PRESS RELEASE

· New antibody program targets Tau protein, a major cause of Alzheimer’s disease

· License agreement potentially worth more than Swiss Francs 400 Million (approximately USD 418 million*)

Lausanne, Switzerland, 18 June, 2012 – AC Immune SA, today announced that it has entered into a second exclusive worldwide license agreement and research collaboration with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) for the research, development and commercialization of AC Immune’s anti-Tau antibodies for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases.

Under the terms of the agreement, AC Immune will receive an undisclosed upfront payment and is eligible to receive research, development and commercialization milestone payments totaling more than Swiss Francs 400 million (approximately USD 418 million*) for Alzheimer´s disease and other indications. Additionally, AC Immune is eligible to receive royalties on net sales of products resulting from the collaboration. Under the multi-year joint research collaboration, AC Immune will work in partnership with Genentech to identify and formulate several pre-clinical candidates. Genentech will have global responsibility for pre-clinical and clinical development, manufacturing and commercialization of antibodies resulting from the collaboration.

Prof. Andrea Pfeifer, CEO of AC Immune said: “We are delighted to continue our excellent relationship with Genentech through this second landmark deal to fight Alzheimer’s disease. This underlines Genentech’s trust in AC Immune’s proprietary technology platform and we are confident in our joint abilities to develop not only
first-in-class but also best-in-class medication for one of the biggest healthcare problems of this century.”

“This second licensing deal gives us financial security to continue AC Immune’s
world-leading efforts to develop disease modifying therapies and diagnostics. We are now recognized as having one of the broadest and most advanced Alzheimer’s pipelines in the industry”, remarked Martin Velasco, Chairman of The Board of AC Immune .

Commenting on the deal, James Sabry, Genentech’s Vice President of Partnering , said: “Genentech is committed to bringing innovative treatments to patients suffering from devastating neurodegenerative diseases, and is developing a number of approaches to tackle Alzheimer’s disease. The addition of this anti-Tau program to our CNS pipeline complements other approaches we are investigating, including crenezumab which we in-licensed from AC Immune in 2006.”

About the anti-Tau Program

The Tau protein forms twisted fibers inside brain cells and build tangles that are considered by many in the scientific community as the second major cause of Alzheimer’s disease besides Abeta-plaques. The anti-Tau antibodies were discovered and humanized by AC Immune through its proprietary SupraAntigen TM technology.

“The anti-tau-antibodies have proven highly specific to misfolded Tau in relevant animal models for Alzheimer’s disease and are therefore well suited to be developed as a disease-modifying drug. This has significant potential as there are at present no known cures for Alzheimer’s disease,” said Dr. Andreas Muhs, Chief Scientific Officer
of AC Immune .

About Crenezumab

An anti-Abeta antibody, crenezumab was discovered and humanized by AC Immune. It is designed to bind to amyloid beta (Abeta), the main constituent of amyloid plaque in the brains of patients with Alzheimer’s disease. Abeta is considered to be a major cause in the development of the disease. Genentech is currently evaluating crenezumab in a Phase II clinical study in Alzheimer’s patients with mild to moderate symptoms. At the time the deal with Genentech was announced in December 2006, it was stated to have a potential total value of more than USD 300 million in clinical and regulatory milestone payments to AC Immune, excluding royalties.

In May 2012, crenezumab was selected to be tested in the world’s first-ever prevention trial in healthy individuals who are genetically destined to develop Alzheimer’s disease. This landmark study to investigate whether an anti-amyloid treatment can stave off the disease is being run by the US National Institutes of Health (NIH), the Banner Alzheimer’s Institute (BAI), the University of Antioquia in Colombia and Genentech.

About Alzheimer’s Disease

Alzheimer´s is the most common form of dementia. It is degenerative, irreversible and terminal. The memory and thinki ng of the patients is progressively destroyed. Besides the personal aspect there is a huge social and economic impact. Alzheimer´s disease is recognized as a significant health crisis of the 21st century with currently more than
36 million patients worldwide. This number is expected to double in the next 20 years and to triple to more than 116 million by 2050. In 2010 global worldwide costs were estimated to be USD 604 billion and were exceeding 1% of the global domestic product (Reference: World Alzheimer Report 2011, Alzheimer’s Disease International).

Scientists don’t yet fully understand what causes Alzheimer’s disease, but it has become increasingly clear that it develops because of a complex series of events that take place in the brain over a long period of time. Two proteins – Tau and Abeta – are perceived as the major causes of neurodegeneration: tangles and other abnormal forms of Tau protein accumulate inside the brain cells, while plaques and oligomers formed by Abeta occur outside the brain cells of people with Alzheimer’s disease.

