Use of generic medicines plans to save money..

The proposals of an increase to make generic medicines in primary care cheaper have been set out of England.

Generic Medicines are less cost effective than a branded equivalent and the Department of health is keen to use them.

Many suggestions contain establishing a list of products for replacement and another list of items that would be excused.

The proposals will be made known for public consultation over the next 3 months. The NHS spends around £9bn a year on branded prescription medicines in the UK.

A 5 year voluntary agreement negotiated between government and the pharmaceutical industry last year, includes measures aimed at reducing NHS expenses on branded medicines by an average of 5% a year over the lifetime of the plan.

Generic medicines - which have to include the same active ingredient as the branded originals, and can be sold once the originator’s patent protection has expired - can save substantial costs.

Currently, around 83% of prescriptions issued by the NHS are for generic drugs, but ministers want this to rise by around 5%.

Blaze at Mersey chemicals plant

A FIRE started at a chemicals factory in Knowsley early this morning.

Firefighters have said that the blaze may cause the whole area being evacuated.

Two crews from Kirkby Fire Station took on the fire at Contract Chemicals, on Knowsley Business Park, Prescot, around midnight after security guards raised the alarm.

The fire was in the manufacturing site’s main vent and piping which was caused by a faulty extractor fan.

A firefighter who was at the scene called the incident a “close call” and said the blaze could have led to a “cloudburst” operation – declared after major accidents like chemical leaks.

Under these tight guidelines, people are normally ordered to stay indoors, evacuated or exclusion zones set up.

One firefighter said: “We stopped the fire from moving to the main building and narrowly avoided a cloudburst situation, which could have led to the area being evacuated.

“It was a very close call because of all the chemicals in there.”

Contract Chemicals supply chemicals for the pharmaceutical and agrochemical industries, as well as detergents and fragrances.

Andy Bailey, Kirkby Fire Station, said: “Fortunately there was no need for a cloudburst situation. They had people on site and we dealt with it quite rapidly.”

Cardinal Health announces new board member

Cardinal Health has announced the date of new board member Carrie Cox.

Ms Cox will begin her position on the board right away, the organisation exposed.

She has before taken such posts as executive vice-president and president of global pharmaceuticals at Schering-Plough and president of Pharmacia’s global pharmaceutical company.

Subsequent to the end of Schering-Plough’s merger with Merck in November, Ms Cox’s contract with the past corporation came to an end.

George Barrett, chairman and chief executive officer of Cardinal Health, believed that the firm is “excited” to be welcoming Ms Cox and her knowledge to the company.

“Carrie brings an extraordinary range of experiences from her 30 years in biopharmaceuticals and healthcare,” he said.

Hanningfield Christmas Closure

Dear Customers, Associates and Suppliers,

Hanningfield Process Systems will be closed over the Christmas period from Wednesday 23rd December 2009 until Monday 4th January 2010. Please direct any enquiries or contact through our enquiry form or our e-mail address. We will get back to you as soon as possible.

We would like to take the opportunity to thank you for your cooperation and custom this year and hope that 2010 is both prosperous and enjoyable.

We wish everyone and their families a Merry Christmas and a Happy New Year.

Merry Christmas & A Happy New Year!

FROM EVERYONE AT HANNINGFIELD PHARMACEUTICAL

WE WISH YOU A MERRY CHRISTMAS

AND A HAPPY NEW YEAR

AND HOPE TO SEE AND HEAR FROM YOU IN THE NEW YEAR!!

China Pediatric Pharmaceuticals, Inc. Announces Change in Stock Symbol

China Pediatric Pharmaceuticals, Inc. today announced that effective from December 14, 2009, the Company altered its stock symbol from LHSI to CPDU and finished a 2-for-7 turn around split of its Common Stock.

Effective from October 14, 2009, the business filed a modification to our Articles of Incorporation with the Secretary of State of Nevada to offer for a seven old common shares for two new common shares reverse share split. No fractional shares will be issued in association with the adaptation; instead, China Pediatric Pharmaceuticals will round up the fractional share to the nearest whole number.

“We are very pleased to announce our new stock symbol. We are also delighted to announce the completion of the reverse stock split which represents an important step forward in our near-term goal to position China Pediatric Pharmaceuticals to list our common stock on a senior stock market in the US,” said Mr. Xia, CEO and Chairman of China PediatricPharmaceuticals, Inc

Glaxo Have ‘Paid’ $1 Billion in Paxil Suits

GlaxoSmithKline Plc has paid almost $1 billion to decide lawsuits over Paxil since it introduced the antidepressant in 1993, plus about $390 million for suicides or attempted suicides said to be linked to the drug, says court records and people common with the cases.

As part of the sum, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil habit and birth-defect cases and $400 million to end antitrust, fraud and design claims, coming from the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.”

The London-based company hasn’t told of the agreement total in business filings. It has made public some accords. Glaxo’s provision for legal and other non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion), apparent in its latest annual report. This integrated all legal matters, not just Paxil. The company said 112 million pounds of this sum would be “reimbursed by third-party issuers.”

