Frequently asked questions

Ovuplant^® has considerable upside potential for two key reasons:

• Ovuplant^® is not used extensively in breeds other than thoroughbreds because of cost. With the increase in use of shipped and frozen semen in breeds other than thoroughbreds, the need for precision ovulating becomes more apparent
• Registration in several European countries is expected in 2007

Difficulties with our US contract manufacturer meant the product has not been available since the 2004 US breeding season. We are currently preparing our new facility at Macquarie Park to meet FDA requirements so that we can produce locally for the US market.

Ovuplant^® is a high priced specialist product. It is indeed the only product in its class approved by FDA. However, human chorionic gonadotropin ("hCG"), which has a similar claim is one sixth the price and is thus used extensively in the breeding of mares from breeds where fees are small and the use of a vet is limited. Furthermore, hCG is derived from human urine - its use in breeding barns, particularly by females is not well liked.

hCG does not provide the same precision as Ovuplant^® in timing ovulation. Multiple use, as occurs when a mare does not become pregnant, can lead to a refractory response which, in some cases, can be dangerous.

Vaccine technology has several shortcomings. In general the response to vaccines is highly variable and often unpredictable. Most animals will respond to the vaccines but the duration of that response, the critical factor, will vary widely. Vaccines against self-antigens (e.g. GnRH) generally require a powerful adjuvant to ensure a robust anamnestic response (i.e. to get a good antibody titre). As the adjuvant becomes more aggressive the more likely it is that an unwanted injection site reaction will occur. This is unacceptable in domestic pets.

Vaccination against some of the ova specific antigens or ZP3 antigens has an inherent danger that on occasion they can lead to an auto-immune response, making registration by the FDA or any other body virtually impossible.

Lastly the chance of self-inoculation with vaccines is real and once injected they cannot be reversed or removed.

The Peptech Animal Health technology circumvents all the above. Being a solid implant, manufactured using proprietary methodology from benign lipids, it does not cause any local or systemic inflammatory reaction following application. If self injected, which would be extremely difficult unless intentional, it can be easily removed as it is ultrasound opaque. This also means that if the pet owner changes their mind, the implant can be removed. There is no danger of an auto-immune response and the response is less variable.

Sperm or ova antigens are sex-specific - the Peptech Animal Health technology is efficacious in both sexes.

There are no known side effects and this class of drug has been in human medicine for the treatment of prostate cancer in humans or many years.

The benefits over castration and spaying are several fold: The animal is not put to the risks associated with anaesthesia and surgery - both carry considerable risk. The one-year product will allow vets to schedule health programmes around revisits, not possible if an animal is surgically neutered in a one off process - i.e. the Peptech Animal Health product allows scheduling for annual check-ups. The drug can be used to treat certain disease e.g. Benign Prostatic Hyperplasia, present in over 50% dogs over 6 years old. There are other indications which will become public over the next months.

The technology allows choice.

The FDA registration process has begun and we are conversing with the FDA to ensure that the product we manufacture and the clinical trial design is acceptable to the FDA. We have already submitted a dossier to the EU and have received a reply from them already. We are currently compiling a series of responses to them, and expect to have this completed by mid-late 2006. Note that we must also provide these authorities with data from batches manufactured in our new facility over the next few months as the original dossier contained data from our previous site.

The patent referred to is intentionally quite specific. This patent provides strong cover for the specific technology being used as a contraceptive i.e. a lipid formulation delivery deslorelin over a long period. This is the key patent in a patent area that is very crowded. It is the lead patent in a series of patents which cover the delivery of the different agonists of GnRH and also various classes of molecules. The patent recently granted in the USA, the second of the series, covers other GnRH agonists and in effect blocks competitors from using the Peptech Animal Health formulation with other molecules, for the same indication. This is a very important patent in the series. The third patent application covers most other active pharmaceutical molecules such as the statins, ACE inhibitors etc and effectively gives Peptech Animal Health control of its technology for other pharmacological uses of the delivery system.

A patent is a temporary monopoly in a technological innovation, which provides the patent owner with the right to exclusively exploit the invention for the life of the patent (generally 20 years). The idea or invention claimed must be novel, non-obvious, and have a real utility.

Under the Patent Co-operation Treaty (PCT), the process and timetable is as follows:

• File provisional patent [Day 0 - Priority Date]
• Up to 12 months later - Complete filing as PCT application. A PCT application automatically ensures submission of the patent in all countries that are parties to the treaty
• About 16 months from Day 0 - International Search Report (looking for prior art etc) issues
• 18 months from Priority Date - Publication of PCT application. This is the first occasion that the existence of the patent application reaches the public domain
• 20 - 21 months from Priority Date - Entry into National Phase. At this time costs can be limited by reducing the number of countries in which the patent application is examined be examined

After this, each country will examine the patent application according to their own internal timetables and practices, which in the case of Japan can take several years. It is common for there to be a number of rounds of written and verbal discussions between the applicant and the Examiner, directed to specific questions or issues.

In the US, the practice is to allow one "invention" or novel idea, per patent. If the patent office considers there is more than one invention in the PCT application, they will divide the patent into a number of separate applications, or divisionals, each with the same title as the original PCT but with different application numbers. These divisionals will then normally be examined separately.

In certain countries (excluding the USA), any party who feels that a patent should not be granted has a period of time (which varies up to six months) after a patent office publishes a notice that it intends to grant a patent, to object to the granting of that patent. Both parties then argue their case before the patent office or a specific court, and a decision is made in favour of one of the parties.

Generally, no. The US Patent and Trademark Office does publish some procedural information, but never discloses the content of discussions between an applicant and the USPTO or the exact stage of examination of an application. Also, in most cases, a company will receive documents from the USPTO well before the existence of such documents (e.g. Notices of Allowance etc) is listed on the patent office web site.