Jaguar Animal Health and Napo Pharmaceuticals Announce Details for Proposed Merger
Merger Would Allow Jaguar to Recognize an Important Revenue Stream from First-in-Class, Novel Mechanism of Action of the Anti-diarrheal Mytesi
The LOI contemplates a 3-to-1 Napo-to-Jaguar value ratio (inclusive only
of in-the-money convertible securities of Jaguar at the time a
definitive agreement is entered into) to calculate the relative
ownership of the merged entity. As of
A merger of the two companies, should it occur, would allow Jaguar to
recognize revenue from sales of crofelemer, under the brand name Mytesi™
(formerly known as Fulyzaq®), an important Napo revenue
stream. Crofelemer was approved by the
Napo is continuing development of Mytesi™ for other antidiarrheal indications, with investigational studies completed in irritable bowel syndrome, cholera, traveler’s diarrhea, and in pediatric patients, and two planned investigator-initiated trials of the product in breast cancer patients suffering from chemotherapy-induced diarrhea. Diarrhea is a common adverse event seen with chemotherapy agents in the therapeutic classes of epidermal growth factor receptor (EGFR) monoclonal antibodies and tyrosine kinase inhibitors (TKI). The increased need for and use of these agents has made diarrhea one of the most disabling issues for cancer patients. Crofelemer offers the potential for an appropriate mechanism of action against this likely secretory diarrhea and has prompted interest among physicians concerned about this diarrheal symptom, stimulating the aforementioned investigator-initiated trials.
Crofelemer is also the active pharmaceutical ingredient (API) in
Canalevia™, Jaguar’s lead prescription drug product
candidate, intended for the treatment of various forms of diarrhea in
dogs. Jaguar is planning a multi-site pilot study of Canalevia™
in dogs with malignancies treated with toceranib phosphate, another TKI,
with diarrhea as a frequent adverse effect. Dr.
Canalevia™ is under license for exclusive global veterinary rights to Jaguar from Napo. Twelve members of Jaguar’s team contributed to the successful development of crofelemer for human indication while at Napo.
As previously announced, Napo and Jaguar have been engaged in
exploratory discussions since
“We are confident that a merger will enable both companies, through a
joint management team, to maximize the potential value creation for
The final pivotal field trial for Canalevia™ is ongoing for acute diarrhea in dogs, the first planned indication for this Jaguar drug product candidate. Jaguar expects to enroll approximately 200 dogs in the study. Jaguar has completed enrollment for the dose determination study for Equilevia™ and expects top line results to be available next month. More than 100 horses have been enrolled in the Equilevia™ study.
Jaguar is also announcing that
The LOI is non-binding and any agreement is subject to the negotiation
and execution of a definitive transaction agreement, which may vary from
the terms set forth in the LOI. A final transaction also is anticipated
to be subject to material conditions, including, but not limited to, the
approval of: (i) the respective boards of directors of Jaguar and Napo,
(ii) the shareholders of each company, (iii) the
Napo’s proprietary, patented gastrointestinal compound, crofelemer, is a first-in-class anti-secretory agent isolated and purified from Croton lechleri, a medicinal plant sustainably harvested under fair-trade working conditions in several South American countries. Crofelemer (trade name Mytesi™) was approved in 2012 and is indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer is in various stages of clinical development by Napo for the following indications:
- Crofelemer for diarrhea predominant irritable bowel syndrome (IBS-D), Phase 2,
- Crofelemer for acute infectious diarrhea, including cholera, Phase 2,
- Crofelemer for pediatric diarrhea, Phase 1, and
- Crofelemer for chemotherapy-induced diarrhea, Phase 2.
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
For more information, please visit www.napopharma.com.
For more information, please visit www.jaguaranimalhealth.com.
Important Additional Information will be Filed with the
This press release may be deemed solicitation material regarding the
potential merger contemplated by the LOI. In connection with a potential
merger with Napo, Jaguar currently intends to file with the
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
Certain statements in this press release constitute “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. These include statements regarding the proposed merger between Jaguar and Napo, that a merger would allow Jaguar to recognize an important Napo revenue stream, Napo’s ability to meet certain capitalization requirements that would be required for a merger to occur, the belief that a combination of the two companies would enable both companies to maximize the potential value creation for stockholders, the belief that both Jaguar and Napo would benefit from the synergies and economies of scale that a merger should allow related to the manufacture and ongoing commercialization of crofelemer for various human and animal indications, the belief that the merged entity would be well positioned to accelerate the development of crofelemer for both human and veterinary applications, the belief that the commercial readiness that Napo’s team would bring to a combined entity would prove beneficial for Jaguar as Jaguar prepares for the launch of its first prescription products, if approved, for canine diarrhea (Canalevia™) and equine gastric ulcers (Equilevia™), Jaguar’s expectation that top line results from its dose determination study for Equilevia™ will be available next month, the belief that a merger would align with Jaguar’s strategic plans, 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,” “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.
KCSA Strategic Communications
Garth Russell, 212-896-1250