colorectal cancer

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

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Matuzumab in doubt after trial failure

Wed, 29 Aug 2007 06:59:56 -0400

There's trouble at Merck Serono's program for Matuzumab, which is in development for colorectal cancer. Merck KGaA says it is "reconsidering" further development of the therapy after the drug failed to hit its endpoint in a Phase II trial. Merck Serono and Takeda have a joint development pact for the drug, which failed to meet their expectations. More work, though, is being planned for other tumor types.

- check out the release

Related Articles:
Takeda expands R&D budget, may look for buyout. Report
Merck KGaA buying control of Serono. Report

Press Release: Results Show XELOX Provides Equivalent Overall Patient Survival Compared To FOLFOX

Maureen Martino — Mon, 22 Jan 2007 11:39:27 -0500

Roche Release: Results Show XELOX Provides Equivalent Overall Patient Survival Compared To FOLFOX In Advanced Colorectal Cancer

NUTLEY, N.J., Jan. 22 -- Overall survival results from an international, Phase III study (NO16966) suggest that XELOX (Xeloda(R) plus oxaliplatin) is an effective alternative to the current standard treatment, FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin), for advanced (metastatic) colorectal cancer. In the study, XELOX -- a more convenient therapy including Roche's oral Xeloda -- provides equivalent patient survival compared to FOLFOX-4. These data were presented at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI) in Orlando, FL.

The Independent Review Committee (IRC) analysis also confirmed previous results indicating that the addition of Avastin to combination chemotherapy (XELOX or FOLFOX) significantly improved the chance of delaying the progression of the disease (progression-free survival, or PFS).

"These important survival results continue to affirm our initial hypothesis that XELOX is a viable, effective alternative to the current standard of care for advanced colorectal cancer," said Professor Jim Cassidy, co-lead investigator for the study and Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. "These data underscore the tremendous promise of combinations using cornerstone therapies such as Xeloda, and the potential benefit of adding Avastin to achieve greater progression-free survival."

Additional analysis of these data is ongoing and will be presented at an upcoming international scientific meeting.

"Now, with evidence of overall survival in addition to progression-free survival, we can move closer to offering patients a convenient option of an oral component to their chemotherapy treatment," said Lars Birgerson, Vice President, Medical Affairs, Roche. "Based on these findings and results from international Phase III study (NO16967), Roche will submit a supplemental new drug application for XELOX (Xeloda plus oxaliplatin) in advanced colorectal cancer."

In 2004, colorectal cancer was one of the leading cancers and accounted for 13 percent of all cancers; it is estimated that more than 394,000 people die worldwide from colorectal cancer each year. Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimated in 2006 that more than 148,000 people in the U.S. would be diagnosed and about 55,000 people would die from the disease.

About the Study

Study NO16966 is a large, randomized, international, Phase III trial of 2,034 advanced colorectal cancer patients that initially compared first-line XELOX (Xeloda + oxaliplatin) versus FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil + oxaliplatin). After release of Avastin data in colorectal cancer in 2003, the protocol was amended to investigate, using a 2 by factorial design, XELOX + placebo versus XELOX + Avastin (7.5 mg/kg q3w) versus FOLFOX-4 + placebo versus FOLFOX-4 + Avastin (5.0 mg/kg q2w).

The primary study objectives were to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved results compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.

The results presented at ASCO GI represent only the original arm of the study, which recruited 634 patients.

About XELOX

XELOX is an abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.

About XELODA (capecitabine)

Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.

A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required.

The most common adverse events (greater than or equal to 20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.

Roche
CONTACT: Ginny Valenze of Roche, Office: +1-973-562-2783,virginia.valenze@roche.com; or Daphne Hoytt of Manning Selvage & Lee,Office: +1-212-468-3558, or Cell: +1-917-406-2779, daphne.hoytt@mslpr.com

Press Release: Xeloda Combination Meets Primary Endpoint in Phase III Study

Maureen Martino — Sun, 10 Dec 2006 11:36:50 -0500

Xeloda Combination Meets Primary Endpoint in International Phase III Advanced Colorectal Cancer Study

- XELOX (Xeloda plus oxaliplatin) Delays Disease Progression in Patients with Recurring Cancer -

NUTLEY, N.J., Dec. 11 -- Roche announced today that a large, international Phase III study (NO16967) of 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival. Study results showed that the chemotherapy combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).

"Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer."

Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2006, more than 148,000 people in the U.S. will be diagnosed and about 55,000 people will die from the disease.

