Glenmark Primes Complex Generics Play With Abraxane Copy Deal
Executive Summary
Glenmark has firmed up an alliance with Particle Sciences for a generic version of Celgene’s chemotherapy Abraxane as it shapes plans for a significant play in the complex generics space.
Glenmark Pharmaceuticals Inc. US has entered into a development, license and commercialization agreement with Particle Sciences Inc for a generic version of Celgene Corp.’s Abraxane (paclitaxel protein-bound particles for injectable suspension).
The deal will see Particle develop the product exclusively for Glenmark in return for milestone payments at various stages of the product’s development from the Indian group, including royalties on sales. Glenmark has global exclusive marketing and distribution rights of the product upon commercialization.
Asked about the firm's preference to source the product from Particle rather than pursuing in-house development, Glenmark's chairman and managing director, Glenn Saldanha, told Scrip that Particle Sciences has "very strong" technical capabilities and understanding of particulate injection products and this can be leveraged to develop the generic version of Abraxane.
US Filing
Glenmark said that the development of generic Abraxane has been initiated for the US and the company expects to file an ANDA in FY19; filings will be made subsequently in other key global markets.
In March this year, Allergan PLC confirmed that it had filed an ANDA with the FDA for generic Abraxane 100 mg/vial. Allergan believes it is "a first applicant" to file an ANDA for the product entitling it to 180 days of market exclusivity.
Abraxane is covered by several patents in the US – the last of which is said to expire in 2024. In April this year Celgene filed an infringement action against Actavis (now Allergan) in the US District Court for the District of New Jersey as a result of which the FDA cannot grant final approval of Allergan's ANDA until the earlier of a final decision that each of the concerned patents is invalid, unenforceable and/or not infringed or Aug. 24, 2018, Celgene said in a July filing with the US Securities and Exchange Commission
Glenmark, though, noted that Abraxane is a "challenging" product to develop and expects it to remain a limited competition opportunity.
Abraxane reported sales of $990m globally, with US sales of $669m as per IMS December 2015 moving annual total (MAT) data.
Complex Generics
The partnership with Particle is seen as an important component of Glenmark’s complex generics strategy – one that will focus on the company’s core segments, namely dermatology, oncology and respiratory.
Saldanha told Scrip that the firm's strategy is to leverage both "in-house and external capabilities" to develop its complex generic products portfolio. This will play a significant role in the firm's growth strategy in various developed and emerging markets in which it operates.
He maintained that Glenmark already has a few complex generic products in its "filed pipeline" and would continue to develop more products in-house, but provided no specifics.
"In addition, we will look to leverage external partnership as long as it fits with the company’s overall long-term growth strategy," he added.
Glenmark's October 2015 alliance with Celon Pharma SA, Poland, for generic Seretide Accuhaler in Europe is one such partnership. Under the deal, Glenmark has semi-exclusive marketing and distribution rights of the product across 15 European countries including the UK, Germany, Belgium, the Netherlands, Italy, Sweden, Norway and Romania, among others. (Also see "Seretide Competition Builds Up But Substitutability Holds Key?" - Scrip, 23 Oct, 2015.)
Several Indian firms have been migrating towards complex generics as they seek to carve a niche in limited competition areas with an eye on profitable growth. Complex generic products like aripiprazole and pregabalin have played a key role in revenue growth in Europe for companies like Dr. Reddy's Laboratories Ltd. in 2015-16.