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China Sky One Medical Obtains SFDA Approval for Ciclopirox Olamine Vaginal Suppositories

July 24, 2010 By vani Leave a Comment

HARBIN, China, July 23 /PRNewswire-Asia-FirstCall/ — China Sky One Medical, Inc. (“China Sky One Medical” or “the Company”) (Nasdaq: CSKI), a leading fully integrated pharmaceutical company in the People’s Republic of China (“PRC”), today announced that the Company has obtained approval from the State Food and Drug Administration (SFDA) in China for the production of Ciclopirox Olamine Vaginal Suppositories. The document number for this drug is H20103320.

Ciclopirox Olamine Vaginal Suppositories were developed by CSKI’s internal R&D team based on registration standards of similar imported drugs. The drug’s main ingredient, Ciclopirox Olamine, is a synthetic broad-spectrum antibacterial that has been proven effective in clinical studies for treatment of fungal vaginal infections (candida albicans vaginitis) and fungal vaginal inflammation (colpits mycotica). It can resist or restrain most pathogenic streptomyces, including skin fungus and candida albicans as well as many kinds of nonpathogenic streptomyces, gram negative bacilli and gram positive bacilli. The drug is a good treatment option for partial infection as it is minimally absorbed by the skin.

“We greatly appreciate the dedicated efforts of our R&D and sales teams to bring new drugs like Ciclopirox Olamine Vaginal Suppositories to market,” said Mr. Yan-Qing Liu, Chairman and CEO of China Sky One Medical. “We expect to launch this product in early 2011 and plan on gaining share in this large market by leveraging our extensive distribution network and strong OTC pharmaceutical sales force.”

About China Sky One Medical, Inc.

China Sky One Medical, Inc., a Nevada corporation, is a holding company. The Company engages in the manufacturing, marketing and distribution of pharmaceutical, medicinal and diagnostic products. Through its wholly-owned subsidiaries, Harbin Tian Di Ren Medical Science and Technology Company (“TDR”), Harbin First Bio-Engineering Company Limited (“First”), Heilongjiang Tianlong Pharmaceutical, Inc. (“Tianlong”) and Peng Lai Jin Chuang Pharmaceutical Company (“Jin Chuang”) the Company manufactures and distributes over-the-counter pharmaceutical products, which make up its major revenue source. For more information, visit http://www.cski.com.cn .

Safe Harbor Statement

Certain of the statements made in the press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the use of forward- looking terminology such as “believe,” “expect,” “may,” “will,” “should,” “project,” “plan,” “seek,” “intend,” or “anticipate” or the negative thereof or comparable terminology. Such statements typically involve risks and uncertainties and may include financial projections or information regarding the progress of new product development. Actual results could differ materially from the expectations reflected in such forward-looking statements as a result of a variety of factors, including the risks associated with the effect of changing economic conditions in The People’s Republic of China, variations in cash flow, reliance on collaborative retail partners and on new product development, variations in new product development, risks associated with rapid technological change, and the potential of introduced or undetected flaws and defects in products, and other risk factors detailed in reports filed with the Securities and Exchange Commission from time to time.

For more information, please contact:

Company Contact:
China Sky One Medical, Inc.
Yan-qing Liu, CEO
Email: ir@cski.com.cn

Investor Relations Contact:
CCG Investor Relations
Mr. Crocker Coulson, President
Tel: +1-646-213-1915
Email: crocker.coulson@ccgir.com
Web: http://www.ccgirasia.com

Ms. Mabel Zhang, Vice President
Tel: +1-310-954-1353
Email: mabel.zhang@ccgir.com

SOURCE China Sky One Medical, Inc.

Filed Under: International News Tagged With: Broad Spectrum, Candida Albicans, china prc, China Sky, D Team, diagnostic products, food and drug administration, Gram Negative Bacilli, Gram Positive Bacilli, Medical Inc, New Drugs, PRNewswire, Qing Liu, Registration Standards, Skin Fungus, Sky One, State Food, Streptomyces, Vaginal Infections, Vaginal Suppositories

UPDATE 1-NicOx says key drug rejected by FDA

July 23, 2010 By vani Leave a Comment

PARIS, July 22 (Reuters) – The U.S. Food and Drug Administration has rejected NicOx’s (NCOX.PA) pain drug Naproxcinod, recommending further trials, the French biotechnology group said on Thursday.

NicOx, which has spent about 10 years and 100 million euros ($127.6 million) to fund the U.S. launch of its lead anti-inflammatory drug, said it would hold talks with the FDA as soon as possible to discuss potential next steps.

Citing a response letter, NicOx said the FDA had recommended conducting more long-term controlled studies to assess the safety of Naproxcinod on a cardiovascular and gastrointestinal level.

