The diabetes community has long been calling for cheaper, generic glucose test strips that would ideally work with a variety of meter brands. Dream on, right?
In fact, some companies out there are making excellent headway in the "generic" category, despite being under siege by "the big guys."
One of those is a small Southern California-based company called Pharma Tech Solutions that's looking to enter the market with a product it's eager to distribute called the Shasta GenStrip -- a more affordable alternative that can be used with the top-selling JnJ LifeScan meters (OneTouch and Ultra brand meters lead the U.S. market).
So they're bravely going up against one of the largest players to offer users strips for roughly half the price (!), but won't we patients be compromising on quality, we wondered? What if the cheap-o strips just don't work as well?
Not a problem, according to Pharma Tech Solutions and its parent company, Decision Diagnostics Corp.
Marketing materials on the company website claim that Shasta GenStrips are comparable to existing OneTouch strips but are more accurate and half the cost. They are "likely to cost 50% of the branded product without sacrificing quality," the company claims.
Decision Diagnostics submitted the GenStrip to the FDA for pre-market 510K approval in December 2010, and just recently on Nov. 30, 2012, received FDA notice that their strip was "substantially equivalent" to the strips already on the market and could be sold in the U.S.
Terminology is important, the company's chief financial officer Keith Berman told me by phone earlier this week.
"They're not 'generic,'" insists Berman. "A generic is an indication that your product is exactly the same as the one it's based off of. This isn't. It's an independently developed diagnostic product, an alternative. It's the same product for half the price, and a little better."
Clinical data compiled by the company shows that the GenStrip exceeds the current FDA accuracy standard — 99.8% of the time for results at 75 mg/dL or above, the strip is within 20% accuracy range; and 97.1% of the time, it's within 15% when results are lower than 75. That's apparently better than the existing LifeScan OneTouch meters, developed years ago.
To fellow PWD and diabetes investment industry analyst David Kliff, the key question really isn't about definitions.
"You say tom-AH-to and I say tom-AT-to... whatever they want to call it, it's a generic if it's working in someone else's product," he said. "But it's tough to define what generic means to everyone, and really there are bigger fish to fry. We haven't had, to date, a successful launch of a strip that works on an existing system and that has a lot lower price. This isn't the first company to walk down this road, but most don't make it."
Pharma Tech Solutions tells us they've secured a contract with Walmart to distribute the product in all 5,000+ stories nationally, and that other retailers like Target, Costco and CVS are on the radar. With this recent 510K approval, Berman says they are beginning the strip manufacturing process here in the U.S. and hope to be able to start getting strips on the shelves by the end of 2012 (whoa, the clock is ticking). If not this year, then they'll be selling by early 2013, he says.
Talking to Berman and reading the marketing materials online, the point of the Shasta GenStrip is very clear: to compete with the biggest blood strip maker out there. With an estimated $22.5 billion worldwide market, Decision Diagnostics expects its GenStrip will directly compete with JnJ products, used by more than three million PWDs in the U.S.
Basically, it's Business 101 and Decision Diagnostics is trying to tap a piece of a lucrative market — something many before have tried, but failed to do so far.
Private label strips and meters have become very lucrative for many companies, since store-brands like Up&Up and ReliOn now rival traditional brands in quality. And those store brands got a boost in sales when the economy slowed down, and even PWDs with insurance needed more strips than what private or public insurers would pay for.
The list retail price will be $29.95 for a box of 50 GenStrips, with smaller pharmacies able to sell the same box for $24.95. They also plan to create a "Medicare box" specifically for those patients on that system, and also eventually a 100-count vial option of GenStrips once a second manufacturing line is opened sometime next year, Berman says.
Comparatively, a box of 50 OneTouch Ultra Blue strips at Walmart costs $58, while a similar box of Accu-Chek Aviva strips runs almost $60. Meanwhile, the Walmart ReliOn Ultima brand strips costs $20. At Target, the Up&Up strips cost $19.99 for a box of 50.
So GenStrip could be a great boon to the patient community, it seems!
But not so fast... it's important to take a look at why others have failed at the generic strip play.
Just because the GenStrip has gained FDA clearance, doesn't mean it's market entry is a sealed deal. The federal courts may still have something to say about this strip being sold to PWDs.
In September 2011, LifeScan sued in federal court in California, accusing Pharma Tech and all the corporate players of patent infringement in making strips that work with its meters. That case hasn't progressed very far, although the federal court did refuse to put the patent infringement case on hold before any FDA decision as that would prejudice LifeScan's case.
More than a year into the litigation, it's tough to say who appears to have the upper hand. LifeScan is filing amended complaints and the court docket says a trial date could be scheduled sometime in late 2013, although settlement is always a possibility.
Berman doesn't think the litigation will delay plans for introducing the GenStrips. "Litigation in the healthcare field is commonplace, sad to say. And I don't think this is going to have an impact on what we do," he said.
Others, like Kliff, aren't as convinced.
"Everyone knows that IP is a minefield," Kliff said. "So even if you get FDA approval, that's not the end of the story. The question becomes: Do I have the capital to fight the big brand-name companies? To date, most (alternative strip makers) have been paid to go away."