Vernalis Acquires U.S. Rights To MOXATAG® (Amoxicillin Extended-Release Tablets) From Pragma Pharmaceuticals

First and Only Approved Once-a-Day Formulation of the Antibiotic, Amoxicillin

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Oct 02, 2015, 07:00 ET

BERWYN, Pa., Oct. 2, 2015 /PRNewswire/ -- Vernalis Therapeutics Inc. today announced that its parent company, Vernalis plc (LSE:VER) has acquired U.S. rights to MOXATAG^® (amoxicillin extended-release tablets) from Pragma Pharmaceuticals, LLC (Pragma). MOXATAG^® is the first and only approved once-daily formulation of the widely-used antibiotic amoxicillin.

Approved by the FDA in 2008, MOXATAG^® is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years of age or older. It was approved based on a Phase III efficacy study and is protected by six Orange Book listed patents, the last of which expires in 2027. It has not been actively promoted since 2010.

Vernalis Therapeutics will be responsible for the sales, marketing, and distribution of MOXATAG^® in the United States.

In consideration for the acquisition, Vernalis has paid to Pragma an undisclosed up-front cash payment and will make a further payment upon successful manufacture of re-launch finished dose product, expected to be by the end of 2015. Vernalis will take over supply chain responsibility for MOXATAG^® in the United States and will pay Pragma royalties on net sales and further potential sales-related milestones.

"The addition of MOXATAG^®, a once-daily formulation of the widely-used antibiotic amoxicillin, further underscores Vernalis Therapeutics' commitment to building a commercial presence in the U.S. market," said Tom Parker, Senior Vice President of Commercial Operations, Vernalis Therapeutics, Inc. "We look forward to re-launching the product in early 2016, and believe it will be a natural complement to our recently launched 12-hour codeine-based prescription medication, Tuzistra™ XR, as both products offer patients and physicians an extended-release alternative to existing treatments."

The U.S. Antibiotic Market

According to IMS Health, (MAT February 2015 data) 14 million patients diagnosed with tonsillitis and/or pharyngitis secondary to S. pyrogenes were treated with antibiotics, and of these patients, three million people 12 years of age and older were treated with amoxicillin. The target market is estimated to be between two and three million prescriptions annually for patients 12 years of age or older that are treated by primary care physicians.

Indication

MOXATAG^® is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adult and pediatric patients 12 years of age or older.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MOXATAG^® and other antibacterial drugs, MOXATAG^® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

How to take MOXATAG^®

Other amoxicillin tablets must be taken 2 or 3 times a day (depending on how serious the infection is) for 10 days¹. MOXATAG^® requires only one dose a day for 10 days. That means fewer tablets for the patient to swallow.

Tonsillitis and/or Pharyngitis

The recommended dose of MOXATAG^® is 775 mg once daily taken within 1 hour of finishing a meal for 10 days. The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes.

Do not chew or crush tablet.

The technology behind once-daily dosing

Through its delivery system, MOXATAG^® releases medicine in 3 separate pulses over time in different parts of the intestinal tract. This timed release of medicine throughout the day ensures that there is enough amoxicillin in your system to treat your infection with 1 dose each day for 10 days.

Important Safety Information

Severe life-threatening reactions can occur with MOXATAG^®. Do not take MOXATAG^® if you have had a previous reaction to amoxicillin or penicillin.

If you develop diarrhea that becomes severe and watery or does not go away, stop taking MOXATAG^® and call your health care professional. This could be a sign of a serious medical problem.

Tell your health care professional right away if you develop other infections.

Do not take MOXATAG^® if you have mononucleosis (mono).

Oral contraceptives may be less effective if you are taking MOXATAG^®.

Before taking MOXATAG^®, tell your health care professional if you are pregnant, plan to become pregnant or are breast-feeding. If you become pregnant while taking MOXATAG^®, call your health care professional.

The most common side effects of MOXATAG^® are yeast infection, diarrhea, nausea, vomiting, abdominal pain, and headache.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Click here for full Prescribing Information

About Vernalis Therapeutics, Inc.
Vernalis Therapeutics, Inc., commercializes prescription pharmaceutical products in the U.S. on behalf of its parent organization, Vernalis plc (LSE: VER). The Company is currently focused on marketing and distributing prescription products that are uniquely engineered to relieve cough, cold and allergy symptoms for extended periods of time. In addition to Tuzistra™ XR, there are four additional extended-release cough cold products in active development. For more information, visit www.vernalistherapeutics.com.

Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialization of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialization and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of Tuzistra™ XR, MOXATAG^®, frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.

Reference:
1. Amoxicillin package insert. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=13bd4214-9b7f-425b-af5f-fc1ddc678230

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SOURCE Vernalis Therapeutics, Inc.