The drugmaker has condensed its insurance coverage to contain costs, “accepting a greater degree of uninsured exposure,” the annual report states. “Recent insurance loss experience, including pharmaceutical product-liability exposures, has increased the cost of, and narrowed the coverage afforded by, insurance for pharmaceutical companies generally,” Glaxo said.

Pharmaceutical step up on health care bill

The Senate will continue debate Monday afternoon on a popular suggestion to allow U.S. citizens to purchase cheaper drugs from distant countries, which led to a last-minute lobbying push by drug makers last week and bogged down discussions over a heath-care improvement bill.

The offer is one of numerous intense disputes that provoked a surge in lobbying by hospitals, insurers and other major industries attempting to persuade the legislation in their favor as lawmakers work through a handful of difficult issues. Medical providers, for example, are battling hard against a planned Democratic concession that would jettison a public insurance option in favor of a limited development of Medicare, while the U.S. Chamber of Commerce flew dozens of corporate executives to Capitol Hill to meet with lawmakers.

The fight over the imported drugs pitch poses a predominantly difficult biased challenge for President Obama, who co-sponsored a similar bill when he was in Congress and who included support for the idea in his first budget.

But the pharmaceutical industry — which has been a key follower of health-care reform after getting an agreement with the White House earlier this year — has responded with a severe lobbying campaign aimed at killing the suggestion, focusing on Democratic senators from states with large drug and investigate sectors.

Pharmaceutical Society unimpressed over cocaine issue

The President of the Pharmaceutical Society of Ghana, Dr. Alex Doodo, has severely criticized the Police Service for the unethical conduct put up by some of its personnel who carried out a search at the Spintex Road warehouse of Kinapharma, a Pharmaceutical Company, and its subsequent ordering of a hunt and taking chemicals for further study, all in bid to hang a “cocaine-dealing” noose around the neck of three managers of the company.

He has also urged the media to use a bit of caution in their reportage and not be too hasty in taking out conclusions about cases under police investigations.

“The pharmacy society can be viewed as having an interest in the story, …In doing their routine job, they (police) must be seen to be fair, but most importantly, how stories get to the newspapers is indeed worrying,” he said.

The police has been getting a lot of criticism recently following specific acts of unprofessionalism exhibited by some of its personnel and this latest messed up hunt for narcotics at Kinapharma, based on a warning, seems to be high point of their amateurism, particular when Kinapharma is demanding an official apology from the Police with plans of even initiating a law suit against the Service.

In an interview with Kwami Sefa Kayi on PEACEFM’s “Kokrokoo”, Dr. Doodo articulated worry about the tainting of Kinapharma’s image with cocaine by the police officials, particularly when field tests had proved questionable.

“The story has really worried the pharmaceutical society and there is a need to guard the industry from any intruder…Kinapharma is a big localpharmaceutical industry…, and it is really vital that not just Kinapharma, but Ernest Chemists, Tobinco, Kama and all the local industry players are accorded the needed respect and decorum…,” he said.

According to him, “If you go to a Pharmaceutical Company, you will always find white powder, because most powders are white,” pointing out that that is not indicative of illicit drug trade.

More reasearch & development back by Darling

Chancellor Alistair Darling has said he wants more research and development in the pharmaceutical and biotechnology industries, allowing a new 10 pence less corporation tax on income which comes from patents in the UK.

The government is also working with the Wellcome Trust, Cancer Research UK and University College London to reach “the largest institute in Europe for research into long term medical challenges”, the chancellor said.

During the speech, chancellor Alistair Darling said that the pre-Budget report would give the vision of “building a fairer society and securing opportunity for all”.

Darling said that he was “confident that the UK economy will start growing by the turn of the year”. He is sticking to his previous Budget forecast of economic growth of 3.5 per cent in the UK in 2011-12.

But also added: “We can’t be complacent. We must continue to support the economy until recovery is established.”

This year, public sector investment reached a 30-year high, he says.

Sir Tom McKillop returns to Pharmaceutical Industry

Previous banker Sir Tom McKillop has been given a new £54,000-a-year job.

The past chairman of RBS, Sir Tom has come back to thepharmaceutical industry, which he worked for many years and how he earned his knighthood in 2002.

Sir Tom will sit beside a Belgian prince and other European luminaries on the board of directors for pharmaceutical giant UCB, after taking up his position at an astonishing general meeting on 6 November.

As chairman of RBS, Sir Tom watched over the lead-up to the major corporate failure in UK history, and even apologized to a House of Commons Treasury select committee for RBS’s failure. He also come out about having no qualifications in banking.

The panel of directors for UCB – including Prince Lorenz of Belgium – met just seven times in 2008, and Sir Tom will be salaried £900 for each meeting he attends this year, on top of a base pay of £54,000.

A spokeswoman for the firm was reported as saying that Sir Tom was selected for his “great knowledge in the pharmaceutical world”.

