breast cancer

EMEA issues host of decisions

Maureen Martino — Fri, 25 Jul 2008 10:54:29 -0400

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has been busy. The drug regulator released a host of decisions today, so here's the round-up:

The Committee for Medicinal Products in Human Use (CHMP) recommended approval of Bayer's blood-thinning pill Xarelto. The drugs, which Bayer hopes will generate €2 billion in sales, prevents thrombosis in patients bedridden after major orthopaedic surgery. Report
Sanofi-Aventis' Taxotere got shot down, as the agency recommended against using the drug to treat HER2 positive breast cancer. Report
The EMEA restricting the use of antibiotics based on moxifloxacin--marketed by Bayer under the name Avelox--because of the potential risk of liver damage, and also wants strengthened warnings. Report
A positive opinion was issued on marketing authorization for Ceplene for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia. Release
Novartis' osteoporosis drug Aclasta was recommended to treat the disease in men who are at increased risk of fractures. Release

Elan wins $55M judgment in patent scrap

John Carroll — Mon, 16 Jun 2008 07:38:16 -0400

Ireland's Elan won a $55.2 million judgment against Abraxis BioScience on Friday, prevailing in its case that Abraxis' breast cancer drug Abraxane uses a technology protected by an Elan patent. Abraxane was approved by the FDA three years ago. This fight is far from finished, as Abraxis says it plans to appeal the ruling.

- read the report from RTT News

ALSO: Investors are anxiously awaiting a Phase II update from Elan and Wyeth on bapineuzumab, a potential blockbuster drug targeted at the root causes of Alzheimer's. Significant success in the clinic would pave the way for a new drug to compete against therapies that offer little long-term benefit. Report

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

SPOTLIGHT: Pertuzumab slows breast cancer in study

Fri, 30 May 2008 06:59:53 -0400

Roche announced that a combination of Herceptin and pertuzumab slowed the spread of breast cancer. Pertuzumab is the first in a new class of agents known as HER dimerization inhibitors. HDIs block the ability of the HER2 receptor to collaborate with other HER receptor family members. Report

Sonus, OncoGenex to merge

Wed, 28 May 2008 06:59:58 -0400

Bothell, WA-based Sonus Pharmaceuticals is merging with Canada's OncoGenex Technologies and will operate under the name OncoGenex Pharmaceuticals. OncoGenex's CEO Scott Cormack will head up the new company.

Sonus has been struggling since September when it pulled the plug on its lead therapy for breast cancer. Since then the company said it has been looking for ways to rebuild shareholder value. A merger with OncoGenex was the best way to do that, CEO Michael Martino said in a release.

The combined company has a strong oncology pipeline with three candidates in various stages of clinical development. Its lead candidate, OGX-011 for prostate cancer, is being evaluated in five Phase II clinical trials.

- see the merger release

Merck's osteoporosis drug performs in Phase II

Wed, 28 May 2008 06:59:56 -0400

Merck's experimental osteoporosis drug odanacatib turned in positive results in a Phase II trial. The drug reduced measures of bone turnover (breakdown and rebuilding of bone) in women with breast cancer that has spread to the bones. Odanacatib beat out Novartis's med Zometam in the trial.

Odanacatib inhibits cathepsin K enzyme, which plays a key role in breaking down the protein in bone. By inhibiting cathepsin K activity, odanacatib could offer a different approach for treating metastatic bone disease.

"Based on these findings, larger Phase III studies using the 5 mg daily dose of odanacatib are being planned for patients with breast and prostate cancer," said Antonio Lombardi, M.D., senior director, Merck Research Laboratories.

- check out Merck's release for more
- read the BusinessWeek article

Optimistic Dendreon revs up second program

Wed, 16 Apr 2008 06:59:57 -0400

Dendreon is making bullish noises about its development efforts. The CMO of the Seattle biotech says that Provenge will deliver positive new data to the FDA on the delayed cancer therapy Provenge later this year. And that advance is allowing Dendreon to free up some money so researchers can get back to its number two program: Neuvenge for breast cancer, which has already gone through two early-stage trials.

