Avastin

Roche CEO: Emphasizing drugs for primary care

John Carroll — Wed, 02 Jul 2008 09:43:34 -0400

The new CEO at Roche is sending out some strong signals that the pharma giant's development process will include more new therapies for primary care. Roche is a big player in the field of hospital-based meds. But Severin Schwan (photo) is also emphasizing more experimental therapies that are bound for use by general practitioners to fight common diseases like diabetes.

"I do wonder whether the pharma model is really broken," Schwan tells the Financial Times in a wide-ranging interview. "I fundamentally believe if you are able to come up with innovative medicines including diagnostics, there will be demand."

Faced with a negative reaction to Avastin from regulators in the U.K., Schwan also noted that the best response was not to cut prices on therapies, but rather develop the kind of clinical data that would justify the use of a drug in a broader patient population.

- check out the story from the Financial Times

ALSO NOTED: Genta places notes;Vaccine research blasts off; and much more...

Fri, 06 Jun 2008 06:59:50 -0400

> Genta announced that it has struck definitive agreements with investors to place senior secured convertible notes due in 2010 totaling in aggregate up to $40 million in gross proceeds before fees and expenses. Release

> A Lehman Brothers analyst is bullish on Regeneron's cancer drug aflibercept, saying it compares well to Avastin. That opinion came after investors shaved 20 percent off the value of Regeneron shares after seeing disappointing data for ovarian cancer. Report

> The biotech start-up Iatrica is moving into new space at the John G. Rangos Building in East Baltimore. The building opened in April. Story

> Sangamo BioSciences has completed patient enrollment into its Phase II clinical trial in subjects with moderate to severe diabetic neuropathy. Release

> Topical applications of a naturally occurring fat molecule have the potential to slow down skin aging, whether through natural causes or damage, researchers report. Release

And Finally... Vaccine research is heading to outer space. Report

SPOTLIGHT: Avastin leaves ASCO ahead of Erbitux

Tue, 03 Jun 2008 06:59:53 -0400

Shares of Genentech have been buoyed by news from ASCO that Avastin will likely be preferred to Erbitux for treating lung cancer. Avastin offers an extra month of average survival time compared to Erbitux. Report

Kennedy's surgery may be followed by experimental therapy

Mon, 02 Jun 2008 06:59:58 -0400

Legendary Duke neurosurgeon Dr. Allan Friedman is scheduled to remove Senator Ted Kennedy's brain tumor this morning, and there's already significant speculation that the lawmaker will undergo experimental therapy in a follow-up treatment. According to a statement, the Duke neurosurgeon will surgically remove the tumor and the senator will undergo radiation and chemotherapy to combat the glioblastoma. About half of all glioblastoma patients die within a year of surgery. Median survival time is 12 to 15 months.

Kennedy, though, is in the hands of the countries best neuro-oncologists. In addition to the chemo drug Temodar, Kennedy may be treated with Avastin. While approved for other cancers, using Avastin to starve the tumor of blood is still only in the experimental stage for brain tumors.

- read the AP report

A deluge of pre-ASCO data hits the market

Fri, 16 May 2008 06:59:57 -0400

As we mentioned earlier this week, data from almost 5,000 clinical studies was released last night in preparation for next week's ASCO meeting. And some of the most interesting data won't be released until the conference. In the meantime, here's a sampling of the trial results that are making waves today.

Kidney cancer patients taking Novartis' RAD001 (everolimus) had progression of their disease delayed by a year, a significantly better result than in those taking placebo. Release
Amgen's brain tumor drug AMG-102 may only work on a subset of patients. The data is from a small Phase II study of the drug. On a better note, Amgen said denosumab cut the risk of bone fractures in cancer patients, outperforming Novartis' Zometa in an early stage trial. Release
A Phase III trial of Avastin for early-stage colon cancer will be available sooner than previously thought, said Genentech, because of faster data collection and more patients with the disease. Data will be available in 2008--a full year earlier than previously planned. Release
BioVex said data from a Phase II trial of OncoVEX demonstrated an impressive rate and durability of response in patients with advanced metastatic melanoma. Release
Nektar Therapeutics announced results form a Phase I study of NKTR-102. The data shows significant anti-tumor activity in patients with refractory solid tumors. Release

