Industry Blog

Powerful drug for arthritis approved in Scotland.

An arthritis drug that is quite powerful has been approved in Scotland after it was feared it was too expensive for patients in England & Wales.

 

The NICE (National Institute for Health & Clinical Excellence) has said that the drug Tocilizumab was too expensive for people not living in Scotland.

 

The treatment aims an inflammatory signaling molecule to reduce symptoms, used in combination with standard anti-inflammatory drug MTX researchers have discovered that Tocilizumab can improve remission rates for those with arthritis.

 

Leading rheumatologist Professor John Isaacs, from the Institute of Cellular Medicine at the University of Newcastle, said: “This is fantastic news for people in Scotland who suffer from this disabling, life-long disease.

“However, it also highlights the disparities in accessing treatment between Scotland and the rest of the UK.”

Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society, which receives support from pharmaceutical companies including Roche, said: “The SMC’s decision provides people with rheumatoid arthritis in Scotland who face a life of pain and potential disability another chance of combating their disease.

“We strongly hope that Nice will revise its draft guidance to ensure that people with rheumatoid arthritis across the country are able to benefit from RoActemra.”

 

 

J&J Paid Kickbacks to hike sales of deadly drug.

Johnson&Johnson have paid tens of millions of dollars in kickbacks in aid of nursing homes putting more patients on its Schizophrenia medicine, U.S Prosecutors have said.

A complaint was filed last Friday stating that J&J paid rebates and other forms of kickbacks to Omnicare Inc. (the biggest dispenser of prescription drugs in nursing homes). Omnicare are alleged then recommended that nursing home patients which have signs of Alzheimer’s disease to be prescribed the powerful drug ‘Risperdal’, which has been found to cause death in elderly patients.

“Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving,” U.S. Attorney Carmen Ortiz said in a statement. “Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy.”

Drugs company pledges £10m to increase testing at the Olympics

GlaxoSmithKline, the British drug-maker, will build a £10 million laboratory to test thousands of athletes during the 2012 Olympics and Paralympics under a sponsorship deal announced yesterday by London organisers.

It is the first time that an anti-doping programme at an Olympic Games has been sponsored and it will raise eyebrows that it has been supported by a pharmaceutical company.

The cost of running an independent lab required by the IOC to analyse blood and urine samples from competitors has previously been covered by the local organising committee.

The deal was welcomed by anti-drugs campaigners for increasing the resources available to King’s College London, which has been involved in testing at two summer Games and has the contract for 2012, but raised concerns about the commercial interests of the world’s second biggest pharmaceutical company.

GSK will provide equipment and scientists to the lab, which will be accredited by the World Anti-Doping Agency (Wada) and operate from one of the company’s facilities in Hertfordshire or Essex.

David Cowan, the director of the college’s drug control centre, said that the deal would increase his capacity by between ten and 14 times in terms of the number of tests and the scientists at his disposal. More than 5,000 tests were conducted in Beijing last year. London organisers aim to test half of the 10,500 athletes competing at the Olympics and 1,500 athletes at the Paralympics.

“There is no way we could have done it with our existing facility,” he said. “I think this will be a winning solution and the higher volume of testing will act as a deterrent.”

The centre at King’s College conducted more than 8,000 tests across 70 sports last year as part of UK Sport’s anti-doping programme. Cowan stressed its independence from any pharmaceutical group. “There is a definite wall between us,” he said.

However, there are concerns about the potential influence of a company, some of whose products are made with ingredients banned by the IOC.

Substances on Wada’s prohibited list include salbutamol, which is permitted for asthma sufferers under an exemption. Its abuse by athletes as an alternative to clenbuterol, which reduces body fat, means it has been a prohibited substance. From 2010, however, the use of inhaled salbutamol — the key ingredient in Ventolin, GSK’s best-selling asthma treatment — will no longer be banned.

Michele Verroken, an international anti-doping expert, said the involvement of a pharmaceutical company in the anti-doping fight called for greater transparency in the decisions that lead to revisions of the banned list.

She said: “Anti-doping is a huge financial strain on sport so I welcome the extra resources, but I am uncomfortable that some of Glaxo’s products may end up with a more favourable status than others when it comes to therapeutic use exemptions.”

GSK denied that its support of the London 2012 drug-testing programme was commercially motivated. A spokesman said: “Our sponsorship prohibits any leverage of our brands. We cannot put the Olympic rings on Lucozade or Ribena bottles or any of our pharmaceutical products. A better scientific understanding is where our future vested interest is.”

Source: TIMES ONLINE

Glenmark settles patent dispute with Medicis

Pharma firm Glenmark today said it has settled all pending patent disputes with US-based Medicis Pharmaceutical Corp over a skin disease drug, besides signing a licensing agreement for new drug delivery system (NDDS).

The company through its US-based subsidiary Glenmark Generics Inc has announced the settlement of all litigation pending between Medicis and Glenmark related to the generic version of Vanos and Loprox gel, used in the treatment in dermatology therapeutic area, Glenmark Pharmaceutical spokesperson told PTI.

Under the terms of the agreement Glenmark will be able to market and distribute the generic version of Vanos cream under license from Medicis from December 2013. In addition, Glenmark will be able to launch the generic version of Loprox gel in 0.77 per cent strength immediately, he added.

