February 4, 2011

Tacere Therapeutics Reacquires Rights to Develop and Commercialize its Hepatitis C Compounds in Asia

SAN JOSE, Calif., Feb. 3, 2011 /PRNewswire/ -- Tacere Therapeutics, Inc., an RNA interference (RNAi)-based therapeutics company, announced today that it has reacquired the development and commercialization rights to its Hepatitis C Virus (HCV) compounds throughout Asia from its strategic partner, Tokyo-based Oncolys BioPharma Inc.

"We are very happy to have regained control of the Asian development and commercialization rights to our family of HCV compounds," said Sara Hall Renison, Chief Executive Officer of Tacere. Mike Catelani, Chairman, President and CFO, added, "With the continued promising development of our lead HCV compound in partnership with Pfizer, holder of the non-Asian worldwide development and commercialization rights, we believe that we are well-positioned to commence regulatory activities in Asia."

About Tacere's family of HCV compounds

Tacere's family of HCV compounds, are novel therapeutic products containing three separate RNAi elements targeted against the Hepatitis C virus itself and encapsidated in an adeno-associated virus (AAV) protein coat. AAV delivery methods have demonstrated clinical safety, and preclinical animal studies with TT-034, the lead compound in the family, have shown the ability to penetrate hepatocytes (the site of HCV replication) at high levels following a single intravenous administration. In preclinical animal studies, this "cocktail in one drug" monotherapy targeted and cleaved the Hepatitis C virus itself at three different sites simultaneously without toxicity.

About Tacere Therapeutics, Inc.

Tacere is an innovative biotechnology company focused on developing therapeutics to treat human diseases using its proprietary knowledge in the development of RNAi therapeutics. Tacere is located in San Jose, California, USA. For additional information, please visit http://www.tacerebio.com/.


Mike Catelani
Chairman, President & CFO
+1 408 839-1818

SOURCE Tacere Therapeutics, Inc.


Study shows cytokines lymphotoxin can lead to liver cancer

Thursday, February 03, 2011 1:21 PM

VIENNA, Feb. 3, 2011 (Xinhua News Agency) -- Austrian scientist Johannes Haybaeck discovered that increased levels of cytokines lymphotoxin could cause liver infection and develops to liver cancer later. The findings made him win the Pfizer (NYSE:PFE) Research Awards 2011 presented by Medical University Graz, Austria, on Thursday.

Accordingly, a high-level concentration of cytokines lymphotoxin (LT) alpha and beta and their receptor LT beta R can be found in the liver tissue of patients infected with hepatitis B- or hepatitis C virus.

The lymphotoxin ultimately led to a liver infection that developed to liver cancer later. In addition, the altered liver cells form metastases that spread within the liver.

In addition to chronic alcohol abuse, drug abuse or fungal toxins, virus infection was believed to be one of the most common causes of liver inflammation and liver cancer.

The scientists obtained the results by conducting tumor therapies in mice. They produced a lot of LTs to the liver tissues of the mice though a genetic material change and finally came to the experimental results.

Whether the observations in the mice can also play a role in the human liver tumor cells is still unclear. Hayb?ck and his research colleagues are underway.

(Source: )
(Source: Quotemedia)


Hepatitis C remains prominent among injection drug users

Updated: 2011-02-02 14:19:52 CST

While injection drug users may be contracting HIV at lower rates than they did two decades ago, they are receiving positive hepatitis C tests just as frequently as ever. These are the findings of a new study published in the Journal of Infectious Disease.

The Johns Hopkins University researchers who led the study said that the findings show that efforts to curb the spread of blood-borne diseases are showing some positive results. However, they said that more needs to be done to combat the dangerous spread of hepatitis C.

For the study, the researchers looked at infection rates among injection drug users of both HIV and hepatitis C, or HCV, dating back to 1988. While the numbers showed a significant decline in HIV cases, HCV infections remained more constant.

