A 505(b)(2) with 8 years of exclusivity. That is the prize that Calla Therapeutics will receive upon approval of its innovative vaginal cream drug candidate for the treatment of recurrent vulvovaginitis (RVVC). Premier Consulting helped Calla obtain Qualified Infectious Disease Product (QIDP) designation for its 505(b)(2) drug candidate. Let’s take a closer look at QIDP designation and how Calla’s product met the requirements and gained designation.

What Is QIDP?

QIDP (Qualified Infectious Disease Product) designation is offered by the US FDA to help incent the development of treatments for infectious diseases. Title VIII of FDASIA, Generating Antibiotic Incentives Now (GAIN), added section 505E of the Food, Drug & Cosmetic Act, providing incentives for the development of antibacterial and antifungal drugs for human use intended to treat serious and life-threatening infections (21 CFR § 317.2, 2017). In order to counter the threat of antibiotic resistance, the Act provides incentives and additional guidance to pharmaceutical companies developing innovative antibiotic products. Innovative includes both 505(b)(1) as well as 505(b)(2) drug candidates.

Benefits of QIDP Designation

Incentives available to sponsors of QIDP include fast track designation, priority review designation, and 5 years of additional market exclusivity. “Additional” is the key operative word. Exclusivity under the GAIN provisions adds 5 years of additional market exclusivity under certain circumstances to drugs with the QIDP designation and that are eligible for another type of exclusivity.

Incentive Example

For example, NCE (New Chemical Entity) exclusivity provides 5 years of market exclusivity upon approval if a drug includes an active moiety that has not been previously approved by the FDA while a 505(b)(2) drug candidate that completes a new clinical investigation essential for approval is granted 3 years of market exclusivity. Once the QIDP designated drug product, whether 505(b)(1) or 505(b)(2), completes the necessary clinical trials and is approved by the FDA, the QIDP designation will provide an additional five years of market exclusivity, starting from the date of New Drug Application (NDA) approval. Additional protection can be provided by the Company’s patents.

Based on the United States Government Accountability Office (GAO) 2017 report on antibiotics and QIDP, during the period covering 2012 through December 2015, the FDA granted 101 out of 109 requests for the QIDP designation. The FDA also approved six drugs with the QIDP designation for market in the United States during this period. The QIDP designation applies to a specific drug product for a specific use for which it is being studied. Therefore, one drug may receive more than one QIDP designation. From July 2012 through December 2015, there were 56 unique drugs that received at least one QIDP designation.

505(b)(2) Product Eligibility

Remarkably, according to the FDA, all QIDP drugs approved to date have contained a NME (New Molecular Entity), which is an active ingredient that contains no active moieties that have been previously approved by the agency or have been previously marketed as a drug in the United States. As indicated above, 505(b)(2) drug candidates are eligible for QIDP designation if the regulatory requirements are met. The lack of pursuit of this designation may be a result of the limited information and lack of guidance describing the QIDP designation and its requirements, even though QIDP designation has clear benefits.

The GAO, while acknowledging that the FDA has encouraged product development, is concerned that pharmaceutical companies lack information to pursue QIDP designation. The FDA’s revised guidance documents related to antibiotic development in accordance with GAIN, remain in draft form with language suggesting that the guidance is for discussion purposes only. Moreover, the FDA has not produced written guidance that describes the requirements and benefits of the QIDP designation. This suggests that many sponsors, including those with 505(b)(2) drug candidates, might not take advantage of the designation and its benefits because of lack of awareness or information on its benefits.

QIDP Success

Premier Consulting recently assisted Calla Therapeutics, LLC, in their pursuit for QIDP designation for MT-001, the company’s innovative vaginal cream drug candidate for the treatment of recurrent vulvovaginitis (RVVC). Calla received notification on December 15, 2017, that the FDA granted QIDP designation to MT-001 for the treatment of RVVC. MT-001 is a 505(b)(2) drug candidate. RVVC is a serious condition caused by a pathogen, Candida species, that is a ‘‘qualifying pathogen’’ that has the potential to pose a serious threat to public health, under section 505E(f) of the FD&C Act (further specified in 21 CFR § 317.2, 2017). There are currently no approved therapies in the United States for RVVC. The local administration of MT-001 offers the application of the drug to the site of infection, where it is needed, while limiting the amount of drug that gets into the systemic circulation, which drive the safety and tolerability concerns. Data were available in the published literature that supported the premise.

Premier Consulting provided Calla the innovative strategy and regulatory knowledge regarding the requirements and criteria that needed to be met in order to obtain QIDP designation status. Calla will be positioned to reap the benefits of QIDP designation with not only the additional 5 years marketing exclusivity, but also increased communication with the FDA and an expedited review of the QIDP-designated drug application.

QIDP Opportunities

If you have an already-approved API [505(b)(2) antibacterial and antifungal drug candidate] to treat a serious condition and address an unmet medical need, QIDP designation may be attainable. Premier Consulting is ready to assist you in the pursuit with our regulatory knowledge, exhaustive use of data in the published literature, and innovative strategies. Contact us to learn more.

Authors:

Stacey Ayres, PhD
Senior Director, Scientific and Regulatory Affairs

Ruth Stevens, PhD, MBA
Strategic Advisor

Ken Phelps
Strategic Advisor