"Roche is committed to advancing treatment for patients with colorectal cancer," said Lars E. Birgerson, Vice President, Medical Affairs, Roche. "Based on the data from the NO16966 and NO16967 studies, we are pleased to report that our filings with worldwide regulatory authorities will continue as planned."

Results from the NO16967 study will be submitted for presentation at future major medical meetings.

About the Study

The NO16967 trial is a large, international phase III trial that randomized 627 patients who had previously received chemotherapy and whose disease had returned or continued to progress. The trial compared XELOX (oral Xeloda plus oxaliplatin) vs. FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil/leucovorin plus oxaliplatin) as first line colorectal cancer treatment. The primary objective was to determine whether the XELOX regimen was as effective as FOLFOX-4 in terms of progression-free survival (a measure of time to disease progression or death). The secondary outcomes included overall survival, overall response rates and safety profile. There were no unexpected safety findings in the study.

About XELOX

XELOX is an abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.

About XELODA (capecitabine)

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.

Amgen launches price war on Vectibix OK

Wed, 27 Sep 2006 20:01:38 -0400

After winning the FDA's approval for its new cancer drug Vectibix, Amgen swiftly pegged the price of the new drug at a 20 percent discount on Erbitux, which works in much the same way. Analysts immediately seized on the move as an indication that the biopharma industry is becoming increasingly sensitive to criticisms that new cancer therapies are priced at huge premiums for drug developers. But even at the discount, analysts note, Vectibix will still cost more than $100,000 a year. Most patients, though, are only likely to survive a few months. Vectibix was approved as a therapy of last resort for colorectal cancer victims.

The pricing move was another bout of bad news for ImClone, which makes Erbitux. It already has a shareholder revolt on its hands and the news of the discounted competition took a bite out of its share price. Analysts estimate that Vectibix is likely to claim annual sales ranging from $500 million to $2 billion.

- read the article on Vectibix from The New York Times

ALSO: Investor Carl Icahn is calling for the removal of six ImClone directors. Report

ALSO NOTED: Takeda may scrap licensing deal; Humira approved for new use;and much more...

Sun, 30 Jul 2006 20:00:50 -0400

> Disappointed by poor efficacy data from two Phase III trials of Tavocept, Japan's Takeda announced that it has told BioNumerik Pharmaceuticals that it may scrap their licensing deal on the drug. Report

> The FDA has approved Abbott's Humira for an inflammatory disease of the spine and spinal joints. Report

> Shares of CytRx ticked up on its release of positive data from a Phase I trial of its HIV vaccine DP6-001. CytRx says the trial successfully demonstrated both HIV-specific T-cell and antibody immune responses. Researchers will file a summary of the data with the FDA next month. Report

> Roche Holding AG says that both Avastin and Xeloda met their primary endpoints in a Phase III trial for colorectal cancer. Report

> Repligen says that it was won a summary judgment against ImClone in its patent case regarding the cell line used in making Erbitux. Repligen and MIT allege that the cell line was created under contract for the National Cancer Institute by a predecessor to Repligen and subsequently transferred from the NCI to ImClone for use in research and development only. Release

> The FDA has accepted Merck's NDA for MK-0431A--a combination of Januvia and metformin for Type 2 diabetes--for standard review. Report

> Napo Pharmaceuticals made a good impression in its debut on the London exchange, rising eight percent. Napo concentrates its research on AIDS diarrhoea, Irritable Bowel Syndrome, acute infectious diarrhoea and paediatric diarrhea. Report

> Momenta Pharmaceuticals has filed an IND for its lead candidate, M118, for acute coronary syndromes. Release

> Schering AG has voluntarily recalled its contrast agent Ultravist Injection 370 mgl/ml. Report

And Finally… It's getting easier and easier to make customized viruses, and fears continue to grow of its possible use by bioterrorists. Article

ALSO NOTED: Companies compete for microdosing tests; Bayer to expand facility; and much more...

Mon, 12 Jun 2006 20:00:50 -0400

> Two small U.S. companies are competing to make the first tests that will register results for newly-allowed microdosing trials. Under new FDA rules, drug developers can test tiny amounts of experimental therapies in humans to get some insight into efficacy before launching expensive studies. The potential specialized drug testing market for microdosing is estimated at $500 million. Report

> Bayer is embarking on a $100 million expansion of its East Walpole, MA facility. Report

> Bayer and Onyx have received the FDA's fast-track status for Nexavar, an experimental therapy for liver cancer. Shares of Onyx were buoyed by the news. Report

> The FDA has fast-tracked Genitope's MyVax cancer treatment. Report

> The FDA has granted a priority review of Amgen's panitumumab for patients with metastaic colorectal cancer. Report

