Evofem Signs Phexxi® License Agreement for Middle East with Pharma 1
Evofem Biosciences (OTCQB: EVFM) has signed a License and Supply Agreement with Pharma 1 Drug Store for the Middle East rights to Phexxi, its FDA-approved hormone-free contraceptive. Pharma 1 will have exclusive commercialization rights in several Middle Eastern countries, including the UAE, Kuwait, Saudi Arabia, and Qatar. The company plans to file for regulatory approval in the UAE in Q3 2024.
The UAE contraceptive drug market is projected to reach $185.1 million by 2030. This agreement aligns with Evofem's strategy to expand and diversify its revenue stream. Phexxi is the first and only locally-acting contraceptive gel approved by the FDA, applied before intercourse to maintain a vaginal pH inhospitable to sperm and certain pathogens.
Evofem Biosciences (OTCQB: EVFM) ha firmato un Accordo di Licenza e Fornitura con Pharma 1 Drug Store per i diritti nel Medio Oriente su Phexxi, il suo contraccettivo privo di ormoni approvato dalla FDA. Pharma 1 avrà i diritti esclusivi di commercializzazione in diversi paesi del Medio Oriente, tra cui gli Emirati Arabi Uniti, il Kuwait, l'Arabia Saudita e il Qatar. L'azienda prevede di presentare domanda di approvazione normativa negli Emirati Arabi Uniti nel terzo trimestre del 2024.
Si prevede che il mercato dei contraccettivi negli Emirati Arabi Uniti raggiunga $185,1 milioni entro il 2030. Questo accordo è in linea con la strategia di Evofem di espandere e diversificare il proprio flusso di entrate. Phexxi è il primo e unico gel contraccettivo a azione locale approvato dalla FDA, da applicare prima del rapporto sessuale per mantenere un pH vaginale sfavorevole per lo sperma e alcuni patogeni.
Evofem Biosciences (OTCQB: EVFM) ha firmado un Acuerdo de Licencia y Suministro con Pharma 1 Drug Store para los derechos del Medio Oriente de Phexxi, su anticonceptivo aprobado por la FDA y libre de hormonas. Pharma 1 tendrá derechos exclusivos de comercialización en varios países del Medio Oriente, incluyendo los EAU, Kuwait, Arabia Saudita y Qatar. La empresa planea solicitar la aprobación regulatoria en los EAU en el tercer trimestre de 2024.
Se proyecta que el mercado de medicamentos anticonceptivos en los EAU alcance $185.1 millones para 2030. Este acuerdo se alinea con la estrategia de Evofem de expandir y diversificar su flujo de ingresos. Phexxi es el primer y único gel anticonceptivo de acción local aprobado por la FDA, que se aplica antes de la relación sexual para mantener un pH vaginal inhóspito para los espermatozoides y ciertos patógenos.
Evofem 바이오사이언스(OTCQB: EVFM)는 중동 지역에서 Phexxi의 라이센스 및 공급 계약을 Pharma 1 약국과 체결했습니다. 이 제품은 FDA에 의해 승인된 호르몬이 없는 피임약입니다. Pharma 1은 아랍 에미리트, 쿠웨이트, 사우디아라비아 및 카타르를 포함한 여러 중동 국가에서 독점적인 상업화 권리를 갖게 됩니다. 이 회사는 2024년 3분기에 아랍 에미리트에 규제 승인 신청을 할 계획입니다.
아랍 에미리트의 피임약 시장은 2030년까지 $185.1 백만에 이를 것으로 예상됩니다. 이 계약은 Evofem이 수익원을 확장하고 다양화하려는 전략과 일치합니다. Phexxi는 FDA에 의해 승인된 최초이자 유일한 국소 작용 피임 젤로, 성관계 전에 적용하여 정자와 특정 병원체에 불리한 질 pH를 유지합니다.
Evofem Biosciences (OTCQB: EVFM) a signé un accord de licence et de fourniture avec Pharma 1 Drug Store pour les droits au Moyen-Orient concernant Phexxi, son contraceptif sans hormones approuvé par la FDA. Pharma 1 aura des droits exclusifs de commercialisation dans plusieurs pays du Moyen-Orient, y compris les Émirats Arabes Unis, le Koweït, l'Arabie Saoudite et le Qatar. L'entreprise prévoit de demander une approbation réglementaire aux Émirats Arabes Unis au troisième trimestre de 2024.
Le marché des médicaments contraceptifs aux Émirats Arabes Unis devrait atteindre 185,1 millions de dollars d'ici 2030. Cet accord s'inscrit dans la stratégie d'Evofem d'élargir et de diversifier ses sources de revenus. Phexxi est le premier et unique gel contraceptif à action locale approuvé par la FDA, à appliquer avant les rapports sexuels pour maintenir un pH vaginal défavorable aux spermatozoïdes et à certains pathogènes.
