VALSARTAN IS NOW APPROVED FOR YOUNGER PATIENTS WITH HYPERTENSION

ATLANTA, Georgia – 19 May 2021The Food and Drug Administration (FDA) has expanded the approval of Diovan (valsartan) to include patients 1 to 5 years of age for the treatment of hypertension. Previously, the treatment was indicated for patients 6 years of age and older.

In response to the announcement by the FDA, Dr. Bobby Khan, Executive Director of Carmel Biosciences, stated that the FDA-approved product PREXXARTAN™ (valsartan oral solution) allows the opportunity of highly accurate dosing of valsartan to very young patients that meet the approved clinical conditions of this drug.

 

CARMEL BIOSCIENCES ANNOUNCES CLARIFICATION TO INDICATE NO RELATIONSHIP WITH NUTRIBAND

ATLANTA, Georgia – 11 February 2019 Carmel Biosciences, an Atlanta, Georgia based pharmaceutical company, announced today a clarification that no business or working relationship exists with Nutriband, Inc. This announcement was made in light of previous news releases from September 2018 that indicated that Nutriband (based in Orlando, Florida) had acquired Carmel and its pharmaceutical and nutraceutical assets. Discussions for potential acquisition originated in May 2018 and a letter of intent was signed in June 2018. However, no Definitive Agreement was ever finalized and no acquisition event occurred.

In November 2018, both Carmel and Nutriband terminated any further discussions for acquisition, and notification was made by Nutriband to the Securities and Exchange Commission in a Form 8-K report. Carmel Biosciences is a pharmaceutical company that addresses critical needs in reformulation for cardiovascular and metabolic therapies to provide a high degree of safety, efficacy, and ease of dosing. The company retains the New Drug Application (NDA) and ownership rights to Food and Drug Administration-approved Prexxartan, the first and only approved oral liquid dosage form of the angiotensin receptor blocker (ARB) valsartan in the United States. Carmel also maintains the ownership and rights to develop and market Carmel’s pipeline including CAR-509, CAR-510, CAR-511 and CAR-512, currently in pre-Investigational New Drug (IND) phase.

 

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

 

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."