Tag: Kashiv Biosciences

A Shakeout of Potential New Filgrastim Competition?

According to reports by Big Molecule Watch, two patent litigation suits have been dropped involving prospective filgrastim makers and the reference manufacturer Amgen. Sudden announcements like this have generally meant one of two things in the biosimilars arena.

The announcements came within days of each other: first, Accord BioPharma and Amgen announced that they jointly filed for dismissal of their ongoing suit. Then, on November 25, Big Molecule Watch reported that Kashiv Biopharma and Amgen have similarly dropped their patent litigation.

Three Scenarios Affecting Filgrastim Biosimilar Competition

Filgrastim market
Computer-Simuilation of a Filgrastim Molecule

The first potential scenario is that Amgen has come to an agreement with the respective manufacturers in terms of licensing or royalties associated with the sales of the biosimilar. We have seen this most recently with Pfizer bevacizumab biosimilar, where the Genentech and Pfizer’s filing to dismiss the patent suit came within days of an announcement of the new agreement. However, the new announcements involve filgrastim, a product that has been marketed since 2015, with ample competition (that is not subject to previous licensing arrangements). A new licensing agreement would be a bit less likely here, since Amgen owns less than 50% of the filgrastim share (Neupogen’s competitors Zarxio® and Granix® hold 31.7% and 20.3%, respectively, according to February 2019 IQVIA figures).

The second possibility is that Amgen has simply dropped the respective suits because of their lower marketshare; that is, the biosimilar genie is already out of the bottle, and litigating these ongoing lawsuits are simply a waste of resources.

A third possibility is that these prospective manufacturers, both of which have run into difficulties obtaining approval for their potential biosimilars in the US, have actually stopped development. This may be the most likely reason.

We reported back in May that Apobiologix (the US biosimilar subsidiary of Apotex) has likely ceased biosimilar development. They first filed for approval in early 2015, with no FDA action reported since that time. The lawsuit regarding this product was being defended by Accord (which was a subsidiary of Intas Pharmaceutical, a partner with Apotex in the development of the biosimilar); Accord’s name was substituted on the suit for Apotex’s in August 2019. Perhaps the rights for the filgrastim biosimilar reverted back to them.

Has Kashiv Biosciences Also Lost Interest in Filgrastim?

In the case of Kashiv Biosciences, this manufacturer purchased Adello Biologics in January 2019, which had been developing biosimilar versions of filgrastim and pegfilgrastim. Kashiv, which hasn’t issued a press release since the initial announcement of the purchase of Adello, still lists both agents on its pipeline. In January, the company stated to BR&R that it was proceeding with its development of the pegfilgrastim biosimilar, with a filing possible before the end of 2019. The filgrastim biosimilar filing in September 2017 is likely to have resulted in at least one complete response letter. No action from the FDA has been reported. One might also assume that the commercialization efforts for this product have been aborted.

If this is true for both cases, further litigation would be pointless. It may simply be additional evidence of a shakeout of the remaining competition in the first-generation biosimilar market.  

Biosimilar Maker Adello Biologics Bought by Pharma Research Company

The assets of biosimilar drug developer Adello Biologics were sold to Kashiv Pharma, LLC, the companies announced on January 4, 2019. The new company will now be known as Kashiv Biosciences, with its headquarters in Bridgewater, New Jersey.

Adello Biologics

Adello Biologics had been one of a handful of “pure-play” biosimilar companies, in that it was not involved with any other pharmaceutical sectors. Its two biosimilar products in most advanced development (filgrastim and pegfilgrastim) would be subject to heavy competition if approved. The acquisition by Kashiv now broadens the pipeline. In a press release, Kashiv cited “As a result of the acquisition, Kashiv BioSciences’ broad business offering includes drug delivery platforms incorporating delayed-release technology and gastric retention systems that improve the efficacy and safety of known drugs; a 505(b)(2) pipeline of seven development products targeting unmet clinical needs.” It does not appear that any of the 505(b)(2) agents are currently being evaluated for approval by the FDA.

A privately held company, it had been known as Therapeutic Proteins International since November 2016. Adello filed for Food and Drug Administration (FDA) approval for its filgrastim biosimilar in September 2017, with a decision expected in the third quarter of 2018. The delay in approval lends speculation to the possibility that FDA issued a complete response letter to the company. This filing was based on the submission of phase 1 data only. In March 2018, Amgen filed a lawsuit against Adello in New Jersey District Court, claiming patent violations and that Adello failed to follow the necessary biosimilar development protocol outlined by law.

The company’s pegfilgrastim biosimilar (TPI-120) had completed two phase 1 studies by the beginning of 2018, and it was hoped that the company would submit its FDA 351(k) application before the end of the year. Executive Vice President & Chief Business Officer Pavan Handa confirmed in an E-mail that the pegfilgrastim program “is in active development and we continue to make significant progress towards a filing. ”

Adello’s journey highlights the potential financial problems that biosimilar-focused companies may face. As a privately owned company, its capitalization was likely limited, and delays in reaching the market become even more critical for companies without other revenue-generating products. The deal with Kashiv breathes new life into the enterprise, but Kashiv, too, does not yet have an approved biosimilar product (nor approved innovative drugs) to its credit. Before the acquisition, Kashiv had focused on “applying novel technologies to improve the delivery of compounds with otherwise problematic physical and/or chemical properties” and on abuse-deterrent technologies for opioid products.

It appears to us that the purchase of Adello by Kashiv, another private company, is an effort at doubling down, to attain more immediate revenue from drug sales.