An FDA advisory panel had already voted against approving the drug in May, sending NicOx shares to a four-year low. [ID:nLDE64C05Z]

NicOx Chief Executive Michele Garufi told Reuters last month he remained hopeful for the drug, even as some analysts questioned the group’s drug development technology. [ID:nLDE65F295] (Reporting by Lionel Laurent and James Regan; Editing by David Holmes) ($1=.7836 Euro)

Filed Under: International News Tagged With: $100 million, 6 million, advisory panel, Biotechnology Group, chief executive, david holmes, Development Technology, Food And Drug, food and drug administration, Garufi, gastrointestinal, inflammatory drug, James Regan, launch, Lionel, Low Id, Michele, Nicox, Response Letter, reuters

Vivus’ weight-loss drug faces key U.S. test

July 16, 2010 By vani Leave a Comment

(Reuters) – The first potential U.S. prescription weight-loss pill in more than a decade could move closer to market on Thursday if it can overcome safety hurdles that have plagued diet drugs for years and led to tepid sales despite the growing number of obese Americans.

Vivus Inc is seeking Food and Drug Administration support to sell its drug, Qnexa, to adults to use once-a-day along with exercise and diet changes to slim down.

On Thursday, a FDA advisory panel will weigh Qnexa — the first of three potential new diet drugs — and decide whether the benefits of shedding pounds outweigh safety concerns such as the drug’s effect on fetuses, mental health and heart rate.

The FDA will weigh the panel’s recommendation before later making its final decision.

Although more than two-thirds of Americans are overweight or obese, weight-loss drugs have not gained much traction. Most only trim a few pounds but carry serious or unpleasant side effects such as heart risks or gas.

“The critical factor in looking at the data is the enormous benefit that (Qnexa) provides,” said Ira Loss, a healthcare analyst for Washington Analysis Corp who follows the FDA for financial clients. “The risks are not insurmountable. They can be managed.”

Last year, prescription and over-the-counter diet drugs took in just $381.5 million in 2009, according to IMS Health.

If Qnexa wins the FDA’s green light, that could more than double. Analysts estimate Vivus’ drug could take in nearly $689 million in sales by 2014, according to consensus forecast data from Thomson Reuters.

It would be the second U.S. drug for the biotech, which saw its last drug — an erectile dysfunction suppository — approved 14 years ago. Its efforts to market a sexual dysfunction cream for women flopped in 2006.

Investors, buoyed by the potential for wider sales among millions of overweight Americans (link.reuters.com/vup37m), have been lured to the company. Shares of Vivus have more than doubled in the last year, and are up more than 35 percent so far in 2010.

FDA staff have said the company’s data clearly shows the drug works and largely meets the agency’s new guidelines for obesity drugs issued in 2007.

Patients taking Qnexa saw between 3 and 9 percent weight loss over placebo depending on how much of the drug they took, the staff said. They also benefited from improved blood pressure, and better fats and sugar levels in the blood.

But first Vivus must convince FDA’s panel of outside experts that it does not harbor significant safety issues that have sidelined past options.

Qnexa attempts to improve on the infamous “fen-phen” diet drug. It combines one of fen-phen’s ingredients — the appetite suppressant phentermine — with the anti-seizure drug topiramate. Fen-phen’s other ingredient, fenfluramine, was yanked in 1997 when serious heart valve problems emerged.

FDA staff earlier this week said they were particularly focused on five potential risks: the potential for congenital defects, psychiatric problems such as depression, memory loss and other cognitive issues, increased body acids, and higher heart rates.

“I think it’s pretty well established that Qnexa has strong efficacy … The real question will be how the members of the panel view those safety concerns against the efficacy benefits,” Canaccord Adams analyst Adam Cutler told Reuters.

The agency plans to ask its panelists to weigh each area of concern before voting on whether to back the drug.

FDA officials usually follow their panelists’ advice. A decision is expected by October 28.

Industry watchers and competitors will also be looking at clues on the FDA’s thinking ahead of similar reviews on two rival drugs later this year by Arena Pharmaceuticals and Orexigen Therapeutics.

Diet pills already on the market include Abbott Laboratories’ Meridia, which carries several heart-related risks, and Roche Holding AG’s Xenical, which causes liver problems and uncontrolled bowel movements.

“Imagine what a drug can do that doesn’t have side effects and removes more weight,” said Leerink Swann analyst Steve Yoo.

On Wednesday, shares of Vivus closed down 2.7 percent at $2.11. Shares of Orexigen closed up more than 11 percent, while Arena closed up nearly 2 percent.

(Reporting by Susan Heavey; additional reporting by Susan Kelly in Chicago; Editing by Bernard Orr)

Filed Under: International News Tagged With: Administration Support, critical factor, Diet Changes, Diet Drugs, Enormous Benefit, fetuses, Financial Clients, food and drug administration, Forecast Data, Healthcare Analyst, heart risks, Ims Health, Obese Americans, Prescription Weight Loss, Qnexa, Slim Down, Suppository, Unpleasant Side Effects, Vivus Inc, Weight Loss Drugs

Analysis: Negative Avandia vote may bring new GSK legal woes

July 15, 2010 By vani Leave a Comment

(Reuters) – A negative ruling in a fateful U.S. regulatory vote on Wednesday over GlaxoSmithKline Plc’s Avandia diabetes drug could spark a new wave of litigation and spell more difficulty for the company in court.

