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CARMEL ANNOUNCES FDA APPROVAL OF PREXXARTAN™ (Valsartan Oral Solution, 4 mg/mL)

ATLANTA, Georgia – 19 December 2017 Carmel Biosciences Inc. today announced that the US Food and Drug Administration (FDA) has granted final approval of the company's New Drug Application (NDA) for PREXXARTAN™(Valsartan Oral Solution, 4 mg/mL). PREXXARTAN™ is the first and Only approved oral liquid dosage form of the angiotensin receptor blocker (ARB) valsartan in the United States.

Bobby V. Khan, MD PhD, Executive Director at Carmel Biosciences, Inc. stated, "The effectiveness of valsartan in managing hypertension, heart failure, and myocardial infarction is well known. With the approval of PREXXARTAN™, we now have a valsartan product that can be safely administered and accurately dosed in children and in patients that have difficulty in swallowing tablets"

About PREXXARTAN™

PREXXARTAN™ (valsartan oral solution) is indicated for treatment of hypertension in adults and children six years and older. PREXXARTAN™ is also indicated for use as therapy for the treatment of heart failure (NYHA class II-IV). Additionally, PREXXARTAN™ has also been indicated for stable left ventricular failure or left ventricular dysfunction after myocardial infarction.

About Carmel Biosciences, Inc.

Carmel Biosciences is a pharmaceutical company that addresses critical needs in new drug and liquid reformulation for cardiovascular and metabolic therapies. The Carmel Biosciences team combines a deep understanding of lipid biochemistry and clinical expertise in the cardiovascular and metabolic space.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications: PREXXARTAN™ is contraindicated for patients with diabetes. PREXXARTAN™ should not be used in patients with known hypersensitivity to any component.

Warnings and Precautions/Adverse Reactions: PREXXARTAN™ may cause the following conditions.

• Fetal Toxicity

• Hypotension

• Impaired Renal Function

• Hyperkalemia

Adverse reactions associated with valsartan have generally been mild and transient, with the overall incidence of adverse effects being similar to that of placebo. The most common side effects include headache and dizziness

Talk to your healthcare provider about other possible side effects with PREXXARTAN™. To report SUSPECTED ADVERSE REACTIONS, contact Medicure at 1-800-509-0544, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

ADMINISTRATION

PREXXARTAN™ (Valsartan Oral Solution, 4 mg/mL), is not therapeutically equivalent to tablet formulation of Diovan (valsartan tablet). Follow dosing instructions for PREXXARTAN™.

Please click the link for full Important Safety Information, full Prescribing Information and Medication Guide: Full Prescribing Information

 

MEDICURE ACQUIRES LICENSE TO SELL AND MARKET PREXXARTAN™ IN THE U.S. FROM CARMEL BIOSCIENCES

WINNIPEG, Manitoba & ATLANTA, Georgia – 31 October 2017 Medicure, Inc. (TSXV:MPH)(OTC:MCUJF) and Carmel Biosciences, Inc. today announced a license agreement to develop and commercialize drugs for the treatment and management of cardiovascular diseases. Specifically, the collaboration will seek to further develop, market, and distribute Carmel’s lead compound, PREXXARTAN™.

The compound is the first of a class of orally-deliverable reformulation compounds that allow the administration of drugs in a stable oral solution form. Under terms of the agreement, Medicure obtains exclusive rights in the United States and territories to develop, manufacture and market PREXXARTAN™ for a seven year term, with potential extensions to the term available. Medicure will pay to Carmel milestone payments on achievement of certain objectives from United States net sales revenues. In addition, Carmel will receive royalties on net sales of products resulting from the agreement. Further details of the agreement are not being disclosed.

“The licensing of PREXXARTAN® fits well with Medicure’s mission of being a significant cardiovascular specialty pharmaceutical company focused on the U.S. market,” commented Medicure’s President and CEO, Albert D. Friesen, PhD. “PREXXARTAN™ will add to Medicure’s revenue in the near term and utilizes the current commercial infrastructure in place for AGGRASTAT® (tirofiban HCl).”

"As a specialty cardiovascular pharmaceutical company, Medicure is an outstanding and knowledgeable partner for the distribution and commercialization of products such as PREXXARTAN™," said Bobby V. Khan, M.D., Ph.D., Carmel founder and Executive Director. "We believe this partnership validates the potential of PREXXARTAN™ and our platform to focus on an unmet need—to expand treatment options to patients with hypertension and other cardiovascular diseases."

Source: Business Wire

 

CARMEL ANNOUNCES U.S. FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR CAR-501

ATLANTA, Georgia – 1 March 2017 Carmel Biosciences, Inc. (the Company or Carmel) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for CAR-501 with broader indications for the Treatment of Primary Hypertension with Complications and Secondary Hypertension in adult and pediatric. The review classification for the application is Standard Review, and the user fee goal date under the Prescription Drug User Fee Act (PDUFA) is October 30, 2017.

CAR-501, a leading cardiovascular drug with gold standard clinical data offers a stable user-friendly liquid dosage form with the appropriate level of controls for the management of patients who have difficulty swallowing tablets/capsules.

 

FDA GRANTS SMALL BUSINESS WAIVER TO CARMEL FOR CAR-501 NDA

ATLANTA, Georgia – 14 April 2016 Carmel Biosciences announced that the U.S. Food & Drug Administration has granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee for its New Drug Application (NDA) for CAR-501, their first human drug application. CAR-501 will be a new user-friendly liquid dosage form of a leading cardiovascular drug with “Gold Standard” clinical data.

"It’s great news for Carmel! We are obviously pleased with the FDA’s waiver approval of the PDUFA fee for CAR-501 NDA," Dr. Bobby Khan, Executive Director of Carmel Biosciences. “As a first-time new drug filer with the FDA we have the opportunity to receive an application fee waiver if we meet certain requirements, which we did, and the $2.4M savings will assist us in moving forward."