Titan Pharmaceuticals Inc (TTNP)

[TRUISM]

Two Drug Firms Fighting Opioid Abuse
Teva and Intellipharmaceutics are incorporating technology to curb abuse and prevent overdoses.
October 9, 2014

Click For barrons.com Link


Maxim Group

Teva Pharmaceutical Industries announced they have initiated a rolling New Drug Application submission for CEP-33237 (hydrocodone bitartrate), which is expected to be completed by year-end 2014.

Teva’s (ticker: TEVA ) (rated at Buy) CEP-33237, an investigational, 12-hour, acetaminophen-free, extended release hydrocodone will be the first approved pain killer with advanced abuse deterrent technology (ADT). The drug can be taken twice daily, and in previously reported intranasal (snorting) and oral (crushing) HAL (Human Abuse Liability) studies, showed significantly lower abuse potential in recreational users.

However, the abuse potential for taking the whole pill was the same as placebo. This suggests CEP-33237 can prevent hard-core abusers who need to snort, crush and inject to get high but does not preclude the development of addiction by recreational or nonabusive users (patients with chronic pain). However, CEP-33237 is a step in the right direction.

The competition appeared to have moved past Intellipharmaceutics International ( IPCI ) late this summer, and we downgraded the company to Hold (combined with lower-than-expected sales of generic Focalin XR). However, our meeting with management and a description of their first of its kind Paradoxical OverDose Resistance Activating System (PODRAS) technology to prevent overdose, drove us to re-evaluate the company’s ability to compete in the ADT space. This combined with changes in key management, including replacing the chief financial officer, prompted us to change our rating back to Buy.

What is PODRAS? While management did not disclose the details of exactly how it works, the basic concept is that it prevents a potential overdose. PODRAS, as presented to us, causes the patient to have the analgesic effect of only one pill even if they abuse the drug by taking a lot of pills at once. For, example, Intellipharmaceutics’ Rexista uses a similar ADT IntelliMatrix to CEP-33237, but both drugs only prevent manipulating the pill to snort, inject and/or crush to get high. Neither ADT alone can prevent overdose or development of abuse when taken whole. Rexista incorporates the PODRAS technology which is what differentiates it from CEP-33237. Drug users can take all they like but can’t get high or overdose.

Why does PODRAS matter? Intellipharmaceutics discussed with us at great length the potential of the PODRAS platform and the implications to everything from Tylenol (what if you could prevent accidental overdose and eliminate liver toxicity?) to the regulatory concerns about multiple dosing of narcotics like Oxycodone. The data we discussed were impressive, and we see PODRAS potentially changing how drugs are manufactured.




TRUTH