ddn Online

The Blog of Drug Discovery News

Eisai invests $200 million in U.S. personalized medicine unit

Seems that Japanese company  Eisai has put together a biotech start-up in the United States by the name of H3 Biomedecines, intended to focus on discovering and developing next-generation cancer drugs and with an aim to generate new treatments “aimed at fulfilling the promise of personalised cancer medicine.”

H3, based in Cambridge, Mass., will be wholly owned by Eisai, which has committed to putting up $200 million in research funding. Eisai officials say the establishment of H3 is distinct from similar companies because it will have the “resources and capabilities of an established pharmaceutical company, while also encouraging and rewarding innovative and entrepreneurial spirit.”

Eisai also that its involvement will allow H3 to benefit from a longer-term view of its drug discovery activities compared to most venture-backed start-up companies.

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January 31, 2011 Posted by | Corporate | | Leave a comment

Saying “no” to snow

In all my years of journalism, most of which has been at medical associations, healthcare organizations, health advocacy non-profits or a pharmaceutical business publication (that last one would be ddn, of course), I’ve covered a lot of conventions, conferences and shows. Some of them I’ve actually attended and some of them I’ve only written pre-show coverage for.

But I have to say that since entering this world of reporting and editing as a paid professional around 1992, I think that I’ve only encountered one major conference that was ever held in winter at anyplace with snow, and that was at Colorado Springs, which had skiing and upscale shops to make it a major draw for convention attendees.

Folks, where’s the love for New England in late January with the possibility of ice storms or Chicago in early February, with bone-chilling winds coming off Lake Michigan?

I know, I’m a pipe dreamer.

Also, I know this is kind of a throwaway post, but it’s been a long week and I promised a post every weekday (for as long as my New Year’s resolution resolve hold out), so that’s what I’ve got today.

Have a great weekend!

January 28, 2011 Posted by | Academia & Non-Profit, Corporate, Editorial/Journalism Musings | Leave a comment

Did President Reagan suffer from Alzheimer’s disease while in office?

ddn has written countless stories about drug discovery and research efforts in the critical area of Alzheimer’s disease, and one area that researchers, clinics and drug manufacturers seem to be focusing on lately is pinpointing the onset of the debilitating disease. For example, in October, we reported on efforts by the Alzheimer’s Prevention Initiative (API) to test potential Alzheimer’s treatments and identify new biomarkers that could lead to earlier and more accurate diagnoses for Alzheimer’s patients. Researchers at the API told us that although there are many promising treatments being studied in Alzheimer’s symptomatic patients, by the time most people begin to show symptoms of the disease, it has already ravaged the brain, rendering these treatments ineffective.

This cold, hard reality has been making headlines lately with the release of a new book, “My Father at 100: A Memoir,” a close-up account of the life of President Ronald Reagan as seen through the eyes of his son, Ron Reagan. The book, which came out a few weeks shy of what would have been the former president’s 100th birthday on Feb. 6, is “an exploration of his character,” Ron Reagan says, but addresses the ongoing question of whether his father suffered with Alzheimer’s while in office.

President Reagan was diagnosed with Alzheimer’s in August 1994 at the age of 83, and he informed the nation about his diagnosis in a handwritten letter later that year. Although President Reagan’s White House doctors said they saw no evidence of Alzheimer’s while he was president, there was during his time in office widespread speculation that he demonstrated symptoms of mental degeneration. For example, former CBS White House correspondent Lesley Stahl wrote in her own memoir that at her final meeting with President Reagan in 1986, “Reagan didn’t seem to know who I was.” The president regained his alertness at the end of the meeting, Stahl wrote, adding, “I had come that close to reporting that Reagan was senile.”

Ron Reagan writes that that he noticed evidence of dementia as early as President Reagan’s first term. “I felt the first shivers of concern” during the 1984 reelection campaign, he writes, “that something beyond mellowing was affecting my father. My heart sank as he floundered his way through his responses. He looked tired and bewildered.” By 1986, President Reagan “had been alarmed to discover, while flying over the familiar canyons north of Los Angeles, that he could no longer summon their names,” his son writes.