About AC Immune SA
AC Immune SA is a Swiss-based biopharmaceutical company and a leader in Alzheimer´s disease drug development. AC Immune develops innovative therapeutics with “best in class” potential against Alzheimer´s disease and other conformational diseases along three axes: vaccines, antibodies and small molecules. The anti-Abeta antibody (crenezumab) for passive immunization is partnered with Genentech and is in Phase II development. The company continues to develop in house the small molecule ACI-91 and the vaccine ACI-24 in Phase II and Phase I/IIa clinical development respectively. These three clinical programs are focused on Alzheimer’s disease, and are backed by a rich portfolio of preclinical compounds. The therapeutic molecules are also leveraged for Alzheimer´s disease diagnostic and other central nervous system and non-CNS diseases, such as Glaucoma. Since its foundation in 2003, AC Immune has raised CHF 64 million from private investors.

-Anita M. Harris
Disclosure: I will be working with AC Immune at the Biotechnology Industry Organization today in Boston.

New Cambridge Observer is a publication of the Harris Communications Group, an award-winning strategic public relations,  marketing communications and thought leadership firm in Cambridge, MA.

In an effort to harness and allow sharing of exponentially-developing genetic data, the Broad Institute will launch “Genome Space,”–a co-operative Web based tool aimed at “frictionless” data transfer, later this week.

So said Jill Merisov, PhD, the Broad’s associate director and Chief Informatics officer,  in a keynote speech at the opening of the Bio-IT World conference  yesterday,  in Boston. The Broad is a Harvard-MIT research center located in Kendall Square, Cambridge.

In her talk, Merisov pointed out that just ten years ago,  scientists announced that they had identified all of the genes present in human beings.  Since then, researchers  have discovered 30 million genetic variations among 1000 different individuals, 3000 genetically-related disease traits, and a multitude of cancer types. Such findings are  now being used to determine the genetic bases of  many diseases, to develop treatments for those diseases, and to determine for which patients particular treatments are likely to be effective. In another ten years,  she said, such “personalized medicine” will be commonly used by doctors, in clinics.

These advances are due in large part to less expensive,  increasingly sophisticated and sensitive computer technologies that have led to an “explosion”  of data ,  to less “noisy”  data, and to new, international ways of  reviewing  the data, Merisov explained.  Scientists can now buy the technology and carry out sequencing in their own labs and “”computing is now integral to every aspect of biomedical research.”

But these developments also mean that there are now  seven-to-ten  thousand bioinformatics tools available for download on the Web and five thousand databases–many of  which are “out of reach”  for scientists who do not have sophisticated programming skills.

The new tool  “bridges the gaps between bioinformatics tools, making it possible for [scientists ] to move data smoothly between these tools, leveraging the available analyses and visualizations in each of these tools,” according to the Genome Space Web site.

Genome Space also allows for data storage in the Amazon cloud [a computing platform of Amazon.com]  and “provides necessary file format transformations whenever a scientists selects an analysis or visualization within one of the tools.

The GenomeSpace project is a collaboration of the Mesirov and Regev laboratories at the Broad Institute; the Chang laboratory at Stanford University; the Ideker laboratory at the University of California, San Diego; the Nekrutenko laboratory at Pennsylvania State University; the Segal laboratory at the Weizmann Institute of Science; and the Haussler and Kent laboratories at the University of California, Santa Cruz. GenomeSpace is funded by the National Human Genome Research Institute, with additional support from Amazon Web Services, according to the Genome Space Web site.

The Bio-IT Conference Expo 2012   goes through April 26.

–Anita M. Harris

You don’t need to be a geek to get into some of the newest technology for keeping track of your health. I was blown away when I heard about pill bottle caps that will tell  you (or your doctor or your caretakers)  if you’ve forgotten to take your meds…a kazoo that measures the chemistry of the air from your lungs…and a telephone that can assess whether you’re depressed–from the tones of your voice.

These gizmos are the brainchildren of David Rose, an entrepreneur who is now the CEO of Vitality, Inc., in Cambridge.  Rose has also invented bathroom scales that can show whether you’ve lost or gained weight, an umbrella that can sense whether it’s going to rain, and objects that assess air quality.

Rose was one of four panelists who spoke last week at a program sponsored by the Medical Development Group about some astounding new health gadgets, most of which are actually on the market. (MDG is a Boston area organization for individuals involved in the medical device and technology industries). 

