PJO
9年前
FluoroPharma Enters Development and Commercialization Agreement for China and Canada
MONTCLAIR, NJ -- (Marketwired) -- 06/06/16 -- FluoroPharma Medical Inc. (OTCQB: FPMI) has entered an exclusive agreement with Sinotau USA Inc., a wholly owned subsidiary of Sinotau Pharmaceutical Group, a pharmaceutical enterprise with a focus on critical therapeutic areas. With this agreement, Sinotau will develop and commercialize FluoroPharma's proprietary cardiac imaging assets CardioPET and BFPET in China and Canada. These agents address two different aspects of cardiovascular disease (CVD) with Positron Emission Tomography (PET) imaging.
In exchange, FluoroPharma expects to earn significant revenue based on unit sales to Sinotau and royalties based on Sinotau's sales of both imaging agents. In addition to a $550,000 upfront payment to FluoroPharma, up to $1.4 million in development milestone payments have also been established.
CardioPET, the company's lead imaging asset, is a fatty acid analog that targets the heart's primary energy source, and promises to provide unique insight into cardiac physiology versus older technologies like SPECT. CardioPET has completed enrollment in a Phase II study in Europe, and will advance to additional clinical studies in the US.
BFPET, entering Phase II studies in the US, is a marker of mitochondrial membrane integrity and can be used to evaluate myocardial perfusion with all the potential benefits of Fluorine-18 PET imaging, such as higher image resolution fewer image artifacts.
"We are pleased to have reached agreement with such a well-established partner as Sinotau," said Thomas Tulip, Ph.D., President and Chief Executive Officer of FluoroPharma. "As cardiovascular disease prevalence continues to rise in China, Canada, and around the world, we believe these assets will play a major role in how heart disease is diagnosed and managed appropriately."
According to the World Health Organization, the death rate from cardiovascular disease in China is nearly double that of cancer, and across Asia it now exceeds the mortality rates for CVD in other developed countries.
"We are pleased to have a partnership that combines FluoroPharma's radiopharmaceutical assets with our extensive development, regulatory, sales, and marketing capabilities," commented Xu Xinsheng, Sinotau President and CEO. "Our goal is to offer novel radiopharmaceutical approaches to improve care and patient outcomes with the growing cardiovascular disease problem in China. Ultimately, we are focused on having an impact on the growing concern of cost implications and quality of care in such a large population."
As part of the agreement, Sinotau is responsible for the costs and conduct of clinical studies and regulatory applications to obtain approval by the China Food and Drug Administration (CFDA) and Health Canada. Upon approval, Sinotau will be primarily responsible for all CardioPET and BFPET sales, marketing, market access and medical affairs activities in China and Canada. FluoroPharma and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programs pending CFDA and Health Canada approvals.
"This is the first of many important partnerships which we anticipate during the course of our clinical development," added Dr. Tulip. "The ongoing advance of CVD and the need for better and more efficient solutions in healthcare worldwide give us increased confidence in the inherent value of our portfolio, and our ability to deliver shareholder value as well."
PJO
9年前
MONTCLAIR, NJ -- (Marketwired) -- 12/29/15 -- FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, announced today the appointment of Dr. Thomas Tulip, PhD as Chief Executive Officer.
Dr. Tulip joined FluoroPharma as President in October 2015 and assumed responsibility for the company's day-to-day operations, with a focus on global product and business development strategies.
Additionally, Walter Witoshkin has accepted the role of interim Chairman of the Board. Mr. Witoshkin has been a member of the Board since 2011. The company's previous Chairman and CEO, Thijs Spoor, will remain a member of the Board. The company also recently announced the resignation of Dr. Joseph A. Pierro from the Board, and the appointment to the Board of Austin Lewis IV, CEO of Lewis Asset Management Corporation.
Commenting on the announcement, Dr. Tulip stated, "I am extremely excited to work with the extended FluoroPharma team to advance the company to the crucial next step in its evolution. The company has accomplished many significant milestones under Thijs's leadership, for which we are extremely grateful. Thanks to his efforts, we believe we are now well positioned to move to the next phases of development for our promising cardiovascular imaging agent portfolio, and thereby demonstrate the value of our cutting edge technology."
Dr. Tulip added, "We will continue to focus on the execution of critical development milestones necessary to advance our assets to commercialization and to build shareholder value. We believe it is becoming increasingly clear that current challenges in the management of patients with cardiovascular disease will be better addressed with the innovative technologies that we are developing."
