Stockholm, 2015-10-20 08:30 CEST (GLOBE NEWSWIRE) --
Significant events during the quarter
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Net result for the quarter amounted to SEK -11 431 (-11 265) k and to -35 025
(-30 714) k for the nine-month period
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Cash and cash equivalents at the end of the period amounted to SEK 59 313
(40 675) k
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Cash flow from operating activities for the quarter amounted to SEK -10 273 (-7 124) k and to -41 939 (-28 808) k for the nine-month period
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Result per share for the quarter amounted to SEK -0.4 (-0.5) and to -1.2 (-1.4) for the nine-month period
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PledPharma's key patent application for the active pharmaceutical ingredient of the drug candidates PledOx® and Aladote® has received a "Notice of Allowance" from the United States Patent and Trademark Office (USPTO) meaning that the USPTO intends to grant the application
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Patent for the anticancer-effect of PLED compounds approved by the European Patent Office and an important use patent for PLED compounds granted by authorities in Canada, Russia and Australia.
- Aladote® approved as a trademark in the US
Other significant events during 2015
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Top-line results from phase IIb study presented in March - PledOx® reduces nerve damage in conjunction with chemotherapy by 43 percent
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Aladote® approved as a trademark in the EU
- Further clinically relevant and statistically significant results from the Phase IIb study with PledOx® presented at the MASCC scientific congress.
CEO comment
Earlier this year PledPharma presented groundbreaking results from a Phase IIb study of PledOx®. During the last quarter, intensive work has been ongoing on the completion of the comprehensive briefing package to be discussed at the upcoming meeting with the FDA. The goal of the meeting is to clarify the scope and design of the continued clinical development studies needed up to submission of a registration application. After this, we are ready to intensify discussions with potential commercial partners. Ahead of this important phase, we also commissioned a group of leading international experts, with extensive experience and deep knowledge of the global pharmaceutical industry's requirements, to perform an analysis of the project from a preclinical, clinical, pharmacological, manufacturing, and regulatory perspective. The analysis confirms that the PledOx® project confirms to a very high international standard and that no additional activities are deemed necessary before contract negotiations.
The commercial value of these results will of course be significantly higher if they can be combined with strong intellectual property protection. It is therefore rewarding that intellectual property protection for PledOx® has strengthened further during the past quarter. In September, the US Patent Office, USPTO, announced that it intends to grant a compound patent covering the active ingredient calmangafodipir. A composition of matter (compound) patent is normally the most desirable form of patents for pharmaceutical companies because it offers stronger protection than use patents. Getting our compound patent - which extends until December 2032 - issued on the world's largest pharmaceutical market is a very big step for PledPharma. Since another of our drug candidates - Aladote® - is based on the same active pharmaceutical ingredient as PledOx®, the announcement from the patent authorities is also of great value for this project. Aladote® has been developed to prevent the severe liver damage that often occurs in connection with an overdose of acetaminophen - the most common method for suicide attempts among young people aged 10-19 years. A clinical phase II study is expected to be initiated during in 2016.
Furthermore, patent protection in other parts of the world has been strengthened by a series of positive official statements. The European Patent Office has approved a patent for the anti-cancer effect of PLED substances. Thus, this patent is now approved in all major pharmaceutical markets. Meanwhile, authorities in Canada, Russia and Australia granted an important use patent for PLED substances. Together, these two patents provide supplementary protection around the central and fundamental compound patent.
I look forward to the meeting with the FDA, which will give us guidance on how to present an attractive package to potential partners based on a professionally executed project with unique clinical results, a strong patent position, and a well-defined development plan. The aim is to achieve an agreement that maximizes our ability to quickly and effectively make PledOx® available for the long-suffering of cancer patients, while at the same time building significant value for our shareholders.
Jacques Näsström
CEO, PledPharma AB (publ)
PledPharma in brief
PledPharma develops new drugs that protect the body against oxidative stress – a condition that can be caused by chemotherapy treatment and acetaminophen (paracetamol) poisoning. The company's most advanced project PledOx® reduces nerve damage associated with chemotherapy. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. The project PP-099 seeks to limit the damage that occurs to the heart muscle during myocardial infarction. PledPharma’s most advanced project with PledOx® has completed Phase II trial. PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bankaktiebolag is the company’s Certified Adviser (tel +46 8 463 80 00). For more information, see www.pledpharma.se
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Johan Stuart, CFO cell +46 70 66 44 096