Rose focused on the above-mentioned pill bottle “Glo-Caps”, which “sense”  when a patient takes a medication, and, via a wireless Internet connection, show health care professionals, patients or caregivers whether reminders are needed.  

The caps light up, play a melody, and even ring a home phone to remind patients to take their pills.  The caps can send weekly emails to remote caregivers, create accountability with doctors through an adherence report, and automatically refill prescriptions. 

Glo-Caps are not currently available for purchase by individuals, but they are being used by patients enrolled in programs sponsored by certain health insurers and pharmacies.

Panelist Ben Rubin, Co-Founder and Chief Technology officer of Zeo, in Newton, MA, described Zeo’s novel  headset and device that monitor an individual’s REM sleep and factors influencing sleep patterns.  Knowing how well you sleep is important because sleep is closely tied to health conditions like obesity, depression, diabetes and the like, Rubin said. “If you measure it, you can manage it.” 

Zeo’s sleep devices, which cost $250,  connect to  an Internet site. For an additional $100, Zeo provides email advice coaching to help individuals improve their “sleep hygiene.” 

There’s also a  Smart Phone application designed to promote better sleep:  using the Ap, you put your phone under your pillow to measure your movement (and restlessness) during sleep.

Panelists also described glucose monitors that send data to doctors via patients’ Smart Phones and Nike running shoes that measure your steps. At one point, Rose pulled out a keychain that tells him whether he’s met his daily walking goals and whether he’s on track (ha ha) to meet his monthly goals.

Also mentioned  were Internet tools such as a Google Ap to measure flu trends; Healthmedia, through which Johnson & Johnson provides digital coaching for managing stress and chronic disease, Philips Direct, which provides live coaching over email, and various “calorie and other body monitors through which individuals can receive online coaching through gyms.

All of these devices fall under a category moderator David Barash, MD, CEO of Concord [MA] Health Strategies calls “local health monitoring” –meaning that the devices can be used by patients or consumers almost anywhere–rather than just at home or in a hospital,  doctor’s office or lab.

 According to a recent review by my client, Scientia Advisors, “remote health monitoring” devices are the fastest growing category in a booming home health care market. 

The devices are growing in popularity in sync with an aging population, increasing chronic disease, and new Internet technologies, Barash said.

Panelist Frank McGillin, Vice President of Global Marketing for Philips Healthcare, which markets a variety of home monitoring devices, said  remote monitoring  will become increasing important in light of growing health care costs.

Gillin cited government statistics showing that  health care current accounts for 17.6 percent of the  gross domestic product in the US, and that by 2050, half of the population in the developed world will be chronically ill—making traditional medical care  fiscally overwhelming. 

Devorah Klein, PhD, a principal at Continuum, in Newton, MA, who designs devices and evaluates patient adherence to therapy regimes for diabetes, asthma, arthritis, multiple sclerosis and erectile dysfunction, emphasized that  simple designs are key because “many patients are not all that interested” in learning to use devices.

And Barash pointed out that while many consumers may be intrigued by these gizmos, doctors have been slow to embrace them.

 For one thing, with a dearth of clinical trials to assess devices’ effectiveness, insurers are reluctant to reimburse doctors for evaluating the data thus compiled.

For another,  it’s not clear how doctors can manage or assess  potentially large amounts of additional data, or  how data collected for individual conditions can be assessed in relation to data collected elsewhere for other, possibly related, conditions.

–Anita M. Harris

New Cambridge Observer is published by the Harris Communications Group, a  writing  and public relations firm in Cambridge, MA.  All rights reserved.

Over lunch at the Cambridge Innovation Center on Wednesday,   Mass Life Sciences Center (MLSC) President and CEO Susan Bannister told a gathering of some 100 life science afficionados that the first year of Gov. Deval Patrick’s Life Science Initiatiative has been a success. 

“There’s still capital out there and life science is a good place to put your money,” Bannister said.  “By putting state money into the pot, we have ‘de-risked’ investment that the state would have had to find elsewhere”.

 The funded projects–in biotechnology, pharmaceuticals, medical devices, diagnostics and bioinformatics–could create some 950 jobs in the near term, Bannister said.

By adding employment opportunities,  Massachusetts’  investments and incentives could help to absorb some of the job losses expected in other sectors, according to Bannister.

Frank Reynolds, CEO of InVivo Therapeutics, which is developing stem cell/ polymer technology aimed at halting the effects of traumatic spinal cord injury, said that receiving a $500 thousand loan just as  venture capital possibilities tanked this fall made a tremendous difference in his company’s ability to proceed. ”  It’s a great program,” Reynolds said. (Disclosure:   I work with InVivo).

