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Monday, October 17, 2011

Roche Will Acquire Anadys For $230 Million.

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Anadys Pharmaceuticals, Inc. (NASDAQ: ANDS) today announced that the two companies have entered into a definitive merger agreement for Roche to fully acquire Anadys at a price of USD 3.70 per share in an all-cash transaction. This corresponds to a total cash consideration of approximately USD 230 million.
Based in San-Diego, California, USA, Anadys develops oral, small molecule therapeutics for the potential treatment of hepatitis C virus (HCV) infection. Setrobuvir (ANA598), Anadys’most advanced drug candidate, is a direct-acting antiviral compound that is currently being evaluated by Anadys in a phase II study in combination with Roche’s pegylated interferon (Pegasys) and ribavirin (Copegus).
  • Jean-Jacques Garaud, Global Head of Roche Pharma Research and Early Development, said: “This acquisition augments our already strong HCV portfolio. Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure, even without the use of interferon. Anadys’ compounds provide additional modes of action that could lead to interferon-free treatment regimens without viral resistance.”
  • Steve Worland, President and Chief Executive Officer of Anadys, said: “Since Anadys was founded, our focus has been on driving forward research that would make a real difference to the lives of patients, especially those with hepatitis. With Roche’s considerable capabilities and experience in HCV, this acquisition provides the best chance of success for the new potential treatments our team has been dedicated to developing.”

In addition to its lead programme with ANA598, Anadys is developing ANA773, an oral, small-molecule inducer of innate immunity in Phase I trials that may prove useful for treating HCV as well as other chronic infections and cancer.

Terms of the agreement

Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of Anadys’ common stock at a price of USD 3.70 per share in cash. This price represents a 256% premium to the closing price on 14 October 2011. The closing of the tender offer will be subject to the tender of a number of shares that, together with the shares owned by Roche, represent a majority of the total number of outstanding shares (assuming the exercise of all vested and unvested options and warrants having an exercise price per share less than the tender offer price) and other customary conditions. In addition, the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The closing of the tender offer is expected to take place still in 2011.
Following completion of the tender offer, Roche will acquire all remaining shares through a second step merger. Directors and officers beneficially owning approximately 7.9% of the shares have agreed to tender their shares and otherwise support the transaction.
Citigroup Global Markets Inc is acting as financial advisor to Roche and Davis Polk & Wardwell LLP is acting as legal counsel. Lazard Ltd is acting as financial advisor to Anadys.

About setrobuvir (ANA598)

Setrobuvir is an investigational, orally administered, direct-acting antiviral (DAA) currently being evaluated for the treatment of chronic hepatitis C (HCV) infection. Specifically, it is a non-nucleoside polymerase inhibitor, and is currently in Phase IIb trials in combination with the current standard of care, Pegasys and Copegus. In clinical trials to date, setrobuvir has shown potent antiviral activity with a good safety profile. Roche plans to explore its use in combination with other direct acting antivirals already within its portfolio, with and without interferon.

Wednesday, October 05, 2011

Oral Teriflunomide for Relapsing Multiple Sclerosis Treatment

Teriflunomide, a new oral disease-modifying therapy for relapsing forms of multiple sclerosis was tested under a randomized trail and has provided satisfactory results. The TEMSO Trial Group has concluded that Teriflunomide significantly reduced relapse rates, disability progression and MRI evidence of disease activity, as compared with placebo.
The trial was funded by Sanofi-Aventis; TEMSO ClinicalTrials.gov number, NCT00134563

Sanofi-Aventis Press Release;

Findings from Two-Year Pivotal Phase III TEMSO Trial Published today in The New England Journal of Medicine -
PARIS, Oct. 5, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today the publication of the pivotal Phase III TEMSO study with investigational once-daily oral medication teriflunomide in The New England Journal of Medicine (NEJM).  Results showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions.  Teriflunomide has a well-characterized safety profile, with a similar proportion of trial participants reporting adverse events compared to placebo.

"The TEMSO data demonstrate the effect of teriflunomide in terms of reducing relapse rates, disability progression and Magnetic Resonance Imaging (MRI) lesions," said Dr. Paul O'Connor, Director of the MS Clinic at St Michael's Hospital, Toronto, Canada and principal investigator in the TEMSO study.  "These results, sustained over two years, provide clinically meaningful data for teriflunomide."

The two-year TEMSO (TEriflunomide Multiple Sclerosis Oral) trial involved 1,088 people with relapsing forms of MS from 126 centers across 21 countries. TEMSO is the first study from a broad clinical development program that includes more than 4,000 trial participants in 36 countries and is one of the largest and broadest clinical programs of any oral MS agent under development, with five Phase III clinical trials either completed or underway.

"The publication of the teriflunomide results in the New England Journal of Medicine is an exciting milestone as we continue the development of our product," said Dr. Elias Zerhouni, President, Global Research & Development, Sanofi. "As we continue our commitment to research, innovation and the Multiple Sclerosis community, we look forward to providing therapeutic options for patients across the Multiple Sclerosis spectrum."

Teriflunomide has been filed with the FDA in August of 2011 and the EMA filing is expected in the first quarter of 2012.  The results from the TEMSO study are and will be included in each regulatory submission.

TEMSO findings showed that, compared to placebo, teriflunomide once daily:

Significantly reduced the risk of annual relapses, the primary endpoint, by 31% (both p<0.001) for 7mg and 14mg doses.

Significantly increased the time to first relapse, and allowed significantly more trial participants to remain free of relapses during the two years of the study: 53.7% (7mg, p=0.01 vs. placebo), 56.5% (14mg, p=0.003 vs. placebo) and 45.6% (placebo).

