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Cephalon Exercises its Option to Acquire Ception Therapeutics

http://finance.yahoo.com/news/Cephalon-Exercises-its-Option-prnews-2359689579.html?x=0&.v=1

Ception Delivers Positive Results from a Phase II Study of CINQUIL in Adult Eosinophilic Asthma


Press Release Source: Cephalon, Inc.; Ception Therapeutics, Inc. On Tuesday February 23, 2010, 8:00 am EST

FRAZER, Pa. and MALVERN, Pa., Feb. 23 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:CEPH - News) announced today that it has exercised its option to acquire Ception Therapeutics, Inc., following receipt of positive data from a clinical study in adults with eosinophilic asthma. A Phase II clinical trial of Ception's lead compound, CINQUIL™ (reslizumab), in 106 patients demonstrated improved asthma control in adult patients with moderate to severe asthma and eosinophilic airway inflammation, as measured by the primary study endpoint, a change in Asthma-Control -Questionnaire or ACQ score (p=0.054). In addition, an analysis of the FEV1, a measure of lung function, showed a statistically significant improvement with CINQUIL compared to placebo (p= 0.002).

"This study showed a strong treatment signal and compelling internal consistency on the effect of CINQUIL on measurements of asthma and lung function," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "These data provide confidence that CINQUIL shows a meaningful treatment effect in this patient population. We look forward to advancing CINQUIL into Phase three clinical trials."

Based on these Phase II results, Cephalon exercised its option to acquire Ception on February 22, 2010. Following the exercise of its option, Cephalon's obligation to enter into a merger agreement relating to the acquisition is subject to Cephalon's rights under, and Ception's satisfaction of certain conditions set forth in, the option agreement. The merger agreement is subject to customary closing conditions, including expiration of applicable antitrust waiting periods. Upon the closing of the merger, Cephalon would purchase all of the outstanding capital stock of Ception for $250 million, subject to adjustment for any third party debt held by Ception. Ception shareholders could receive additional payments related to clinical and regulatory milestones.

"The acquisition of Ception is consistent with our strategy to diversify into biologics and provides us with an important Phase three asset for further development," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon.

"Today marks an important milestone for Ception, as well as the asthma community," said Stephen Tullman, President and CEO, Ception Therapeutics. "These encouraging results will allow the advancement of this novel therapeutic for the many people suffering from this severe, poorly controlled form of asthma. The Ception team has done an excellent job, and I am extremely thankful for the support provided by Cephalon and our investors."

About the Study

The four-month, double-blind, placebo-controlled Phase II clinical trial assessed the efficacy and safety of CINQUIL in the treatment of patients with poorly controlled eosinophilic asthma. In this study, 106 adults patients received CINQUIL (3mg/kg) or placebo administered intravenously once every 28 days for four cycles. Patients entering the study were required to have persistent asthma symptoms, despite high doses of inhaled corticosteroids, and elevated eosinophils in their sputum. The primary study endpoint was improvement in asthma control as assessed by the change in Asthma-Control-Questionnaire (ACQ) score at week 15. Patients on CINQUIL showed an improvement on the ACQ compared to placebo (p=0.054). In this clinical study, CINQUIL was generally well tolerated with an adverse event profile comparable to placebo. The most commonly observed side effect associated with CINQUIL versus placebo was nasopharyngitis.

Secondary endpoints and analysis of a subgroup of patients in the study showed the following:

* A significant reduction in sputum eosinophil counts for CINQUIL compared to placebo (p=0.006)
* A significant improvement in FEV1 and FVC for CINQUIL compared to placebo (p=0.002 and 0.004 respectively). FEV1 and FVC are indices for assessing airway obstruction, bronchoconstriction or bronchodilation
* In a subset of patients with both asthma and nasal polyps (n= 38), patients on CINQUIL compared to placebo showed a significant mean improvement in ACQ (p=0.011) and FEV1 (p=0.046)
* Fewer patients on CINQUIL compared to placebo experienced clinical asthma exacerbations. Clinical asthma exacerbations were defined as a 20 percent decrease in FEV1 from baseline, emergency treatment or hospital admission and treatment for three or more days of oral corticosteroids


Cephalon will further evaluate the study data and work with the FDA to determine the necessary and appropriate steps to move clinical development of CINQUIL forward to Phase III.

About CINQUIL

CINQUIL is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, growth and chemotaxis (movement) of eosinophils, which are inflammatory white blood cells implicated in a number of allergic diseases including asthma. This investigational agent is currently administered as an intravenous injection; a subcutaneous formulation is being developed.