ddn Online

The Blog of Drug Discovery News

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

On the move…

I briefly considered some “I have a dream…”-style post musing about something and glomming onto the theme of MLK Day, then decided the Rev. Martin Luther King Jr. has been in his grave a short enough period that he might roll over, roll out, and clonk me on the head for sheer impertinence (and I’d deserve it). So, as some of us work today, and some of us don’t, but most of us try to remember how short a time ago (historically speaking) it was that civil rights in the United States was a painful joke and keep moving beyond that era, I’ll just keep it simple with a pair of “People & Promotion”-style items that go right to the top.

Xhale Innovations Inc.
Craig T. Davenport
Chief Executive Officer
GAINESVILLE, Fla.—With more than 35 years of experience in the healthcare industry and “a proven track record of leading, building, managing and investing in rapidly growing medical device technology companies,” Craig Davenport has been announced as the new CEO of Xhale Innovations Inc. Recently, he he had served as chairman, president and CEO of Endocare and, over six years, built the company into a leading provider of minimally invasive technologies to treat prostate, kidney, lung and other cancers using cryotherapy. Earlier in his career, he was chief operating officer and president of Tokos Medical Corp. when it was an early stage medical device manufacturer and clinical services provider, and over nine years he spearheaded the company’s growth from a handful of people to more than 3,000 employees, took the company public in 1990 and grew revenues from $3.7 million to more than $120 million.

Crescendo Biologics
Mike Romanos
Chief Executive Officer
CAMBRIDGE, U.K.—Crescendo Biologics has announced the appointment of Dr. Mike Romanos as CEO after having served as chief scientific officer of the company since May 2009, a position in which he led the formation of the company and the development of its proprietary antibody fragment technologies. During this time, Crescendo notes, the company has made significant progress in the establishment of its team and its technology platforms. This has included the establishment of a colony of engineered mice completely devoid of endogenous antibody polypeptides, announced in September. The proprietary ‘triple knockout’ mice are believed to be unique and have the immunoglobulin heavy chain (IgH), kappa light chain and lambda light chain loci all functionally silenced by large-scale genomic deletion. Romanos brings more than 23 years’ biotech and pharma industry experience and within the last 10 years has held senior global positions leading major parts of GlaxoSmithKline Discovery.

January 17, 2011 Posted by | Corporate, Promotions and Moves | Leave a comment

Good news, bad news

As is so often the case, I greet stories of mergers with a sense of “yes, a company successful enough to be bought out by (or combine with) someone larger…congrats to them!” that is mixed with the “oh crap, more people are going to be jobless now, probably” feeling.

Case in point: Valeant Pharmaceuticals in California is laying off 500 people subsequent to the fall merger deal with the former Biovail, which had been Canada’s largest publicly traded pharma company…

Read more (and try not to weep; at least it isn’t the thousands upon thousands that so many Big Pharmas have announced are getting the axe in recent months, as ddn Chief Editor Amy Swinderman talked about here and here.)

January 14, 2011 Posted by | Corporate, M&A activity | , , , , , | Leave a comment

Delays, delays…

Perhaps one of many reasons Genzyme seems more willing to talk with sanofi-aventis about possibly being acquired in a peaceful fashion instead of in a hostile takeover (or having no deal at all)? …

Genzyme lowers guidance following Fabrazyme production delay

Jan. 13, 2011

Genzyme has lowered 2011 financial projections after delaying the date that it expects Fabrazyme production to return to normal. The manufacture of Fabrazyme (agalsidase beta) had been moved to a plant in Framingham, Mass.,  but production levels have not yet returned to earlier levels. Genzyme had expected supply to meet demand in the first half of 2011 but has now pushed back that timeline.

January 13, 2011 Posted by | Corporate, M&A activity | , , | Leave a comment