The Massachusetts attorney general joined that federal lawsuit accusing Johnson & Johnson of paying kickbacks to push the antipsychotic Risperdal and other drugs into nursing homes. AG Martha Coakley didn’t stop there; however, her office is also investigating other companies that market antipsychotics to nursing homes in the state.

At issue is whether drug companies are touting antipsychotic drugs for unapproved uses, such as dementia. The FDA has warned that use of the atypical antipsychotics in elderly dementia patients can increase the risk of death. “The inappropriate off-label marketing of antipsychotic drugs to nursing homes is a significant health and safety issue for our seniors,” Coakley says in a statement released by her office (as quoted by the Boston Globe). “We have taken strong action on this issue in the past and are continuing to monitor it very closely moving forward.”

The federal lawsuit was filed in January by the U.S. attorney in Boston. It alleges that J&J paid millions of dollars to nursing-home pharmacy provider Omnicare, which in turn would incentivize nursing homes to buy Risperdal. Sales of J&J products to Omnicare almost tripled during that time, to $280 million from $100 million, the suit claims. J&J denies any wrongdoing. Spokeswoman Carol Goodrich told the Globe that “airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.”

Source: FiercePharma

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The Orphan Drug Act has been around since 1983 offering tax incentives and competition protection for drugs aimed at treating rare diseases. But there have been relatively few orphan drugs developed, so the FDA is beating the bushes for more participation.

FDA staffers recently ran a two-day workshop in Claremont, Calif., to help drug developers fill out the application to get orphan-drug status, the WSJ says in an article this morning. Another workshop is planned for the University of Minnesota in August and there’s talk about doing one in Europe.

There are roughly 350 orphan drugs currently approved, covering about 150 rare diseases. The core requirement for orphan status is that the medicine treats a disease affecting fewer than 200,000 Americans, a limited market that often makes such treatments very expensive. Last year, 250 requests for orphan designation were filed with the FDA, and 160 received it.

Of course, getting more applications doesn’t mean more drugs will make it through the FDA approval process, orphan status or not, the WSJ notes. But the FDA officials with the orphan program hope that increasing the application pool will boost the chances of getting more rare-disease treatments to market.

The first workshop drew 29 potential sponsors, three-quarters of which said they had never filed an orphan-drug application before. Not that the process is really that hard. “It’s not ‘War and Peace,’ ” an FDA official told the WSJ. “The applications are six or seven pages.”

Source: The Wall Street Journal

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U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc’s Fosamax and certain thigh bone fractures.

The Food and Drug Administration issued its statement following the publication of case reports of atypical subtrochanteric femur fractures — or fractures in the bone just below the hip joint — in women with osteoporosis using oral bisphosphonates.

Bisphosphonates are a class of drug aimed at preventing bone fractures and offsetting bone loss associated with menopause.

They include Fosamax, Roche Holding AG’s Boniva, Novartis AG’s Reclast and Procter and Gamble Co’s Actonel.

In June 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications.

The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue.

Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.

But in 2008, the FDA said the drugs showed no overall risk of heart problems. The agency’s review followed reports in the New England Journal of Medicine of serious atrial fibrillation, a type of abnormal heartbeat.

In January, a Manhattan federal judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill.

Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.

“In clinical studies, Fosamax has not been associated with increased fracture risk at any skeletal site,” Merck spokesman Ron Rogers said in a statement.

“Low energy femoral shaft and subtrochanteric fractures have been reported in the medical literature as occurring in non-bisphosphonate users,” Rogers noted, adding that Merck is currently conducting studies “to further investigate the issue of low energy femoral shaft and subtrochanteric fractures.”

The FDA recommended patients keep taking their medication unless told not to by their doctor. It also recommended that healthcare professionals be aware of a “possible risk” of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.

Source: Reuters

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Eli Lilly, Amylin and Alkermes will be holding their collective breath this Friday when the FDA will reveal whether it will approve Byetta LAR, the long-acting form of the bestselling diabetes drug Byetta. Thanks to technology from Alkermes that helps the drug stay in the patient’s bloodstream, Byetta LAR can be administered just once a week rather than requiring twice-daily injections.

