The collaboration between Human Genome Sciences (HGSI) and GlaxoSmithKline (GSK) continues.
The two partners were the first to bring a new lupus-treating drug to market in over fifty years with Benlysta earlier this year, and the pipeline development continues as the two companies announced this week the initiation of another Phase III trial.
According to a press release issued on Thursday, "dosing has been initiated in BLISS-SC, a new Phase 3 trial to evaluate the efficacy, safety and tolerability of BENLYSTA® (belimumab) administered subcutaneously (SC) once-weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE)."
The trial is expected to enroll over 800 patients and marks another potential application for Benlysta on the open market.
Although the commercial roll-out of Benlysta has not met previous expectations, the pace of sales is expected to pick up over the course 2012 with significant market penetration having been gained by 2013.
Additionally, the collaboration between HGSI and GSK led to a significant share price spike a couple of months ago when it was rumored that Glaxo was looking to make an all-out bid to fully purchase its smaller partner.
HGSI reached highs of over fifteen bucks during that surge, before quickly falling back down to earth when nothing materialized from the buyout talk.
The announcement of the initiation of the latest Phase III trial had no impact on the HGSI share price, which dropped below the seven dollar mark for a brief time on Thursday.
It's likely, however, that we haven't seen the last of the buyout speculation regarding GlaxoSmithKline.
With many high profile drugs coming off-label over the course of the next few years, the large pharmaceutical companies may be looking towards the small biotech and developmental pharmaceutical companies as a means to boost their pipelines. For Glaxo, it may be worth the company's while to wait and see how much impact Benlysta will actually have on the lupus market before making a move, but as long as the collaboration between the two companies exists, expect to hear about a potential takeover every now and again.
Pfizer (PFE) is another big player who may be out looking to make a deal with a small biotech or two, as the company takes a huge hit as the blockbuster Lipitor comes off label.
Already Pfizer is on the prowl for new, ground breaking products and technology and its relationship with the small, but up and coming, Lpath Inc. (LPTN) may provide some insight into the next generation developmental strategies of big pharma.
Lpath has developed a novel technology based on biolipid science that allows its potential treatments to target bioactive lipids in a manner that will inhibit the spreading and growth of various modern day diseases.
The platform used to achieve this medical breakthrough is ImmuneY2, from which Lpath has two flagship products in development, iSONEP and ASONEP, for the treatment of Wet AMD and cancer, respectively.
A third product candidate, Lpathomab, is still in earlier stages of development and the company recently announced a funding deal to advance this product through trials.
The key here is that Pfizer has already jumped on board and secured a partnership for iSONEP and a 'first right of refusal' for ASONEP.
While the Pfizer backing is huge for Lpath, it comes at a relative 'chump change' price for Pfizer - with little risk, to boot.
Should the development of Lpath's pipeline pan out, Pfizer would have secured itself a potentially blockbuster technology for relatively nothing in terms of monetary risk, especially when compared to the costs of developing new drugs from scratch.
That strategy could usher in the next generation of pipeline building for large companies like Pfizer; get a foot in the door when the companies are early-on in development and looking for cash. It also marks a noticeable shift from the strategies of the recent past that has seen larger companies wait until the conclusion of Phase III trials before deciding whether or not to partner.
Although the case is somewhat different for Glaxo and Human Genome, since the two have already brought a product to market together, it might - at some point - still make sense to see the two merge.
Such an event might mark the end of the generation of late-stage takeovers, while the Pfizer and Lpath collaboration could mark the beginning of a new era for how the big players beef up their pipelines with a smaller company's early-stage pipeline.
Disclosure: Long HGSI.