Dendreon presented new data on Neuvenge at AACR. The Post-Intelligencer reports that two of 11 patients with breast cancer whose disease had spread had their tumors stabilize after being on the Dendreon treatment for 49 weeks and 72 weeks, respectively. Researchers at the University of California-San Francisco and Mayo Clinic in Rochester, MN., didn't see any cases of tumor shrinkage.

Neuvenge is an offshoot of the prostate cancer drug Provenge, which reengineers patients' white blood cells to kill cancer cells. Earlier this month Dendreon announced that it had raised $47 million from an unnamed institutional investor. The unnamed investor, the Post-Intelligencer reports, is Susquehanna International Group.

- read the article in the Seattle Post-Intelligencer
- here's the earlier P-I story on the financing deal

Related Articles:
FDA accelerates Provenge timeline. Provenge report
FDA's stand on Provenge riles cancer patients. Provenge Report
Provenge delay triggers furor among cancer victims. Dendreon report
Dendreon gets approvable letter for Provenge. Dendreon report

ALSO NOTED: FDA approves Orencia; Delay on Amgen clotting drug decision; Icahn files suit for Biogen Idec papers; and much more

Wed, 09 Apr 2008 06:59:50 -0400

> The FDA has approved Bristol-Myers Squibb's Orencia for juvenile arthritis. Release

> Amgen says that the FDA will delay a decision on its blood clotting drug by three months. A decision had been expected by April 23. Release

> Not satisfied with Biogen Idec's explanation of its failed effort to find a buyer, Carl Icahn has filed suit to get a hold of internal documents on the search. No way, responds Biogen Idec, which says it's just another ploy aimed at forcing a sale. Report

> Antigenics has raised $21 million in a private placement. The money will be used to market Oncophage, a cancer vaccine that just won regulatory approval in Russia. Release

> Potentia Pharmaceuticals has completed a $12 million round of financing. The funds will allow Potentia to complete Phase I and move into Phase II clinical development of Potentia's novel investigational drug candidate, POT-4. Release

> Schering-Plough has officially terminated its partnership with Novacea for its Asentar prostate cancer program. A clinical trial was halted earlier due to an imbalance of deaths between the two treatment arms. Release

> The FDA has rebuked GlaxoSmithKline for failing to regularly report post-marketing Avandia data. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

> The heparin death toll is far worse than we originally thought. The FDA has tripled the number of deaths it's attributing to allergic reactions to the blood thinner since January 2007, to 62 from 19. Report

> Just why would Novartis pay $11 billion for one-fourth of eye-care Alcon company and promise another $28 billion for another big chunk? Report

> Expect the FDA to stay out of the Vytorin fray, at least for now. Report

> In the latter part of the 20th century, the conventional wisdom in the drug industry was simple: bigger is better. But now the Big-Big management model is cracking up. Report

And Finally... It turns out that hundreds of bacteria can actually 'eat' antibiotics, according to researchers at Harvard Medical School. Report

Kosan axes staffers (again), scouts for partners

Wed, 19 Mar 2008 07:59:57 -0400

Kosan Biosciences is laying off more than a third of its 91 workers as the developer concentrates its resources around its lead cancer therapies in a restructuring that has also shuffled its newly appointed president into the CEO's post. Altogether 31 workers are being pink slipped, and Kosan says it may seek out partners among developers looking for early-stage prospects. This isn't the first cutback at Kosan. A year ago the Hayward, CA-based developer slashed 39 jobs and reduced its payroll to 80.

"We believe that this restructuring will strengthen our ability to effectively manage our resources, execute on our development goals and advance our high-value, near-term commercial opportunities," said Helen Kim, the new CEO. Kim joined Kosan as a senior VP in January and was named president last month.

Kosan will circle the wagons around its lead clinical programs: tanespimycin in multiple myeloma and in metastatic breast cancer, and epothilone KOS-1584 in non-small lung cancer.