What’s at stake for these companies? Amylin has the most invested. An approval could provide the drugmaker with billions in revenues for years to come. According to the Wall Street Journal, one analyst projected $2.1 billion in sales for the drug by 2015, while another industry watcher predicts $3 billion in U.S. sales. For Lilly, Byetta LAR would boost a product lineup that’s facing one of the steepest patent cliffs in the coming years. And Alkermes is set to reap 7.5 percent royalty on worldwide sales.

Xconomy’s Luke Timmerman maps out the four possible outcomes from the FDA’s decision Friday:

The FDA approves Byetta LAR with only a standard warning, though JP Morgan analyst Cory Kasimov says there’s not much chance of that happening.

Byetta LAR could be approved, but with a severe black box warning about the possibility of patients developing thyroid cancer.

Third–most likely, according to Kasimov–the FDA will delay its response and ask for additional, but minor, data on the drug. In that case, the companies could still have an approval in hand by the end of 2010.

Finally, the worst-case scenario: FDA could issue a “complete response” letter asking for major new set of data that would severely delay the drug’s approval. If that happens, look for Amylin stock to lose half its value and Alkermes to dive about 33 percent.

Needless to say, the stakes are high for all involved.

Source: FierceBiotech

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An FDA expert panel voted 9-3 Tuesday in favor of InterMune’s Esbriet (pirfenidone), a treatment for idiopathic pulmonary fibrosis. IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. If approved, Esbriet would be the first treatment for U.S. IPF sufferers. The treatment has already received approval in Japan on the condition that there will be a post-marketing period during which the drug won’t be widely available until further data are available.

Not all the panelists were convinced of the drug’s efficacy; however, most voted that the potential benefits of the drug outweighed these concerns. “I voted yes because I’ve been straight down the middle the entire time. I didn’t see substantive evidence of efficacy per the FDA regulations but there was clinical meaningful effect on the disease. You need to offer patients hope. If this offers a smidgen of hope, then it is worth approving,” one panelist said, according to TheStreet’s Adam Feuerstein. Added another, “I voted yes, opposite of my vote on the question of substantial efficacy because I don’t believe there is substantial evidence of efficacy; but if I got this disease, I’d be on the next Delta flight to Japan.”

The FDA doesn’t have to follow the panel’s recommendations, but it usually does. In a conference call, CEO Dan Welch said that if the drug is approved, it may take the company some time to ramp up production. “We chose not to make certain investments in commercial or other areas of the company until we had visibility from this meeting. So one should not expect that Esbriet would be available immediately after the approval.”

During the call, analysts also attempted to suss out how InterMune would price the biologic if approved. InterMune also manufactures Actimmune, a treatment for chronic granulomatous disease that’s been used off-label for the treatment of IPF. On-label, Actimmune runs in the range of $8,000 to $20,000 per year. When used off-label for IPF patients, the annual cost price per year shoots up to $50,000. “I don’t know what you draw from that,” noted Welch, unwilling to reveal the possible price of Esbriet. A final decision is expected May 4.

Source: FierceBiotech

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Another day, another stock-price jump.

First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.

The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.

This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s advisory committee meeting weren’t uniformly negative.

The stock price then barely budged yesterday and trading in the shares was halted today in anticipation of the meeting news. But in after-hours trading today, the news sent the shares soaring up 65% to $38.43. That compares with the stock’s price under $15 at the close last Thursday.

The experts voted 7-5 on the question of data for pirfenidone showing “substantial evidence” of effectiveness. The medicine passed the safety vote 9-3. InterMune had told the panel that “pirfenidone provides a clinically meaningful benefit to patients by reducing decline in lung function.”

Panel member Leslie Hendeles of the University of Florida told Dow Jones Newswires that he didn’t think the data met FDA’s substantial-effectiveness test, but he voted in favor of the medicine because he would want a chance to take the drug if he were diagnosed with pulmonary fibrosis.

The FDA is giving the InterMune drug candidate a priority review process that’s reserved for advances over existing treatments. There aren’t any FDA-approved drugs now for IPF. Here’s more on the disease.

Source: The Wall Street Journal

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Ever wonder how the cancer drug Sutent made it to market? Barely, according to a behind-the-scenes piece from Bloomberg. The drug almost hit the R&D discard pile back in 2003, said Dr. George Demetri, an oncologist who was involved in testing it. It was a meeting with FDA officials encouraged by the data that got the drug back on track, Demetri said.

