setting the record striaght

Wubzee, I am sure you and many others would know that, on HC, it is an oft-used but nonetheless tired ruse for some posters to attempt to promulgate negative sentiment about a company under the guise of 'apparently' exacting and well-intentioned research. It's probably fair to say that those so inclined are economical with the truth for the sole purpose of benfitting themselves or harming others, often both.

To redress the balance I will attempt to answer some of the questions and clarify other misconceptions that are 'apparently' causing consternation in some quarters.

1) Le Trait

SA DO NOT manufacture prefilled syringes at Le Trait. They buy standard ready to fill syringes from Gerresheimer Bunde and Schott Glass, among others, and then fill them with drugs or vaccines. The retractable safety component of the syringe is then clipped onto the syringe by a secondary automation system, thus turning the orignal ready to fill syringe into a prefilled safety syringe. As was clearly demonstrated by Alan Shortall at the AGM, this is bulky and ineffective technology when compared to the Unifill.

I will not bother talking about the 70% packaging, transportation and storage costs SA and other pharmaceutical companies will save by utilising Unilife's Unifill technology. Nor will I bother repeating the fact that Unilife's technology is fully compatible with SA's existing automated filling lines at Le Trait and their other global facilities, indeed was specifically designed to be compatible. What's the point when it falls on (deliberately) deaf ears?

I would have thought that the doubling of SA's filling capacity for Lovenox at Le Trait signals not only their confidence in the drug, but also in the rapidly expanding global market for prefills. Moreover, I also would have hought that, the more SA invest in their syringe filling systems at Le Trait and elsewhere for their injectible drugs and vaccines, the greater the opportunity for Unilife moving forward. And should demand for Lovenox lessen when it comes off patent in 2012, SA are in the happy position of having that filling capacity available for other new pipeline products.

In this regard I would also imagine that when the Therapeutic Drug Class list is finalised we will see that SA intend to utilise Unilife's Unifill and Unifill Select technology across a wide range of their products. After all, isn't that the foundation and raison d'etre on which negotiations for the Exclusive Therapeutic Drug list are founded?

2) NMT of Scotland

Even the most cursory research will tell anyone truly interested, that the NMT syringe is very similar to RTI's Vanishpoint, the BD Integra and OMI's retractable effort. Firstly, that they employ a bulky clip-on device and secondly, that each require an independent action to activate the retraction mechanism, meaning the user must first remove the syringe from the patient prior to activating needle rectraction. This exposes the user to blood and tissue spatter when the needle retracts with forces up to five Kilograms. This spatter becomes aerosol, which if inhaled or 'ingested' in the eye, exposes the user to blood-borne virus and disease.

Unilife's patented technology is the only safety syringe in the world that addresses and overcomes this problem. It is why six years ago, after a global search for best-in-class technology, SA chose to partner with Unilife and why they have spent so much time, money and effort in developing the Unifill, (and in time the Unifill Select), to the level of commercial readiness we now enjoy. It is also why Unilife have been granted a Freedom to Operate by the USPTO.

Unlike all other retractable safety syringes currently available, Unilife's range of products employ two distinct features - the needle can be retracted while 'in situ' in the patient, and secondly the rate of retraction is controlled by the user, which means that the user does not surrender control of the needle retraction to an independent mechanism. Taken together, these unique features eliminate the possibility of blood and tissue spatter, and thus user infection.

The efficacy, uniqueness and benefits of Unilife's technology are not in doubt, and again, have been clearly explained and demonstrated many times by Alan Shortall in various shareholder and investor presentations, and can be viewed on the website.

Laslty on this, the NMT deal with Roche was not for a fully funded prefill, but instead was for NMT's PLASTIC retractable syringe to be filled with Fuzeon. Nor did this deal come with any pre-order/pre-revenue commitment from Roche. Unlike the Unilife deal with Sanofi. Go figure.

3} The Unilife IM

I think I have mentioned before, though am reluctant to do so again, but I have a legal background, (hence my wordiness) and have in previous lives been employed in Company Secretarial capacities.

For all intents and purposes, an IM is a prospectus, albeit a far more rigorous legal document, in which EVERY statement and claim must be independently verified BEFORE it can be released. This means that the internal Due Diligence Committee comprised of Senior Managment respnsible for critical aspects of the business, directors, CFO, internal Legal Counsel and the CEO, and also including the company lawyers in Australia and New York, and investment advisors, must EACH sign off on ALL Unilife internal/external legal documentation, Agreements with Pharma partners, customers, suppliers, employment contracts, patents, and all other statements and claims made in the IM about the company and its business, verifying that EVERYTHING as stated in the IM is the TRUTH, and perhaps more importantly, that there are no hidden obligations or risks that have not been included.

Only when this is done can the IM be released. However, that release is not to shareholders. Not yet. First it is given to the ASX to review. When ASX have signed off, it goes to ASIC for their review. Following that, and because the Scheme of Arrangement is a judicial matter run under the auspices and supervision of the Supreme Court, it is given to a Supreme Court Judge for his/her review. When this final review is completed and approved, then and only then is it released to the market and shareholders.

I think it is fair to say that very few Australian companies have ever undergone such rigorous scrutiny and come through with flying clours. So, as others have said on this subject, if anyone has any questions, the IM is THE complete reference guide to the company, its products, executive, employees, business partners, markets and business model that has been signed off as true and correct IN ALL ASPECTS, not only by the internal Due Diligence Committee, but also by three Independent Bodies including a Supreme Court Judge.

As for the past, the only mistake is not to learn from your mistakes. In my opinion, Alan Shortall has well and truly learned from his. I wonder how many others here can say the same thing?