At PLUS THERAPEUTICS, we fully understand that establishing successful relationships with global business partners and suppliers are essential to fulfilling our company mission in discovering, developing, and delivering complex and innovative treatments for patients battling rare cancers.
We aim to collaborate with parties that share similar priorities and values and can benefit from PLUS THERAPEUTICS’ strengths — proprietary technology, deep product and clinical development expertise, in-house manufacturing and analytical testing capabilities, and close proximity to and relationships with world-renowned cancer institutions and researchers in the state of Texas. We are also seeking collaborations with parties that can help PLUS THERAPEUTICS continue to innovate, advance and expand our pipeline, and deliver new treatments to patients in need around the globe.
We believe that we can create more value for and establish a higher bar in the healthcare industry by working together.
BUILT TO PERFORM
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We have completed facility validations at our nanoparticle manufacturing facility located in San Antonio, Texas, USA. The facility and processes are designed to comply with cGMP per FDA and EMA regulations to manufacture drug candidates for research, development, clinical, and commercial use. Upon approval of our drug product candidates, our manufacturing capabilities will include validated manufacturing processes for drug product as well as a quality assurance product release process with the ability to ultimately scale-up the process to meet increasing market demands. We believe our strategic investments in the analytical and manufacturing capabilities, including personnel from drug discovery through drug development, will allow us to advance our product candidates more rapidly.
Expertise gained in manufacturing RNL™ DocePLUS™, and DoxoPLUS™ may be applied to other formulations in the future, allowing us to further leverage our capabilities. Our San Antonio facility enables us to produce drug product in a cost-effective manner while retaining control over the process and timing. As needed, the use of a qualified Contract Manufacturing Organization may be utilized to perform various manufacturing processes as we deem appropriate to meet our operational objectives.
Our current principal suppliers for our business are LGM Pharma and ScinoPharm Taiwan, which supply our active pharmaceutical ingredients, or APIs, doxorubicin and docetaxel, respectively, as well as Lipoid, LLC and Dishman Netherlands, which supply us with other raw materials used in the manufacture of our DocePLUS™ and DoxoPLUS™ drug candidates, and Eurofins, Columbia who supplies testing support for all products.
PLUS THERAPEUTICS’ approach to drug delivery with PEGylated liposomes is both proprietary and versatile, offering potential partners a nanotechnology platform with which to reformulate a wide range of hydrophilic and lipophilic Active Pharmaceutical Ingredients, or APIs, for a multitude of new clinical applications. Partnering with PLUS THERAPEUTICS may represent a means to expand commercial opportunities while reducing cost and time associated with development activities.
To learn more about our PEGylated liposomes, please contact us at firstname.lastname@example.org.
PLUS THERAPEUTICS’ is constantly striving to find novel ways to broaden and fortify the applicability and relevance of our nanotechnology platform. We are open to exploring how to enhance our PEGylated liposomes to carry and locally deliver one or more drugs:
+ in a safer and more effective manner
+ via new routes of administration, and
+ for new clinical indications with significant unmet needs.
Do you have an idea on how we can accomplish this goal? If so, please contact us at email@example.com.
Patented Rhenium NanoLiposome (RNL™): seeking co-development and out-licensing opportunities
Patented Doxorubicin-Rhenium NanoLiposome (DRNL™): seeking co-development and out-licensing opportunities
PLUS THERAPEUTICS’ RNL™ is a radiotherapeutic consisting of a BMEDA-chelated rhenium radiation particle encapsulated within a nanoliposome. RNL™ is currently being evaluated in the ReSPECT™ U.S. FDA-approved Phase 1 clinical trial for recurrent glioblastoma and preclinical animal studies for breast, head and neck, leptomeningeal, liver, and ovarian cancers.
PLUS THERAPEUTICS’ DRNL™ is a radiotherapeutic consisting of a BMEDA-chelated 186-rhenium radiation particle co-encapsulated with doxorubicin within a nanoliposome. DRNL™ is currently being evaluated in preclinical animal studies for squamous cell carcinoma of the head and neck.
According to a December 2018 report from Future Market Insights, the worldwide radiotherapeutics market is anticipated to experience a compounded annual growth rate (CAGR) of 14% and reach sales of $1.8 billion USD by 2028.
There has been a reasonable amount of deal activity recently within the radiotherapeutic market:
- In 2019, Fusion Pharma raises $105 million USD to support development of targeted alpha-particle radiotherapeutics for cancer
- In 2018, Novartis acquires Endocyte for $2.1 billion USD, gaining drug conjugation technology to develop targeted therapies with companion imaging agents including 177Lu-PSMA-617 for prostate cancer
- In 2018, Novartis acquires Advanced Accelerator Applications for $3.9 billion USD, gaining access to LUTATHERA® (lutetium Lu 177 dotatate) for neuroendocrine tumors; LUTATHERA® achieved global sales of $120 million in the U.S. and Europe with an ongoing launch in Europe
- In 2013, Bayer acquires Algeta for $2.9 billion USD, gaining access to XOFIGO® (radium Ra 223 dichloride) for prostate cancer; XOFIGO® achieves global sales of $414 million in 2018
PLUS believes both RNL™ and DRNL™ hold significant promise for patients and welcomes the opportunity to discuss various partnering approaches and pathways. If interested, please contact us at firstname.lastname@example.org.
