SAN FRANCISCO--(BUSINESS WIRE)--Napo Pharmaceuticals, Inc., a company focused on the development and commercialization of proprietary pharmaceuticals for the global marketplace from plants traditionally used in rainforest areas, announces today that it has signed an agreement with Alamo Pharma Services, Inc. for the establishment and management of a national sales team for Mytesi™ (formerly known as Fulyzaq). Mytesi™, launched by Napo in October 2016, is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Under the terms of the agreement, Alamo will provide a team of shared sales representatives to supplement the dedicated Napo representatives who will promote and sample Mytesi™ in key metropolitan areas throughout the United States. The sales representatives will reach out to doctors who have large populations of HIV patients and, therefore, are high-volume prescribers of antiretroviral therapies.
Alamo is a specialized provider of contract sales solutions to pharmaceutical and biotech companies headquartered in Doylestown, Pennsylvania. BexR, a full service kitting and pick pack sample fulfillment provider, will continue to offer telesales support for Mytesi™, as they have since October 2016, to detail HIV healthcare providers in geographic areas not covered by sales representatives. Alamo and BexR are part of the Mission Family of Companies.
“We are excited about the unique partnership established with Napo, utilizing services within the Mission Family of Companies,” stated Terry Herring, President, Alamo Pharma Services.
“The establishment of an experienced pharmaceutical field sales team for Mytesi™, supported by a vibrant telesales team, will allow us to reach many high-potential prescribers,” commented Dr. Katie MacFarlane, Sr. VP of Commercial Operations for Napo. “We are also deploying a sampling program for Mytesi™ so patients can start therapy immediately. Based on our market research findings, we believe the key difference between current Mytesi™ prescribers and non-prescribers is awareness—most have simply never heard about the product. Patient and prescriber surveys show that 1 in 5 HIV+ patients suffer from diarrhea.”
The active pharmaceutical ingredient (API) in Mytesi™ is crofelemer, Napo’s proprietary, patented gastrointestinal anti-secretory agent sustainably harvested from the rainforest. Crofelemer is also the API in Canalevia™, the lead prescription drug product candidate for companion animals from Jaguar Animal Health, Inc. (NASDAQ:JAGX). As announced on February 8, 2017, Napo and Jaguar have entered into a binding agreement of terms to merge. Jaguar is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Jaguar and Napo expect to enter into a definitive merger agreement in March 2017. Jaguar expects to file a registration statement related to the merger with the SEC in the first quarter of 2017.
Napo and Jaguar estimate the potential U.S. market for Mytesi™ to be approximately $100 million in gross annual sales, and forecast that Mytesi™ will generate approximately $7.0 million in net sales in 2017, with the greatest impact on prescription growth coincident with the deployment of the sales force and sampling program.
“We’re very excited about the agreement with Alamo. The medical need for Mytesi™ is significant, compelling, and unmet. Patients are looking for something that works differently than the options currently available, and clinical trials demonstrated that nearly 80 percent of Mytesi™ users experienced an improvement in their diarrhea over a four-week period,” stated Lisa Conte, Napo’s interim CEO and Jaguar's president and CEO. “Upon effectiveness of the merger, Jaguar and Napo together are poised to realize a number of synergistic, value-adding benefits—and an expanded pipeline of important human and animal follow-on indications for Mytesi™ upon which to build global partnerships.”
Mytesi™ (crofelemer 125mg delayed-release tablets) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi™ is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi™. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). Please see complete Prescribing Information available at Mytesi.com
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners.
For more information, please visit www.napopharma.com.
About Jaguar Animal Health, Inc.
Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia™ is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. Equilevia™ (formerly referred to as SB-300) is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia™ and Equilevia™ contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are the Company’s lead non-prescription products. Neonorm™ is a standardized botanical extract derived from the Croton lechleri tree. Canalevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm™ in six additional target species, formulations of Equilevia™ in horses, and Canalevia™ for cats and dogs.
For more information, please visit www.jaguaranimalhealth.com.
