antibodies

Galapagos inks development pact with MorphoSys

John Carroll — Wed, 26 Nov 2008 08:34:48 -0500

Shares of Belgium's Galapagos surged on the news that it had partnered with Germany's MorphoSys AG to develop antibodies for bone and joint diseases. The two companies plan to jointly invest 30 million to 60 million euros to advance three new programs into the clinic over the next four to five years. The two developers will split the costs as well as the revenue that is produced by the new programs.

Analysts were quick to endorse the pact, which they said could prove very profitable. And the two companies said that they may expand the partnership later as they progress.

"With this alliance, we are adding a biologics strategy to our small molecule drug discovery," said Onno van de Stolpe, CEO of Galapagos. "Galapagos is the world leader in discovery of novel targets, and this alliance with MorphoSys enables us to explore the potential of proprietary antibody targets. Antibody approaches have proven to be successful in developing new therapies for major diseases, including rheumatoid arthritis. Having both approaches, small molecules and antibodies, to fill our product pipeline in bone and joint disease will further establish Galapagos as the leader in this field."

- check out the press release

Symphogen inks $330M collaboration pact with Genentech

John Carroll — Wed, 11 Jun 2008 11:15:13 -0400

Denmark's Symphogen has inked a $330 million collaboration deal with Genentech to discover new antibodies for three infectious disease targets. Symphogen gets an undisclosed equity investment as well as an undisclosed upfront payment, which will be used to fund a lead program in a mid-stage trial. Genentech gets a worldwide license on the developed candidates and will fund related R&D costs. The pact is a coup for Symphogen, which has smaller deals in place with Sweden's Biovitrum AB and Japan's Meiji Seika Kaisha.

According to a report in BioWorld, Symphogen has developed a rapid process for cloning antibodies as well as a more efficient manufacturing process.

"This deal underscores our belief that Symphogen's technologies offer a valuable approach to create next-generation therapeutics that address critical unmet medical needs in the treatment of serious infections," said Kirsten Drejer, Ph.D., CEO of Symphogen.

- check out the press release
- read the story from BioWorld

ALSO NOTED: Acorda shares soar; Lexicon wins fast track; NIH grants $533N in research funds; and much more...

Tue, 03 Jun 2008 06:59:50 -0400

> News yesterday that Acorda Therapeutics' experimental MS drug helped patients walk better sent its shares up 27 percent. Report

> The FDA has provided fast-track status to Lexicon Pharmaceuticals' therapy for carcinoid syndrome. Story

> Cougar Biotech says it presented positive Phase I and Phase II data for CB7630, an experimental therapy for castration resistant prostate cancer. Release

> Arana Therapeutics and Greenovation Biotech have forged a pact to develop up to five anti-cancer antibodies. Report

> China's Genesis Pharmaceuticals Enterprises has raised $30 million in a private placement. Release

> Novartis "stole the show" at ASCO, Forbes says. Between the big Zometa news--that the bone drug may actually prevent breast cancer recurrence--and dramatic data on an experimental med, the Swiss pharma came out of ASCO looking pretty sweet. ASCO report

> Guess who's the new up-and-comer in pharma? Brazil. Report

> It's not a new question, but it's one whose urgency is growing: How long can Pfizer pay its big dividend? Report

> Eugene Melnyk (photo) said he'd do it, and now he has. The founder of Canada's Biovail launched a proxy battle for the company, looking to sweep out its board and senior management. Report

And Finally… The Scripps Transitional Research Institute was one of 14 research groups that will gain $533 million from the NIH over five years. The funds are earmarked to speed the development of new technologies. Report

ALSO NOTED: GSK releases new Cervarix data; FDA mulls DTC ads; and much more...

Fri, 16 May 2008 06:59:50 -0400

> GlaxoSmithKline has released new Cervarix data that demonstrates the vaccine's ability to generate a high and sustained level of antibodies to neutralize the two most prevalent strains of cervical cancer for up to 6.4 years. Cervarix report

> The French pharma industry worries that up to 32,000 jobs are fodder for the axe, citing pricing pressures, generics, and globalization among the threats to drugmakers. Report

> Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. Release

And Finally... The five key vaccine makers say they plan to produce a record 143 million doses of flu vaccine for the U.S. market next season, which should be enough to satisfy demand. Vaccine report

Talecris' antibody drug gets priority review

Fri, 09 May 2008 06:59:54 -0400

The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. It's already approved to treat one autoimmune disease, and bring in about $650 million a year. The company is now pursuing an indication for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare neurological disorder in which patients suffer from weakness and impaired sensory function in the legs and arms. Gamunex previously received fast track and orphan drug status.