Dr. Tulip has spent more than 25 years in the development and commercialization of radiopharmaceuticals and imaging agents, with a track record of success in R&D, business development, brand and alliance management, and international business. From 2011-2015, he served in senior leadership roles at Navidea BioPharmaceuticals, Inc., where he led one of the few successful recent launches of an innovative radiopharmaceutical; established a number of global partnerships; and, in-licensed a pair of best-in-class neuroimaging assets. Previously, Dr. Tulip held senior leadership positions at Alseres Pharmaceuticals, Lantheus Medical Imaging (LMI), Bristol Myers Squibb (BMS), and DuPont, where his roles spanned product discovery and development, business and technology planning, brand and alliance management and international business management. While at BMS and DuPont, he was instrumental in the development, commercialization and international management of the highly successful nuclear cardiology franchise; successfully built the BMS Medical Imaging international business; and led planning activities for innovative PET tracers at LMI/BMS. He was a Board Member of the Academy of Molecular Imaging and Chairperson of its Institute for Molecular Technologies. Dr. Tulip was Chairperson of the Society of Nuclear Medicine Corporate Advisory Board and served as a Director of the Council on Radionuclides and Radiopharmaceuticals. He serves on the Board of Directors of the Medical Imaging Technology Association (MITA) and leads its PET Working Group. He earned a B.S. from the University of Vermont, and an M.S. and Ph.D. from the Northwestern University.
An investor call is planned for Wednesday, January 6th at which time Dr. Tulip will share his vision for FluoroPharma and address questions. Details of this call will be forthcoming shortly
mulletman99
9年前
Last chance to buy cheap
Lets think about it.
- They just raised over $2mil.
- They increased the note to $3mil, so IMO, its a safe bet that more is coming in
- They owe the CRO for CardioPET $500k (see 10Q) - They raised enough to pay this. IMO, its safe to assume this has been paid with the $2mil raised and the data is in hand. We know they need a blind read of the results. There are 3 options here: a) this is already happening b) they are waiting for more $$$ from the note to start
- BFPET P2 is set up and ready to go. I am betting that thet are enrolling and we will get an announcement soon. I have seen others guess that they are waiting for the first patient to be scanned.
Based on the above, the news is about to start flowing, and so is the data. Data = attention, especially P2 data, which anyone who knows anything about biotech knows.....this is the de-risking stage. Companies that WANT to partner, will almost always wait until after P2 data.
Once the CardioPET P2 data rolls in, there will be presentations, conferences, (analysts???) etc. This will bring some attention to the stock and get it out of the bargain-bin pricing territory.
And while the final P2 data from CardioPET P2 is still being presented, we should start seeing initial P2 data from BFPET P2 in the form of scans, either from the company, or from MassGen at industry conferences. This should happen very quickly, since as I have said, there are a lot of fat people in Boston.
This company is about to come out of the darkness. Before it entered this quiet period due to finances, the pps was in the $0.60s. I fully expect to see that again (at minimum) by years end. Thats only 3 1/2 months away.
Its time folks. Here we go!
Oh yeah......dont make me look stupid management......LETS GO ALREADY!!!!!
All IMO......do your own DD and think for yourselves.
hmoney
10年前
FPMI DD:
DD below:
Company Overview
FluoroPharma Medical, Inc. is a biopharmaceutical company specializing in discovering, developing and commercializing molecular imaging pharmaceuticals with initial applications in the area of cardiology. Molecular imaging pharmaceuticals are radiopharmaceuticals that enable early detection of disease through the visualization of subtle changes in biochemical and biological processes. Our initial focus has been on the development of novel cardiovascular imaging agents that can more efficiently and effectively detect and assess acute and chronic forms of coronary artery disease, or CAD.
FluoroPharma Inc. was organized to engage in the discovery, development and commercialization of proprietary products for the positron emission tomography (PET) market.
Positron emission tomography (PET)
Positron emission tomography (PET) is a nuclear medicine, functional imaging technique that produces a three-dimensional image of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide (tracer), which is introduced into the body on a biologically active molecule. Three-dimensional images of tracer concentration within the body are then constructed by computer analysis. In modern PET-CT scanners, three dimensional imaging is often accomplished with the aid of a CT X-ray scan performed on the patient during the same session, in the same machine.
License with Massachusets General Hospital
On June 26, 2014, FPMI & Massachusetts General Hospital (“MGH”) entered into two license agreements, which Agreements replace the single license agreement between the Company and MGH dated April 27, 2009, as amended by letter dated June 21, 2011 and agreement dated October 31.
The Agreements provide exclusive licenses for the Company’s two lead product candidates, BFPET and CardioPET, two of the three cardiac imaging technologies covered by the Original Agreement.
