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Allergan, Editas Medicine to develop genomic medicines to treat eye diseases

BY Sandra Levy

Allergan and Editas Medicine, a leading genome editing company, have joined forces to develop and commercialize EDIT-101 globally for the treatment of Leber Congenital Amaurosis, or LCA, a group of inherited retinal degenerative disorders caused by mutations in at least 18 different genes.

LCA is the most common cause of inherited childhood blindness, with an incidence of two to three per 100,000 live births worldwide. Symptoms of LCA appear within the first years of life, resulting in significant vision loss and potentially blindness. The most common form of the disease, LCA10, is a monogenic disorder caused by mutations in the CEP290 gene and is the cause of disease in approximately 20%-30% of all LCA patients.

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a tool that can be programmed to target specific stretches of genetic code and edit DNA at precise locations in the human genome. The technology allows researchers to permanently modify genes.

“CRISPR-based medicines have the potential to be game-changers for patients with both genetically-defined and genetically-treatable diseases of the eye,” Allergan chief research and development officer David Nicholson said, in a statement.”The Allergan team is excited to work with colleagues at Editas Medicine to develop EDIT-101 and potentially deliver a transformative medicine for LCA10 patients.”

“Today marks a significant milestone in our collaboration with Allergan and in our work to develop genomic medicines to treat eye diseases,” Editas Medicine president and CEO Katrine Bosley said, in a statement. “Allergan is a long-time innovator in ophthalmology, and their deep experience in developing, manufacturing, and commercializing medicines globally will meaningfully advance the EDIT-101 program and maximize our ability to bring this transformative medicine to people living with LCA10.”

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Lannett, Andor partner to launch methylphenidate hydrochloride ER tablets

BY Sandra Levy

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.

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ANI looks to boost pipeline with WellSpring Pharma acquisition

BY Sandra Levy

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.

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