PHARMACY

Alnylam posts significant year-on-year increase

BY Drew Buono

CAMBRIDGE, Mass. Alnylam Pharmaceuticals has released its financial results for the fourth quarter and year that ended on Dec. 31, 2007.

On Dec. 31, 2007, Alnylam had cash, cash equivalents, and marketable securities of $455.6 million, compared to $217.3 million at the end of 2006. The significant increase in cash from 2006 was primarily due to $331 million received from the RNAi therapeutic alliance with Roche that closed in August 2007.

Revenues in the fourth quarter of 2007 were $18.2 million, as compared to $7.0 million for the same period last year. Revenues for the full year ended Dec. 31, 2007, were $50.9 million as compared to $26.9 million for the prior year.

“A major event for the year was the advancement of our lead program ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus infection, into Phase II trials and the recent achievement of positive results with statistically significant anti-viral activity. We look forward to presenting the detailed results of the GEMINI study later this month at a clinical meeting,” stated Barry Greene, president and chief operating officer of Alnylam. “In addition, we are very pleased with our continued leadership in the advancement of delivery solutions for RNAi therapeutics and efforts on miRNA therapeutics, as measured by our scientific publications and presentations at scientific meetings. These efforts pave the way for the advancement of RNAi therapeutics with both direct and systemic delivery.”

Alnylam expects that its cash, cash equivalents and marketable securities balance will be greater than $390 million at Dec. 31, 2008.

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PHARMACY

HealthPort receives SureScripts’ certified approval

BY Drew Buono

COLUMBIA, S.C. HealthPort’s Electronic Medical Record application is now certified to connect to The Pharmacy Health Information Exchange operated by SureScripts.

HealthPort’s e-prescribing module replaces old error-prone approaches to prescribing such as handwritten prescriptions, computer-printed prescriptions, and computer-faxed prescriptions. It also reduces the risk of medication errors associated with poor handwriting, illegible faxes, similar sounding/named drugs, and manual data entry.

As a SureScripts Certified Solution Provider, HealthPort’s physician clients who use its electronic medical record product can now connect to the Pharmacy Health Information Exchange, operated by SureScripts. The Pharmacy Health Information Exchange allows physicians and pharmacists to electronically exchange prescription information and electronically transmit new prescriptions and refill requests during routine and emergency care.

Today, more than 95 percent of all pharmacies are certified on the Pharmacy Health Information Exchange and approximately two-thirds are processing prescriptions electronically.

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FDA is not ready to pursue authority to approve follow-on biologics

BY Drew Buono

WASHINGTON Food and Drug Administration spokesperson Christopher Kelly recently said that, despite comments from an agency official on Monday, the agency will not submit to Congress a legislative proposal to seek authority to approve generic versions of biotechnology medications, CongressDaily reports.

FDA chief operating officer John Dyer had said on Monday that the agency had begun to draft language for such a proposal. In addition, a congressional aide said that the FDA informed the House Energy and Commerce Committee about plans to submit such a proposal but did not disclose a timeline.

Kelly said that the comments from Dyer resulted from a misunderstanding. Fiscal year 2009 budget documents refer to a legislative proposal that will provide recommendations on an FDA approval process for generic versions of biotech medications. Kelly said that the reference to such a proposal was an “expression by FDA of our interest in moving this forward, not an actual proposal.”

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