After many years it looks like Cyclopharm's long suffering share...

After many years it looks like Cyclopharm's long suffering share holders will soon have something to smile about...

January 2008 - Cyclopharm receives regulatory approval in Italy

February 2008 - Cyclopharm makes its first sale of Technigas products in Russia

March 2008 - Cyclopharm establish its first PET Radiopharmacy in Sydney

May 2008 - Cyclopharm receives regulatory approval in Brazil for Technegas and records its first sales in mexico

June 2008 - TGA advisor Mr James McBrayer appointed as the new Managing Director

December 2008 - Lodgement of application to sell Technegas in United States

December 2009 - Cyclopharm Limited settles claim for US$1.8m

May 2010 - Cyclopharm receives regulatory approval in China for Technegas Plus generator

February 2011 - Cyclopharm Receives Clinical Protocol Approval from United States Food and Drug Administration

December 2011 - Cyclopharm Receives Approval from United States FDA to Commence Technegas Clinical Trials

Cyclopharm have now received approval from the United States Food and Drug Administration to commence Phase 3 clinical trials with Technegas.

The FDA approval is based on the successful review of Cyclopharm’s Investigational New Drug application for Technegas submitted to the FDA last month. Technegas is a lung ventilation imaging agent used primarily to detect pulmonary embolism. The product is distributed in over 50 countries. The United States represents the largest nuclear medicine market in the world.

Based on Technegas’ success in the Canadian market, the company is expected more than double its current size within 3 to 5 years of attaining United States marketing authorisation approval.

Cyclopharm announced earlier in the year that it had reached clinical protocol agreement with the FDA through the Special Protocol Assessment process. A Special Protocol Assessment is a mechanism through which the FDA and sponsor reach agreement on the design, size, clinical endpoints, and data analysis of a clinical trial that is intended to support an efficacy claim in a New Drug Application for regulatory approval. The Special Protocol Assessment ensures that the agreed clinical trial design meets the FDA's expectations for a pivotal study.

750 patients will be imaged during the trial period at several leading clinical sites across the United States. The trial is expected to cost up to USD $4m to complete. Subject to patient recruitment frequency Cyclopharma expect marketing approval could be granted by 2014.

Detailed Description:
This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.

With the FDA endorsement in hand Cyclopharm have commenced site qualification, product installation and user training procedures in initial clinical sites. They expect that the first United States patients to have access to the life saving technology will occur by the end of January 2012.

With this significant milestone achieved Cyclopharm have made an enormous step forward in gaining marketing approval for Technegas in the USA. The speculation is now over. Cyclopharm is now about to enter into a phase that will allow the company to actually demonstrate the benefits of Technegas to the clinical community in the United States. - Cyclopharm Receives approval from FDA to Commence Clinical Trials
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Benefits using Technegas
Technegas offers significant advantages over all other agents because it behaves as a true gas allowing its nano sized particles to penetrate deep into the alveoli where they remain bound to the lining of the alveoli resulting in a very stable image of the highest quality. Showing a higher sensitivity and specificity result over traditional planar V/Q, Technegas is considered the agent of choice for quality SPECT-VQ.

Proven diagnostic accuracy
Sensitivity, specificity and accuracy at least the equivalent of CTPA giving the clinician interpretive confidence first time, every time.

Plus these specific benefits:

•Non invasive
Aids patient comfort and compliance.

•Detects PE
Even on the subsegmental levels.

•Proven track record
More than 21 years and 20million scans worldwide without a single documented adverse event.

•Low radiation burden to the patient
in compliance with ALARA principles and FDA recommendation, Technegas is the right exam, for the right reason, at the right time.