Still, as he hits the press junket, Ron Reagan is careful to say that we cannot know for certain whether President Reagan exhibited signs of Alzheimer’s during his presidency. He also asserts that he believes if Reagan had gotten the diagnosis during his two terms, he would have stepped down.

In this video with TV personality Joy Behar, Ron Reagan clarifies his characterization of his father’s illness in his book.

“One can deduce that the disease must have been present, but I say specifically that I saw no dementia-like signs when he was in office,” he tells Behar. “Let’s recall that this was the oldest president ever elected (President Reagan was in his 70s). By the time he’s reaching his mid-70s, he’s losing his hearing, he’s been shot and nearly killed—which will take a little of the wind out of your sails—and of course I am worried about him all the time, because it’s a very tough job with a lot of stress. Every once in a while I would see—almost like when you are watching television, and it momentarily goes out of focus and snaps back. You think, ‘what did I just see?’ But I didn’t know what it was, I just knew I was concerned about him for all sorts of reasons. In retrospect, it’s possible that some of those early things were signs of Alzheimer’s, but I don’t know, and I can’t really make that claim.”

Some of the controversy, Ron Reagan tells Behar, may stem from “the confusion between Alzheimer’s the disease and dementia, which is a symptom of the disease—which usually arrives in the later stages.”

“Knowing what we know now about Alzheimer’s, that it’s a process that extends for years or even decades before symptoms arise, it’s kind of an academic question as to whether the disease was present when my father had” the debilitating disease, Ron Reagan says in this interview.

I think many of the researchers who read our publication would agree. What do you all think of Ron Reagan’s assertions? How does this “academic question” impact efforts to treat, manage or even reverse damage caused by Alzheimer’s?

January 27, 2011 Posted by | Academia & Non-Profit, Corporate, Labwork & Science | , , , , , , , , , | Leave a comment

PhRMA’s take on the State of the Union

Washington, D.C.—Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani released the following statement after President Barack Obama’s State of the Union address:

“We commend the President for offering an ambitious agenda that focuses on bolstering the economy, job growth and strengthening our education system to ensure that we attract and retain the world’s best and brightest talent.

“While innovation and American competitiveness were also central themes in the President’s address, we believe that medical innovation specifically will continue to play a crucial role in advancing patient health and spurring economic growth in the U.S. The President recognized this crucial point tonight, as he stressed the need for investments in biomedical research. The good news is that this important research is already taking place—with more than $65 billion invested in R&D by the biopharmaceutical industry in 2009 alone.

“There is no doubt that innovation is a critical building block for growing the U.S. economy. For this reason, it is important that the Administration and Congress view the biopharmaceutical research sector—one of the most innovative, technology-driven sectors in America—as a national health and economic asset. Our global leadership in medical progress, and the domestic jobs and economic output that goes along with it, is ours to lose if our nation’s leaders don’t support policies that help preserve and nurture future medical innovation.

“We will continue to work with the Administration and members of Congress, on both sides of the aisle, on bipartisan solutions that can help spur growth in the U.S. economy, preserve timely patient access to new medicines, maintain market-based competition and foster future development of life-enhancing and life-saving treatments.”

January 26, 2011 Posted by | Corporate, Government | , , , | Leave a comment

Amgen to acquire BioVex for as much as $1 billion

THOUSAND OAKS, Calif. and WOBURN, Mass.—Marking another move in Big Pharma to capitalize on the growing area of cancer vaccines, Amgen has entered into a definitive acquisition agreement under which it plans to acquire BioVex Group Inc., a privately held, venture-funded, biotechnology company headquartered in Woburn, Mass. BioVex is developing OncoVEX(GM-CSF), a novel oncolytic vaccine currentl in Phase III clinical development, that “may represent a new approach to treating melanoma and head and neck cancer.”

Amgen will pay as much as $1 billion to get the deal done, $425 million of that in cash at closing and as much as $575 million in additional payments upon the achievement of certain regulatory and sales milestones. The transaction has been approved by the boards of directors of each company but remains subject to customary closing conditions, including regulatory approvals. The company expect, however, that the deal will close in the first quarter of 2011. Following the completion of the transaction, BioVex will become a wholly owned subsidiary of Amgen.