Given the fact that these infections generally spread from injection drug users into the general population, the researchers said that it is important to institute more effective programs for preventing the spread of infection, such as needle exchange programs.

"Current prevention efforts delay but do not prevent HCV at the population level and will need to be further intensified to reduce risk of HCV infection to the level of HIV," the researchers said

Astex Therapeutics Receives Milestone from Wellcome Trust for Pioneering HCV Research

2011-02-01, Source: Astex Therapeutics

Astex Therapeutics, the UK-based biotechnology company developing targeted therapies for oncology and virology, announced that it has received a milestone payment of £1 million from the Wellcome Trust to support the Company's pioneering work in the area of infectious disease caused by Hepatitis C Virus (HCV). The payment is the second installment of an award of £2 million made by Wellcome to Astex in 2009 under its ''Seeding Drug Discovery" initiative.

The milestone payment was triggered by the identification of potent, small molecule inhibitors of HCV NS3 - a key protein involved in viral replication. The compounds act as allosteric modulators of the NS3 protein resulting in inhibition of the enzyme activities of both protease and helicase in wild type and in drug resistant variants of HCV that have arisen in the clinic during treatment with active site inhibitors. As such the Astex compounds offer the potential to be differentiated from existing HCV protease inhibitors. Astex retains all commercial rights to the resulting drug candidates from this programme. Harren Jhoti, Chief Executive Officer of Astex said, "We anticipate that targeted agents like these will provide new therapeutic options for patients with HCV infections where current treatments are not optimal and where resistance to current treatments is a recurring problem."


Jeremy Carmichael, PhD Director of Business Development Astex Therapeutics Ltd 436 Cambridge Science Park Milton Road, Cambridge CB4 0QA, UK Tel: +44(0)1223 226200 Fax: +44(0)1223 226201 j.carmichael@astex-therapeutics.com http://www.astex-therapeutics.com/

About Astex Therapeutics

Astex is a UK-based biotechnology company that discovers and develops novel small molecule therapeutics. Using its pioneering fragment-based drug discovery platform Pyramid(TM), Astex has built a pipeline of molecularly-targeted oncology drugs, of which three are currently being tested in clinical trials with others in discovery and pre-clinical development. In addition to its proprietary research programmes, Astex's productivity in lead discovery has been endorsed through numerous partnerships with major pharmaceutical companies, including AstraZeneca, GlaxoSmithKline, Johnson and Johnson and Novartis.

For further information on Astex please visit the Company's website at http://www.astex-therapeutics.com/

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. http://www.wellcome.ac.uk/

Vertex Urges CDC to Recommend Hep C Screening, To Nudge “Second Tsunami” of Patients

Luke Timmerman 2/2/11

If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.

The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has operations in San Diego, has joined other drugmakers in supporting studies they hope will persuade the CDC to recommend routine screening for hepatitis C, Vertex CEO Matt Emmens said in a recent interview. The company is one of the sponsors of what’s called the Viral Hepatitis Action Coalition, a public-private partnership with the CDC, which is conducting studies known as BEST-C. These studies could determine how effective it is to screen patients for hepatitis C infection more widely.

These studies, which are expected to cost a total of $3.6 million, could be worth billions to Vertex if they show that screening random Baby Boomers is worthwhile.

An estimated 600,000 patients in the U.S. are expected to seek treatment that could include Vertex’s drug, or a rival offering from Merck, if the FDA clears the new drugs for sale as analysts expect in the middle of this year. The two new protease inhibitors are being hailed as major steps forward, as they have been shown to roughly double cure rates of hepatitis C, a viral infection that damages the liver over many years. Vertex’s drug, telaprevir, has shown it can push the cure rate up as high as about 75 percent, while cutting the treatment time in half to about six months. That means patients don’t have to endure such a long period of flu-like symptoms, which has traditionally discouraged many patients from getting treatment.

