The Silicon Review
Founded in 2010, BioPharmX is a specialty pharmaceutical company focused on the dermatology market. The company was created to develop more effective drug delivery methods to address unmet medical needs in large, underserved markets.
The company started its journey with BPX-01, which is a novel topical gel formulation of minocycline that is delivered using the company’s HyantX™ anhydrous hydrophilic delivery system, which for the first time stabilizes and solubilizes minocycline so it can penetrate the skin where acne forms.
Minocycline was first introduced in 1971 and has been widely used in oral form to treat acne and other skin conditions. Drug developers were never able to create a stable topical formulation of minocycline. But, BioPharmX did it and it was something close to amazing, giving the company significant recognition in the industry.
Dermatologists found that BPX-01 may be an effective acne treatment and are expressing enthusiasm for it. Due to the small amount of active ingredient required when delivered topically, BPX-01 may minimize the risk of antibiotic resistance. Moreover, the unique delivery system allows for targeted delivery, minimizing systemic uptake and reducing the biggest issue in dermatology – side effects.
Over the years, BioPharmX has gained popularity in the industry and today it is well on its way to becoming a leading firm in the industry bringing new products to market by identifying optimal delivery mechanisms and/or alternative applications for FDA-approved or well-characterized active pharmaceutical ingredients (APIs) and biological materials.
“Our focus is to develop products that treat health or age-related conditions that are not being adequately addressed or those where current therapies and approaches are suboptimal,” says Anja Krammer, Co-founder, and President.
In-Conversation with the Elegant Leader of BioPharmX, Anja Krammer:
Q.What challenges did you face in your initial years? What can your peers learn from it?
Funding is always a significant issue for start-ups and even more so in drug development. And it is a challenge for BioPharmX. So, to overcome this hurdle and to make the most out of every dollar raised, we take a measured, smarter approach to clinical research, being careful to scale trials to demonstrate efficacy.
In a world where new-drug R&D can cost up to $2 billion, we expect to get through BPX-01 Phase 3 clinical trials for less than $150 million. Our focus on proven actives has lowered development costs. Also, we continually look for innovative ways to measure product effectiveness. For example, working with the Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, we were the first to use Pharmacokinetic Tomography imaging to confirm the highly localized delivery of BPX-01 to the area of the skin where acne develops. This could help other companies determine how effectively a topical penetrates the skin before incurring clinical research costs.
Q.A company’s behavior is as important as its economic performance or the quality of its products. How do you interpret this saying?
We interpret this to mean that a company must stand for something beyond the bottom line and we at BioPharmX do that.
Patient needs guide everything we do. We created this company to address a market that has been all but forgotten. There has been no innovation for dermatology patients in decades, so we set out to change that and hope to make our product accessible to all patients for a reasonable price.
Q.Trust is a difficult attribute to measure and a delicate dynamic to maintain. How do you maintain this with your stakeholders?
We are committed to being as transparent as possible. Although our acne and rosacea products are still in clinical research, we invest significant time and energy sharing information with the dermatology and shareholder communities. We publish research findings as they become available and encourage real dialogue around the data. We’ve built special advisory councils and patient-centric panels. We believe that the more dermatologists know about the research results, the better they can judge the effectiveness of our ultimate products. They are on the front lines with patients and their insights are invaluable as we move forward with further research and development.
Q.Is your company a ‘leader’ or a ‘follower’? Do you formulate your own core values?
We believe BioPharmX is really beginning to set the pace for innovative drug development in dermatology. In an industry that tends to be very traditional, we are quietly finding new ways to deliver proven actives. We’ve helped blaze trails in the use of imaging technology for drug development and are developing products for half the cost of some competitors. Along the way, we found a novel way to deliver minocycline in a unique topical gel formulation. And, for the record, we’ve invented a variety of other delivery systems that are patented or have patents pending.
The Future Vision
BioPharmX is driven by a commitment to innovation. Others view development opportunities through the filter of what the industry has done. But, BioPharmX first understands what patients need and then finds new ways to address those needs.
Looking into the future, BioPharmX is embarking on a Phase 3 study for its lead candidate and initiating a Phase 2 study on its second asset. Less than 10% of all drugs survive all phases of clinical trials to win FDA approval and make it to market. The company is optimistic that its products will be among them, providing patients with long-overdue, innovative dermatologic treatments.
The Leading Lady Behind The Success
Anja Krammer, Co-founder, and President: Anja is a Silicon Valley veteran with a significant talent for helping companies identify and fulfill unmet patient and consumer needs. She has led commercial organizations, including aesthetic market leader Reliant Technologies, biomedical engineer Medtronic, imaging manufacturer Tektronix and telecommunications giant AT&T, and counseled companies like American Express, GSK, Medicis Pharmaceuticals, and Weight Watchers NA.
“We deploy a market-driven approach to identify the limitations of current treatment options and work to develop products that may address these limitations in areas of efficacy, safety, and/or patient experience.”