Pharmaceutical Company get £15m Financing Deal

Nymox Pharmaceutical Corp. said Thursday it has obtained a pledge for $15 million financing from investors.

The money will be used for general group purposes. The financing also will help the business keep on with research into new drugs including one called NX-1207, which could treat an swollen prostate.

The investors may get common stock at a 3% reduction to the market price, the company said.

The timing and quantity of each placement is in the sole maturity of the company. There are no warrants, price resets, and no limits on other corporate financing.

Products currently marketed by Nymox include tests for measuring tobacco product exposure sold under the NicAlert and TobacAlert names and a test to aid in the analysis of Alzheimer’s disease.

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

Drugs groups face increases in tax rates

Pharmaceutical companies are set to face "significant" increases in tax rates over the coming decade, as their businesses evolve and governments clamp down on avoidance, a leading tax adviser warns today.
In a report "Taxing times ahead", PwC says that rising public sector deficits and a shift in the strategy of pharmaceutical companies will intensify countries' efforts to clamp down on methods used by drugs groups to keep taxes low.
"For the past 20 years, pharma has benefited from a benign legislative and commercial environment that has enabled it to report low and stable tax rates," it said. "These elements are changing."
It said the trend by many large companies away from simply developing drugs to providing a broader range of healthcare services would reduce their ability to switch profits from high to low tax jurisdictions.
The pattern of cost cutting, improved research productivity, a broader mix of products, expansion in the emerging markets and offering "outcomes" rather than simply medicines will all have "major repercussions", it warned.
PwC said tax authorities were increasingly clamping down on "transfer pricing": the practice of shifting costs to higher tax regions and income to lower tax ones. They were also working more with their counterparts in other countries to reduce the ability to use crossborder transactions.
It cited more aggressive measures taken by the Internal Revenue Service in the US, and the measures adopted by the Organisation for Economic Cooperation and Development to blacklist tax havens.

It said such measures would offset continued moves by some countries to offer tax advantages to encourage domestic research and development by large foreign companies.
The consultancy highlighted wide variations in corporation tax rates currently paid by the large drugs manufacturers, ranging from 29.3 per cent in 2008 for Bayer of Germany to as low as just 14 per cent for Novartis of Switzerland.

In the US, it showed that pharmaceuticals including biotechnology remained among the lowest taxed corporate sectors at 32.5 per cent. Among the large companies, the average effective rate last year was 23.8 per cent.

PwC said companies might shift their legal status from being corporations to partnerships, create regional hubs and manage value added tax centrally to minimise tax bills in future.

Source: FT.Com

Shire and Teva settle Adderall dispute

Pharmaceutical group Shire and Teva Pharmaceuticals USA have settled litigation concerning Shire's supply of a generic version of Adderall XR.

Shire has been supplying Teva with authorised generic Adderall XR since April 1 but its ability to supply the product was limited by US Drug Enforcement Administration restrictions on amphetamine, the product's active ingredient.

Teva filed suit claiming Shire was in breach of its supply contract. The DEA then granted Shire an additional quota for 2009, allowing it to supply Teva.

Teva has now dismissed its lawsuit, including its claim for damages. No consideration was exchanged as part of the settlement.

Story provided by Business Financial Newswire

Simcere Pharmaceutical suspends production at Yanshen unit because of quality control problems

Drug developer Simcere Pharmaceutical Group said Wednesday it suspended production at its Jiangsu Yanshen Biological Technology Stock Co. unit to conduct an internal inspection following the discovery of quality control problems.

Simcere said it discovered quality control issues at the unit after obtaining a controlling stake in October. Specifically, there were problems with the production of Yanshen’s human-use rabies vaccine.

American Depository Shares of the China-based drug developer closed at $8.03 Tuesday.

Source: LATimes

Local Pharmaceutical Sector Posts High Growth

In a troubled world economy and in a world threatened by the spread of epidemics, the Tunisian pharmaceutical sector which provides 50% of market needs in drugs and 60% in volume is posting a stronger growth.

The sector which comprised only 3 production units in 1987 boasts today 41 units (public and private) employing 3800 people, 37% of which are pharmacists reports the Tunisian daily newspaper “Le Temps”.These units produce locally 293 million dinars worth of medicine with 54% of licensed drugs and 46% of generic drugs.

The Tunisian pharmaceutical industry has been the focus of a cabinet meeting, held last week.
The meeting took initiatives aiming at achieving 60% of coverage of the domestic demand and boosting pharmaceutical exports by 2016.

Observers note that the growth of pharmaceutical industries in Tunisia, whose privatization started in 1989, is due to the setting up of a legal framework regulating the sector as well as fiscal and commercial incentives.
The sector imports medical products from European countries such as France, Italy, Switzerland, Denmark, the UK and Germany worth 346 million dinars and exports pharmaceutical products worth 320 million dinars to such countries as Libya, Algeria, France and Morocco as well as Mauritania, Senegal, Jordan, Yemen and Saudi Arabia.