About Alamo Pharma Services
Founded in 2011, Alamo Pharma Services offers pharmaceutical and biotech companies vital solutions to bring their products to market efficiently and successfully. Based out of its offices in Doylestown, Pa., Alamo offers companies vast commercialization experience, customized recruiting of sales teams, superior training, and committed support services. For more information regarding Alamo, visit AlamoPharmaServices.com, or email newbusiness@AlamoPharmaServices.com.
About BexR Logistix, LLC
BexR Logistix, LLC is a full-service, independent, U.S.-based third-party Logistics Provider (3PL) and telesales organization supplying a complete spectrum of premier, secure logistical support and management services to a broad range of industries from pharmaceuticals and biotech to foods and more. BexR has achieved a Verified-Accredited Wholesale Distributors (VAWD) accreditation, and has commercial offices in Doylestown, Pennsylvania, a distribution center in Boerne, Texas, and its telesales operation in Broomfield, Colorado. BexR subsidiary, EPIC Fulfillment, Inc., hosts its warehousing and distributions operation in Broomfield, Colorado as well. For more information regarding BexR, visit BexR.com.
Alamo and BexR are part of the Mission Family of Companies, a collection of wholly-owned subsidiaries created by Mission Pharmacal to diversify offerings and build forward-thinking partnerships with other pharmaceutical and biotech companies. Other Mission companies include BioComp Pharma, Inc., a generic drug marketer; ProSolus, Inc., a transdermal drug developer and manufacturer; and Espada Dermatology, Inc., a consumer dermatology division. To learn more, please visit missionpharmacal.com.
Important Additional Information will be filed with the SEC
This press release may be deemed solicitation material regarding the intended merger between Jaguar and Napo. Jaguar currently intends to file with the SEC a Registration Statement on Form S-4 that will include a proxy solicitation. Jaguar also plans to file other relevant materials with the SEC. Stockholders of Jaguar and Napo are urged to read the proxy solicitation/prospectus contained in the Registration Statement when it becomes available and any other relevant materials filed with the SEC because these materials will contain important information about the potential merger. Once available, these materials will be made available to the stockholders of Jaguar and Napo at no expense to them. The Registration Statement, proxy statement/prospectus and other relevant materials, including any documents incorporated by reference therein, once available, may be obtained free of charge at the SEC’s website at www.sec.gov or from Jaguar at www.jaguaranimalhealth.com or by emailing firstname.lastname@example.org.
Jaguar and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies in connection with the potential merger. Information about the executive officers and directors of Jaguar is set forth in Jaguar’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 as filed with the SEC on March 29, 2016 and Definitive Proxy Statement for the 2016 Annual Meeting of Stockholders of Jaguar filed with the SEC on April 29, 2016.
Notice as to Unregistered Securities
In connection with the intended merger, shares of common stock and other securities of Jaguar have been and will be offered to accredited institutional and individual investors pursuant to one or more exemptions from registration under the Securities Act of 1933, as amended (the “Securities Act”). These securities have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the U.S. absent registration or an applicable exemption from registration requirements.
Certain statements in this press release constitute “forward-looking statements” within the meaning of section 27A of the Securities Act and section 21E of the Securities Exchange Act of 1934, as amended. These include statements regarding Napo and Jaguar’s estimate that the potential U.S. market for Mytesi™ is approximately $100 million in gross annual sales, Napo and Jaguar’s forecast that Mytesi™ will generate approximately $7.0 million in net sales in 2017, Napo and Jaguar’s expectation to enter into a definitive merger agreement, Jaguar’s expectation to file a registration statement related to the merger with the SEC in the first quarter of 2017, the combined company’s ability to access a number of synergistic, value-adding benefits, including an expanded pipeline of important human and animal follow-on indications for Mytesi™ upon which to build global partnerships, Jaguar’s plan to develop formulations of Equilevia™ in horses and species-specific formulations of Neonorm™ in additional target species, and Jaguar’s plan to develop formulations of Canalevia™ for cats and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “forecast,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.