The government in India has granted the rights to an indigenous pharmaceutical group to manufacture a generic version of the cancer treatment drug Nexavar.
For the first time, an Indian drugs firm has been approved to produce a medication under licence when the original's still patent-covered.
As a result of the agreement, the firm - Natco Pharma - is obliged to forward six per cent in royalties back to Bayer, which presently markets Nexavar alongside Onyx Pharmaceuticals.
Bayer, meanwhile - according to reports - isn't best pleased with the Indian government's move. "We are disappointed about this decision", company representative Sabrina Cusimano stated in comments made to the Associated Press. "We will see if we can further defend our intellectual property rights in India".
Nexavar Cancer Drug
Nexavar is the market name for sorafenib, an orally-taken medication now approved to treat two types of cancer - advanced hepatocellular carcinoma (liver cancer and advanced renal cell carcinoma (kidney cancer .
The kidney cancer approval came first, in 2005, when the US FDA declared its satisfaction with the product. It did the same for the drug as a liver cancer treatment two years later and, with clinical trials now in progress, thyroid cancer could be the next condition added to this approved treatment list.
Controversially, the drug's not available as a
UK liver cancer treatment, after being rejected - on grounds of cost - by the National Institute for Health and Clinical Excellence in November 2009.
Natco Generic Nexavar Approval
The Natco generic Nexavar approval decision will see the production of drug copies priced at the equivalent of £112 for a box of 120: less than £1.00 each. This is dramatically cheaper than the original drug, with the same quantity presently priced at over 30 times that cost.
The Indian pharmaceutical firm believes that the drug's availability is key to the treatment of close to 9,000 cancer patients in India.
"This is a victory for Indian patients and for India's generic manufacturers, which are under attack", Natco Pharma's General Manager, Madineedi Adinarayana, stated according to the BBC, adding: "many more such cases will follow."
One Pennsylvania doctor in 2008 wrote 1,913 prescriptions for the antipsychotic drug Risperdal - a bit more than 5.2 per day in that leap year, counting weekends and holidays - costing Medicaid $341,273.71.
The top 10 prescribers in Pennsylvania's system that year wrote 9,557 Risperdal scripts costing Medicaid $1.76 million, according to figures provided by a state official to U.S. Sen. Charles Grassley (R., Iowa , who has pushed for disclosure of such information and the relationship between doctors and pharmaceutical companies.
The numbers raised questions for Grassley, and Pennsylvania officials sent letters to scores of doctors emphasizing the need for safety in prescribing antipsychotic drugs. Twelve were suspended, dropped from Medicaid, or are under investigation, according to a copy of a letter to Grassley released Tuesday by the state welfare department.
The numbers also play a role in the U.S. Department of Justice's efforts to fight health care fraud. In the case of Risperdal, the Justice Department is negotiating with Johnson & Johnson, whose Janssen subsidiary makes the drug, to address allegations that the company illegally promoted it to doctors and through Medicaid programs.
Medicaid is the taxpayer-funded insurance plan for poor Americans and is administered by the federal and state governments.
J&J previously disclosed that it set aside money to settle criminal and civil charges in the Risperdal litigation, though it had not specified the amount.
Reports over the weekend from the Wall Street Journal and Bloomberg News said the Justice Department had demanded a payment of about $1.8 billion, an increase from the $1 billion figure reportedly negotiated by the U.S. Attorney's Office in Philadelphia in December.
Spokesmen for J&J, the Justice Department, and the U.S. Attorney's Office declined to comment.
The $1.8 billion figure would be the largest settlement for a case involving a single drug, but some of the other big settlements also involved antipsychotic drugs.
"Both Sen. Grassley and the Department of Justice are making great headway in the battle against Medicaid fraud," said Allen Jones, the former investigator for Pennsylvania's Office of Inspector General whose findings were ignored by state officials in 2004.
Jones was fired by state officials when he took the information to the New York Times, but his whistle-blower lawsuit resulted in J&J's paying $158 million to settle charges that it illegally marketed Risperdal through the Texas Medicaid system. Jones will get a portion of that settlement. He now works as an adviser to attorneys in related litigation.
Eli Lilly & Co. paid $1.7 billion to settle charges of illegal marketing of its antipsychotic drug Zyprexa. Pfizer Inc. paid $2.3 billion to settle charges of illegal marketing of several drugs, notably Bextra, but also its antipsychotic Geodon. Late in 2011, GlaxoSmithKline P.L.C. said it had reached a deal to pay $3 billion to settle charges related to several drugs, including Avandia, but the Justice Department has declined to comment on that one as well.
Jones provided The Inquirer with state figures sent to Grassley's office in 2010 by Michael Nardone, then an official with the Pennsylvania Medical Assistance Program.
New Jersey never responded to Grassley's 2010 request for information nor a follow-up letter dated Jan. 24. State officials could not be reached for comment Tuesday. Delaware Medicaid officials responded to Grassley in 2010 and again in February.
J&J's Risperdal lost patent protection at the end of 2007, so the 2008 figures were the beginning of the decline in costs as generic versions were used more often.
As a comparison, AstraZeneca P.L.C.'s antipsychotic, Seroquel, is just now losing patent protection on most versions.
In 2008, the top 10 prescribers in Pennsylvania wrote 18,705 prescriptions for Seroquel, costing Medicaid $3.67 million. State officials provided The Inquirer with the most recent response to Grassley. That letter says the top 10 prescribers wrote 17,692 scripts for Seroquel, costing Medicaid $5.73 million.
In 2010, AstraZeneca paid $520 million to settle charge of illegal marketing of Seroquel.