Source: AllAfrica.com

Templeton Backs Sun Pharmaceutical Bid for Taro

Mark Mobius, chairman of Templeton Asset Management Ltd., backed Sun Pharmaceuticals Ltd.’s year- long bid to buy Israeli drugmaker Taro Pharmaceutical Industries Ltd., saying he wants the deal completed “as fast as possible.”

Taro sued the Indian drugmaker for failing to disclose key information in its offer. Buying Taro would help Mumbai-based Sun expand its market reach in the U.S., where demand for generics will grow as health-care costs surge and more blockbuster drugs lose patent protection.
Templeton owns 10 percent of Taro, located 30 kilometers (19 miles) from Tel Aviv. Mobius said he wants Sun to take over the Israeli company to improve disclosure of Taro’s accounts.

“There have been no audited accounts from the Taro management and they recently wanted to have a shareholders’ meeting to approve dispensation of the directors for responsibility for the accounts,” Mobius said in a Bloomberg Television interview. “That’s alarming so we said we wanted to back Sun to take over this company as fast as possible so that we could see those accounts.”

Roanne Kulakoff, a spokeswoman for Taro, couldn’t immediately be contacted in New York, where her voice mail said she is out of the office until Dec. 3.
Sun, India’s largest drugmaker by market value, fell 0.4 percent to 1,533 rupees as of 11:56 a.m. after surging as much as 6.4 percent.

“Although the news that the third-largest shareholder is now backing Sun’s bid to take control of Taro is positive, it has no implications for the outstanding legal dispute,” Abhishek Singhal, an analyst at Macquarie Group, wrote in a note to clients today. “A positive court ruling is essential for Sun to take eventual control.”

Source: Bloomberg.com

Pharmacists happy over bigger POYC

The Malta Chamber of Pharmacists and the Pharmaceutical Division of the GRTU, Chamber of Small and Medium Enterprises, expressed satisfaction that the Minister of Finance had in the Budget speech consolidated the government's commitment to the further roll-out of the Pharmacy of Your Choice scheme, to serve 50,000 new patients in the near future.

This statement is a further seal of success that endorses the tripartite vision for primary health care through the provision of personalised pharmaceutical care services by community pharmacists to benefit registered patients, the chamber said.

“This is a further step towards the full attainment of the objective where Malta should rank positively with the other EU member states in equitable access to community pharmacists’ services to patients including the medicines they need.”

Source: The Independent

Addex set for partner deal after drug hits target

Swiss biotech group Addex Pharmaceuticals' said its lead drug candidate met its main target in a mid-stage clinical trial in heartburn, potentially paving the way for a lucrative partnering deal.
Analysts say positive data on ADX10059 sets the stage for a deal with a bigger drugmaker, which would provide much-needed funds for Addex, a start-up company that does not yet have a product on the market.

"With good phase IIb data Addex's next step is to license the drug to a larger pharmaceutical company. We reckon this process has already started, thus would expect a deal in 2010," said Andrew Weiss, analyst at Swiss bank Vontobel.
Addex shares had jumped 16 percent to 37 Swiss francs by 0821 GMT on Monday, compared with an almost flat European healthcare sector .SXDP.

In a Phase IIb trial, the drug increased the number of symptom-free days fivefold when used as a monotherapy in gastroesophageal reflux disease (GERD), which causes heartburn, the company said on Monday.

Drug discovery groups like Addex are aiming to match the success of Actelion (ATLN.VX), which has developed its own billion dollar selling drug, but many have fallen by the wayside as medicines fail to live up to potential and cash runs short.

The problems of such small start-up biotechs are shown by Addex's stock, which had lost 16 percent this year before Monday, underperforming a stronger European sector.

Source: reuters.com

Simcere Pharma Q3 Profit Plunges On Higher Expenses - Update

Chinese drug manufacturer Simcere Pharmaceutical Group (SCR: News ) Monday reported a 82% decline in net income for the third quarter, impacted negatively by higher expenses.
Net income for the quarter attributable to the company was RMB 16.43 million or RMB 0.14 per share, much lower than RMB 91.16 million or RMB 0.72 per share in the prior-year quarter. In US dollars, net income attributable to Simcere was $2.41 million or $0.02 per share for the most recent quarter.

Earnings per American depository shares, or ADS, plunged to RMB 0.29, or US$0.04, from RMB 1.44 in the year-ago quarter.
On an average, four analysts polled by Thomson Reuters expected earnings of US$0.09 per share for the quarter. Analysts' estimates typically exclude special items.
Total third-quarter revenues increased slightly to RMB 443.7 million or US$65.0 million from RMB 443.4 million a year earlier. Analysts estimated revenues of US$69.09 million for the quarter.

Commenting on the results, Jinsheng Ren, chairman and chief executive officer, said, "Our sales and gross profit margins remained stable this quarter. However, lower sales in Endu, impacted by the restructuring of the sales team, and an increase in sales and marketing expenses for new to market drugs like Anxin and Sinofuan, caused a significant decrease in operating income."
Product revenues slipped to RMB 439.02 million from RMB 441.21 million in the prior-year quarter. Within this, revenues from Endu, Simcere's patented anti-cancer biotech product, amounted to RMB 21.6 million, or US$3.2 million, down 60.2% from RMB 54.4 million for the same period in 2008.

