Phase III “Death” – Tragedy or Transformation?

Medical Patents Broker Inc.
By Kenneth Pearce, President

In the world of biotechnology and pharma, we are trained to think that a failed Phase III means the bitter end—that the regulatory walls have broken us and the capital has vanished forever.

Maybe, Maybe Not - It Depends...

In the United States, the captains of industry frequently arise from the midst of naysayers and bankruptcy to create something special. Visionaries don’t need to reinvent the wheel; the wheel has accomplished its purpose for millennia. But for billions of users, it was the invention of steel-belted tires that finally eliminated the blowouts.

As we know, drugs and biologics must be safe and effective for the intended human. When the data fails to show this, public stocks can spiral and private capital can dry up, leaving scientist to wonder how a "sure thing" could fall so flat.

The Pivot vs. The Funeral

For failed Phase III clinical trials, sometimes the asset does need to be buried. However, over the history of medicine, some of our greatest "blockbusters" were rescued from certain death. Instead of a funeral, there was a pivot. Meanwhile, the patents still have their 20-year lifespan from the filing date.

Medical Patents Broker Inc. (MPB) views the patent as the foundation. How much time remains before expiration? How much additional Hatch-Waxman extension is available?

Finding the Hidden Truths

Before locking the data away in a secure archive, a final look often reveals truths that the original Phase III model was never designed to capture. The data may not have proven the initial treatment plan, but did it show a fast-acting antiemetic effect? Did it reveal enhanced liver clearance, improved creatinine levels, or a significant change in appetite?

Could it be that an IM or IV injection was problematic, while an oral dosage or a patch could be both safe and effective?

If a Phase III trial has successfully demonstrated safety, the hardest hurdle is already cleared. By pivoting to a different indication or a more stable delivery vehicle, that "failed" asset can still become a life-saving medicine!

MPB doesn’t conduct the trials. However, MPB’s Patent Maestro® trade secret metrics assist in the IP transfer to a third party—someone ready to conduct a new Phase III with a fresh, data-driven hypothesis.