Cancer Drugs

Safety fears derail late-stage Amgen cancer trial

John Carroll — Thu, 20 Nov 2008 10:30:10 -0500

Amgen has been dealt a serious blow to its hopes to develop new cancer therapies. Researchers for Amgen and Takeda suspended enrollment in a late-stage trial for motesanib after tracking a higher death rate among patients taking the oncology drug compared to the control group. The data monitoring committee also recommended that patients with squamous non-small-cell lung cancer stop taking the drug. They did not suggest halting treatment of the non-squamous cancer type.

Analysts have been closely tracking the motesanib trial. Amgen ranked it as one of three cancer trials that were expected to deliver key data in 2009 and 2010. Motesanib works by halting angiogenesis, starving cancer tumors of their blood supply.

"While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC. Working with our development partner, Takeda, we will continue to evaluate the therapeutic potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumors."

- read the Amgen release
- read the AP story

Cancer drugs cure Type 1 diabetes in mice

John Carroll — Tue, 18 Nov 2008 10:40:03 -0500

A team of scientists from Plexxikon and UC San Francisco say they were able to eliminate symptoms of Type 1 diabetes in mice by treating them with Gleevec and Sutent, two well known cancer drugs. In a study published in the Proceedings of the National Academy of Sciences, the scientists say they were also able to delay disease progression by giving the genetically modified mice daily treatments of Gleevec. Report

Genentech buyout still on Roche's to-do list

John Carroll — Tue, 21 Oct 2008 10:30:30 -0400

Roche hasn't lost its appetite for a proposed multibillion-dollar acquisition of Genentech. The pharma giant reaffirmed its bid for the biotech company as it outlined how its nine-month revenue figures had slipped two percent in Swiss francs.

The numbers help explain precisely why Roche remains an avid suitor. Cancer drugs are pumping money into the company. Avastin posted a 37 percent increase in revenue while Tarceva sales jumped 24 percent. MabThera/Rituxan (rituximab) for non-Hodgkin's lymphoma grew 16 percent to 4.3 billion francs, while sales of Herceptin (trastuzumab) were up 12 percent to 3.8 billion francs.

"I would like to reaffirm that we remain committed to the deal and we aim for a negotiated settlement," said CEO Severin Schwan (photo) about Roche's bid for the 44 percent stake in Genentech it doesn't already own. Schwan, though, was mum on the details.

- read the report from PharmaTimes

Bayer strikes deal for Nycomed cancer therapies

John Carroll — Fri, 08 Aug 2008 10:20:58 -0400

A Swiss company's decision to drop its cancer programs will help Bayer beef up its oncology pipeline. Bayer has agreed to buy Nycomed's preclinical cancer therapies in a deal worth up to €52 million. The deal covers two preclinical drug candidates and back-up therapeutics that target a kinase involved in the growth of cancer cells. Bayer Schering Pharma assumes full development and marketing rights.

Bayer discovery chief Andreas Busch says that the acquisition is complementary to the pharma company's oncology work. Bayer's Nexavar is a kinase inhibitor that helps prevent the growth of new blood vessels that feed tumors. Nycomed announced earlier this year that it was getting out of the cancer arena to focus on other programs. 4SC bought eight of its oncology programs in June.

- read the AFX report
- read the report from PharmaTimes

Genetic mutation will narrow target cancer groups

Mon, 02 Jun 2008 06:59:55 -0400

The K-ras gene is coming in for some star treatment at the ASCO meeting in Chicago. The gene plays a key role in several cancers, and new research indicates that the common genetic mutation makes Erbitux useless for slightly more than a third of all patients who may currently qualify for the drug.

The Wall Street Journal notes that the genetic signpost is helping R&D teams design clinical trials for new cancer drugs, using the genetic information to help them identify patients most likely to respond. The developers will benefit by increasing their shot at producing statistically significant data but will likely have to scale back the potential size of their market--a trade-off that payers in the U.S. will be glad to see.

- read the article in the Wall Street Journal

Pfizer gets new cancer team to advance key drugs

Thu, 15 May 2008 06:59:56 -0400

With the clock ticking on its patent for Lipitor, Pfizer has turned to a group of new executives to lead the company to the promised land of new cancer therapies.

Garry Nicholson, a 30-year Eli Lilly vet, will be responsible for overseeing every aspect of Pfizer's new oncology programs, from the first clinical trial to marketing, notes Forbes. Neil Gibson, formerly chief scientific officer at biotech OSI Pharmaceuticals, has been brought in to direct oncology research. And Briggs Morrison, who was able to speed clinical trials at Merck, has been brought in to do trial design.

