lung cancer

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

SPOTLIGHT: Antisoma gets $25M milestone from Novartis

Thu, 29 May 2008 06:59:53 -0400

Antisoma has received a $25 million milestone payment from Novartis, triggered by the recent initiation of a phase III trial of ASA404 in non-small cell lung cancer. 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

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

ALSO NOTED: Arqule hires new CEO; Kosan launches mid-stage study; and much more...

Tue, 15 Apr 2008 06:59:50 -0400

> Is the U.S. drug industry bargain-basement land right now? Analysts say that the low, low dollar means low, low prices for pharma companies. Rivals in Asia and the Eurozone could snap up drug companies just like they've bought up Manhattan condos. Report

> Chutes & Ladders: Arqule has hired Paolo Pucci, currently president of the Bayer-Schering Pharmaceuticals Global Oncology/Specialized Therapeutics divisions, as its new CEO. Pucci is taking over in June, following Stephen Hill, who was named the new CEO of Solvay. Report

> Kosan Biosciences has launched a mid-stage study of an experimental therapy for non-small cell lung cancer. Release

> Innogenetics has completed a $9.5 million settlement and licensing agreement with U.S. group Abbott Laboratories, ending a lawsuit. Story

> Medivir has entered into a co-promotions deal with GlaxoSmithKline for the Swedish market. Release

> AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. Report

> Remember that drug-safety database Congress required the FDA to set up? Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth. Report

> A few prominent research doctors are saying "No, thanks," to any payments from drug and device companies. Report

> The FDA's China office is slated to open next month. Report

And Finally... Contrary to what most of us would like to believe, decision-making may be a process handled to a large extent by unconscious mental activity. Release

ALSO NOTED: Antisoma gets $25M milestone; Takeda pays out retention bonuses; and much more...

Fri, 11 Apr 2008 06:59:50 -0400

> Novartis has kicked off a late-stage trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer, triggering a $25 million milestone payment to Antisoma. Release

> Following the $8.8 billion acquisition of Millennium, Takeda will fork over retention bonuses to Millennium employees to prevent them from jumping ship. Report

> Health experts say that an outbreak of mumps two years ago among college students occurred even though most of them had received a recommended vaccine. Report

> Shares of Crucell jumped after the developer announced that an early-stage trial of an experimental tuberculosis vaccine demonstrated a promising immune response in volunteers. Report

> An outbreak of dengue fever in and around Rio de Janeiro has afflicted more than 75,000 people since the beginning of the year, with 12 people dying in just the past week. Report

> The transplant drug probe is widening. FDA says it's identified 16 cases of an often-fatal neurological disease among patients taking Roche's CellCept drug, used to prevent organ rejection. Report

> Pharma knows that self-regulation is the best kind. That's why 12 drug and device makers have promised Sen. Chuck Grassley that they are working on plans to disclose CME grants. Report

> When Jean-Pierre Garnier makes his exit from GlaxoSmithKline next month, he'll walk away with the promise of a $4.9 billion options bonus that will pay off sometime in 2010. Report

And Finally... If you want to market your drug to patients, a new study shows the Web is not the place to do it. Report

Inhaled insulin lung cancer warning riles investors

Wed, 09 Apr 2008 06:59:58 -0400

The inhaled insulin field got blitzed again today after Nektar Therapeutics and Pfizer reported an increased number of lung cancer cases among patients taking the therapy during clinical trials. Nektar swiftly dumped its effort to find a new marketing partner--Pfizer had already announced its plans to pull out--and saw its stock plunge 30 percent. Even harder hit was Mannkind, which is developing its own inhaled insulin. Its stock went into free fall, losing 60 percent of its value as investors applied some dour logic from Nektar's failure to the whole area of drug development. Looking over trial data, researchers noted that six of 4,740 patients taking Exubera developed lung cancer compared to one in the control arm. Those figures were too small to reach a statistically valid conclusion whether the drug caused the cancer, and all patients were known smokers and therefore already in a high risk category. A warning on the cancer risk will be put on Exubera labels.