- read Kosan's release for more
- check out the report from the East Bay Business Journal

Related Article:
Roche drops out of Kosan development deal. Report

Insulin retreats blamed for Generex stock drop

Tue, 11 Mar 2008 07:59:58 -0400

Generex is firmly in the camp that sees the glass as half full. After seeing its share price slide 16 percent yesterday, the developer attributed the sudden setback to decisions by Eli Lilly, Pfizer and Novo Nordisk to pull out of programs to develop other inhaled insulin products.

Worried? No, says Generex, happy to extol its late-stage drug's safety profile. The company says its Oral-lyn insulin doesn't leave a deposit in the lungs. And there's reason for cheer; the departure of the big companies removes some heavyweight competitors, says Generex.

Generex's stock woes followed a recent announcement from Alkermes that Eli Lilly is dropping out of their collaboration on an inhaled insulin therapy. Novo Nordisk and Pfizer have already pulled out of their respective programs. MannKind, meanwhile, reiterated its plans to forge ahead in the field.

- see the statement from Generex
- read the MarketWatch report

Related Articles:
Analyst gives bullish assessment of Generex program. Report
Generex initiates Phase II Trial in breast cancer patients. Report
MannKind bets the farm on inhaled insulin. Report
Pfizer kills off Exubera, hunts for deals. Report
Novo Nordisk shelves inhaled insulin, axes staffers. Report

Experts debate FDA signals on cancer drug approval

Tue, 04 Mar 2008 06:59:55 -0500

When is a cancer therapy good enough? The Boston Globe examines answers to that question following the recent controversy over the FDA's decisions in the field. Most recently, Avastin gained a new approval after it demonstrated an ability to delay the development of breast cancer tumors. But researchers never demonstrated an improvement in symptoms or the drug's ability to extend patients' lives.

"If the goal of any new therapy is to cure metastatic breast cancer, it is going to be a very long time--if ever--before we see it," Dr. Maurie Markman, vice president for clinical research at M.D. Anderson Cancer Center in Houston, tells the Globe.

But where's the real benefit for patients? A number of experts say that research should set out to prove if a therapy actually improves their quality of life. But others are quick to add that that can be a very ambiguous standard.

- read the report in The Boston Globe

Related Articles:
Does Avastin nod lower approvals bar? Report
Genentech awaits Avastin decision. Report
Will FDA care about new Avastin study? Report

ALSO NOTED: Avastin approval may lower FDA bar; GTX shares skyrocket on cancer data; Novartis wins approval; and much more...

Mon, 25 Feb 2008 06:59:50 -0500

> Medicure shares plunged 80 percent this morning after the developer announced that its lead therapy, MC-1 for cardiovascular disease, failed to meet its primary endpoint in a late-stage trial. Company executive say they're disappointed but still hold hopes for the therapy's future. Report

> Some see the FDA's approval of Avastin for breast cancer as a sea change. In this view, the FDA has now lowered the bar for other cancer-drug approvals. That's because Avastin proved effective at stopping tumor growth but not at extending survival time, which has long been the gold standard for cancer treatments. If Avastin got an OK based on disease progression, so might many other cancer hopefuls waiting in the wings. Or so the theory goes. As we say, fortunetelling can be a dicey business. Report

> Shares of GTX shot up this morning after the company announced that late-stage data for toremifene citrate demonstrated its ability to reduce symptoms of prostate cancer. Based on the data, GTX says it will file an NDA by summer. Release

> Novartis has won approval from European regulators of its new combinatorial drug Eucreas for diabetes. Release

> In the latest round of cutbacks at Seattle companies, Rosetta Inpharmatics announced plans to lay off 12 workers. Report

> Actelion has formally withdrawn its application to the EMEA to extend approval of Zavesca. Release

> The NIH has kicked off a big trial pitting Avastin against Genentech sister med Lucentis. Eye docs have commonly used Avastin off-label, saying it's almost as effective as Lucentis, and costs significantly less. Report

> The Bush administration wants to hand the FDA more authority over food and drugs made overseas for U.S. use. But as several reports and audits have concluded recently, the FDA is already overladen with mandates and under-endowed with funding. Report

> Could Big Pharma be held to account for gray market sales of its drugs? Report

And finally… Researchers have identified a gene that plays a key role in baldness. That discovery is likely to generate new therapies for hair growth. Article

