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Internal Medicine News - Trial data added to coreg label

admin — Sun, 04 Jan 2009 12:21:02 +0000

The label of Coreg (carvedilol) has been changed to include data from two clinical trials that show reduced risk of repeat MI and reduced risk of MI in heart failure patients. Patients participating the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction (CAPRICORN) study experienced a 40% reduction in fatal or nonfatal MI. According to the trial results, when carvedilol was initiated within 21 days and maintained long term in patients following an MI that damaged the heart, the risk of dying was reduced by 23%.

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New indications for once-daily CoregFlamel Technologies Welcomes FDA Approval of COREG CR™Flamel Technologies Welcomes Nationwide Availability of COREG CR™New & approved: Coreg biotronik home monitoring systemGSK unveils more convenient form of Coreg, targets oncology

In the Carvedilol or Metoprolol European Trial (COMET) 3,029 patients with heart failure were randomized to receive either carvedilol or immediate-release metolprolol tartrate. All-cause mortality was 34% in the patients treated with carvedilol, compared with 40% in the metoprolol-tartrate group.
For more information, contact GlaxoSmithKline by calling 888-825-5249 or by visiting www.gsk.com.
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Chain Drug Review - Glaxo products

admin — Fri, 02 Jan 2009 00:06:03 +0000

Advair HFA inhalation is now on the market. Manufactured by GlaxoSmithKline PLC, the medicine is used to treat asthma. The FDA has also approved the company’s Coreg for treating hypertension, post-myocardial infarction left ventricular dysfunction, and mild-to-severe heart attack.

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Trial data added to coreg labelNew indications for once-daily CoregFlamel Technologies Welcomes FDA Approval of COREG CR™Flamel Technologies Welcomes Nationwide Availability of COREG CR™New & approved: Coreg biotronik home monitoring system

M2 Presswire - Notifies Shareholders of Flamel Technologies.

admin — Sun, 28 Dec 2008 20:01:02 +0000

M2 PRESSWIRE-23 October 2006-www.MarketGainer.com: Notifies Shareholders of Flamel Technologies(C)1994-2006 M2 COMMUNICATIONS LTD RDATE:23102006 Market Gainer is quickly emerging as the one stop shop for international small-cap investors looking to stay a step ahead of the markets. Today’s activity on the Nasdaq exchange has brought Flamel Technologies (NASDAQ:FLML) to the attention of our research team.

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Our goal is to create a community of international investors who consistently and effectively capitalize on the enormous gains the small-cap Canadian and American exchanges …

Read the rest of this article with a Free Trial at HighBeam Research.

Chain Drug Review - Caraco gets clearance

admin — Sat, 27 Dec 2008 05:36:03 +0000

Caraco Pharmaceutical Laboratories Ltd. has received tentative approval for generic Coreg tablets. The product (carvedilol) is for teating mild to severe heart failure of ischemic or cardiomyopathic origin.

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Internal Medicine News - New indications for once-daily Coreg

admin — Mon, 22 Dec 2008 08:46:02 +0000

The Food and Drug Administration has approved a new application for Coreg CR (carvedilol phosphate) extended-release capsules for the treatment of mild to severe heart failure, the reduction of cardiovascular mortality in patients who have survived the acute phase of myocardial infarction, and hypertension.

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Trial data added to coreg labelFlamel Technologies Welcomes FDA Approval of COREG CR™Flamel Technologies Welcomes Nationwide Availability of COREG CR™New & approved: Coreg biotronik home monitoring systemGSK unveils more convenient form of Coreg, targets oncology

The drug, the controlled-release formulation of the immediate-release [beta]-blocker Coreg (carvedilol), will be launched in the first quarter of 2007. For more information, call the manufacturer, GlaxoSmithKline, at 888-825-5249.
COPYRIGHT 2007 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Business Wire - Teva Reports Third Quarter 2007 Results

admin — Tue, 16 Dec 2008 17:51:03 +0000

The world’s largest generics company is also expected to be strong in biogenerics. In 2004, Teva purchased Sicor, which markets G-CSF, human growth hormone and interferon alpha in Eastern Europe and emerging markets. Gate, a subsidiary of Teva, sells human growth hormone in the United States as branded Tev-Tropin.
In 2005, Teva acquired Ivax, which is developing generic insulin and human growth hormone.
The company is growing quickly. Net sales for the third quarter of 2006 increased 74 percent to $2.3 billion, compared with $1.3 billion in the third quarter of 2005. The main contributors to the year-over-year growth in sales were several new product launches in the United States, including Simvastatin, Sertraline, Bupropion and Pravastatin, and sales of Ivax products.

