Royalty Report: Drugs, Respiratory, Pharmaceuticals – Collection: 263068

License Grant

Licensor granted Japanese Licensee the right to manufacture and procure such API and clinical supply, and forfeited rights to all future milestone payments related to Licensee’s development of solithromycin in Japan.  Under the terms of this Amended Agreement, Licensor is legally relieved of all obligations related to the supply of API or clinical supply to Licensee.

License Property

Solithromycin is an active pharmaceutical ingredient ('API') contained in our products and product candidates, as well as the preparation of finished products and their packaging for human therapeutic uses, other than for ophthalmic indications or any condition, disease or affliction of the ophthalmic tissues.

The Licensor is a commercial-stage pharmaceutical company focused on developing and commercializing differentiated anti-infectives for the hospital and select non-hospital, or community, settings that address the need for effective treatments for infections due to resistant gram-negative and gram-positive bacteria.  They currently market four antibiotics to treat a variety of infections caused by these resistant bacteria.

Solithromycin has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP) and applications for approval for both intravenous and oral capsule formulations have been accepted for review by the FDA and the EMA.  Solithromycin is also in a Phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia.

Field of Use

Licensee owns exclusive rights to develop and commercialize solithromycin in Japan for respiratory tract infections and other indications in adults and pediatric patients.

License Grant

The Koran Licensor grants to Licensee the license to use, import, package, sell, and offer for sale Products within the Field in the Territory.

The parties agreed to amend the agreement to include but not limited to Co-Promotion, Supply price for the API product, milestone and royalty payments.  Except as is expressly provided herein the License shall remain in full force and effect.

License Property

Product means any compound containing Gemifloxacin as an active ingredient, including API and Final Product.

API means Active Pharmaceutical Ingredient.

Gemifloxacin is a novel fluoroquinolone antibiotic.

Field of Use

Gemifloxacin is used to treat a variety of bacterial infections.  Gemifloxacin is used to treat different types of bacterial infections in the lungs.

The Licensee is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity.

License Grant

The licensing arrangement contemplated that Licensee will purchase the API from Licensor of Japan to manufacture the Product for sale in the Territory.

By this addendum the parties desire to expand the scope of the licensing arrangement under the License Agreement so that Licensee may purchase certain Product from Licensor and sell such Product in the Territory, and also desire to make certain amendments to the License Agreement.

This agreement will include, in addition to the license currently granted, an exclusive license to offer to sell, sell and have sold in the Territory the Licensor Supplying 200mg Product and the Licensor Supplying 400mg Product under the Patents, the Technical Information and the Product Registrations.

In the original agreement, Licensor granted an exclusive, non-assignable U.S. license to manufacture and sell SPECTRACEF, using cefditoren pivoxil supplied by Licensor, for its currently approved therapeutic indications and to use Licensor’s SPECTRACEF trademark in connection with the sale and promotion of SPECTRACEF for its currently approved therapeutic indications. The License and Supply Agreement also extended those rights to additional products and additional therapeutic indications of products containing cefditoren pivoxil supplied by Licensor that are to be jointly developed by the parties and which the Parties agree to have covered by the License and Supply Agreement.

License Property

The product is Cefditoren Pivoxil, a broad-spectrum antibiotic, taken by mouth to treat pneumonia and other infections.

Field of Use

Spectracef is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.  Spectracef is used to treat many different types of bacterial infections that can cause bronchitis, tonsillitis, pneumonia, or skin infection.

Cefditoren pivoxil is approved for use in the treatment of acute exacerbations of chronic bronchitis (AECB), mild-to-moderate community-acquired pneumonia (CAP), acute maxillary sinusitis, acute pharyngitis/tonsillitis and uncomplicated skin and skin structure infections (indications may differ between countries).

License Grant

Licensor grants the Licensee of the Netherlands an exclusive, even as to Licensor, license, with the right to sublicense, under the Licensor IP, to
—  Develop, manufacture, make, have made, distribute, market, promote, sell, have sold, offer for sale, import and otherwise Commercialize Worldwide License Products in the Worldwide Territory.
—  Develop, distribute, market, promote, sell, have sold, offer for sale, import and otherwise Commercialize Limited License Products in the Limited Territory.

