In the United States, each year approximately 18 million venous access procedures (Requires that tubes be placed into the body which receives medications, including an IV or nutrients directly into the blood stream or gastrointestinal system or blood can be drawn) are performed in pediatric patients. During this procedure on pediatric patients, medical guidelines advocate the use of topical anesthetics. However, compliance is difficult to enforce, because of the limitation of available products.
Anesiva Incorporated (formerly Corgentech Incorporated – name changed on June 21, 2006), a late stage biopharmaceutical company develops commercialized novel of therapeutic treatments for pain. The company is based in South San Francisco, California. Currently, the company is working on developing three pain relief applications, one of which is called 3268, in the most advance stage of testing, and has completed Phase 3 clinical trials. The second drug is called 4975, undergoing mid-stage clinical trials, and third is called 1207, undergoing pre-clinical development and is anticipated to enter the clinic stage of testing in 2006. Anesiva Incorporated announced in July 2006, will be filling to seek approval from the Food and Drug Administration (FDA) for the sale and distribution of 3268, in the timeframe of September / October 2006. 3268 has shown to substantially reduce pain as a local anesthetic associated with vein punctures (Process obtaining a sample venous blood from a patient’s vein). The topical anesthetic would be for pediatric patients, (Also, applicable for adults upon completing further trial study.) and the company is hopefully the FDA will approve the anesthetic for use in 2007.
During Anesiva Incorporated pre-filling for seeking approval of 3268 with the FDA, in July 2006, the company agreed to one additional Phase three trial in adults, which would seek broader product labeling. Expected during the fourth quarter of 2006, new trial will begin and should take less than six months to complete. The trial study will encompass the same type of study that had shown pain reduction in pediatric trials, confirming pain reduction for this topical anesthetic (needle-free – disposable system), when comparing vein punctures vs. a placebo. The topical anesthetic delivers micro-crystals of lidocaine, which uses compressed gas to accelerate the lidocaine particles that are absorbed into the epidermis (top layer of skin), and provides analgesia (The inability to feel pain while being conscious) in one to three minutes after administration.
Upon approval of 3268, Anesiva Incorporated plans on a sales force of 35 – 40 representatives, and expects future revenue between $150 – $200 million. Initially the company plans on distributing 3268 to hospitals, and later when the FDA will approves 3268 for adult application (After Phase three trials are successful), the local anesthetic will be distributed to adult emergency departments and pre-surgery markets, according to John P. McLaughlin Chief Executive Officer of Anesiva. Also, he stated: “With its ease of use and onset of action within one to three minutes, 3268 is a highly differentiated product that may provide significant benefits over currently available therapies, which can take 30 to 60 minutes to provide analgesia, and 3268 may also enable physicians and nurses to reduce the pain and anxiety of their patients undergoing venous access procedures.” Also, the 3268 application would include outpatient settings of oncology clinics and hemodialysis centers.
In June 2006, Corgentech Incorporated, prior to their name change (NASDAQ symbol: ANSV), accepted a commitment for up to $30 million in stock equity financing from Azimuth Opportunity Limited. The funds will be allocated for general expenses and drug development.