Santarus, Inc, a specialty pharmaceutical company, said it has signed over exclusive rights related to its prescription and over-the-counter immediate-release omeprazole products including Zegerid to GlaxoSmithKline plc (GSK).
The $11.5 million transaction is to commercialise the drugs for a number of markets in GSK's International Region (including Africa, Asia, the Middle-East, and Central and South America), and to distribute and sell Zegerid brand prescription products in Puerto Rico and the US Virgin Islands (USVI).
Under the license agreement, GSK will be responsible for the development, manufacture and commercialisation of Licensed Products in up to 114 countries, excluding the US, Europe, Australia, Japan and Canada. In addition, under a separate distribution agreement, GSK will distribute, market and sell Zegerid brand prescription products in Puerto Rico and the USVI beginning in the first quarter of 2008. GSK will bear all costs for its activities under the license and distribution agreements.
GSK will pay Santarus an $11.5 million upfront fee and tiered double digit royalties, subject to reduction in certain circumstances, on net sales of any products sold under the license and distribution agreements. The term of the license agreement continues so long as GSK is obligated to pay royalties and the term of the distribution agreement continues as long as GSK sells the products, unless the agreements are terminated earlier by either GSK or Santarus under specified circumstances. GSK has an option to make a buy-out payment 20 years after the effective date of the agreements, after which time, GSK's royalty obligations generally would end. To support GSK's initial launch costs, Santarus will waive the first $2.5 million of aggregate royalties payable under the license and distribution agreements.
"As a leading global pharmaceutical company, GSK has well established international commercialisation capabilities. We believe its demonstrated success in the gastrointestinal therapeutic area make GSK an ideal partner for Santarus in the covered markets," said Gerald T. Proehl, president and chief executive officer, Santarus. "We also believe this relationship with GSK is a major advancement of our strategic objective to leverage our immediate-release proton pump inhibitor intellectual property in international markets and to further diversify our potential sources of future revenues."
"This agreement combines GSK's commercial strength in these countries with a great opportunity in the form of ZEGERID immediate-release omeprazole products," commented Dr. Russell Greig, president, GSK Pharmaceuticals International.
Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension contain a combination of omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation.
In the US, Zegerid capsules and Zegerid powder for oral suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, and gastric and duodenal ulcers. Zegerid powder for oral suspension is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients.
These Zegerid products offer a distinct pharmacological profile - rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control, with a median 24-hour gastric pH of greater than 4 ranging from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. Zegerid can be conveniently taken once-a-day on an empty stomach, at least one hour before a meal.
PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs in the US, other than Zegerid, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, Zegerid capsules and powder for oral suspension utilize an antacid in lieu of an enteric coating. The antacid neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption and suppression of gastric acid.
The most frequently reported adverse events with Zegerid are headache, diarrhoea, and abdominal pain. In critically ill patients treated with Zegerid, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with Zegerid and with the comparator (acid-controlling) drug. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercialising proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company's current marketing efforts are primarily focused on Zegerid capsules and powder for oral suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI.