Senator Herb Kohl, who chairs the Special Committee on Aging, sent letters to AstraZeneca, GlaxoSmithKline, Eli Lilly, Novartis, Pfizer, and Sanofi-Aventis.

Kohl said Americans on average pay twice as much as people in other industrialized countries.

“While I firmly believe that drug quality should not be sacrificed for cost, the large discrepancies in the cost of identical drugs cannot be explained by differences in production or manufacturing,” Kohl wrote to the companies.

Some Democrats have attacked drugmakers as the U.S. Congress works on an overhaul of U.S. healthcare system.

The pharmaceutical industry has pledged to pay $80 billion over 10 years in price cuts and other concessions to help fund wider insurance coverage as part of a healthcare overhaul under consideration in Congress.

Some lawmakers have criticized that amount as a small price to pay for a $315 billion-a-year industry that stands to gain tens of millions of new customers if insurance coverage expands. Democrats are trying to pass a final bill for President Barack Obama to sign into law in the coming weeks.

Eli Lilly, responding to Kohl’s letter, said drug prices were lower in other countries for various reasons including currency value, market dynamics or government price controls.

The United States “relies on competition rather than government-imposed price controls that contain costs” and U.S. patients “have the greatest access to the newest medicines,” Lilly spokesman Ed Sagebiel said.

Pfizer spokeswoman Kristen Neese said the company “stands behind the value our innovative medicines bring to patients.” The company provides free or discounted medicines to uninsured other needy patients, she said.

Novartis is reviewing the senator’s request and will respond to the committee, a company spokeswoman said.

GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company had no comment.

Officials at other companies had no immediate comment or could not immediately be reached.

Source: Reuters

The settlement agreement also requires Sanofi to analyze its sales-rep compensation and, wherever disparities between men and women are found, to adjust pay accordingly. The company also has to be more equitable about promoting women; in the past, Sanofi had favored men over women for training courses that prepare employees for management, the suit claims. Finally, the company has to boost its female reps’ base pay, to the tune of $2 million now and up to nearly $10 million over the next three years, Pharmalot reports.

In fact, it’s this pay adjustment that’s the real win for women at Sanofi, as BNet Pharma points out. “Any female sales force employee who receives an upward base pay adjustment will then receive future pay raises from a higher base-level salary,” the settlement states, “thus potentially having a significant future impact on class members’ total compensation.”

Source: FiercePharma

Astellas’ nominees include some well-known biotech faces, including Aptuit founder Michael A. Griffith and Jill Kanin-Lovers, a veteran of the Alpharma board. They’ll be expected to make the case that a combination of OSI and Astellas would help generate faster progress in the development of new cancer therapies.

OSI’s major objection to the Astellas bid, of course, has nothing to do with R&D synergy. The OSI board has shunned Astellas’ $52-a-share offer as far too low. And investors were quick to bid up the share price several dollars past that point in anticipation of a higher offer. To help nudge things along, OSI said yesterday that it is in talks with other potential buyers, including some unnamed Big Pharma players.

In a follow-up release, OSI said that it “believes the Astellas director nominees’ only mandate is to support Astellas in acquiring OSI at an inadequate price.”

Source: FierceBiotech

That’s lots of growth and lots of sales. And if the big kahunas of pharmaceuticals don’t change quickly, they’ll miss out on the lion’s share. Right now, the top 15 drugmakers get less than 10 percent of their sales in these fast-growth areas. That average masks big individual differences, but even the emerging markets pioneers risk losing out to local drugmakers with their local distribution networks and local manufacturing–not to mention local drug approvals.

“Our experience points to the clear advantages that exist for the early movers,” IMS Health’s David Campbell says in a statement. “Pharmaceutical manufacturers that lead in building out organizational competencies, tailoring portfolios and adapting business models to these new markets will reap the benefits of differentiation and entrenched presence compared to those that wait.”

Source: FiercePharma

Cancer cells spread and grow because they can divide indefinitely.

But a study in mice showed that blocking a cancer-causing gene called Skp2 forced cancer cells to go through an aging process known as senescence — the same process involved in ridding the body of cells damaged by sunlight.

If you block Skp2 in cancer cells, this process is triggered, Pier Paolo Pandolfi of Harvard Medical School in Boston and colleagues reported in the journal Nature.

And Takeda Pharmaceutical Co’s experimental cancer drug MLN4924 — already in early-stage clinical trials in people — appears to have the power to do just that, Pandolfi said in a telephone interview.

The finding may offer a new strategy for fighting cancer.

“What we discovered is if you damage cells, the cells have a built-in mechanism to put themselves out of business,” Pandolfi said. “They are stopped irreversibly from growing.”

For the study, the team used genetically altered mice that developed a form of prostate cancer.

In some of these, they inactivated the Skp2 gene. When the mice reached six months of age, they found those with an inactive Skp2 gene did not develop tumors, while the other mice did.

When they analyzed the tissues from lymph nodes and the prostate, they found many cells had started to age, and they also found a slow rate of cell division.

This was not the case in mice with normal Skp2 function.

They got a similar effect when they used the Skp2-blocking drug MLN4924 in lab cultures of human prostate cancer cells.

To see if this would work in mice, they transplanted the cells and treated the mice with the drug.

“We put human cancer cells into mice. We fed them with a drug and these cells do senesce (age),” Pandolfi said.

“The same mechanism of damage caused by the sun can be evoked pharmacologically in cancer cells.”

He said this Skp2-related aging pathway appears to be active in cancer, and not other cells. “We have no intention of aging the patient. But only the cancer,” he said.

Source: Reuters

In a clinical trial, 110 people had electrodes implanted in their brains and their seizures were monitored.

Forty-one per cent of patients showed a reduction in seizures after 13 months while 56% experienced a reduction after two years.

The patients all suffered from regular epileptic seizures and had failed to respond to drug treatment.

Deep brain stimulation (DBS) is a surgical treatment involving the implantation of a medical device called a brain pacemaker, which sends electrical impulses to specific parts of the brain.

In the group of patients who received brain stimulation, researchers noted a 41% reduction in seizures compared to a 14.5% decline in seizures in a control group. This group did not receive stimulation.

Invasive therapy

Epilepsy is a common neurological disorder which is characterised by recurrent seizures. These seizures can cause temporary loss of consciousness, convulsions, confusion or disturbances in sensations.

According to the World Health Organization, epilepsy affects 50 million people worldwide.

Previous studies indicate that one third of those with epilepsy do not respond to anti-epileptic drugs.

Dr Robert Fisher, director of the Epilepsy Centre at Stanford University and lead author of the study, said electrical deep brain stimulation does reduce seizure frequency in patients.

But he cautioned: “DBS therapy is invasive and serious complications can occur. Additional clinical knowledge would help to determine the best candidates for DBS therapy.”

Simon Wigglesworth, deputy chief executive at UK charity Epilepsy Action, said: “We have been hopeful for some time that deep brain stimulation may be a treatment option for some people with epilepsy.

“This study is exciting news and could be an important development in the treatment of epilepsy in the 30% of people whose seizures don’t respond to traditional drug therapies.”

The research is published online in the journal Epilepsia.

Source: BBC NEWS

The Merckle family put Ratiopharm up for sale to raise money to pay down debts. The company has a couple of big inducements: Its solid position in Germany, Europe’s largest pharma market, and its role as a generics maker at a time when many top drugmakers are looking to diversify into that market.

So, the company has attracted quite a lot of interest; the bidders that remain include Teva Pharmaceutical Industries, the world’s largest generics maker, and Actavis, the generics firm based in Iceland that reportedly could take Ratiopharm public. Word is that Actavis’ offer is the largest now on the table at about 3 billion euros ($4.1 billion); sources have also said the winning bid could come in as high as $4.4 billion.

Pfizer reportedly has pledged to plow lots of money into growing Ratiopharm, making it the flagship of its new established products unit. However, it may also look at Stada as a “consolation prize” if it loses out on Ratiopharm, Reuters reports. And some see Stada as a better fit for the pharma giant. “It would make a lot of sense for Pfizer to look at [Stada] and, in fact, it is probably a more attractive fit because it also has some emerging market businesses which Ratiopharm doesn’t,” Reuters quotes one banker as saying.

Still, one can expect some drama over the next two days. Whatever the promises, whatever the bids, we’re likely to get news of a winner soon. The waiting is almost over.

Source: FiercePharma

Mapatumumab is designed to trigger apoptosis, or cancer cell death, a popular strategy in the cancer field. The antibody binds to a protein known as TRAIL receptor 1 and HGS is also studying it for multiple myeloma and hepatocellular cancer. The biotech says it will have progression-free survival data available from the multiple myeloma study in mid-2010 and expects to initiate the randomization stage of the hepatocellular cancer study before the end of 2010. Today’s release didn’t include any specific data readouts, though. Those will be released at a scientific meeting sometime later in the year.

HGS’ cancer program is its most advanced mid-stage product. But investors who have fueled a skyrocketing share price have been concentrating primarily on the far more promising prospect for Benlysta, which amazed the company’s closest observers with unexpectedly positive late-stage lupus results last year. HGS also faces an October 4 PDUFA date for its hep C drug Zalbin. HGS shares slid only about one percent after the cancer news was announced.

