The Food and Drug Administration said Friday that bits of steel, rubber and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients.

Despite those problems, the FDA said the products would remain on the market, because there are few alternative treatments.

{tiny;GENZ;1}FDA regulators say doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the product to Genzyme if they suspect contamination, the agency said. Physicians should also watch for potential allergic reactions, blood clots and other problems in patients.

Shares of Genzyme Corp. dropped $4.17, or 7.8 percent, to $49 in afternoon trading.

The FDA announcement is the second case of contamination for the Cambridge, Mass.-based company this year. In June, Genzyme was forced to shut down a key production facility due to viral contamination.

Genzyme did not return repeated calls for comment Friday.

{tiny;BMRN;1}BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) told investors that Genzyme had notified their company that, in rare circumstances, it has detected foreign particles in some products filled at the Allston Landing facility.

To ensure that patients are not exposed to foreign particles during product administration, Genzyme has issued a "Dear Doctor" letter to all physicians treating patients with enzyme replacement products that it markets, including Aldurazyme.

The letter states that foreign particles have been found in some vials filled at Genzyme's Allston Landing facility and reminds physicians, as a preventive measure, to use a 0.2-0.22 micron filter during administration.

 

by Marc Lichtenfeld, Healthcare Expert Wednesday, November 11, 2009: Issue #1135 Investing in the biotech sector can be risky – no doubt about that. But you know what? There are a lot of ways to make money from biotech stocks, too. If you know what to look for, that is. Two obvious examples include: Picking the company [...]

(ASH) Investing in the Biotech Sector: Here’s An Easy Way to Profit from Biotech Stocks

Investing in the Biotech Sector: Here’s An Easy Way to Profit from Biotech Stocks by Marc Lichtenfeld, Healthcare Expert Wednesday, November 11, 2009: Issue #1135 Investing in the biotech sector can be risky – no doubt about that.[More...]

On 7/13/09, BioMarin Pharma (NASDAQ:BMRN) announced that patient enrollment has been completed for its Phase I/II clinical trial for BMN-110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The Company expects to report initial results during 1H10. BMRN stated that the enrollment of 20 patients is a critical milestone for the MPS IVA program and the data generated from this study will be valuable in demonstrating safety and could be instrumental in designing a successful Phase 3 trial, including assessments from the Phase I/II study such as plasma and urine keratan sulfate levels, pulmonary function and walk tests to establish optimal Phase 3 endpoints. During the dose escalation phase of the study, subjects will receive weekly intravenous infusions of BMN-110 in three consecutive 12-week dosing intervals. The objectives of the Phase I/II study will be to evaluate safety, pharmacokinetics, pharmacodynamics and to identify the optimal dose of GALNS for future studies.

On 7/13/09, OSI Pharma (NASDAQ:OSIP) announced that SATURN, a pivotal Phase 3 study of Tarceva (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The new data will be presented during the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009 in San Francisco. The overall survival data will be submitted to the FDA to support the supplemental New Drug Application (sNDA) for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC that was submitted on 3/17/09 with an expected PDUFA action date of 1/18/10.

Also, Roche (OTC:RHHBY) (VTX:ROG), OSI's international collaborator for Tarceva, will submit the overall survival data to the European Medicines Agency (EMEA) to support the application for use of Tarceva as a first-line maintenance treatment submitted in March 2009. The U.S. and EU submissions were based on positive data from SATURN that were presented at ASCO on 5/31/09. SATURN met its primary endpoint and showed patients with advanced NSCLC who received Tarceva as a first-line maintenance treatment had a 41% improvement in the time they lived without the disease advancing (progression-free survival or PFS) compared to placebo.

On 7/13/09, Abraxis BioScience (NASDAQ:ABII) announced that it has completed patient enrollment of a pivotal, phase 3 clinical study comparing the Company's chemotherapy agent ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) with Taxol (paclitaxel) injection, both in combination with carboplatin, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The study is being conducted at 111 global sites and includes 1,050 patients. ABII expects to file a supplemental new drug application (sNDA) with the FDA during 1H10 for what would be a second indication for ABRAXANE, which is currently approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

On 7/15/09, the Oncologic Drugs Advisory Committee will review Johnson & Johnson's (NYSE:JNJ) Yondelis (trabectedin) NDA, which seeks approval in combination with Doxil (doxorubicin) for the treatment of relapsed ovarian cancer in women. Briefing documents posted online 7/13/09 questioned whether interpretations of imaging scans designed to show a halt in progression of the patients' cancer status were reliably assessed in the main study of the drug. Patients taking Yondelis and Doxil together lived an average of 7.3 months without disease progression versus 5.8 months for patients taking Doxil alone. FDA staff said they would ask the Advisory Panel if the results are reliable, clinically significant, and associated with an acceptable benefit/risk ratio. A final FDA decision is expected during late 3Q09 for the Yondelis NDA.

Disclosure: No positions.