- here's the Talecris release
- read this report for more

Related Article:
Talecris backers design a $1 billion IPO

ALSO NOTED: Novartis buys bigger stake in Alnylam; FDA chastises ZymoGenetics' marketing campaign;and much more...

Thu, 08 May 2008 06:59:50 -0400

> Novartis has scooped up a bigger share of Alnylam stock. The pharma giant now owns 13.3 percent of the company. Alnylam release

> Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. FDA report

> The FDA has chastised ZymoGenetics' maiden effort to commercialize a therapy, saying that its claims for a genetically engineered form of Thrombin are "false or misleading." ZymoGenetics' marketing material notes that the drug has a lower level of antibody formation compared to a competitor, creating the impression that bovine thrombin's antibodies are less safe. Story

> Genzyme has expressed an interest in setting up an Israeli biotech incubator. Report

> Proteome Sciences said it has won a grant of €571,000 to study the proteomics end of a new generation of in-vitro assays. Report

> Did GlaxoSmithKline try to monopolize the Wellbutrin market? A lawsuit now certified as class-action says so. GSK report

> Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak hopes. DTC report

> New CEOs often clean house. Biovail's Bill Wells looks like he's trying to gut and rebuild it. The company announced it would shutter two plants in Puerto Rico as it shifts focus to specialize in central nervous system meds, "a market where unmet medical needs and growth potential are high," Wells said. Biovail report

> Merck's layoffs have inspired one newly unemployed poet to write in verse. Report

And Finally… Vaccine experts are pondering just how long vaccines will be able to provide immunity in a world where some diseases are all but eliminated and natural exposure to many common viruses has ended. Vaccine report

Novartis reports strong meningitis vaccine response

Tue, 06 May 2008 06:59:54 -0400

In a head-to-head trial, researchers for Novartis say that the experimental meningitis vaccine Menveo produced a more potent immune response than the standard therapy in use. And other data has underscored that the vaccine is effective in infants not covered by the current vaccine--Menactra. Bacterial meningitis kills about one in ten of its victims and leaves many of the rest deaf or suffering from seizures. In the new study, the Menveo group of 11 to 18-year-olds developed higher levels of antibodies against three of the five subtypes of meningitis and an equal amount of antibodies to a fourth.

"The number of adolescents that achieved protective antibody levels was also higher with the new vaccine," says Colin Marchant, a Boston University pediatrician.

- see this release on the data
- read the report from USA Today

EUSA Pharma spins off assets as it narrows focus

Thu, 01 May 2008 06:59:56 -0400

The transatlantic EUSA Pharma has spun off its monoclonal antibody research operation along with a development program for leukemia as it narrows its focus to late-stage drug development and marketing. France's International Drug Development snared the antibody operation while the Alize Pharma Group snagged the recombinant L-asparaginase therapeutic research program for acute lymphoblastic leukemia. EUSA's antibody research business is based in Dardilly, France, and includes a library of approximately 600 murine antibodies.

Bryan Morton, chief executive of EUSA Pharma said: "As we continue to rapidly build our business around our commercial infrastructure in the US and Europe, we are creating the opportunity to compete effectively with major players as an attractive partner for companies seeking specialist transatlantic commercialization and late-stage development expertise in the oncology, pain control and critical care areas."

- read EUSA's release for more information

Breakthrough reported in flu vaccine research

Mon, 10 Mar 2008 07:59:57 -0400

A Japanese chemical company saw its stock shoot up 20 percent this morning, the maximum allowed on the Japanese market, after researchers for NOF and Japan's National Institute of Infectious Diseases announced that they had found a way to create a new vaccine that could protect people from all types of bird flu viruses. One of the researchers said that the new approach targets the inside of the virus, preventing it from replicating. Current vaccines rely on alerting the immune system to attack the virus and become ineffective when the virus mutates.

"We are continuing the joint study in the hope that it will have universal effect on human influenza as well as a variety of other influenza viruses," said NOF. Any vaccine for human use is still far off, though. Researchers plan to start testing the vaccine in biotech mice in April.

- read the AFP report

Related Articles:
Breakthrough in understanding mechanism of bird flu. Report
Antibodies used to protect against bird flu. Report
Bird flu scientist says annual mutations likely. Report
Experimental vaccines show efficacy against H5N1 viruses. Report

Morphotek licenses anti-cancer antibody

Thu, 06 Mar 2008 06:59:57 -0500

Morphotek has inked a deal with Human Monoclonals International to get rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. The company hopes to develop a lead therapeutic MAb and high-titer cell lines suitable for scalable manufacturing. Morphotek, which was acquired by Eisai last year, has a pipeline of antibodies in development for cancer, rheumatoid arthritis, and infectious disease. Financial terms of the deal were not disclosed.

