INSMED INC (INSM) SPO
|Company Name||INSMED INC|
|Company Address||9 DEER PARK DRIVE
MONMOUTH JUNCTION, NJ 08852
|Employees (as of 12/31/2011)||42|
|State of Inc||VA|
|Fiscal Year End||12/31|
|Exchange||Nasdaq SmallCap Market|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||11/12/2012|
We estimate that the net proceeds from the sale of the 6,304,102 shares will be approximately $25.6 million. We intend to use the net proceeds from this common stock offering for general corporate purposes, including working capital, capital expenditures, research and development and clinical trial expenditures.
The biotechnology and pharmaceutical industries are highly competitive. We face potential competitors from many different areas including commercial pharmaceutical, biotech and device companies, academic institutions and scientists, other smaller or earlier stage companies and non-profits organizations developing anti-infective drugs and drugs for respiratory diseases. Many of these companies have greater human and financial resources and may have product candidates in more advanced stages of development and may reach the market before our product candidates. Competitors may develop products that are more effective, safer or less expensive or that have better tolerability or convenience. We may also face generic competitors where third- party payors will encourage use of the generic products. While we believe that our formulation delivery technology, respiratory and anti-infective expertise, experience and knowledge in our specific areas of focus provide us with competitive advantages, these potential competitors could reduce our commercial opportunity. Major Competitors Our major competitors include pharmaceutical and biotechnology companies that have approved therapies or therapies in development for the treatment of chronic lung infections. Most of these competitors are focused on the CF market for their lead indication. Inhaled antibiotics are a standard of care in the treatment of CF to manage the chronic Pseudomonas infections due to the high concentrations of drug deposited directly into the lung, where the infection resides. We are not aware of any other companies developing an inhaled antibiotic for NTM lung infections. Inhaled tobramycin (Tobi) was the first inhaled antibiotic to be approved by the FDA and has been sold in the U.S. since January 1998 and is currently marketed by Novartis. Tobi is administered for 15 to 20 minutes twice daily and continues to dominate the treatment landscape as the first line standard of care in most countries. A second inhaled tobramycin (Bramitob®) has also been approved and is marketed in several European countries by Chiesi Group. Additionally, specialty pharmacies in the U.S. compound generic tobramycin originally formulated for IV use and sell it for inhalation purposes. Tobi Podhaler® (tobramycin inhalation powder), a dry powder version of tobramycin was approved by the EU in 2011 for use by patients with CF. We also believe that Novartis filed for approval of Tobi Podhaler in the U.S. in 2011. Although it was reported that Tobi Podhaler was approved and launched in Canada and at least one country in Europe in 2011, we are not aware of the company reporting sales to date. Forest Laboratories markets inhaled colistin (Colomycin®) in Europe. Colomycin is used in Europe primarily as an adjunct therapy and in some cases as a primary therapy. Because it is less expensive than Tobi, Colistin is used as a first line treatment in some countries that have a more restrictive reimbursement system. Colistin is not approved for inhaled treatment in the U.S., but it is frequently used off label (via pharmacist compounding) for patients that cannot use Tobi and for more severe patients in the off month alternating with Tobi in an attempt to maintain lung function in patients who are deteriorating on Tobi alone. Gilead Sciences received approval from the FDA for Cayston® (aztreonam for inhalation) in early 2010. It was launched in the U.S. that same year with less convenient three times per day inhalation over about 10 minutes in total. Gilead received conditional approval for Cayston in Europe during September 2009. The approval is for one cycle of treatment only and limited to adult patients. Market data on marketed competitors as reported by the individual companies is summarized below. 