Antisoma buys Xanthus for $52M

Fri, 16 May 2008 06:59:56 -0400

Looking to boost its pipeline, the U.K.'s Antisoma is paying $52 million for Boston oncology company Xanthus Pharmaceutical. Antisoma gains three drug candidates:

Xanafide, which is in Phase III trial in secondary acute myeloid leukemia,
Oral fludarabine, which has been submitted to the FDA for marketing approval for the second-line treatment of chronic lymphocytic leukemia, and
the Flt3 program, which is in preclinical testing for non-oncology indications. Antisoma says it may out-license this drug.

The deal lessens Antisoma's dependence on ASA404, a non-small cell lung cancer treatment. Last year the company announced it would pit the drug against Roche and Genentech's Avastin in a late-stage trial. Glyn Edwards, CEO of Antisoma, said: "This is a transforming deal. Combining Antisoma and Xanthus produces a company with the critical mass and mature pipeline needed to become a major player in oncology."

- here's the release on the deal
- read the MarketWatch article for more

ALSO NOTED: Ambrilia touts data; Amarin raises $60M; and much more...

Wed, 14 May 2008 06:59:50 -0400

> Ambrilia Biopharma reported positive 24-week Phase III top-line results for prolonged-release formulation of Octreotide. Release

> Amarin is raising $60 million through a stock placement. Release

> Acorda Therapeutics CEO Ron Cohen has exercised stock options for 31,432 shares. Report

> A federal proposal requiring drug and device makers to disclose payments to doctors got a boost yesterday when Eli Lilly became the first Big Pharma to back it. Lilly report

> In an interesting twist on the usual generics news, it's the copycat makers who are predicted to suffer as competitors undercut their products. The source of this competition? None other than China. Generics report

> The NIH's Avastin/Lucentis trial could fundamentally reshape relations between payers and pharma, according to IMS Health. Report

> After weeks of pressure from Congress to request more money for the agency--and weeks of refusals to specify a figure for beefing up FDA's safety operations-FDA commissioner Andrew von Eschenbach has asked lawmakers for $275 million. FDA report

And Finally... South Korean officials have wiped out the poultry population of Seoul in an effort to combat the spread of the avian flu virus. Report

Avastin, Erbitux battle for lung cancer market

Mon, 21 Apr 2008 06:59:54 -0400

Genentech's stock was down this morning on results from a Phase III study of Avastin for non-small cell lung cancer. While the drug did meet the primary endpoint--an improvement in progression-free survival--it missed the secondary endpoint of prolonging overall survival.

Meanwhile, ImClone and European partner Merck KGaA are getting ready to announce results from a trial of Erbitux that shows the drug succeeded where Avastin did not. Erbitux successfully prolonged survival in lung cancer patients, but the specifics are being kept under wraps until the annual ASCO meeting in June. TheStreet observes that while the Avastin results won't cause doctors to stop using the drug, they may back off on the higher doses, which could shrink Genentech's revenue.

- see this release on the trial
- read TheStreet report for more on Erbitux

Related Articles:
Erbitux clears late-stage hurdle for lung cancer. Erbitux report
FDA approves Avastin for lung cancer. Avastin 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

AstraZeneca's Recentin fails lung cancer trial

Wed, 27 Feb 2008 06:59:58 -0500

AstraZeneca says it will push ahead with late-stage studies of Recentin for colorectal cancer after shelving plans for a Phase III in non-small cell lung cancer due to toxicity concerns. The announcement represents a major blow to AstraZeneca, which stood to benefit from a much bigger market for lung cancer than colorectal cancer, where it could end up in a face-off with Avastin. AstraZeneca's possible earnings for Recentin in lung cancer had been estimated at a potential billion dollars. Now AstraZeneca, which has been plagued by trial failures, faces an uphill struggle in late-stage trials proving Recentin works better than Avastin.

"Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III," said the company about the lung cancer trial.

- check out the release
- read the report from ShareCast

Related Articles:
AstraZeneca may shake up R&D with spin-off. Report
AstraZeneca drops the axe in global R&D shakeup. Report
Big Pharma brings home the cash, slices payroll. Report
AstraZeneca lays out road map for recovery. Report
AstraZeneca touts biologics pipeline. 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

Genentech's blistering growth starts to cool

Tue, 15 Jan 2008 06:59:54 -0500

For several years now, Genentech has been the belle of the biotech ball. But with sales of Avastin and Rituxan weakening, some of the glow is being lost. Profits were up 32 percent last year, far off the 74 percent pace hit in the previous two years. The analysts are forecasting a more ho-hum profit pace of 15 percent to 20 percent for several years--the kind of growth most companies would die for.

"We think Genentech's best growth days are behind it, as sales of its major products are reaching plateaus, especially Avastin, which continues to be viewed among investors as a high-growth product," says Friedman Billings Ramsey analyst Jim Reddoch.

- check out the AP report for more

Related Articles:
Genentech touts pipeline prospects as doubts fester. Report
Genentech fights to keep edge in drug development. Report
Genentech hiring researchers in big R&D push. Report
Genentech shifts its focus to immunology. Report

ALSO NOTED: FDA nixes Avastin for breast cancer; P&G reveals Phase II UC data;and much more...

Thu, 06 Dec 2007 06:59:50 -0500

> Avastin got the big thumbs-down from an FDA advisory panel yesterday. The Genentech drug, approved for use against colon and lung cancer, was up for consideration as a breast-cancer therapy, but expert panelists weren't impressed with the data. Report

> Procter & Gamble is touting two Phase III studies of Asacol, an ulcerative colitis treatment. Asacol was effective and well-tolerated treatment for patients with inflammation of the lining of the colon and rectum, including isolated proctitis. Patients with isolated proctitis who took Asacol, experienced significant improvement of UC symptoms as early as three weeks, and sustained improvement at six weeks. Release

> What's the biggest risk of relying on Chinese drug manufacturers? Ask any five people on the street, and you'd likely get "contamination" as your answer five times. But experts are increasingly worried that China's explosive growth in drug and active-ingredient manufacturing presents a national-security risk. Report

> Eli Lilly is prediction a big year in 2008, with 14 percent growth in net profits and seven billion-dollar-plus products. Report

And Finally... It's not fat but fitness that predicts longevity in adults over the age of 60. Report

Antisoma shares tank on bold new trial strategy

Tue, 20 Nov 2007 06:59:58 -0500

Shares of Antisoma took a dive this morning after researchers announced that they would pit ASA404 against Roche and Genentech's Avastin in a late-stage trial. And investors were further unnerved by the announcement that AS1411 will not begin a mid-stage study early next year, as had been planned. Antisoma shares slid 13 percent on the news, with analysts fretting over the decision to pit the cancer therapy against Avastin. Originally, Antisoma and its partner Novartis had planned to only go after squamous cancers, leaving Avastin's non-squamous patients out of the mix. By switching strategies and going after both cancers, investors appeared worried that researchers would find it difficult to attract enough patients away from Avastin to complete the trial in a timely fashion. On the up side, a successful pivotal trial for squamous and non-squamous cancers would double the potential market for the drug.

- see this release
- check out the MarketWatch report on the trial strategy fallout

Related Articles:
Top 5 deals of the first half of 2007--Novartis and Antisoma. Report
Antisoma shares spike on positive cancer data. Report
Novartis inks $890M cancer therapy deal. Report
Antisoma trial delivers positive returns. Report

ALSO NOTED: Avastin delivers promising data for brain cancer; Genelabs regains development rights; and much more...