“OncoVex has demonstrated encouraging anti-tumor activity in clinical studies for the treatment of melanoma and head and neck cancer, and BioVex is currently enrolling patients into pivotal Phase 3 trials in both indications,” says Dr. Roger M. Perlmutter, Amgen’s executive vice president for research and development. “Amgen is particularly excited about joining with BioVex and its talented staff to focus on advancing this late-stage investigational therapy, with the hope of bringing it to market within the next few years.”

“Amgen is ideally positioned to leverage the potential of OncoVEX in multiple solid tumor indications given their impressive oncology franchise and expertise in biologics manufacturing and development,” adds Philip Astley-Sparke, CEO of BioVex. “We have a shared vision and commitment to bring novel therapeutics to market and we are looking forward to being able to combine our efforts towards this common goal.”

We at ddn will provide you with additional details, in the print issue or on the website, in the coming days and weeks.

January 25, 2011 Posted by | Corporate, M&A activity | Leave a comment

Oncological pies in the sky

This just in from the Hastings Center, which deals with bioethics and public interest issues…

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Unrealistic Optimism Appears Common in Early Cancer Trials

Study suggests it may compromise informed consent

GARRISON, N.Y.—Can optimism be ethically problematic? Yes, according to a new study, which found unrealistic optimism prevalent among participants in early-phase cancer trials and suggested that it may compromise informed consent.

Many cancer researchers and ethicists assume that hope and optimism in the research context are “always ethically benign, without considering the possibility that they reflect a bias,” write the authors of the study, which appears in IRB: Ethics & Human Research. “Others have claimed that unrealistic expectations for benefit are a result of misunderstanding and that the proper response to them is to provide patient-subjects with more information…” But the study cast doubt on both assumptions.

The study included 72 patients with cancer who were enrolled in early-phase oncology trials in the New York metropolitan area between August 2008 and October 2009. Questionnaires assessed signs of unrealistic optimism, as well as participants’ understanding of the trials’ purpose. Unrealistic optimism, which social psychologists define as being specific to a situation and consider a form of bias, is distinct from “dispositional optimism,” which is a general outlook on life and is neither realistic nor unrealistic. Individuals can have one form of optimism without the other.

Study respondents exhibited unrealistic optimism in response to three of five questions about the likelihood of particular events happening to them compared with other trial participants: having their cancer controlled by drugs administered in the trials, experiencing a health benefit from the drugs in the trials, and not experiencing a health problem from the drugs in the trials.

However, a substantial majority of the respondents – 72 percent – accurately understood that the purpose of the trials was to advance knowledge with the potential to benefit future patients and not necessarily to benefit them. Misunderstanding the purpose was not significantly related to unrealistic optimism, the study found.

The authors said that unrealistic optimism has the potential to compromise informed consent “by interfering with the ability to apply information realistically.” They concluded: “Improving the consent process in oncology research will require us to do more than address deficits in understanding. It will require us to pay more attention to how patient-subjects apply information to themselves and to become more aware of the social-psychological factors that might impair decision-making in this context.”

The authors are Lynn A. Jansen, PhD, of Oregon Health and Sciences University; Paul S. Appelbaum, MD, of Columbia University; William M.P. Klein, PhD, of the National Cancer Institute; Neil D. Weinstein, PhD, of the University of Arizona College of Medicine; Jessica S. Fogel, BA, of Columbia University; and Daniel P. Sulmasy, MD, PhD, of the University of Chicago.

January 24, 2011 Posted by | Academia & Non-Profit, Corporate | , , , | Leave a comment

Mixed bag regarding MS

Datamonitor: Good and bad news from EU regulators for major MS players

Despite Biogen’s resolve to maintain its leading position in the MS market, rejection of Fampyra (dalfampridine) today and Novartis’s Gilenya (fingolimod) recommendation for European marketing authorization will deal another blow to its franchise, says independent analyst Datamonitor.

Dr. Trung Huynh, healthcare analyst at Datamonitor, comments: “Gilenya’s recommendation comes as welcome news for European MS sufferers. However, the committee’s negative opinion of Fampyra is a surprise given that it was approved by the FDA.”