The Company and MGH are in discussions regarding the exclusive license to VasoPET, the third product candidate covered by the Original Agreement, the Company’s rights to which ceased upon the termination of the Original Agreement contemporaneously with the execution of the new Agreements. The Agreements were entered into primarily for the purpose of separating the Company’s rights and obligations with respect to its different product development programs. Each of the Agreements requires the Company to pay MGH an initial license fee of $175,000 and annual license maintenance fees of $125,000 each. The Agreements require the Company to meet certain obligations, including, but not limited to, meeting certain development milestones relating to clinical trials and filings with the United States Food and Drug Administration.
MGH has the right to cancel or make non-exclusive certain licenses on certain patents should the Company fail to meet stipulated obligations and milestones. Additionally, upon commercialization, the Company is required to make specified milestone payments and royalties on commercial sales. The Company is amortizing the cost of these intangible assets over the remaining useful life of the Agreements of 10 years.
Understanding the Use of 18-F aka Fluorine-18
FPMI uses 18F as their tracer for CardioPET & BFPET.
Fluorine-18 (18F) is a fluorine radioisotope which is an important source of positrons. It has a mass of 18.0009380(6) u and its half-life is 109.771(20) minutes. It decays by positron emission 97% of the time and electron capture 3% of the time. Both modes of decay yield stable oxygen-18.
Fluorine-18 is an important isotope in the radiopharmaceutical industry, and is primarily synthesized into fluorodeoxyglucose (FDG) for use in positron emission tomography (PET scans). It is substituted for hydroxyl and used as a tracer in the scan. Its significance is due to both its short half-life and the emission of positrons when decaying. In the radiopharmaceutical industry, it is made using either a cyclotron or linear particle accelerator to bombard a target, usually of pure or enriched oxygen-18-water [1] with high energy protons (typically ~18 MeV protons).
Drivers: CardioPET and BFPET
CardioPET-
• Phase II of clinical trials at four sites in Belgium. The trial, like the patent, is through a 3rd party- SGS Life Sciences Servies .
• SGS has registered offices in Belgium for clinical research services relating to the Company’s CardioPET Phase II study to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients. The phase II trial is an open label trial designed to assess the safety and diagnostic performance of CardioPET as compared to stress echocardiography, myocardial perfusion imaging and angiography as a gold standard of background disease.
• The Phase II clinical trial plan for 18-F FCPHA is an open label trial designed to assess the safety and diagnostic performance of 18-F FCPHA as compared to myocardial perfusion imaging and angiography as a gold standard of background disease.
• The Phase II trial consisted of between 30-100 individuals with known stable chronic CAD who cannot undergo stress-testing for the evaluation of suspected or proven CAD
• Enrollment for the Phase II trial was closed on December 15th and final analysis is being completed.
• 17 million potential patients
BFPET-
• Successfully completed Phase I trial with 12 healthy volunteers with no adverse events.
• FPMI anticipates BFPET has a much higher revenue potential than CardioPET. Their January 2015 Investor Presentation reveals their belief the Bfpet market could exceed $8billion in 5 years.
• For use in combination with stress-testing in patients with presumptive CAD. Essentially, opportunity to become standard for measuring cardiovascular blood flow.
• Phase II was initiated in Sept 2014. The trial, like the patent, is through a 3rd party- PPD Development, LP.
• On May 23, 2014, the Company entered into a Master Services Agreement with PPD Development, LP, a clinical research organization engaged in the business of managing clinical research programs and providing clinical development and other related services, for the clinical research services relating to the Company’s BFPET Phase II study.
• The Phase II trial will be an open label trial designed to assess the safety and diagnostic performance of BFPET. Multiple trial sites are planned in various locations in the United States. In connection with this agreement, the Company has accrued $90,000 as of September 30, 2014 related to start-up costs.
• Enrollment for phase II has been very slow. They expect enrollment to commence in the first quarter of 2015. The estimated cost of this program is $1.7 million.
• BFPET would replace SPECT in institutions with PET capability.
• 12 million potential patients
• FDA enrollment monitoring link https://clinicaltrials.gov/ct2/show/NCT02252783
Evaluating Risks
1) 3rd Party Patent –FPMI licenses patents from 3rd party owners.
2) Patent Expiration – Patents for BFPET & CardioPet continue through 2025.