Source: ptinews.com

APP Pharmaceuticals Receives Approval for the First Generic Chlorothiazide Sodium for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi
Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today that it has
received approval from the U.S. Food and Drug Administration (FDA) to market
Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide
Sodium for Injection, USP in the fourth quarter of 2009.

Chlorothiazide Sodium for Injection, USP is therapeutically equivalent to the
reference-listed drug Diuril, which is marketed by Lundbeck Pharmaceuticals.
According to 2008 IMS data, sales of this product in the United States were
approximately $51 million1. Chlorothiazide is a diuretic used to treat high
blood pressure (hypertension), as well as fluid retention in people with
congestive heart failure, cirrhosis of the liver, kidney disorders, or edema
caused by taking steroids or estrogen.

“The recent stream of ANDA approvals reinforces APP`s commitment to provide our
customers and the patients they treat with a consistently expanding portfolio of
products,” said Thomas H. Silberg, president and chief executive officer of APP
Pharmaceuticals.

Source: www.reuters.com

Generics tear into J&J third-quarter pharma sales

Johnson & Johnson has begun the quarterly results season by posting a major decline in pharmaceutical revenues, though profits edged up on the back of cost-cutting.

Group net earnings for the third quarter were up 1.1% to $3.35 billion while turnover was down 5.3% to $15.08 billion. Worldwide pharmaceutical sales reached $5.25 billion, a fall of 14.1%, as two of its older products were hit by loss of patent protection.

Turnover from the antipsychotic Risperdal (risperidone) collapsed 40.0% to $192 million, as generic competition tore into US sales of the blockbuster (down 71.3% to just $35 million). The longer-acting form of the drug, Risperdal Consta, was up 4.4% to $353 million.

The epilepsy drug Topamax (topiramate) was also hit by generics and brought in $175 million, down 76.0%. Sales of J&J’s anaemia therapy Procrit/Eprex (epoetin alfa) fell 12.4% to $542 million, hurt by continued concerns over cardiovascular safety for the entire erythropoiesis-stimulating class of drugs. The Alzheimer’s disease drug Reminyl/Razadyne (galantamine) sank 29.7% to $97 million, and the USA contributed just $1 million to that total, while turnover from the attention-deficit hyperactivity disorder therapy Concerta (methylphenidate) fell 28.6% to $284 million.

On the positive side, J&J’s biggest seller was once again the anti-inflammatory Remicade (infliximab), sales of which were up 5.9% to $1.04 billion, while Velcade (bortezomib), for the treatment of patients with multiple myeloma and mantle cell lymphoma, was up 21.6% to $231 million. Sales of the new HIV therapy Prezista (darunavir) were up 91.1% to $151 million.

As for J&J’s other divisions, medical devices and diagnostics sales reached $5.84 billion, a 2.3% increase, while turnover from the consumer division was down 2.7% to $3.99 billion. Chief executive William Weldon was pleased with the performance saying that the firm continues to successfully manage “our broad base of businesses and deliver solid earnings despite the impact of patent expirations and the challenges posed by the current economic environment”.

He added that the group has completed “multiple acquisitions and strategic collaborations and received several new product approvals” in the quarter that will drive future growth. These include buying major stakes in Elan Corp and Crucell, plus a US approval for Stelara (ustekinumab) for the treatment of psoriasis and a European thumbs-up for the arthritis drug Simponi (golimumab).

Analysts were disappointed with the scale of the decline in pharmaceuticals turnover but were pleasantly surprised by J&J upping its 2009 earnings per share target to $4.54-$4.59, excluding certain items, from $4.45-$4.55.

Source: www.Pharmatimes.com

Pharmaceutical giants eye China’s booming market

China’s ambitious $124-billion effort to provide basic health coverage for the vast majority of its 1.3 billion citizens by 2011 is a brimming opportunity for global pharmaceutical companies.

As growth in the US and European markets remains sluggish, many giant pharmaceutical companies are expanding their sales forces, distribution channels and research operations in China to tap into the country’s robust drug market.

China’s drug market is expected to grow about 22 percent annually over the next five years, said Mandy Chui, senior principal of (Intercontinental Marketing Services) IMS Health Inc.

Chui is the China expert at IMS Health, which provides market data on the pharmaceutical and healthcare industries.

“We see companies continuing to invest in China because the other markets are not growing,” Chui said. “For companies, (China’s growth) is certainly a good story to tell to Wall Street, right?”

With a huge and aging population, rapid urbanization and adoption of Western lifestyles that give rise to hypertension, obesity and other diseases, China is poised to become the world’s third-biggest pharmaceutical market by 2013, up from its current No 5 spot, said Chui.

The $24.5-billion market is expected to swell to betweem $68 billion and $78 billion by 2013, Chui said, leaving it behind only the US and Japan.

“China is taking over from Germany and France,” she said.

“It’s like a big wake-up call. If they (big pharmaceutical companies) are not in there at this point in time, all of them are not going to grow,” Chui said.

In the race to penetrate the Chinese market, she said European drug makers such as Bayer AG, AstraZeneca PLC and Sanofi-Aventis SA have taken the lead.

www.chinadaily.com.cn

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