Notable Mergers and Acquisitions 9/21: (AGN) (BGS) (EBIO)
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Non-Alcoholic Steatohepatitis (NASH) is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.ii NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer, and eventual liver failure.ii NAFLD and NASH affect approximately 30% and 5%, respectively, of the US populationiii and NAFLD affects more than 20% of the population worldwide.iv
AKN-083 is a potentially best-in-class preclinical farnesoid X receptor (FXR) agonist in development for the treatment of NASH, and is highly complementary to compounds in development by Tobira Therapeutics, Cenicriviroc (CVC) and Evogliptin. Allergan announced the acquisition of Tobira earlier today.
"The acquisition of Akarna adds to our strategic approach to investing in innovation to advance the treatment of NASH for millions of patients who currently do not have therapeutic options to treat the disease," said Brent Saunders, CEO and President of Allergan. "We look forward to advancing this unique compound into later stages of development, and to advancing our overall portfolio of NASH programs, as we focus on bringing forward effective treatments for this critical disease area."
"AKN-083 is a highly differentiated, selective FXR agonist which is a strongly validated therapeutic mechanism for the treatment of NASH," said David Nicholson, Chief Research & Development Officer, Allergan. "In addition, AKN-083 is a non-bile acid FXR agonist that in preclinical studies has shown high affinity, potency and selectivity with a better tolerability profile. These characteristics make AKN-083 a great addition to our portfolio of assets for the treatment of NASH."
"We are excited to be working with Allergan, a company that shares our vision to develop the best possible treatments for NASH," said Raju Mohan, Ph.D., Founder and Chief Executive Officer, Akarna Therapeutics. "Allergan shares our commitment to help patients with NASH live longer, healthier lives."
*** B&G Foods, Inc. (NYSE: BGS) announced that it has entered into an agreement to acquire the spices and seasonings business of ACH Food Companies, Inc., a leading supplier of spices and seasonings to retail and food service customers, for approximately $365 million in cash, subject to a post-closing inventory adjustment. The ACH spices and seasonings business includes the Spice Islands, Tone’s and Durkee brands. The business also includes Weber brand sauces and seasonings, which are sold under license. As part of the acquisition, B&G Foods is also acquiring a manufacturing facility in Ankeny, Iowa. B&G Foods expects the acquisition to close during the fourth quarter of 2016, subject to customary closing conditions, including the receipt of regulatory approvals.
“We are very pleased to add ACH’s spices and seasonings business, including the Spice Islands, Tone’s, Durkee and Weber brands to the B&G Foods portfolio. This acquisition will significantly broaden our position in the large and growing spices and seasonings category, which we believe is very relevant to today’s consumer, who is looking for healthier options, simple ingredients and enhanced flavor,” stated Robert C. Cantwell, President and Chief Executive Officer of B&G Foods.
Mr. Cantwell continued, “Consistent with our acquisition strategy, we expect the acquisition to be immediately accretive to our earnings per share and free cash flow.”
B&G Foods projects that beginning in 2017, the acquired business will generate on an annualized basis net sales in the range of $220.0 million to $225.0 million, adjusted EBITDA in the range of $38.0 million to $40.0 million and adjusted diluted earnings per share in the range of $0.26 to $0.28. Because the acquisition will be structured as an asset purchase, B&G Foods expects to realize approximately $83.0 million in tax benefits on a net present value basis. At the midpoint of B&G Foods’ 2017 projected adjusted EBITDA for the business, the acquisition represents a purchase price multiple of approximately 9.4 times adjusted EBITDA (or 7.2 times adjusted EBITDA net of expected tax benefits).
B&G Foods intends to fund the acquisition and related fees and expenses with cash on hand, including the net proceeds of its August 2016 public offering of common stock, and additional revolving loans under its existing credit facility.
*** Eleven Biotherapeutics, Inc. (Nasdaq: EBIO) and Viventia Bio Inc., announced that the two companies and the shareholders of Viventia entered into a definitive share purchase agreement under which Eleven Biotherapeutics agreed to, and simultaneously completed, the acquisition of Viventia. Under the agreement, Eleven purchased all of the outstanding capital stock of Viventia in exchange for the issuance of 4,013,431 newly issued shares of Eleven common stock, which represented approximately 19.9% of the voting power of Eleven as of immediately prior to the issuance of such shares, and the agreement by Eleven to pay to the selling shareholders certain post-closing contingent cash payments upon the achievement of specified milestones and based upon net sales related to Viventia’s lead product candidate, Vicinium.
The acquisition creates a NASDAQ-listed company focused on the development of novel therapies based upon antibody fragments genetically fused to cytotoxic proteins, or targeted protein therapeutics (TPTs), as new treatments in areas of oncology with significant unmet need. The combined company will continue to be named Eleven Biotherapeutics, and Stephen Hurly, formerly Viventia’s chief executive officer, was appointed President and Chief Executive Officer of Eleven in connection with the acquisition. Abbie C. Celniker, Eleven’s former President and Chief Executive Officer, will remain a director of Eleven Biotherapeutics.
Eleven’s pipeline now includes Viventia’s lead product candidates Vicinium and Proxinium. Vicinium is in a Phase 3 clinical trial for high grade non-muscle invasive bladder cancer (NMIBC), with topline data expected in the first half of 2018. To date, Vicinium has been evaluated in more than 100 patients. In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40% at three months with no drug-related serious adverse events observed in the trial.
Proxinium is expected to enter Phase 2 development in early 2017 for the treatment of late-stage squamous cell carcinoma of the head and neck. In previous clinical trials, Proxinium was generally safe and well-tolerated and showed signs of anti-tumor activity. Proxinium has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and Fast Track designation from the FDA. Both product candidates are anti-EpCAM (epithelial cell adhesion molecule) fusion proteins that have been optimized for local tumor administration.
Eleven’s pipeline now also includes Viventia’s earlier stage pipeline of next generation TPT candidates that are designed and optimized for systemic administration for the potential treatment of a broader spectrum of cancer types.
“We are excited to join with Eleven to create a company with extensive experience in engineering and developing novel protein therapeutics for local delivery that we believe may maximize efficacy and reduce toxicity. Our TPTs combine specific tumor targeting with a protein based tumor killing payload, and will be developed to serve cancer patients in areas of high unmet need. Together we have a strong Board of Directors, management team, product pipeline and technology platform, and the capital needed to support the Company’s development plans into 2018,” said Stephen Hurly, Chief Executive Officer of Eleven Biotherapeutics.
“As previously announced, Eleven performed an extensive review of our strategic alternatives, and our Board of Directors believes that the acquisition of Viventia offers Eleven shareholders a compelling opportunity for enhancing long-term value,” said Abbie Celniker, Ph.D., former President and Chief Executive Officer of Eleven Biotherapeutics and current member of Eleven’s Board of Directors. “Our combined company will continue to support Roche as they develop EBI-031, and will benefit from the capital contributed by this partnership, which provides the necessary funding to enable further development of Vicinium and Proxinium.”
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