Hanningfield Process Systems Join SHAPA

Hanningfield Process Systems are proud to announce they have been accepted in to the exclusive Solids Handling and Processing Association (SHAPA). SHAPA was founded in 1981 and is recognised as the foremostspecialist association for the solids handling and processing industry.

Managing Director, Colin Ellis, reflected the company’s excitement at the move stating “in a very important period for our company the time was right to seek to join SHAPA. This will give us access to a greater network of expertise and opportunities, whilst helping us to sustain our commitment to continuously improve production techniques by drawing upon the knowledge the association has to offer.“

For more information on any aspect of Hanningfield’s solids handling and processing expertise, please feel free to contact us.

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 LundbeckPharmaceuticals.
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

Pharmaceutical companies to pay $124M over Medicaid fraud charges

According to the Justice Department, four pharmaceutical companies will pay $124 million to resolve claims of Medicaid fraud.

Mylan Pharmaceuticals, UDL Laboratories, AstraZeneca Pharmaceuticals and Ortho McNeil Pharmaceutical have signed settlement agreements focusing on violations of the False Claims Act, which claimed they failed to pay appropriate rebates to state Medicaid programs for drugs.

“The settlement with Mylan and UDL is the largest healthcare fraud recovery that the U.S. Attorney’s Office in New Hampshire has ever obtained,” said John P. Kacavas, U.S. Attorney for the District of New Hampshire. “The settlements show that the government is committed to identifying healthcare fraud and ensuring that companies that benefit from doing business with the government agree to play by the rules.”

The Medicaid Prescription Drug Rebate Program was enacted by Congress in 1990 out of concern for the costs that Medicaid was paying for outpatient drugs.

By participating in the rebate program, the four companies agreed to pay quarterly rebates to Medicaid that were based upon the amount of money that the healthcare program paid for each company’s drugs. The amount of a rebate is determined in part by whether a drug is considered an “innovator” or a “non-innovator.”

The settlements resolve allegations that the companies sold innovator drugs that were manufactured by other corporations and had been classified as non-innovator drugs. The improper classification of these drugs allegedly enabled the companies to pay smaller rebates.

Mylan and UDL agreed to pay $118 million to resolve allegations involving several drugs from each company. AstraZeneca will pay $2.6 million to resolve allegations that it underpaid its rebate obligations with respect to Albuterol. Ortho McNeil will pay $3.4 million to resolve allegations that it underpaid its rebate obligations with respect to Dermatop.

“The Civil Division will continue to work with our state partners to ensure that Medicaid programs, which provide healthcare to more than 58 million Americans, receives the same discounts that any larger insurer gets,” said Tony West, Assistant Attorney General for the Civil Division. “These cases exemplify the strong cooperation between the Department of Justice and the states in protecting American taxpayers.”

The case was brought under the False Claims Act, which allows for private persons to file suits on behalf of the government. The whistleblower, Ven-A-Care, a corporation located in Key West, Fla., will receive almost $10.8 million as its share of the recovery.

Source: www.healthcarefinancenews.com

Australian Pharmaceutical Industries: a turnaround story

FULL-line drug distribution hasn’t been a brilliant sector: health minister Nicola Roxon is on a rampage to cut subsidies, there’s been unsettling realignments and constant pressure from cheaper generic drugs as the branded ones come off patent.

Australian Pharmaceutical Industries hasn’t been a brilliant investment generally, but it can’t all be blamed on Canberra’s stance on thePharmaceutical Benefits Scheme and the community service obligation (CSO) scheme (which subsidises distributors for providing obscure drugs to remote chemists).

We’ve had the impression API wouldn’t still be around had it not been for the competition regulation problems inherent in a rival taking over the company (they’ve tried).

The happier side to the API yarn is that new management has made strides in restoring margins and honing the company’s business strategy, which straddles health and beauty retailing via its Priceline chain, drug wholesaling to captive chemists under its Soul Pattinson and Pharmacy Advice banners and wider distribution to other pharmacies.

API this morning reported a “stronger than expected” (company’s words) net profit of $18.6 million for the full-year to August 31. More importantly, it’s joined the capital raising conga line to raise $150m and restore the stretched balance sheet to the industry average.

API chief Stephen Roche denies the banks forced the company into the placement and the non-renounceable rights issue, which is being done at a 38 per cent discount (patient 25 per cent shareholder Washington H Soul Pattinson has agreed to participate).

“There was no breach of covenants in the last financial year,” he says.

Priceline has proved a desirable asset in tighter times: women, it seems, haven’t forsaken lippie and shampoo but if they can get it cheaper then they will shop around.

Roche says sales have been bolstered by the introduction of a loyalty program, Club Card. Three million customers have signed up compared to MyerCard’s 3.2 million — and Priceline doesn’t have the Jennifer Hawkins factor.