License Property

Licensor has developed the Limited License Products and MabIgX Platform, and includes patents.

MabIgX Technology means the Licensor technology for the identification of antibody producing B-cells,  MabIgX® Antibody Discovery Platform & Development of Rare, Potent Human mAbs.  The MabIgX technology is designed to rapidly identify rare, potent antibody-producing B-cells from patients who successfully overcame an infection, then quickly convert the discovered B-cell into a stable manufacturing substrate. This technology immortalizes and stabilizes the antibody-producing human B-cells from the patient, enabling large scale manufacturing of fully human mAbs for treatment of the masses.

AR-301, Fully Human mAb Against Staphylococcus aureus,  (or Salvecin®) is a fully human monoclonal IgG1 antibody (mAb) that specifically targets S. aureus alpha-toxin, an important virulence factor that is secreted by both methicillin-resistant S. aureus (MRSA) and methicillin-sensitive S. aureus (MSSA).   AR-301 protects against alpha-toxin mediated destruction of host cells, preserving the human immune cells.

AR-105 is Broadly Active Human Monoclonal Antibody (mAb) Against Pseudomonas aeruginosa.  The Gram negative bacterium Pseudomonas aeruginosa is one of the most important public health pathogens and is associated with a number of difficult-to-treat infections such as pneumonia, bacteremia, and cystic fibrosis lung infection.  

AR-101, Fully Human mAb Against Pseudomonas aeruginosa LPS serotype O11, (or AerumabTM) is a highly specific monoclonal antibody targeted against P. aeruginosa lipopolysaccharide serotype O11. Binding of AR-101 to P. aeruginosa bacteria facilitates human complement binding and improves immune recognition and destruction by circulating human phagocytes. AR-101’s mechanism of action is distinct from mechanisms of antibiotic resistance, and is effective against multidrug resistant LPS serotype O11 P. aeruginosa clinical isolates.  

AR-201, Fully Human mAb Against Respiratory Syncytial Virus, is a human IgG1 monoclonal antibody (mAb) directed against the F-protein of respiratory syncytial virus (RSV).   AR-201 was isolated from antibody-producing B-cells of an infant infected with RSV.  This mAb broadly neutralizes RSV clinical isolates, including RSV strains that are resistant to standard of care mAb Synagis®.  Licensed Product shall mean the Worldwide License Products, and the Limited License Products.

Limited License Products shall mean certain of Licensor’s products currently in development, comprising the products known as AR-301, AR-105, AR-101.

Field of Use

The field of use in each case Indication is to be a target to an infectious disease predominantly of economic impact in the Developing World.

Licensee is granted right to Licensor' clinical stage programs AR-301 (ventilator associated pneumonia), AR-105 (ventilator associated pneumonia), and AR-101 (hospital acquired pneumonia

AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA and MSSA.

AR-105 (Aerucin®) is a broadly active, fully human IgG1 monoclonal antibody targeted against P. aeruginosa alginate, a widely distributed cell surface polysaccharide involved in surface adhesion, biofilm formation, and protection against the human immune system.

AR-101 is intended to be a first-line adjunctive therapy for patients with severe P. aeruginosa pneumonia being treated in intensive care units, and has orphan drug designation from the U.S. FDA and Europe’s EMA regulatory agencies.

AR-201 is engineered to have long plasma half-life sufficient to last through the duration of the RSV infection season in a single dose.

License Grant

Licensor hereby grants to Licensee an Exclusive License in the Territory, under Licensort Technology, for all Pharmaceutical Uses, with the right to grant sublicenses to (i) research, develop, make or have made, Compound A, Compound B and Product(s); (ii) apply for and obtain Regulatory Approvals, all as may be required to manufacture and commercialize Product(s); and (iii) register, use, import/export, market, offer to sell and sell, Product(s) and Compound A and Compound B.

License Property

COMPOUND A means the compound known as ABT-773, its enantiomers, racemates, isomers and any pharmaceutically acceptable salt or complex thereof, in its current and any other formulation, and including any Prodrugs and active metabolites, whether made before or after the Effective Date.

