Actavis’ Namenda IR must remain on market, appeals court rules
NEW YORK – The United States Court of Appeals for the Second Circuit on Friday upheld a lower court‘s decision ordering Actavis to keep its Alzheimer's treatment Namenda IR on the market until generic competition is available.
Actavis has a newer once-daily formulation, Namenda XR, and had planned on switching patients to the new drug before the Namenda IR patent expires in October, according to reports. Generic equivalents could be on the market as soon as July, The Wall Street Journal reported.
“While we are disappointed by the Court's decision to uphold this ruling, we intend to continue our strong efforts to convey the significant benefits of Namenda XR to physicians, patients and caregivers,” said Brent Saunders, CEO and president of Actavis. “Patient demand for Namenda XR is currently trending at more than 50% of the total product line's days of therapy and growing, underscoring the strong physician, patient and caregiver demand for our once-daily product.”
The Department of Health and Human Services reported in early May that pulling Namenda IR from the market completely could cost Medicare and its beneficiaries $6 billion over the next decade.
Contract manufacturing to get a big boost from biosimilar approvals
NEW YORK – The U.S. Food and Drug Administration's (FDA) recent approval of Zarxio (filgrastim-sndz) – the first biosimilar product approved in the United States – points toward growth in the contract manufacturing organization industry, Kalorama Information reported Friday. The mainstream CMO industry is geared to the production of small-molecular drugs and lacks the infrastructure to produce major biopharmaceutical products.
The healthcare market research publisher's report, "Biopharmaceutical and Vaccine Production Markets," found that, though there are uncertainties, a large number of CMOs are positioning themselves to capitalize on the anticipated increase in the demand for biomanufacturing.
Sandoz' Zarxio, approved in March, is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
"The most volatile factor in CMO growth is likely to be the approval and adoption of biosimilar products," said Bruce Carlson, publisher of Kalorama Information. "If these biologic generics deliver on the promise of massive cost savings for extremely expensive biopharmaceuticals, growth of biosimilars will spur dramatic growth in contract manufacturing production capacity. "
Further the report says that since many biosimilar developers cannot lay claim to their own biomanufacturing facilities – and that a significant number of follow-on versions are successful for each current successful product – we can expect that the CMO market will profit from biosimilars development, with active pharmaceutical ingredients biologics manufacturing in particular an area of demand.
Aurobindo Pharma submits for tentative approval of new HIV medicine
LONDON – ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative announced Tuesday that Aurobindo Pharma has submitted an abbreviated new drug application for dolutegravir 50 mg to the Food and Drug Administration for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of ViiV Healthcare's Tivicay (dolutegravir) for sale in the United States.
"This first ANDA for a generic dolutegravir confirms that our strong commitment to thinking and acting differently to pursue new ways to expand access to our medicines, for people living with HIV in countries where the need is most pressing, is working," stated Dominique Limet, CEO, ViiV Healthcare.
Upon receiving tentative approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President's Emergency Plan for AIDS Relief program, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.
This submission comes less than five years after ViiV Healthcare and CHAI signed an agreement to collaborate with the goal of bringing innovative formulations of medicines for the treatment and prevention of HIV/AIDS to people living with HIV in developing countries, on an affordable yet sustainable basis.
CHAI and ViiV Healthcare worked together to identify a generic partner after conducting feasibility research. Following this initial joint work, ViiV Healthcare submitted necessary documentation to the FDA providing a selective waiver letter for the five-year period of New Chemical Entity exclusivity that would have otherwise prevented FDA review and tentative approval of Aurobindo Pharma's ANDA at this time.
The filing by Aurobindo Pharma is the second result of the agreement between CHAI and ViiV Healthcare and comes less than six months after another generic manufacturer announced that it had received tentative approval from the FDA for pediatric formulations of another ViiV Healthcare antiretroviral (also under PEPFAR for sale in licensed countries outside of the United States), through innovative collaboration with ViiV Healthcare and CHAI.
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