Source: rttnews.com

Swine flu causes surge of garlic sales in Serbia

Belgrade's open-air markets were a welter of busy customers on Friday, pushing and shoving to buy one item — garlic.
In Serbia, garlic has long been regarded as a good-luck charm and a guard against many ailments. As far as the public is concerned, that includes the swine flu pandemic, which recently has spread in Serbia and triggered near panic among the local population.
That is now evident in Belgrade's produce markets, where the price of garlic has shot up, thanks to a sudden increase in demand. The smell of the little white cloves also has become prevalent in public places as people munch on them as if eating apples.

Health officials have publicly urged the population not to take garlic's healing properties so seriously. Instead, they recommend opting for more conventional precautions, such as washing hands, wearing face masks, or eventually getting vaccinated.
But those calls seem to have been in vain.

"Garlic is the best, forget the vaccines," said Marko Jankovic, an elderly Belgrader, with the pungent smell of garlic obvious as he spoke at the crowded Kaleniceva Pijaca market. "From the vaccine, you can get sick. From garlic, you can only get bad breath."
Facing a surge of swine flu cases, Serbia's Health Ministry on Friday ordered 3 million vaccines from Swiss pharmaceutical company Novartis AG.

The authorities said Serbia has about 270 proven swine flu cases and eight deaths — up from about 130 cases and two deaths at the beginning of November.
In many parts of the world, the distinct taste and smell of garlic are considered essential in many meals. But in Serbia — as elsewhere in the Balkans — many people consider it more important than that.

Garlic is kept on doorsteps or in pockets to keep vampires away, and under babies' pillows to ensure a healthy and prosperous life. Serbs often consume garlic as a snack together with slivovitz, a strong plum brandy.
These days, Serbian media often compare what happened at two popular music festivals as proof of the alleged medicinal virtues of garlic.
That's because Serbia's first swine flu cases were confirmed after the annual Exit rock music festival in July in the town of Novi Sad, where authorities say the mostly young audience indulged in beer and marijuana.

By contrast, the media say, no swine flu cases resulted from the equally popular folk music festival in Guca, central Serbia, where the generally older, more tradition audience gorged on meat dishes heavily spiced with garlic, and drank slivovitz.

For centuries, garlic has been regarded by many people around the world as a successful medical treatment for everything from indigestion to respiratory problems. Recent medical studies also have shown that garlic can reduce a person's blood pressure.

But in Serbia, doctors are telling the public to stop considering it as a swine flu defense.
"People must take this pandemic more seriously and focus on real prevention and medicine," not garlic, said Zoran Djordjevic, a virology doctor at a Belgrade hospital.

Source: rep-am.com

Themis Medicare drops

Themis Medicare declined 2.06% to Rs 145.05 at 13:38 IST on BSE, after a fire and explosion took place in one of the sections of the company's Vapi factory on Friday, 13 November 2009.
The company made this announcement during trading hours today, 16 November 2009.
Meanwhile, the BSE Sensex was up 207.51 points, or 1.23%, to 17,056.34.
On BSE, 1,469 shares were traded in the counter as against an average daily volume of 3,948 shares in the past one quarter.

The stock hit a high of Rs 149 and a low of Rs 149 so far during the day. The stock had hit a 52-week high of Rs 164.80 on 5 November 2009 and a 52-week low of Rs 49 on 6 March 2009.
The small-cap stock had outperformed the market over the past one month till 13 November 2009, rising 21% as compared to the Sensex's 1.04% fall. It had also outperformed the market in the past one quarter, gaining 44.07% as compared to the Sensex's return of 8.57%.
The company's equity capital is Rs 8.05 crore. Face value per share is Rs 10.
The current price of Rs 145.05 discounts the company's Q2 September 2009 annualized EPS of Rs 47.20 by a PE multiple of 3.07.

The company is fully insured and steps are being taken to restore normalcy at the exploded section of the plant. The other plants are in operation, the company said.
Themis Medicare's net profit galloped 787.9% 9.50 crore on 10.9% rise in net sales to Rs 60.98 crore in Q2 September 2009 over Q2 September 2008.

The company is engaged in manufacturing and selling pharmaceutical products. The group's products are used in therapeutic areas like antituberculosis, antimalarials, cardiology, pain management, anti-infectives, haematinics, Health and Nutrition. It also engaged in co-marketing its research-based formulations with other pharmaceutical companies in India and abroad.

Source: indiainfoline.com

Bristol-Myers to spin off Mead Johnson Nutrition

Drug-manufacturer Bristol-Myers Squibb Co. announced on Sunday that it would spin off its Mead Johnson Nutrition Co. in order to focus on its bio-pharmaceutical business.
Under the deal, Bristol-Myers will give its shareholders roughly $1.11 of Mead Johnson shares for each $1 in Bristol share they tender.