The new advance from Vertex, demonstrated in a trio of pivotal clinical trials, has created this huge wave of pent-up demand from patients and doctors. Knowing this, many analysts have projected the product will be pretty much an instant hit, topping $2 billion in U.S. sales after just a couple years. But then, some expect sales to taper off, as many of the most motivated patients get cured, and don’t need the drug anymore. Essentially, they see Vertex possibly becoming a victim of its own success.

That’s not how it will play out, says Emmens, a marketing veteran who spent much of his career at Merck. An estimated 3.2 million to 3.9 million people in the U.S. have chronic hepatitis C infections. That’s a lot more than the initial wave of patients, which is mostly composed of people who sought treatment before but relapsed. Besides those patients, many more candidates are Baby Boomers who don’t know they contracted the hepatitis C infection decades ago through unprotected sex, IV drug use, or blood transfusions from contaminated supplies. Many of these infections lie dormant for about 20 years or more, but are just now starting to emerge over the decade to come, Emmens says. Some patients won’t see symptoms at all, and as the AP pointed out in this solid feature last month, it’s hard to tell which infected patients are likely to get the worst symptoms. The unluckiest ones will end up suffering severe liver scarring (cirrhosis), liver cancer, liver transplants, and ultimately, premature death.

Connecting with that massive crowd of patients, who aren’t motivated to seek treatment today because they don’t see any really bad symptoms yet, is one of the big marketing challenges Vertex faces. The company is planning to spend some of its $1.3 billion cash hoard on a public awareness campaign designed to urge people to get tested to see if they have the virus, Emmens says. But even more important than the ad campaign, Vertex is hoping the CDC will recommend routine hepatitis C screening, which would start turning up a lot more positive tests. If it does, Emmens he predicts it could prompt another 1 million patients to seek treat treatment around 2014 and later, right as the most people in the initial wave of highly motivated patients go home having been cured.

“You have an estimated 2 million people out there who are not aware they are infected,” Emmens says. “Some don’t know, or just don’t give a damn, or have other problems, and won’t seek treatment. But if you found 1 million new patients over a two or three-year period, there’s a second tsunami.”

As for analysts predicting telaprevir will rise and fall, Emmens shook his head. “That’s absurd. I understand they’ve got to do their job. But from a marketing guy’s perspective, that just doesn’t happen unless you lose your patent,” Emmens says. “Docs use what works. Patients will come in, and they will want the highest chance they can get of a cure. That’s what they really care about.” A shorter treatment period, and more convenient twice-daily dosing instead of thrice-daily are a couple of other features Vertex is hoping to incorporate into hepatitis C treatment, he adds.

Vertex has clearly been spending a lot of time lately thinking about making its case to insurers. The trick will be to persuade insurers that it’s worth spending quite a bit of money upfront on a potent new drug to attack a dormant infection, as opposed to waiting to see if patients get sick years later and rack up big hospital bills. Emmens notes that liver transplants cost around $300,000, and, obviously, not everyone who wants a new liver actually survives long enough to get to the top of the waiting list. Vertex, citing an actuarial study it sponsored to try to measure the cost of future treatment, says medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion—presumably when factoring in a lot of liver transplants.

I must say I’m personally wary of drugmakers who use their money and influence to rewrite health guidelines that end up favoring their bottom line. Companies that want to sell more drugs for high blood pressure, osteoporosis, and obesity have been known to push for new health guidelines that classify many more people as “Suddenly Sick” as a couple of my former Seattle Times colleagues wrote in a terrific investigative story in 2005. Whether this aggressive new treatment is really beneficial to people’s health over the long run is often unknown.

This case strikes me as somewhat different, though, because today’s available hepatitis C treatment is really so poor. Vertex and Merck are essentially coming along with drugs that represent a big leap ahead with potential to cure hundreds of thousands, maybe millions, of people. It will probably cost taxpayers a few billion dollars a year for many years to come, and it’s always hard to say for sure how many billions you might save down the road when people don’t end up in the hospital getting liver transplants. But you can be sure Vertex is working hard behind the scenes right now to convince officials that an ounce of prevention is worth a pound of cure.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman.