cancer drug

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

Medarex shares dented on analysts' skepticism

Tue, 03 Jun 2008 06:59:56 -0400

Investors dented the value of Medarex shares after analysts doused its recent claims concerning its late-stage cancer drug ipilimumab with cold water. BMO Capital Market's Jason Zhang says that Medarex doesn't have the data to back up claims that a combination of ipilimumab and dacarbazine work better than ipilimumab alone. Its shares slipped seven percent on the news.

"There is no randomized data with a chemotherapy control supporting ipilimumab's survival-prolonging abilities," said Zhang in a note. Mid-stage study data demonstrated median overall survival of 449 days on the combo therapy compared to 351 days with ipilimumab alone. That was not a statistically significant difference in survival.

- read the AP story

Pfizer rumored to be eyeing MediGene buyout

Wed, 14 May 2008 06:59:57 -0400

Rumors are swirling that Pfizer is looking to take over the German biotech MediGene. Shares of the smaller company leapt more than 12 percent today as reports of a possible deal hit the newswires. Neither company would comment on whether they've held talks, as reports suggest.

MediGene specializes in cancer, autoimmune disease and skin disease; its two marketed products are the prostate cancer treatment Eligard and a genital warts med Veregen. European approval for a skin drug, Oracea, is pending. In the pipeline: a pancreatic cancer drug, Endotag.

- see the story in Forbes
- check out the brief at Thomson Merger News

FDA staffers say that Eisai sedative appears safe

Mon, 05 May 2008 06:59:54 -0400

FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in general anesthetics. Eisai gained rights to fospropofol disodium with its acquisition of Minneapolis-based MGI Pharma. And an FDA expert committee is scheduled to meet on Wednesday to consider Eisai's application for marketing approval. The sedative is designed for use during a number of procedures, including colonoscopies. Researchers say the sedative has a safer profile than existing meds.

- read the report in the Wall Street Journal

Medarex shares slide on news of drug app delay

Mon, 28 Apr 2008 06:59:55 -0400

Shares of Medarex slipped seven percent this morning as investors digested Friday's announcement that its application for a new cancer drug will be delayed into 2009. The developer says that the FDA wants more data on ipilimumab, which is in late-stage trials. Bristol-Myers Squibb is partnered on the therapy, which is being investigated as a new treatment for metastatic melanoma. The agency is looking for more data on overall survival rates. That left the analysts scrambling to calculate the revenue the company will lose as a result of the delay. Medarex shares have lost more than half of their value since last summer.

- see Medarex's release
- read the AP report

SPOTLIGHT: CuraGen sells Belinostat stake to TopoTarget

Tue, 22 Apr 2008 06:59:53 -0400

CuraGen Corporation has sold its stake in Belinostat to TopoTarget for $39 million upfront in a combination of cash and stock. TopoTarget will now take full control of the cancer drug's development. "CuraGen has been a good partner and helped us over a high risk period," said Dr. Peter Buhl Jensen, CEO of TopoTarget. CuraGen said the move allows it to focus on other clinical programs. Release

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

In survival mode, Genta hunts for funds

Tue, 15 Apr 2008 06:59:54 -0400

NJ Biz examines Genta, which has gone into survival mode as it seeks a way to gain FDA approval of its lead cancer therapy, Genasense. The FDA turned thumb's down on the therapy in 2004, and the company--which has yet to turn a profit--has been forced to lay off more than half of its staff since the end of 2007. Genta's auditors, meanwhile, have placed a 'going concern' warning on the biotech company and the developer is selling off its only marketed product.

CEO Raymond Warrell takes the view that everything will work out, eventually. "In biotech, you learn to focus on the long term, not on the next calendar quarter." The story also makes the point that biotechs are often cash-hungry concerns that know how to go into "turtle mode" when they need to hunker down and raise funds.

- read the article from NJ Biz

Related Articles:
FDA extends review time for Genta's appeal. Genta report
FDA rejects Genasense. FDA report
Advisory committee rejects Genta cancer drug. Genta report
Genasense hits primary endpoint in late-stage cancer trial. Genta report

Takeda makes $8.8B bid for Millennium

John Carroll — Thu, 10 Apr 2008 08:51:20 -0400

Looking to expand out of a budget-bound Japanese market, Takeda is taking a big chunk of its $10 billion war chest and offering $8.8 billion in cash for U.S.-based Millennium Pharmaceuticals. The $25 per share offer is a 65 percent premium over Wednesday's close. Millennium is best known for the cancer drug Velcade, which Takeda is looking to turn into a global blockbuster. That would go a long way toward overcoming the looming patent expirations for Actos and Prevacid.

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the 14th largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology.

"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited.

- here's the release
- see this article from Forbes

Millinneum News:
Millennium chief scientist takes offbeat approach
Millennium spent $1.3M on lobbying
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster

Takeda News:
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Safety, efficacy problems sink Takeda drug
Cell Genesys scores $320M blockbuster deal with Takeda

Takeda makes $8.8B bid for Millennium

Thu, 10 Apr 2008 06:59:58 -0400

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the fourteenth largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology. "Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda.

