Biotech company Genzyme Corp. (GENZ), faced yet another setback recently when the U.S. Food and Drug Administration (FDA) announced that vials of five drugs marketed by the company were found to be contaminated.   The affected drugs include Cerezyme, Myozyme, Fabrazyme, Aldurazyme and Thyrogen. All these drugs, excluding Thyrogen, are indicated for the treatment of rare disorders. The vials were found to be contaminated with stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process which could potentially harm patients.   As adverse events are yet to be reported and given the lack of alternative treatments for these drugs which treat rare disorders, the FDA did not issue a product recall. Instead, Genzyme has issued letters to U.S. healthcare providers reminding them to conduct a visual inspection of the vials and to filter them before using the products.   Genzyme has been ...

Isis Pharmaceuticals Inc. (ISIS) reported a net loss of 7 cents per share in the third quarter, which was wider than the Zacks Consensus Estimate of a net loss of 5 cents. The company had reported a net income of 2 cents in the year ago period. The wider-than-expected loss was due to lower revenues and higher operating expenses.  Revenues declined 9.1% to $26.8 million. Revenues include license fees, milestone-related payments and other payments. Revenues declined during the reported quarter as the company finished amortizing the revenue associated with the $50 million upfront payment received from Johnson & Johnson’s (JNJ) Ortho-McNeil-Janssen in 2007.  The company reported higher expenses during the quarter mainly due to the expansion of its clinical development programs, including additional expenses associated with the phase III clinical program for mipomersen, expenses for Regulus as it builds its core team and expenses related ...

Genzyme (GENZ) reported third quarter earnings of 31 cents per share, in-line with the Zacks Consensus Estimate but well below the year-ago earnings of 53 cents per share. Moreover, revenues declined 9% to $1.06 billion.

The company has been under significant pressure following the shutdown of its Allston manufacturing facility in June 2009. The shutdown is a major setback as three drugs -- including key product Cerezyme -- were being manufactured at the facility. Although Genzyme has resumed production, new lots will not be available until later this year.

The shutdown has affected the company s performance causing Genzyme to slash its outlook for 2009. Supply constraints, manufacturing issues and delays in new product launches will continue to weigh on the shares. We would avoid the name.Zacks Investment Research

Earlier this week, Isis Pharmaceuticals, Inc. (ISIS) reported positive top-line results on its type II diabetes candidate, ISIS-113715. Results from the phase II study showed consistent and statistically significant reductions in multiple short and intermediate measures of glucose control. Besides lowering blood glucose, the candidate also caused statistically significant and clinically meaningful reductions in low-density lipoprotein (LDL) cholesterol.   Importantly, a tendency towards weight loss was observed without strict dietary control. The candidate’s safety profile was favorable with no clinically significant adverse effects being observed. Full results will be presented at an upcoming medical meeting.   ISIS-113715 is a novel insulin sensitizer that reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). The candidate’s ability to normalize glucose without exacerbating hypoglycemia, and reduce LDL-C levels and weight could provide patients who are obese and at high cardiovascular risk with a new treatment option.   ISIS-113715 has been developed using ...

On Wednesday, Genzyme Corp. (GENZ) provided a mixed update on its supply schedule for Cerezyme and Fabrazyme. The two key contributors to the company’s top line are produced at its Allston plant. Last June, Genzyme had to temporarily shut down this unit due to contamination issues.

While we were pleased to hear that Cerezyme production is on track and new batches of the product will be available for shipment in the November-December timeframe, we were disappointed to hear that new lots of Fabrazyme will not be available for shipment till mid-December. Moreover, the volume of finished products of Fabrazyme will be lower than expected.

