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Medicure develops novel Aggrastat formulation

Winnipeg, Manitoba
Friday, September 28, 2012, 12:00 Hrs  [IST]

Medicure Inc., a specialty pharmaceutical company focused on the development and commercialization of novel small molecule therapeutics has announced the development of a transdermal delivery formulation of its lead drug, Aggrastat (tirofiban Hcl).

Aggrastat (tirofiban HCl), in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, Aggrastat has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. Aggrastat has been studied in a setting that included aspirin and heparin.

The ability to administer a drug transdermally (i.e. through the skin) provides a convenient way to deliver a stable, therapeutic level of medication to the patient. Aggrastat and other antiplatelet drugs of its class (known as glycoprotein IIb/IIIa inhibitors or GPIs) are currently only administered by intravenous infusion. In vivo proof of principle for the transdermal delivery of therapeutic levels of Aggrastat's active ingredient, tirofiban, was recently established in animal studies conducted in collaboration with 4P Therapeutics, Inc. (Alpharetta, GA). 4P Therapeutics, a world leader in the research and development of novel transdermal products, has entered into an agreement with the company's subsidiary, Medicure International, Inc., to further develop transdermal tirofiban.

The company's initial target use for transdermal tirofiban is the treatment of acute coronary syndromes for which the drug is already approved by the United States Food and Drug Administration and currently receives a Class 1 recommendation from the nationally recognized ACCF/AHA treatment guidelines. The delivery of tirofiban by a novel, transdermal method has potential to provide significant advantages over the current treatments used in this setting, including the potential for increased use prior to hospitalization.

"The introduction of a transdermal glycoprotein IIb/IIIa inhibitor would have a significant impact on the management of several cardiovascular conditions," stated Dr David Lee, director of the Cardiac Catheterization and Coronary Intervention Laboratories, Stanford University Medical Centre. "This innovation would not only further enhance the ease-of-use and convenience associated with this class of drugs, but may also facilitate earlier, prehospital administration as well as a number of other new applications."

The global market for antiplatelet drugs is over $8 billion per year, of which Aggrastat and the other intravenous GPIs make up approximately $500 million per year. The largest share of the market is held by oral antiplatelet drugs, such as clopidogrel (Plavix) and ASA (Aspirin), which by virtue of their route of administration can be used in a variety of settings where intravenous administration is not feasible. While these treatments will continue to serve an important role in cardiovascular therapy, the use of oral antiplatelet drugs for some patients and conditions is limited by a number of drawbacks including inter-individual variability, resistance, drug-drug interactions and delays in reversal of effect. Transdermal tirofiban has the potential to avoid these problems and to carry the unique benefits of a GPI, including the ability to dissolve and to directly prevent formation of platelet aggregates (blood clots).

If successful in advancing transdermal tirofiban, the Company may also look to expand the development and application of this product to other indications that aren't satisfactorily treated with current antiplatelet drugs. One such potential application may be in providing platelet inhibition to patients who have been required to stop use of oral platelet inhibitors prior to surgery (commonly referred to as "bridging therapy"). Tirofiban's properties as a broadly effective, rapidly reversible, small-molecule platelet inhibitor, combined with a simple means of delivering the drug outside of a hospital setting, make this a promising opportunity.

"The development of transdermal tirofiban is a component of our Aggrastat life cycle management strategy that builds upon our traditional expertise in cardiovascular drug development," added Dawson Reimer, president and chief operating officer of Medicure. "A product that delivers tirofiban non-invasively through the skin may create value first in the same settings where the drug is currently approved and then, with further investment, in other applications. Patent and regulatory protection for transdermal tirofiban also provides opportunity for the Company to realize value both in and outside of the US market."

The company's subsidiary, Medicure International, Inc., holds international patent applications related to transdermal tirofiban.

"Based on the data generated to date, I have reason to believe that our team will be able to develop a convenient, efficient way to transdermally deliver therapeutic levels of this proven and well established intravenous drug," stated Steve Damon, CEO, 4P Therapeutics. "The fact that big pharma companies have spent hundreds of millions of dollars on attempts to introduce a non-intravenous, oral delivery form of this type of drug should serve as a testament to the market potential for this product and, most importantly, to the potential clinical benefit for patients."

4P Therapeutics is a private company focused on the research and development of novel drug delivery technologies and novel drug delivery based therapeutics.


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