3) Cash flow- Burning Cash because of trials
4) $100k to marketers - On March 24, 2014, the Company entered into a consulting agreement with the Del Mar Consulting Group, Inc. ("Del Mar") for investor and public relations services. The consulting agreement has an initial term of four months with successive one month renewal periods until terminated by either party upon not less than 10 days prior notice.
a. The Company paid an upfront fee of $125,000 payable at the Company's option either in cash or in restricted shares based on the market price of its common stock preceding the Effective Date.
b. The Company will also pay a monthly cash retainer of $10,000 during the term of the consulting agreement. In addition, provided the consulting agreement remains in effect, the Company will pay to Del Mar a $125,000 renewal fee within 10 days following the five month anniversary of the Effective Date at the Company's option either in cash or in restricted shares based on the market price of its common stock preceding the Effective Date.
5) $325,000 Lawsuit Pending - On July 16, 2013, Todd Nelson, as plaintiff, served Fluoropharma Medical, Inc. with process in the matter captioned, Todd Nelson v. Fluoropharma Medical, Inc.; and Does 1 through 10, No. 13 CV 01152 JAD CWH, which is pending before the United States District Court for the District of Nevada. In this action, the plaintiff alleged that he suffered damages attributable to the Company’s refusal to honor certain stock options after February 28, 2012. Plaintiff seeks at least $325,200 in damages, as well as punitive and exemplary damages, prejudgment interest, and costs. No resolution has occurred yet.
6) CEO contract is up in 2015 – Contract expires on July 30, 2015. Foresee it being renewed.
7) Lease Expiration - Offices are located in Montclair, New Jersey. However, their lease expires on April 30, 2015. On July 1, 2014, the Company increased its office space and amended this agreement. The amended monthly lease payments for this office space are $6,350 per month plus common area costs.
Competitors
Competition will come from Lantheus, Bracco, GE Healthcare, and Mallinckrodt.
If approved, 18-F TPP’s primary competition in the non-acute setting will be perfusion imaging agents such as:
• Sestamibi produced by Lantheus Medical (On market for at least 10 years)
• Tetrophosmine aka Myoview is produced by GE Healthcare (On market since 2003)
• Generic Thallium, the primary U.S. supplier being Mallinckrodt.
Private Placements
Company has done an excellent job of using private placements to raise capital instead of diluting the equity and negatively affecting shareholders.
Articles & Research
1) A new F-18 labeled PET tracer for fatty acid imaging (10/25/14) http://link.springer.com/article/10.1007%2Fs12350-014-0012-4
2) Zachs Research Report (11/20/14)
http://scr.zacks.com/files/Nov-20-2014_FPMI_Marckx_v001_z0g2b2.pdf
3) Lifetech Capital Research Report (6/11/14)
http://lifetechcapital.com/ltc/wp-content/uploads/2014/06/Mid-Day-Note-06-11-14-FPMI.pdf
4) Forbes Article (1/10/14)
http://www.forbes.com/sites/johnfarrell/2014/01/10/pet-imaging-market-poised-to-grow-with-new-compounds/
5) Diagnostic & Interventional Cardiology Article (7/23/2013)
http://www.dicardiology.com/article/pet-vs-spect-%E2%80%94-will-pet-dominate-over-next-decade
Clinical Research Services Agreements
1) On September 7, 2012, the Company entered into a Clinical Research Services Agreement (“CRS Agreement”) with SGS Life Science Services (“SGS”), a company with its registered offices in Belgium, for clinical research services relating to the Company’s CardioPET Phase II study to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients. The phase II trial will be an open label trial designed to assess the safety and diagnostic performance of CardioPET as compared to stress echocardiography, myocardial perfusion imaging and angiography as a gold standard of background disease. Two trial sites are planned in Belgium and are expected to be concluded in the second half of 2014.
In March 2012, the Company had signed a Letter of Intent (“LOI”) that provided for the pre-payment of $290,271 for start-up services. The CRS Agreement provides for additional payments of $346,234 to SGS subject to a schedule of milestones relating to the progress of the clinical trial. Immediately before entry into the LOI, the Company engaged FGK Representative Service GmbH to serve as the Company’s sponsor in compliance with the laws governing clinical trials conducted in the European Union. On February 28, 2013, the Company announced that the Phase II trial had begun. On February 6, 2014, the Company presented interim data from the trial at the SNMMI mid-winter meeting.
2) On May 23, 2014, the Company entered into a Master Services Agreement with PPD Development, LP, a clinical research organization engaged in the business of managing clinical research programs and providing clinical development and other related services, for the clinical research services relating to the Company’s BFPET Phase II study. The Phase II trial will be an open label trial designed to assess the safety and diagnostic performance of BFPET. Multiple trial sites are planned in various locations in the United States. In connection with this agreement, the Company has accrued $90,000 as of September 30, 2014 related to start-up costs. The trial is expected to commence in the fourth quarter of 2014. The estimated cost of this program is $1.7 million.
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