Novartis finds its next mass-market ophthalmology drug candidate at a small virtual biotech with a global view
Like me, you may never have heard about Lubris BioPharma before today. But Novartis has. And that is by far more important.
Today the pharma giant reached out and exercised an option on a recombinant lubricant Lubris drew from nature’s medicine chest and applied for dry eye disease. There are no terms, no big biobucks on the record (though someone told the Boston Business Journal that the package was worth up to $1 billion). But the deal marks a definite transition phase for little Lubris as it shifts its focus on the same therapy to a different set of ailments in mind, while Novartis eyes an addition to its late-stage pipeline.
Lubris’ big idea was to take a natural lubricant — lubricin — that is found just about wherever two tissues in the bodies meet and industrialize it, turning it into a replacement protein therapy dubbed ECF843. Last year they tested it in a small Phase II dry eye study with 40 moderate to severe patients, putting it up against sodium hyaluronate (HA), which figures prominently in a slew of over-the-counter artificial tear products like Blink.
Here’s what they found in humans:
Lubricin demonstrated statistically significant improvements against HA in the following objective signs of dry eye: corneal fluorescein staining (OD/OS: 43.8%, 50.0%, vs. 26.5%, 23.3%, p<.0398, p<.0232), TFBUT (p<.010), eyelid erythema (p<0.004), conjunctival erythema (p<.0013).
Symptoms of the disease dropped 70% from baseline and CEO Ed Truitt tells me that when the study transitioned to self-application Lubricin patients used much less of it to get better results.
Having that human data, as opposed to preclinical animal results, is what really captured Novartis’ attention, says Truitt. They struck the option deal, quietly, last year. And when the Big Pharma player exercised the option today, Novartis was careful to highlight how this drug fit into its pipeline for front-of-the-eye therapies — a mass market with an eye on millions of patients — as well as its dealmaking strategy, which included buying Encore Medical for the treatment of presbyopia.
Truitt himself is based in Seattle, one of four full-time staffers. There’s an office in Framingham, MA. Scientific founders are Dr. Greg Jay of Brown, Tannin Schmidt of the University of Calgary and David Sullivan of Mass Eye and Ear and Ben Sullivan for the work he did while at UCSD. Their funding so far has mostly come from angels and high net worth individuals, which is why you haven’t been hearing about any venture rounds. But it’s been enough.
The big advantage of any virtual company is keeping costs low. You can stretch a buck further, turning to contract staffs in manufacturing and research.
The down side?
If you don’t have your own lab, where the team is committed and pushing hard, burning the midnight oil, you have contract groups doing specifically what they have been told to do, says Truitt. Instead of managing the staff, you wind up managing dozens of workers at the vendors.
“Things can go a little slower,” says Truitt. “They don’t think outside the box.”
On the other hand, now that Novartis has put money into the company, following a European deal with Milan-based Dompé Group, Truitt has a “substantial runway” to go after the next set of non-eye targets, says the CEO. That will start with dry mouth, maybe a side effect of head and neck cancer therapy that destroys the salivary glands. Interstitial cystitis, recoating the damaged bladder lining, is on the short list.
But Truitt is also happy to note that his protein therapy could be used in place of HA for a long list of products. And maybe more partners will line up for these other indications as they continue to work on new human studies.
It’s time to push on to the next big thing at little Lubris.