Hospira

4Q Revenues: $946.1 million (+34%)

4Q Earnings:  $76.1 million (+61%)

FY Revenues: $3.4 billion (+28%)

FY Earnings: $136.8 million (-43%)

Comments: Sales in the quarter and FY excluding Mayne Pharma sales grew 8% and 4%, respectively. Injectable pharmaceutical contract manufacturing revenues dropped 14% to $37.4 million in 4Q07 and 19% to $149 million for FY07. R&D expenses in 4Q were down 2% to $53.8 million and acquired in-process R&D expenses were $3.2 million, down 68%. Results include assets amortization of $12.5 million related to the Mayne Pharma acquisition; charges of $4.1 million related to the closures of the Donegal, Ireland; Ashland, OH; Montreal, Canada; and North Chicago, IL facilities (part of Hospira's manufacturing optimization initiatives); Mayne Pharma integration charges of $927 million; and $7.5 million related to the impairment of the intangible asset for brain-function monitoring devices.

Eli Lilly and Co. received a not approvable letter from the FDA for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance of schizophrenia in adults. Zyprexa LAI is an investigational formulation that combines the antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, for an extended delivery of up to four weeks.
   
In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about 1% of patients in clinical trials.  
   
"We are disappointed by the FDA's decision and we are committed to ongoing discussions to better understand the agency's perspective regarding this recent case of excessive sedation and to define the path forward and the associated timeline," said Dr. Jennifer Stotka, vice president of U.S. regulatory affairs, Eli Lilly and Co. "Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia."
   
Regulatory reviews of Zyprexa LAI applications are ongoing in the EU and other countries including Canada and Australia.

Cobra Biomanufacturing Plc has entered into a manufacturing development agreement with an undisclosed pharmaceutical partner to produce a protein from the SARS virus in CHO (Chinese Hamster Ovary) cells under cGMP.

Simon Saxby, Cobra Biomanufacturing's chief operating officer, remarked, "We are delighted to work with the company, which is one of the top global players on the biopharmaceutical market. This agreement will leverage Cobra's significant expertise in manufacturing recombinant proteins in compliance with worldwide cGMP requirements."
 
Cobra's partner will carry out the upstream manufacturing of the SARS protein and ship media containing the protein of interest to Cobra. Cobra will perform the downstream work to isolate and purify the protein at its Oxford facility. The SARS protein will be used in Phase I clinical trials.

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