> GlaxoSmithKline's Wellbutrin XL has been approved for seasonal depression. Report

> Beginning in July, Japan's Takeda will deploy its U.S. sales force to co-promote Cephalon's Provigil for sleep disorder. Report

> Chutes & Ladders: Germany's DeveloGen says its CEO, Dr. Guenther Karmann, will leave the company by mutual agreement. Release

> Galapagos will buy the drug discovery service operations of Discovery Partners International for $5.4 million. Report

> The CEO of Belgium's giant UCB told shareholders that the company is exploring "targeted acquisitions." Report

> N-Gene has released positive Phase II data for BGP-15, an insulin sensitizer. Release

> Rigel has received $1 million in milestone payments from Merck. Release

And Finally… A new study shows that people are generally successful at matching the pictures of drivers with their cars, showing that most people typically project a public profile that is easily recognizable by others. Article

C&L: Tedford resigns early from Patheon

Tue, 09 May 2006 20:01:32 -0400

Contract drug manufacturer Patheon has announced that Robert Tedford has turned in his resignation 10 months ahead of schedule. Patheon chairman Peter Green, president and CEO Nick DiPietro, and CFO and executive vice-president Douglas Ludwig have formed the "office of the chief executive."

Raven biotechnologies has named George F. Schreiner, M.D., Ph.D., as CEO and director.

Drug marketing company PDI has named Michael Marquand as its new CEO, replacing interim CEO Larry Ellberger.

Calypte Biomedical announced that Roger I. Gale, chairman of the board since November 2004, has been appointed president and CEO.

Epix Pharmaceuticals announced that Michael Astrue has resigned as interim CEO.

BioPheresis Technologies has named Bernhard R. M. Ehmer, MD, chief CEO.

ImpactRx announced that CEO and President Nancy Lurker will be leaving the company to take a new job.

Immtech Pharmaceuticals announced the retirement of T. Stephen Thompson, president and member of its board of directors.

AVANIR Pharmaceuticals announced that Michael J. Puntoriero has joined the company as senior vice president of finance and, effective May 15, 2006, will be appointed CFO.

NeoPharm announced the resignation of Imran Ahmad as executive vice president and chief scientific officer.

Pharmacopeia CFO Michio Soga is resigning to pursue other opportunities.

Ambrx announced the appointment of Hazel M. Aker as senior vice president of operations and business affairs.

Biovail Corporation has named Dr. Peter Silverstone senior vice-president, medical and scientific affairs.

David J. Tyler has joined ChondroGene as director, product development and quality assurance.

Pro-Pharmaceuticals has retained James T. Gourzis, M.D., Ph.D., on a consulting basis to provide clinical management and strategic development of its Europe-based Phase III colorectal cancer trial.

Neose Technologies has elected L. Patrick Gage, Ph.D. as non-executive chairman of the board.

Avecia has announced a new three-man board for its parent, Avecia Holdings. They are: CEO & Director Adrian Buckmaster; CFO Duncan McLellan; and Executive Director Dr. Kevin Cox.

INNOVIVE Pharmaceuticals has elected Neil Herskowitz to its board of directors.

Dr. Brian Adger has been appointed as chairman of De Novo Pharmaceuticals' new Scientific Advisory Board, together with Dr. John Dixon and Dr. Peter Warne.

Othera Pharmaceuticals has elected Katherine Crothall, Ph.D. and Bruce A. Peacock to its board of directors.

ALSO NOTED: Serono files sBLA for Rebif; Germany's Ingenium raises €9.2M in VC; and much more...

Mon, 03 Apr 2006 20:00:50 -0400

> Switzerland's Serono has filed a supplemental BLA for a new formulation of its MS drug Rebif. According to Phase III data, the new formulation is more easily tolerated by patients. Report

> Achillion Pharmaceuticals has filed for a $75 million IPO. Report

> Germany's Ingenium has raised €9.2 million in its fourth round of venture capital. Release

> Unhappy Chiron shareholders were won over by Novartis' newly sweetened bid offer, paving the way for a merger. Report

> The FDA has granted a priority review for Avanir Pharmaceuticals' Neurodex, a drug for under-treated emotional disorder. Report

> The FDA has granted priority review for Remicade as a treatment for pediatric Crohn's disease. Report

> Chutes & Ladders: SIGA Technologies' CEO Kasten Bernard has resigned. Report

> Canada's Bioniche Life Sciences announced that the FDA has given its approval for a second Phase III trial of an experimental bladder cancer therapy. Article

> ArQule is reporting positive Phase I data for ARQ501, its lead cancer therapy. Release

