Santarus Adds Two Novel Biologic Drug Candidates to Pipeline
Signs Agreements with Pharming for Exclusive North American Rights to Late-Stage Biologic Drug RHUCIN
Acquires Worldwide Rights for Anti-VLA-1 Antibody Through Acquisition of Covella Pharmaceuticals
Conference Call with Accompanying Slide Presentation to Begin at 9:00 a.m. Eastern Time Today
SAN DIEGO, Sep 13, 2010 (BUSINESS WIRE) -- Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets. Santarus has signed exclusive license and supply agreements with Pharming Group NV (NYSE Euronext: PHARM) granting Santarus the right to commercialize RHUCIN(R) (recombinant human C1 inhibitor) in North America for the treatment of acute attacks of hereditary angioedema (HAE) and other future indications. Santarus also has acquired the worldwide rights to a novel biologic drug candidate, an anti-VLA-1 antibody that has shown activity in multiple preclinical models of inflammatory and autoimmune diseases, through the acquisition of Covella Pharmaceuticals, Inc., and by amending a related license agreement with Biogen Idec MA Inc.
"The addition of these two promising product candidates to our development pipeline reflects an important step toward transforming Santarus into a premier biopharmaceutical company focused on specialty markets," said Gerald T. Proehl, president and chief executive officer of Santarus. "We believe that these biologic products offer significant future revenue potential with attractive proprietary positions, including 12 years of data exclusivity if approved by the FDA, strong intellectual property and significant manufacturing barriers to competition. With successful clinical development and commercialization, these product candidates have the potential to address substantial unmet medical needs and dramatically enhance shareholder value."
He added, "In the past week we have completed three business development transactions under financial terms that are primarily success-based that add an attractive commercial product and two development products to our portfolio. We now have a diverse development pipeline with three late-stage product candidates - RHUCIN, budesonide MMX(R) and rifamycin SV MMX(R) - in Phase III clinical programs and a promising earlier stage anti-VLA-1 antibody, all of which offer significant commercial potential. Last week we announced the expansion of our commercial portfolio with the addition of CYCLOSET(R), an FDA-approved, novel product to treat type 2 diabetes. CYCLOSET is an excellent strategic fit with GLUMETZA(R) that allows us to leverage our sales organization. We believe that our cash, cash equivalents and short-term investments and borrowings available under our line of credit with Comerica Bank will be sufficient to fund our operations at least through the end of 2011."
RHUCIN Agreements and Background
Santarus has entered into exclusive license and supply agreements with Pharming granting Santarus the right to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Under terms of the license agreement, Santarus will pay Pharming a $15 million upfront fee and an additional $5 million milestone upon U.S. Food and Drug Administration (FDA) acceptance of Pharming's Biologic License Application (BLA) for RHUCIN. Santarus may also pay Pharming additional success-based clinical and commercial milestones, including upon achievement of certain aggregate net sales levels of RHUCIN. Santarus will purchase its commercial supply of RHUCIN from Pharming at a tiered supply price, based on a percentage of net sales of RHUCIN. For additional terms of the license and supply agreements with Pharming, please refer to Santarus' Form 8-K to be filed today summarizing certain provisions of the agreements.
The FDA has granted Orphan Drug and Fast Track Status to RHUCIN for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
Pharming has conducted two randomized, placebo-controlled, double-blind studies and four open-label studies with RHUCIN for the treatment of acute HAE attacks. Both placebo-controlled clinical studies showed highly statistically significant and clinically relevant improvement in time to beginning of relief of symptoms and time to minimal symptoms at RHUCIN dosage strengths of 50 U/kg and 100 U/kg compared to placebo.
Pharming plans to submit the BLA for RHUCIN to the FDA in late 2010 or in January 2011 and believes that it has sufficient data to commence the FDA review process. At the same time, based on prior discussions with the FDA, Pharming is planning to initiate an additional placebo-controlled, double-blind clinical study with approximately 50 patients to provide additional data in support of the 50 U/kg dose. Data from the placebo-controlled study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of RHUCIN. An open-label extension of the clinical study will be conducted to confirm the efficacy, safety and lack of immunogenicity of RHUCIN at 50 U/kg for the repeated treatment of acute HAE attacks.
Regarding this transaction, Mr. Proehl said, "RHUCIN is designed to provide an attractive alternative to currently marketed plasma-derived C1 inhibitors, bypassing potential constraints of human blood supply limitations such as plasma donor restrictions and possible viral and other disease transmission risks. Assuming successful clinical development and regulatory approval, we expect to promote RHUCIN through a small specialty sales force to the approximately 1,000 immunologists and allergy specialists in the U.S. who treat HAE."
Anti-VLA-1 Antibody Agreement and Background
Santarus has acquired the exclusive worldwide rights to a humanized anti-VLA-1 antibody, through the acquisition of closely held Covella Pharmaceuticals, Inc., and a related amended license agreement with Biogen Idec. The anti-VLA-1 antibody was initially developed by Biogen Idec and licensed to Covella in January 2009.
Under the terms of the acquisition, Santarus is paying a total in cash and stock of approximately $1.8 million in a combination of upfront consideration, assumption of Covella liabilities, and transaction expenses. Santarus will also make clinical and regulatory milestone payments based on success in developing product candidates, and will pay a royalty on net sales of any commercial products resulting from the anti-VLA antibody technology.
Under the amended license agreement, Santarus will make additional clinical, regulatory and sales milestone payments to Biogen Idec based on success in developing and commercializing product candidates and will pay a royalty on net sales of products developed under the license agreement. For additional terms of the agreements, please refer to Santarus' Form 8-K to be filed today summarizing certain provisions of the Covella and Biogen Idec agreements.
