This includes three marketed products: recently approved and launched Vabomere (vaborbactam/meropenem), and established commercial products Orbactiv (oritavancin) and Minocin IV (minocycline).
The acquisition was unanimously approved by Melinta’s board of directors and is expected to close in the first quarter of 2018, subject to satisfaction of customary closing conditions, including Melinta stockholder approval.
Melinta believes that the acquisition will result in a focused portfolio of high-value marketed assets with significant commercial synergies, allowing Melinta to maximize the value associated with the marketed products and drive the company to profitability.
It also bolsters Melinta’s commercial team, which has been built out in preparation for the launch of Baxdela (delafloxacin), with experienced anti-infective professionals from The Medicines Company who can drive value across the combined portfolio.
“The assets we are purchasing are an ideal complement to our existing business, allowing us to focus on multiple valuable segments of the anti-infectives market simultaneously,” stated Dan Wechsler, Melinta’s president and chief executive officer. “We will be able to better serve the providers and the patients they serve who need medicines for serious infections by delivering a robust portfolio of treatment options.”
“We believe the transaction announced today places our novel antibiotic products and many of our outstanding employees, into the Melinta organization, a highly-capable, pure-play, emerging leader in the antibiotics space.
“We believe Melinta will grow these products strongly and – as both partner and shareholder — we look forward to their success as we focus our efforts and resources on inclisiran, which we believe has the potential to be a competitively-dominant, blockbuster product for the millions of at-risk, often non-adherent, patients worldwide who continue to struggle with high cholesterol given the limitations of available therapies,” said Clive Meanwell, M.D., Ph.D., chief executive officer of The Medicines Company.
The acquisition includes the purchase of global rights for three marketed products and the business supporting those products. Recently launched Vabomere is a novel fixed-dose combination agent comprising vaborbactam, a beta-lactamase inhibitor, and meropenem, the leading carbapenem.
Vabomere was approved by the U.S. Food & Drug Administration (FDA) after priority review in August 2017 and is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible Enterobacteriaceae. Vabomere’s Phase 3 TANGO II trial, a randomized trial comparing Vabomere to the best available therapy for the treatment of serious carbapenem-resistant Enterobacteriaceae (CRE) infections, was stopped early by an Independent Data and Safety Monitoring Board following a risk-benefit analysis of available data which was in favor of Vabomere. Vabomere’s Marketing Authorization Application is currently under regulatory review by the European Medicines Agency (EMA) for cUTI.
Orbactiv is an injectable product approved by the FDA and EMA for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible designated gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
Minocin IV, an injectable product, is a tetracycline derivative approved in the U.S. for the treatment of infections due to susceptible strains of several important designated gram-positive and gram-negative pathogens, including infections due to Acinetobacter species, which typically occur in hospitalized patients.
Vabomere and Orbactiv were granted priority review and approval as Qualified Infectious Disease Products (QIDP) by the FDA in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which secured five-year regulatory extensions of exclusivity for each product.
Through this acquisition, Melinta will enhance its commercial portfolio, led by Baxdela, a novel fluoroquinolone antibiotic recently approved by the FDA for the treatment of patients with ABSSSI and launching in Q1 2018.
Baxdela is differentiated from other therapies currently available, since therapy can be initiated on either IV or oral formulations, has full coverage of gram positive pathogens, including MRSA, and gram negative pathogens, has tolerability and fixed dose simplicity, and has limited drug and disease interactions. Once the acquisition closes, Melinta will have a portfolio of four complementary marketed antibiotic assets: Baxdela, recently launched Vabomere, and established commercial products, Orbactiv and Minocin IV.
More than 14 million patients in the U.S. are treated for ABSSSI on an annual basis. While the majority of these patients are treated successfully in the community, many patients will require treatment in emergency departments and urgent care centers on an outpatient basis (estimated by Melinta to be 1.6 million), and a significant portion will receive treatment as hospital inpatients (2.9 million).
The rise in CRE was formally recognized as an urgent threat by the Centers for Disease Control and Prevention in 2013. Melinta estimates that ~138,000 patients are candidates for antibiotic therapy that targets carbapenem resistance. Patients with CRE infections are at increased risk of poor outcomes, including extended hospital stays, higher rates of mechanical ventilation, higher treatment cost, and death.
Acinetobacter is a genus of gram-negative bacteria belonging to the Moraxcellaceae family. According to the CDC, 63 percent of Acinetobacter infections are multi-drug resistant, meaning that they are resistant to three or more classes of antibiotics. Melinta estimates that there are approximately 50,000 cases of multi-drug resistant Acinetobacter infections per year.
The combined Melinta and The Medicines Company infectious disease product portfolio significantly enhances Melinta’s multi-channel strategy of delivering antibiotic solutions for ABSSSI and gram-negative infections within the hospital, emergency department, and community settings. Each product in the portfolio has distinct value in the marketplace.
With Melinta’s commercial team now built out and preparing for Baxdela’s launch, coupled with the professionals that will join from The Medicines Company, Melinta will have an experienced team of focused antibiotic experts as well as the therapeutic scale necessary to maximize the value of the portfolio.
Melinta will continue to progress the additional clinical studies designed to enhance and expand the potential for the four marketed products, and fund the discovery and development of its novel class of antibiotics via the ESKAPE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and Escherichia coli) pathogen program.
Outside the U.S., Melinta retains global rights to the acquired products. Melinta will continue ongoing regulatory discussions with the European Medicines Agency for the approval of Vabomere, and pursue ex-U.S. partnering opportunities with the now even more compelling suite of treatment options.
Under the terms of the acquisition agreement, the purchase price consists of (i) a payment by Melinta to The Medicines Company of $165 million in cash and the issuance to The Medicines Company of a number of shares of Melinta common stock equal to $50 million, divided by 90% of the volume weighted average price for the trailing 10 trading day period ending 3 trading days prior to closing; (ii) a payment by Melinta to The Medicines Company of $25 million following each of the twelve and eighteen month anniversaries of the closing date, and (iii) payment by Melinta to The Medicines Company of certain royalty payments, based on tiered net sales of the acquired products in certain jurisdictions.
Funding for this acquisition will be provided through both debt and equity. In conjunction with the closing of the acquisition, Melinta will enter into a Loan and Security Agreement with Deerfield Management Company, L.P. (“Deerfield”).
Deerfield and certain funds managed by Deerfield will initially provide a total of $190 million in debt and equity financing. An additional $50 million of debt is available to Melinta within 24 months of the acquisition close upon the achievement of certain sales thresholds. In addition to the funding from Deerfield, certain investors are committed to make a $30 million equity investment at closing.
These funds will be used to fund the initial cash acquisition price of $165 million and to retire existing company debt of $40 million. Additional information on the acquisition and related financing will be contained in the proxy statement related to the proposed transactions. Melinta stockholders holding approximately 52% of the outstanding common stock have executed voting agreements agreeing to vote their shares in favor of the transaction.