News and Events - 20 Mar 2012

Newspaper Report: Generic Drug maker Could Profit From Own Shortage

19.03.2012 18:48:37

Drug maker could profit from own shortage [Winnipeg Free Press (Canada ]   From Winnipeg Free Press (Canada (March 17, 2012   OTTAWA -- The generic drug maker at the centre of the nationwide medication shortage stands to profit from the...

Generic Boniva Approved for Osteoporosis

2012-03-19T21:04:06Z

MONDAY, March 19 (HealthDay News -- The first generic versions of the once-monthly osteoporosis drug Boniva (ibandronate have been approved by the U.S. Food and Drug Administration.

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New and Generic Drug Approvals

19.03.2012 23:01:00

Drug Approval Listing

Mylan Canada Receives Health Canada Approval for Generic Version of Crestor

16.03.2012 1:43:40

PITTSBURGH and TORONTO, March 15, 2012 /PRNewswire/ -- Mylan Pharmaceuticals ULC, the Canadian subsidiary of Mylan Inc. (NASDAQ: MYL , today received approval from Health Canada for Mylan-Rosuvastatin Calcium Tablets, 5mg, 10mg, 20mg and...

FDA approves first Boniva generics to treat or prevent osteoporosis

19.03.2012 22:01:00

The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

News and Events - 18 Mar 2012

Drugmakers' fury as China plans to widen price-cutting system

16.03.2012 14:00:00

Lynne Taylor

Domestic and multinational drugmakers in China have strongly criticised government plans for a wider roll-out of a piloted competitive tendering system for medicines procurement which has been shown to cut the prices of essential drugs by at least 30%.

The plans were announced at the annual National People's Congress in Beijing, where national leaders said the tendering system would be rolled-out further to support an increase in state health insurance coverage and moves to make health care more affordable.

Related Links

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Although the tendering scheme was piloted in five Chinese provinces, it is generally referred to as the "Anhui model" because in Anhui, the country's fourth-poorest province, it has been shown to reduce prices of essential drugs by an average of 53% below their officially-set maximum retail prices, with some price levels being slashed as much as 90%.

"The tendering system that we have implemented for basic drugs has proved to be effective and able to guarantee the drugs' safety, reasonable price and timely supply. Our next step is to further improve on these plans," Bloomberg reports Sun Zhigang, deputy director of the National Development and Reform Commission and head of the health care reform bureau at the State Council, as saying.

Currently, the tendering system covers 307 essential drugs but Ministers want to increase this to around 800 products, and also to cover the procurement of more expensive drugs used in hospitals in the treatment of diseases such as cancer. Research-based drugmakers say that doing so would force them to compete on price with generics makers, but supporters of the proposal point out that most such drugs are expensive imports.

While some observers feel that drugmakers will benefit as the government continues to add more products to the essential drugs list and extend state health insurance coverage to more and more of China's 1.3 billion population, others believe that manufacturers are being used as scapegoats and sector leaders are unhappy at the implications for their industry of a wider roll-out of the Anhui model. Several domestic firms have warned that their profits are likely to be cut as a result of the widening of the competitive tendering model, with some saying that they have already had to take a loss in order to sell their drugs to the authorities in Anhui.

The healthcare reform "is basically about tendering to compete on prices," but what needs to be prioritised is "guaranteeing quality first, rather than focusing on just prices, or this will be very unfair to China's drugmakers," Bloomberg quotes Guo Guangchang, chairman and co-founder of Fosun International, which controls the major drug maker Shanghai Fosun Pharmaceutical Co, as saying.

Last year, IMS Health forecast that drug spending in China will increase at the fastest rate globally during 2010-1015, with annual growth averaging 19%-22% and reaching as much as $125 billion by the end of the period.

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Indian health groups welcome country’s first compulsory licence | BMJ

16.03.2012 20:38:00

1. 
   Ganapati Mudur
   
   

Author Affiliations

1. 
   