A U.S. Food and Drug Administration advisory panel weighing evidence of heart risks with Avandia will recommend whether the drug should be removed from the market, one of five options that include restricting its use or keeping the drug on the market without a heart-attack warning.

Safety concerns over heart risks have engulfed Avandia since 2007, leading to a steep sales decline for the company’s one-time second-biggest-selling drug and precipitating a flood of lawsuits.

Glaxo appears to be trying to move past the litigation. Bloomberg News, citing unnamed sources, reported on Tuesday that Glaxo has agreed to pay about $460 million to resolve about 10,000 of an estimated 13,000 lawsuits. A company spokeswoman declined to comment on the report.

The amount tallies with estimates from some Wall Street analysts that the company will ultimately pay less than $1 billion related to the litigation and that it is already adequately reserved.

But a vote by the FDA advisers to pull the drug could raise new problems, including possibly another rash of lawsuits against the company, plaintiffs attorneys say. Such an event could restart the clock that began ticking in 2007 that would allow more Avandia users to sue the company.

“It could open up a whole host of other potential claims because it could be a new triggering of statute of limitations,” said Joe Osborne, a Florida-based attorney whose firm represents more than 100 Avandia plaintiffs.

While some potential plaintiffs may have previously been reluctant to sue, some may be “encouraged now to do it if the FDA sort of confirms this is a bad drug and they’re not just reading lawyer ads,” said Michael Williams, an Oregon-based attorney who represented plaintiffs in litigation over the fen-phen diet pill combination.

Removal of Avandia also could build momentum in the courts against Glaxo.

“If the FDA is taking the drug off the market, the judges are going to think the plaintiffs’ claims are probably meritorious,” Williams said. “It is sort of a change in attitude for the judiciary.”

Further, said Osborne, “it significantly hampers GSK’s defense about the safety profile of the drug if they now can no longer claim it’s on the market.”

Glaxo also this week was hit with other potentially damaging disclosures about Avandia. U.S. lawmakers released internal company documents that they said show Glaxo sought to downplay scientific findings that raised questions about Avandia’s safety as far back as 2000, shortly after the drug was approved. Glaxo said the documents were being taken out of context.

“I think they’re going to be in for a very difficult time,” said Barry Knopf, a New Jersey attorney whose firm represented plaintiffs against Merck & Co over the withdrawn Vioxx painkiller.

“If anyone goes out and hides information which they are required to reveal that certainly opens them up for punitive damages,” Knopf said. “That can be significant.”

The litigation has drawn parallels to that faced by Merck over Vioxx, which Merck removed from the market in 2004. Both drugs were multibillion-dollar sellers that studies showed increased the risk of heart attacks.

Merck took an aggressive legal strategy, maintaining from the day of the Vioxx withdrawal it would fight on a case-by-case basis.

Merck won most of the cases that went to trial, which provided leverage when in 2007 the drugmaker entered into a $4.85 billion agreement to resolve most personal injury claims, far less than some initial estimates.

Glaxo, which has been more reticent to discuss its strategy, appears to be taking a different approach. It said in June it settled the first Avandia case that had been set to go to trial in state court in Philadelphia for an undisclosed amount.

That confirmation by Glaxo followed reports by plaintiff lawyers last month that about 700 cases had been settled for around $60 million. And this week emerged the report that Glaxo had settled more than half of the 13,000 cases the company is estimated by analysts to face.

The next state trial is expected to start in the fall, and the first federal trial is expected to start in Philadelphia in October.

In a statement to Reuters, Glaxo said it was “fully prepared to defend any litigation because we are confident that when courts and juries look at actual clinical data, the manner in which we communicated with the FDA and physicians, and our openness in posting studies on our website, the facts will support our position.”

Glaxo has set aside 2.3 billion pounds (about $3.5 billion) as of March 31 as an aggregate provision for legal and other disputes.

“We believe even in the worst-case scenario that if Avandia were to be withdrawn, Glaxo has probably made sufficient provisions for the settlements and legal costs that might arise,” RBS analyst Michael Leacock said.

While Vioxx was shown to double the risk of heart attack and stroke, evidence has indicated that Avandia might increase heart attacks by 30 percent or 40 percent, UBS analyst Gbola Amusa said. “Avandia may therefore have a fraction of the risk of Vioxx based on the scientific data put forward,” Amusa said.

Amusa, speaking before the report of the latest settlement, said the stock has underperformed by more than $6 billion based on expectations for the liability.

“This is a buying opportunity because it looks like the liability could be less than $1 billion,” Amusa said.

(Reporting by Lewis Krauskopf; Additional reporting by Susan Heavey in Washington, Ben Hirschler in London and Jonathan Stempel in New York; Editing by Richard Chang)

Filed Under: International News Tagged With: advisory panel, Avandia, Avandia Diabetes, company spokeswoman, Diabetes Drug, Fda Advisers, food and drug administration, Glaxo, GlaxoSmithKline, Glaxosmithkline Plc, heart attack, heart risks, Legal Woes, Michael Williams, plaintiffs, safety concerns, Statute Of Limitations, unnamed sources, wall street analysts, Weighing Evidence

Q+A: Should Avandia be pulled? Questions remain

July 15, 2010 By vani Leave a Comment

(Reuters) – U.S. advisers opened a two-day meeting on Tuesday to consider whether GlaxoSmithKline’s diabetes drug Avandia is too dangerous to stay on the market.