> Halozyme Therapeutics says that preclinical and Phase I data for Chemophase supported the safety profile of the enzyme-chemo combination for bladder cancer. Release

> Biosite and Oxford Genome Sciences have announced a collaboration to evaluate protein-based disease markers for colorectal cancer. Release

> In a preclinical data presentation Antisoma said that data showed that a combination of its AS1404 and Avastin performed markedly better than Avastin alone in inhibiting the growth of human colon and lung tumour xenografts. Release

And Finally... California plays a leading role in the spread of influenza, and researchers are struggling to find out why. Article

Spectrum acquires Targent cancer assets

Sun, 19 Mar 2006 19:01:36 -0500

Spectrum Pharmaceuticals is buying Targent's cancer drug assets in a deal that could potentially be worth more than $6.5 million. Spectrum will pay Target 600,000 shares for the cancer assets, which primarily involves levofolinic acid, and up to 650,000 shares more for certain regulatory and sales milestones. An NDA has been filed for levofolinic acid as a therapy for bone cancer. The drug has been assigned orphan status as a combination therapy with existing chemotherapies for bone cancer and colorectal cancer.

- here's the AP report for more

Erbitux approved for head and neck cancers

Wed, 01 Mar 2006 19:01:36 -0500

The FDA has approved ImClone's Erbitux for head and neck cancer, the first new therapy for those indications in almost half a century. "This is the first drug approved for head and neck cancer that has shown a survival benefit in this population," the FDA said. The approval came for head and neck cancer that couldn't be removed by surgery. Merck, which markets the therapy in Europe, said last week that a European drug committee issued a favorable opinion of Erbitux for head and neck cancer. Erbitux was originally approved for colorectal cancer.

- read this report from TheStreet.com for more information

Safety concerns halt Avastin trial

Sun, 12 Feb 2006 19:01:39 -0500

Genentech and Roche Holdings, its majority owner, have suspended enrollment in a Phase III trial of Avastin for colon cancer after the deaths of four patients. Three of those four patients were younger people taking Avastin with Xeloda, which particularly troubled researchers. The news immediately hit shares of Roche in early trading. Researchers are exploring the utility of Avastin as an adjuvant therapy for post-surgical colon cancer. The Data Safety Monitoring Board believes that the rapid enrollment of 200 patients a month may have hindered proper safety evaluations.

Genentech said that it was right to temporarily halt enrollment so they could do a thorough analysis of safety data. Avastin is approved for colorectal cancer in patients whose disease has metastasized, an indication that should earn the companies $1.5 billion this year. Analysts doubted that the trial setback would create any significant long-term damage for either company's earnings.

- read this article from the Financial Times

VC: Celladon pockets $30M

Wed, 14 Dec 2005 19:01:32 -0500

Celladon pockets $30 million in funds.

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Celladon La Jolla, CA	$30M second	Kleiner Perkins Caufield & Byers	The funding will enable Celladon to complete preclinical testing and advance Mydicar, its product to improve calcium handling in failing hearts
Domantis Waltham, MA	$29M second	Novo Nordisk, MC Life Science Ventures	The financing will go to developing Domantis' twelve lead programs for treating major diseases including COPD, rheumatoid arthritis, asthma and colorectal cancer
Optimer Pharmaceuticals San Diego	$22.2M fourth	ProQuest Investments	Money will go to development of PAR-101, a narrow-spectrum antibiotic to treat Clostridium difficile-related diarrhea
Cellartis Sweden	8M euros N/A	Bio Fund Management	The financing will allow Cellartis to accelerate drug discover and move forward with the company's planned international expansion
Lpath Therapeutics San Diego	$6M N/A	Roaring Fork Capital SBIC	Proceeds will move the company toward an IND filing of cancer drug Sphingomab and development of second product candidate.
AngioChem Quebec	$6M N/A	BDC Venture Capital	AngioChem expects to file an IND for the treatment of brain cancer in late 2006.

Domantis pockets $29M in new venture funds

Sun, 11 Dec 2005 19:01:36 -0500

Domantis has raised $29 million in new venture funds. New investors Novo Nordisk and MC Life Science Ventures--a subsidiary of Mitsubishi Corporation--led the round. "Domantis' twelve lead programs are based on novel dAb products for treating major diseases including COPD, rheumatoid arthritis, asthma and colorectal cancer," said Domantis CEO Robert Connelly. "This financing, together with the growing revenue stream from our nine partnerships, provides sufficient resources to fund the clinical development of these programs." Domantis is based in Waltham, MA and the UK.

