|Teva questions safety of MS drug from rival Biogen; FDA Approves Bayer's Skyla™|
|By Staff and Wire Reports|
|Wednesday, 09 January 2013 20:43|
Teva Pharmaceutical Industries Ltd, (NYSE:TEVA) which makes the market-leading multiple sclerosis drug Copaxone, has filed a petition with the U.S. FDA that could, if granted, delay entry to the market of a rival drug developed by Biogen Idec Inc (NASDAQ:BIIB).
Teva's petition asks that the FDA not approve any new multiple sclerosis drug until its safety has been evaluated by a panel of outside advisors, and said it had uncovered "troubling information" on a publicly accessible website about the safety of Biogen's drug, BG-12.
Israel-based Teva said the information showed that kidney changes were observed after repeated administration of BG-12 in mice, rats, dogs and monkeys. The company suggested that as a result, "there is a substantial probability the risk is applicable to humans as well."
Biogen spokeswoman Kate Niazi-Sai, echoing comments made by company chief executive, George Scangos, at the J.P. Morgan Healthcare Conference earlier this week, said the company is "confident" in BG-12's safety data.
Niazi-Sai said the incidence of kidney problems was similar between patients taking BG-12 and those taking a placebo, she said. A late-stage clinical trial showed that 21 percent of patients taking the placebo experienced kidney problems, compared with 22 percent of patients taking BG-12 twice a day and 25 percent of patients taking BG-12 three times a day.
Teva asked the FDA not to approve any new MS drug unless or until it has convened a panel of outside advisors and listened to the panel's recommendations. And it said its motives were to protect patients.
"Teva filed the petition, on behalf of the more than 300,000 patients with relapsing remitting multiple sclerosis in the U.S.," Denise Bradley, a spokeswoman for Teva, said in an emailed statement. She said the company wants to "ensure that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile."
So far the agency has not scheduled such a meeting for BG-12, though it could do so at any time. An advisory committee meeting would delay BG-12's entry to the market.
The FDA is scheduled to rule on whether to approve BG-12 by the end of March, three months later than the original decision date. Biogen has said the agency did not require additional information, just more time to review application.
Brian Abrahams, an analyst at Wells Fargo Securities, said he doubts Teva's petition will cause the FDA to delay BG-12's approval, "though one cannot rule out the possibility of a minor process-related delay as FDA necessarily evaluates/responds" to the petition.
Bayer HealthCare Pharmaceuticals Inc. (NYSE:MOH) announced the U.S. FDA approved Skyla™ (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years.
"Research shows that nearly 50 percent of pregnancies in the U.S. are unintended,2 which emphasizes the need for increased education and access to effective birth control options," said Anita L. Nelson , M.D., Professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. "Skyla is more than 99 percent effective at preventing pregnancy and may be appropriate for women who want a birth control method that they do not have to take daily. Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don't want to become pregnant for up to three years."
Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a progestin hormone called levonorgestrel. The size of the Skyla T-body is 28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone enter the blood. During the first three to six months of using Skyla, women may experience irregular periods and an increase in the number of bleeding days. Women may also have frequent spotting or light bleeding. Some women may have heavy bleeding during this time. After using Skyla for a while, the number of bleeding and spotting days is likely to lessen, and there is a small chance that periods may stop altogether.1,3
Women can have Skyla placed by a healthcare provider during an in-office visit. Skyla is intended for long-term use for up to three years but may be removed by a healthcare provider at any time. Women could become pregnant as soon as Skyla is removed, so they should use another method of birth control if they do not want to become pregnant. About 77% of women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.3
"The approval of Skyla expands Bayer's IUD portfolio and highlights our continued commitment to empower women with a variety of birth control options at different reproductive stages of their lives," said Pamela A. Cyrus , M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "We are pleased to bring the first new IUD to market in the U.S. in 12 years, and to provide women who are seeking contraception with an important new and effective option to consider with their healthcare providers."
Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of February 11.
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CONMED Corporation (NASDAQ: CNMD) announced today that it expects to report fourth quarter 2012 financial results before the market opens on Thursday, February 14, 2013, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.
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Foster Wheeler AG (Nasdaq: FWLT) announced today that it has acquired Yonkers Industries, Inc., a 30-year-old US-based firm that specializes in the management of construction and commissioning of pharmaceutical and biotech facilities, with capabilities to also manage the full EPCm (Engineering, Procurement and Construction Management) of such facilities.
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PerkinElmer, Inc. (NYSE: PKI) and Verinata Health, Inc., today announced a strategic agreement for expanding access to Verinata’s verifi® test, the most comprehensive non-invasive prenatal test (NIPT) currently available for high-risk pregnancies.
Rand Capital Corporation ("Rand") (NASDAQ: RAND), a business development company (BDC) founded in 1969, and its subsidiary, Rand Capital SBIC, Inc. announced that in 2012 its portfolio investment activity exceeded $6 million and represented the largest single investment period in the 40+ years of the fund.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that data from a study assessing the differences between cancer of unknown primary (CUP) and metastatic solid tumors of known primary metastases (KPM) by profiling microRNA expression were recently published in Clinical Experimental Metastasis, in an article entitled "Global microRNA profiling in favorable prognosis subgroups of cancer of unknown primary (CUP) demonstrates no significant expression differences with metastases of matched known primary tumors."
SmartMetric, Inc. (OTCQB: SMME) Speaking today, the President and CEO of SmartMetric, Inc., Ms. Chaya C. Hendrick, said, "SmartMetric, Inc. to start selling soon direct to the public in the United States, its Electronic Medical Records device."
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