KVK Tech, Inc. Announces 1-2-3 Savings Program for Lomaira™ (phentermine hydrochloride USP) 8 mg Tablets, CIV Cost Savings for Lomaira Patients

NEWTOWN, PA., May 2, 2018 /PRNewswire/ — KVK Tech, Inc. (KVK), a leading American developer, manufacturer, and marketer of FDA-approved pharmaceuticals today announced the LOMAIRA 1-2-3 program. The 1-2-3 program allows patients to start a branded medication at a generic price.

Two-thirds of Americans pay out-of-pocket for their weight-loss prescription medications, so we wanted to create an affordable option,” said Anthony Tabasso, President and CEO at KVK. With the 1-2-3 program, the price for LOMAIRA is set at $5 for the patient taking LOMAIRA once daily, $10 for patients taking LOMAIRA twice daily, and $15 for patients taking LOMAIRA three times daily.” The 1-2-3 program is for a limited time only and available with a voucher and prescription from the healthcare professional.

The 1-2-3 program complements LOMAIRA’s no-expiration savings card, which ensures patients pay $43.50 per month if prescribed 3 tablets per day. This is a significant difference in comparison to other, higher priced weight-loss treatments such as Qsymia ($204.18), Belviq XR ($286.60), and Contrave ($264.57). 1

LOMAIRA is an appetite suppressant available by prescription only and used for a short period of time (a few weeks) for weight reduction in adults with a body mass index (BMI) of 30 or more or 27 or more with a weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol. LOMAIRA should be used together with increased physical activity and a reduced-calorie diet. The limited usefulness of this drug class (appetite suppressants), including LOMAIRA, should be measured against possible risk factors inherent in their use. Please see Full Prescribing Information for LOMAIRA at www.lomaira.com.

Unlike the higher strengths of phentermine HCl that are dosed once daily before or shortly after breakfast, LOMAIRA is FDA-approved to be used up to 3x daily before each meal.2 The quick onset of action (30 minutes) allows patients to take LOMAIRA when they need it most. It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet three times a day 30 minutes before meals. The LOMAIRA tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine HCl is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.

IMPORTANT SAFETY INFORMATION

Don’t take LOMAIRA if you have a history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure or uncontrolled high blood pressure); are taking or have taken a monoamine oxidase inhibitor drug (MAOI) within the past 14 days; have overactive thyroid, glaucoma (increased pressure in the eyes), agitation or a history of drug abuse; are pregnant, nursing, or allergic to the sympathomimetic amines such as phentermine or any of the ingredients in LOMAIRA.

Taking phentermine with other drugs for weight loss is not recommended. Primary pulmonary hypertension

(PPH), a rare fatal lung disease, has been reported in patients who had taken a combination of phentermine and fenfluramine or dexfenfluramine for weight loss. The possible association between phentermine use alone and PPH cannot be ruled out. Patients should report immediately if they experience any decrease in the amount of exercise that they can normally tolerate, shortness of breath, chest or heart pain, fainting or swelling in the lower legs.

Serious heart valve problems or disease have been reported in patients taking a combination of phentermine and fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine has not been established, therefore the possibility of an association between heart valve disease and the use of phentermine alone cannot be ruled out.

If your body becomes adjusted to the maximum dose of phentermine so that its effects are experienced less strongly, the maximum dose should not be exceeded in an attempt to increase the effect.

Caution is advised while engaging in potentially hazardous activity such as driving or operating machinery while taking phentermine. Phentermine has the potential to be abused. Keep LOMAIRA in a safe place to prevent theft, accidental overdose, misuse or abuse. Using alcohol with phentermine may result in an adverse drug reaction.

Phentermine can cause an increase in blood pressure. Tell your doctor if you have high blood pressure, even if it’s mild. If you are taking medicines for type 2 diabetes, your doctor may have to adjust these medicines while taking phentermine.

Some side effects of phentermine that have been reported include pulmonary hypertension, valvular heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation and changes in sexual drive. These are not all of the potential side effects of phentermine. For more information, ask your doctor or pharmacist.

To report negative side effects of prescription drugs, contact FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

See Full Prescribing Information at www.lomaira.com.

About KVK Tech

KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. Founded in 2004, KVK takes pride in its ability to advance generic pharmaceutical development and offer low-cost alternatives in response to today’s healthcare challenges. All of KVK’s products are made in the U.S.A. in a state-of-the-art facility in Newtown, PA. KVK is committed to maintaining its entire business operations in America, as it continues to build strong, lasting relationships with the nation’s largest pharmacy chains, wholesalers and distributors.

1 GoodRx.com, lowest cash pay pricing for a month of treatment.

2 LOMAIRA package insert, Newtown, PA.

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5W Public Relations

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