LUTATHERA is a registered trademark of Advanced Accelerator Applications SA
XOFIGO is a registered trademark of Bayer
Patented DocePLUS™: seeking co-development and out-licensing opportunities
DocePLUS™ is an albumin-stabilized PEGylated liposomal docetaxel that is being developed as a new therapy for small cell lung cancer and potential replacement for HYCAMTIN® (topotecan), the only U.S. FDA-approved second-line therapy. According to Decision Resources, topotecan generated $190M USD in sales in 2018 across the U.S., EU5, and Japan.
The World Health Organization has reported that 1.1 billion people smoke tobacco around the world. Given that tobacco smoking is by far the leading cause of small cell lung cancer and that treatment regimens have changed little since HYCAMTIN® was approved 20 years ago, we believe there is potentially a significant global market opportunity for DocePLUS™. We are actively seeking development and commercial partners for this Phase 2-ready asset for all markets, with a priority on the United States, Europe, and China.
Further, based on results from 1) comprehensive, independent, primary market research performed with U.S. medical oncologists and payers and 2) the completed U.S. Phase 1 clinical trial, we believe there is also a compelling market opportunity for DocePLUS® as a therapy for other solid tumors, including pancreatic cancer, breast cancer, esophageal cancer, and cholangiocarcinoma. The combined annual revenue potential for DocePLUS™ for these clinical indications is estimated at over $600M.
Please contact us at email@example.com if interested in DocePLUS™ for small cell lung cancer or other clinical applications.
HYCAMTIN is a registered trademark of Novartis Pharmaceuticals Corporation.
Complex Generic DoxoPLUS™: seeking divestiture opportunities
DoxoPLUS™ is a PEGylated liposomal doxorubicin that represents an opportunity to offer healthcare providers and their patients a lower-cost complex generic alternative to CAELYX® or DOXIL® for the treatment of breast cancer, ovarian cancer, multiple myeloma, and/or Kaposi’s sarcoma. In July 2019, PLUS THERAPEUTICS announced decisions to focus on developing its patented DocePLUS™ asset and halt development of and divest its complex generic DoxoPLUS™ asset. We believe DoxoPLUS™ can make a strong addition to the product portfolio of a large, multi-national pharmaceutical company seeking complex generic oncology injectables.
The European market for PEGylated liposomal doxorubicin is stable, estimated at $130M+ annually, and held entirely today by the originator-reference drug, CAELYX®. No generic versions of CAELYX® are currently approved in Europe. There is an opportunity for a generic, such as DoxoPLUS™, to take significant market share away from CAELYX®.
The Chinese market for PEGylated liposomal doxorubicin is growing rapidly, estimated at $250M+ annually. While CAELYX® was withdrawn from the market many years ago, generic versions from CSPC Pharma, Jemincare, and Fudan-Zhangjiang have filled the void. The U.S. market for PEGylated liposomal doxorubicin is stable, estimated at $180M+ annually, and held among the originator drug, DOXIL®, along with generic versions from Sun Pharma and Dr. Reddy’s. Because of their large patient populations, we believe there remains room in China and the U.S. to capture an attractive market share with DoxoPLUS™.
We have completed a substantial amount of nonclinical and clinical development work to support regulatory approvals in Europe, China, and the U.S. PLUS THERAPEUTICS’ completed bioequivalence clinical study of DoxoPLUS™ versus CAELYX® can be leveraged in Europe and China. However, in the U.S. where Sun Pharma’s Lipodox® is the reference drug, an additional bioequivalence clinical study comparing Lipodox® to DoxoPLUS™ will be required for FDA approval.
Please contact us at firstname.lastname@example.org if interested in DoxoPLUS™ for Europe or other major markets.
CAELYX and DOXIL are registered trademarks of Janssen Products, LP.
Lipodox is a registered trademark of Sun Pharmaceutical Industries Ltd.
PLUS THERAPEUTICS is continually evaluating the most efficient and effective way to get things done. In many cases, we have the right people, materials, equipment, and facilities in-house to complete a particular task, project, or process. In other cases, outsourcing and partnering is a preferred alternative.
We are looking for new suppliers and vendors to help us in the areas of raw materials, product and clinical development, analytical chemistry, manufacturing, quality, regulatory affairs, and industry partnerships. If interested, please contact us at email@example.com.