Genentech awaits Avastin decision

Fri, 22 Feb 2008 06:59:58 -0500

All eyes are on the FDA today as Genentech waits with baited breath for the agency's decision on Avastin for breast cancer. In December an advisory committee voted 5-4 against the therapy. Avastin in combination with Bristol-Myers Squibb's Taxol delayed tumor growth much longer than Taxol alone. But the bad news was that the Avastin patients didn't live significantly longer, and suffered from more unpleasant side effects. Now it's up to the FDA to decide if slower tumor growth is enough to approve the drug if patients aren't living longer as a result. A positive decision could signify a new way of thinking about cancer treatments. If stopping tumor growth is enough for Avastin, then it could be enough for a host of other treatments currently in development.

Many breast cancer experts are eager to see the drug OK'd despite the committee's negative opinion. The FDA may break with the committee's recommendation, or simply delay it's decision until later this year. Avastin is Genentech's cash cow, bringing in $2.3 billion in sales last year.

- read this AP article for more

Related Articles:
Genentech faces crucial Avastin decision. Report
Will FDA care about new Avastin study? Report
EU blesses Avastin for broader use. Report
FDA: Avastin lackluster in breast cancer. Report

Genentech faces crucial Avastin decision

Tue, 19 Feb 2008 06:59:55 -0500

South San Francisco-based Genentech is nearing a crucial final decision from the FDA on the use of Avastin for breast cancer. An approval, notes the San Francisco Business Times, could boost its revenue by a billion dollars a year. If regulators agree with an advisory committee's recommendation against Avastin, though, the biotech giant stands to lose out big time in the breast cancer market. Genentech currently earns significant revenue from physicians' use of the drug as a therapy for breast cancer--money that is likely to evaporate rapidly with any rejection of its application.

- see this release
- read the story from the San Francisco Business Times

Related Articles:
Genentech's blistering growth starts to cool. Report
Will FDA care about new Avastin study? Report
EU blesses Avastin for broader use. Report
FDA: Avastin lackluster in breast cancer. Report
Avastin re-submitted to FDA. Report

Eisai faces delay for cancer drug

Fri, 01 Feb 2008 06:59:55 -0500

The FDA has delayed Eisai's NDA submission for E7389 (eribulin mesylate) for third-line treatment of advanced breast cancer. The company was hoping to gain accelerated approval for the drug, but can't because Bristol-Myers Squibb won approval for another drug for the same indication last October. The drug is also in Phase II trials for prostate cancer.

- see this release for more

Related Articles:
Eisai expands U.S. ops with $3.9B MGI buyout. Report
Eisai acquires Morphotek in $325M deal. Report
Eisai plans $105M expansion in NC. Report

ALSO NOTED: Big Pharma rethinks animal testing; FDA extends telavancin review; and much more...

Fri, 11 Jan 2008 06:59:50 -0500

> In a move that will please animal rights activists, a number of pharmaceutical companies have determined that they will no longer conduct acute toxicity tests. They say that new technology has rendered these animal tests redundant, slowing down the drug development process. Report

> The FDA is calling for more reviews of Theravance's telavancin. Report

> Merck's good news? It looks as if enough plaintiffs will sign on to the $4.85 billion Vioxx settlement. Merck's bad news? Some plaintiffs are opting out, and some lawyers are challenging settlement provisions designed to prevent that. Report

> Just how did Merck and Schering-Plough get themselves into hot water with the ENHANCE trial, which compared Zetia and Vytorin to a generic cholesterol drug? Maybe by excluding their lead investigator from key discussions. Report

> Here's more evidence that the developing world is hot, hot, hot. Teva Pharmaceutical Industries plans to invest a whopping $1 billion in India. The generics giant will spend between a quarter and a third of that on new manufacturing plants. The rest will go into acquisitions. Report

> Will Florida join other states suing makers of atypical antipsychotics? Report

And Finally... Researchers have identified small pieces of ribonucleic acid that suppress the spread of breast cancer to the lungs and bone. Release

ALSO NOTED: Anemia drugs back in the spotlight; Biodel completes VIAject enrollment; and much more...

