Lannett, Andor partner to launch methylphenidate hydrochloride ER tablets
Lannett has entered into an exclusive perpetual licensing agreement with Andor Pharmaceuticals for a potential generic of Concerta ER (methylphenidate hydrochloride extended-release tablets), the company announced Tuesday.
Andor’s pending Abbreviated New Drug Application of methylphenidate included all bioequivalence metrics recommended by the Food and Drug Administration and is expected to be approved as an AB-rated generic equivalent to Concerta. Lannett will primarily provide sales, marketing and distribution support of Andor’s Methylphenidate ER product, for which it will receive a percentage of the net profits.
“We look forward to returning to this AB-rated Methylphenidate market,” said Lannett CEO Tim Crew. “Based on Andor’s target action date of Feb. 1, 2019, we are optimistic about launching the product well within calendar 2019. The product adds to the sizable number of products we expect to launch in the near term. In June, we commenced marketing four products and, in the coming months, expect to begin marketing several others. While we build out our pipeline, we remain focused on near-term growth opportunities, which include commercializing the products in our portfolio and forming strategic alliances to in-license/acquire products.”
Methylphenidate is s a central nervous system stimulant primarily used to treat attention deficit hyperactivity disorder, or ADHD, in children between the ages of 6 years old to 12 years old, adolescents, and adults up to age 65 years old. The Andor generic will be available in 18-, 27-, 36- and 54-mg dosage strengths.
Methylphenidate hydrochloride extended-release tablets had a market value of approximately $1.8 billion for the 12 months ended June 2018, according to IQVIA.
ANI looks to boost pipeline with WellSpring Pharma acquisition
ANI Pharmaceuticals on Tuesday announced its acquisition of WellSpring Pharma Services, a Canadian contract development and manufacturing organization, or CDMO. The company said the acquisition is expected to boost its efforts to increase its generics pipeline.
“In the second quarter of 2018, ANI continued to successfully execute on its strategy to grow the brand and generic business platforms, and to advance our key pipeline assets. In addition, today, we announced that we acquired WellSpring, a contract development and manufacturing business located near Toronto, Canada in order to expand our third business platform, contract manufacturing, and to increase our capacity to re-commercialize our pipeline of acquired ANDAs that require a tech transfer,” Arthur Przybyl, ANI president and CEO, said.
WellSpring has capabilities in solid oral, semi-solids and liquids. The company has about 100 employees and a 100,000-sq.-ft. site that ANI has acquired as part of the transaction. WellSpring currently generates $15 to $20 million dollars in annual revenues.
With a focus on brand and generic drug products, WellSpring currently manufactures 17 commercial products for 11 different customers, and is assisting customers on 13 additional products that are in development or awaiting FDA approval, according to ANI.
The site manufactures drug products for the United States and Canadian prescription drug markets, and has substantial capacity, ANI said.
FDA approves new indication, vial presentation for Teva’s Granix
Teva has received the green light from the Food and Drug Administration for a new indication and vial presentation of its Neupogen biosimilar, Granix (tbo-filgrastim), the company announced Tuesday. It is now indicated in pediatric patients one month old and older.
The product is indicated to reduce the duration of severe neutropenia in adult and pediatric patients one month old and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Teva said the product will now be available in 300 mcg/1 ml and 480 mcg/1.6 ml single-dose vials, with its prefilled syringe presentation still available.
“The new pediatric indication and vial presentation of Granix expand the range of treatment options that can be of benefit to both patients and healthcare providers,” said Brendan O’Grady, Teva’s executive vice president and head of North America commercial.