The cancer warning creates yet another black eye for the prospects of inhaled insulin. Once upon a time inhaled insulin was seen as a likely garden of blockbuster therapies. But that has turned around fast, as major drug developers wash their hands of pacts and go on to other programs. Exubera was once thought to be worth more than $2 billion a year, but sales have fallen far, far short of that mark.

"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Joe Feczko, MD, Pfizer's chief medical officer.

- see Nektar's release
- read the report in the Wall Street Journal

Related Articles:
Pfizer gives Nektar $135M for Exubera settlement
Pfizer kills off Exubera, hunts for deals
Exubera becoming a big disappointment for Pfizer
UK: Exubera not worth the price.
MannKind bets the farm on inhaled insulin

ALSO NOTED: Takeda, Abbott split TAP; Alseres raises funds; investigators close in on another case of drug counterfeiting;and m

Thu, 20 Mar 2008 07:59:50 -0400

> As expected, Takeda is paying Abbott $1.5 billion to disband a joint venture launched 30 years ago. In the deal to break up TAP, Abbott will keep the cancer drug Lupron and 300 sales people. Takeda will keep Prevacid and two experimental therapies along with 5,000 staffers. Release

> Alseres Pharmaceuticals has raised $5 million. Release

> Nereus Pharmaceuticals says that enrollment has begun in a Phase Ib study evaluating the vascular disrupting agent NPI-2358 in combination with standard chemotherapy in patients with non-small cell lung cancer. Release

> A Vietnamese company is beginning a human trial of a new bird flu vaccine. Report

> Hong Kong officials were quick to make sure that the recent deaths of several children in an influenza epidemic had no link to bird flu. And the city has moved aggressively to stop the spread of the flu as well as the fear it has inspired. Report

> A professor at the University of Toronto is warning that researchers may find it increasingly difficult to enlist volunteers for new trials exploring the safety and efficacy of experimental AIDS vaccines. Volunteers opted out of Merck's international STEP program because they feared that they would test positive for HIV because of the antibodies produced by the vaccine. Report

And Finally...The fevered search to find the cause to the fatal reactions to heparin is closing in fast around another case of drug counterfeiting in China. Article

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

SPOTLIGHT: Cancer drug flunks Phase III

Tue, 18 Mar 2008 07:59:53 -0400

BioNumerik Pharmaceuticals and ASKA Pharmaceutical said that a late-stage trial of Tavocept failed to produce a statistically significant response in patients with advanced non-small cell lung cancer. Researchers say that the small number of patients in the trial was probably responsible for the failure, though it highlighted the fact that researchers observed a 50 percent decrease in severe sporadic or cumulative neuropathy. "A surprising and medically important observation from the trial was an observed increase in the median survival time for patients receiving Tavocept as compared to those receiving placebo." Release

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: North Carolina steps up biotech funding; Petra Group plots start-up; ProMetic in development deal; and much more...

Tue, 26 Feb 2008 06:59:50 -0500

> North Carolina lawmakers have boosted their support of the biotech field, adding $83 million to support research, training and manufacturing initiatives. Report

> The Petra Group in Kuala Lumpur is in talks to create a new biotech company devoted to biophotonics with the University of St. Andrews. Report

> Dr. Giuseppe Giaccone has presented the final results from a positive double-blind, placebo-controlled Phase II trial with talactoferrin alfa in non-small cell lung cancer. This was the second successful, randomized, double-blind, placebo-controlled trial with oral talactoferrin in NSCLC. The first was with talactoferrin in combination with first-line chemotherapy. Release

> ProMetic Life Sciences will garner $2 million over the next 12 months in upfront fees and milestones after inking a deal with Kedrion to develop two hyperimmunes. Release

> Lotus Pharmaceuticals has raised $5 million in a private placement. Release

> In a study that may change the way that cancer drugs are developed and prescribed, scientists have determined that genetic mutations are different in every cancer patient, suggesting that drugs will need to be "tailored" for small groups. Report

> The International Stem Cell Forum is meeting in San Francisco, bringing together 21 stem cell research institutes and representatives from 19 countries to review such issues as the moral and ethical guidelines needed for research and the registry of ESCs lines. Report