- here's the release
- check out the report from Forbes

Related Articles:
Millennium chief scientist takes offbeat approach
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Cell Genesys scores $320M blockbuster deal with Takeda

ALSO NOTED: Dendreon shares jump on investment deal; Iomai in pact with Merck; Foundation antes millions for MS leads; and much

Thu, 03 Apr 2008 07:59:50 -0400

> Schering-Plough has proven quick on the layoff trigger. The company announced a plan to cut costs by $1.5 billion by 2012 in the wake of the latest round of Vytorin controversy. Roughly 5,500 employees will lose their jobs, or about 10 percent of the company's workforce. Report

> Shares of Dendreon jumped seven percent on the news that an institutional investor will buy up 47 million in shares and warrants. That money is earmarked for Dendreon's prostate cancer drug Provenge and other drug candidates in its pipeline. Release

> Iomai has forged a deal with Merck to conduct proof-of-principle preclinical studies evaluating the use of the Iomai needle-free immunostimulant patch. Merck has first option to negotiate an exclusive license. These preclinical proof-of-principle studies will be conducted using an undisclosed Merck vaccine. Release

> The Myelin Repair Foundation has spent $10 million so far to identify 18 new drug leads for multiple sclerosis. Report

> Chutes & Ladders: Akers Biosciences has promoted Robert J. Paratore to chief financial officer. Report

> Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. The impetus? A Consumer Reports poll that showed 16 percent of respondents had a side effect serious enough to send them to the doctor or hospital--but 35 percent of respondents didn't know they could report side effects to the FDA. Report

> The U.K.'s National Health Service is spending around $3.9 billion annually to treat patients for adverse reactions to prescription drugs. Report

And Finally... A professor at the California Institute of Technology is walking away with the $1 million Gotham Prize for an original approach to killing cancer cells. Report

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

Cephalon, investors await FDA Treanda decision

Wed, 19 Mar 2008 07:59:54 -0400

After seeing its stock price shed about a third of its value since last summer, Cephalon is keeping its fingers crossed that tomorrow's scheduled regulatory decision on its cancer drug Treanda can turn things around. At least that's what the analysts are seeing. Some expect a sharp upturn if the agency approves Treanda for chronic lymphocytic leukemia.

"This is the first big step. It will be the foundation for our oncology business," Liz Barrett, vice president of Cephalon's oncology unit, told the Wall Street Journal. Analysts peg its potential in the neighborhood of $250 million a year. But Cephalon is also looking for additional approvals, including using the therapy as an add-on to Rituxan, which could make it a seven-figure market blockbuster.

- here's Cephalon's release
- read the report in the Wall Street Journal

Related Articles:
Cephalon, NitroMed make cuts jobs. Report
Positive Phase III results for Cephalon's Treanda. Report
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

QLT stock rockets as acne drug is cleared for takeoff

Tue, 18 Mar 2008 07:59:57 -0400

Shares of QLT rocketed up 55 percent in a tense market yesterday after the biotech finished a lengthy task in persuading the FDA that a blood test should not be required before doctors prescribe its new acne medication. QLT's Aczone was approved three years ago but never commercialized as the company set out to prove in clinical trials that a blood test should not be required. The regulatory approval also clears the way for QLT to complete its planned sale of its U.S. division, which holds the rights to aczone and eligard, a prostate cancer drug. QLT says the acne medication has the potential to earn around $100 million a year. Analysts say that even if a buyer can't be found QLT can go ahead and launch the new drug.

QLT has been restructuring, laying off more than 100 workers near the start of year. QLT was disappointed by the sales of Visudyne, a therapy for age-related macular degeneration, but hopes that tests of a combination therapy using Visudyne will demonstrate it can be a cheaper, quicker alternative to current therapies. A new acne drug is also in the pipeline.

- see QLT's release for more
- check out the report in the Globe and Mail

Related Articles:
QLT posts 'for sale' sign. Report
QLT gains drug delivery tech in $42M buyout. Report
QLT says therapy fails Phase II trial. Report
QLT slashes spending as competition looms. Report

ALSO NOTED: Ipsen files new BLA;Amgen selects Vectibix test; and much more...

Mon, 17 Mar 2008 07:59:50 -0400

> Ipsen says it has submitted a new BLA for Reloxin, addressing concerns raised by the FDA when the agency declined to file its BLA in January. Release

> Amgen says it will use Lab21's diagnostic test to see which patients are suitable for its cancer drug Vectibix. Report

> NanoBio Corporation reported that a Phase IIb study of NB-001, a topical lotion to treat cold sores, met its primary and secondary endpoints by demonstrating clear efficacy and safety in 482 patients. Release

> The FDA is hustling up new programs designed to shore up confidence in drug safety--and in its own ability to ensure it. Report

> Pay for the CEOs of Wyeth and Pfizer was down in 2007. Report

> The wrestling match in Biovail's boardroom is getting ugly. Founder and former CEO Eugene Melnyk called for a housecleaning on the company's board. Report