Regulators in Europe also will meet this month to debate whether the pill should be restricted or even banned.

Documents released on Friday show the experts strongly disagree about the drug’s safety.

Here are some questions and answers about Avandia:

WHAT IS THE PROBLEM WITH THIS DRUG?

Diabetes is a serious chronic illness and is a direct cause of heart disease, but several studies have shown that Avandia, known generically as rosiglitazone, may itself damage the heart. Both Avandia and rival drug Actos, made by Takeda Pharmaceutical Co and known generically as pioglitazone, raise the risk of heart failure.

Two studies published last month showed that Avandia raises the risk of heart attack and stroke compared to Actos, but a third study showed that diabetics who took Avandia had a lower risk of heart attack, stroke or death than patients taking drugs of a different type.

Avandia is a member of a drug class called thiazolidinediones or glitazones. They affect a gene called PPAR-gamma and help the body use insulin more effectively. The first drug in the class, Rezulin or troglitazone, was pulled from the market in March 2000 after 63 people who took it died from acute liver failure and nearly 40 others needed liver transplants.

WHO DID THE STUDIES?

One of the studies was a “meta-analysis” of 56 trials involving people taking Avandia or other diabetes drugs. Done by longtime Avandia critic Dr. Steven Nissen at the Cleveland Clinic it found those taking Avandia were 28 percent to 39 percent more likely to have a heart attack.

The second study by David Graham and colleagues at the U.S. Food and Drug Administration and the U.S. Centers for Medicare and Medicaid Services found people taking Avandia had 1.25 times the risk of heart failure compared with those taking Actos, 1.27 times the risk of a stroke and 1.14 times the risk of dying.

The third study, paid for by the U.S. National Institutes of Health, found that adding Avandia to the mix of diabetes drugs lowered the risk of heart attack, stroke or death by 28 percent.

WHY IS THIS DRUG STILL ON THE MARKET?

That is just what consumer groups such as Public Citizen and Consumers Union are asking.

But it can be difficult to show that a drug is dangerous, especially in a disease like diabetes, which is already usually complicated with heart disease and other symptoms as well.

More than 700 pages of internal documents released on Friday showed FDA staffers disagree about how to interpret the studies.

Members of the U.S, Congress, including Republican Senator Charles Grassley, Democratic Representative Rosa DeLauro and Senate Finance Committee Chairman Max Baucus, have questioned the FDA’s regulation of Avandia.

A current trial called Tide is designed to directly compare Avandia and Actos.

The FDA has scheduled an advisory panel meeting on the heart safety of Avandia on July 13-14. The European Medicines Agency’s Committee for Medicinal Products for Human Use will discuss the issue in London on July 19-22.

HAVE PEOPLE SUED OVER THIS?

Yes. In May, a lawyer involved in some of the suits said Glaxo had settled with nearly 700 people who said they suffered harm because they took Avandia.

Joseph Zonies, one the lead plaintiffs’ lawyers in the federal case pending in a U.S. District Court, estimated that 3,000 cases have been filed in the federal litigation and says another 4,000 to 6,000 could be filed later.

WHY IS THIS DRUG NECESSARY?

The World Health Organization estimates that 171 million people globally had diabetes in 2000 and projected that number will nearly double by 2030 to 366 million.

Diabetes raises the risk of heart disease, stroke, kidney failure and other illnesses. Uncontrolled blood sugar levels can damage the blood vessels, and patients can lose toes, feet and legs to diabetes, while kidneys can fail and damage in the eyes can cause blindness.

While diet and exercise can control diabetes, many people also take prescription drugs.

WHAT OTHER DRUGS ARE THERE?

Diabetics have 12 classes of drugs to choose from.

New drugs include Merck’s Januvia and AstraZeneca and Bristol-Myers Squibb’s Onglyza. Many other drugs are in clinical trials, attacking diabetes with a variety of approaches.

Older drugs such as metformin and a class known as sulfonylureas are available generically and can also help lower blood sugar.

(Writing by Maggie Fox; Editing by Lisa Richwine and Tim Dobbyn)

Filed Under: International News Tagged With: Acute Liver Failure, Avandia, cause of heart disease, Centers For Medicare And Medicaid, Centers For Medicare And Medicaid Services, Cleveland Clinic, Diabetes Drug, Diabetes Drugs, Dr Steven Nissen, Drug Avandia, food and drug administration, heart failure, Liver Transplants, Market Regulators, meta analysis, pharmaceutical co, Rezulin, risk of heart attack, takeda pharmaceutical, taking drugs

UPDATE 1-Shampoo maker BaWang says products safe as shares dive

July 15, 2010 By vani Leave a Comment

HONG KONG, July 14 (Reuters) – Chinese herbal shampoo maker BaWang International (Group) (1338.HK) said on Wednesday that its products met safety standards as its shares tumbled following a media report that they contained a toxic chemical.