"It's an exceptional situation," says Nicholson. "And for someone like me, who is in the business to get as many cancer drugs that extend survival to patients as possible, it is the best situation that I know of."

Pfizer needs all the help it can get. The drug giant is likely to lose 25 percent of its current revenue to generic competition for Lipitor.

- see Pfizer's statement on Nicholson's appointment
- read the article from Forbes

Eisai drug flunks Parkinson's trial

Fri, 11 Apr 2008 06:59:57 -0400

Eisai's has halted development of Perampanel (E2007) for Parkinson's after the drug failed a late-stage trial. Compared with placebo, E2007 didn't show a significant difference in the primary endpoint of reduction of "off" time (how long it takes for the signs and symptoms of Parkinson's disease return as the effect of levodopa wears off).

Perampanel is in development for a number of other indications, including neuropathic pain, epilepsy, multiple sclerosis and migraine prophylaxis. Eisai stressed that this trial failure was not indicative of larger problems with the drug. "The decision to terminate the Parkinson's disease program is due to lack of efficacy over placebo seen in the recently completed two Phase III studies only, and is not predictive of activity in the other indications including epilepsy and neuropathic pain."

In three years Eisai will lose patent protection for Aricept, a Alzheimer's drug which accounts for 40 percent of the company's sales. Finding drugs to make up the gap is a top priority for the the company.

- see Eisai's release for more

Abraxis buys Shimoda, subsidiary

Fri, 04 Apr 2008 07:59:54 -0400

Abraxis BioScience has completed acquisition of South Africa's Shimoda Biotech and its subsidiary, Platco Technologies. Abraxis bought the companies for $15 million up-front, plus potential additional payments upon the achievement of specified milestones. Shimoda is combining off-patent molecules with its drug delivery platform, in order to achieve faster onset and improved bioavailability characteristics of that platform. Platco Technologies focuses on the development of novel platinum-based anti-cancer drugs. Shimoda has one product on the market--Dyloject, an injectable painkiller for the treatment of post-surgical pain.

- here's the release

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Pfizer halts Phase III cancer trial on poor results

Wed, 02 Apr 2008 07:59:58 -0400

Pfizer's big push into cancer drugs has hit a snag. The company announced that it is halting a late-stage trial of tremelimumab for advanced melanoma after researchers concluded it was no more effective than standard chemotherapy. More data from the clinical development of the drug will be revealed at the annual ASCO meeting in June. The move to shutter the trial follows Pfizer's decision to beef up its R&D spend on cancer therapies from 12 percent of its budget to 20 percent. And Pfizer has every intention of staying focused on the field as well as tremelimumab.

"Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high-risk area of research with significant unmet medical need," said Dr. Charles Baum of Pfizer Global Research and Development. "We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer."

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

ALSO: The news from Pfizer stung at Medarex after analysts concluded that a failure for tremelimumab also spelled trouble for another partnership it has with BMS to develop ipilimumab. Its stock dropped 14 percent. Report

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Cephalon paying $10M in cancer tech deal

Mon, 31 Mar 2008 07:59:54 -0400

Cephalon is paying out $10 million to acquire the IP rights to Acusphere's Hydrophobic Drug Delivery System for oncology applications along with the rights to AI-850, the formulation of paclitaxel.

"We are very pleased with the terms of this transaction, which establishes a strong value for part of our technology platform that is at an early stage of development," said Sherri C. Oberg, president and CEO of Acusphere. "We are confident that Cephalon is the right partner for one application of this important technology, given its strong focus on oncology. Just six months ago, we announced that AI-850 was a potential bio-equivalent to the one of the fast-growing anti-cancer drugs, Abraxane. This transaction confirms the potential for our technology in the oncology arena, which is one of many potential applications for our HDDS technology."

- check out the press release for more info

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Avanti launches bionano company

Fri, 28 Mar 2008 07:59:54 -0400

Avanti Therapeutics launched a new bionanotechnology company for targeted drug delivery called Chikujee Therapeutics. Chikujee will use Avanti's drug delivery technology to enhance the performance of drugs, specifically anti-cancer drugs. The first drug classes the company will focus on are taxols (Paclitaxel and Docetaxel) and camptothecin for chemotherapy. Chikujee is Avanti's third early-stage company.

- here's the release

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NJ officials want to expand biopharma biz

Wed, 26 Mar 2008 07:59:54 -0400

A state economist for New Jersey has spelled out some of the biggest threats to the Garden State's biopharma industry. In a recent address, James Hughes underscored that New Jersey is losing its reputation as the country's "medicine chest," reports Gannett. Its high concentration of pharma jobs has slid badly during this decade while states like Texas have come up with major new programs to back research into cancer drugs.

