blockbusters

Wall Street swoons over Amgen's D-mab future

John Carroll — Tue, 29 Jul 2008 12:16:12 -0400

It's been a long time since I've heard the words "love" and "Amgen" in one sentence, but that's the approach the Los Angeles Times took in covering Wall Street's enthusiastic response to D-mab's performance in a recent clinical trial. Oppenheimer's Bret Holley says the drug is on track to break the billion-dollar mark in 2010 with an approval possible in 2009. And that helped send shares of Amgen surging to a 14-month high.

- reaad the story from the Los Angeles Times

Daiichi snares Germany's U3 in $235M acquisition

Wed, 21 May 2008 06:59:58 -0400

Daiichi Sankyo is buying Germany's U3 Pharma for $235 million in cash. The Japanese pharma company gains a developer that's been winning kudos for its work developing antibodies to fight a variety of cancers. And its lead program is bound for the clinic later this year.

Edmond de Rothschild Investment Partners has been backing U3 since 2003, when it was won over by the research work of Axel Ullrich of the Max Planck Institute. Ullrich's research has helped create such cancer blockbusters as Herceptin and Sutent.

"Our acquisition of U3 Pharma is an ideal strategic fit for our oncology portfolio," said Takashi Shoda, president and CEO of Daiichi Sankyo. "We currently have three human monoclonal antibodies in development. Additionally, in March, 2008, we announced that we were expanding our joint research venture with another German company, MorphoSys, for its advanced Human Combinatorial Antibody Library and its phage display technologies."

- check out the press release
- read the AFX report

Deloitte sees 'fundamental shift' in drug dev. strategies

Tue, 13 May 2008 06:59:58 -0400

Deloitte sees a major shakeup going on in clinical research strategies at the large pharma companies. Instead of focusing on the development of a small portfolio of blockbuster meds, pharma pipelines are shifting to create a host of new therapies that will have higher efficacy in smaller groups--the genotype-basing approach that's been so much discussed in biotechnology. By targeting smaller populations with promises of greater efficacy, says the accounting firm, the pharma industry can still rely on bigger per-treatment revenues.

The shakeup in R&D strategies is coming after the industry marks only mixed results from outsourcing and other efforts aimed at improving efficiency. And it marks a period of high stress for the companies, as they transition from blockbusters to targeted meds. A "fundamental shift in the industry's operating environment is under way."

- check out the report from Seeking Alpha

ALSO NOTED: Apoptos gains $28M Series A; Commonwealth Biotechnologies venture to recruit 1,000 chemists in China;and much more.

Tue, 06 May 2008 06:59:50 -0400

> Apoptos will get a two-tranche Series A of $28 million from a group of investors that includes Venrock, ARCH Venture Partners, OrbiMed Advisors, and Advanced Technology Ventures. The developer is engaged in apoptosis research. Apoptos release

> Commonwealth Biotechnologies has formed a joint venture with Venturepharm Laboratories to build new research facilities in China that will appoint up to 1,000 chemists over the next three years. Release

> Auspex Pharmaceuticals announced a $13.875 million Series B financing led by Thomas, McNerney & Partners with participation from co-investors CMEA Ventures and Costa Verde Capital. Ausphex release

> REGiMMUNE has closed its Series B financing for a total of $8 million. The money is earmarked to advance the company's lead program, RGI-2001, to human clinical trials for graft versus host disease. REGiMMUNE release

> About 300 R&D workers at Roche Diagnostics' Indianapolis facility are being laid off as the company transfers operations to Germany. Some workers will be offered transfers, but not many. They identify reagents used in test kits for HIV and other diseases. Report

> Generics makers are up in arms over proposed patent rules in Canada. The drug copycats say the rules will delay generic Lipitor and several other blockbusters by as much as two years. Report

> The number of U.K. kids taking antipsychotics has doubled in recent years, expert say, as use of the meds has broadened to hyperactive and autistic children. Report

> UCB Pharma was delirious with glee when it managed to launch its new TNF inhibitor Cimzia for Crohn's disease just 48 hours after the FDA gave its blessing. Cimzia report

> UK cell biologist Robert Edwards says he can see a time in the not-too-distant future when humans will be able to grow new body parts through the use of stem cell technology. Report

And Finally… Two doctors engaged in RNA research--Dr. Joan Steitz, Ph.D., and Dr. Elizabeth Blackburn, Ph.D.--became the first women to win the prestigious Albany Medical Center Prize, one of the richest awards available for biomedical research. Report

Merck shares hammered after FDA rejects Cordaptive

Tue, 29 Apr 2008 06:59:58 -0400

Shares of Merck were sliding again this morning on the news that the FDA has turned thumbs down on MK-0524A, its new cholesterol therapy. The stock dropped eight percent after regulators announced that the experimental therapy, a combination of niacin and laropiprant that had been high up on the drug giant's list of potential blockbusters, failed to make the grade. Getting an approval on Cordaptive, as the therapy was dubbed, would have gone a long way to easing the sting from the massive fallout that has hit Merck since new Vytorin data cast doubt on its efficacy.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, executive vice president of the company and president of Merck Research Laboratories, in a prepared statement.