"This agreement provides yet another important addition to our therapeutic antibody portfolio," said Nicholas Nicolaides, Ph.D., Morphotek's president and CEO. "Safety data and positive clinical observations from an exploratory Phase I clinical trial in patients with metastatic melanoma have been reported. Our antibody optimization and development expertise will enable the further development of this promising antibody and clinical proof-of-concept studies in more types of cancer."

- check out the release

Related Articles:
Eisai acquires Morphotek in $325M deal. Report
Morphotek gains $40M in fourth venture round. Report

Officials toss Genentech antibody patent

Tue, 26 Feb 2008 06:59:55 -0500

Genentech says the U.S. Patent Office has rejected a patent covering the way it uses recombinant DNA technology to make antibodies. The biotech giant says it uses the 415 patent in making a number of therapies, has licensing agreements on the technology covered in the patent and earns royalties on claims to the patent. The Patent Office's decision came after Genentech asked it to reexamine the issue after patent officials originally rejected 36 patent claims. Genentech says it may appeal.

- see this release
- check out the AP story

Related Articles:
Patent ruling threatens $300M in Genentech revenue. Report
MAbs are hottest segment of biotech industry. Report
Standards on biotech patents get tougher. Report

FDA approves Wyeth's hemophilia therapy

Fri, 22 Feb 2008 06:59:57 -0500

Wyeth has won FDA approval Xyntha, a treatment for patients with hemophilia A, a rare blood-clotting disorder in which sufferers lack a key protein (Factor VIII) that prevents excessive bleeding. Xyntha is a genetically engineered version of the missing blood protein that's essential for clotting. "This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, director of FDA's CBER. The product is entirely synthetic; previous treatments for the disease used monoclonal antibodies derived from mouse cell lines. About 15,000 people in the U.S. suffer from the disease.

- check out the release
- and here's the FDA's statement on the approval

Related Articles:
Wyeth may cut 10% of jobs. Report
Wyeth stumbles badly trying to develop new drugs. Report

Genmab buys antibody plant in $240M deal

Thu, 21 Feb 2008 06:59:58 -0500

PDL BioPharma has inked a deal to sell its U.S. antibody manufacturing plant to Denmark's Genmab for $240 million. The deal--which will enable Genmab to transition three antibody products from research to manufacturing--covers a facility that can produce multiple antibodies as well as leased space for a development lab. And PDL will continue to obtain testing material from the plant. Genmab has tapped Torben Lund-Hansen to run the operation in Brooklyn Park, MN, where all 170 employees are being retained.

This deal is just the latest in a string of asset sales for PDL, which announced plans to maximize shareholder value last fall. Its cardiovascular products were acquired by EKR Therapeutics and Japan's Otsuka bought out Busulfex IV in December.

"We are pleased to enter into this agreement with Genmab, which we believe is the optimal transaction to fully realize the value of our biologics manufacturing facility. Importantly, it also represents another step in delivering on our commitment to maximize the value of PDL's assets for our stockholders, following on the recent sale of our commercial assets," said L. Patrick Gage, the company's interim chief executive.

- see this release
- and here's the report from The Street

Related Articles:
PDL BioPharma puts out 'for sale' sign. Report
PDL sells assets, cuts jobs. Report
Rumors of buyout interest heat GenMab stock. Report
Genmab shares up on new antibody tech. Report

SPOTLIGHT: Research links efficacy to thoughts

Thu, 31 Jan 2008 06:59:53 -0500

A patient's thoughts and feelings can play a big role in determining just how effective their annual flu shot can be, says a new study from the University of Wisconsin. In the study, researchers divided young women into two camps: one group that felt they were living up to their goals and satisfied with their lives and another group that wasn't. That first group with poor self-esteem demonstrated a significantly weaker response to their flu shot--delivered during the flu season--with lower levels of immunoglobulin M antibodies. Report

Analysis: OncoMed deal puts a premium on preclinical

Mon, 14 Jan 2008 06:59:55 -0500

OncoMed's $1.4 billion antibody development pact with GlaxoSmithKline is dissected by the San Francisco Business Times, which highlights just how unusual it is for preclinical programs to earn that kind of potential reward. Researchers at OncoMed have been focused on developing antibodies that can target cancer stem cells, greatly increasing the chance that a patient's cancer can be knocked out without a recurrence.

"There was speculation that Big Pharma would not do large deals like this for preclinical candidates," says attorney Alan Mendelson, who represented OncoMed during the negotiations. "I think the OncoMed deal is evidence that, for the right technology, with the prospect of multiple product opportunities, the farsighted pharmaceutical companies are doing some preclinical transactions."