Bannister cautioned  that in the current economic downturn, tax revenues are “iffy” and it’s not yet clear how much money will be available for the Initiative in 2010.

For more details, please visit  Harriscomblog.wordpress.com.

—Anita Harris

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

As a graduating  PhD, Robert Langer, now Institute Professor at MIT, was having trouble finding work.

As he told the Health Innovators Group of Combined Jewish Philanthropies on Friday, most of his classmates took jobs with oil companies but  he knew that wasn’t for him.  Having helped found an alternative high school in Cambridge, he  applied for 50 or 60 jobs in curriculum development, but no one wrote him back. Then he tried medical schools and hospitals, but “they didn’t write back, either.”  Finally, someone  in his lab told him that someone at Children’s Hospital sometimes hired “unusual people.”

That “someone” was Judah Folkman, who, in 1974,  was beginning to work on angiogenesis, which involved the idea that cutting the blood flow to tumors could halt  their growth.  The possibility  intrigued Langer, who  was hired–but made a rather inauspicious start.

As a post doc, he spent half of his time scraping meat off of cow bones delivered from a South Boston slaughterhouse. He   discovered 200 methods that didn’t work;. He  faced  hostile scientists who told him they didn’t believe anything he said, and,  as time went on,  was denied many patents by officers who were were unwilling to accept his proof.

It took until 2002 for  the first angiogenisis drug to gain FDA approved.  By then, Bob, who wouldn’t take “no” for an answer, was MIT’s most prolific inventor and a University Professor who had helped found many companies and   inspired countless students–who now run departments, labs, and companies of their own.

I’ve known Bob since the 7th grade…and was in the 8th-grade English class  in which, he tells people , he was so shy that he froze during a public speaking exercise, and got an F.  We both went to Cornell, where, he’s told me, he found that he learned more studying on his own (and playing bridge) than going to class.  And I remember sitting in a pizza parlor with him in  1982, watching as he diagrammed  his ideas on a mechanism for “slow release” for pharmaceuticals–on a napkin.

Despite his success, a recent writeup in Nature,  and much  excitement about possible “pharmacies on a chip,”,  a stem cell device to help individuals with spinal cord injuries,  and an adhesive for heart surgery based on the sticky-stuff that allows gekkos to climb up walls, Bob  remains the same old Bob, who sometimes gets  ideas for new devices, materials and methods  from television and magazine magazines.    He’s still down-to-earth, supportive, and even funny.   (Did  you know that the most  surgical devices are invented by doctors who use household materials to fit their operating needs…which is why the “stretchiness” material used in artificial heart is the same stuff used in ladies’ girdles? )

So- for job hunters out there the message is simple but profound. Believe in yourself and your ideas, treat people kindly, and  keep on going.

Great talk, Bob. Once again, bravo.

AMH

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

I’m  helping Cambridge Heart and Kogs Communications get out the good news that the company’s non-invasive test, which is administered much like a stress test, on a treadmill, accurately predicts the risk of sudden cardiac arrest–the leading killer in the US.

Here’s today’s release:

Tewksbury, Mass., March 3, 2009 – Cambridge Heart, Inc. (OTCBB-CAMH), today announced the publication of five articles supporting the use of Microvolt T Wave Alternans™ (MTWA) testing in a supplement to the March issue of the Heart Rhythm journal. Featured in the supplement is a comprehensive meta-analysis of 6,000 patients confirming the value of MTWA as a non-invasive marker of risk for sudden cardiac arrest (SCA).

The MTWA test, administered much like a stress test on a treadmill, was developed by Cambridge Heart as a diagnostic tool to help physicians determine a patient’s risk of sudden cardiac arrest — the leading cause of death in the United States.

The meta-analysis, conducted by a group led by Stefan Hohnloser, MD, FHRS, of the JW Goethe University Division of Cardiology in Frankfurt, Germany, assessed 13 MTWA clinical studies involving approximately 6,000 cardiac patients.

“The results demonstrate that MTWA testing is a consistently accurate predictor of sudden cardiac death and cardiac arrest in patients who do not already have implantable cardiac defibrillators (ICDs),” said Dr. Stefan Hohnloser. “These are the patients for whom MTWA testing is intended.”

The meta-analysis authors also conclude that:

· Patients who test negative for MTWA abnormalities are at extremely low risk (0.3%) for SCA in the next 12 months.