The Hong Kong-listed company made the statement in response to a report in local magazine Next alleging that tests showed some of the company’s shampoo products contained the cancer-causing chemical dioxane, sending is shares down 18 percent to HK$4.81 on Wednesday. By the midday trading break, the shares were at HK$5.05, down 14.1 percent.

BaWang said in a statement obtained by Reuters that all of its products had undergone stringent quality tests and met standards required by the mainland and Hong Kong authorities.

It said its products also complied with safety requirements prescribed by the U.S. Food and Drug Administration and “the level of dixoane is far below the world safety guidance and will not jeopardise health”.

BaWang, which hired movie star Jackie Chan and pop singer Faye Wong to promote its products, was one of most popular IPOs in 2009, when it listed on July 3.

Its retail public offering portion was 446 times subscribed and the company priced its HK$1.67 billion ($213.6 million) IPO at the top end of the indicative range. HSBC (0005.HK) and Morgan Stanley (MS.N) managed the deal. (US$1=HK$7.76) (Reporting by Donny Kwok; Editing by Chris Lewis)

Filed Under: International News Tagged With: Dioxane, Faye Wong, food and drug administration, Herbal Shampoo, Hong Kong Authorities, international group, Listed Company, Midday Trading, morgan stanley, pop singer, Public Offering, Quality Tests, safety guidance, Safety Requirements, Safety Standards, Shampoo Products, Star Jackie Chan, Stringent Quality, Toxic Chemical, World Safety

Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax

July 15, 2010 By vani Leave a Comment

ROCKVILLE, Md.–(Business Wire)–
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a
contract valued at up to $107 million with the Office of the Biomedical Advanced
Research and Development Authority (BARDA) of the Department of Health and Human
Services (HHS), to develop and obtain regulatory approval for large-scale
manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55. Building
55 is the company`s large-scale state-of-the-art vaccine manufacturing facility
in Lansing, Michigan.

“In line with Emergent`s mission of protecting life, we are proud to be working
with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the
Food and Drug Administration (FDA) for the prevention of anthrax infection,”
said Fuad El-Hibri, chairman and chief executive officer of Emergent
BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the
country`s biodefense infrastructure and to protect our military and civilian
populations.”

This cost plus fixed fee development contract has a total value of $107 million
and consists of a two-year base period of performance valued at $54.6 million
and three option years that, if exercised by BARDA, would increase the contract
value to up to $107 million. Under the contract, the company anticipates
recognizing revenues of up to $10 million and pretax earnings of up to $5
million during the second half of 2010. A substantial majority of the value of
the $107 million contract will be realized in the first three years of
performance (July 2010 to July 2013), assuming exercise of the first option
year.

The contract award is based on a technical proposal provided to BARDA that
projects an annual large-scale manufacturing capacity of 26 million doses in
Building 55. This is a significant increase from the company`s current capacity
of approximately 7-8 million doses per annum.

The company has developed a comprehensive plan to demonstrate comparability
between the current manufacturing process and the large-scale manufacturing
process for BioThrax. The contract will fund activities related to process
validation, assay validation, fill/finish, and if required, non-clinical and
clinical studies. The plan also includes regulatory activities in support of the
submission to FDA of a supplemental Biologics License Application (sBLA) for
BioThrax at the expanded scale. The company expects to begin manufacturing
consistency lots as early as the fourth quarter of 2011.

Emergent has invested significant resources in Building 55, which has been
designed to manufacture up to 25 to 30 million doses of BioThrax as currently
configured, and is expandable by adding a second manufacturing train that would
double annual capacity, based on demand. This is aligned with the company`s core
strategy to enhance its manufacturing capabilities to meet the increasing
government demand for anthrax vaccines for inclusion in the SNS.

The company also continues to enhance the attractiveness of BioThrax as a
significant component of the SNS, most recently through FDA approval of extended
shelf life to four years. In addition, based on data from a seven-year study by
the Centers for Disease Control and Prevention, the company has submitted to FDA
an sBLA to further reduce the BioThrax vaccination schedule to three doses
within six months with triennial booster vaccinations. To date, Emergent has
supplied over 42 million doses of BioThrax to the U.S. government with
additional deliveries scheduled through the third quarter of 2011 pursuant to
the current procurement contract with HHS.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of vaccines and antibody
therapies that assist the body`s immune system to prevent or treat disease.
Emergent`s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only
vaccine approved by the U.S. Food and Drug Administration for the prevention of
anthrax infection. Emergent`s product pipeline targets infectious diseases and
includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.
Additional information may be found at www.emergentbiosolutions.com.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax
infection. It is indicated for the active immunization of adults who are at high
risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate,
made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S.
government has procured over 42 million doses of BioThrax. During that time
period, more than 9.6 million doses have been administered to nearly 2.4 million
military personnel. For full prescribing information, please visit
www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements, other than
statements of historical fact, including statements regarding our strategy,
future operations, future financial position, future revenues, projected costs,
prospects, plans and objectives of management, including any potential future
securities offering, our expected revenue growth and net earnings for 2010, and
any other statements containing the words “believes”, “expects”, “anticipates”,
“plans”, “estimates” and similar expressions, are forward-looking statements.
There are a number of important factors that could cause the company`s actual
results to differ materially from those indicated by such forward-looking
statements, including appropriations for BioThrax® procurement; our ability to
obtain new BioThrax® sales contracts; our plans to pursue label expansions and
improvements for BioThrax®; our plans to expand our manufacturing facilities and
capabilities; the rate and degree of market acceptance and clinical utility of
our products; the success of our ongoing and planned development programs,
preclinical studies and clinical trials; our ability to identify and acquire or
in license products and product candidates that satisfy our selection criteria;
the potential benefits of our existing collaboration agreements and our ability
to enter into selective additional collaboration arrangements; the timing of and
our ability to obtain and maintain regulatory approvals for our other product
candidates; our commercialization, marketing and manufacturing capabilities and
strategy; our estimates regarding expenses, future revenue, capital requirements
and needs for additional financing; and other factors identified in the
company`s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and
subsequent reports filed with the SEC. The company disclaims any intention or
obligation to update any forward-looking statements as a result of developments
occurring after the date of this press release.

Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com

Filed Under: International News Tagged With: anthrax infection, anthrax vaccine, Barda, Base Period, biodefense, chief executive officer, Civilian Populations, Contract Value, Development Contract, emergent biosolutions inc, food and drug administration, Food and Drug Administration (FDA), Fuad, Md Business, Nyse, Pretax Earnings, regulatory approval, Substantial Majority, Technical Proposal, unwavering commitment

Lawsuits may reveal more Avandia data

July 14, 2010 By vani Leave a Comment

(Reuters) – Lawyers for patients who say they have been harmed by GlaxoSmithKline Plc’s Avandia say critical data is still under wraps even as a U.S. advisory panel prepares to weigh the fate of the controversial diabetes drug.

The lawyers, who represent thousands of patients or family members suing the British drugmaker in multi-district federal litigation, say they have uncovered critical documents.

They are pushing the court to allow their release to both the U.S. Food and Drug Administration and the Senate Finance Committee, which has investigated Glaxo’s handling of Avandia.

An FDA advisory panel is already wading through hundreds of pages of conflicting data and studies, and is due to meet for two days starting Tuesday on whether to recommend that Avandia be pulled off the market due to heart risks.

Avandia has been under fire since 2007 over concerns that it raises the risk of heart attack, stroke and death more than Takeda Pharmaceutical Co’s rival diabetes pill Actos.

It is unclear what the court-sealed documents contain, but it raises questions about whether the FDA will be acting on Avandia without the benefit of all available information.

“We think there are very important documents involved,” said Joseph Zonies, one of the lead plaintiffs lawyers in the federal case, which is pending in a U.S. district court.

But unless the court lifts current confidentiality protections, the soonest the documents could come to light would be September 5, at a scientific court briefing, he added.

A court-appointed master is considering the request to lift the documents’ confidentiality, but it is unclear when that decision will be made and how it would impact the drug’s fate.

Glaxo has defended Avandia, saying the overall data shows Avandia does not increase heart attacks or related problems.

Still, it faces numerous lawsuits from patients and family members who allege that use of Avandia led to injury or death. Zonies estimated 3,000 cases have been filed in federal litigation while another 4,000 to 6,000 could be filed later.

FDA officials have said they’ve reviewed all the data possible in assessing Avandia’s risks. On Friday, they released more than 700 pages of documents — including one analysis of 52 studies — from various agency scientists that showed the agency is still split over what to do.

“We’ve reviewed the new data to the extent that we have access to it,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told reporters last week.

The FDA panel of outside experts will discuss the data and hear from researchers, patients and public health advocates at the July 13-14 meeting before offering their advice, which could range from leaving the drug on the market and collecting more data to calling for its withdrawal.

But at least one expert witness for the plaintiffs, a Canadian cardiologist, said what he saw was so critical that he sought to testify before the FDA advisers this week. He did not indicate the nature of the documents.

In a letter to the FDA, McGill University’s Allan Sniderman said he has “access to data that has not previously been available to any similar group” but is barred by a court protective order from discussing the documents he has seen.

“These data are, in my opinion, essential to review,” he wrote last month.

Sniderman did not return calls seeking comment, but Zonies said the cardiologist later withdrew his request. Glaxo spokeswoman Mary Anne Rhyne said the company gave consent for Sniderman to speak with court approval but that he withdrew his request before the court could act.

Rhyne also said Glaxo “has consistently said that experts in the litigation may share their views on the data relating to Avandia” with FDA and Senator Charles Grassley, the top Republican on the Senate Finance Committee, as long as the judge gave permission.

The once $3-billion-a-year drug has seen its sales slip but it still brings in about $1 billion in annual sales. Glaxo has taken 2 billion pounds ($3 billion) in litigation provisions, but analysts have said the company’s liability risk is unclear should Avandia be pulled from the market.