> High rainfall, biodiversity and rapidly growing populations are considered breeding grounds for new outbreaks of diseases like SARS and Ebola. Report

And Finally… Patients most likely to benefit from genetic testing are either avoiding it altogether or paying for it themselves to keep hereditary disease out of their health records--and most importantly, off the books of their insurers. Report

Onyx shares tumble after Nexavar failure

Thu, 21 Feb 2008 06:59:55 -0500

The Motley Fool has been counting the casualties since Onyx and Bayer halted their trial for Nexavar as a therapy for non-small cell lung cancer. Onyx's stock has shed 31 percent of its value since Monday, with more losses yesterday. Nexavar has now proven itself for liver and kidney cancers with disappointing results for skin and lung cancer, taking some of the luster off of the prospects of the one-time wonder drug. There are still distinct possibilities for the therapy in lung cancer, though. A number of analysts have noted that Nexavar appears to be particularly unsuccessful in cases involving squamous cell cancer and future trials could exclude that group. Meanwhile, companies like OSI and AstraZeneca, which sell therapies for lung cancer, are being benefited by the latest news on Nexavar.

- read the report from MSNBC
- and here's the report from Thomson Financial

Related Articles:
Nexavar failure raises questions for developers. Report
Bayer stops Nexavar lung cancer trial. Report
Nexavar OK'd for use against liver cancer. Report
Bayer, Onyx tout Nexavar data. Report
Bayer, Onyx announce disappointing Nexavar results. Report

Nexavar failure raises questions for developers

Tue, 19 Feb 2008 06:59:57 -0500

Shares of Onyx Pharmaceuticals tanked on disappointing data from its latest cancer trial of Nexavar as a therapy for non-small cell lung cancer. With no hope of seeing data that patients lives were being extended, researchers shuttered a study of the drug. Forbes' Matthew Herper is raising a series of questions about the drug and the field. Should patients with squamous cell cancer have been excluded from the trial? Will the monitoring boards of two other lung cancer studies meet to review the consequences of this recent move? Should studies be modified to have a better chance of demonstrating a benefit to patients? Look for some answers as Onyx and Bayer, partners on the drug, address some severely disappointed investors.

TheStreet notes that Onyx has been the feel-good biotech story of 2007, seeing its stock rise a record 440 percent last year.

- see the release from Bayer
- check out the report from Forbes
- and here's the article from TheStreet

Related Articles:
Bayer stops Nexavar lung cancer trial. Report
Nexavar OK'd for use against liver cancer. Report
Bayer, Onyx tout Nexavar data. Report
Bayer, Onyx announce disappointing Nexavar results. Report

Dara BioSciences goes public in reverse merger

Wed, 13 Feb 2008 06:59:55 -0500

Dara BioSciences has completed a reverse merger with the nearly-defunct Point Therapeutics, taking the company public. In the deal Dara technically became a subsidiary of Point as a preliminary move to changing the combined company's name to Dara BioSciences. Point Therapeutics jettisoned its executive staff and all but two full-time employees after it shuttered a late-stage trial of talabostat for non-small cell lung cancer. Dara's shareholders control 96.4 percent of the combined company's stock.

- see this release
- read the report from MassHighTech

Related Articles:
DARA owners acquire troubled Point Therapeutics. Report
Dara licenses Bayer drugs. Report
More cuts at troubled Point Therapeutics. Report

Mixed data from two Threshold cancer trials

Fri, 18 Jan 2008 06:59:55 -0500

California-based Threshold Pharmaceuticals has released an update on its glufosfamide program. According to the company's release, a Phase II trial of the drug for soft tissue sarcoma "provided evidence of clinical activity." Threshold will continue trials of the drug for this indication, but said that dosing will have to be adjusted in later studies. The news was not so good from the ovarian cancer trial. The company has decided to drop glufosfamide due to a lack of efficacy and enrollment challenges.

In October, Threshold cut its staff and expenses after reporting disappointing data from Phase II trial of glufosfamide for small cell lung cancer. The drug is also undergoing Phase III trials for pancreatic cancer, and is in Phase I trials for the treatment of solid tumors.

