May 23, 2006

Vertex rides the wave

Editor's Note:

You are reading a report on a company that is in the forefront of developing drugs to fight Hep C. Once again, we find an amazing story of the capitalist model - of the greed for more profits - even when it comes to a matter of life and death.

Shouldn't the tax payer's money be used for R & D of these drugs - that when produced - it will be of a great help to the common people?

When you allow a Private Entity to run up a huge bill in developing a drug, here in this instance for HEP C, the danger is that the drugs they produce are going to be so expensive - that the government swill have to pay for it anyway.

I am all for competition, private enterprise and all that. But hey! Not in health-care and education.

The profit to a state by taking care of health-care and education is a population of Healthy and Educated people, a must for any nation building.

Is anyone listening to me?

Vertex jumps on hepatitis C drug advancement



BOSTON (MarketWatch) -- Shares of Vertex Pharmaceuticals jumped Tuesday on news that the company was preparing to initiate three key Phase IIb clinical trials for its hepatitis C drug candidate VX-950.

According to Vertex chief executive officer Joshua Boger, Vertex (VRTX :
Vertex Pharmaceuticals Inc
Last: 30.75+1.30+4.41%
12:19am 05/24/2006
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VRTX
30.75, +1.30, +4.4% )
has already started a large-scale Phase IIb trial clinical trial in the U.S. that will test to see how long VX-950 can keep the body clear of the liver-destroying virus. A similar trial will be launched next month in Europe. The trials will consist of hepatitis C patients who have not yet received therapy for their condition.

Shares of Vertex closed up 4% at $30.75 after hitting a session high of $31.65.
Boger also said that Vertex will be initiating a Phase IIb trial later this year to see how the drug performs in patients who have already failed standard therapy for the disease. The three Phase IIb studies will all be monitoring patients for three to six months after therapy to see if the virus returns.
"We expect the first Phase II data in early 2007," said Boger, adding that the company will have about 1,000 patients in VX-950 clinical trials by the beginning of 2007. "We anticipate we'll be running some sort of Phase III trials starting in mid-2007."
About 3.4 million Americans have hepatitis C, the company said.
Currently, the standard hepatitis C therapy calls for bombarding a patient's body with two powerful drugs -- pegylated interferon and the antiviral medication ribavirin -- for up to a year.
Despite the treatment, which can be highly debilitating, the virus returns in about 50% of recipients. Patients are considered to have been treated successfully if their bodies show no sign of the virus six months after the treatment has ended.
Because of the need for better treatments, analysts have forecasted the market for hepatitis C drug could reach $8 billion in 2010, and that VX-950 should have peak sales of around $4 billion, if approved.
Boger said the earliest Vertex could probably file to have VX-950 approved would be in 2008. He said the company still hopes to have the drug on the market in 2009.
Schering-Plough (SGP :
Schering-Plough Corporation
Last: 19.00-0.02-0.11%
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Sponsored by:
SGP
19.00, -0.02, -0.1% )
, meanwhile, also has a hepatitis C drug, SCH 503034, in Phase II clinical testing. Like VX-950, SCH 503034 belongs to a class of drugs known as protease inhibitors.
Boger said despite the similarities, that he remains confident that VX-950 is superior to Schering-Plough's candidate. "The data so far suggests that our drug is as much as 100 times more effective as an antiviral agent," said Boger.

May 22, 2006

CUBA'S HEPC WAR



Hepatitis C: Efficient Treatment Developed

Marta Gómez Ferrals*

Havana, May 21 (Prensa Latina) Cuban biotechnology took a new and very important step in obtaining an efficient treatment for Hepatitis C, a disease that affects about 200 million persons in the world.

Herbeviron is the name given to this novel drug that is the basis of a new therapy. It is part of a kit prepared by specialist of the Engineering Genetic and Biotechnology center (CIGB in its Spanish acronym), one of the pillars of the science region in the outskirts of the capital.

It is produced by the Heberbiotec factory in Cuba that is in charge of commercialization of its biotechnological products.

