Regulatory roundup

Here are just a few highlights of recent regulatory activities worldwide, from patents approved to designations granted to drugs given the green light for one indication or another

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MediciNova allowed new patents for three potential products
LA JOLLA, Calif.—Biopharmaceutical company MediciNova Inc. got word in early February that it had received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application that covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of nonalcoholic steatohepatitis. The patent maturing from this allowed patent application is expected to expire no earlier than December 2032. The allowed claims cover a method of treating NASH, a method of reducing liver inflammation in NASH, a method of reducing hepatic fibrosis in NASH and a method of reducing damage to liver cells in NASH using MN-001 or MN-002. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms.
A few days earlier, the company also noted that it had received a new patent from the Japanese Patent Office covering MN-029 (denibulin) di-hydrochloride that will expire no earlier than July 2032 and whose allowed claims cover a compound, pharmaceutical composition and method of treating certain cell proliferation diseases, including solid tumors, based on denibulin di-hydrochloride.

FDA grants Breakthrough Therapy designation to Roche’s MPDL3280A
BASEL, Switzerland—Following a Breakthrough Therapy designation for MPDL3280A from the U.S. Food and Drug Administration (FDA) in bladder cancer in 2014, Roche has gotten a second such designation for the investigational anti-programmed death-ligand 1 (anti-PDL1) cancer immunotherapy for treatment of people with PD-L1-positive non-small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).
“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,’’ said Dr. Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “We are committed to personalized healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines. ”

Symplmed announces FDA approval of Prestalia for hypertension
CINCINNATI & BEND, Ore.—Jan. 26 saw Symplmed Pharmaceuticals announce that the FDA had approved Prestalia (perindopril arginine and amlodipine) tablets, licensed from French pharma Servier, for the treatment of hypertension. Prestalia, the first fixed-dose combination of these two medications, may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.
“This is a significant milestone for Symplmed and for our development partner Servier, as it is the first product from our perindopril pipeline to receive FDA approval,” said Erik Emerson, president and CEO of Symplmed Pharmaceuticals. “With ACE inhibitors and calcium channel blockers being two of the most highly prescribed products for the treatment of cardiovascular disease, we are excited to be able to provide physicians and patients these two therapeutic classes in a single pill combination right from the start of the treatment for hypertension.”
FDA approval of Prestalia was based on data from the 837-patient Phase 3 PATH trial (Perindopril Amlodipine for the Treatment of Hypertension). The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. There are additional clinical studies that demonstrate use of these classes of drugs together may reduce cardiovascular events.

ApoCell gains EU Orphan Drug designation for graft-versus-host disease
JERUSALEM—Enlivex Therapeutics announced recently that the European Medicines Agency had granted Orphan Drug status to the company's lead product candidate, ApoCell, for the prevention of graft-versus-host disease (GvHD). Previously, ApoCell received the same designation from the FDA. The company plans to initiate a Phase 2b/3 trial of ApoCell in GvHD in 2015.
“The EMA's Orphan Drug designation of ApoCell is a significant step forward in our clinical program. GvHD is a serious complication that affects 30 percent to 70 percent of bone marrow transplant patients and is a substantial contributor to transplant-related morbidity and mortality,” said Alon Moran, CEO of Enlivex. “With orphan status now secured in both Europe and the United States, we believe that we are well positioned to advance the development of the product and address the significant unmet medical need arising from the current absence of effective GvHD treatments.”

FDA approves Triferic for iron replacement and maintenance of hemoglobin in hemodialysis patients
WIXOM, Mich.—In late January, Rockwell Medical Inc., a fully-integrated biopharmaceutical company targeting end-stage renal disease and chronic kidney disease, noted that the FDA had approved its drug Triferic for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.
“We are extremely pleased with the FDA approval of Triferic. It is the first drug approved to replace ongoing iron losses and to maintain hemoglobin levels in hemodialysis patients,” stated Robert L. Chioini, founder, chairman and CEO of Rockwell. “Triferic's unique ability to be delivered via dialysate and to deliver iron without increasing iron stores strengthens its potential to become the market-leading iron therapy treatment for hemodialysis patients. [This is a] major development both for Rockwell and for the entire hemodialysis patient population who now have a significantly better treatment option for addressing their iron losses. We are highly confident in executing a successful commercial launch and penetrating the market.”

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