- see this release from Threshold for more

Related Articles:
Threshold slashes staff in effort to cut burn rate. Report
Threshold halts lung cancer study. Report
Threshold delays release of glufosfamide analysis. Report
Threshold slashes staff in wake of quarterly loss. Report
Threshold shares drop after Phase III suspension. Report

ALSO NOTED: Agennix OK'd to launch late-stage lung cancer trial; QLT reorganizes; Ventana still resisting Roche bid; and much m

Thu, 17 Jan 2008 06:59:50 -0500

> Houston-based Agennix has been given a green light to launch a late-stage trial of a new therapy for lung cancer that includes an ingredient found in mother's milk. Talactoferrin closely resembles human lactoferrin, which establishes a baby's immune system. Report

> QLT is laying off more than a hundred workers and selling its QLT USA division and its Vancouver HQ is it undertakes a restructuring that will leave it focused on marketing Visudyne. Report

> Roche has extended its offer for Ventana Medical Systems, but Ventana is still urging shareholders not to tender their shares. Report

> Targacept has priced an offering of 3.8 million shares at $7.07 apiece. Report

> Eisai's takeover of MGI Pharma has been approved by federal regulators. Report

> RNCOS estimates that the global vaccines market should hit $21 billion by 2010. Report

> Doctors overprescribe brand-name meds, and it's pharma's fault. Or so says a new report from the UK's Committee of Public Accounts. Report

> Did Schering-Plough execs peek at the Vytorin trial data and, spooked, bail out of millions worth of stock? Report

And Finally… In what may become the most far-reaching effects of the failed Vytorin trial, experts are questioning the sacred link between cholesterol and heart disease. 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

Celgene goes global with $2.9B Pharmion buyout

Mon, 19 Nov 2007 06:59:58 -0500

Celgene took a big stride toward its goal of becoming a global marketer of blood cancer therapies with the news over the weekend that it is buying Pharmion for $2.9 billion. That buyout amount is 11 times Pharmion's annual revenue and a 46 percent premium for its shares. Pharmion sells Vidaza and Thalomid and has extensive operations in Europe, where Celgene has been particularly interested in expanding. Celgene owns Thalomid and sells the multiple myeloma drug in the U.S. Celgene's lead therapy is Revlimid. The buyout also covers a late-stage therapy for small-cell lung cancer and the mid-stage oncology drug MGCD0103.

"The rationale for the deal is fairly clear," says Celgene CEO Sol Barer. "It's another important step as we evolve to become what we want to become: a global leader in hematology and cancer." Celgene is the seventh largest biotech by sales volume. The deal is expected to close next summer.

- see this release
- read the report on the buyout from TheStreet.com
- and here's the article from Forbes

Related Articles:
Array partners with Celgene, nets $40M upfront. Report
Celgene accelerates program on positive psoriasis data. Report
Pharmion nets cancer therapy in Cabrellis buyout. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

ALSO NOTED: Antigenics releases positive cancer results; NovaBay raises $24M; Bionovo wraps stock offering; and much more...

Fri, 26 Oct 2007 06:59:50 -0400

> Antigenics says that a Phase I/II trial of cancer vaccine Oncophage delivered positive results, with 11 out of 12 patients exceeding median benchmarks on survival from time of recurrence. Researchers also said that all patients demonstrated an immune response. The company launched a Phase II trial of Oncophage earlier this month to evaluate overall survival in glioma patients. Report

> San Francisco-based Exelixis has announced positive Phase II data for XL647 for non-small cell lung cancer. The company also revealed interim Phase II data for XL880, a renal cell cancer drug. Release | Release

> NovaBay Pharmaceuticals raised $24 million in their IPO, which priced at $4 a share, the bottom of their range. Report

> Bionovo raised about $24 million in a new stock offering. Report

> Isis Pharmaceuticals will receive $9.9 million from the non-profit CHDI to develop a therapy for Huntington's disease. Report

And Finally...Are you hearing messages in white noise? That could be an early sign of schizophrenia. Release