Continue reading Sanofi-Aventis Breast Cancer Drug Fails

Sanofi-Aventis Breast Cancer Drug Fails originally appeared on BloggingStocks on Fri, 28 Jan 2011 14:00:00 EST. Please see our terms for use of feeds.

Bristol-Myers Squibb (BMY) cancer drug rejected originally appeared on BloggingStocks on Fri, 21 Nov 2008 13:48:00 EST. Please see our terms for use of feeds.

Genentech (DNA) soars on Avastin breast cancer approval originally appeared on BloggingStocks on Mon, 25 Feb 2008 11:59:00 EST. Please see our terms for use of feeds.

That the FDA has granted accelerated approval to Genentech (NYSE: DNA) for Avastin for the treatment of patients with breast cancer is not just big news for the company, but great news for women around the world in their fight against the dreaded cancer.

"There is no cure for metastatic breast cancer, so it is important to control the disease as early and for as long as possible," said Kathy Miller, M.D., Associate Professor of Medical Oncology, Indiana University School of Medicine and lead investigator on the E2100 trial. "Now with Avastin plus Paclitaxel, we can increase the time a woman's cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone."

"As an oncologist who has treated women with metastatic breast cancer, I know how important the first course of therapy can be," said Susan Desmond-Hellmann, M.D., M.P.H., president, Product Development, Genentech. "New treatments are needed, and this approval provides women who have not yet received chemotherapy for their metastatic breast cancer a new option to consider with their physician and families."

Continue reading FDA approval great for Genentech and Women

FDA approval great for Genentech and Women originally appeared on BloggingStocks on Sun, 24 Feb 2008 09:40:00 EST. Please see our terms for use of feeds.

Huge biotech firm Genentech, Inc. (NASDAQ: DNA) had high hopes that its drug Avastin would be effective in treating breast cancer patients. The product is currently used for colon and lung cancer and brought the company about $1.7 billion last year. One source said that the drug has brought in almost $2.65 billion so far this year.

The FDA turned Genentech down. According to The Wall Street Journal, an agency panel "on a 5 to 4 vote, said the data provided by the company wasn't sufficient to provide a favorable risk benefit analysis for Avastin." Many on Wall Street had expected the drug to get the green light. Jim Reddoch of Friedman Billings Ramsey looked particularly foolish when he predicted this morning that "a Food and Drug Administration panel will recommend Genentech Inc.'s drug Avastin be approved as a breast cancer treatment." Hopefully, the firms clients did not follow his lead.

When the news hit, Genetech's shares dropped 9% to $66.29, a new 52-week low.

The lesson in all of this is that listening to guesses from research firms can be a dangerous game. Better to wait and see what the feds say.

Douglas A. McIntyre is an editor at 247wallst.com.

Genentech's latest drug fails FDA approval originally appeared on BloggingStocks on Wed, 05 Dec 2007 18:57:00 EST. Please see our terms for use of feeds.

Genentech (NYSE: DNA) is halted down $6.65 to $66.13. The FDA's Oncologic Drugs Advisory Committee rejected Avastin for the use in breast cancer. As of Dec. 31, 2006, Roche Holdings owned a 55.8% position in DNA. DNA call option volume of 83,833 contracts compares to put volume of 46,382 contracts. DNA December option implied volatility of 50 is above a level of 33 from an hour ago and its 26-week average of 25 according to Track Data, suggesting larger price risk.

Daily Options Update is provided by Stock Specialist Paul Foster of theflyonthewall.com

Option update 12-5-07: Genentech volatility spikes as FDA rejects Avastin originally appeared on BloggingStocks on Wed, 05 Dec 2007 14:51:00 EST. Please see our terms for use of feeds.

Peregrine Pharmaceuticals Incorporated (NASDAQ: PPHM) is in such poor financial shape that it has been delisted has received a notice of its failure to meet continuing NASDAQ Capital Market requirements and may soon be delisted. The stock is currently priced at $0.70 and does not publicly trade.

Why should investors care whether a small biopharmaceutical company implodes like so many long-ago dot coms? Because Peregrine is running several important clinical trials testing whether its product, bavituximab, might be another weapon in the fight against prostate and breast cancers, diseases which kill tens of thousands of Americans every year. In the fight against cancer, every likely beneficial treatment scenario needs to be pursued aggressively.

Peregrine recently raised $21 million from institutional investors in order to fund the continued collection of data in its clinical trials. This is good news, except that the clinical trials are being run not in the US, but in India where there are fewer patient protection policies and data collection and analysis is much cheaper to produce. Presumably, credible evidence from the India clinical trials will convince the FDA to allow clinical trials using bavituximab in the US.

A recent piece of good news for Peregrine is that the Department of Defense is investigating whether bavituximab may be effective in treating hemorrhagic fever. It is possible that Peregrine will be awarded a five-year contract worth almost $45 million to develop treatment protocols and run clinical trials investigating this use of its product. Such a contract would help Peregrine immensely. In its most recent quarterly report, Peregrine recorded a net loss of $4.65 million, less than last year's $5.45 million loss, but hardly good news. Peregrine did post $1.6 million in earnings from its wholly owned contract drug manufacturing subsidiary Avid Biosciences. If bavituximab does prove effective in the fight against some types of cancer, and if the drug does win FDA approval for use in the U.S., then Peregrine will have in-house manufacturing facilities. The need for such expertise currently seems a long ways away for Peregrine, which may be an attractive buy-out candidate by a much larger pharmaceutical company.

Peregrine Pharmaceuticals (PPHM) may be delisted; clinical trials at risk originally appeared on BloggingStocks on Fri, 14 Sep 2007 08:29:00 EST. Please see our terms for use of feeds.

Pfizer (NYSE: PFE) is looking for additional uses for its popular drug Viagra in order to keep up sales when its patent expires in a few years. One possible use for Viagra is being studied at Henry Ford Hospital in Detroit. The study is to determine whether patients who have suffered moderate strokes will recover more rapidly if given Viagra within 7 days of stroke symptoms. Can the brain on Viagra form new blood vessels and nerve connections better than without Viagra?

In another clinical trial, Viagra, repackaged in white (not blue) 20 milligram pills and renamed Revatio, is used to treat pulmonary hypertension, a lung disorder affecting both adults and children. So we should give our kids a form of Viagra with their Flintstones vitamins? Pfizer has come under some criticism for the cost of Revatio compared to that of Viagra. Taken 3 times per day as Revatio, the drug costs $33.50 per day or over $11 per 20 milligram pill. Taken as Viagra in 100 milligram doses, the drug costs just over $11 per pill. Pfizer argues that the 20 milligram pill costs as much as the 100 milligram pill because of the increased costs to gain federal approval for use in an entirely new group of patients.

Viagra is also being studied for possible use in treating high blood pressure in pregnant women and to ease menopause symptoms. This last use has been challenged recently, particularly by a group of women in Utah. According to an article by Brooke Adams in The Salt Lake Tribune, at least 75 women have joined together to form a class action suit against Pfizer. The women claim that taking Pfizer's Provera, synthetic progesterone, to control menopause symptoms caused them to develop breast cancer.

Pfizer trying to keep up Viagra use originally appeared on BloggingStocks on Mon, 05 Mar 2007 10:29:00 EST. Please see our terms for use of feeds.