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November 29, 2017

Melinta to Acquire Infectious Disease Business of The Medicines Company

  • Melinta Therapeutics said today it has agreed to acquire The Medicines Company’s infectious disease business for $265 million, in a deal that expands the buyer’s antibiotics portfolio by quadrupling its number of marketed treatments.

    The Medicines Company’s infectious disease business includes three marketed drugs: The recently approved and launched Vabomere® (meropenem/vaborbactam) and two established commercial products, Orbactiv® (oritavancin) and Minocin IV® (minocycline). 

    Those treatments will be combined with Melinta’s Baxdela® (delafloxacin) into an expanded antibiotics portfolio that, the buyer reasons, will allow it to achieve profitability through cost-savings or “commercial synergies” that maximize the value of the marketed treatments.

    Melinta said it also anticipates an expanded commercial team as professionals it hired in connection with the launch of Baxdela are joined by new colleagues from The Medicines Company.

    “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,” Dan Wechsler, Melinta’s president and CEO, said in a statement. “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.” 

    Baxdela is a novel fluoroquinolone antibiotic approved in June by the FDA for patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is set to be launched in the first quarter of 2018.

    Vabomere is a novel fixed-dose combination agent consisting of vaborbactam, a β-lactamase inhibitor, and meropenem, a carbapenem antibacterial.  Approved by the FDA in August, Vabomere is indicated for adults with complicated urinary tract infections (cUTI), including pyelonephritis caused by designated susceptible Enterobacteriaceae. The European Medicines Agency (EMA) is reviewing a Marketing Authorization Application for Vabomere for cUTI.

    Orbactiv is an injectable product approved by the FDA and EMA for adults with ABSSSI caused by susceptible designated Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).  Orbactiv and Vabomere were both granted Priority Review and Qualified Infectious Disease Products (QIDP) status by the FDA through the Generating Antibiotics Incentives Now (GAIN) Act, which allowed five-year exclusivity extensions for each product.

    Minocin IV is an injectable tetracycline derivative approved by the FDA to treat infections due to susceptible strains of several important designated Gram-positive and Gram-negative pathogens, including infections due to Acinetobacter species that typically occur in hospitalized patients.

  • Shifting Focus to Cholesterol

    “We believe Melinta will grow these products strongly,” added Clive Meanwell, M.D., Ph.D., The Medicines Company’s CEO. “And—as both partner and shareholder—we look forward to their success as we focus our efforts and resources on inclisiran.”

    Inclisiran is a first-in-class PCSK9 synthesis inhibitor being developed to treat hypercholesterolemia through an up-to-$205 million collaboration by The Medicines Company and Alnylam Pharmaceuticals launched in 2013.

    Earlier this month, The Medicines Company and Alnylam initiated the Phase III program for inclisiran by dosing the first patient in the ORION-11 trial, which is designed to compare inclisiran versus placebo in patients with atherosclerotic cardiovascular disease (ASCVD), or ASCVD-risk equivalents (such as type 2 diabetes and familial hypercholesterolemia) and elevated low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated doses of LDL-C–lowering therapies.

    On August 28, The Medicines Company and Alnylam trumpeted positive data from the Phase II ORION-1 study showing a mean LDL-C reduction of 56% at day 150 and 51% at day 180, following a starting dose of 300 mg given on day 1 and day 90.

    Melinta has agreed to pay The Medicines Company $165 million in cash, $25 million on the 12-month anniversary of the closing date, another $25 million on the 18-month anniversary of the closing date, and $50 million in Melinta common stock divided by 90% of the volume-weighted average price for the preceding period of 10 trading days ending 3 trading days prior to closing.

    In addition, Melinta agreed to pay The Medicines Company royalties based on tiered net sales of the acquired products in certain regions.

    A total of $190 million in debt and equity financing toward the purchase will come from Deerfield Management Co. and funds overseen by Deerfield, while undisclosed investors have committed to a $30 million equity investment in Melinta at closing. The funds will pay for the initial $165 million cash acquisition as well as the retirement of existing company debt totaling $40 million.

    Melinta’s board of directors has unanimously approved the deal, which is expected to close in the first quarter of 2018, subject to Melinta shareholder approval and other customary closing conditions. Holders of approximately 52% of Melinta’s outstanding common stock have agreed to vote their shares in favor of the transaction.

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