· MTWA testing can help doctors guide ICD therapy to appropriate patients and overcome the widespread reluctance of patients and referring physicians to accept ICD therapy.

· In clinical trials, appropriate ICD shocks are an unreliable surrogate endpoint for SCA and can skew results of risk stratification studies.

“This comprehensive analysis confirms the findings of numerous peer-reviewed studies which underscore the important role of MTWA in assessing a patient’s risk of sudden cardiac arrest,” said Ali Haghighi-Mood, PhD, Chief Executive Officer of Cambridge Heart.

The Heart Rhythm supplement also includes:

· A second meta-analysis of MTWA testing in patients with non-ischemic heart disease, authored by Gaetano De Ferrari, MD and Antonio Sanzo, MD of the Department of Cardiology at Fondazione IRCCS Policlinico San Matteo, Pavia Italy. Analyzing eight available trials involving 1,450 patients, the paper indicates that in this population negative MTWA results can help patients and their physicians decide whether ICD therapy may safely be avoided.

· An article by Michael J. Mirro, MD, Medical Director of the Parkview Health System Clinical Research Center in Fort Wayne Indiana, who describes how his center has incorporated MTWA testing into clinical practice to complement other methods for identifying and educating patients about the risk of SCA.

· A review of numerous studies concerning the underlying cellular mechanisms of T-wave alternans. The authors conclude that microvolt T-wave alternans is a marker of cellular changes that make the heart susceptible to sudden cardiac arrest. The review was carried out by Michael Cutler, DO, PhD, and David S. Rosenbaum, MD, of the Heart and Vascular Research Center at the Department of Biomedical Engineering at Case Western Reserve University in Cleveland.

· A review by Navinder Sawhney, MD and Sanjiv Narayan, MD of the University of California at San Diego that underscores the value of MTWA testing in patients who have had heart attacks but do not fall within current guidelines for ICD implantation.

The articles in the supplement can be found on the Heart Rhythm journal website at:

http://www.heartrhythmjournal.com/issues/contents?issue_key=S1547-5271(09)X0006-8

About Cambridge Heart, Inc.

Cambridge Heart develops and commercializes non-invasive diagnostic tests for cardiac disease, with a focus on identifying those at risk for sudden cardiac arrest (SCA). The Company’s products incorporate proprietary Microvolt T-Wave Alternans measurement technologies including the patented Analytic Spectral Method^® and ultrasensitive disposable electrode sensors. Medicare reimburses the Analytic Spectral Method^® under its National Coverage Policy. Cambridge Heart, founded in 1990, is based in Tewksbury, MA. The company’s Microvolt T-Wave Alternans™ (MTWA) test, developed by Cambridge Heart (OTCBB: CAMH), is based on research originally conducted at the Massachusetts Institute of Technology. http://www.cambridgeheart.com.

Statements contained in this press release are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. In some cases, we use words such as “believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences include failure to achieve broad market acceptance of the Company’s MTWA technology, failure of our sales and marketing organization to market our products effectively, inability to hire and retain qualified clinical applications specialists in the Company’s target markets, failure to obtain or maintain adequate levels of third-party reimbursement for use of the Company’s MTWA test, customer delays in making final buying decisions, decreased demand for the Company’s products, failure to obtain funding necessary to develop or enhance our technology, adverse results in future clinical studies of our technology, failure to obtain or maintain patent protection for our technology and other factors identified in our most recent Annual Report on Form 10‑K/A under “Risk Factors”, which is on file with the SEC and available at www.EDGAR.com. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as may be legally necessary, even if our estimates should change.

The New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

I’m pleased to announce that Scientia Advisors has launched ScientiaNET,  a “knowledge network” for  health care and the life sciences. ( True,  they are my client, but I AM pleased).

The network now has 10 thousand member/experts and is seeking additional ones.  Members are leading scientists, physicians, practitioners, academics and industry professionals who are  paid their hourly rates to provide Scientia and its clients with analyses, opinions, surveys and consultation on life science tools and technologies, medical devices, diagnostics, biotechnology, pharmaceuticals, functional foods, and regulatory issues.

The member/experts typically consult with business leaders and decision-makers on industry trends and developments, operational problems/solutions, or specific products/services.

If you’d like to become a ScientiaNET member or engage one (or many)   please visit www.scientiaadv.com. 

AMH

Scientia Advisors, based in Cambridge, MA and Palo Alto, CA, is a global management consulting firm specializing in strategic growth and operational strategies  for major and emerging companies in health care and the life sciences.

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.