> Rumor Mill: Less than 10 days after CEO Jeffrey Kindler pooh-poohed big acquisitions, U.K. markets are awash with rumors that Pfizer is on the hunt for British pharma group Shire. Report

And Finally... A fresh controversy over tainted drugs may be just what the FDA needs to win new federal funding. Article

ALSO NOTED: Genentech options Exelixis inhibitor; Millennium reports positive data for cancer cocktail; Immtech CEO takes a pay

Fri, 14 Mar 2008 07:59:50 -0400

> Exelixis announced that Genentech has exercised an option to develop Exelixis' XL518, a selective inhibitor of MEK which is currently in a Phase I clinical trial. Exelixis earns $3 million on the option. Release

> Millennium Pharmaceuticals has posted positive data in a study of a drug cocktail that includes its cancer drug Velcade. The combo was being tested on patients with multiple myeloma who were ineligible for stem-cell transplantation. Report

> Immtech CEO Eric L. Sorkin has volunteered to take a pay cut during this fiscal year. Release

> AVI BioPharma has acquired all the outstanding shares of Ercole Biotech it didn't already own. Ercole has been working on alternative RNA splicing technology. Report

> Calando Pharmaceuticals, a subsidiary of Arrowhead Research, has asked the FDA for a green light to begin an early-stage trial of a cancer therapy. Report

> For the first time, federal authorities are conceding a link between vaccines and autistic symptoms--just not the link activists thought. Report

> The venture capital group Perseus has pumped $10 million dollars into NanoBio, bringing its total investment in the University of Michigan spin-off to $30 million. Report

Most popular this week: Breakthrough reported in flu vaccine research. Report

And Finally...New Jersey, an aggressive suitor of biotech companies, is offering ImClone $32 million in tax rebates to woo it to the Garden State. Report

Novartis ends cancer trial early after hitting endpoint

Thu, 28 Feb 2008 06:59:58 -0500

Novartis has brought a late-stage study of its kidney cancer drug everolimus to a premature close after an independent review committee determined the therapy had extended patients' lives without disease progression--the primary endpoint. The oral drug--formerly code named RAD001--works by inhibiting the mTOR protein, which regulates cell division in tumors, much like Wyeth's Torisel. Complete data will be presented at the ASCO meeting in May. And Novartis plans to examine the therapy's use in other cancers.

"This progression-free survival benefit demonstrates the possibilities of continuous mTOR inhibition as a promising target in oncology," said David Epstein, head of Novartis' oncology unit. "Everolimus is the first compound in our dynamic oncology late-stage pipeline with six compounds in registration trials to show exciting clinical data this year."

- check out the release
- see the report from MarketWatch

ALSO: Investors are wearing frowns over Novartis' pipeline prospects. Article

PLUS: Novartis has been making an argument for use of its experimental flu vaccine ahead of any potential outbreak. Report

Related Articles:
CEO: Novartis plans big restructuring. Report
Lagging sales spur Novartis layoffs. Report
Novartis--Top 15 R&D Budgets. 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

Adherex's melanoma drug earns orphan status

Fri, 22 Feb 2008 06:59:55 -0500

North Carolina-based Adherex Technologies has won orphan drug designation from the FDA for its experimental melanoma therapy ADH-1. The drug is currently in Phase IIb trials in combination with regional melphalan. Adherex is also conducting Phase I trials of ADH-1 in combination with Taxotere and Xeloda.

"Our experience to date combining ADH-1 and melphalan for the treatment of in-transit melanoma has been very encouraging," said Adherex CEO Dr. William Peters in a statement. "To continue with the rapid development of this combination, two additional centers, Lehigh Valley and H. Lee Moffitt, have joined our Phase IIb trial which is ongoing at Duke and the MD Anderson."

- here's the release for more

Related Article:
Adherex takes full control of failed cancer drug. Report

Amgen, Takeda ink massive development deals

Mon, 04 Feb 2008 06:59:58 -0500

Struggling under the weight of falling anemia drug sales, Amgen is selling the Japanese rights to a slate of some 13 experimental therapies to Takeda in a deal that may be worth more than $1 billion. For Takeda, which is putting up $200 million upfront and $340 million in worldwide research costs, the pact marks a major lunge into the biologics market.

The deal includes $362 million in milestones payments and a deal to to acquire Amgen KK, Amgen's Japanese subsidiary. And in a separate deal, Takeda has signed on to partner with Amgen on the cancer drug motesanib. Takeda will play $100 million up front and $175 million in a schedule of milestone paydays. Amgen announced plans to out-license some of its drugs last summer, when weakening sales forced the company to launch its first-ever cost-cutting move. "We have more assets in our pipeline than we can develop ourselves," said Amgen CEO Kevin W. Sharer recently.

- see this release
- here's the article from The New York Times

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

Related Articles:
Amgen - Top 5 layoffs of 2007. Report
Amgen makes big workforce, budget cuts. Report
Amgen income hammered as anemia drug use drops. Report
Takeda expands R&D budget, may look for buyout. Report