Pharma NewsBytes - Oct 13

Selected press releases - Sept 22nd-October 13th

• Vaccine may help pancreatic cancer patients [more]

• FDA Panel Backs New Alzheimer's Drug [more]

• AstraZeneca Says Crestor Starts Strongly [more]

• Pfizer hypertension drug OKed for heart failure[more]

Vaccine may help pancreatic cancer patients

Sept 22 (Reuters) - Researchers at the Memorial Sloan-Kettering Cancer Centre in New York reported that Antigenics' Oncophage vaccine produced encouraging clinical results and raised hopes for a new treatment for one of the deadliest cancers. Pancreatic cancer is not as common as other types of the disease but it is one of the most difficult to treat, because often by the time it is diagnosed it has already spread. More than 95 percent of sufferers die within two years of diagnosis, but three out of 10 patients who were treated in a pilot study with Oncophage are still alive between two and five years after treatment. "It is very early data but at least it is promising," Dr Robert Maki, who headed the trial, said in an interview. "Three people are still alive and their survival times without disease are five (for one) and two years for the other two." The ten patients were carefully chosen for the trial, which was delayed midway while the vaccine was improved, and all had operable tumours. But surgery is not an option for patients in whom the disease is too extensive. The overall survival of the 10 patients was 2.5 years. Oncophage is a personalised vaccine based on heat shock proteins (HSPs), molecules involved in immune system response, derived from the tumour of each patient. Maki said the vaccine is made in a three or four stage process using very standard chemical techniques and can be done in a few days. "The concept is that you use the vaccine several times in a row to stimulate the immune system maximally so that it tries to wipe out any microscopic disease that might remain (after surgery)," he said.[more].

FDA Panel Backs New Alzheimer's Drug

Sept 24 (Reuters) - Forest's new Alzheimer's disease drug, Memantine won backing from U.S. advisers on Wednesday and soon may be the first treatment approved for helping patients in the late stages of the mind-robbing illness. The advisers voted unanimously that memantine, was safe and effective for treating moderate to severe Alzheimer's, although panel members stressed the drug's benefits appeared modest. Studies showed a "very small effect ... but I feel it's been adequately and consistently demonstrated," said Dr. Claudia Kawas, a neurologist from the University of California at Irvine and the panel's chairwoman. Memantine is the Forest's most important new product candidate, and analysts predict annual sales will top at least $500 million. The drug is the first of a new type of medicines for treating Alzheimer's, the degenerative disease that afflicts an estimated 4 million Americans. Forest told the panel that studies showed memantine, either alone or with another Alzheimer's drug, slowed the decline in awareness, reasoning and daily function. Researchers evaluated thinking, memory and daily tasks such as washing and feeding themselves. Over about six months of treatment, patients given memantine generally fared better than those given a placebo. Some patients actually improved, but in most cases the drug appeared just to slow the worsening of symptoms. Memantine is believed to act by blocking glutamate transmission distinguishing it from other treatments that inhibit acetylcholine esterase. "It's likely the initial use will be toward severe or moderate to severe patients, but the drug's safety profile should let it be used more broadly over time," said Robert Hazlett, analyst at SunTrust Robinson Humphrey, who said peak sales could hit $750 million. Analyst Michael Hearle of Leerink Swann said he upgraded Forest's stock Wednesday to outperform from market perform, with a $60 price target. He predicted peak sales of $800 million by three years after launch. (Additional reporting by Kim Dixon in Chicago and Bill Berkrot in New York)[more].

AstraZeneca Says Crestor Starts Strongly

Oct 2 (Reuters) - AstraZeneca Plc said on Thursday its Crestor drug had got off to a strong start since its U.S. launch last month, winning more than 2 percent of new prescriptions for cholesterol-lowering medicines. "The start has been terrific," Chief Executive Tom McKillop said, ahead of an annual business update for analysts and investors at the company's U.S. headquarters in Wilmington, Delaware. Crestor, which is already on sale across much of Europe and Canada, is AstraZeneca's biggest new drug hope but Europe's second biggest drugmaker faces a formidable marketing challenge since the product is going head-to-head with Pfizer Inc.'s Lipitor, the world's top-selling medicine. AstraZeneca is relying on Crestor, which analysts think could eventually generate worldwide sales of more than $3 billion a year, to help offset declining sales of ulcer pill Losec, or Prilosec, which has been hit by generic competition.

Pfizer hypertension drug OKed for heart failure

Oct 8 (Reuters) - Pfizer, the world's largest drugmaker, on Wednesday said U.S. regulators approved use of its hypertension drug Inspra for patients with congestive heart failure who have suffered a heart attack. An estimated one-third of heart attack survivors develop heart failure, putting them at risk of other heart attacks and death. Heart failure, a condition in which the heart is unable to pump enough blood to the body, is one of the few types of heart disease that continue to grow. In clinical trials, patients who took Inspra along with standard therapies had a 15 percent reduction in death compared with controls. An estimated 5 million Americans have heart failure, often the last stage of chronic heart disease. Half of the 500,000 people who are diagnosed annually die within five years. Inspra is the first heart failure drug among a new class of medicines that work by blocking the hormone aldosterone, which controls levels of sodium and potassium in the blood. The U.S. Food and Drug Administration approved Inspra last year for treating high blood pressure. Some industry analysts expect the Pfizer medicine to post eventual annual sales over $1 billion, qualifying it as a blockbuster. [more]