MannKind halts talks with partners based on inhaled insulin data
VALENCIA, Calif. After Pfizer issued warnings for cancer risks from taking its inhaled insulin product Exubera, MannKind Corp. decided to follow suit and halt any discussion for its own similar product, Technosphere insulin.
The announcement came a day after Pfizer placed an added warning on its label based on a clinical study that found six of 4,740 Exubera patients developed lung cancer. According to published reports, MannKind has been strongly rallying the effectiveness of its drug, even after companies like Eli Lilly and Novo Nordisk’s halted its development of their inhaled insulin products Elkermes, and AERx, respectively.
MannKind suffered the worst hit out of all companies seeing a plunge of 60 percent in its shares. Although, throughout all the clinical data, which included a two-year carcinogenicity study on rats, the company found that inhalation was tolerated for 104 consecutive weeks, and another six-month carcinogenicity study in transgenic mice also revealed similar data. The company claimed that based on the data, “there were no indications that our product or the carrier material alone had carcinogenic potential or caused cellular proliferation in the lungs.”
Even though growing concerns over the products’ risks have halted talks with potential partners, it is still continuing its studies on its products since the company claims that, “we have seen no adverse effects on the measures of pulmonary function that have been reported to occur with Exubera.” According to published reports, despite MannKind’s trust in its product, analysts at Piper Jaffray have cut its price target from $19 to $1.50, since physicians will be less inclined to sell an inhaled insulin product based on Pfizer’s data.
FDA announces safety review of two immunosuppressive drugs
WASHINGTON The Food and Drug Administration issued an early communication today stating that an ongoing safety review is taking place about the immunosuppressive medications CellCept by Roche and Myfortic by Novartis.
The drugs have been linked in safety data provided by Roche to progressive multifocal leukoencephalopathy, a sometimes fatal disorder that affects the central nervous system.
Roche has recommended including this information in the CellCept label. The active ingredient in CellCept, mycophenolate mofetil, is metabolized by the body to MPA (mycophenolic acid), the active drug ingredient in Myfortic.
The FDA anticipates taking two months to complete its review of the safety data and the proposed revised labeling for CellCept and Myfortic that includes information about PML.
MyInsuranceExpert.com launches in nine states
BLOOMFIELD HILLS, Mich. A new Web site called MyInsuranceExpert.com helps individuals and families research and purchase insurance policies, according to published reports.
MyInsuranceExpert.com is available in Michigan and eight other states and hopes to expand to 40 states by the end of 2009. So far, he said the site’s biggest business comes from states like Texas and Florida, where there are fewer companies offering insurance to employees.
People go to the site to receive online quotes and ultimately purchase their insurance policy. But the site also has personal, licensed advisers who work with each client to ensure they have the most cost-effective policy possible.