In an interview with PharmaShots, Dr. Allitia DiBernardo, Global Head of Medical Affairs for Neurology at the Janssen share her views on the availability of Ponvory in the US for MS patients.

Shots:

• Ponvory offers patients superior efficacy in reducing annualized relapses and brain lesions over established oral therapy teriflunomide (Aubagio), with a safe and generally well-tolerated profile
• In conjunction with its availability, Janssen has designed a comprehensive patient support program to help Ponvory patients start and continue treatment while aiming to help improve their overall wellness
• The US FDA has approved Ponvory for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Tuba:  Discuss the importance of the US FDA's approval of PONVORY for the company and MS patients.

Dr. Allitia: Multiple sclerosis (MS) is unpredictable, with a range of physical and cognitive symptoms that affect each person differently, which makes diagnosis and treatment especially challenging. With such a variable disease, it is critical for patients to have access to multiple treatment options.

PONVORY is a significant addition to the MS treatment landscape that provides superior reductions in annualized relapse rates and brain lesions compared to another oral treatment. We are excited to bring PONVORY to people living with MS as another treatment option to help them better manage this unpredictable disease

Tuba:  Unveil the clinical data supporting the approval.

Dr. Allitia: The PONVORY approval is based in large part on results from OPTIMUM, a two-year head-to-head prospective, multicenter, randomized, double-blind Phase 3 study in adults with relapsing MS, in which PONVORY 20 mg:

• Proved superior on the primary endpoint of reduced annualized relapse rate (30.5% reduction vs. teriflunomide)
• Significantly reduced the number of new GdE T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively
• Did not show worsening of 3-month disability in nine in 10 PONVORY-treated patients
• Demonstrated a safe and generally well-tolerated profile

PONVORY showed similar, strong efficacy in the 24-week, Phase 2 study, reducing annual relapses by 21% compared to placebo in the PONVORY, 20 mg group and the mean cumulative number of new GdE T1 lesions by 70% compared to placebo.

Importantly, in two long-term, open-label extensions of Phase 2 clinical trial 50% of patients who elected to continue treatment remain on PONVORY 20 mg after 8+ years.

Tuba:  After the EU & the US, what are the geographies in focus for seeking approval of PONVORY ?

Dr. Allitia: There are no pending regulatory applications outside of Europe at this time.

Tuba:  What is PONVORY? Discuss it MoA, RoA, benefits, and potential side effects.

Dr. Allitia: PONVORY is a once-daily oral, cell-trafficking inhibitor that is selective for the S1P1 receptor and is the first and only oral disease modifying therapy approved by the FDA that was studied against an established oral comparator. PONVORY was proven superior to an older oral MS treatment in a Phase 3 study in reducing relapses and brain lesions, with proven safety and a generally well-tolerated profile.

In the two-year Phase 3 study, PONVORY demonstrated superior efficacy in significantly reducing annual relapses and reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions compared to teriflunomide. PONVORY also prevented disability from worsening for most people. While the difference in rates of disability progression was not statistically significant between the PONVORY and teriflunomide groups, nine in 10 PONVORY-treated patients did not have to worsen of 3-month disability. PONVORY demonstrated a safe and generally well-tolerated profile over more than 10 years of the cumulative clinical patient experience.

Adverse event rates were similar to placebo in the Phase 2 trial, and similar to teriflunomide in the Phase 3 trial, with an upper respiratory infection, hepatic transaminase elevation (abnormal liver tests), and hypertension (high blood pressure) the most common side effects. Additionally, if a patient needs to stop treatment, PONVORY leaves the blood within a week, and its effects wear off in one to two weeks, which can be helpful for family planning and treating infections.

PONVORY does not rely on the destruction or genetic alteration of immune cells, unlike many current MS treatments, and is believed to work by sequestering immune cells called autoreactive lymphocytes in lymph nodes. The exact way PONVORY exerts therapeutic effects in MS is unknown, but it is presumed that PONVORY by keeping autoreactive lymphocytes out of circulation, that it prevents them from reaching the central nervous system where they could cause damage in MS.

Tuba:  Briefly tell us about Janssen CarePath. How this program is supporting patients that are taking PONVORY?

Dr. Allitia: Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

Because MS is a progressive, individualized disease, we designed the Wellness Companion Program by Janssen CarePath to provide patients with dedicated support during the treatment onboarding process. Patients can connect one-on-one with a dedicated Wellness Companion to get started on treatment, as well as learn more about PONVORY and living with relapsing MS. This education support program is built around patients' needs, their daily life, and their schedules.

Tuba:  Is there any plan to evaluate PONVORY in children and pregnant women?

Dr. Allitia: There are future to evaluate PONVORY, but the exact details have not been finalized.

Tuba:  As the PONVORY is available in the US, what is its cost?

Dr. Allitia: PONVORY is similar in price point to other MS treatments.

Johnson & Johnson takes a responsible approach to price, carefully considering our responsibility to patients today and patients tomorrow. Our medicines are priced by taking a balanced approach to value to patients, the health care system, and society. Our number one priority is to ensure affordable access to medicines for those who need them.

Additionally, PONVORY patients can utilize Janssen CarePath, which provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

Tuba:  How PONVORY is different from its other competitors like Novatis Gilenya and BMS Zeposia? Also, discuss the pricing difference.

Dr. Allitia: PONVORY is the first and only FDA-approved oral disease modifying that was studied against an established oral competitor, teriflunomide. In the two-year, Phase 3 study in adults with relapsing MS, PONVORY 20 mg proved superior on the primary endpoint of reduced annualized relapse rate (30.5% reduction vs. teriflunomide). Further, it significantly reduced the number of new GdE T1 lesions and the number of new or enlarging T2 lesions.

As PONVORY provides superior reductions in annualized relapse rates and brain lesions compared to another oral treatment, alongside a safe and generally well-tolerated profile, we believe it is a significant addition to the MS treatment landscape.

PONVORY is similar in price point to other treatments.

Tuba:  Give the key takeaways of your patient support program. Is Janssen running or planning for any digital or innovative programs for HCP and patients to increase awareness and adherence

Dr. Allitia: We are providing patients with comprehensive support programs designed to help them start and continue treatment. As with other Janssen products, PONVORY patients can utilize Janssen CarePath, which provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

Because MS is a progressive, individualized disease, we've also designed The Wellness Companion Program by Janssen CarePath to provide PONVORY patients with dedicated support during the treatment onboarding process. Patients will be able to connect one-on-one with a dedicated Wellness Companion to get started on treatment, as well as learn more about PONVORY and living with relapsing MS. This education support program is built around patients' needs, their daily life, and their schedules.

About Allitia DiBernardo:

Allitia DiBernardo currently serves as the Global Head of Medical Affairs for Neurology at The Janssen Pharmaceutical Companies of Johnson & Johnson. An experienced medical affairs leader, she has worked across several disease and therapeutic areas.

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