|Cubist Pharma Reports Publicant of Pivotal Data from SIVEXTRO ESTABLISH-2 Trial; Chelsea Therapeutics Announces the Expiration of the Hart-Scott-Rodino Waiting Period|
|By Staff and Wire Reports|
|Friday, 06 June 2014 19:27|
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™ (tedizolid phosphate), which is being eveloped for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI). The results will also appear in a forthcoming print issue of the journal. The authors note that ESTABLISH-2 was the first prospectively designed clinical trial consistent with the fundamental elements outlined in the final U.S. Food and Drug Administration (FDA) ABSSSI Guidance released in 2013.
SIVEXTRO is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The published data are based on one of the two global Phase 3 clinical studies of SIVEXTRO (ESTABLISH-1 and ESTABLISH-2), which met the primary and secondary endpoints defined by the FDA and European Medicines Agency (EMA). The clinical trials enrolled 1,333 people in the U.S., Europe and other regions worldwide. As outlined in The Lancet Infectious Diseases, a focus of the ESTABLISH-2 clinical trial was to evaluate the efficacy and safety of the I.V. to oral transition of SIVEXTRO in the treatment of ABSSSI. The randomized, controlled Phase 3 clinical trial compared SIVEXTRO 200 mg given as a once daily dose for six days with linezolid 1200 mg divided as a twice daily dose for 10 days, both administered by I.V. with a possible switch to oral study treatment, when pre-specified criteria were met. Results showed a six-day course of once-daily SIVEXTRO to be non-inferior to 10 days of twice-daily linezolid for the treatment of ABSSSI. In the ESTABLISH-2 study, the adverse event rates were similar for both SIVEXTRO and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups.
“Publication of ESTABLISH-2 clinical trial results in The Lancet Infectious Diseases contributes important information to the infectious disease community worldwide about SIVEXTRO,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “These data provide further support for the potential of SIVEXTRO as a novel treatment option that might be used in the transition from I.V. to oral therapy in a short, six-day course of treatment for patients with serious skin infections.” “Acute bacterial skin and skin structure infections are a common problem that we see every day in emergency departments and clinics across the U.S. These infections can be devastating to patients, and are among the most common infections treated in hospitals. MRSA is recognized as a frequent cause of these infections, and is now declared a serious public health threat in the U.S. because of increasing incidence in the last decade,” said Gregory J. Moran, M.D., Clinical Professor, UCLA Dept. of Emergency Medicine. “With limitations of some existing therapies, including resistance to certain agents, there is a need for new antibiotics in addition to a focus on appropriate use. It is encouraging to see these clinical trial data in hospital and outpatient settings, as SIVEXTRO may become a potential treatment option for acute bacterial skin and skin structure infections, including those caused by MRSA.”
Data from the ESTABLISH-2 study, along with data from the previously published ESTABLISH-1 study, served as the basis for Cubist's New Drug Application (NDA) for SIVEXTRO, for which Cubist is seeking approval in acute bacterial skin and skin structure infections (ABSSSI). The FDA accepted the NDA in December 2013 for Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. On March 31, 2014 the FDA Anti-Infective Drug Advisory Committee (AIDAC) voted unanimously to recommend approval of SIVEXTRO. The Company also recently announced that the EMA accepted for review its Marketing
Authorization Application (MAA) for SIVEXTRO, for which Cubist is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI).
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR Act") in connection with the previously announced Agreement and Plan of Merger, dated as of May 7, 2014 (the "Merger Agreement"), by and among Chelsea, H. Lundbeck A/S ("Lundbeck"), and Charlie Acquisition Corp., an indirect wholly owned subsidiary of Lundbeck ("Acquisition Sub").
As announced on May 23, 2014, Lundbeck has commenced a tender offer (the "Offer") to purchase all of the outstanding shares of Chelsea for $6.44 per share in cash and one contingent value right that may pay up to an additional $1.50 per share upon achievement of certain net sales milestones, for a total potential consideration of up to $7.94 per share, or an aggregate of $658 million on a fully diluted basis.
As described in Chelsea' Solicitation/Recommendation Statement on Schedule 14D-9 (the "Statement") filed with the Securities and Exchange Commission (the "SEC") and mailed to Chelsea's stockholders on May 23, 2014, Chelsea's Board of Directors has unanimously recommended that Chelsea's stockholders accept the Offer and tender their shares pursuant to the Offer. The initial expiration date of the Offer is at 12:00 midnight, New York City time, on June 20, 2014 (one minute after 11:59 p.m., New York City time, on June 20, 2014), subject to extension in certain circumstances as permitted under the Merger Agreement and applicable law.
Subject to Acquisition Sub's irrevocable acceptance for payment in the Offer of at least a majority of Chelsea's common stock outstanding on a fully diluted basis and to the satisfaction or waiver of certain other customary conditions, Acquisition Sub will merge with and into the Company (the "Merger") and, subject to certain exceptions, each Chelsea share not tendered in the Offer will be cancelled and converted into the right to receive in the Merger the same consideration per share paid in the Offer. The Merger will be effected as soon as practicable after the closing of the Offer.
Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the closing of the Offer and the Merger. The Offer and the Merger remain subject to other customary closing conditions.
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