COMPOUND B means the compound known as ABT-210, its enantiomers, racemates, isomers and any pharmaceutically acceptable salt or complex thereof, in its current and any other formulation, and including any Prodrugs and active metabolites, whether made before or after the Effective Date.  Commercialize cethromycin, a novel ketolide antibiotic in Phase III clinical development for the treatment of respiratory tract infections. Ketolides, a new class of antibiotic to treat respiratory tract infections, have demonstrated strong activity against bacteria that are resistant to many currently marketed antibiotics. Following the offerings, we intend to conduct two pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate community acquired pneumonia.

Field of Use

The rights granted apply to Pharmaceutical Uses.

License Grant

Upon Licensees exercise or deemed exercise of the Option, Licensor grants an exclusive license, with the right to sublicense, under the Licensor Technology to
—  engage in clinical and regulatory activities directed towards obtaining Regulatory Approval, make, have made, Manufacture, use, sell, offer for sale, import, export and otherwise Commercialize the Compound and Products in the Field in the Territory, subject to any reductions in such rights which may be indicated by Licensee in its exercise notice; and
—  Manufacture, make, have made, use, sell, offer for sale, import, and export Derivatives solely and exclusively for the purposes of making, having made, or Manufacturing the Compound or a Product, or, activities that are necessary to seek or obtain Regulatory Approval of or for the Compound or a Product, provided that the rights to sell or offer for sale Derivative referenced above in this clause shall only be exercised with respect to sales of Derivatives, or offers for the sale thereof, to Third Parties to whom Licensee, an Affiliate thereof, or a Sublicensee has granted rights under Know-How or Patents owned, licensed, or controlled by Licensee or an Affiliate thereof to make, use, and sell Compound or Product and the right to sell Derivative, shall further only be exercised pursuant to a written agreement containing provisions explicitly limiting the use of such Derivative solely to the manufacture of Compound or Product or activities that are necessary to seek or obtain Regulatory Approval of or for the Compound or Product.

Licensor grants an exclusive license, without the right to grant sublicenses, during the Option Period under the Licensor Technology to conduct the Evaluation Program or otherwise evaluate, test, or analyze the Licensor Materials, provided that, notwithstanding the foregoing prohibition on sublicensing, Licensee and its Affiliates shall be entitled to engage Approved Subcontractors to perform Licensees  portion of the Evaluation Program or otherwise evaluate, test, or analyze the Licensor Materials.

License Property

Licensor owns or controls certain intellectual property rights, including patents, with respect to Macrolides and/or the synthesis or manufacture thereof, and owns or controls certain know-how, technology, documentation, data, and other materials relating thereto.

The Compound means solithromycin, and any enantiomer, diastereomer, racemate, salt, hydrate, solvate, polymorph or co-crystal thereof.

Macrolide means any macrolide or ketolide, including but not limited to any 14-, 15-, or 16 membered lactone-ring-based compound, which shall include but not be limited to any 14-, 15-, or 16-membered lactone containing a 1,2,3 triazole, including but not limited to solithromycin, any aza-macrolide, including but not limited to azithromycin, and any derivatives of any of the foregoing.

Field of Use

The initial commercialization of solithromycin, if approved, will utilize the semi-synthetic process that begins with clarithromycin. Sometime later, a shift to a fully synthetic process for solithromycin could occur with validation and approval by the FDA.  Clarithromycin is used to treat a wide variety of bacterial infections.

Solithromycin has completed Phase 3 clinical trials and a New Drug Application (NDA) is in progress for the treatment of community acquired bacterial pneumonia. Solithromycin is currently manufactured using clarithromycin, a fermentation–derived antibiotic, as the starting material.

License Grant

The parties entered an agreement regarding the development of Baxdela.

License Property

Baxdela, a Captisol-enabled delafloxacin-IV. Delafloxacin is a novel hospital-focused fluoroquinolone antibiotic candidate with potency against a variety of quinolone-resistant Gram-positive and Gram-negative bacteria, including quinolone-resistant Methicillin-resistant Staphylococcus aureu or MRSA.

Field of Use

Licensee is currently completing Phase 3 clinical trials for the development of  Baxdela.   In 2015, Licensee reported positive top-line results on the first of two planned Phase 3 clinical trials of delafoxacin for the treatment of Acute bacterial skin and skin structure infections (ABSSSI), including infections caused by MRSA.