Fri, 04 Jan 2008 06:59:50 -0500

> The FDA has revealed two new studies that show cancer patients may be more likely to die while using Amgen's blockbuster drugs Aranesp and Epogen (also sold under the brand name Procrit by Johnson & Johnson). Report

> Biodel has completed enrollment of its two Phase III clinical trials of VIAject, an injectable meal-time insulin for use by patients with Type 1 and Type 2 diabetes. Release

> Chutes & Ladders: Pharmos has made a number of changes to its board of directors and management. Release

> Chutes & Ladders: ViroPharma has appointed Thomas F. Doyle as vice president, strategic initiatives. J. Peter Wolf has been promoted to vice president, general counsel and secretary of the Board of Directors. Release

> So far, personalized medicine isn't perfectly personalized. New data shows that diagnostic tests to determine whether women should take certain breast cancer drugs have a failure rate of up to one-quarter. Report

> At a Morgan Stanley pharma conference yesterday, Schering-Plough CEO Fred Hassan was quizzed and requizzed by investors about the Vytorin-Zetia controversy. Report

> It's increasingly apparent that some of our most-lauded new oncology agents carry pretty serious baggage: they can cause heart attacks. Report

And Finally... The pharmaceutical industry spends twice as much on marketing and promotion of drugs as it does on R&D. Report

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

Denosumab: Amgen's salvation?

Fri, 14 Dec 2007 06:59:54 -0500

2007 has been a rough year for Amgen. The world's largest biotech stumbled as it dealt with fallout from the anemia drug controversy. Safety concerns about the drug led to an FDA warning and caused sales of Amgen's most profitable drug to plummet. Analysts looked at the aging biotech and wondered if Amgen's glory days were over.

Now Amgen is looking to take a bite out of the $7 billion osteoporosis market with denosumab, a fully-human monoclonal antibody currently in Phase III testing. The drug is undergoing trials for bone loss induced by hormone ablation therapy for breast cancer or prostate cancer, prevention of cancer-related bone damage, postmenopausal osteoporosis, and prevention of bone metastases.

According to one analysts, denosumab "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." That would go a long way in turning around the company's fortunes. And denosumab is even more important to the company, as it's the only potential blockbuster nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.

- see this WSJ article for more

ALSO: Take a look at Amgen's pipeline. Report

Related Articles:
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report
Top 10 drug warnings and recalls of 2007. Report

ALSO NOTED: Pantec raises $5.67 for drug delivery work; Medarex gets milestone payment; and much more...

Fri, 07 Dec 2007 06:59:50 -0500

> You can take your $4 million and keep it. David Stout (photo), GlaxoSmithKline's president of pharmaceutical operations, evidently wants no part of the reported $4 million incentive package he was offered after being passed up for the top job. Report

> Pantec Biosolutions, a drug delivery company specializing in laser micro-poration technology for the transdermal delivery of large molecular weight drugs, has announced the successful initiation of its Series A equity investment round raising $5.67 million. Report

> Florida-based Catalyst Pharmaceutical is reporting positive Phase II results for vigabatrin for the treatment of cocaine addiction. Catalyst's lead compound, CPP-109, is bioequivalent to vigabatrin. Release

> Medarex will receive an undisclosed milestone payment from J&J's Centocor for the FDA submission of ustekinumab (CNTO 1275). Ustekinumab is an experimental drug for chronic moderate to severe plaque psoriasis. Release

> Cancer specialist and FDA advisory panel member Aman Buzdar cast one of the 'no' votes against Genentech's Avastin, which failed to measure up in extending survival times of breast cancer patients. Report

> Medicare took a look at what they say hospitals have been paying for the new biologics that treat non-Hodkin's lymphoma and decided to slash what it will pay for Bexxar and Zevalin to $16,000 per treatment. That may sound like a lot, but it's only slightly more than half of the companies' sticker price. Report

> A group of IT and pharma-related companies has begun lobbying for changes in the rules around controlled drugs which would allow physicians to prescribe them electronically. Report

And Finally... The next cancer-fighting therapeutic could be growing in your garden. Release