Reports: Legislation proposed for biosimilars, overseas drug manufacturers
NEW YORK — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
The Pittsburgh Post-Gazette reported that the bills, sponsored by Republican Rep. Tim Murphy of Pennsylvania, would create an expedited FDA approval pathway for follow-on versions of biogenetic medications such as vaccines and drugs made from human tissue and plasma.
According to the newspaper, Murphy said the legislation would make the medications more affordable and accessible while ensuring that offshore drug makers are held to the same manufacturing standards as those based in the United States.
The Post-Gazette reported that the House Energy and Commerce Committee passed the legislation 46-0 and now heads to the House floor.
Reports: Pfizer ‘quietly’ giving up on Lipitor marketing
NEW YORK — Pfizer apparently is relenting on its attempt to drive sales of its top cholesterol drug as several new generic versions look set to enter the market, according to published reports.
The Associated Press reported that Pfizer was "quietly" giving up on the drug Lipitor (atorvastatin) after an $87 million campaign to continue marketing the drug despite generic competition.
Lipitor lost its patent protection on Nov. 30, 2011, facing competition from a generic version made by India-based Ranbaxy Labs. Ranbaxy, as the first company to win approval for a cheaper, generic version of the drug, was entitled to 180 days in which to compete exclusively with the branded version, but that exclusivity period is expiring. This will allow other generic drug makers to enter the market with their own versions, which will depress the price of the drug even further.
Lipitor had sales of $8.2 billion in 2011, according to IMS Health.
Product launches, Cephalon acquisition drive Teva’s Q1 revenues
JERUSALEM — Net revenues for Teva rose more than 24% for the first quarter ended March 31, thanks to new drug launches and the company’s acquisition of drug maker Cephalon.
First-quarter net revenues totaled $5.1 billion, compared with $4.1 billion in the year-ago period, while net income and earnings per share totaled $1.3 billion and $1.47 diluted earnings per share, an increase of 39% and 41%, respectively, compared with first quarter 2011.
For its generic business, Teva reported net revenues in the first quarter were $2.6 billion (including API net revenues of $199 million), an increase of 12%, compared with $2.3 billion in the first quarter of 2011, thanks to the launch of such products as escitalopram, modafinil, progesterone, irbesartan and irbesartan/HCTZ, quetiapine and olanzapine ODT. Teva also said its U.S. generics business continued to benefit from its agreement with fellow generic drug maker Ranbaxy relating to the launch of generic Lipitor.
Teva also noted an "inventory step-up" due to its acquisition of Cephalon ($56 million). Teva added that it realized an increase in branded products revenues, primarily due to the inclusion of Cephalon sales (i.e., Provigil with $291 million in revenues, Treanda with $148 million and Nuvigil with $84 million).
"2012 is off to a good start for Teva," Teva president and CEO Shlomo Yanai said. "We enjoyed a quarter of strong growth for our branded products, in our U.S. generics business, and in the developing markets Teva operates in. All of these served to offset weaker generics sales in Europe, which resulted primarily from the macroeconomic conditions in that region."
Yanai retired from his post at the company this month, being replaced by former Bristol-Myers Squibb executive Jeremy Levin.
"It has been an immense privilege to lead Teva’s outstanding global team through such an exciting period," Yanai said. "Together we turned Teva into a highly diversified global pharmaceutical company, with an expanded geographical footprint and additional lines of business. Over the last few months I have had the great pleasure of working closely with my successor [Dr. Jeremy Levin] to ensure a smooth transition. I am very confident that Jeremy will lead Teva to even new heights and I wish him every success."