“Gilenya, which is widely regarded as a more convenient and effective alternative, will provide heavy competition for Biogen in the market and will lead to a decline in sales for the company. In the sort term though, Biogen will still see sales figures grow as a result of recent price rises on its leading therapies Avonex and Tysabri.”

“Novartis is now set to become the leading player in the multibillion-dollar market and can expect to generate annual revenues of around $2.5 billion by the end of the decade. However, Biogen’s strong pipeline suggest the company will not go down with a fight,” concludes Huynh.

January 21, 2011 Posted by | Corporate | , , , , | 1 Comment

Genentech fires back at FDA

FDA doesn’t want to give the thumbs up for Avastin’s use as a first-line therapy for breast cancer, and Genentech has a few things to say about that:
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GENENTECH SUBMITS RESPONSE TO FDA’S NOTICE OF OPPORTUNITY FOR A HEARING ON PROPOSAL TO WITHDRAW APPROVAL OF METASTATIC BREAST CANCER INDICATION FOR AVASTIN

SOUTH SAN FRANCISCO, Calif. (January 18)—Genentech Inc., a member of the Roche Group, today submitted its response to the U.S. Food and Drug Administration’s (FDA) Notice of Opportunity for a Hearing (“NOOH”) on the Agency’s proposal to withdraw approval of the metastatic breast cancer (mBC) indication for Avastin (bevacizumab). Genentech has submitted the response and supporting documentation electronically to http://www.regulations.gov under Docket No. FDA-2010-N-0621. Regulations.gov controls the timing of the documents being made public on its website. Click here to view the response on Genentech’s website.

The response explains Genentech’s right to a hearing to allow full and fair discussion of the issues in a public forum, and sets forth the data, analyses and information on which Genentech intends to rely at a hearing to demonstrate why Avastin should remain an FDA-approved option for women in the United States with HER2-negative mBC.

Genentech believes women with mBC in the United States are entitled to Avastin as an FDA-approved choice and that accelerated approval of Avastin in combination with paclitaxel should be maintained. The company has proposed conducting a new confirmatory trial of Avastin plus paclitaxel, the chemotherapy combined with Avastin in the study that led to accelerated approval, in HER2-negative mBC to the FDA. The trial would have a biomarker component with the intent of identifying people who may be more likely to derive a greater benefit from Avastin.

At this time and until the conclusion of the proceedings with the FDA, Avastin remains approved for use in combination with paclitaxel for the first-line treatment of HER2-negative mBC in the United States. The effectiveness of Avastin in HER2-negative mBC is based on an improvement in progression-free survival in the E2100 study. There are no available data showing that Avastin improves disease-related symptoms or survival in HER2-negative mBC. Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

Doctors with questions about the use of Avastin for mBC can call Genentech’s Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage can call Genentech’s Access Solutions Group at (866) 4 ACCESS.

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Also worth noting is a story from the San Francisco Business Times:

Genentech Inc. responded to the Food and Drug Administration, saying it wants to present evidence and make arguments against the FDA’s plan to withdraw approval for use of Avastin as a breast cancer treatment.

The FDA said Dec. 16 it planned to withdraw its OK for Avastin as a first-line treatment for metastatic HER2-negative breast cancer combined with paclitaxel. South San Francisco-based Genentech asked the FDA for a hearing on Dec. 23. Today’s submission includes all the evidence and data that Genentech plans to rely on in its arguments at the hearing, for which no date has yet been set.

Genentech, which is owned by Swiss giant F. Hoffman-La Roche Ltd., told the FDA that “a hearing is particularly warranted” because the drug has already been used for this treatment (the FDA approved it in early 2008) and because European regulators, who reviewed the same data, supported the use of Avastin in breast cancer.

“Since this approval, thousands of women with MBC have been treated with Avastin in the United States,” Genentech said.

For its part, the FDA looked at Avastin when it was later tested in combination with two other types of chemotherapy than paclitaxel. Avastin didn’t do as well in those tests as it did with paclitaxel. Genentech disagrees with the FDA’s interpretation of that data and those two tests.