- read the report from the San Francisco Business Times

Related Articles:
GSK offers $1.4B to license OncoMed therapies. Report
MAbs are hottest segment of biotech industry. Report
OncoMed snares $13.9M in first round. Report

SPOTLIGHT: Crucell forges pact with Sanofi

Thu, 03 Jan 2008 06:59:53 -0500

Crucell stands to gain $112 million in a new development pact with Sanofi Pasteur, which wants to use its antibodies for a rabies vaccine. Report

2008 biotech industry predictions

John Carroll — Wed, 02 Jan 2008 15:01:21 -0500

In biotechnology, the recent past serves as a reliable prologue. If you want to look for clues for what trends will dominate the industry, look at the past 12 months. Turn around and you can see ahead. For a business where the headlines always seemed packed with surprises--some pleasant, some exciting, and many just plain nasty for all involved--the learning curve stretches over a lengthy time horizon.

There are no overnight success stories in biotech. Antibodies didn't just emerge from the lab and burst into the clinic. Their striking advances--a prelude to the more exciting late-stage data we can expect in 2008--were the result of years of painstaking science. As more money finds its way to drug discovery, it will flow naturally to the most promising therapies at the latest stage of development.

Along the way, though, every misstep by a public company is likely to hammered by investors. Biotechnology has attracted quite a crowd of speculators who feed off the sudden market gyrations. That market amplification is only likely to grow more pronounced in the year ahead if Wall Street profits are hard to come by. For a journalist, it's hard to find a more interesting business to cover. Every day will bring a new set of examples of the major trends on display below. - John Carroll

1. More mixed messages from the FDA

2. Gaming the system will dominate start-ups

3. Dealmaking stays big even as the markets tremble

4. Biotechnology will expand its global reach

5. More jaw-dropping scientific advances lay ahead

Amgen reveals promising D-mab data

Mon, 17 Dec 2007 06:59:57 -0500

Amgen's great osteoporosis hope--denosumab, or D-mab--increased bone strength in women receiving hormone replacement therapy for breast cancer. The first complete analysis of late-stage trial data on the drug showed a 5.5 percent increase in bone density among the women. On Friday, researchers for Amgen noted that the drug increased density in the spongy part of the bone. Amgen has great expectations for denosumab, which has the potential to reach blockbuster status with $1 billion to $2 billion in sales.

"In this study, denosumab data looks promising and, as a clinician, I look forward to having a potential alternative to existing therapies," said lead investigator Dr. Georgiana Kehr Ellis, from the oncology division at the University of Washington School of Medicine in Seattle.

- here's Amgen's release
- check out the AFX report for more

ALSO: Oxford Genome Sciences has inked a deal with Amgen to collaborate on new antibodies for treating cancer. Release

Related Articles:
Denosumab: Amgen's salvation? Report
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report
Analyst: Anemia drug warnings 'not bad'. Report

Investors: Biologics are 'hot' right now

Tue, 04 Dec 2007 06:59:57 -0500

Kate Bingham, managing partner at SV Life Sciences, says that biologics are "hot" right now for investors. Speaking at a European conference, Bingham said that deal-making and greater innovation were driving the growth of the continent's biotech sector. "Innovation is being concentrated on drugs being prescribed by specialists in hospitals," she told the group, with antibodies also attracting a lot of attention.

- read the report from AFX

Related Articles:
MAbs are hottest segment of biotech industry. Report
Sanofi: We're looking for biotech deals. Report
Pfizer's future rests with biotech. Report
Lines blur as Big Pharma crosses borders into biotech. Report

Novartis, MorphoSys ink $1B antibody deal

Mon, 03 Dec 2007 06:59:58 -0500

There's fresh evidence this morning that antibodies remain one of the hottest commodities in biotechnology. Novartis has extended its antibody development deal with Germany's MorphoSys, agreeing to pay $60 million a year in R&D support along with technology access fees and up to $400 million in milestone payments. Investors loved the major league endorsement of MorphoSys, sending its shares up 32 percent. Novartis gains access to MorphoSys' library of antibodies, expanding a pact that was originally signed three years ago. The pharma giant also gains an option to extend the deal by another two years. Analysts applauded the deal and seemed particularly enthusiastic about the length of Novartis' commitment.

- see the release on the deal
- check out the AFX report for more

ALSO: MorphoSys used the attention garnered by the announcement to say that much of the money it gains from Novartis will go into developing its own pipeline. Report

PLUS: Read more about Novartis' pipeline. Report

Related Articles:
Novartis bankrolls a drug manufacturing revolution. Report
Novartis makes the "Biggest Splash." Report
Lagging sales spur Novartis layoffs. Report
Novartis plots $700M biotech plant. Report