Craig A. Collard
While we review the highlights and financial performance of 2012, let's take a look into 2013 and what lies ahead. In addition to our marketed products, we're developing a promising pipeline and are working diligently to move these products forward to approval and commercial launch. Leveraging our commercial strength and all the know-how from growing the products already in our portfolio, we are confident in our prospects. Let's start with CRTX 067, our hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension, which is a generic equivalent of Tussionex indicated for the relief of cough and upper respiratory systems associated with allergy or a cold in adults and children 6 years of age and older. The FDA approved the product at the end of second quarter 2012, and we plan to launch it through Aristos Pharmaceuticals, our generic division. While it had been our stated goal to have CRTX 067 on the market shortly after approval, the delay at FDA approval and timing for completion of scale up and validation activities precluded us for making this happen in 2012. We are pleased with the progress of the manufacturing efforts and look forward to entering the market for the upcoming 2013 cough and colds season. In the fourth quarter, we entered into an agreement with Chiesi to license a second product, BETHKIS, approved by FDA in October of 2012. It is a Tobramycin Inhalation Solution containing the inhaled aminoglycoside antibacterial tobramycin. The product is indicated for the management of cystic fibrosis patients with pseudomonas aeruginosa. We have an exclusive license for the U.S. market from Chiesi and patents that cover the product until 2022. There's currently only one approved nebulized tobramycin product on the market and it generated approximately $270 million in net revenue in 2011. And the market is expected to grow steadily over time, as the average life expectancy for patients with cystic fibrosis continues to increase. We anticipate marketing BETHKIS as an effective option for CF patients who struggle with this very common form of infection. Patients with CF enter a tremendous treatment burden, taking numerous drugs often multiple times per day. The most burdensome of these treatments are the nebulized pulmonary drugs, which require substantial time to prepare the drug, inhale the drug and clean the device 2x or 3x per day. These drugs often have side effects that affect patient comfort and ultimately compliance to the prescribed therapy. The gold standard for treatment of chronic pseudomonas infection and cystic fibrosis has long been nebulized tobramycin. And to date, the only FDA approved nebulation has been Novartis' Tobi. BETHKIS is a new formulation of a higher concentrated tobramycin that can be administered in approximately 15 minutes. We believe that BETHKIS will be a very good treatment option for cystic fibrosis patients. As preparation continues for commercial launch, we have been working through process validation efforts. We've had no significant issues in the process up to this point and believe we are on track to launch the product in Q3 of this year. In regards to LIXAR, or lixivaptan, our product candidate for the treatment of hyponatremia, we continue to evaluate the viability of this investigational product candidate. Following the FDA's issuance of the Complete Response Letter and the request for additional clinical study, we will be requesting an end of review meeting with the FDA this month. We're requesting an expedited meeting date. However, we recognize FDA may not grant such a meeting date until late Q2 2013. Following that meeting, we will evaluate the FDA's feedback and determine appropriate next steps for LIXAR, which may or may not result in the abandonment of the development program. As part of the EKR transaction, Cornerstone secured the rights to the asset RETAVASE. During the time, PDL and EKR had the productommercial availability of RETAVASE was suspended as EKR, and now Cornerstone, attempt to qualify a new raw material supplier and transfer certain aspects of the manufacturing process. In December 2012, we received a Complete Response Letter from the FDA requesting further information regarding the new active ingredient supplier, as well as certain intermediate and finished product attributes. Efforts to address these items were either already in process or are now underway. Along with these requests from FDA, the drug product on stability in support of our sBLA build its sporadic failure results for single specification, which led to the write-off of acquired RETAVASE inventory, as Alastair mentioned earlier. We're investigating the matter in an attempt to identify root cause or causes. Our goal is to complete the investigation and manufacture new pivotal stability batches by year-end. Timing for such effort is predicated upon successful resolution of the open investigation. We believe this matter can be resolved and remain diligent in our pursuit of the relaunch of RETAVASE. The required stability and subsequent FDA review has set our estimated launch timelines back to 2015. The market for thrombolytics continues to grow. And when the aforementioned matters described are resolved, there will be opportunities for further development with this API. We believe we have a good understanding of the development pathway for the catheter clearance indication. Once we resolve the stability issues with RETAVASE, we plan to move forward with a catheter clearance program. As previously stated, we continue to actively seek new business development and acquisition opportunities to deepen our penetration in the hospital market. This includes companies, as well as products, market, registration stage and late-stage development. We believe there are further opportunities for M&A and we are closely evaluating candidates that: a, fit within our strategic focus in the hospital space; or b, have an immediate impact on sales growth. We want to pick winners and there are couple of product assets that we're currently looking at, which we believe we can grow and will benefit from infrastructure that we already have in place. As the market consolidates, we intend to establish ourselves as a clear leader. I'll wrap up the call by addressing a recent development with Chiesi. On February 18, our Board of Directors received a letter from our majority shareholder containing a proposal to acquire the remaining outstanding shares in Cornerstone and take the company private. A special committee has been formed whose mandate is to coordinate Cornerstone's response to the proposal from Chiesi. The committee has also hired outside counsel and in the process of engaging bankers to support its efforts to obtain an independent evaluation of the company and to assess Chiesi's proposals. No decisions have been made regarding the offer, and you will understand that there's not anything more I can say on this offer or on pricing valuation at this stage. Therefore, we will not be taking any questions regarding Chiesi today. With this, we are ready to take your questions that do not involve the Chiesi proposal. Operator?