Mon, 19 Nov 2007 06:59:50 -0500

> A mid-stage study of Avastin shows promising results in treating a form of brain cancer. Release

> Genelabs Technologies says it's regained development rights to the experimental lupus drug Prestara from Mitsubishi Tanabe Pharma. Release

> Keryx Biopharma has presented early results from a mid-stage study of perifosine or KRX-0401 in patients with recurrent malignant gliomas. Release

> Here's some somber news: The FDA has tallied more than 200 reports of deaths linked to Trasylol, the suspended blood-clotting drug made by Bayer. Report

> Pfizer whistleblower Dr. Peter Rost (photo) will get his day in court. The U.S. Court of Appeals has overruled an earlier ruling, reinstating Rost's suit against the company. Report

> Poor Puerto Rico. Pharmaceuticals firms are shutting down plants in the U.S. territory, eliminating some 3,000 jobs. Report

> It looks like a drug, it acts like a drug, but if comes in a cosmetics tube instead of an eyedropper, is it still a drug? Lumigan, a glaucoma remedy sold by Allergan, has the unusual added benefit of promoting eyelash growth. Report

And Finally… The melatonin supplements that many people take to fight jet lag could have a down side inhibiting memory formation. Release

ALSO NOTED: Lilly grabs rights to pain therapy; Study outlines billions in potential R&D savings; Takeda shares hit by FDA move

Tue, 30 Oct 2007 07:59:50 -0400

> Eli Lilly has agreed to pay India's Glenmark Pharmceuticals $45 million up front and up to $215 million in scheduled milestones for the North American, European and Japanese rights to the experimental pain therapy GRC 6211. Another $90 million is up for grabs for other approved uses of the therapy. Release

> A new study outlines how biotech and pharma companies could potentially save billions in R&D expenses. Report

> Shares of Sepracor surged more than 17 percent on the news that it would cut some 300 positions. Release

> Yesterday's news that the FDA wanted Takeda to halt high dosage studies of a key cholesterol-lowering drug took a 12 percent bite out of its stock value. Report

> The diagnostics company Genoptix prices its IPO shares at $17 apiece. Report

> Living Cell Technologies has raised $6.4 million of additional capital. Report

> On second thought, maybe Genentech won't restrict supplies of Avastin. This turnabout announcement comes after the company met with eye specialists who were hopping mad that patients might be forced to buy Lucentis at $2,000 per dose versus Avastin at $40. Report

> Chinese regulators have arrested 774 people over the last two months for violations of food and drug safety rules. They've also destroyed 1,000 tons of counterfeit products and instituted a new quality standard for pharmaceuticals licensing. Report

> An $80 million Emerging Technologies and Innovation Center planned for UMass Lowell will concentrate on nano- and bio-manufacturing research and is expected to play a role in moving life sciences companies from R&D into production. Report

> Pfizer vice chairman David Shedlarz could walk away with $43 million in benefits and deferred compensation when he retires later this year. Release | Report

And Finally... Researchers have completed an animal study that suggests placing mice on a buzzing platform for 15 minutes a day caused them to lose a significant amount of weight while improving bone structure. 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

Genentech to curb Avastin sales

Fri, 12 Oct 2007 06:59:54 -0400

Genentech will no longer sell Avastin to certain pharmacies that are repackaging the drug and selling it to consumers as a low-cost alternative to Lucentis, the company's wet macular degeneration drug. Compounding pharmacies, as they are known, are dividing doses of Avastin into smaller amounts that can be injected in the eye, creating a $50 alternative to Genentech's $2000-a-month Lucentis treatment. Avastin is chemically similar to Lucentis but is not approved to treat wet AMD.

Genentech notes that there is the risk of microbial contamination when compounding pharmacies divide up Avastin doses. Additionally--and perhaps more importantly for Genentech--off-label Avastin use is cannibalizing Lucentis' sales. U.S. Avastin sales totaled $1.1 billion in the first six months of this year, while Lucentis sales were $420 million. About 200,000 people are diagnosed with wet AMD each year, which could mean big buck for Genentech.

- read the WSJ article for more

Related Articles:
Doctors balancing effects, costs of Lucentis and Avastin. Report
Lucentis gets the green light from regulators. Report
Genentech's Lucentis improves vision in trial. Report