Products

Fentanyl TAIFUN®

PRODUCT OVERVIEW:

AKELA Pharma is developing Fentanyl TAIFUN inhaler, a next generation treatment for breakthrough cancer pain. Based on AKELA’s proprietary multi-dose dry powder inhalation platform, Fentanyl TAIFUN promises cancer patients a significant advance in the management of breakthrough pain.

Fentanyl is a well studied opioid analgesic first approved as an intravenous agent in 1968 (USA).  Since then, fentanyl has been incorporated into a number of different dosage forms for the treatment of both acute and chronic pain in the outpatient setting.

AKELA Pharma is developing fentanyl in its TAIFUN inhalation delivery platform.  Inhalation is a very attractive alternative to intravenous administration when the objective is rapid onset of action and greater convenience.  When compared with other dosage forms used for the treatment of breakthrough pain, the inhalation route offers greater convenience and a more rapid onset of pain relief.



MEDICAL NEED:

Breakthrough cancer pain has a rapid onset of action, often within seconds, and lasts for minutes to hours, with a median duration of about 30 to 60 minutes, before spontaneously subsiding. Breakthrough cancer pain is a significant problem for cancer patients despite taking optimal chronic pain medication.  It is estimated that 800,000 cancer patients in the USA, and 700,000 patients in Europe, suffer from breakthrough cancer pain.



PARTNERSHIP STATUS:
AKELA Pharma is seeking to partner the development and commercialization of Fentanyl TAIFUN for the North American market. AKELA currently has partnerships with Janssen Pharmaceutica NV for the European Union and with Teikoku Seiyaku and SK Pharma for selected Asian markets.

 

AKELA GHRH

PRODUCT OVERVIEW:

AKELA PHARMA’s GHRH (growth hormone releasing hormone) is in clinical Phase II development for the treatment of malnutrition in patients with Stage IV (pre-dialysis) chronic renal failure. LAB GHRH is a novel 29 amino-acid long peptide analogue that has demonstrated superior in-vivo potency in animals. LAB GHRH has exhibited increased resistance to proteolysis and a relatively high binding affinity to the human GHRH receptor in in-vitro studies, in comparison with human native GHRH (1-29)-NH2. AKELA GHRH acts in a more natural manner on the pituitary gland in the brain to stimulate release of growth hormone which further induces a cascade of actions including the release of IGF-1 which has a direct effect on lean muscle mass. 

MEDICAL NEED:

Chronic renal failure is associated with a number of significant medical challenges including high blood pressure, anemia, weak bones, poor nutritional health and nerve damage. In sever cases, chronic renal failure leads to kidney failure and a requirement for dialysis. Malnutrition becomes a significant issue in more advanced cases and results in a loss of muscle mass that can further complicate renal disease and give rise to additional complications. The ability to prevent the loss of muscle mass while maintaining proper nutrition has the potential to improve day-to-day health as well as slow down the progression of chronic renal failure.


MARKET OVERVIEW:

An estimated 400,000 Americans have Stage IV (pre-dialysis) chronic renal failure and are in need of significant supportive care.  In addition there are 300,000 with Stage V disease (dialysis) and 7.6 million patients with Stage III disease. It has been estimated that the total cost of kidney disease in the US was $35 Billion in 2003 (USRDS). There are no approved products for the management of malnutrition in chronic renal failure although growth hormone is used off-label for this indication.

PARTNERSHIP STATUS:

AKELA Pharma is developing AKELA GHRH through Phase II validation studies with the intention of securing a partner to support further development and commercialization.