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Recent product launches for the company include generic Famvir and Coreg tablets.
Mylan is a global pharmaceutical company with market leading positions in generic pharmaceuticals, transdermal technology and unit dose packaged products.
Mylan operates through three principal subsidiaries: Mylan Pharmaceuticals a world leader in generic pharmaceuticals; Mylan Technologies, the largest producer of generic and branded transdermal patches for the U.S. market; and UDL Laboratories, the top U.S. supplier of unit-dose pharmaceuticals.
The company announced its financial results for the first quarter of fiscal 2008, which included adjusted diluted cash earnings per share of $0.52 compared with $0.35 in the first quarter of fiscal 2007. Mylan’s first quarter was a record in terms of both net revenues, which increased by 55.6 percent to $542.7 million compared with $348.8 million in the year-ago quarter, and operating income, up $70.9 million from the year-ago quarter to $188.1 million for the three months ended June 30, 2007. The record net revenues were achieved excluding any contribution from Matrix Laboratories Limited, which was acquired in the fourth quarter of the prior year. Additionally, Matrix’s sales of $91.3 million increased 15 percent over the fourth quarter of fiscal 2007.
A year ago Barr acquired Croatian company Pliva and it’s expected that the company will be strong in developing insulin and human growth hormone. Pliva is developing G-CSF (granulocyte-colony stimulating factor) and has received European approval for generic erythropoietin.
Barr reported net earnings growth for fiscal 2006 of 56.5 percent year-on-year, to reach $336.5 million. This compares with net earnings of $215.0 million in fiscal year 2005.
Generic sales for the Woodcliff Lake, N.J.-based company for fiscal 2006 were $839 million, a 12 percent increase over fiscal 2005, when generics generated revenues of $751 million. The company currently markets 75 generic products in approximately 100 dosage forms and strengths. Its strongest product lines are in oral contraceptives and warfarin sodium. Last year it also launched an authorized generic version of contraceptive Seasonale (levonorgestrel/ethinyl estradioal).
Lupin Pharmaceuticals is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five pharmaceutical companies in India. Lupin entered the U.S. generic pharmaceutical market in 2003 with the ANDA approval for cefuroxime axetil, the generic of the antibiotic ceftin. Since then, it has received more than a dozen Food and Drug Administration approvals. Six of Lupin’s 14 ANDA approvals were the first granted by the FDA, reinforcing its ability to gain approvals on time.
The company recently received drug approvals for generic Norvasc, Mavik and Geodon.
The company also has received an exclusive license to use the Suprax trademark in the United States. The drug is an anti-infective medication used in pediatric practice.
For the financial year ending March 2006, Lupin’s revenue and profit were $310 million and $41 million respectively.
Sandoz is the generic arm of Novartis, and it has the only product approved as a ‘follow-on’ drug (as opposed to a biogeneric) in the United States. Omnitrope was approved as a biosimilar in Europe, Australia and other countries as a human growth hormone.
According to Sandoz, the company has six biopharmaceutical projects in its pipeline, and expects to file another NDA this year. Last year Sandoz signed exclusive collaboration with Momenta Pharmaceuticals to focus on developing complex generics and follow-on biotechnology drugs
Sandoz reported generic pharmaceutical sales in 2006 of $5.9 billion. Its generics focus on antibiotics, preparations for treating the central nervous system, the gastrointestinal area and cardiovascular system as well as hormones and antiallergics. Last year it launched generic versions of blockbuster drugs Xanax and Zithromax.
There are already several of Wockhardt’s biologic drugs on the Indian market, but the company is expected to partner with drug companies in Europe and the United States when a pathway is created for the approval of biogenerics.
Wockhardt’s revenue for third quarter 2006 increased 22 percent compared with the third quarter 2005 to $99.4 million). This increase was seen both internationally (an increase of 11 percent) and domestically fan increase of 38 percent).