The risk of 12-week confirmed disability progression, the key secondary endpoint, was significantly reduced by 30% (p=0.03) for the 14mg dose and numerically reduced by 24% (p=0.08) for the 7mg dose.

Improved several standard magnetic resonance imaging (MRI) measures of disease activity as compared to placebo including new or worsening brain lesions with an apparent dose dependent effect in favor of the 14mg dose:
Reduced burden of disease (by 39.4% [p=0.03] and 67.4% [p<0.001] for 7mg and 14mg, respectively);
Reduced gadolinium-enhancing T1 lesions (relative risk reduction of 57% and 80%, p<0.001 for both doses);
Reduced unique active lesions per scan (relative risk reduction of 48% and 69%, p<0.001 for both doses).

Similar adverse events, serious adverse events, and adverse events leading to treatment discontinuation were observed with teriflunomide compared to placebo. No serious or opportunistic infections and no deaths occurred in trial participants treated with teriflunomide.  The proportion of participants who discontinued the study medication because of disease progression was significantly smaller in the group receiving the 14mg of teriflunomide than in the placebo group (p=0.02). Malignancies were reported in three participants in the placebo group and one in the teriflunomide 14mg group.

Teriflunomide adverse events were usually of mild to moderate intensity, managed with existing therapies and rarely led to treatment discontinuation. The most common were diarrhea, nausea, liver enzyme increases (that were mainly mild and asymptomatic with no dose effect) and mild hair thinning/decreased hair density. In general, diarrhea, nausea and alopecia, were mild to moderate, transient, and infrequently led to treatment discontinuation.

About Teriflunomide
Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of MS. Teriflunomide blocks the proliferation and functioning of activated T and B  lymphocytes - which are thought to be especially damaging in MS - by selectively and reversibly inhibiting a critical mitochondrial enzyme. Slowly dividing or resting lymphocytes are unaffected by teriflunomide, leaving the immune system's response to infection uncompromised. With nine years of continuous use in a Phase II extension, teriflunomide has the longest clinical experience of any investigational oral MS therapy. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in people with RMS. A Phase III study, TOPIC, is also underway in early MS or CIS (clinically isolated syndrome). Teriflunomide is also being evaluated as an adjunct therapy to interferon-beta in the Phase III TERACLES trial.

(*) Aubagio™ is the registered name submitted to health authorities for the investigational agent teriflunomide.

About Multiple Sclerosis
Today more than 2,000,000 people around the world suffer from MS, a chronic autoimmune disease that affects the central nervous system - the brain, spinal cord and optic nerves. In MS, immune cells called lymphocytes mistakenly attack myelin, the fatty "insulation" that surrounds and protects nerves, resulting in abnormal nerve transmission and MS symptoms such as fatigue, weakness, walking and balance problems, vision problems, pain, spasticity and cognitive difficulties. MS is the most common disabling neurological disease in young adults after accidents, and is two to three times more common in women than in men. MS is usually characterized by relapses followed by periods of complete or incomplete recovery. There is no typical individual with MS, as the disease is a very variable condition and the symptoms depend on which areas of the central nervous system are affected. MS symptoms can vary from time to time and can change in severity and duration, even in the same person. The vast majority of people with MS - approximately 90 percent - are initially diagnosed with a relapsing form of MS.

Magnetic resonance imaging (MRI) is a common and important tool used to help establish a diagnosis of MS and monitor the course of the disease and effects of treatment. Providing a highly sensitive, non-invasive way to image the brain, spinal cord or, other areas of the body, MRI has made it possible to visualize and understand a great deal about the underlying pathology of MS.

About Genzyme, a Sanofi Company
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients.  The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology.  Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.

Genzyme's Multiple Sclerosis business unit is responsible for the development of teriflunomide, along with the investigational MS therapy alemtuzumab.

About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

FDA Releases A Report On Driving Biomedical Innovation

FDA Innovation Initiative PDF Cover

FDA released “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”a new report today, The report outlines “immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans."

The blueprint focuses on implementing the following major actions:

• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.

It is very timely and we are in need of it.
FDA released a report containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans. The report addresses concerns about the medical product development pipeline, one of the most pressing challenges facing the biomedical industries.
Release of the report, kicks off a new FDA-wide Innovation Initiative, which promises to redouble the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy.
We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.
Printer Friendly PDF (6.3MB)
Press Release: FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans
Fact Sheet

Relieve Stress By Being Mindful!

Stress has become a part of life many people. We, day to day deal with hectic life styles and phases and knowingly or unknowingly accept the stress' that comes along with them.
So usual reaction is to tune out to relieve the stress but big doctor from Harvard, Michael Craig Miller, M.D., Editor in Chief, Harvard Mental Health Letter says may be not too fast.
According to an article he published, being mindful may be the answer to make stress not stick.
"The practice of mindfulness, which has its roots in Buddhism, teaches people to be present in each moment. The idea is to focus attention on what is happening now and accepting it without judgment.Although it sounds simple, and even simplistic, mindfulness is a powerful therapeutic tool. It has been shown to ease stress, prevent major depression from reappearing, alleviate anxiety, and even reduce physical symptoms such as pain or hot flashes. As my colleague Carolyn Schatz wrote on this blog a few months back, one way mindfulness works its magic is by improving connections in the brain."
He also gives some tips on being mindful;
"you can do this on your own by practicing a few simple techniques, like sitting quietly, focusing on your breathing, becoming aware of your surroundings, and watching what comes and goes in your mind."
If the article interested you at all, then there is more complete information on being mindful,  "Mind over Matter" article in the October 2011 Harvard Mental Health Letter



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