Glaxo has not confirmed the total number of lawsuits it faces. While it has already settled some state lawsuits, others are pending along with federal litigation.

The federal case combines lawsuits filed in various federal district courts and is set to go to trial October 5. Another state case is also scheduled for October.

The federal case is IN RE: Avandia Marketing, Sales Practices and Products Liability Litigation, U.S. District Court, Eastern District of Pennsylvania, MDL No. 1871, No. 07-md-01871.

(Reporting by Susan Heavey; Editing by Tim Dobbyn.)

Filed Under: International News Tagged With: advisory panel, Avandia, Confidentiality Protections, Controversial Diabetes Drug, Critical Documents, Diabetes Pill, Federal Case, Federal Litigation, food and drug administration, Glaxo, GlaxoSmithKline, Glaxosmithkline Plc, heart attacks, heart risks, pharmaceutical co, reuters, risk of heart attack, Senate Finance Committee, takeda pharmaceutical, Zonies

Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for BENLYSTA, a Potential New Treatment for Systemic Lupus Erythematosus

July 14, 2010 By vani Leave a Comment

ROCKVILLE, Md. & BASEL, Switzerland–(Business Wire)–
Human Genome Sciences, Inc. (Nasdaq:HGSI) and Lonza today announced an agreement
for the future commercial supply of BENLYSTA (belimumab), which is currently
under regulatory review in the United States and Europe as a potential new
treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by
HGS and GlaxoSmithKline (GSK) under a co-development and commercialization
agreement entered into in 2006.

“Our HGS large-scale manufacturing facility has ample capacity to provide
worldwide supply of BENLYSTA following approval, and for the first two or three
years following launch,” said Randy J. Maddux, Vice President, Manufacturing
Operations, HGS. “However, we believe that we will eventually require additional
capacity. After a careful review of proposals from a number of highly qualified
commercial manufacturing organizations, we have selected Lonza, a leader in
biologics manufacturing with a global network of large-scale production sites.
We are confident that Lonza is the right choice to fill this critically
important role.”

In June 2010, GSK submitted a Marketing Authorization Application to the
European Medicines Agency, seeking approval to market belimumab in Europe for
treatment of autoantibody-positive patients with SLE, and HGS submitted a
Biologics License Application (BLA) to the U.S. Food and Drug Administration
seeking approval to market belimumab in the United States. No new drug for lupus
has been approved by regulatory authorities in more than 50 years.

“We are enthusiastic about supporting the future production of BENLYSTA with our
cutting-edge capabilities and expertise in biopharmaceutical manufacturing,”
said Dr. Stephan Kutzer, Chief Operating Officer, Lonza Custom Manufacturing.
“Working on such an important new drug for lupus patients will be very rewarding
and the basis for a long-term, collaborative relationship with HGS.”

About BENLYSTA (belimumab)

Belimumab is an investigational human monoclonal antibody drug that specifically
recognizes and inhibits the biological activity of B-lymphocyte stimulator, or
BLyS. BLyS is a naturally occurring protein discovered by HGS that is required
for the development of B-lymphocyte cells into mature plasma B cells. Plasma B
cells produce antibodies, the body`s first line of defense against infection. In
lupus and certain other autoimmune diseases, elevated levels of BLyS are
believed to contribute to the production of autoantibodies – antibodies that
attack and destroy the body`s own healthy tissues. The presence of
autoantibodies appears to correlate with disease severity. Preclinical and
clinical studies demonstrated that belimumab reduced autoantibody levels in SLE.
The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, demonstrated
that belimumab reduced SLE disease activity.

About Lonza

Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare
and life science industries. Its products and services span its customers` needs
from research to final product manufacture. Lonza is the global leader in the
production and support of active pharmaceutical ingredients both chemically as
well as biotechnologically. Biopharmaceuticals are one of the key growth drivers
of the pharmaceutical and biotechnology industries. Lonza has strong
capabilities in large and small molecules, peptides, amino acids and niche
bioproducts which play an important role in the development of novel medicines
and healthcare products. Lonza is a leader in cell-based research, endotoxin
detection and cell therapy manufacturing. Lonza is also a leading provider of
value chemical and biotech ingredients to the nutrition, hygiene, preservation,
agro and personal care markets. Lonza is headquartered in Basel, Switzerland and
is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690
billion. Further information can be found at www.lonza.com.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to bring
innovative drugs to patients with unmet medical needs.

For more information about HGS, please visit the Company`s web site at
www.hgsi.com. Health professionals and patients interested in clinical trials of
HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at
(877) 822-8472.

HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences,
Inc. Other trademarks referenced are the property of their respective owners.