Drugs Prolong Life After Heart Attack

admin — Wed, 10 Dec 2008 12:56:03 +0000

Jan. 9, 2007 — For heart attackheart attack survivors, it really is important to
follow doctor’s orders: A Canadian study shows you may be less likely to die if
you continue taking the drug he prescribes.
The study of 31,455 heart attack survivors found 24% of the patients worst
about continuing their medicine died over the course of the study, compared to
16% of those best at taking their medication.
The patients, who were 66 and older, were followed for 2.4 years, on
average, after their heart attack.
They had prescriptions for at least one of the following types of heart
drugs: statins, beta-blockers, or calcium channel blockers.
Researchers, including the University of Toronto’s David Alter, MD, PhD,
FRCPC, studied how long the patients continued refilling their prescriptions.
Their report appears in The Journal of the American Medical
Association.
About the Drugs
All of the patients survived at least one year and three months after their
heart attack.
Most took their drugs faithfully for the first year. But adherence fell
later on.
One of the types of drugs prescribed, statins, cuts cholesterol and includes
such drugs as Crestor, Lipitor, Pravachol, and Zocor.
Beta-blockers include such drugs as Coreg and Toprol-XL. They help the heart
relax and slow heart rate, boosting the heart’s pumping ability over time.
Calcium-channel blockers include Norvasc, Plendil, and Cardizem. They treat
chest pain (anginaangina) and high blood
pressurehigh blood pressure.
Of the Canadian patients, 57% filled a prescription for a statin, 77% filled
a prescription for a beta-blocker, and 30% for a calcium-channel blocker within
three months after hospital discharge for their heart attack. (Some took more
than one type of drug.)
Pharmacy Use
Among those with statin prescriptions, 13% had stopped taking their statins
by the time the study ended. A fifth of those with beta-blocker prescriptions
quit taking their beta-blockers. A third of those with calcium-channel blocker
prescriptions had stopped taking those drugs.
It’s not clear why the patients stopped taking the drugs, which were free
under the Canadian health care system.
Better Adherence, Longer Lives
About 14,300 patients stuck with their statin prescriptions for at least 80%
of the days studied. Those patients had the lowest death rate — 16% — during
the study.
An additional 2,407 patients followed their prescriptions for 40% to 79% of
the days studied. They had the second-lowest death rate: 20%.
The highest death rate occurred in the patients with the lowest drug
adherence.
Those patients took their drugs for less than 40% of the days studied.
Nearly a quarter of them — 24% — died during the course of the study.
Survival Rate by Drug
People who kept taking their statin drugs had the best survival rates,
followed by those taking beta-blockers.
Calcium-channel blockers weren’t associated with longer (or shorter)
lives.
The study doesn’t prove the drugs alone saved the patients’ lives. For
instance, the researchers didn’t look at exercise habits, diet, or smoking
status.
But they did adjust for many factors, including the patients’ age and other
health problems.
Moral of the story? It’s important to follow prescriptions carefully. And if
you have concerns about a drug you’re taking, talk with your doctor before
quitting the drug or making changes.

Business Wire - Fitch Publishes Third Quarter Global Pharmaceutical R&D Pipeline Report

admin — Mon, 08 Dec 2008 06:56:02 +0000

CHICAGO — The Fitch Ratings global pharmaceutical team is presenting its ‘Global Pharmaceutical R&D Pipeline’ report for the third quarter, today. The overview details the most current developments of late-stage R&D brand name pharmaceutical projects of major drug developers and provides details about relevant industry issues.
Successful R&D is more critical for the industry compared to previous years, in order to mitigate exposure to potentially dramatic intellectual property losses which will affect many industry participants after the end of the decade.

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The majority of marketing approvals could be seen in Europe during the third quarter. The European Agency for the Evaluation of Medicinal Product’s marketing approvals doubled those of the Food and Drug Administration, and included several potential blockbuster pharmaceuticals. The lower number of U.S. approvals reflects the heightened safety issues that continue to play into regulatory decisions granting marketing authorization of new pharmaceuticals.
On the other hand, first-time U.S. generic competition for major products in the third quarter was limited to European names and mainly hit GlaxoSmithKline’s Coreg and Novartis’ Lamisil.
In terms of sales growth, U.S. names were leading the third quarter sales growth of 8.1% (up from 7% in the second quarter), driven by Bristol-Myers Squibb (25%), Abbott Laboratories (20%) and Eli Lilly (19%). The world’s two largest pharmaceutical companies, GlaxoSmithKline and Pfizer, saw a slight sales decline driven by patent expiry in the third quarter.
The trend towards shareholder-friendly stances continued in the third quarter, as demonstrated by the industry collectively paying dividends of $8 billion and repurchasing common shares totaling more than $11 billion. Credit concerns are heightened if the shareholder-friendly trend is not accompanied by moderation of acquisition activities.
The full ‘Global Pharmaceutical R&D Pipeline - Third Quarter 2007′ can be found on the Fitch Ratings’ web site www.fitchratings.com. The report incorporates three year periods (two years for European companies) as it looks forward to calculate revenues potentially subject to generic competition as well as a historical presentation of sales from market introduction. The Fitch team will continue to issue this report on a quarterly basis following earnings reporting.
Fitch’s rating definitions and the terms of use of such ratings are available on the agency’s public site, www.fitchratings.com. Published ratings, criteria and methodologies are available from this site, at all times. Fitch’s code of conduct, confidentiality, conflicts of interest, affiliate firewall, compliance and other relevant policies and procedures are also available from the ‘Code of Conduct’ section of this site.
COPYRIGHT 2007 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Business Wire - Merck Serono and Flamel to Collaborate on an Extended Release Formulation for Therapeutic Proteins

