Microsoft word - luitpold - roxro press release.doc


December 13, 2010

Luitpold Pharmaceuticals, Inc. Acquires
ROXRO PHARMA, Inc., a U.S. Company Developing
Acute Pain Products

Contact Information:
Walter Tozzi, RPh, MS, MBA
Sr. Director of Marketing & Professional Services
Shirley, N.Y. (December 13, 2010) – Luitpold Pharmaceuticals, Inc. a New York based U.S.
subsidiary of Daiichi Sankyo Co., Ltd. (Corporate Headquarters: Tokyo, Japan) announced
today that it has signed a binding merger agreement with ROXRO PHARMA, Inc. (Roxro), a
privately held U.S. specialty pharmaceutical company, developing products for the treatment of
acute pain conditions. The financial terms of the acquisition were not disclosed.
In May of 2010, Roxro obtained FDA approval for SPRIX® (ketorolac tromethamine) Nasal
Spray, for the short‐term (up to 5 days) management of acute moderate to moderately severe
pain that requires analgesia at the opioid level. SPRIX® is a prescription intranasal formulation
of the analgesic ketorolac tromethamine (previously marketed as Toradol® by Roche
Laboratories), a non‐steroidal anti‐inflammatory drug (NSAID). SPRIX® is designed to
provide ambulatory patients with a convenient, potent, and fast‐acting option for acute
moderate to moderately severe pain relief.
Mary Jane Helenek, president and CEO of Luitpold said, “We are pleased to be able to provide
healthcare professionals with an important new non-narcotic analgesic to treat acute pain in
ambulatory patients. We believe that SPRIX® will be highly complimentary to Luitpold’s existing
product line and our continuing strategy to diversify our product portfolio and further grow our
U.S. pharmaceutical business.”
“We are delighted that Luitpold will be marketing SPRIX®”, said Roberto Rosenkranz, chairman
and CEO of Roxro Pharma, Inc. “We believe that Luitpold has the infrastructure, expertise and
capabilities to successfully bring this novel treatment to patients with moderate to moderately
severe acute pain.”
Luitpold’s legal and financial advisers on the transaction were Sheppard Mullin Richter and
Hampton LLP and Aquilo Partners, L.P., respectively.
Roxro’s legal and financial advisers were Goodwin Proctor LLP and Lazard, respectively.
About SPRIX®
SPRIX® is a novel intranasal formulation of the potent non‐steroidal anti‐inflammatory drug
(NSAID) ketorolac. Currently, ketorolac is most often administered in the hospital setting as an
injection for the short‐term treatment of moderately severe pain. Formulated as an
easy‐to‐use nasal spray, SPRIX® is rapidly absorbed through the nasal mucosa, achieving
peak blood levels as fast as an intramuscular injection of ketorolac. SPRIX® has been studied
in patients with moderate to moderately severe pain, both alone and in combination with
morphine. The New Drug Application package for SPRIX® included data from more than 1,000
subjects and 14 clinical trials. SPRIX® has been tested in four controlled efficacy studies, and
met the primary efficacy endpoints in each trial. Phase 3 studies of adults who underwent
elective abdominal or orthopedic surgery (n=300 and n=321) indicated that SPRIX® provided a
statistically significant greater reduction in the summed pain intensity difference, a commonly
accepted measure of pain, over 48 hours as compared to those using placebo. SPRIX® has
also demonstrated a 26‐36 percent reduction in morphine use by patients over a 48 hour
period as compared with placebo.

Important Safety Information About SPRIX®

• Limitations of Use – The total duration of use of SPRIX and other ketorolac formulations
• Gastrointestinal (GI) Risk – Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal. SPRIX is CONTRAINDICATED in patients with peptic ulcer disease or history of GI bleeding. • Bleeding Risk – SPRIX inhibits platelet function and is CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding. • Cardiovascular (CV) Risk – NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk. SPRIX is CONTRAINDICATED for treatment of peri‐operative pain in the setting of coronary artery bypass graft (CABG) surgery. • Renal Risk – SPRIX is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. Mild, transient nasal discomfort was the most frequently reported side‐effect of SPRIX use. SPRIX is contraindicated in patients with known hypersensitivity or a history of allergic reactions to aspirin, ketorolac, other NSAIDs or EDTA; in patients at risk for GI bleeding; prior to major surgery or during the perioperative period in CABG surgery; in patients with advanced renal disease or volume depletion; patients with certain bleeding risk and during labor and delivery. SPRIX should not be used concurrently with probenecid or pentoxifylline. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX. About Luitpold Pharmaceuticals, Inc.
Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over
80 pharmaceutical products including Venofer® (iron sucrose injection, USP), the # 1 selling IV
iron therapy in the U.S., through its human health subsidiary, American Regent, Inc. Luitpold
Pharmaceuticals, Inc., a Daiichi Sankyo group company, also markets dental bone regeneration
products and veterinary pharmaceuticals through its Osteohealth and Animal Health divisions.
Daiichi Sankyo Company, Ltd., established in 2005 after the merger of two leading century-old
Japanese pharmaceutical companies, is a global pharmaceutical innovator, continuously
generating innovative drugs that enrich the quality of life for patients around the world.
ROXRO PHARMA, Inc. is a late‐stage specialty pharmaceutical company developing hospital
strength acute pain products for convenient use by patients in the home setting. The company is
led by a seasoned management team that has discovered, developed and commercialized
several pain and cardiovascular medicines that are widely prescribed today.
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