Former Pennsylvania Gov. Mark S. Schweiker told the group that the best way to expand biopharma was to adopt a regional approach, with south New Jersey, southeastern Pennsylvania and Delaware joining forces to promote a "Greater Philadelphia" approach. Schweiker, it should be noted, is now president and CEO of the Greater Philadelphia Chamber.

- read the article from Gannett

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ALSO NOTED: Neurochem pursues new Kiacta trial; Teva drug fails ALS trial; Columbus tapped as promising new life sciences hub;

Thu, 13 Mar 2008 07:59:50 -0400

> Neurochem is forging ahead with plans to launch a new late-stage trial for Kiacta in a renewed bid for regulatory approval. Regulators had declined to approve the amyloidosis therapy, saying they needed to see more data. Release

> Teva says that a mid-stage trial of glatiramer acetate (GA) 40 mg for ALS failed primary and secondary endpoints. Release

> In a review of up-and-coming tech hubs, Forbes picked Columbus, OH as the most promising new hub on the U.S. map, in part because of the life sciences work being done at the Battelle Memorial Institute. Palm Beach County also lands high up on the list, as new R&D institutes spring up for discovery work. Report

> CyDex has filed for an IPO that could be valued at up to $50 million. The Lenexa, KS-based developer has patented technology used to improve solubility, stability, bioavailability, safety and dosing. Release

> Dani Bolognesi, the co-founder of Trimeris, is back at the helm of a start-up biotech company, hoping that B3Bio can score advances for inflammation, cancer and infection. The start-up is relying on technology developed at Duke and the University of Texas. Story

> Sciele Pharma has paid $29 million to buy Verus's Twinject epinephrine auto-injector along with other products. Release

> Juvaris BioTherapeutics has tapped Grant Pickering to replace founder Martin Cleary at the helm. Pickering had earlier founded Pharmada, a developer of cancer therapies. Cleary remains as chairman of the board. Release

> Avexa announced "excellent" data from a Phase IIb trial of its HIV therapy, with 90 percent of patients achieving undetectable viral loads after 48 weeks of therapy. Report

> Urigen announced positive mid-stage results for its experimental therapy for a painful bladder syndrome. Release

> The investment firm Warburg Pincus has taken a 13.7 percent stake in ZymoGenetics. Report

> Researchers figured out how two different cancer drugs--Avastin and Erbitux--might lead to side effects. Report

> Yesterday, the embattled Endo Pharmaceuticals named a pharma veteran David Holveck (photo), who some call "Mr. Fix-It," to replace its departed executive officer. Report

And Finally… Hong Kong closed its schools after three children died from influenza. Officials say there's no sign of SARS or bird flu in the outbreak. Article

ALSO NOTED: Manhattan Pharma closes JV deal; Abbott, Genentech, WEHI in cancer collaboration; and much more...

Wed, 27 Feb 2008 06:59:50 -0500

> Manhattan Pharmaceuticals has closed on its joint venture agreement with Nordic Biotech Venture Fund II K/S to develop and commercialize Hedrin for head lice for the North American market. Manhattan Pharmaceuticals pocketed a $2 million cash payment plus $2.5 million of equity in the newly established joint venture, named Hedrin Pharmaceuticals K/S. Release

> Abbott, Genentech, and WEHI have joined in a tripartite research collaboration to discover anti-cancer drugs. Release

> Stem Cell Therapy International and South Korea's Histostem have announced plans to merge. "We are very pleased with the opportunity for us to be working with Histostem. They have made remarkable progress in the field of umbilical stem cell research and therapy," says Calvin Cao, CEO of SCTI. Release

> Genentech has expanded its license regarding Sagamo BioScience's proprietary zinc finger DNA-binding protein nuclease (ZFN) technology. Release

> Tough luck to unwary buyers, Chinese regulators say. The country's drug safety agency said today that it strictly controls chemicals for use in pharmaceuticals but it's not ultimately responsible for product safety. Report

> A new analysis of the blockbuster anemia drugs sold by Amgen and Johnson & Johnson concludes they raise the risk of death among cancer patients by about 10 percent. Report

> The FDA piggy bank isn't near full enough to overhaul operations as they ought to be, agency chief Andrew von Eschenbach admits. And that's a big admission; von Eschenbach is in essence agreeing with critics who've said his agency simply isn't up to the task of ensuring drug and food safety. Report

> Here's a study guaranteed to put almost every drugmaker on the defensive. Researchers analyzed every antidepressant study they could get their hands on--including a bunch of unpublished data obtained via the U.S. Freedom of Information Act--and concluded that, for most patients, SSRI antidepressants are no better than sugar pills. Report

And Finally… Cases of drug-resistant tuberculosis have spiked to their highest level ever and may start spreading even faster. The highest rate was in a city in Azerbaijan, where one in four cases of TB is unresponsive. Article

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

ALSO NOTED: LAB Research gains financing; BMS, AstraZeneca, Wyeth report earnings; and much more...

