Royalty Report: Drugs, Disease, Cancer – Collection: 230671

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Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 3

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 3

Primary Industries

  • Drugs
  • Disease
  • Cancer
  • Therapeutic
  • Pharmaceuticals

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 230671

License Grant
The Company entered into an agreement with Licensor that provides the Company with an option to license the Licensor patent rights and know-how to develop and commercialize compounds (CTP-499 and each metabolite thereof) and products, as defined in the agreement.

Upon exercise of the option, the Company will have an exclusive, royalty-bearing right and license, including a right to sublicense, under Licensor intellectual property and joint intellectual property, to develop, manufacture, use and commercialize, including filing for, obtaining and maintaining regulatory approval for, products in all medical fields on a global basis.

License Property
PCS-499 (previously known as CTP-499), is an oral tablet that is an analog of an active metabolite of an already approved drug. The advantage of PCS-499 is that it potentially may work in many conditions because it has multiple pharmacological targets that it affects that are important in the treatment of these conditions. The compound has previously been shown to be safe and tolerable with a trend toward efficacy in diabetic nephropathy. The Comapny has identified other unmet medical need conditions where the use of PCS-499 may result in clinical efficacy. These include Necrobiosis Lipoidica (NL) and Radiation-Induced Fibrosis (RIF) in head and neck cancer patients. NL is a chronic, disfiguring condition for which most patients do not have any treatment options. It develops more commonly in women than in men on the lower extremities, and ulceration can occur in approximately 30% of NL patients, which may lead to more severe complications, such as deep tissue infections and osteonecrosis that can threaten life of the limb.
Field of Use
The compound has already been shown to be safe with a trend toward efficacy in diabetic nephropathy (DN).  Diabetic nephropathy is damage to your kidneys caused by diabetes. In severe cases it can lead to kidney failure. But not everyone with diabetes has kidney damage.

The Company has met with the FDA on the first indication, Necrosis Lipoidica (NL), a chronic, disfiguring condition for which most patients do not have any treatment options.  Necrobiosis lipoidica is a necrotising skin condition that usually occurs in patients with diabetes mellitus but can also be associated with rheumatoid arthritis. In the former case it may be called necrobiosis lipoidica diabeticorum (NLD).

IPSCIO Record ID: 264654

License Grant
The Parties assigned the Agreement from Party A to the Licensee and the Licensee exercised the exclusive commercial license option for the PCS-499 compound from Licensor.  The Agreement provides the Licensee with an exclusive (including to Licensee) royalty-bearing license to Licensee’s patent rights and know-how to develop, manufacture, use, sub-license and commercialize compounds (PCS-499 and each metabolite thereof) and pharmaceutical products with such compounds worldwide.
License Property
PCS-499 is an oral tablet that is a deuterated analog (i.e., a compound having a structure similar to that of the original molecule but differing from it in respect to deuterium replaces hydrogen at certain positions in the molecule) of an active metabolite of an already approved drug called pentoxifylline (PTX).

PTX (Trental®) was approved by the FDA on August 30, 1984 for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. In the body, PCS-499 is broken down into multiple metabolites some of which are exactly the same as PTX metabolites and others that differ by deuterium replacing hydrogen at specific sites on the molecule. In addition, PCS-499 is reversibly metabolized to a deuterated form of PTX. PCS-499 and its metabolites have the same basic pharmacological properties as PTX and its metabolites regardless of the molecule having deuterium or hydrogen in animal and healthy human volunteer studies, the systemic exposure to PCS-499 and certain key active metabolites after PCS-499 administration is two times greater than the exposure to the non-deuterated equivalents after the same dose of PTX. Despite the greater exposure to these pharmacologically active molecules, a dose of PCS-499 50% greater than the highest administered safely tolerated PTX dose is well tolerated in animal toxicology and human volunteer safety studies.

Field of Use
PCS-499 may potentially provide clinical benefit over other on-label or off-label products used for the various conditions. These conditions include Necrobiosis Lipoidica (NL). NL is a chronic, disfiguring condition for which most patients do not have any treatment options. It develops more commonly in women than in men on the lower extremities, and ulceration can occur in approximately 30% of NL patients, which may lead to more severe complications, such as deep tissue infections and osteonecrosis that can threaten life of the limb. Other conditions such as radiation induced fibrosis (RIF), Type 1 diabetes, venous leg ulcers, psychopathological symptoms in patients with cerebrovascular insufficiency, acute pancreatitis, and numerous other conditions have been treated with PTX with some efficacy reported in case studies or small clinical studies.

Necrobiosis lipoidica is a necrotising skin condition that usually occurs in patients with diabetes mellitus but can also be associated with rheumatoid arthritis. The cause of necrobiosis lipoidica diabeticorum (NLD) is unknown. It is thought to be linked to blood vessel inflammation related to autoimmune factors. This damages proteins in the skin (collagen).

IPSCIO Record ID: 29157

License Grant
The Company announced that the Licensor decided not to exercise its option under the product development and commercialization Agreement between the Licensor and the Licensee to License XL784 for further development and commercialization. The Licensee announced in October 2007 that a phase 2 trial of XL784 did not meet its primary endpoint of reducing proteinuria compared with placebo in patients with proteinuria associated with diabetic nephropathy. As a result of the Licensor's decision, the Licensee has the right to develop and commercialize XL784 either independently or in collaboration with third parties, subject to royalty payments to on sales of any products incorporating the compound. The Company itself does not intend to invest further in the development of this drug, but will seek a partner with which to take the compound forward.
Field of Use
XL784 is a potent small molecule inhibitor of the ADAM-10 metalloprotease enzyme, which plays a role in blood vessel formation and cell proliferation that can cause renal fibrosis and impairment.  Diabetic nephropathy (nephropatia diabetica), also known as Kimmelstiel-Wilson syndrome and intercapillary glomerulonephritis, is a progressive kidney disease caused by angiopathy of capillaries in the kidney glomeruli. It is characterized by nephrotic syndrome and diffuse glomerulosclerosis. It is due to longstanding diabetes mellitus, and is a prime cause for dialysis in many Western countries.  Nephropathy means kidney disease or damage. Diabetic nephropathy is damage to your kidneys caused by diabetes. In severe cases it can lead to kidney failure.  The kidneys have many tiny blood vessels that filter waste from your blood. High blood sugar from diabetes can destroy these blood vessels. Over time, the kidney isn't able to do its job as well. Later it may stop working completely. This is called kidney failure.
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