   
   ¹New Delhi
   

India’s controller of patents has granted the country’s first compulsory licence on a patented drug, allowing a domestic drug company to manufacture a generic version of Bayer’s sorafenib tosylate (marketed as Nexavar , used in chemotherapy for hepatic and renal cancers.

Natco Pharma asked for the right to manufacture sorafenib tosylate, saying that it would make available a generic version that would cost patients 8800 rupees (?110; ˆ135; $175 a month rather than the 280?000 rupees a month it costs for Bayer’s product. The controller granted the licence and ruled that Natco Pharma should pay Bayer a royalty fee of 6% on sales of the generic version.

Experts in public health who have been campaigning for better access to inexpensive generic drugs have hailed the controller’s decision, but sections of the pharmaceutical industry have said that compulsory licensing should be invoked only in public health emergencies and not to reduce the prices of drugs.

Bayer, which has the right to appeal, has said it is disappointed by the decision.

However, patient support groups are looking forward to more compulsory licences in other therapeutic areas. Yogendra Sapru, chief executive of the Cancer Patients Aid Association, said in a statement released after the controller’s decision this week, “Many other cancer medicines are sold at exorbitant prices in India.”

A single vial of patented trastuzumab (Herceptin , which is used in combination with paclitaxel to treat metastatic breast cancer, costs about 132?000 rupees in India, says a report from the Centre for Trade and Development, a policy think tank in New Delhi.

Malluparambil Santhosh, associate fellow at the think tank, said, “Herceptin chemotherapy in India is currently beyond the reach of the vast majority of patients who need it.”

A patented version of interferon used to treat hepatitis C virus infection is another example of a drug that most patients can’t afford, he said.

A senior health economist said that India will need to use all available tools to reduce prices of drugs given the government’s plans to introduce universal healthcare, including free drugs, announced last year (
BMJ
2011;343:d6774, doi:
10.1136/bmj.d6774 .

Sakthivel Selvaraj, an economist with the Public Health Foundation of India, New Delhi, said, “Compulsory licensing fits in with the goal of government procurement of drugs and distribution of free medicines for inpatient and outpatient healthcare.”

India changed its patent laws in 2005 to allow product patents on drugs, including the provision of compulsory licensing—as have other countries, as this is allowed under World Trade Organization rules. Brazil and Thailand have already used compulsory licences to make available antiretrovirals and anticancer drugs to their populations.

“India has been lagging behind on compulsory licensing despite huge expenses on drugs,” Dr Selvaraj told the
BMJ
. A nationwide survey of healthcare spending has shown that expenditure on drugs had accounted for about 68% of total personal spending on healthcare in India between April 2009 and March 2010.

The Organisation of Pharmaceutical Producers of India, which mainly represents international drug companies, has said that it has no objection to the use of compulsory licensing in a national emergency but believes that broadening its scope for “affordability” could result in the abuse of this provision.

India’s Association of Biotechnology Led Enterprises has said that it supports strong protection of intellectual property and opposes compulsory licences on “frivolous” grounds. “The government should clearly specify the criteria for issuing compulsory licences,” said Nandita Chandavarkar, its director of operations.

But health groups say that such reactions are predictable. “The idea that compulsory licensing should be limited only to emergencies is a myth promoted by multinational companies,” said Anand Grover, a director of Lawyers Collective, a non-government organisation that has represented cancer and HIV patients’ groups in court.

Mr Grover said that members of the World Trade Organization, including the United States and the European Union, had signed the Doha Declaration in 2001, which recognises the right to grant compulsory licences and the freedom to determine the grounds on which such licences are granted.

“India is likely to experience intense pressure from the developed countries and multinational corporations in the coming weeks to go slow on compulsory licensing,” said the Centre for Trade and Development’s Mr Santhosh.

Notes

Cite this as:
BMJ
2012;344:e2132

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US drug shortages could continue for years : The Lancet

16.03.2012 8:44:00

Sharmila Devi

Recent shortages of critical drugs in the USA have hampered patient care and attracted much media attention. Sharmila Devi examines the problems with America's drug supply.