Evofem Biosciences (OTCQB: EVFM) hat eine Lizenz- und Liefervereinbarung mit Pharma 1 Drug Store für die Rechte im Nahen Osten an Phexxi, seinem von der FDA zugelassenen hormonfreien Verhütungsmittel, unterzeichnet. Pharma 1 erhält exklusive Vermarktungsrechte in mehreren Ländern des Nahen Ostens, darunter die VAE, Kuwait, Saudi-Arabien und Katar. Das Unternehmen plant, im 3. Quartal 2024 einen Antrag auf behördliche Genehmigung in den VAE zu stellen.
Der Markt für Verhütungsmittel in den VAE wird voraussichtlich bis 2030 einen Wert von 185,1 Millionen Dollar erreichen. Diese Vereinbarung steht im Einklang mit der Strategie von Evofem, ihren Einnahmestrom zu erweitern und zu diversifizieren. Phexxi ist das erste und einzige local wirkende Verhütungs-Gel, das von der FDA genehmigt wurde und vor dem Geschlechtsverkehr aufgetragen wird, um einen vaginalen pH-Wert aufrechtzuerhalten, der für Spermien und bestimmte Krankheitserreger ungünstig ist.
- Exclusive licensing agreement for Phexxi in Middle Eastern countries
- Potential expansion into UAE contraceptive market projected to reach $185.1 million by 2030
- Diversification of revenue stream for Evofem Biosciences
- Pharma 1 to handle regulatory approvals, distribution, sales, and marketing in the region
- None.
Insights
The signing of the exclusive licensing agreement between Evofem Biosciences and Pharma 1 Drug Store is a significant milestone that could potentially boost Evofem’s revenue streams. This move aligns with Evofem's strategy to diversify its market. By tapping into the Middle East, a market projected to reach
This agreement is particularly noteworthy given the rising demand for hormone-free contraceptive options in the Middle East. The Middle East market, especially the UAE, shows promise for growth in this segment due to cultural preferences and increasing awareness about hormone-free alternatives. Market research indicates that Phexxi could be well-received among OB/GYNs and their patients due to its unique selling proposition of being non-hormonal and on-demand. With Pharma 1’s established presence and expertise in the region, the product could gain rapid acceptance and robust sales, further strengthening Evofem's market position.
Phexxi’s unique mechanism of action and FDA approval are significant selling points. As the first and only locally-acting contraceptive gel, it addresses a niche market for women who prefer hormone-free options. This product can potentially cater to a significant portion of the female population in the Middle East, where there is a growing preference for non-systemic birth control methods due to cultural and health considerations. If Pharma 1 successfully obtains regulatory approvals in the UAE and other GCC countries, this could set a precedent and ease regulatory pathways for similar products in the future.
— Pharma 1 anticipates filing
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Under the terms of the agreement, Pharma 1 will have the exclusive commercialization rights for Phexxi in the
"This agreement for Phexxi reflects our unwavering commitment to improve women's health in the member states of the Gulf Cooperation Council (GCC)," said Abdulwahab Atfah, CEO of Pharma 1 Drug Store. "We expect to file for regulatory approval of Phexxi in the
"The Phexxi licensing agreement for the
Since its inception in 2019, Pharma 1 has continued to successfully execute its mission of offering practical solutions to fulfill health care needs based on scientific studies and accurate surveys. The company's success reflects its substantial expertise, scientific approach, and agility to adapt to the very dynamic and growing market in the GCC.
Phexxi is the first and only locally-acting contraceptive gel approved by the FDA. It is applied zero-to-60 minutes before intercourse using a pre-filled applicator and works, without hormones, by maintaining the normal vaginal microbiome with a pH that is naturally inhospitable to sperm as well as certain viral and bacterial pathogens.
About Evofem Biosciences
Evofem Biosciences, Inc., is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.
In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older and bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose.
In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt intends to acquire Evofem. The parties amended and restated the Merger Agreement, as amended, in its entirety in July 2024. The companies are targeting a September 30, 2024, closing.
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Phexxi® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.
About Pharma 1
Pharma 1 Drug Store is an Emirati company dedicated to providing practical solutions, backed by scientific studies and accurate surveys, that cater to the ever-evolving healthcare needs of people in the GCC and support development of a healthier community. Pharma 1 are agents to a growing number of pharmaceutical companies, with a variety of commercial products and medications in process with the Ministry of Health. Learn more at https://pharma1ds.com/.
Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding anticipated regulatory filings and approvals and timing thereof, anticipated demand for hormone-free, on demand contraception in the territory, and anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.
Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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SOURCE Evofem Biosciences, Inc.
FAQ
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