Mycovia Pharmaceuticals, Inc. Announces AllianceRx Walgreens Pharmacy and Walgreens Community-based Specialty Pharmacies as Exclusive Distributor of VIVJOA®

News provided by

Mar 26, 2024, 08:30 ET

- VIVJOA is available through Walgreens specialty pharmacies

- Patients with chronic yeast infections benefit from holistic patient care through Walgreens specialty pharmacies

DURHAM, N.C., March 26, 2024 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company, today announced that patients now have exclusive access to VIVJOA® through AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies, subsidiaries of Walgreens Boots Alliance, Inc.

VIVJOA (oteseconazole) is the first FDA-approved medication to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC), or chronic yeast infection, in post-menopausal women or women who are not of reproductive potential.

"Mycovia is proud to have Walgreens and its breadth of national and nearly 300 community-based specialty pharmacies as our partner for the distribution of VIVJOA," said Patrick Jordan, CEO of Mycovia and Managing Partner at NovaQuest Capital Management. "The attention and responsiveness the Walgreens specialty pharmacy teams provide in making patients and their healthcare providers a priority help ensure our drug gets to the right patients, right when they need it."

"We are honored Mycovia selected us as a specialty pharmacy provider for patients with RVVC," said Tracey James, RPh, Chief Operating Officer of Walgreens enterprise specialty. "We share a desire to provide holistic patient care and optimal outcomes for our patients."

When prescribing VIVJOA, healthcare providers can simply send the prescription to any Walgreens pharmacy and the prescription will be routed to the appropriate specialty pharmacy location for the patient within minutes. The Walgreens specialty pharmacies will provide prior authorization assistance, help connect commercially insured patients to co-pay programs, and provide delivery direct to the patient's door.

About Recurrent Vulvovaginal Candidiasis
RVVC is a debilitating, chronic infectious condition that affects 138 million women worldwide each year. RVVC, also known as chronic yeast infection, is a distinct condition from vulvovaginal candidiasis and defined by the Centers for Disease Control and Prevention as three or more symptomatic acute episodes of yeast infection in 12 months. Primary symptoms include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain.

About VIVJOA®
VIVJOA® (oteseconazole) is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA is the first FDA-approved medication that provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators.

Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selective interaction is also toxic to fungi, resulting in the inhibition of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes. The FDA approved VIVJOA based upon the positive results from three phase 3 clinical trials of oteseconazole – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including 875 patients at 232 sites across 11 countries.

Please click here for full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).

VIVJOA is contraindicated in pregnant and lactating women.

VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.

WARNINGS AND PRECAUTIONS
Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo- fetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.

ADVERSE REACTIONS
The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).

DRUG INTERACTIONS
VIVJOA is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates, which may increase the risk of adverse reactions associated with these drugs.

Please see full Prescribing Information and Patient Information.

To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Mycovia Pharmaceuticals, Inc.
Mycovia Pharmaceuticals, Inc. is an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. VIVJOA® (oteseconazole) capsules, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan.

Mycovia also recognizes a tremendous potential for its oral fungal inhibitors and a growing need to treat a range of multi-drug resistant fungal pathogens. For more information, please visit www.mycovia.com.

About NovaQuest Capital Management
Founded by a team of accomplished industry professionals in 2010, NovaQuest Capital Management is a premier biopharma and life sciences investment firm. NovaQuest pioneered a Product Finance solution for the industry, providing at-risk, nondilutive funding that enables partner companies to advance pivotal clinical trials, launch new brands, license products, and acquire accretive products or companies. NovaQuest has invested in scores of biopharmaceutical assets across therapeutic areas with a clinical success rate significantly higher than the industry average. NovaQuest is actively evaluating and investing into global opportunities. For more information, please visit www.novaquest.com.

SOURCE Mycovia Pharmaceuticals, Inc.