Valeant earnings per share could take hit in 2013 from herpes ointment generic
MONTREAL — The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.
Canada-based Valeant Pharmaceuticals International said that while it expected Mylan to receive approval for a generic version of Zovirax (acyclovir) ointment, it did not include the approval in its original budget expectations and thus expected its earnings per share in fiscal year 2013 to be reduced by 30 to 40 cents.
"But there are other actions, such as several product acquisitions, the replacing of our term loan debt and continued operational performance that have occurred since we provided financial guidance in January, and we believe that these activities will mitigate the impact of the generalization of Zovirax ointment," Valeant chairman and CEO J. Michael Pearson said. "We continue to expect once again to deliver outstanding performance in 2013, and we will provide an update to our 2013 guidance on our first quarter financial results conference call in May."
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Florida Senate committee passes biosimilar bill
WASHINGTON — A committee of Florida’s state Senate has passed a bill that could limit the use of biosimilars in the state.
The Florida Senate Committee on Health Policy passed S.B. 732, sending it to the full state senate. The legislation would require pharmacists to inform doctors when a follow-on biologic was substituted for a brand-name biotech drug. The bill is similar to one signed into law last month by Virginia Gov. Bob McDonnell.
Like the Virginia law, the bill in Florida has a five-year sunset clause stating it will expire in July of the fifth year after the Food and Drug Administration’s approval of a follow-on biologic as interchangeable with a branded biologic.
The legislation received support from the Biotechnology Industry Organization, a Washington-based trade group representing biotech companies.
"Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and different manufacturing processes will rarely, if ever, be exactly the same, hence the name ‘biosimilar,’" a statement from BIO in response to the legislation read.
FDA grants tentative approval to Aurobindo HIV drug
HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.
Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences’ Atripla.
Tentative approval means that the drug meets the FDA’s requirements for approval, but the agency can’t give it final approval because the branded drug’s patent protection hasn’t expired. The tentative approval was given under the President’s Emergency Plan for AIDS Relief, or PEPFAR, which aims to provide low-cost HIV medications to people in poor countries.
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