admin — Tue, 02 Dec 2008 10:21:03 +0000

Flamel’s Medusa([R]) technology designed to allow less frequent administration of therapeutic proteins and peptides
LYON, France — Flamel Technologies (Nasdaq:FLML) today announced that it has entered into a collaboration with Merck Serono, a division of Merck KGaA, to investigate the applicability of Flamel’s Medusa([R]) technology for the extended release of a therapeutic protein of Merck Serono’s portfolio. Under the terms of the agreement, Merck Serono will make an upfront payment of EUR 2 million to Flamel for investigating the therapeutic protein and Merck Serono will fund R&D efforts to be performed at Flamel. Financial terms of a license agreement up through potential commercialization of this formulation have been agreed between the parties.

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“We are delighted to enter into this partnership with Flamel, as it gives Merck Serono access to a technology that may further improve the therapeutic potential of compounds in our portfolio,” said Bernhard Kirschbaum, Merck Serono’s Head of Research. “As Flamel’s Medusa([R]) technology allows for longer intervals between administrations of injectable proteins compared to standard formulations, we hope to offer an improved convenience for patients requiring treatment by injection. As a consequence, we anticipate that employing this technology will lead to better treatment outcomes for patients.”
Stephen H. Willard, Flamel’s Chief Executive Officer, stated, “We are pleased to have reached an agreement with Merck Serono. The Medusa([R]) platform is a best-in-class technology for the controlled delivery of proteins, peptides, and other molecules. This applicability to a wide range of molecules is a key strength of the platform, as is the ability to sustain release without affecting bioactivity. Merck Serono is the ideal partner for this project and we look forward to working together on such an exciting opportunity.”
About Medusa[R]
Medusa[R], a self-assembled poly-aminoacid nanoparticle system, is a versatile carrier for the development of novel long-acting formulations of proteins, peptides, and other molecules. The Medusa[R] platform has many advantages in that it enables the controlled delivery of fully-human, non-denatured proteins with full bioactivity. Flamel believes that this will lead to a third-generation of protein-based drugs offering greater effectiveness and reduced toxicity and side effects to patients. A new microparticulate adaptation of Medusa[R] has been developed that potentially can extend pharmacokinetics to two weeks or more, offering an infusion-like release profile, also without loss of bioactivity.
About Flamel Technologies
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Flamel’s Medusa technology is designed to deliver controlled-release formulations of therapeutic proteins and peptides and other molecules, without reduction in bioactivity. Micropump([R]) is a controlled release and taste-masking technology for the oral administration of small molecule drugs; it is the intellectual platform licensed by GlaxoSmithKline for COREG CR([R]).
About Merck Serono
Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck, was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.
Merck Serono has leading brands serving patients with cancer (Erbitux[R]), multiple sclerosis (Rebif[R]), infertility (Gonal-f[R]), metabolic and cardiometabolic disorders (Glucophage[R], Concor[R], Saizen[R], Serostim[R]), as well as psoriasis (Raptiva[R]). With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurodegenerative Diseases and Oncology, as well as new therapeutic areas potentially arising out of our research and development in Autoimmune and Inflammatory Diseases.
About Merck
Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 30,962 employees in 61 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
This document contains a number of matters, particularly as related to financial projections and the status of various research projects and technology platforms, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

News: Flamel Technologies Announces Nomination of Dr. Frank Fildes …

admin — Thu, 27 Nov 2008 04:01:03 +0000

Flamel Technologies (Nasdaq:FLML) announced today that the Board
of Directors has elected Dr. Frank J. Fildes, PhD to serve as a member
of the Company’s Board of Directors. Dr. Fildes was elected to replace
Cor Boonstra, who is retiring from his position with Flamel. Dr.
Fildes will also assume Mr. Boonstra’s position on the Audit Committee
of the Company.

