Complicated drug formulations are generally viewed as a barrier to generic competition, but that is not stopping India’s Glenmark from placing Celgene’s cancer drug Abraxane in its sights.
Glenmark has just signed a licensing deal with U.S. firm Particle Sciences for a generic version of Abraxane–an albumin-bound injectable formulation of paclitaxel–and says it plans to start filing the generic in 2019, starting with the U.S. market.
Used for pancreatic, breast and lung cancer, Abraxane is still a big earner for Celgene with sales rising 14% to $967 million last year, despite increasing competition from new breast and lung cancer therapies. Two-thirds of sales–some $654 million–came from the U.S.
The Indian drugmaker said the deal with Particle Sciences is a step forward in its plans to develop complex generics such as particulate injections–in which active drugs are bound to micro- and nanoparticle carriers. Complex generics cost more and take longer to develop, but tend to give a higher return on investment than simple generics as they generally face less competition.
Particle Sciences, a subsidiary of Lubrizol LifeSciences, will be responsible for developing the generic for Glenmark in return for unspecified milestones and royalties on sales should the drug reach the market.
In the U.S., a launch will likely depend on the outcome of patent litigation, as Celgene is claiming exclusivity on its drug out to 2023. It has already filed a lawsuit against Allergan, which filed for approval of an Abraxane clone in March.
“This is a challenging product to develop and we expect it to remain a limited competition opportunity,” commented Robert Matsuk, president of Glenmark’s North American division.
Celgene is still banking on significant growth for Abraxane, thanks to a steady stream of new indications, and has said the drug could hit $1.5 billion in sales in the next couple of years. It is starting to move into early-stage breast cancer, with an EU filing due shortly, and is in mid-stage clinical testing for colorectal cancer, melanoma, and head and neck cancer, among other solid tumors.
It is also a key component of Celgene’s efforts to develop combination therapies for cancer. Earlier this year the company reported positive results with the drug in combination with Roche’s PD-L1 inhibitor Tecentriq in triple-negative breast cancer, a form of the disease which has few options at the moment.
Last year, Celgene was denied a patent on Abraxane in India, where the drug is sold by partner Biocon, opening the door for the launch of generic rivals.
Natco was selling a generic version of the drug called Albupax in India a few years ago, but withdrew it from the market after a regulatory review concluded its quality was substandard. Since then Cipla, Panacea Biotech, and Fresenius Kabi have entered the market with their own versions of Abraxane.
By Phil Taylor
Source: Fierce Pharma
After attending the annual Pulmonary Embolism Symposium last week in Austin, Texas, the analysts predicted clinical guidelines could shift toward catheter-based therapy once data from ongoing randomized trials is available.
SAS – the AI and analytics company – has been selected by AstraZeneca to help boost efficiency and drive automation in the delivery of statistical analyses for clinical and post-approval submissions to regulatory authorities.
After the Centers for Medicare & Medicaid Services (CMS) revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines.