According to Roche, Club Card holders account for 40 per cent of retail revenue and spend an average 30 per cent more than other punters.

On the distribution side, margins are still inadequate but the company claims to have won profitable market share.

Roche is sanguine about the current negotiations between the Pharmacy Guild and government over a new five-year agreement which will re-set the terms of full-service drug distribution.

“My personal view is the government wishes the CSO to remain intact … I don’t see fundamental industry change.”

The government, he notes, has priorities other than taking on the renowned force of the pharmacy lobby.”

If Criterion were an existing API holder he would take up the rights. Finally, a turnaround is in the offing.

Source: www.theaustralian.news.com.au

Transformative Times for BioSante Pharmaceuticals

The last 75 days have been transformative for BioSante,” Bill Milling, Sr. Dir Operations for BioSante Pharmaceuticals, Inc. (BPAX) told BioMedReports. Yesterday, the company announced positive safety data in its ongoing LibiGel Phase III clinical development program.

“First we closed a financing in August having raised $12 million,” explained Milling. “We then closed a merger on October 14 which brought in an additional $23 million and added a strong portfolio of cancer vaccines. Yesterday we reported very positive safety data in our LibiGel development program for the treatment of female sexual dysfunction. Overall, we now have enough cash to get through LibiGel clinical data and to an NDA.”

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism and yesterday they reported that the DMC reviewed all unblinded adverse events in the safety study including all “serious adverse events” and all “adverse cardiovascular and breast cancer events” in 1,055 women with 883 women-years of exposure. To date, there have been no deaths, one myocardial infarction and only three breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante LibiGel Phase III development program will continue as planned.

BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.

Last week, BioSante and Cell Genesys, Inc. (CEGE) announced the successful completion of their previously announced merger into BioSante, under which BioSante now has acquired all of the outstanding shares of Cell Genesys common stock. That deal was valued at $38 million.

BioSante Pharmaceuticals Inc. said Wednesday that it completed an all-stock buyout of Cell Genesys Inc. and the combined company will focus on developing a topical testosterone gel intended to treat sexual dysfunction in women, but it also plans to develop Cell Genesys’ cancer treatment GVAX. Cell Genesys, based in South San Francisco, Calif., was developing GVAX, as an immune treatment for prostate cancer, but discontinued testing last year after one trial was likely to fail and another had an unexpectedly high rate of patient deaths.

The company said GVAX is now being tested as a potential treatment for pancreatic cancer, leukemia and breast cancer.

BioSante also now owns a stake in Ceregene Inc., a former subsidiary of Cell Genesys, which is developing gene therapies for neurodegenerative disorders.

Several analysts are feeling bullish about the stock and feel it has good potential given it’s current Phrase III trial, cash reserves, latest safety news and the BioVant™ H1N1 adjuvant in their pipeline.

In August, BioSante announced that BioVant™, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.

Source: http://seekingalpha.com

Tory technology tsar calls for more support for scientists and engineers

Source: The Guardian

Sir James Dyson insists on cultural changes to ensure Britain takes prominent role in hi-tech development.

Vacuum cleaner entrepreneur Sir James Dyson today used his new position as Tory technology tsar to call for better support for scientists and engineers.
Dyson told the Conservative conference in Manchester that it was time for Britain to take a leading international role in the development of technology.
He hit out at banks that had created “illusory wealth” and warned that finances should be a “means to an end, not an end in themselves”.
The inventor is set to head a Conservative taskforce exploring ways in which Britain can become the leading hi-tech exporter in Europe.

The taskforce will look at how the country can harness the resources of its university science and engineering departments and generate a significant expansion of hi-tech product development.
Dyson told the conference: “As someone passionate about engineering and solving problems, I have a question for you: can Britain now only make money from money?
“Or can it make money from making things too?”

He added: “Britain’s long-term need to develop and sell new technology has been neglected.
“Exports have dwindled and imports have risen sharply, while the debt grows and grows. That’s why I’m here – not to make a party political comment or to blame any particular government but to call for a change in policy and attitude.
“More than ever, we need to value our scientists and engineers. Our future wealth depends on it.”
Dyson said scientists needed better financial support, such as further tax incentives, but insisted “cultural changes” were vital.

Source Location: http://www.guardian.co.uk/politics/2009/oct/05/dyson-scientists-money

L-DOS47 to be Highlighted at Pharmaceutical Industry Conference

Helix BioPharma Corp. today announced that a presentation on L-DOS47 formulation and analytical method development will be made at the “Formulation Strategies for Protein Therapeutics” conference to be held on October 13 to 15, 2009, in Raleigh, North Carolina. The conference is sponsored by IBC Life Sciences.