Severe shortages of drugs such as sterile injectables that have forced physicians in the USA to practise medicine from crisis to crisis are likely to continue for several more years, say regulators and health-care providers.

Around 280 drugs, almost all manufactured in the USA, remain in short supply because of factors including a dwindling number of makers of some drugs, deteriorating conditions in factories, and low prices for generics leading to a lack of investment to upgrade plants.

The shortages have led to delays in surgery and cancer treatments, left patients in pain, and forced hospitals to prescribe less effective treatment, said a review by the Associated Press late last year. At least 15 deaths in 15 months were blamed on the shortages, according to data compiled by the Institute for Safe Medication Practices, a patient safety group, and the true number might be higher because many deaths and injuries caused by shortages go unreported.

“We don't have any expectation the issue will be resolved soon”, Sandra Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, told The Lancet. “It will be several years before companies building new plants get them up and running.”

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Popular Prescription Drugs Hitting the Market in Generic Form

15.03.2012 14:47:32

Source: Food and Drug Administration
Related MedlinePlus Page:
Drug Safety

Levitra Genérico, Propecia Generico Brazil, Avodart Genérico

16.03.2012 13:41:08

Levitra Genérico é usado no tratamento de problemas do foro sexual, como impotência ou disfunção eréctil. O genérico é produzido pela Indian FDA-produtor aprovado em GMP. VARDENAFIL é usado no tratamento dos problemas de erecção nos homens.
Levitra generico comprar funciona mais rápido que o Sildenafil (Viagra® e é menos provável que tenha distúrbios visuais como efeito secundário.


Propecia Generico é usado no tratamento dos sintomas de hiperplasia prostática benigna (BPH em homens com a próstata alargada. É também usado para tratar certos tipos de queda de cabelo (alopecia androgénica em homens.
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Forest mourns as Teva celebrates launch of generic Lexapro - FiercePharma

16.03.2012 8:47:00

Forest Laboratories (
$FRX could well be playing a dirge at corporate headquarters today. The company's leading drug,
Lexapro, now has new generic competition. Teva Pharmaceutical Industries (
$TEVA got FDA approval for its version yesterday, and immediately started shipping the product, putting some $2.9 billion of Forest's annual sales at risk.

Though Forest has been anticipating this event for years now, and has made some progress at filling the impending sales gap, it's not going to have an easy time over the next couple of years. Lexapro is far and away the company's biggest drug, accounting for around half its U.S. revenue.

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New and Generic Drug Approvals

16.03.2012 23:14:00

Drug Approval Listing

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News and Events - 16 Mar 2012

Generic Nexavar Cancer Drug Go-Ahead for Natco

Pharma International's US Correspondent

13.03.2012 11:48:07

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."

Risperdal has role in J&J probe by U.S. By David Sell INQUIRER STAFF WRITER

14.03.2012 13:32:00

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.

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Indian Govt uses special powers to slash cancer drug price by 97% - The Times of India

13.03.2012 4:48:00

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.

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Teva gets exclusive 180 days to market generic antidepressant and anti-anxiety pill Lexapro

editors

15.03.2012 22:02:00

Teva Pharmaceutical Industries Ltd. Has won U.S. approval to sell the first generic version of Lexapro for depression and anxiety. Teva has been granted a 180-day exclusivity, so no other firm can market the generic medication in the United States in that timeframe, the Food and Drug Administration (FDA said in a news release.

http://www.news-medical.net/news/20120315/Teva-gets-exclusive-180-days-to-market-generic-antidepressant-and-anti-anxiety-pill-Lexapro.aspx#comment

AstraZeneca sues to protect Seroquel rights - - The Buffalo News

13.03.2012 11:27:00

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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Annette Bourdeau: '80s TV Shows We'd Like To See Revived (In Movie Form

15.03.2012 23:22:13

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?

http://news.moviefone.ca/annette-bourdeau/80s-tv-shows-movie-remakes_b_1347704.html#comments