The accurate ratio will be determined by a 10 per cent discount to the daily volume-weighted average prices of Bristol-Myers and Mead Johnson shares from December 8 to December 10.
New York-based Bristol-Myers, which possesses 83 per cent of Mead stock, said that the deal was a part of its divestment strategy that would transform it from a traditional drug firm into a bio- pharmaceutical company.

James M. Cornelius, Chief executive of Bristol-Myers said, "With a successful execution of this split-off, we fully consider ourselves a BioPharma company."
The exchange offer is scheduled to expire on December 14.

Source: topnews.co.uk

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

Top Five International Pharmaceutical Company Awards Comprehensive Cardiac Safety Study to iCardiac

iCardiac Technologies, Inc., a global leader in advanced cardiac core lab services and QT analysis, announced today that a top five pharmaceutical company has awarded iCardiac a comprehensive "Thorough QT" (TQT) study. iCardiac will provide end-to-end study management, international equipment deployment and scientific reporting, as well as advanced ECG analytics. The study will utilize iCardiac's Highly Automated QT and Dynamic QT beat-to-beat(sm) service offerings to dramatically improve study precision and reduce false positives and negatives.

"iCardiac's ability to reduce sample size as well as false positives in TQT studies continues to be well received by the pharmaceutical industry," said Sasha Latypova, Executive Vice President. "As these methods are now accepted as part of the regulatory review of cardiac safety, we expect the speed of adoption to continue to accelerate."

In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision, high rate of false positives/negatives and high cost of the "gold standard" manual or semi-automated QT measurements has lead to efforts toward providing more advanced cardiac safety analytics.

Source: EARTH TIMES

Sanofi Taps Biotech Firm to Bolster Its Pipeline

Increasing its bet on biotechnology, Sanofi-Aventis said it would pay an additional $1 billion over eight years to Regeneron Pharmaceuticals for the discovery of new drugs.

The agreement, announced Tuesday, is an extension of one signed in 2007, The New York Times’s Andrew Pollack reported. Sanofi, a big drug company based in France, had previously agreed to provide $100 million a year to Regeneron, a biotechnology company based in Tarrytown, N.Y. The amount is being increased to $160 million a year, and the pact is being extended five additional years through 2017.

Dr. Leonard S. Schleifer, the chief executive of Regeneron, said the arrangement represented a way for a large pharmaceutical company and a biotechnology company to collaborate without suffocating the smaller company.

“They leave Regeneron and its culture to do its thing,” he said. “It’s everything a biotech company could dream of.”
Sanofi already owns 19 percent of Regeneron as a result of previous deals but will not increase its stake as part of the new transaction.

The drugs being developed are monoclonal antibodies, which are engineered versions of proteins naturally made by the immune system. Regeneron has developed genetically engineered mice that can produce human antibodies.

Under the deal, if Regeneron develops a drug it believes is ready for clinical trials, Sanofi can opt to co-develop it with Regeneron. So far, four antibodies have entered clinical trials in two years, and the companies aim to put four or five new ones into trials each year. That rate is higher than the norm for the industry.

Like most big pharmaceutical companies, Sanofi-Aventis is negotiating deals with smaller companies to bolster its pipeline. In particular, it and other big companies are trying to move more into biotechnology, making drugs from living cells instead of from the chemicals they usually use.

In some cases, the biotech drugs can do things that chemical drugs cannot. The biotech drugs are also not subject to the same sudden generic competition that can devastate sales of chemical drugs. Sanofi recently started facing generic competition in some markets for its big-selling anti-clotting drug Plavix and its cancer drug Eloxatin.

Source: NEW YORK TIMES

Vertex Pharmaceuticals Announces Agreements to Exchange $109.0 Million of its 2013 Convertible Senior Subordinated Notes into Common Stock

Vertex Pharmaceuticals Incorporated announced today that holders of its 4.75% Convertible Senior Subordinated Notes due 2013 have agreed to exchange approximately $109.0 million in aggregate principal amount of those notes and accrued interest for approximately 4.8 million shares of the Company’s common stock, which is approximately 140,000 shares more than the number of shares into which the notes were convertible under their original terms.

The Company anticipates that the exchanges will be completed by the close of business on November 13, 2009. Upon completion of the exchanges, the aggregate principal amount of the Company’s 4.75% Convertible Senior Subordinated Notes due 2013 will be reduced to approximately $35.0 million. Upon issuance of the common stock in exchange for the notes, Vertex will have approximately 186 million shares of common stock outstanding.

This announcement is neither an offer to exchange nor a solicitation of an offer to exchange any of these securities. The exchanges are exempt from registration under Section 3(a)(9) of the Securities Act of 1933.

Source: Newsticker.welt.de

China Aoxing Pharmaceutical Company to Present at Brean Murray, Carret & Co. 2009 China Growth Conference

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the Company will present at the 2009 China Growth Conference held by Brean Murray, Carret & Co. at the The Millennium Broadway Hotel in New York City, on November 19, 2009.