"I liken the DOJ effort to a storm surge building for a long time," Jones said, crediting Grassley and a few others in Congress for helping to push the issue. "They have a clear eye on the dirty ways of fraudulent marketing and are systematically exposing it. It is changing the way antipsychotic drugs are marketed in America."
Contact David Sell at 215-854-4506 or
dsell@phillynews.com.
MUMBAI: In a landmark decision that could set a precedent on how life-saving drugs under patents can be made affordable, the government has allowed a domestic company, Natco Pharma, to manufacture a copycat version of Bayer's patented anti-cancer drug, Nexavar, bringing down its price by 97%.
In the first-ever case of compulsory licencing approval, the Indian Patent Office on Monday cleared the application of Hyderabad's
Natco Pharma to sell generic drug Nexavar, used for renal and liver cancer, at Rs 8,880 (around $175 for a 120-capsule pack for a month's therapy.
Bayer offers it for over Rs 2.8 lakh (roughly $5,500 per 120 capsule. The order provides hope for patients who cannot afford these drugs.
The approval paves the way for the launch of Natco's drug in the market, a company official told TOI, adding that it will pay a 6% royalty on net sales every quarter to Bayer. The licence will be valid till such time the drug's patent is valid, i.e. 2020. As per the CL (compulsory licence order, Natco is also committed to donating free supplies of the medicines to 600 patients each year.
Bayer said it was "disappointed" and would "evaluate options to defend intellectual property rights" in the country. In July 2011, Natco had applied for the CL in the Mumbai patent office to make Sorafenib Tosylate for which Bayer has a patent in the country since 2008.
LONDON (AP - Drug maker AstraZeneca has filed a suit in the United States that seeks to extend its exclusive rights on some forms of its antidepressant drug Seroquel until December.
The Anglo-Swedish company said Tuesday that it had filed its suit in the U.S. District Court in Washington, D.C.
The suit seeks to overturn a ruling last week by the U.S. Food and Drug Administration that generic copies of the drug would not have to carry the same warnings about possible side effects - including suicidal thoughts and elevated blood sugar - that were required of AstraZeneca.
The patent on the active ingredient in Seroquel and Seroquel XR expired in September.
Seroquel was AstraZeneca's second best-selling product, and the fifth biggest seller in the United States.
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Hollywood seems intent on reviving popular '80s TV shows for the big screen these days, with varying degrees of success. Flicks like
The A-Team
and
Miami Vice
fell a bit flat, while ventures like
Alvin & the Chipmunks
(the first and second movies, anyway actually lived up to the '80s TV series.
This week's release
21 Jump Street
, thankfully, falls into the latter category. The big screen adaptation of the popular '80s cop show starring Johnny Depp is fast-paced, funny and even has a little heart. (And yes, Depp has a great cameo. Stars
Jonah Hill and
Channing Tatum play well off of each other as the sensitive nerd and dumb beefcake, respectively.
As in the series, our two heroes are undercover cops based out of a run-down church on Jump Street. This time around, they get sent back to high school to infiltrate a deadly drug ring. This triggers major anxiety for Hill's character, since high school was no picnic for nerds in his day. Tatum's character, on the other hand, goes into the operation expecting to be big man on campus again.
Of course, once they get to school they realize everything has changed. This leads into one of the funniest scenes in the movie as they try to identify the new social order among today's teens who embrace nerdiness and doing good, as opposed to the nonchalant badasses and jocks who ruled the schoolyard when they were teens.
Hill is funny, charming and endearingly vulnerable as the nerd who gets a second chance at popularity. Tatum fills his jock role adeptly. (Although I must say -- I feel like I'm missing something when it comes to him. He just seems so generic. But I digress.
It's refreshing to see an '80s remake actually done well. Which got us to thinking about other '80s TV shows we'd like to see on the big screen. (Done well, that is. No phoned-in cash grabs like
The A-Team
.
1.
Golden Girls
. The original cast is irreplaceable, so no remake could even hope to be as good as the original. However, it's a solid concept that could translate into a pretty decent movie. Besides, we really could use some more flicks about women over 40. And not the plastic-Barbie-Demi Moore kind of women over 40. I'm thinking something funny, outrageous and even a little sexy, a la
It's Complicated
meets
Grandma's Boy
. Shirley Jones (
The Partridge Family
would be great as sexpot Blanche.
2.
ALF
. Paul the stoner extraterrestrial was great, but as far as sassy aliens go, there's no topping ALF. I'm envisioning an action-comedy with ALF on a quest to rescue Rhonda, his Melmackian girlfriend, from some evil Area 51-types holding her captive for experiments. ALF's Willy-style nerdy best friend accompanies him on his journey.
3.
Doogie Howser
. It ain't easy being a child prodigy. The big screen adaptation could follow Doogie's quest to have some semblance of a normal teenage life. I'm thinking an Apatow-style dramatic comedy with heart.
4.
Who's the Boss?
I'm surprised this hasn't already been remade. After all, who doesn't like the idea of having a hunky housekeeper who becomes so-much-more? I'm envisioning a rom-com starring Mark Ruffalo and Drew Barrymore.
5.
Perfect Strangers
. We've seen the fish-out-of-water/free-spirit-loosens-up-uptight-businessman thing done time and again in movies. But there's something special about Larry and Balki that just might be worth revisiting on the big screen. Maybe
Horrible Bosses
co-stars Jason Bateman and Charlie Day could reunite as the uptight businessman and wacky distant cousin.
Any '80s TV shows
you'd
like to see made into movies?
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