“We look forward to the opportunity to present our views more fully on these important issues,” said Michelle Rohrer, Genentech’s vice president of regulatory affairs, in a letter to the FDA.

Until talks with the FDA are finished, the drug is still being used to treat breast cancer along with paclitaxel. Avastin isn’t used by patients who’ve already had chemotherapy.

January 20, 2011 Posted by | Corporate, Government | 2 Comments

Laying down the law

Here at ddn, there have been some notable times when we’ve covered a big merger and acquisition-style story and just as we’ve put the issue to bed, and sent it off to the printer, something major changes in the negotiations, motivations or suitors for the company in question. As such, we’ve started to ask ourselves how early in the process of such transactions do we want to start covering them. Along with that, once they seem to be reaching a climax or conclusion, how long do we wait before reporting on it?…just to make sure…

Granted, that’s become less of an issue with our increasing use of the blog and the website to handle breaking news in a way that the monthly print publication cannot. Still, one doesn’t want to look silly with reporting that has been rendered moot or incorrect printed in four-color glory in tens of thousands of hard copies that cannot be changed, without an army of elves wielding white-out and really tiny pens.

All that is by way of me saying that lawsuits are even worse to cover in a monthly publication, and maybe that’s why you don’t see them covered very often in ddn. Depending on the district, judge, litigants and defendants, it often plays out like a ping-pong match between two people who’ve just taken a dose of Ambien.

And even when there’s a ruling, it might get turned over or held up weeks later on an appeal. It all gets very frustrating to cover and, worse yet, almost never will any of the companies involved speak on the record (or at all) until they have a definitive victory.

So, in short, they are boring.

Usually.

I still think there is value in covering them (as long as you keep it short and can readjust quickly to changes), and I see today some breaking news that Life Technologies has a new company to sue (AB Sciex). I’m sure Illumina or one of the other big guys will find a new victim to drag into court again soon, too, so I’ve decided to keep tabs on some of the big cases here in the blog, even though they may not make for big posts. So, we have yet another new category here for your reading pleasure: Lawsuits and Legal Matters.

As you can probably guess from the name, there may not only be lawsuit coverage gut also the occasional overflow here from the Government Watch section of ddn, in which we often cover state and federal legislation and other legal topics.

Stay tuned. It’ll be fun, I promise (you can trust me; I have my right hand on a stack of Mad magazines)

January 19, 2011 Posted by | Lawsuits & Legal Matters | , , | Leave a comment

Headlines and real messages

As I consulted the news feeds this morning, I saw this headline, and boy did it catch my attention…

GSK faces Q4 profit wipe-out on $3 billion legal hit

Wipe out!

$3 billion!

Legal hit!

The sky is falling!

OK, got a little snide with that last one.

Anyway, if you want to read the full Reuters story, it’s here, but I don’t really want to talk about the fourth-quarter news but rather the business of reporting that news…and other happenings in pharma and biotech.

There is nothing wrong with that headline, technically speaking. All the words are accurate. But taken as a whole…my, isn’t it dramatic! Now, Reuters is pretty much mainstream news media, and the mainstream news does tend to get excitable when there are big numbers, and they want to excite the public so that they can generate more attention for themselves as the news reporters.

No shame there, really.

But it does make me stop and think, because whenever I’m looking to write a headline for one of my articles, I like to get something catchy and/or exciting. It might be a play on words or a dramatic presentation or something else. That’s the job of a headline. It’s supposed to grab attention.

However, I think I’ll be a bit more careful now, after seeing that Reuters headline. Truth is, so what if GSK pretty much had a wash with its Q4 profits? Yes, it hurts, but as the story points out, the company is trying to clear its plate of some legal entanglements and move forward. Does anyone who really understands the world of business and the pharma industry think that GSK won’t be right back to make significant profits in the next quarter…two at the outside?

Will they be as much profit as the company wants or needs? Maybe not.

But we can call off Chicken Little, no matter how much the headline begs for him to start spreading word of this “devastating” news. The sky is not falling.

January 18, 2011 Posted by | Corporate, Editorial/Journalism Musings | Leave a comment