The Company will update the Company business including product portfolio, development pipeline, financial highlights and its long-term growth strategies.
For further details, please contact your institutional sales representative.

Source: CNN.Money.Com

Pharmaceutical company GlaxoSmithKline to donate 50 million doses of swine flu vaccine to WHO

Pharmaceutical company GlaxoSmithKline will donate 50 million doses of H1N1 vaccine to the World Health Organization (WHO). APA reports that the related agreement was signed in Geneva.

WHO Director-General Margaret Chan said WHO will work to see that these vaccines are distributed to those who need them.

GlaxoSmithKline expects to prepare the first shipments of vaccine to the WHO by the end of November. WHO has prepared a list of 95 developing countries that are slated for receiving vaccines from GSM, and it intends to cover 10 percent of the population in these countries.

Source: APA.Az

Jazz Pharmaceuticals to Present at Investor Conference

Jazz Pharmaceuticals announced today that company management will present a corporate overview at an upcoming investor conference.

Robert M. Myers, President of Jazz Pharmaceuticals, will speak at the Lazard Capital Markets 6th Annual Healthcare Conference on Wednesday, November 18, 2009 at 2:15 p.m. EST at The St. Regis Hotel in New York City.

After the presentation, the slides may be accessed by visiting the Investors section of the Jazz Pharmaceuticals website. The slides will be available on the site for two weeks following the presentation.

Source: Money.CNN.Com

Pharma bracing for tougher FDA guidance on trials

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said.

“The playing field is leveled across the world,” Tadikonda said. “Previously, if you wanted to get competitive intelligence on a drug, you had to read numerous trade journals, and patients had to guess whether they could participate in a trial.” Now, the disclosures have to be posted at www.clinicaltrials.gov, a registry developed by the National Institutes of Health and the FDA.

Tadikonda said the regulator’s actions follow high-profile lawsuits, such as those involvingMerck’s painkiller drug Vioxx and GlaxoSmithKline’s diabetes drug Avandia. He said his firm has worked with several New Jersey-based pharmaceutical companies, the FDA and the NIH to clarify and interpret the new rules.

The industry’s pre-eminent advocacy group, the Washington, D.C.-basedPharmaceutical Research and Manufacturers of America, supports FDA’s move, and in October issued its own set of principles to achieve the goals set forth by the agency, according to Jeffrey K. Francer, its assistant general counsel.

But the new disclosure requirements would “necessarily increase the amount of expense in the drug-development process,” Francer said. “It is already enormously expensive, and it is important to make sure that the benefit of additional requirements outweighs the costs.”

Francer said striking a balance between regulatory requirements and compliance costs will be especially important as NIH defines the rules to post the results of clinical trials on the Web.

“The NIH should do so in a way that protects the confidential commercial information and trade secrets [of drug companies] and does not jeopardize companies that register [clinical trials] in the U.S.,” Francer said.

NIH could use specific steps to lower costs, for instance, an automated reporting process that would accept PDF submissions, Francer said. PhRMA has also advocated the International Conference on Harmonization’s format for summarizing clinical trails information, which is accepted by European and Japanese regulators.

Source: NJBiz

Valeant Pharmaceuticals Reports Third Quarter Financial Results

Valeant Pharmaceuticals International VRX today announced third quarter financial results for 2009.

“Valeant continues to perform well, generating strong earnings growth in the third quarter,” stated J. Michael Pearson, chairman and chief executive officer. “All of our businesses are growing and generating positive cash flows this quarter. In particular, I would like to note our 18% organic growth rate from total product sales, at constant currency, and our $65 million of adjusted cashflow from operations.”

Revenues:

Total revenue was $220.3 million in the third quarter of 2009 as compared to $168.4 million in the third quarter of 2008, an increase of 31%.

Product sales in the Specialty Pharmaceuticals segment were $101.6 million in the third quarter of 2009, as compared to $70.1 million in the third quarter of 2008, an increase of 45%. At constant exchange rates, Specialty Pharmaceuticals product sales increased 47%. Within the SpecialtyPharmaceuticals segment, alliance and service revenue was $25.6 million in the third quarter of 2009, which included an $8.5 million profit share related to the 1% clindamycin and 5% benzoyl peroxide product (IDP-111) that was launched by Mylan in August 2009, $5.0 million related to the Dow services business, and $3.8 million of revenue from the GlaxoSmithKline (GSK) collaboration. Because the company entered into the GSK collaboration agreement in October 2008 and acquired Dow in December 2008, no alliance or service revenue was recorded in the third quarter of 2008.

Product sales in Branded Generics - Latin America were $40.7 million in the third quarter of 2009 as compared to $42.6 million in the same period in 2008, a decrease of 5%. At constant exchange rates, product sales in Latin America in the third quarter of 2009 increased 19% as compared to the third quarter of 2008.