Dr. Fildes is the former Senior Vice President: Head of Global
Development for AstraZeneca, PLC, where he was responsible for the
development, registration, and technical support of AstraZeneca
products worldwide. He currently serves as a director of ProStrakan
Group PLC and Piramed, Ltd. He also serves as a member of the
Scientific Advisory Board of UCB Pharmaceuticals; as a member of the
Portfolio Review Board of Ferring Pharmaceuticals; and as a member of
the New Agents Development Committee for Cancer Research UK, the
United Kingdom’s leading cancer charity. Dr. Fildes is a Fellow of the
Royal Society of Medicine and the Royal Society of Chemistry.

Dr. Fildes commented, “In recent months, I have had the
opportunity for an in-depth review of Flamel’s technology platforms
with its scientists and technologists, and I believe that Flamel
offers clinically and commercially compelling drug delivery solutions
to pharmaceutical and biotechnology companies. I am delighted to be
asked to serve as a member of Flamel’s Board of Directors.”

“The Board of Directors and the entire Flamel team are looking
forward to working more closely with Dr. Fildes, who adds a further
wealth of pharmaceutical experience and scientific knowledge to our
Board,” said Elie Vannier, the chairman of the Board of Directors of
Flamel Technologies. Stephen H. Willard, Flamel’s chief executive
officer added: “Dr. Fildes’ drug development roles at AstraZeneca are
of obvious help to us in every aspect of our work. Furthermore, as a
Ph.D in polymer chemistry, he intimately understands the fundamental
science that underpins our technology offerings to clients. Dr. Fildes
has developed a close relationship with many of our top scientists. We
all are pleased and honored that he has agreed to be nominated to
serve the Company as a member of our Board of Directors.”

Mr. Vannier and Mr. Willard continued: “We would also like to
express our deep appreciation and that of our fellow directors for the
intelligence, no-nonsense approach, and time that Cor Boonstra has
dedicated to Flamel Technologies since 2005. He has been a wonderful
resource of business acumen and has contributed in many ways to our
Company over the past few years. He will always have our thanks for
all his efforts on our behalf, and our board will sincerely miss him.”

Flamel Technologies also announced today that Michel Finance,
Executive Vice President and Chief Financial Officer, will be leaving
the Company to pursue other interests. Sian Crouzet, Flamel’s
Financial Controller will assume the role of Principal Financial
Officer.

Mrs. Crouzet has served the company as Flamel’s Financial
Controller since 2005. Mrs. Crouzet previously worked as Financial
Controller France for McCormick & Company Inc. Previous to that, she
was an external auditor with Ernst and Young. She is a UK Chartered
Accountant and a graduate of Bradford University.

Mr. Willard stated, “I wish to thank Michel Finance for his work
over the past two and a half years and wish him well in his future
endeavors. We are very fortunate to have Sian’s experience and
practical knowledge of the Company which has been developed as our
Controller over the past two and a half years. I am looking forward to
working with her in her new role as Principal Financial Officer.”

A conference call to discuss Flamel’s fourth quarter and 2007
annual results is scheduled for 8:30 AM Eastern Standard Time March 4,
2008. The dial-in number is (1) 800-374-1498 (Conference ID number:
36447833). International callers are invited to dial-in (1)
706-634-7261.

Flamel Technologies, S.A. is a biopharmaceutical company
principally engaged in the development of two unique polymer-based
delivery technologies for medical applications. Flamel’s Medusa(R)
technology is designed to deliver controlled-release formulations of
therapeutic proteins and peptides, without reduction in bioactivity.
Micropump(R) is a controlled release and taste-masking technology for
the oral administration of small molecule drugs; it is the
intellectual platform licensed by GlaxoSmithKline for the development
of COREG CR(TM).

This document contains a number of matters, particularly as
related to financial projections and the status of various research
projects and technology platforms, that constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995.

The presentation reflects the current view of management with
respect to future events and is subject to risks and uncertainties
that could cause actual results to differ materially from those
contemplated in such forward-looking statements.

These risks include risks that products in the development stage
may not achieve scientific objectives or milestones or meet stringent
regulatory requirements, uncertainties regarding market acceptance of
products in development, the impact of competitive products and
pricing, and the risks associated with Flamel’s reliance on outside
parties and key strategic alliances.

These and other risks are described more fully in Flamel’s Annual
Report on the Securities and Exchange Commission Form 20-F for the
year ended December 31, 2006.