription guidelines to make opioids the first choice for lower back and other pain conditions that previously did not qualify for these types of drugs. Even the World Health Organization (WHO) has had a hand in this problem, although it restricted its promotion of narcotic painkillers to cancer patients.
- Promoting long-term use of opioids, even though there’s no evidence that using these drugs long term is safe and effective
- Downplaying and misinforming doctors and patients about the addictive nature of opioid drugs. OxyContin, for example, became a blockbuster drug mainly through misleading claims, which Purdue Pharma knew were false from the start. The basic promise was that it provided pain relief for a full 12 hours, twice as long as generic drugs, giving patients “smooth and sustained pain control all day and all night.”However, for many the effects do not last anywhere near 12 hours, and once the drug wears off, painful withdrawal symptoms set in, including body aches, nausea and anxiety. These symptoms, in addition to the return of the original pain, quickly begin to feed the cycle of addiction.7
A 2015 article in The Week does a great job revealing the promotional strategy developed by Purdue, and backed by the US Food and Drug Administration (FDA), that has led to such enormous personal tragedy.
As noted in this article: “The time-release conceit even worked on the FDA, which stated that ‘Delayed absorption, as provided by OxyContin tablets is believed to reduce the abuse liability of a drug.’”
Other recent research has found that medical marijuana lowers prescription drug use.
The Big Q: Could that be why it hasn’t been rescheduled?
There are no other truly compelling reasons why addictive narcotics like OxyContin are legal, while marijuana, which is extremely unlikely to kill even if one take very high amounts is not.
Read Full Article – http://www.livetradingnews.com/big-pharma-promotes-legal-drug-addiction-10406.html#.V6F8KZMrKRs
Whenever there is a report of a drug company jacking up the price of a prescription medication, the pharma industry is often quick to point out that there are non-profit charities ready and willing to help patients get these drugs at a more affordable rate. However, those charities may have very close ties to the drug maker that could not only help the company turn a profit, but avoid some tax obligations. In recent months, several large pharmaceutical companies have been subpoenaed as part of an ongoing federal investigation into these connections.
It works like this: Bob’s Drug Company acquires the rights to prescription drug Gleemonex and decides to jack up the price 500%, knowing that some people will not be able to afford the co-pay. However, it’s in the interest of Bob to keep as many patients using Gleemonex as possible, so it looks for ways to make the drug more affordable to those most in need: low-income patients on Medicare.
Now, Bob’s Drug Co. can’t directly fund the co-pay of a Medicare patient. That would effectively be Bob paying Bob, which is an illegal kickback under federal law. What Bob can do is call Sally’s Drug Charity, which will cover the Medicare co-pay on certain drugs.
So Bob makes a sizable donation, which Sally can then use to make Medicare co-pays, meaning patients continue using Gleemonex.
Thing is, while the Medicare patient isn’t having to go broke paying for Gleemonex, taxpayers might be. After all, the co-pay is usually only a fraction of the full amount that Medicare pays to the drug maker. Thus, Bob continues to get the full Medicare payment and enjoy the tax write-off from his donation to Sally’s charity.
Bloomberg BusinessWeek recently published an entire cover story on how the pharma industry uses these charities for their own financial, tax, and public-relations benefit. You should definitely check it out.
Today, Bloomberg published a story on the string of subpoenas issued to four high-profile pharma companies — Valeant, Gilead Sciencse, Biogen, and Jazz Pharmaceuticals — since last fall, mostly by federal prosecutors out of Massachusetts.
The nature of the subpoenas is vague, though they do reference investigations into the companies’ relationships with co-pay charties.
With Medicare on the hook for the balance of these prescription payments, the federal government is taking a particular interest in the possibility that drug makers have exerted too much influence over these charities as donations have grown.
Since 2010, donations to the seven biggest co-pay charities have more than doubled, reaching $1.1 billion in 2014.
Going back to the above fictional example: Under the law, Sally is not supposed to be swayed by Bob or other donors when it comes to which drugs it chooses to cover, which patients to accept, or how much of each drugs co-pay it will subsidize. So if Sally is covers co-pays for a competitor to Gleemonex, she can’t be swayed by Bob’s big bucks to give preferential treatment to his drug.
Recent reports indicate that some charities’ practices may have been motivated by donor money. For example, former employees at one charity told Bloomberg that when patients needed Jazz narcolepsy medication Xyrem, they were processed in a time manner, while patients seeking co-pay help for competing narcolepsy drugs were sometimes steered away or wait-listed if that other company wasn’t also donating to the charity.
The charities have denied allegations of favoritism of bad practices.
Sourced From – https://consumerist.com/2016/05/27/drug-companies-subpoenaed-over-questionable-charity-connections/