HGS Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. The forward-looking statements are
based on Human Genome Sciences` current intent, belief and expectations. These
statements are not guarantees of future performance and are subject to certain
risks and uncertainties that are difficult to predict. Actual results may differ
materially from these forward-looking statements because of Human Genome
Sciences` unproven business model, its dependence on new technologies, the
uncertainty and timing of clinical trials and regulatory approvals, Human Genome
Sciences` ability to develop and commercialize products, its dependence on
collaborators for services and revenue, its substantial indebtedness and lease
obligations, its changing requirements and costs associated with facilities,
intense competition, the uncertainty of patent and intellectual property
protection, Human Genome Sciences` dependence on key management and key
suppliers, the uncertainty of regulation of products, the impact of future
alliances or transactions and other risks described in the Company`s filings
with the SEC. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of
today`s date. Human Genome Sciences undertakes no obligation to update or revise
the information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.

HGS
Media
Jerry Parrott
Vice President, Corporate Communications
301-315-2777
jerry_parrott@hgsi.com
or
Investors
Peter Vozzo
Senior Director, Investor Relations
301-251-6003
peter_vozzo@hgsi.com
or
LONZA GROUP LTD
Head Corporate Communications
Michael Frizberg
Tel +41 61 316 8624
Fax +41 61 316 9624
michael.frizberg@lonza.com
or
Media Relations
Dominik Werner
Tel +41 61 316 8798
Fax +41 61 316 9798
domink.werner@lonza.com
or
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540
Fax +41 61 316 9549
dirk.oehlers@lonza.com

Filed Under: International News Tagged With: Ample Capacity, Authorization Application, Basel Switzerland, Belimumab, Biologics License Application, edge capabilities, european medicines, food and drug administration, gsk, HGS, Hgsi, Human Genome Sciences, Human Genome Sciences Inc, Lupus Patients, Lupus Sle, Manufacturing Agreement, medicines agency, regulatory authorities, Systemic Lupus Erythematosus, Worldwide Supply

UPDATE 2-US White House AIDS strategy to focus on prevention

July 14, 2010 By vani Leave a Comment

WASHINGTON, July 12 (Reuters) – U.S. President Barack Obama released a domestic AIDS strategy on Monday that aims to cut the infection rate by 25 percent, test 90 percent of those infected and get 85 percent of patients treated right away.

The new plan, to be formally released on Tuesday, also has modest aims to get 20 percent more of the most at-risk groups such as gay and bisexual men and blacks treated with drugs to control their infections.

“Unless we take bold actions, we face a new era of rising infections, greater challenges in serving people living with HIV, and higher health care costs,” the report reads.

The United States should be able to lower the annual number of new infections by 25 percent from 56,300 to 42,225 a year by 2015, the plan said.

It also proposes to cut the HIV transmission rate by 30 percent. Currently, 5 percent of HIV patients infect someone else and the plan aims to lower this to 3.5 percent.

The U.S. Centers for Disease Control and Prevention says 79 percent of people infected with the human immunodeficiency virus that causes AIDS know they have it. The plan aims to increase this to 90 percent.

To this end, the plan calls for the U.S. Food and Drug Administration to make a top priority the review of new HIV diagnostic tests.

It also promises to get 85 percent of newly diagnosed patients into a doctor’s office or clinic within three months. Currently, 65 percent get treated that quickly.

The plan also targets behavior. “Congress and State legislatures should consider the implementation of laws that promote public health practice and underscore the existing best evidence in HIV prevention for sexual minorities,” it reads.

More than 1.1 million people in the United States are infected with the human immunodeficiency virus that causes AIDS, according to the Centers for Disease Control and Prevention.

While only about 5 percent of patients infect someone else, this is enough to keep levels of the virus stable in the United States, the CDC says. The fatal and incurable virus is spread during sex, in blood and breast milk and by contaminated needles.

The U.S. government has a program to fight AIDS globally — PEPFAR, or President’s Emergency Plan for AIDS Relief — but there has not been a similar coherent domestic strategy.

While the administration of former President George W. Bush was praised for coming up with PEPFAR, it was widely criticized for promoting abstinence-only education in place of more comprehensive programs stressing condom use.

The new Obama plan includes abstinence but also stresses other approaches.

“We must also move away from thinking that one approach to HIV prevention will work, whether it is condoms, pills, or information,” the plan reads.

“Instead, we need to develop, evaluate, and implement effective prevention strategies and combinations of approaches including efforts such as expanded HIV testing (since people who know their status are less likely to transmit HIV), education and support to encourage people to reduce risky behaviors (and) the strategic use of medications and biomedical interventions,” it adds.

Some AIDS activist groups began criticizing the policy even before it was released, saying it did not come close to doing what they had hoped.

The AIDS virus infects 33 million people globally and has killed 25 million since the pandemic began in the 1980s.

In Africa, most new AIDS patients are women infected by men during sex. In the United States HIV disproportionately affects men who have sex with men, blacks and Hispanics.

(Editing by Eric Beech)

Filed Under: International News Tagged With: Aids Strategy, Barack Obama, best evidence, Bisexual Men, Bold Actions, centers for disease control and prevention, disease control and prevention, food and drug administration, Health Care Costs, hiv patients, Hiv Prevention, Hiv Transmission, Human Immunodeficiency Virus, living with hiv, Public Health Practice, risk groups, sexual minorities, State Legislatures, top priority, Transmission Rate

US White House AIDS strategy to focus on prevention