Sutent has gone on to prove effective for both kidney cancer and gastrointestinal stromal tumors–and to become one of the more expensive cancer drugs on the market at around $50,000. But even at that price, it’s become key to a treatment approach known as daisy-chaining, in which patients use one drug until it stops working, then move on to another. Some patients have survived as long as seven years this way.

“Improving cancer survival rates are a real success story that sometime get lost in the noise over our healthcare system,” Douglas Blayney, president of the American Society of Clinical Oncology, tells Bloomberg. “Targeted drugs are driving that survival in a major way.”

Is paying for that survival sustainable? In Sutent’s case at least, even the U.K.’s cost watchdog thinks so; the National Institute for Health and Clinical Excellence finally OK’d the drug after Pfizer agreed to pay for the first cycle of treatment, which should weed out the patients who just won’t respond to the drug at all.

But taken together with other expensive therapies, some experts doubt that society can keep paying for such costly treatment. “All the recent health policy talk is that in the U.S. we don’t ration, but that isn’t a true statement,” said UnitedHealth Group’s SVP Lee Newcomer. “We just keep pricing more and more people out of the ability to afford health insurance.”

Source: FiercePharma

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The FDA has approved Cell Therapeutics’ facility to manufacture Pixuvri (pixantrone), an experimental cancer drug that is currently under review. The NerPharMa facility, which belongs to Nerviano Medical Sciences, is based in Nerviano, Italy. “FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved,” says Craig Philips, president of CTIC.

Cell Therapeutics’ closely-watched pixantrone is a potential treatment for relapsed/refractory aggressive non-Hodgkin’s lymphoma. The FDA’s decision will be a make-or-break moment for the struggling developer, with many analysts expecting the FDA to rule against the drug. FDA staffers have raised questions about the treatment, expressing concerns about both the drug’s effectiveness, as well as its safety profile. An ODAC meeting is scheduled for March 22, and the FDA is expected to make a final decision on approval of the NDA for pixantrone by April 23.

Source: FierceBioteck

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That U.S. Senate probe of GlaxoSmithKline and its diabetes drug Avandia may not yield any new regulatory action. But with more than 13,000 personal injury lawsuits outstanding, UBS analysts say, the company could be looking at a multibillion-dollar liability.

The safety of Avandia has been open to debate for almost three years now, and the Senate report didn’t bring up anything entirely new about the drug’s risks. The FDA already was planning to look at safety info on the diabetes med again, with a new advisory panel meeting on the schedule for this summer. The worries focus on a.) political pressure from the Congressional committee that sponsored the probe; and b.) those lawsuits.

“[O]ur concerns are solely on personal injury lawsuits,” UBS analyst Gbola Amusa said. Experts polled by UBS put the potential liability at anywhere from $1 billion to $6 billion; the bank itself expects something less than $3.5 billion. “Bellwether trials start from 1 June and will help narrow our liability range,” Amusa also notes.

Source: FiercePharma

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The FDA staff said it has a bunch of questions about InterMune’s new drug to slow deteriorating lung functioning. But investors figure the concerns weren’t as bad as they could have been, sending the biotech’s shares soaring.

The stock jumped as much as 74% after FDA reviewers said only one of InterMune’s two late-stage trails for the experimental drug pirfenidone had met its main goal and added that “the clinical significance of the treatment effect size is uncertain.” The FDA documents, which were released ahead of an advisory panel meeting to discuss the drug Tuesday, also had a mix of other things to say.

All things considered, an Oppenheimer analyst noted the “tone was less negative than expected,” all things considered and there was room for the drug to still get FDA approval. The shares settled down in later trading, but still finished up nearly 60% for the day.

InterMune often appears on lists of likely biotech takeover candidates. FDA approval of pirfenidone would give it two drugs on the U.S. market.

The new drug would treat idiopathic pulmonary fibrosis, which affects about 200,000 Americans, the majority of whom eventually die of respiratory failure. The FDA noted that there aren’t any approved drugs to treat IPF, although drugs like corticosteroids and drugs that suppress the immune system are used, according to Dow Jones Newswires.

The company also put out material noting that “the slowing of progression in loss of lung volume constitutes a clear benefit to patients,” Reuters said.

Source: The Wall Street Journal

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