|In June 2019, senior management of iX Biopharma attended Bio USA, one of the world's largest pharmaceutical conference, held in Philadelphia.
They had a special mission: Meeting with executives of several companies which made the list drawn up by iX Biopharma's newly-appointed financial and strategic adviser.
"Following our successful Phase 2b study, we are ready to pursue out-licensing for our product, Wafermine," said Eva Tan, iX Biopharma's Commercial Director on Marketing Strategy, in an interview with NextInsight.
iX Biopharma, which has been listed on the Singapore Exchange since 2015, is seeking to out-licence its WafermineTM, the world's first ketamine product delivered sublingually, ie by placing it under the tongue.
Typically, in such pharma licensing agreements, there is a host of payments: upfront payment on contract signing, payments on achievement of milestones in the next and final round of clinical trials, and as the product progresses on its commercialisation path.
iX Biopharma has a portfolio of products in the pipeline for pain management, with Wafermine leading the charge.
The ketamine is enclosed in a tiny wafer (developed and patented by iX Biopharma) which is placed under the tongue and starts dissolving right away.
The ketamine is absorbed through the mucous membrane into the bloodstream, unlike an oral intake which would result in significant loss of the drug to the hostile acidic and enzymatic environment in the gastrointestinal tract.
How iX Biopharma's patented wafer technology works -->
For decades, ketamine has been approved for use all over the world in anaesthesia.
It is delivered intravenously, which is invasive, and has to be administered in supervised medical settings by skilled staff.
“Under a special exemption, doctors in Australia have been able to prescribe Wafermine over the last four years, and so we've got a great body of experience now despite the fact that we are still going through the regulatory approval process.”
iX Biopharma's recently completed Phase 2 clinical trial of its Wafermine demonstrated strong analgesic efficacy and was well tolerated by patients.
(See detailed results in presentation slides delivered at a conference in Copenhagen by Dr Janakan Krishnarajah, iX Biopharma’s Chief Operating Officer.)
iX Biopharma is scheduled to meet with the U.S. Food and Drug Administration (FDA) this quarter for an end-of-Phase 2 meeting to discuss the Phase 3 programme.
The latter is projected to cost US$15 million and take 12-18 months to complete.
Dr Janakan believes Wafermine is attractive to potential licensees: "The development risk is low given Wafermine is in late stage development. Ketamine's safety is already established as an approved drug and its effectiveness as pain medication well demonstrated from clinical experience. The commercial risk, we believe, is also low given it is currently used off-label for this purpose."
"And against the background of an opioid epidemic, the time for ketamine, a non-opiod drug, is now."
In recent months, Janssen Pharmaceuticals obtained approval for intranasally-administered esketamine -- a type of ketamine -- for the treatment of a severe form of depression which current anti-depressants are less effective against.
This approval established ketamine as the first truly new medication for depression in decades.
iX Biopharma is preparing to go into Phase 2 clinical trial of Wafermine for depression.
All in all, iX Biopharma is optimistic about its prospects.
"The size of the market is large for treating acute pain and nerve pain. And it's also large for depression. So there are big unmet clinical needs and we have this unique drug that treats both," said Dr Janakan.
|• Alternatives to Viagra|
|At the heart of iX Biopharma's value proposition is its patented, fast-dissolving wafer formulation, WaferiX.
It consists of a small wafer prepared by proprietary formulation using the freeze-drying process, with millions of tiny amorphous holes to house (encapsulate) the active drug molecule.
Its efficacy was demonstrated last year when iX Biopharma received regulatory approval in Australia for Wafesil, its sublingual (under the tongue) sildenafil product for the treatment of male erectile dysfunction.
Wafesil is the first sublingual sildenafil product in Australia to receive regulatory approval.
It is also iX Biopharma’s maiden pharmaceutical product utilising its sublingual wafer formulation to reach approval and registration.
iX Biopharma says the approval of Wafesil affirms the utility of WaferiX and demonstrates the Group’s ability to bring products from clinical development to registration and launch.
Following closely on its heels, iX Biopharma secured approval and registration for Silcap, a sildenafil drug in a novel capsule form, in August 2018.
Silcap is the first sildenafil capsule to be approved in Australia.
Silcap and Wafesil compete in the growing generic male erectile dysfunction market as alternatives for patients who dislike or are unable to swallow tablets.
Aside from developing pharmaceutical products, iX Biopharma has established a range of health supplements. We'll write about that another day but you can first check them out at https://www.entity-health.com/