The Burrill Report


New data submitted by Chelsea Therapeutics to support approval of its drug to prevent sudden drops in blood pressure is not sufficient, said a U.S. Food and Drug Administration review ahead of an Advisory Committee meeting slated for January 14. The biotech’s shares sank more than 30 percent on the news, the biggest drop in more than a year. The agency rejected its first application for marketing approval for Northera in March 2012, asking for an additional study to show that the drug works for an extended period of time. “This reviewer recommends a Complete Response action for droxidopa in the treatment of symptomatic neurogenic orthostatic hypotension, because of inadequate evidence of effectiveness,” Shari Targum of the FDA wrote in a review dated December 2013, reports Bloomberg. The condition is common in seniors and people suffering from diseases such as Parkinson’s. Targum questioned whether the new data proved Northera worked better than a placebo after one week, according to Bloomberg. Northera is approved for use in Japan.

Medtronic said its renal denervation device failed to meet the primary efficacy endpoint of a change in office blood pressure from baseline to six months in a pivotal trial for treatment-resistant hypertension. However, the Symplicity renal denervation system met the primary safety endpoint of incidence of adverse events. The results were a blow the medical device maker, which had hoped to use the results of the trial as a basis for gaining U.S. regulatory approval for the device. Already marketed in other countries, it was expected to bring in sales of as much as $3 billion annually. The study randomized 535 treatment-resistant hypertension patients in 87 U.S. medical centers. People receiving the investigational treatment were compared with a sham-control group that did not receive treatment, with all patients continuing to take their blood pressure medications. The device consists of a flexible catheter and a proprietary generator that the doctor inserts into the femoral artery and threads up and into both renal arteries in turn to deliver low-power radio-frequency energy to reduce hyper-activation of the sympathetic nervous system, an established contributor to chronic hypertension. The procedure does not involve a permanent implant. Based on these study results, Medtronic intends to form a panel of independent advisors to make recommendations about the future of the global hypertension clinical trial program, which includes nine ongoing studies, as well as provide advice on continued physician and patient access to the Symplicity technology in countries with regulatory approvals. Pending the panel’s recommendations, Medtronic says it will suspend enrollment in the United States, Japan, and India, where trials are being conducted for regulatory approvals, continue to ensure patient access to the device in markets where it is approved, and continue post-market surveillance and studies evaluating the device for other non-hypertension indications. Medtronic expects to incur a one-time impairment charge based on a reassessment of its renal denervation assets, but said it is not changing its 2014 earnings guidance.

Ironwood Pharmaceuticals said it is reducing headcount by approximately 10 percent to align its workforce with its strategy to grow as a leading gastrointestinal therapeutics company. The company plans to maximize the potential of its marketed gastrointestinal drug Linzess, both by building on its successful launch for adult patients with irritable bowel syndrome with constipation or chronic idiopathic constipation and by exploring the potential utility of linaclotide in additional indications and populations where there exists large unmet need. Accordingly, Ironwood’s field-based sales force and medical science liaison team are excluded from the workforce reduction. Ironwood estimates that it will incur aggregate charges of approximately $4.0 million to $4.5 million for severance and benefit costs in connection with its reduction in workforce, of which approximately 85 percent to 95 percent are expected to result in cash expenditures. The reduction in workforce is expected to be complete during the first quarter of 2014.

Aegerion Pharmaceuticals’s shares fell more than 12 percent after the company reported it had received a subpoena from the U.S. Department of Justice, requesting documents related to the marketing and sale of its cholesterol drug Juxtapid in the United States, reports Reuters. Juxtapid was approved in December 2012 to treat patients with homozygous familial hypercholesterolemia, a rare genetic disease that causes the buildup of LDL, or bad, cholesterol in the body. Aegerion said it intended to cooperate with the government investigation. In November, the company received a warning letter from the U.S. Food and Drug Administration about misleading marketing materials that suggested Juxtapid was safe and effective in decreasing cardiovascular events and could be used as a standalone therapy.

Johnson & Johnson will appeal a ruling by a Chinese government agency to strip it of exclusive rights to its OneTouch trademark for diabetes monitoring products, reports Reuters. If the ruling is upheld, other companies could sell similar products under the same name in China, the largest diabetic market in the world with the number of diabetics expected to reach 142.7 million in 2035 from about 98.4 million today. The country spent $17 billion on the chronic disease in 2011. “Johnson & Johnson, which has invested in the Chinese market under this brand for almost 10 years, is extremely shocked by the decision and is very disappointed,” the company told Reuters in a statement. J&J said it would apply for a “judicial review and cancellation of the decision according to applicable law.” The pharma told Reuters that Chinese authorities revoked J&J’s trademark after a lawyer for a Chinese firm who had made use of the OneTouch brand name had applied to cancel the trademark. The decision was made in December.

January 10, 2014
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