Source: FierceBiotech

Johnson & Johnson took over development of the medicine, bapineuzumab, when it bought Elan Corp.’s Alzheimer’s program last year. Patients continue to enroll in the study, said Eric Yuen of Johnson & Johnson’s Janssen Alzheimer Immunotherapy unit. Elan previously said recruitment for the first 18-month study of the drug was completed at the end of 2008, making results available as soon as this year. Pfizer Inc. is jointly developing the treatment and has its own studies under way.

The delay is because Johnson & Johnson is still adding patients. Three other studies are also recruiting subjects. Each study will conclude independently when the last person enrolled has completed 18 months of treatment, said Yuen, head of clinical development for Janssen Alzheimer Immunotherapy.

“This is bad news,” said Guillaume van Renterghem, an analyst at UBS AG in London, in telephone interview yesterday. The companies “were really hoping to get the data as quickly as possible. When Elan started the trial in 2007, people were talking $13 billion in sales for the world. Maybe it’s much, much smaller.” He has a “neutral” rating on Elan’s stock.

Bob Purcell, a spokesman for Elan, said March 16 in an e- mail that the Dublin-based company can no longer comment on the Alzheimer’s program. Elan retained a 49.9 percent stake in the Alzheimer’s Immunotherapy Program that it sold to Johnson & Johnson.

Clinical Impact

“We are conducting some of the largest-scale trials ever in Alzheimer’s disease,” Yuen said March 16 in an e-mailed comment. “When they are complete, we expect to have a very comprehensive understanding of the clinical impact of bapineuzumab.”

Alzheimer’s is a progressive illness that starts with mild forgetfulness and eventually robs patients of memories and independence. It afflicts 30 million people worldwide, a number that may exceed 100 million by 2050, according to Alzheimer’s Disease International, an advocacy group based in London. Existing drugs temporarily ease symptoms; none cure the condition.

There hasn’t been a new drug for Alzheimer’s since Namenda, from New York-based Forest Laboratories Inc., was approved in 2003. Almost a dozen drugs in mid- to late-stage testing have failed since then, according to data compiled by Bloomberg.

‘Very Ambitious’

Elan and Wyeth, acquired by New York-based Pfizer last year, started the third and final phase of testing for bapineuzumab in 2007. The companies initiated the trial six months before the results of the intermediate studies were available in a bid to get the drug to patients as quickly as possible.

“Initiating the trial before the phase 2 results were in – - they were very ambitious,” said van Renterghem of UBS.

Johnson & Johnson has begun an extension trial of two pivotal U.S. studies, known as 301 and 302, to track patients for two and a half years. The main portion of the 302 study in people with a genetic predisposition to Alzheimer’s is fully enrolled, while a portion dealing with brain imaging is still adding patients, Yuen said. Pfizer’s two studies are further back in the process, since regulators outside of the U.S. asked to examine the results of previous trials before enrollment began.

The four studies, involving 4,000 patients worldwide, were initially designed to look separately at patients in North America and elsewhere in the world. Now some European patients are taking part in the North American trials, and a few Americans are participating in other studies, Yuen said.

Separate Studies

The companies had planned to keep the studies separate so that they could file with the U.S. Food and Drug Administration if the North American portion concluded more quickly, said Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin. The mixing of the trials suggests that they may be having trouble getting enough patients, he said in a telephone interview.

“It’s unfortunate for patients and physicians who are looking for some progress in Alzheimer’s disease, but that’s the nature of things,” he said.

The drug’s potential is hard to call, van Renterghem said. He estimates $8 billion in annual sales if the drug makes it to the market worldwide, which he says is unlikely.

“The drug may show no disease modification properties, and then it’s almost dead,” van Renterghem said. “If it really works, and you indeed delay the progression of the disease by say four years, and you know how much an Alzheimer’s disease patient costs in terms of treatment, it’s absolutely massive. Finding out the answer to that question is key.”

Source: Bloomberg.com

“We anticipate filing an sNDA to the FDA during 2011 for what will be the second indication for Abraxane in the U.S,” says Patrick Soon-Shiong, M.D., executive chairman and founder of the firm. The drug is a solvent-free chemotherapy already approved for metastatic breast cancer.

The randomized Phase III study compared Abraxane to Taxol, both in combination with carboplatin. It completed enrollment of 1,052 patients in July 2009 at 102 sites globally and was led by Mark Socinski, M.D., at the University of North Carolina Lineberger Comprehensive Cancer Center. Significant improvement in overall response rate was the study’s primary endpoint.

Abraxane was developed using Abraxis’ nab® platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. By wrapping the albumin around the active drug, Abraxane can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel.

The drug is currently in various stages of investigation to expand applications for metastatic breast cancer as well as to advance into NSCLC, malignant melanoma, pancreatic cancer, and gastric cancer.

FDA approved Abraxane in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Abraxis reported that the drug brought in $314.5 million in revenue during 2009.

Source: GEN News