- read this release for more information

ALSO NOTED: Roche, Protein Design expand collaboration; Mesalamine studies hit endpoints; Wyeth wins fen-phen judgments; and mu

Mon, 31 Oct 2005 19:00:50 -0500

> Roche and Protein Design are expanding their collaboration on daclizumab, with Roche paying $10 million up front. Report

> Two Phase III clinical studies of an advanced formulation of high-strength mesalamine, SPD476, being developed by Shire met their primary endpoints. Release

> Wyeth has won a favorable judgment in three lawsuits regarding fen-phen. Report

> Chutes & Ladders: NeoPharm has chosen Guillermo A. Herrera, formerly with Abbott Laboratories, as its new CEO. Report

> Schering-Plough is seeking Japanese approval for Temodal as a therapy for malignant glioma. Release

> American Pharmaceutical Partners and American BioScience have published Phase I data for Abraxane as a therapy for patients with advanced cancer. Release

> Human Genome Sciences has released safety and tolerability results from a Phase II study of HGS-ETR1 (mapatumumab) in patients with advanced colorectal cancer. Release

And Finally... Canadian researchers say that ginseng can play a small but significant role in reducing the number and severity of colds suffered. Article

Enrollment is suspended in Avastin trial, Genentech shares slide

Thu, 22 Sep 2005 20:01:39 -0400

Shares of Genentech took a hit this morning after researchers announced they were halting enrollment in a Phase II trial of Avastin for ovarian cancer. Five of 44 patients in the study had a perforation in their gastrointestinal tract. People taking the drug will be informed of the risk and may be taken off the drug. Avastin is currently approved for colorectal cancer but has demonstrated widespread utility in other cancers.

- read this report from TheStreet.com for more

ALSO NOTED: NexMed in licensing deal with Novartis; Sanofi touts new Taxotere data; U.S. buying $100M in vaccines; and much mor

Wed, 14 Sep 2005 20:00:50 -0400

> NexMed has licensed an experimental nail fungus treatment to Novartis for $4 million plus up to $47 million more in milestone payments. Report

> Sanofi-Aventis is touting new, interim data from a Phase III trial of Taxotere for breast cancer. Release

> Sanofi Pasteur has signed a $100 million deal to produce vaccines for the U.S. government that could be used to fight the H5N1 influenza virus strain. Release

> UCB said it will file for U.S. and European approval for its experimental anti-epilepsy drug Keppra, saying it demonstrated "non-inferiority" with standard therapies in a late-stage trial. Story

> Chutes & Ladders: AstraZeneca has named Tony Zook to head up its U.S. operations. Report

> Impax Laboratories has received final FDA approval for its generic version of Glucophage XR. Release

> The FDA is warning doctors to monitor patients taking Erbitux for colorectal cancer for an hour after each injection to check for troubling side effects that may occur. Story

> Spectrum Pharmaceuticals will raise $42 million through a stock offering. Story

And Finally… Eli Lily has boosted its pledge for Katrina relief to $3.7 million in aid, more than double what it first announced. That figure is likely to grow. Story

SPOTLIGHT: Emclone seeks expanded Erbitux approval

Mon, 29 Aug 2005 20:01:33 -0400

Imclone has filed for regulatory approval for a new use for Erbitux. Approved in early 2004 for colorectal cancer, Imclone is asking the FDA to approve expanded use for squamous-cell carcinoma of the head and neck. Story

ALSO NOTED: Lilly wins patent fight; Canada OKs Tarceva; Vioxx trial begins; and much more...

Wed, 13 Jul 2005 20:00:50 -0400

> A US appeals court has upheld Eli Lilly's patent on Sarafem for premenstrual stress. Teva had challenged the patent saying it is an exact copy of Prozac, which is no longer under patent protection. Report

> Cryocor has priced its IPO at $11 per share. Report

> Canadian regulators have approved OSI's Tarceva for lung cancer. Report

> The first trial of Vioxx is set to begin after a jury was selected in the small Texas town of Angleton. Story

> Merck has acquired most of the global rights for the cancer treatment UFT for the treatment of colorectal cancer from Taiho Pharmaceutical. Release

> Acambis has launched a Phase II trial of a weakened smallpox vaccine for patients unable to take a full dose. Report

> The FDA has approved Ranbaxy's anti-retroviral drug Zidovudine for use outside the US. Story

And Finally... Scientists report that they have discovered a simple therapy to reduce the high risk of death from SARS. Article

SPOTLIGHT: ImClone pushes new indication

Sun, 19 Jun 2005 20:01:33 -0400

Following the successful conclusion of trials into Erbitux for head and neck cancer, ImClone says it will seek expanded use of the cancer drug in the third quarter. Erbitux is currently indicated for colorectal cancer. Story