FDA stopped short of approving what would have been the first therapeutic vaccine for prostate (or, really, any) cancer--but the prospect has clearly moved out of the domain of risk-taking biotechs and into mainstream pharma.

Earlier this month Dendreon received an "approvable" letter for Provenge (sipuleucel-T)--an immunotherapy product being tested for metastatic, hormone-refractory prostate cancer. FDA has requested more efficacy data.

Sanofi-Aventis, long a world leader in vaccine development and possessor of 25 percent of the market, has also named therapeutic cancer vaccines as a core area of its R&D focus. Its initial target is colorectal cancer, but it is also developing clinical programs for melanoma and lung cancer. The company plans to invest $350 million in cancer vaccines over the next decade, according to Jim Tartaglia, vice president of R&D at Sanofi-Pasteur, the drug giant's vaccine division.

"Scientifically, we know more about the human immune system--about how to turn it on and keep it on," he said. But he was also wary about overstating the role that cancer vaccines will play in treatment. He noted, for instance, that since chemotherapy already has an effect on the immune system, adding a vaccine to the treatment mix could lower the amount of chemo needed--reducing toxicity and side effects. "We're not thinking of these [vaccines] as a magic bullet," Tartaglia said. "We're thinking of these being used in combination therapies."

The debut of the first blockbuster vaccine--Wyeth's Prevnar for pneumonia in 2004--renewed interest in a market that many companies had concluded offered low returns on the high cost of investment and the special challenges of vaccine trials. AstraZeneca, Pfizer, and Novartis are among the companies over the past two years that gained a foothold in the market through acquisitions.

With more players angling for a piece of the market, companies are expanding their horizons beyond the obvious targets and going after diseases like hepatitis B and C, smallpox, and herpes simplex. For cancer, in particular, the market is expected to reach $8 billion by 2012, according to a November report from market research firm Kalorama Information.

The surge of interest has increased pressure on the market's stalwarts, which now have to vie with firms large and small. For instance, where Sanofi-Pasteur used to have 100 percent of the Canadian flu market, it now has just 25 percent. "It's fierce," Tartaglia said about the competition. "People see more and more that there's a business--there's an opportunity." 

In its first quarter earnings report, Sanofi-Aventis reported 44.4 percent growth in its vaccines division compared to the same period last year. Its vaccine revenue for the quarter totaled $1.45 billion.

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Schwarz Pharma is preparing to launch its newly approved skin patch for Parkinson's disease with an educational push that will introduce physicians and patients to this first-in-class product.

Although Neupro (rotigotine) works in the same way as oral treatments that supply the brain chemical dopamine, it has the advantage of once-daily administration. It is approved for patients with early-stage Parkinson's, and will be marketed as a first-line monotherapy.

Michael Davis, Schwarz' CNS group product director, said that the company is trying to avoid the word "convenience"--the selling point of many patch reformulations--when describing Neupro's benefits. It's not just about "convenience," but the continuous, steady delivery of the drug, he noted. "The patients won't have the peaks and troughs [that are common] on their current medication," he said. The patch might also benefit patients who have trouble swallowing because of the condition.

The company will begin stocking the drug--which was approved May 9--by the end of June, and plans to start detailing neurologists and appropriate primary-care doctors by mid-July, according to Davis.

Schwarz also plans to distribute waiting-room patient-education material including unbranded information about how to best manage Parkinson's disease, such as speech therapy and diet and exercise tips. The company is also working with patient groups like the National Parkinson Foundation. "The main focus is really working with advocacy groups," Davis said.

The company will continue to host its parkinsons-disease.com site, which is unbranded.

Neupro represents the first new chemical entity that German-based Schwarz is launching in the United States. The company, which is being acquired by UCB, will eventually work with its new parent firm to promote the product.

Schwarz is already a player in the US Parkinson's market; its combo drug Parcopa (carbidopa-levodopa), a tablet that dissolves in the mouth, brought in $8.2 million last year, according to the company's annual report. Yet Neupro is set to strengthen that position; in the nine months since its launch in 14 European countries, the patch has already brought in $9.7 million.

The company is also testing Neupro in combination with levodopa for advanced Parkinson's, and is also hoping to expand its label as a treatment for restless legs syndrome. It also has a nasal spray in phase II trials that could be used as a "rescue" treatment for patients who need quick symptom relief.

The worldwide market for Parkinson's drugs is valued at $2.9 billion, and the aging population is driving growth of about 8 percent each year, the company reported, citing figures from IMS Health.

Transdermal patches in particular have gotten attention from drug makers because it makes compliance easier for patients, according to an analysis from Greystone Associates, a medical and healthcare technology consulting firm. Advances in synthetic materials have also made patches a viable strategy for extending patent life.

Schwarz's Neupro is company's first new chemical entity launched in US.

New Pitch for a New Patch for Parkinson's Disease

A new study by Wolters Kluwer Health confirmed what many suspected would be the result of the Medicare Part D donut hole--beneficiaries switch to cheaper options and they don't switch back.

Medicare beneficiaries already use generics about 4 percent more often than people insured under commercial plans. And the findings suggest that this gap is likely to widen.

The analysis of Part D's first-year data may turn down the volume on the ongoing argument over how many people would fall into the coverage gap. According to Wolters Kluwer, the final total was 4.2 million, or 32 percent of "standard eligible" beneficiaries. These patients took an average of 3.5 medications.

"I didn't expect [the gap between brands and generics] to be this wide--and still widening in 2007," said Chris Messner, product director in Wolters Kluwer Health's healthcare analytics business. "Patients really picked and chose therapies based on financial constraints."

It's important to note that part of the increase in generic use was due to heavily used brands like Merck's Zocor (simvastatin) going off patent, Messner noted. But the switch was also driven directly by plan constraints. Of the policies offering donut-hole coverage last year, just a handful reimbursed both brand and generics drugs--and that enhanced coverage is even harder to come by this year.

Only 220 insurance plans, or 15.3 percent, reimbursed prescriptions of enrollees once they hit the $2,250 limit and fell into the gap; of these, 33 plans covered both brands and generics, according to an analysis from the Kaiser Family Foundation. This year, 538 plans (28.7 percent) are providing donut-hole coverage, but only 27 will cover brands as well as generics.

Meanwhile, first-quarter 2007 results confirm the trend, indicating that once a generic switch is made, consumers do not return to the branded drug.

When viewed by category, beta-blockers, thyroid hormones, and diabetes products were the most immune to the generics pull, Wolters Kluwer found. On the other hand, beneficiaries were most apt to abandon their brand-name anti-ulcerants and diuretics. Pharmaceutical companies have been responding to the prescription drop by providing vouchers and other rebates to beneficiaries hit by the donut hole.

On the whole, however, Medicare Part D has been driving drug use, not slowing it down. Of the 4.3 percent growth in prescriptions last year, 1.6 percent was attributable to the program. "From an overall perspective, the goal of Part D was to drive patients into preventative medicine--and I think it's really accomplishing that," Messner said.

Beneficiaries don't switch back to brands after trying generics.

Pharmaceutical Executive-05-23-2007

Companies Forge Ahead with Cancer Vaccine R&D

New Pitch for a New Patch for Parkinson's Disease

Donut Hole in Medicare Part D Triggers Generics Switch