Thu, 31 Jan 2008 06:59:50 -0500

> Stem Cell Sciences says a new pact with the Myelin Repair Foundation will provide it with a stable supply of uniform human brain cells for their research program on multiple sclerosis. Report

> Canada's LAB Research--a non-clinical contract research organization--has raised $21.1 million in fresh financing for its expansion plans. Release

> A handful of drug makers released their earnings, and it's a mixed bag: some up, some down, some hit by one-time charges. Here's a roundup. Report

> PsychoGenics has inked a new drug discovery pact with Eli Lilly covering the evaluation of neuropsychiatric drug candidates. Report

> Chutes & Ladders: Genelabs Technologies CEO James Smith has resigned. The company chairman and CFO will run the company until a new CEO is hired on. Report

> The FDA has granted priority review status to Schering-Plough's Peginterferon Alfa-2b, an adjuvant treatment for Stage III melanoma, a rare skin cancer. Release

> If remorse is proportional to the amount you're willing to pay to absolve it, then Eli Lilly must be feeling pretty guilty about Zyprexa. Report

> Can we trust a Chinese manufacturer that not only sold contaminated cancer drugs but tried to cover up the fact? Apparently, the FDA thinks so. Report

> Good news, needle-phobes. South Korean researchers have successfully tested a new approach to delivering vaccines, applying it under the tongue rather than through a needle. Report

And Finally... See that other blue-eyed person at the next table? Go say hi, because genetics proves that you're related to a common ancestor. Release

Pioneering cancer scientist Judah Folkman dies

Wed, 16 Jan 2008 06:59:55 -0500

Dr. Judah Folkman (photo)--whose work on angiogenesis spawned a new category of oncology drugs--died on Monday at the age of 74. His groundbreaking research demonstrating tumors' need for growing numbers of blood vessels led to the development of 10 cancer drugs on the market today and spawned a wide array of follow-up investigations that continue to drive experiments into new cancer treatments. While not a cure for cancer, observers note that Folkman pointed the way to make many cancers a manageable chronic disease. The New York Times notes that deep skepticism greeted Folkman's initial work, but a 1998 study showing how the process eliminated tumors in mice stirred a frenzy of interest.

"I think he was one of the most important investigators of our time," Dr. David Nathan, president emeritus of the Dana-Farber Cancer Institute in Boston, told the Wall Street Journal. "Losing him is like watching a Roman candle go out."

- read the report from the Wall Street Journal
- and here's the article from The New York Times

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

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Novacea ends Asentar trial, shares plunge

Mon, 05 Nov 2007 06:59:58 -0500

Novacea has shuttered its Phase III trial of the prostate cancer drug Asentar, citing an "imbalance of death" recorded in the two arms of the study. Novacea and partner Schering-Plough say that they will study the data to try and glean some insight into the higher death rate among Asentar patients. The study--which had enrolled 900 of a planned 1200 patients--dosed patients with a combination of Asentar and Taxotere. Details are scarce this morning, with little more than a tersely worded press release for information. But it was all that investors had to know before deciding to bail out. The company's stock plunged by 65 percent this morning.

Asentar has been one of two leading therapies in development at Novacea. Last July the company collected $60 million from Schering-Plough in exchange for a commercialization pact on the drug. Schering-Plough had also committed up to $380 million in milestones plus royalties for an approved product.

- see the Novacea release on the trial failure
- read the AP report on the trial
- and check out the stock report

GPC shares crater on Phase III cancer failure

Wed, 31 Oct 2007 07:59:58 -0400

Germany's GPC Biotech saw its already battered stock price crater this morning after announcing that its experimental prostate cancer drug, satraplatin, failed to help patients live longer in a critical late-stage trial. GPC announced it was cutting its workforce by 15 percent to account for the trial disaster, which sliced 65 percent off of its remaining stock value.

The vultures had already been gathering around satraplatin after GPC and its partner, Pharmion, announced that they were withdrawing their FDA application until survival data was in. The data is also expected to have an impact on their European regulatory filing. In the trial, patients taking the therapy in combination with prednisone lived an average of 61.3 weeks compared to 61.4 weeks for the control group. That kind of survival response would not pass muster with regulators. Researchers say they will evaluate how they plan to proceed with the cancer program.

"We are extremely disappointed with the findings,'' said GPC Chief Executive Officer Bernd Seizinger in an understatement of the week. One analyst noted that the company's business model is somewhat "unclear" after the results were announced.

- see this release from GPC
- here's the report from MarketWatch

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