2011 Global Marketing Sales Competitor Indication Product Class of Product Status (in millions) Novartis CF Patients with Pseudomonas Tobi (Tobramycin Lung Infections Inhalation Solution) Aminoglycoside Marketed $ 296 Gilead CF Patients with Pseudomonas Cayston (Aztreonam Lung Infections for Inhalation Solution) Monobactam Marketed Not Reported Forrest CF Patients with Pseudomonas Colomycin Lung Infections (Colistimethate Sodium Marketed for Inhalation) Polymixin in Europe only Not Reported Chiesi CF Patients with Pseudomonas Bramitob (Tobramycin Marketed in some Lung Infections Inhalation Solution) Aminoglycoside European countries Not Reported Novartis CF Patients with Pseudomonas Tobi Podhaler(tobramycin Marketed in EU Lung Infections inhalation powder) Aminoglycoside and Canada Not Reported Examples of competitive therapies in development include inhaled antibiotic products to treat chronic respiratory infections due to Pseudomonas. These include levofloxacin by Aptalis Pharma, dry powder ciprofloxacin by Bayer AG, liposomal ciprofloxacin by Aradigm Corporation, liposomal tobramycin by Axentis Pharma and a combination of fosfomycin/tobramycin by Gilead. Therapeutic antibodies and other technologies are also being developed to treat Pseudomonas lung infections by other potential competitors including Kalobios Pharmaceuticals, Inc., Kenta Biotech Ltd. and Aridis Pharmaceuticals. Although therapeutic antibodies are potential competitors, the early studies conducted by Kalobios are using these compounds as adjunctive/complementary therapy to an inhaled antibiotic. In addition, Kalydeco (ivacaftor) by Vertex was approved in January 2012 by the FDA as the first drug targeted to treat the underlying cause of a rare form of CF representing about 4% of patients with CF. The potential impact on inhaled antibiotic products of Kalydeco or similar products approved by regulatory authorities in the future is uncertain. Vertex also has other drugs in development to treat more common forms of CF.
We are a biopharmaceutical company focused on developing and commercializing novel, targeted inhaled therapies for patients with high unmet need battling serious orphan lung diseases. Our lead product candidate, ARIKACE R (liposomal amikacin for inhalation), is a differentiated, inhaled
antibiotic engineered to deliver a proven and potent anti-infective directly to the site of serious lung infections to improve the efficacy, safety and convenience of treatment for patients. Currently, we are continuing late-stage clinical trials for two initial primary target indications for this product: lung infections caused by Pseudomonas aeruginosa , which we refer to as Pseudomonas, in cystic fibrosis (CF) patients and lung infections caused by non-tuberculous mycobacteria (NTM). ARIKACE is considered a New Chemical Entity by the United States Food and Drug Administration, or FDA, primarily due to its proprietary liposomal technology. The key active ingredient, amikacin, is an FDA-approved antibiotic with proven efficacy in the treatment of gram-negative infections, including Pseudomonas. ARIKACE is in the aminoglycoside class of antibiotics. ARIKACE is differentiated by our proprietary advanced liposomal technology, which is designed specifically for targeted delivery of pharmaceuticals to the lung. We believe ARIKACE provides for potential improvements to the conventional inhalation methods of anti-infective delivery of drugs to the pulmonary system for these indications. Our ongoing ARIKACE clinical development program includes a phase 2 clinical study of ARIKACE in patients with NTM lung disease (TARGET-NTM) as well as a European and Canadian registration phase 3 clinical study of ARIKACE in CF patients with Pseudomonas lung infections (CLEAR-108). We expect to report clinical results from both the CLEAR-108 and TARGET-NTM studies in 2013. Our focus in the near term will be to prepare the Company for commercialization of ARIKACE in Europe and the U.S. ------ We were incorporated in the Commonwealth of Virginia on November 29, 1999. We completed a business combination with Transave, Inc., or Transave, a privately -held, New Jersey-based pharmaceutical company focused on the development of differentiated and innovative inhaled pharmaceuticals for the site-specific treatment of serious lung infections, on December 1, 2010. Our integration with Transave was completed in 2011. Our principal executive offices are located at 9 Deer Park Drive, Suite C, Monmouth Junction, New Jersey 08852 and our phone number is (732) 997-4600. Our Internet address is www.insmed.com.