The company said that Fabrazyme bioreactors were restarted later than planned and output from the two bioreactors is expected to be lower. We believe the delay in resumption of normal supply for Fabrazyme could help Shire’s (SHPGY) Replagal gain additional share of the

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Yesterday, Protalix BioTherapeutics, Inc. (PLX) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to prGCD for the treatment of Gaucher disease, an enzyme disorder that can cause liver and neurological problems. The drug is currently being evaluated in a phase III trial which is scheduled to end this month. Top-line results are expected in October 2009. The company intends to file a New Drug Application (NDA) with the FDA before the end of the year.   Drugs that treat diseases affecting 200,000 or fewer U.S. patients per year are granted "orphan drug" status by the FDA. Drugs in this umbrella qualify for priority and potentially faster review times. They also enjoy funding and tax savings to support its clinical development.   Last month, the U.S. agency granted Fast-Track Designation to the drug. This process allows the filing of different sections of ...

We are disappointed with the failure of Osiris Therapeutics’ (OSIR) Prochymal, a drug derived from human stem cell for the treatment of graft-versus-host disease (GvHD), the most common complication of bone marrow transplants. Currently, there is no approved treatment available for this life-threatening disease.

Based on the preliminary results of two phase III trials conducted by the company, Prochymal was found to be ineffective compared to placebo. Following the setback, Osiris shares fell by 34% to $8.03, their greatest single day decline since August 2006.

In the first trial, where the drug was used along with steroids, 45% of patients responded to the combination compared to 46% who responded to steroid along with a placebo. In the second trial, when Prochymal was used on patients not benefiting from steroids, it did not show statistically significant improvement. However, the drug did have a positive impact on patients with GvHD-affected

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On Friday, Trubion Pharmaceuticals, Inc. (TRBN) agreed to jointly develop and commercialize TRU-016 globally with Facet Biotech Corp. (FACT).  TRU-016 is undergoing early-stage studies for chronic lymphocytic leukemia (CLL).   The deal requires Facet to make a $20 million upfront payment to Trubion coupled with an additional $176.5 million on the achievement of certain milestones. Further, Facet has agreed to buy 2.24 million shares of newly issued Trubion common stock for $10 million. The companies have agreed to contribute equally towards costs related to development, commercialization and promotional activities. All global operating profits will be shared equally.   The TRU-016 program is focused on the development of a novel CD37-targeted therapy for B-cell malignancies, such as Non-Hodgkin's lymphoma (NHL) and CLL. CD37 is a clinically validated target for the treatment of B-cell malignancies and TRU-016 has been designed for a desired therapeutic label surrounding B-cell depletion in these

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div style="text-align: justify;"span style="font-weight: bold;"Genzyme (NASDAQ:GENZ)/span is getting some commentary this morning after the co disclosed on 8/28/09 that the European Medicines Agency (EMEA) issued a letter detailing one major observation and several other deficiencies at the Allston manufacturing facility.br /br /span style="font-weight: bold;"- Baird is downgrading GENZ to Neutral from Outperform /spanwhile lowering their target to $58 (prev. $64). Firm is lowering theior Cerezyme estimates considerably through 2012 as they now feel the odds of continued delays at Allston Landing and longer-lasting fallout from said delays are now higher. While continued snags with FDA’s review of Allston are one thing, now that EMEA has found issues at the plant, they are increasingly wary of further delay at this critical competitive juncture.br /br /span style="font-weight: bold;"EMEA’s turn./span GENZ indicated Friday that EMEA inspected Allston (August 17-21), finding one “major observation” and several other observations. GENZ will respond within 15-days.br /br ...

Yesterday, Protalix BioTherapeutics Inc., a potential competitor for Genzyme Corp.’s (GENZ) lead product Cerezyme, announced that the US Food and Drug Administration (FDA) had granted its pipeline candidate prGCD a fast-track status.

prGCD is an enzyme replacement therapy for the treatment of Gaucher disease. Protalix plans to complete the submission of its new drug application (NDA) for prGCD by year-end. Late-stage data on prGCD should be out in October.

Earlier this month, Genzyme suffered a setback when the FDA approved treatment protocols for two potential rivals - prGCD and Shire Pharma’s (SHPGY) velaglucerase alfa.

The FDA had asked both companies to consider submitting a treatment protocol that would enable the use of their Gaucher drugs in an expanded-access program to make up for a shortage in supply of Cerezyme, which is the leading treatment for Gaucher.

As a reminder, manufacturing issues at Genzyme’s Allston plant led to temporary a

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