Interferon Alfa-2B and Rivavirma, both made in the country, are components of Heberviron and it is used not only to combat the causative virus of Hepatitis C in blood but, in the long range, eliminates lesions in the liver and totally cures the disease.

Doctor in Pharmaceutical Sciences of CIGB, Hugo Nodarse, told the press that Cuban patients have a treatment that increases the possibility to control the disease that tends to become chronic and very damaging in the majority of cases.

Heberviron successfully attacks the virus in circulation, according to tests made in the National Institute of Gastroenterology. In its advanced phase of treatment, forecasts are of a cure of liver lesions and recovery of the enzymes of that vital organ.

Information should be available about Hepatitis C to understand the significant importance of this new Cuban therapy.

Hepatitis, in a general sense, is an illness that produces inflammation of the liver and may have an inflammatory, toxic or viral etiology.

Hepatitis C is a devastating disease that can cause death through cirrhosis or liver collapse shortly after contracting the infection.

However, infected persons who do not present visible signs and symptoms are alarmed about the disease.

Contagion is through contact with the blood of an infected person and can occur as with HIV, through non-protected sexual relations, use of infected needles or contaminated blood transfusions. Also by sharing toothbrushes, shaving blades and manicure equipment that has not been sterilized.

The most general symptoms are a yellowish tinge of the skin, sclerotic eyes, fatigue, loss of appetite, nausea and vomiting, pain in the right side of the abdomen, under the ribs or weight loss although there are more or less asymptomatic persons. It can only be detected through a blood test for Hepatitis C virus.

In the United States Hepatitis C is the first reason for a liver transplant due to hepatic cirrhosis and in Egypt 15 percent of the population suffer the disease.

Cuban science has been working hard on the prevention and treatment of different types of hepatitis.

During the 90s a national vaccine was made against the B variant; also transfusions have greatly improved with top quality technology developed by scientists in the country.

Since the 80s Cuba began the technique of liver transplants that, today, shows good results with more than 100 persons operated.

Scientific research on preventive and therapeutic vaccines against illnesses has amazed nationally and worldwide. It has also received strong governmental investment and support in its broadest sense.

That is the reason behind the interest to obtain the Haemophilus influenzae vaccine that protects the infant population against pneumonia, meningitis and otitis covering Cuban needs and also satisfying requests from abroad.

By the end of this year there will be production of an anti-lung cancer vaccine developed by the Molecular Immunology Center and whose clinical studies are in the final phase. Tests are also being done in the United States.

Work is also underway to obtain vaccines or monoclonal antibodies that open up new hope for the treatment of breast, neck, head, prostate and colon cancers.

In addition Cuba has successfully completed its last clinical assay of a quintuple vaccine against diphtheria, whooping cough, hepatitis B, tetanus and Haemofhilus influenzae.

There is also one prepared against cholera and work is underway to obtain the same results against dengue, hepatitis A and tuberculosis.

(*) The author is a journalist of the Science and Technology Editorial board of Prensa Latina.


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22 March 2006

Cuban combined therapy against chronic Hepatitis C

BY LILLIAM RIERA —Granma International staff writer—

• A Cuban combination therapy for the treatment of chronic Hepatitis C is to be put on the market by the Heber Biotec S.A. company in Latin America, Asia, Africa, the Middle East and Europe, where this firm has registered the Heberon Alfa R (human recombinant Interferon lfa 2b).

Heber Biotec S.A., certified with the ISO 9001:2000 standard, is the exclusive marketer and representative of the Genetic Engineering and Biotechnology Center (CIGB) as well as other institutions in the West Havana Scientific Complex.

Heberviron is the commercial name given to this combined therapy package for the treatment of a condition affecting approximately 300 million people around the world. It contains three doses of Heberon Alfa R, to be administered subcutaneously, three vials of water for the injection, and a bottle of Ribavirina 200 containing 42 capsules of 200 milligrams each, the dosage of which depends on body weight. It also includes three sterile disposable syringes, six needles and three alcohol swabs.

