Genzyme Corporation’s (GENZ) Lumizyme failed to receive approval from the US Food and Drug Administration (FDA) for the treatment of Pompe disease. The FDA issued a complete response letter (CRL) stating that the agency will not grant approval unless the company addresses the manufacturing issues at its Allston Landing plant in Boston. Genzyme said that it believes that other elements like the Risk Evaluation and Mitigation Strategy (REMS), product label and post-marketing requirements, have been satisfactorily addressed. The FDA’s response on Lumizyme does not come as a surprise. The news regarding the delay in Lumizyme’s approval follows a recent announcement regarding the detection of contamination in vials of five drugs marketed by the company. The agency completed its inspection of the company’s plant last week and has provided Genzyme with a list related to the manufacturing deficiencies found at the plant. The company stated that ...

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 ...

AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year. The primary reasons for the increase in revenues were strong US sales of Toprol-XL benefiting from generic withdrawal, US sales of its H1N1 vaccine and robust growth in emerging markets. AstraZeneca recorded strong sales across all geographies. Sales in North America, Emerging Markets and Established Markets increased (at CER) by 13%, 15% and 4%, respectively. The company expects double-digit revenue growth in Emerging Markets for the full year. Among the product categories, apart from gastrointestinal and oncology, which recorded sales decline of 1% and 10% respectively, all other segments increased their revenues. AstraZeneca recorded more than 26% of ...

Gilead Sciences, Inc (GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). Earlier, in September 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data.  In September 2009, the drug received conditional marketing approval in Canada and Europe under the trade name Cayston (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Gilead plans to make the product available in Germany and the UK in early 2010. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation, which has orphan drug status in the US ...

Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately.  The drug is the generic version of Takeda Pharmaceuticals' (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30.  Mylan received quite a few approvals in the recent past. In October, Mylan settled its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole), following which Mylan received the approval to launch the generic version of the drug. Additionally, in September, Mylan received FDA approval for its generic version of Bristol-Myers Squibb's (BMY) Sinemet ...

Cell Therapeutics’ (CTIC) third quarter loss per share came in at 8 cents compared to a loss of $1.14 reported in the year ago period. The company does not have any marketed product at present; it derives revenues primarily in the form of license and contract revenues. Cell Therapeutics recorded revenues of $0.02 million compared to $2.6 million in the third quarter of 2009.  Revenues in the year ago period consisted of product sales of Zevalin, which the company sold to Spectrum Pharmaceuticals earlier in 2009. Operating expenses during the quarter increased 32.5% to $27 million primarily on account of more than 150% increase in SG&A expenses. Cell Therapeutics has started preparing for the launch of pixantrone in 2010 by recruiting key persons and conducting market research; which has pushed SG&A expenses higher.  As a reminder, in August, the US Food and Drug Administration (FDA) had ...

Optimer Pharma’s (OPTR) third quarter loss per share came in at 28 cents, better than the Zacks Consensus Estimate of a loss of 36 cents and loss of 31 cents reported in the year-ago period. The company does not have any marketed products at present; it derives revenues primarily in the form of research grants and from collaborative agreements.  The company reported revenues of $0.18 million, a decline of 26.3% compared to the corresponding quarter of last year. We believe current investor focus is more on the development of the company’s portfolio rather than the financials.  Operating expenses during the quarter were $9.6 million, marginally down from $9.8 million reported in the year ago period. While R&D and marketing expenses did not change much, general and administrative expenses increased 31% compared to the third quarter of 2008. Optimer, in addition to posting third quarterly results, provided an ...

Allos Therapeutics’ (ALTH) third quarter loss per share came in at 21 cents, in line with the Zacks Consensus Estimate. However, the loss increased compared to the net loss of 16 cents reported in the year ago period. Loss increased primarily due to a 41% rise in operating expense. The huge increase in general and administrative expenses by 113% led to a rise in operating expenses.  The quarter has been quite significant for Allos. In September, the company received accelerated approval from the US Food and Drug Administration (FDA) for pralatrexate (Folotyn) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn is Allos' first drug to receive FDA approval. While the drug is available to patients since October, the commercial launch is scheduled for January 2010.  Allos is increasing its sales force from the current strength of 25 to 50 and ...

A panel of experts of the US Food and Drug Administration (FDA) has recently asked for additional data to judge the efficacy of Human Genome Sciences Inc.’s (HGSI) anthrax infection treatment ABthrax (raxibacumab) compared to existing anti-bacterial drugs.  The panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment.  Data from studies had revealed that antibiotic medicines used alone were highly effective against anthrax, thereby raising questions about the added benefit of ABthrax. Furthermore, the drug appeared to be effective when used with antibiotics in rabbits and monkeys. The same panel also voted in favor of using data from the animal studies to predict how the drug will work in humans. However, more data is required for the purpose. Last week, the FDA expressed concerns regarding some ...

Recently, Human Genome Sciences Inc. (HGSI) suffered a setback when the US Food and Drug Administration (FDA) questioned the efficacy of its drug ABthrax (raxibacumab), meant for treating anthrax infection.  The FDA accepted that the medication was more effective than a placebo in treating anthrax exposure in animals. However, it was unsure as to how effective the treatment would be for humans since the reliability of human data is doubtful. Though the drug appeared to be effective when used with antibiotics in rabbits and monkeys, animal studies do not always predict success in humans.  Later today, an advisory panel from the FDA is scheduled to meet to decide whether the benefits of the drug outweigh the risks for treating deadly infections caused by anthrax inhalation.  As a reminder, Human Genome had filed a Biologics License Application with the FDA in May 2009. The company is ...