•A true 'screening' test
A true screening test should have universal application and minimal exclusion criteria. Technegas may be administered to almost all patients including those who are -

?Comatose
?Renally compromised
?Diabetics on Metoformin
?Critically ill
?Suffered from M.I.
?Allergic iodinated contrast
?Claustrophobic
?On long term anticoagulants
?Receiving ventilatory supports
?Female under 45

Lungspect
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Clinical Trial Register - NCT01458639
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Cyclopharm Limited - CYC

Issue - 223,579,418
Market Cap - $8,943,177
FY2011 Revenue - $3,615,429
Top 20 - 74.13% (March 2011)
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Renounceable Rights Issue - Completed December 2011
On the basis of 1 Share for every 3.2 Existing Shares at an Offer Price of $0.04 per Share

31,724,692 take up.
20,842,110 short fall was fully underwritten by *CVC Managers Limited (CVC)
* CVC Limited lists Cyclopharm as one of its "Significant Long Term investments

Directors take up
1,146,908 ($45,876) - Gould
81,783 (3,271) - Heaney
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Cyclopharm Limited
Cyclopharm is a radiopharmaceutical company servicing the global medical community. The Company’s mission is to provide nuclear medicine and other clinicians with the ability to improve patient care outcomes.
Cyclopharm achieves this objective through the provision of radiopharmaceutical products, Technegas (for lung imaging) and Molecular Imaging / PET radiopharmaceuticals (used in cancer, brain and cardiac imaging). Our customers are nuclear medicine departments located within hospitals and clinics.

Technegas
The Technegas technology is a structured ultra-fine dispersion of radioactive labeled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced for a few seconds at around 2,500oC. The resultant gaseous substance is inhaled by the patient (lung ventilation) via a breathing apparatus, which then allows multiple views and tomography imaging under a gamma or single photon emission computed tomography (SPECT) camera for the superior diagnosis of pulmonary emboli (blood clots in the lungs).

Positron Emission Tomography (PET)
PET radiopharmaceuticals target specific tissues / organs, concentrate there, and the attached radioisotope emits radiation, which is then detected by a PET or PET / CT gamma (collectively PET camera). These imaging modalities help physicians improve their ability to detect and determine the location, extent and stage of cancer, neurological disorders and cardiac disease. By improving diagnosis, PET scans aid physicians in selecting better courses of treatment, as well as assessing whether treatment is effective or should be changed.

Macquarie University Hospital and the Macquarie University School of Advanced Medicine
"Macquarie University Hospital is a major medical precinct within the Macquarie University Research Park to complement the Allied Health teaching services offered by Macquarie University. The Macquarie University Hospital is a state of the art facility that delivers health education and research on site."

Macquarie Medical Imaging
"Cyclopharm formed a joint venture with Alfred Health Solutions to provide all imaging services on-site at the hospital. The new venture named Macquarie Medical Imaging (“MMI”) represents a rare strategic opportunity to provide a fully aligned and integrated diagnostic, therapeutic and research platform. MMI offers a range of diagnostic radiology, interventional radiology, nuclear medicine and molecular imaging services for inpatient and outpatients.

The combination of state of the art imaging equipment, a GE cyclotron located on the grounds of MUH, leading surgeons, clinicians and academics will ensure that MMI will become the leading centre of imaging excellence.
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Mr Gould is the Chairman of Cyclopharm and CVC Limited (Cyclopharm's #1 share holder) and wrote the following in the CVC Annual Report 2011:

"In our view Australia has squandered a generational opportunity to embark on nation building programs and reforms and has instead lost its way pandering to minority interests and failing to develop a vision for the future that will enhance the standard of living for all Australians.

Perhaps this is most clearly seen in the debate over carbon dioxide which is 97% caused naturally and Australia’s contribution to the remaining 3% of the world’s output is statistically insignificant.

That is not to say that there are not legitimate moral questions, but in the context of enhancing the well-being of all Australians, it is hardly the major issue.

The great tragedy of the view that environmental concerns are Australia’s number one priority is that it is fundamentally untrue. No one can read the report of Professor Patrick Parkinson (former Chair of the Federal Government’s Family Law Council), For Kids’ Sake, recently published by the University of Sydney, to realise that there are fundamental problems with our society that surely must have a higher priority than environmental concerns."
CVC - Annual Report 2011
CVC - Investor Presentation - 28 November 2011

Amen to that Mr Gould.

Good luck to all Cyclopharm s/holders

Any 4c sellers left out there? No liquidity