- see Merck's release
- check out the report in TheStreet.com

Investors fret over Lilly's pipeline, Prasugel data

Wed, 21 Nov 2007 06:59:55 -0500

Barron's concludes that Eli Lilly's anti-clotting drug Prasrugel will probably make it to the market, but recent safety data is likely to prevent it from becoming the kind of blockbuster the drug company badly needs. How badly? A series of upcoming patent expirations will potentially trim up to 60 percent of its revenue. Other big competitor drugs are going to go generic relatively soon. And if physicians are scared away from preferring Prasrugel to Plavix, that's one more big gap to fill on Lilly's financial horizon. Even more worrisome, analysts can't find any other potential blockbusters in the Lilly pipeline. It all spells trouble for the company's stock price, which has shrunk considerably since it issued its latest batch of Prasrugel data.

- read the report on Lilly from Smart Money

Related Articles:
Doubters see big obstacles for Lilly's Prasrugel. Report
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Anti-TNF blockbuster garners positive Phase III data

Thu, 08 Nov 2007 06:59:58 -0500

Schering-Plough, Johnson & Johnson and Medarex unveiled positive new data from two late-stage studies of golimumab, an experimental anti-TNF therapy designed to treat conditions related to rheumatoid arthritis. The data on reducing symptoms of psoriatic arthritis and ankylosing spondylitis was presented at the American College of Rheumatology meeting in Boston. Golimumab works by blocking tumor necrosis factor (TNF), an inflammatory protein. If approved, golimumab would join the ranks of such anti-TNF blockbusters as Enbrel, Humira and J&J's own Remicade. And the companies say they'll be well positioned to compete. Golimumab requires injections only once a month, compared to higher frequencies for those existing drugs.

Slightly more than half of the psoriatic arthritis patients taking a 50 mg dose reported a reduction of symptoms of 20 percent or more compared to 9 percent of the volunteers receiving a placebo. About 60 percent of the patients taking either the 50 mg or 100 mg dose of the drug reported a 20 percent or greater reduction in symptoms for ankylosing spondylitis after 14 weeks. Late-stage data on rheumatoid arthritis is expected next year, and J&J is planning NDAs on all three indications for 2008.

"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' approach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."

- check out the release for more info

Related Articles:
Study highlights risks of anti-TNF antibody class. Report
J&J presents pipeline to skeptical analysts. Report
Scientists unveil new pathway for rheumatoid arthritis. Report
MAbs are hottest segment of biotech industry. Report

MAbs are hottest segment of biotech industry

Fri, 12 Oct 2007 06:59:57 -0400

Looking for the hottest segment of the biotech industry? Then take a look at monoclonal antibodies (mAbs). A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry. MAbs currently generate global revenues of around $20 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux.

A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. And many current mAb therapies are effective for a large number of diseases, making them even more attractive to drug developers.

- check out the Datamonitor report for more

Related Articles:
FDA approves Rituxan for rheumatoid arthritis. Report
FDA approves Avastin for lung cancer. Report
Remicade approved for psoriatic arthritis. Report
FDA approves expanded use of Humira. Report
Erbitux clears late-stage hurdle for lung cancer. Report

Pfizer tops the charts in global R&D spending

Mon, 08 Oct 2007 06:59:56 -0400

It hasn't had a lot to show for it so far, but Pfizer became the world's number one spender on research and development last year, grabbing the top spot from Ford. The list, assembled by the European Commission, looks at the top 50 research budgets on the planet. Biopharma companies ramped up spending big time last year, according to the EU, overtaking technology hardware and equipment makers. Much of that money was poured into programs designed to introduce a new generation of blockbusters as the current top products face a looming loss of patent protection. Merck, for example, increased R&D spending by 24 percent. Pfizer has been regularly held up to criticism that it has been notoriously ineffective in beefing up its pipeline--with the torcetrapib fiasco used as a prime example of its shortcomings. That helped lead the company to announce a major new initiative last week to launch a biotech center in South San Francisco that will be responsible for advancing critical new products--an announcement that left analysts buzzing for days.

- see the EU's press release
- check out the AP report for more info

Related Articles:
Pfizer hires new R&D chief, launches biotech center. Report
Where's the ROI on drug R&D budgets? Report
Pfizer's future rests with biotech. Report
Pfizer to invest $50M in biotech start-ups. Report
Pfizer goes public with R&D pipeline. Report

Deals and more deals

Thu, 21 Dec 2006 19:01:38 -0500

The surge in values for biotech buyouts this past year has recalibrated quite a few business plans. Just yesterday GlaxoSmithKline willingly put down twice the value of Praecis stock to lock up the buyout. That was just a small deal when compared to the recent buyout of Domantis. These days, when a big pharma company wants to find impressive new therapies it can tout to analysts, it goes straight to biotechnology. That can also lead to big licensing deals, like the record $2.1 billion pact for GebMab's HuMax-CD20, and it can mean a brand new way to evaluate the way biotech companies are worth.

If anything, the pace of deal-making is just likely to keep growing in 2007, at least in the early part of the year. Big drug companies like Merck, Glaxo and Pfizer will have to do quite a lot to convince market analysts that they're positioned to replace blockbusters coming off of patent. And what better way to do that than buy up innovative companies like Domantis (a 2006 Fierce 15 company). Big Pharma has the money and biotech has the innovation; it's a perfect match.