Dr. Tim Kelly, Vice President, Biopharmaceutical Development of KBI Biopharma, Durham N.C., will describe their work on L-DOS47 formulation development. Dr. Kelly’s presentation, entitled “Case Study: Novel Protein Therapeutics, Formulation Development for L-DOS47,” will take place at 12:00 p.m., EDT on October 14. KBI Biopharma provides Helix formulation support and conducts analytical and stability studies on L-DOS47 cGMP materials.

“It is a pleasure to see Dr. Kelly being invited to the forum,” said Heman Chao, chief scientific officer of Helix BioPharma. “It is an exciting opportunity to showcase formulation and analytical method development work completed on the L-DOS47 compound to our industry peers.”

Source: www.in.sys-con.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

PharmaTelevision Turns the Media Spotlight Upon BIO-Europe

PharmaTelevision(R), the authoritative channel for the pharmaceutical, biotechnology and related industries, today announced that it is teaming up with the EBD Group to offer delegates at BIO-Europe a Television Interview and Media Training.

Dr Fintan Walton, CEO of PharmaVentures - the company behind PharmaTelevision - said, “Standing out and attaining share of voice is becoming increasingly difficult in the crowded world of biopharma partnering. Effective communication that makes an impact is critical for attracting partners and winning deals. That is why we have devised this unique package for BIO-Europe delegates.”

Dr Walton continues, “By offering media training, we are helping to make our interviewees excellent communicators through the medium of television.”

Source: www.earthtimes.org

UK Bioscience Centre Planned for Stevenage

Source: Builder and Engineer Online

Plans for a £37m Bioscience Campus in Stevenage, Hertfordshire were announced today by Business, Innovation and Skills Secretary, Lord Mandelson.
The project aims to create a world-leading hub for early-stage biotech companies, operating under a model of open-innovation and collaboration.

The Campus will offer each company access to specialist skills, equipment and expertise, to help stimulate innovation in drug development. By sharing knowledge each company will also increase its chance of success, while retaining its independence so entrepreneurship can flourish.

Speaking ahead of the announcement at the Technology Strategy Board’s Innovate09 Conference, Lord Mandelson said: “The Stevenage Campus represents a huge investment in the future of Britain’s bioscience industry and is a strong new platform for the work of our Office for Life Sciences.”

It’s estimated that development of the campus could create up to 1,500 new jobs, most of which will be high-skilled. It will initially be home to around 25 companies, co-located with GlaxoSmithKline on its existing research site, with plans to increase capacity at the park fivefold over the next 10 years.

Location: http://www.builderandengineer.co.uk/news/environment/bioscience-centre-planned-for-stevenage-4532.html
Date: 13/10/2009

IMS Health: 2010 Global Pharma Sales To Rise 4%-6%

Source: The Wall Street Journal (Online)

Global pharmaceutical sales are expected to increase 4% to 6% next year to more than $825 billion, though overall market growth likely will remain at historically low levels, according to research firm IMS Health (RX).

Executive Murray Aitken said, “While our outlook for the global market is more positive” than earlier this year, the industry still faces funding pressures, a potential gap between new drugs and expiring patents, potential health-care law changes and a weakened global economy.

Stronger-than-expected growth in the U.S. market contributed to the company raising its 5-year global-growth forecast by one percentage point to of 4% to 7%. It predicts the pharmaceutical market to expand to more than $975 billion by 2013. Pricing flexibility and inventory management contributed to the stronger-than-expected U.S. growth, said IMS, but it expects a significant gap between product introductions and patent losses over the next five year, limiting prospects.

Near-term U.S. pharmaceutical sales growth prospects have strengthened in recent months, aided by price increases and tight inventories. The U.S. market is expected to grow 4.5% to 5.5% this year and 3% to 5% in 2010.

IMS noted increases have slowed in countries where there is high out-of-pocket spending on drugs and steep economic downturns, particularly Russia, Mexico and South Korea. But strong growth is likely to hold up in some emerging markets, notably China, where pharmaceutical sales are seen rising more than 20% a year.

Author: Tess Stynes
Date: 13/10/2009
Location: http://online.wsj.com/article/BT-CO-20091008-706578.html

Enhance Your Powder Transfer System with Hanningfield

Hanningfield ‘Uni-Vac’ Conveyors

Pneumatic conveying has long been recognised as a recognised solution for powder handling. Vacuum transfer offers various benefits from increased throughput to improved operator safety, and as such can significantly enhance the efficiency of a process.

Hanningfield Process Systems are able to draw upon over 20 years of expereince to help supply customers with a system that not only providesexcellent and reliable results, but that is also easy to clean and maintain. All Uni-Vac systems are manufactured in-house allowing us to provide customers with bespoke and customised solutions, specific to each individual application.

For more information on our vacuum conveying systems, click here.

Or contact a member of our sales team here.