Palatin to cut staff, cancel work on ED drug
CRANBURY, N.J. Palatin Technologies announced that it would cut its staff by 30 percent and give up on turning its lead drug bremelanotide into a successor for Pfizer’s male enhancement drug Viagra, according to published reports.
The drug is a nasal spray that works through the central nervous system, had shown promise in early clinical trials as a treatment for both male and female sexual dysfunction.
But the Food and Drug Administration interrupted the company’s plans for the drug when last summer it raised question about spikes in blood pressure resulting from use of the drug. Palatin’s partner, King Pharmaceuticals dropped plans to develop the drug shortly thereafter.
Palatin already had instituted a round of job cuts after King bowed out last fall. The latest layoffs bring the company’s work force down to 45 people, a contraction that will save approximately $3 million per year, Palatin said in a filing with the Securities and Exchange Commission.
The company’s chief executive Carl Spana said Palatin was dropping development of bremelanotide as a sexual dysfunction drug entirely, but would refashion it as a treatment for shock due to blood loss.
Besides bremelanotide, the company is developing therapies for diabetes-related obesity in partnership with AstraZeneca. The biotech is also working on another drug to treat acute congestive heart failure and high blood pressure, plus a compound called PL-6983 that is designed to treat sexual dysfunction without bremelanotide’s blood pressure problems.
Study finds more than half of Americans regularly take prescription meds
FRANKLIN LAKES, N.J. For the first time, a majority of Americans with health insurance have some kind of chronic health condition, and young people have experienced the largest increases.
According to research released Wednesday by Medco Health Solutions that examined the prescription claims of around 2.5 million Americans, 51 percent of insured Americans took prescription drugs to treat chronic health problems in 2007. While the elderly still constitute the largest demographic such medications, nearly half of women aged 22 to 44 and a third of men in the same age bracket were also using them. Men and women in that age group experienced a 20 percent increase in use of drugs to treat chronic conditions between 2001 and 2007.
Among men in the 20 to 44 age bracket, drugs to treat hypertension and cholesterol were among the top four, showing an increase in heart disease in this group. Nearly 30 percent of children aged 19 and younger also took chronic medications, mostly to treat asthma, allergies, depression and attention deficit/hyperactivity disorder.
Avastin/Lucentis study may reverberate through industry
NORWALK, Conn. According to IMS Health, a new clinical trial that began this year by a research institute may change the relationship between payers and the pharmaceutical industry, the Financial Times reported.
The National Eye Institute has sponsored a $16 million head-to-head trial of Genentech’s drugs Avastin and Lucentis. Lucentis is approved to treat age-related macular degeneration and Avastin is used to treat cancer but, both drugs are very similar and physicians have been using Avastin off-label for AMD.
The problem with the off-label use is the cost, as a single dose of Lucentis costs $2,000 while a bottle of Avastin can be split up to cost only $40-$75 per injection.
IMS argues that if CATT, the Institute’s study, shows Avastin to be as safe and effective for AMD as Lucentis, it may pave the way for an increasing number of payers to take comparative drug studies out of the hands of the pharmaceutical companies, especially as databases of patients make it much easier to conduct such tests.
But it warns that the move may create a disincentive for companies to study such areas, and creates untested areas of who would approve Avastin for AMD following a late-stage Phase 3 clinical trial which was conducted without any of the usual early-stage testing regulators usually require.
The study is expected to conclude in 2010 and has no involvement with Genentech.