July 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO –A small chemical spill at the San Francisco campus of Genentech sent one employee to the hospital on Wednesday as part of a precautionary measure, SFGate reported Wednesday afternoon.
The incident was apparently minor and the company has not made any announcements on its website about what was spilled or provided any updates on the employee who was taken to the hospital for precautionary reasons.
At the time of the report, the substance that was spilled was unidentified, but was contained within a pool, the paper said. The fire department did not say what spilled because it is a product made by Genentech, KRON of San Francisco reported. Officials said the unknown substance was not a public health concern. The incident happened in a research lab in South San Francisco. The local fire department was assisted by a Genentech response team, SFGate said.
Although the unknown substance incident has garnered press today, Genentech has made some big gains lately, particularly following the U.S. Food and Drug Administration’s approval of its allergic asthma drug, Xolair, children six to 11 years of age. The drug was previously approved for use in children ages 12 and over and since 2003, has been given to more than 200,000 allergic asthma patients.
The company is also anticipating a regulatory ruling for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The FDA has granted the drug a priority review and is expected to make a ruling by Dec. 28. If approved by the FDA and EMA for both indications, OCREVUS would be the first and only treatment indicated for both forms of MS, which affect approximately 95 percent of people at diagnosis. Currently, there are no approved medicines for PPMS, a debilitating form of MS.
But the company has also seen some share of bad news. In June, the U.S. Department of Justice ordered Genentech and partner OSI Pharmaceuticals, LLC to pay $67 million to resolve allegations they made misleading statements about the effectiveness of the oral cancer drug Tarceva to treat non-small cell lung cancer. According to the Justice Department, between January 2006 and December 2011, South San Francisco-based Genentech and New York-based OSI, made misleading representations to physicians and other health care providers about the efficacy of Tarceva for the treatment of lung cancer. Federal officials said “there was little evidence to show that Tarceva was effective to treat those patients unless they also had never smoked or had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.” Because of that lack of evidence, the federal government contended its healthcare programs overpaid for the medication.
In addition, Genentech may owe some health care providers reimbursements after the company recalculated its prices for certain drugs under the federal pricing program, 340B. The 340B program is a federal drug discount program that requires drug manufacturers to provide drugs to eligible health care organizations at significantly reduced prices. The ceiling price is the maximum price a manufacturer can charge for a drug in the program.
