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Methscopolamine/Antihistamine Product Candidate — CBP 058
Overview and Development Status
CBP 058 is a combination methscopolamine and antihistamine product candidate that Cornerstone is developing for the treatment of symptoms of allergic rhinitis. In 2007, Cornerstone met with the FDA regarding its plans to develop a methscopolamine and antihistamine product. Cornerstone plans to file an IND and to commence a clinical trial for the methscopolamine/antihistamine product candidate, CBP 058, in the fourth quarter of 2008 and submit an NDA in 2010. Cornerstone expects that the clinical studies for this product candidate will include a pharmacokinetic study in both fed and fasted states to establish a kinetic profile, as well as at least one clinical study in patients with allergic rhinitis to demonstrate safety and efficacy. Performing the pharmacokinetic study on both patients who have eaten a meal within the past hour and patients who have fasted overnight allows for a determination of the effect of food on the absorption of the drug. Because this product candidate is a combination product, the studies would compare the test product to its two individual components, and the test product must be statistically superior to both. If approved, Cornerstone believes this product candidate would be the first FDA-approved product containing methscopolamine with an indication associated with allergic rhinitis.
Market Opportunity and Current Treatment Options
According to AAAAI, allergic rhinitis has a strong link to other respiratory diseases including chronic sinusitis, middle ear infections, nasal polyps and bronchial asthma. The connection to bronchial asthma has caused great concern among allergists and immunologists. For example, a March 1999 article in Discover magazine described an analysis of over 1,200 asthmatics, approximately half of whom had rhinitis and half whom did not, in which those who had both rhinitis and asthma were more likely to have nighttime awakening due to asthma, 19.6 percent compared to 11.8 percent, to miss work because of asthma, 24.1 percent compared to 12.1 percent, and to meet the criteria for “moderate to severe asthma,” 60.2 percent compared to 51.2 percent. Additionally, asthmatics with rhinitis require more potent medications to control their symptoms. One potential explanation is that severe post-nasal drip triggers episodes of asthma. For example, researchers have found that inflammatory chemicals commonly found in the noses of people with allergic rhinitis drip into the lungs while they sleep, thus causing asthma to worsen.
According to Wolters Kluwer Health, oral solid methscopolamine combination products for the treatment of symptoms of respiratory diseases and allergies generated approximately 1.6 million prescriptions in 2007, representing a growth rate of 15% compared to 2006. In addition, second and third generation antihistamine and antihistamine combination products generated a total of approximately 52 million prescriptions in 2007.
Current treatments for the symptoms of allergic rhinitis consist of both prescription and over-the-counter products. Prescription products include large second generation antihistamine branded families of products, such as Sanofi-Aventis U.S. LLC’s Allegra® (fexofenadine), third generation antihistamine branded families of products, such as UCB, Inc. and Sanofi-Aventis U.S. LLC’s Xyzal® (levocetirizine) and Schering-Plough Corporation’s Clarinex® (desloratadine), and first generation antihistamine and antihistamine combination products, most of which are generic formulations. Over-the-counter products include first generation antihistamines, such as McNeil-PPC, Inc.’s Benadryl® (diphenhydramine) and Schering-Plough Corporation’s Chlor-Trimeton® (chlorpheniramine), and second generation antihistamines, such as Claritin and Zyrtec.
Benefits of CBP 058
If approved, CBP 058 will combine a less sedating antihistamine to combat the histamine released during an allergic reaction with an anticholinergic to relieve symptoms of post-nasal drip and other mucous secretions. This combination of therapies is not currently commercially available in a single tablet. Less sedating second and third generation prescription antihistamines do not have an anticholinergic option, and first generation antihistamine and anticholinergic combination products currently available on the market are more sedating.
Cornerstone anticipates that, if approved based on the results of clinical trials that it plans to conduct, the FDA will grant CBP 058 a three-year period of marketing exclusivity under the Hatch-Waxman Act. In addition, based on FDA precedent with respect to DESI II drugs that are clinically tested and submitted to the FDA for approval, Cornerstone expects that the FDA would require other methscopolamine products, including the first generation antihistamine and methscopolamine combinations currently available, to be removed from the market after a grace period. In such event, Cornerstone believes that CBP 058 would be the only methscopolamine product indicated for the symptoms of allergic rhinitis on the market that physicians could prescribe.
Proprietary Rights
Cornerstone has licensed the rights to market CBP 058 utilizing the Dynamic Variable Release» technology licensed from Neos. Dynamic Variable Release technology is covered under a pending U.S. patent application that if issued would expire in 2024. This licensed technology allows Cornerstone to formulate CBP 058 with one or more active pharmaceutical ingredients that require immediate activation followed by extended release of the remaining active pharmaceutical ingredients.
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