Product sales in Branded Generics - Europe were $40.2 million in the third quarter of 2009 as compared to $40.4 million in the same period in 2008, essentially flat. At constant exchange rates, product sales in Europe in the third quarter of 2009 increased 29% as compared to the third quarter of 2008.

Ribavirin royalties were $12.2 million in the third quarter of 2009 as compared to $15.2 million in the third quarter of 2008, a decrease of 20%. This expected decrease is entirely attributable to the expiration of royalty terms in certain European countries on the ten-year anniversary of product launches in the respective countries.

Source: MSN Money Central

Obesity treatment signed for 1 Billion to Takeda

Takeda Pharmaceutical Co and Amylin have signed a pact potentially worth over $1 billion to the US firm to develop and commercialise products for the treatment of obesity “and related indications”.

The deal covers pramlintide/metreleptin and davalintide, which are compounds currently in Phase II. Cashwise, Amylin will receive a one-time up-front payment of $75 million and is eligible to receive certain development, commercialisation and sales-based milestones that could exceed $1 billion. It also provides for future tiered, double-digit royalty payments.

Amylin will be responsible for development through Phase II at home and Takeda will do the same outside the USA. In most instances, Amylin will be responsible for 20% of development costs associated with obtaining approval for products in the USA and Takeda will pay the rest and 100% abroad.

Yasuchika Hasegawa, chief executive of the Japanese drugmaker, said that by leveraging his firm’s “global development and commercial infrastructure we look forward to maximising the significant potential of the products under this agreement”. He added that both have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need”.

His counterpart at Amylin, Daniel Bradbury, said his company “recognises the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone”.

Sales of Takeda’s key drugs fall

News of the deal came a day after Takeda reported net income for the six months ended September 30 of 189.63 billion yen (around $2.10 billion), a 164.2% increase over the like, year-earlier period when the company booked charges related to the acquisition of Millennium Pharmaceuticals. Sales fell 6.4% to 755.45 billion yen, mainly due to the strength of Japan’s currency.

Takeda’s biggest earner, the diabetes drug Actos (pioglitazone), brought in 194.80 billion yen, down 4.1%, while the gastrointestinal drug Prevacid/Takepron (lansoprazole) decreased 11.5% to 132.00 billion yen. Sales of the blood pressure drug Blopress (candesartan cilexetil) were down 5.8% to 112.40 billion yen, while turnover from the prostate cancer treatment Leuplin (leuprorelin) fell 9.0% to 59.20 billion yen.

Takeda maintained its full-year profit forecast of 280 billion yen but slightly lowered its sales target from 1.50 trillion yen to 1.48 trillion yen.

Source: Pharma Times

GlaxoSmithKline moves EAP provider

Pharmaceutical giant GlaxoSmithKline (GSK) has switched its employee assistance programme (EAP) providers to give staff greater access to cognitive behavioural therapy (CBT).

The firm has switched from Ceridian to PPC, and its 16,000 employees can now access face-to-face CBT counselling, as well as an online service, where they will be asked a series of questions about their problems.

Employees are then given information to help them understand their difficulties and access effective treatment. They can contact a telephone adviser for further assistance.

Harsha Modha, GSK’s director of benefits programmes for the UK, said the service would reduce the stigma around mental health issues in the workplace, and provide the right environment for staff to seek help.:

Source: Employee Benefits

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.

Full-Page Advert in Manufacturing Chemist

To coincide with this year’s PPMA exhibiton, Hanningfield are proud to have a full-page advert on display in the September issue of Manufacturing Chemist.

The advert can be found on Page 86 of the magazine, which will be distributed for free at the exhibition this week. Be sure to look out for our advert or for a sneak preview click here. Please let us know if you have any feedback (info@hanningfield.com)

Enjoy the exhibition everyone! The Team at Hanningfield Process Systems.

Aesica is licensed to manufacture controlled substances in UK

Source: Manufacturing Chemist

Aesica Pharmaceuticals, a global supplier of active pharmaceuticalingredients (APIs), finished dosage forms and custom synthesis solutions, has been licensed to manufacture controlled substances at its site at Cramlington in the UK.

The Home Office licence allows Aesica to manufacture and supply substances listed in Schedule 2 of the Misuse of Drugs Act 1971. Granting of the licence follows a programme of investment to enhance the security of the site and its buildings, and the implementation of special procedures for handling of controlled substances.

The site is now able to offer facilities for contract manufacture of controlled APIs in quantities from a few kg at its GMP pilot plant to tonnes at one of its bulk API plants. The first contract-manufactured controlled drug for one of Aesica’s customers is already in production.

‘This is a significant step forward for Aesica in terms of broadening our capabilities in line with our customers’ demand,’ said Adam Sims, commercial director of Aesica.

Aesica can now offer controlled drug manufacturing at Queenborough and Cramlington in the UK, covering active ingredient synthesis and manufacture and packaging of finished dosage pharmaceutical forms.

Date: 28/09/2009
Source Location: http://www.manufacturingchemist.com/story.asp?sectioncode=109&storycode=56400&c=1