The package, containing a six-day course of treatment was launched on March 15 at the Hepatology 2006 event celebrated in Havana.

Mayda Mauri, general manager of Heber Biotec S.A., informed Granma International that in Cuba Heberviron has achieved a 30.8% increase in therapy response as compared to the Interferon single therapy, a fact which translates into a notable contribution to the control of chronic Hepatitis C.

Since November 2001, a total of 315 patients have been treated on the island with this combined therapy as part of a national program.

The components of Heberviron were developed and are being produced by Cuba: the Interferon by the CIGB and the Center of Bio-products, and the Ribavirina by the Medicament Research and Development Center and Novatec Laboratories, which demonstrates the integration and cooperation of the institutions in the Scientific Complex, Mauri affirmed.




Enzyme-blocking Drug Offers Hope


Enzyme-blocking Drug Offers Hope for Hepatitis C Sufferers


By Alan Fein

(AXcess News) New York - ViroPharma, Inc. (Nasdaq: VPHM) said Sunday that data from a phase 1b trial of an enzyme-blocking drug showed a 97 percent success rate in preventing the Hepatitis C virus from replicating itself. The viral polymerase inhibitor, HCV-796, is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

The findings were presented at the 2006 Digestive Disease Week (DDW) conference in Los Angeles, California.

Steve Villano, ViroPharma's vice president of clinical research and development called the findings of the phae 1b trial "exciting", saying that doses taken orally by patients for 14 days reduced the ALT count signifcantly in patients suffering from chronic hepatitis C who had never received any prior treatment.

"The decline in levels of ALT, an important marker of liver injury associated with hepatitis C infection, that appear to correlate with antiviral activity further support the potential benefit of longer treatment with HCV-796," said Villano.

Of the 16 patients involved in tthe phase 1b study, Seventy two percent were infected with genotype 1 HCV, which is the most common strain of Hepatitis C in the United States. Success rates of existing drug treatment of genotype 1HCV patients is one-in-five, making ViroPharma's results good news for chronic HC sufferers.

Peak antiviral response was achieved at doses of 500 mg twice daily and higher. The 500 mg, 1000 mg, and 1500 mg dose groups achieved peak mean HCV viral load reductions of 96 to 97 percent by the fourth day of a 14-day dosing period. The greatest reductions in serum ALT levels were seen in the 500 and 1000 mg dose groups.

Mild to moderate headache was the most frequently reported adverse event, unlike existing drugs which have severe side effects and can even make patients suicidal.

HCV-796 was given in combination with PEG-Interferon.

Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.

Several Interferon products are available and often given in combination with Ribavirin, but at best, its success rate is 50 percent and then in patients who are diagnosed early with the less debilitating genotypes of the virus.

If untreated, the results of Hepatitis C infection is death as the liver slowly fails. Finding a cure has become a race as more and more people throughout the world become infected with HCV. But the drug companies who developed Interferon and Ribavirin hold a monopoly and critics say they have held back the research of other companies, which they adamantly deny.

Interferon treatment in combination with Ribavirin cost over $1,000 per month just for the drugs, which are taken by hypodermic injection weekly and must be carried through for a full year.

In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the considerable side effects frequently associated with the use of Interferon can lead to discontinuation of therapy in approximately 20% of patients.

For Viropharma, a win with HCV-796 would be a big boost to the pharmaceutical company, that reported $8.2 million in earnings for the first quarter earlier this month. Analysts had expected Viropharma to report 20 cents a share in earnings instead of the 12 cents per share it earned. Viropharma said wholesalers had reduced their stocks of the antibiotic Vancocin.

Net sales of Vancocin had rose 38.8 percent to $29.2 million, though analysts were expecting Viropharma to report $40.2 million.

The company said that underlying prescription demand for Vancocin remains strong, and it therefore reiterated its forecast for net sales of the drug in 2006 of between $160 million and $170 million.

Friday, Viropharma's shares closed up 29 cents at $9.29 for a gain of 3.22 percent. Its shares had tanked when it announced its first quarter results, dropping 30 percent to $7.69 May 4th.