| From the Prelim S-1:
We are an emerging pharmaceutical company focused on developing and commercializing a diversified portfolio of pharmaceutical product candidates to address pain, a large and under-served market. We have three product candidates that we are developing in four clinical programs and one preclinical program. Two of our product candidates are in late-stage clinical development, including ALGRX 3268 which is being evaluated in two phase III clinical trials.
ALGRX 4975 (capsaicin for injection and capsaicin gel for intraoperative use) is being developed in three programs for pain: severe postsurgical pain, post-trauma neuropathic pain, a form of pain resulting from direct injury to nerves that remains long after traumatic injuries, and musculoskeletal pain, including osteoarthritis and tendonitis. In these programs, we have completed one phase I clinical trial and three phase II clinical trials. Our phase II clinical trials have yielded statistically significant improvements in pain scores and have provided us with favorable safety data. We are continuing to evaluate ALGRX 4975 in five phase II clinical trials across the three programs. ALGRX 3268, our most advanced product candidate, is a powder formulation of the local anesthetic lidocaine delivered into the skin using our proprietary needle-free dispenser. We are developing ALGRX 3268 to reduce the pain associated with needle-sticks from blood draws or intravenous line insertions in children. We have recently commenced two phase III clinical trials for ALGRX 3268. We recently in-licensed a third product candidate, ALGRX 1207, a new molecular entity in a new class of anesthetics that is undergoing preclinical development as a topical local anesthetic. We expect to file an investigational new drug application for ALGRX 1207 with the U.S. Food and Drug Administration in the second half of 2005.
Our Product Candidates
ALGRX 4975 (capsaicin for injection and capsaicin gel for intraoperative use)
ALGRX 4975 is our product candidate for the treatment of site-specific severe or intractable pain. These types of pain are poorly treated by existing drugs such as opioids. We are developing ALGRX 4975 to treat patients in three broad areas:
• severe postsurgical pain following a variety of surgical procedures, including bunion removal surgery, total knee replacement and abdominal surgery, such as hernia repair, hysterectomy and gall bladder removal;
• post-trauma neuropathic pain; and
• pain resulting from musculoskeletal diseases, such as osteoarthritis and tendonitis.
During a surgical procedure, ALGRX 4975 is applied directly onto the cut surfaces of skin, muscle and bone. For post-trauma neuropathic pain and musculoskeletal pain, ALGRX 4975 is delivered to the site of pain using a needle and syringe. Although the active ingredient in ALGRX 4975, capsaicin, has been available for many years in over-the-counter products, we believe we are the first to evaluate formulations of capsaicin for use inside the body. We believe that by harnessing capsaicin’s ability to cause changes in nerve endings for a period of 12 weeks or more, ALGRX 4975, if approved, may represent a novel method of providing long lasting, site-specific analgesia without many of the significant side effects associated with opioids and other methods of treating pain.
ALGRX 4975 has been studied in four AlgoRx-sponsored clinical trials that have enrolled a total of 250 patients. An additional five ongoing phase II clinical trials involving a total of 254 patients are designed to study the safety and efficacy of a variety of doses in a broad range of pain conditions. In addition, we believe that ALGRX 4975 may provide long lasting pain relief with infrequent dosing, potentially only four times per year, for patients with certain chronic pain conditions.
ALGRX 3268 (PowderJect® Dermal Lidocaine)
ALGRX 3268 is our product candidate that delivers lidocaine powder into the skin using our proprietary needle-free dispenser. It is intended to provide rapid, easy-to-administer local analgesia to reduce the pain associated with needle-sticks from blood draws or the insertion of intravenous lines in patients. Existing products for this use are characterized by a lengthy onset of action from at least 10 minutes to over an hour. This delay makes the use of these products inconvenient for both health care providers and patients. Current topical anesthetic products also tend to be messy and bulky since they are often formulated as creams and may require patches to be applied over the treatment area. By comparison, ALGRX 3268 has shown efficacy in one minute following application and is administered using a convenient, disposable needle-free dispenser.
The primary target market for ALGRX 3268 would be the estimated 42 million needle-stick procedures that are performed in children in the United States each year. We believe that this market is highly under-served by existing products. Based on our company estimates of unit sales, EMLA® and L.M.X.4®, two leading products, are used in fewer than 15% of pediatric needle-stick procedures. We believe that, if approved, ALGRX 3268’s rapid onset of action, convenience of use and efficacy in reducing pain would be welcomed by health care professionals and would be important factors for increasing physician use of analgesia prior to needle-stick procedures.
We have completed our clinical program through phase II involving 1,139 adults and children to evaluate the ability of ALGRX 3268 to reduce pain when used prior to needle-stick procedures. In clinical studies designed to assess efficacy, ALGRX 3268 achieved statistically significant reductions in pain associated with needle-sticks when compared to placebo, with no serious side effects. We have initiated a phase III clinical program to confirm the safety and efficacy of ALGRX 3268. If this phase III clinical program is successful, we believe that we will submit a new drug application to the FDA for ALGRX 3268 by the end of 2005.
Preclinical Product Candidate
ALGRX 1207, our preclinical product candidate, is a new molecular entity that we are developing as a topical local anesthetic to potentially treat patients with certain types of neuropathic pain and for pre-procedural administration to reduce the pain associated with procedures on the skin. Certain types of neuropathic pain, including pain associated with postherpetic neuralgia, painful HIV polyneuropathy and painful diabetic polyneuropathy, affect almost two million patients in the United States and are not well-treated by current therapies. We believe that a simple-to-use, topical, local anesthetic with a long duration of action and deep penetration into the skin would represent an improvement over existing therapies. Based on studies in animals, ALGRX 1207 has been shown to provide analgesia more rapidly and with a longer-lasting effect than currently available topical anesthetics following direct administration to the skin. In addition, we believe that ALGRX 1207, if approved, could address a wide variety of procedures involving the skin, including dermatological surgery, cosmetic skin treatments and catheter placement, as well as pain arising from surgical incisions that does not subside after surgery has taken place. |
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