Focus

Our primary focus is the development of therapeutics to treat infectious disease that provide “differentiated benefits” to patients. We are actively seeking innovative solutions that target infectious disease, with a particular focus on agents that address the rising concern of multi-drug resistant bacteria. With resources and experts available to analyse and develop promising anti-infective therapeutic programs, we are interested in developing novel solutions to the current crises of infectious disease, irrespective of disease, method of delivery and stage of development.

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Recent regulatory changes have incentivized the development of anti-infective agents to increase commercialization:

The Generating Antibiotics Incentives Now Act (GAIN Act) grants an additional five years of market exclusivity, as well as a streamlined process for priority review by the FDA.

The Neglected Tropical Disease Voucher Program is an incentive for companies to invest in new drugs for the treatment of neglected tropical diseases through the award of a transferable “priority review vouchers.” A Priority Review Voucher can be applied to any drug development program, and typically reduces the time for the FDA to review a new drug application to as little as six months.

The Generating Antibiotics Incentives Now (GAIN) Act, which came into effect on October 1, 2012, provides a favorable environment for the development of new antibiotics. Under GAIN, a qualified infectious disease product (QIDP) is a new “antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens.” Under the Act, sponsors developing QIDPs may benefit from the following incentives:

  1. Market exclusivity. QIDPs would be issued five years of market exclusivity in addition to the periods of exclusivity for which they would otherwise qualify. In the US, new small molecule drugs are granted five years of Hatch Waxman market exclusivity, so this provision would provide a total of ten years of market exclusivity regardless of patent position.
  2. Priority review. QIDPs would qualify for Priority Review by the FDA, which would cut the time to approval to six months.
  3. Fast track review. Sponsors of QIDPs would be provided with early and frequent communications with the FDA, in addition to the typical review opportunities.
  4. Updated guidance. The GAIN Act provides a specific timetable for the FDA to develop and issue final guidance on how to conduct antibiotics trials.
  5. Pathogen focused drug development. The FDA will issue guidance on pathogen-focused antibacterial drug development rather than disease-focused development that currently exists.

Priority Review Vouchers (PRV) came into effect in 2007, with the first voucher issued in 2009. Under the law, a developer of a treatment for a neglected or rare pediatric disease receives a voucher for priority review from the FDA to be used with a product of its choice. PRVs may also be sold to other pharmaceutical companies to improve the return on investment in areas of drug development that previously struggled from a lack of innovation due to more challenging markets. The first three sales of PRVs are detailed below:

  • The first sale of its kind, BioMarin sold their PRV to Sanofi and Regeneron for $67.5M (August 2014)
  • Knight Therapeutics was awarded a PRV upon the approval of Impavido, developed to treat leishmaniasis. This voucher was sold for $125M to Gilead Sciences (November 2014)
  • Retrophin will receive a total of $245M from Sanofi in exchange for their PRV (May 2015)
+ Favorable Regulatory Environment

Recent regulatory changes have incentivized the development of anti-infective agents to increase commercialization:

The Generating Antibiotics Incentives Now Act (GAIN Act) grants an additional five years of market exclusivity, as well as a streamlined process for priority review by the FDA.

The Neglected Tropical Disease Voucher Program is an incentive for companies to invest in new drugs for the treatment of neglected tropical diseases through the award of a transferable “priority review vouchers.” A Priority Review Voucher can be applied to any drug development program, and typically reduces the time for the FDA to review a new drug application to as little as six months.

+ The GAIN Act: Improvements to the Regulatory Environment

The Generating Antibiotics Incentives Now (GAIN) Act, which came into effect on October 1, 2012, provides a favorable environment for the development of new antibiotics. Under GAIN, a qualified infectious disease product (QIDP) is a new “antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens.” Under the Act, sponsors developing QIDPs may benefit from the following incentives:

  1. Market exclusivity. QIDPs would be issued five years of market exclusivity in addition to the periods of exclusivity for which they would otherwise qualify. In the US, new small molecule drugs are granted five years of Hatch Waxman market exclusivity, so this provision would provide a total of ten years of market exclusivity regardless of patent position.
  2. Priority review. QIDPs would qualify for Priority Review by the FDA, which would cut the time to approval to six months.
  3. Fast track review. Sponsors of QIDPs would be provided with early and frequent communications with the FDA, in addition to the typical review opportunities.
  4. Updated guidance. The GAIN Act provides a specific timetable for the FDA to develop and issue final guidance on how to conduct antibiotics trials.
  5. Pathogen focused drug development. The FDA will issue guidance on pathogen-focused antibacterial drug development rather than disease-focused development that currently exists.
+ Priority Review Voucher Program

Priority Review Vouchers (PRV) came into effect in 2007, with the first voucher issued in 2009. Under the law, a developer of a treatment for a neglected or rare pediatric disease receives a voucher for priority review from the FDA to be used with a product of its choice. PRVs may also be sold to other pharmaceutical companies to improve the return on investment in areas of drug development that previously struggled from a lack of innovation due to more challenging markets. The first three sales of PRVs are detailed below:

  • The first sale of its kind, BioMarin sold their PRV to Sanofi and Regeneron for $67.5M (August 2014)
  • Knight Therapeutics was awarded a PRV upon the approval of Impavido, developed to treat leishmaniasis. This voucher was sold for $125M to Gilead Sciences (November 2014)
  • Retrophin will receive a total of $245M from Sanofi in exchange for their PRV (May 2015)