Business briefs: Gilead, Shire, The Medicines Co., HHS

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Gilead announced Monday that two Phase III tests of its hepatitis C nucleotide sofosbuvir worked well among patients when combined with either ribavirin or ribavirin and pegylated interferon. The nucleotide was tested among chronic hepatitis C patients who had not previously received treatment. The results covered the Fission and Neutrino tests. Gilead released information about its Positron study in November and expects to release results of its Fusion study this quarter. Spokesperson Cara Miller told MM&M in an e-mail that the biotech expects to submit its EMA and NDA filings by the middle of this year. The applications would be for an all-oral therapy with sofosbuvir and RBV among genotype 2 and 3 patients who cannot tolerate interferon, as well as a sofosbuvir-RBV-Peg-InF treatment for HCV genotypes 1, 4, 5 and 6.

Shire and the Department of Justice have settled in principle over marketing practices for Adderall XR, Vyvanse, Daytrana, Lialda and Pentasa. The agreement resulted in a $57.6-million charge during Shire's fourth quarter. The company said in a statement that it is working with the DOJ “to establish a final resolution to the investigation.” Allegations regarding the ADHD drugs Vyvanse, Daytrana and Pentasa surfaced in 2009, but Pharmalot noted at the time that “specifics weren't disclosed.” Shire's statement on Friday does little to illuminate what transpired.

The Medicines Company is betting a $25-million dollar upfront payment that Alnylam's experimental hypercholesterolemia drug, belonging to the PCSK9 class, is a winner. The agreement, which includes the potential of $180 million in milestone payments to Alnylam, was announced by the New Jersey drug maker Monday. The Medicines Company's CEO Clive Meanwell described the therapy in a statement as a “gene silencing” treatment that can help keep a lid on unmanageable LDL levels. Alnylam will shoulder the cost of  pre-clinical and in-progress Phase I clinical studies, and the Medicines Company will take over from Phase II onwards, including commercialization.

The government's roster of Text4 programs is increasing by one: TXT4Tots, and the Department of Health and Human Services issued a Request for Information to get a sense of how it could reach as many families as possible. The program includes a library of health-related information for children between 1 and 5, and includes tips about nutrition, snacking and exercise, among other topics. Sample texts include “100% fruit juice has sugar that damages teeth as much as soda. Limit to 4 – 6 oz daily. Try water with fruit slices instead.” The content is based on guidelines from the American Academy of Pediatrics and is available in both Spanish and English. The new service will join Text4Baby, SmokeFreeTXT and QuitNowTXT, among others.

The House Energy and Commerce Committee is taking the FDA to task for what it considers a failure to disclose sufficient information regarding intra-agency correspondence  about the New England Compounding Center—the compounder that has been associated with the 2012 meningitis outbreak that killed 45 patients. In the February 1 letter to the FDA commissioner, lawmakers recounted their frustration with the agency's answers at the November 2012 hearing and assert that the agency has succeeded in submitting only information that was already publicly available. They also wrote that they want communications “from the critical time period of 2002 through 2006 when the FDA conducted three separate inspections of the NECC's facilities, documented numerous public health and safety concerns and considered enforcement actions.” The Congressmen noted that they do have some correspondence—from one district office employee—and that this information raises “new and troubling questions about the agency's oversight of NECC to re-inspect the facility.” The lawmakers said the regulator has to hand over everything by 5 pm February 25. “FDA has not provided a valid reason for the Committee for continuing to withhold these documents,” they wrote. Deputy director of the FDA Office of Public Affairs Erica Jefferson emailed MM&M that the regulator has provided correspondence and inspection documents from the 2002–2006 time period and is working to respond to the committee's request. Jefferson noted that the submitted document count hovers around 3,591 pages related to NECC and its sister company, Ameridose.
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