Shares of Celgene Corporation (NASDAQ:CELG) ended Tuesday session in green amid volatile trading. The shares closed up +1.09 points or 1.03% at $107.40 with 3.27 million shares getting traded. Post opening the session at $106.38, the shares hit an intraday low of $105.69 and an intraday high of $107.50 and the price vacillated in this range throughout the day. The company has a market cap of $82.39 billion and the numbers of outstanding shares have been calculated to be 775.11 million shares.
On September 12, 2016 Celgene Corporation (CELG) announced interim topline data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease.
The trial, CD-001, is an ongoing study evaluating three different treatment regimens of GED-0301 in a 12-week treatment phase, followed by an observation phase up to 52 weeks (off treatment). The primary objective of the study is to explore the effect of GED-0301 on endoscopic outcomes. The trial enrolled a total of 63 patients across multiple countries.
The study was designed to further enhance the understanding of GED-0301 activity in a difficult-to-treat, moderate-to-severe patient population. This population was more diverse than prior GED-0301 studies and included patients with endoscopically confirmed mucosal damage at entry and those who had previous surgeries. The study also included both biologic exposed and biologic naïve patients as well as patients with a diagnosis of Ileitis, Ileocolitis or colitis.
Topline data from CD-001 show that in a proportion of patients treated with oral GED-0301 there was endoscopic improvement (defined as a 25 percent improvement from baseline) and clinical response and remission across all treatment groups at week 12. Findings to date reveal no new safety signals and tolerability is consistent with earlier studies.
“Given the high unmet need in Crohn’s disease, we are pleased that oral GED-0301 showed both endoscopic improvements and clinically meaningful responses and remission at an early timepoint in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “These data are particularly encouraging for several reasons, including the difficult-to-treat patient population evaluated in the trial.”
Shares of Pfizer Inc. (NYSE:PFE) ended Tuesday session in green amid volatile trading. The shares closed up +0.19 points or 0.56% at $33.83 with 15.61 million shares getting traded. Post opening the session at $33.78, the shares hit an intraday low of $33.48 and an intraday high of $33.88 and the price vacillated in this range throughout the day. The company has a market cap of $205.86 billion and the numbers of outstanding shares have been calculated to be 6.07 billion shares.
Pfizer Inc. (PFE) on September 26, 2016 announced that, after an extensive evaluation, the company’s Board of Directors and Executive Leadership Team have determined the company is best positioned to maximize future shareholder value creation in its current structure and will not pursue splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies at this time.
“With this decision, our two distinct businesses will remain separately managed units within Pfizer, which we believe is currently the best structure to continue to deliver on our commitments to patients, physicians, payers and governments, and to drive value for our shareholders,” stated Ian Read, chairman and chief executive officer. “We believe that by operating two separate and autonomous units within Pfizer we are already accessing many of the potential benefits of a split – sharper focus, increased accountability, and a greater sense of urgency – while also retaining the operational strength, efficiency and financial flexibility of operating as a single company as compared with operating as two, separate publicly traded companies. We will continue to generate the financial information necessary to preserve our option to split our businesses should factors materially change at some point in the future.”
As the company previously indicated, the process for making a decision was guided by criteria that included evaluating the performance of each business within Pfizer, determining if each business could compete as a stand-alone entity, assessing if trapped value existed in a combined entity and if any trapped value could be unlocked efficiently. In addition, the company evaluated whether key strategic and operating imperatives could best be achieved in the current structure versus two, separate publicly traded companies.
Both the Innovative Health and Essential Health businesses have delivered solid year-over-year performance over the course of the past three years, as well as strong performance through the first half of 2016, demonstrating their ability to compete on a standalone basis.
“When we first explored the trapped value question several years ago, market valuations of other companies suggested that our two businesses could potentially be worth more as separate companies than they are together in a single company,” explained Frank D’Amelio, executive vice president, Business Operations and Chief Financial Officer. “However, over time, any potential gap between Pfizer’s market valuation and an implied Sum of the Parts (SOTP) market valuation has closed. In our analysis, we concluded that splitting into two companies at this time would not enhance the cashflow generation and competitive positioning of the businesses and the operational disruption, increased costs of a split and inability to realize any incremental tax efficiencies would likely be value destructive.”