The anti-VLA-1 antibody is an inhibitor of the integrin VLA-1 (a1B1) and has shown activity in multiple preclinical models of inflammatory and autoimmune diseases. This integrin, a cell adhesion molecule, plays a key role in the migration, retention and proliferation of activated T cells and monocytes at sites of chronic inflammation. Santarus believes that the anti-VLA-1 antibody has potential application as a drug candidate in multiple inflammatory and autoimmune diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation.
Covella, which was co-founded by Lawrence C. Fritz, Ph.D., Mark C. Totoritis, M.D., and Matthew W. Strobeck, Ph.D., has become a wholly owned subsidiary of Santarus. Dr. Fritz will consult with Santarus on the development of the anti-VLA-1 antibody product candidate and Dr. Totoritis has joined Santarus as senior vice president, biologics with responsibility for the anti-VLA-1 antibody program and the clinical development of other biologic products. Dr. Totoritis, who is board certified in internal medicine and rheumatology, was vice president of medical research and head of the immunology/rheumatology therapeutics group at Biogen Idec from 2003 to 2006 and worked as head of the autoimmune and inflammatory diseases group at IDEC Pharmaceuticals from 1997 through its merger with Biogen in 2003, rising to the position of vice president. He played a key role in the development and approval for rheumatoid arthritis of Rituxan(R), a biologic drug sold by Genentech and Biogen Idec and also approved for non-Hodgkin's lymphoma. While at Syntex Research/Roche Bioscience earlier in his career, Dr. Totoritis was a major contributor to the development of CellCept(R) for use in patients undergoing solid organ transplantation.
Commenting on this transaction, Mr. Proehl stated, "We believe that this novel anti-VLA-1 antibody has potential broad clinical application in inflammatory diseases and other medical conditions characterized by inflammatory cell infiltration. Our clinical and regulatory staff looks forward to working with Dr. Totoritis and consulting with Dr. Fritz, both of whom are leading experts in the development of biologics for inflammatory and autoimmune diseases. We expect to begin a dose-escalation Phase I clinical study in the first half of 2011."
Santarus Conference Call
Santarus has scheduled an investor conference call with accompanying slide presentation regarding this news release at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) today, September 13, 2010. Individuals interested in participating in the call may do so by dialing 888-803-8275 begin_of_the_skype_highlighting 888-803-8275 end_of_the_skype_highlighting for domestic callers, or 706-643-7736 begin_of_the_skype_highlighting 706-643-7736 end_of_the_skype_highlighting for international callers. The accompanying slide presentation is available on the Investor Relations section of the company's website under Events and Presentations at www.santarus.com. A telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 begin_of_the_skype_highlighting 800-642-1687 end_of_the_skype_highlighting for domestic callers, or 706-645-9291 begin_of_the_skype_highlighting 706-645-9291 end_of_the_skype_highlighting for international callers, and entering reservation code 99127804. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company's website at www.santarus.com and a recording of the call will be available on the company's website for 14 days following the completion of the call.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists, endocrinologists and other physicians. The company's current commercial efforts are focused on GLUMETZA(R) (metformin hydrochloride extended release tablets) and CYCLOSET(R) (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage GI product candidates, budesonide MMX(R) and rifamycin SV MMX(R), for the U.S. market. Budesonide MMX is being investigated in a Phase III clinical program for the induction of remission of mild or moderate active ulcerative colitis. Santarus began Phase III clinical testing of rifamycin SV MMX in patients with travelers' diarrhea in the second quarter of 2010. More information about Santarus is available on the company's website at www.santarus.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus' business, including, without limitation: risks related to the license and supply agreements between Santarus and Pharming (including the timing and success of planned development programs for RHUCIN, including the proposed additional clinical study; the timing for the submission of a BLA to the FDA for RHUCIN and whether the FDA accepts the BLA submission and approves RHUCIN in a timely manner or at all; Santarus' ability to generate market demand and sales of RHUCIN, if approved; competition from other products, unexpected adverse side effects or inadequate therapeutic efficacy of RHUCIN; the ability to ensure continued supply of RHUCIN; the scope and validity of patent protection or other regulatory exclusivity for RHUCIN; and the potential for termination of the license and supply agreements with Pharming); risks related to the acquisition of Covella Pharmaceuticals (including the timing and success of planned development programs for the anti-VLA-1 antibody, including the proposed Phase I clinical study; whether the FDA will ultimately approve the anti-VLA-1 antibody in a timely manner or at all; Santarus' ability to generate market demand and sales of the anti-VLA-1 antibody, if approved; competition from other products, unexpected adverse side effects or inadequate therapeutic efficacy of the anti-VLA-1 antibody; the ability to ensure continued supply of the anti-VLA-1 antibody; the scope and validity of patent protection or other regulatory exclusivity for the anti-VLA-1 antibody; and the potential for termination of the Biogen Idec license); whether Santarus will have adequate cash, cash equivalents and short-term investments and borrowings available under its line of credit to fund its operations through the end of 2011; whether Santarus will be able to successfully integrate the RHUCIN, anti-VLA-1 antibody and CYCLOSET programs and products into its existing business and whether the transactions will have a positive impact on Santarus' business and shareholder value; other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus' products; and other risks detailed in Santarus' prior press releases and public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus(R) is a registered trademark of Santarus, Inc. RHUCIN(R) is a registered trademark of Pharming Group NV. CYCLOSET(R) is a registered trademark of VeroScience LLC. GLUMETZA(R) is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX(R) is a registered trademark of Cosmo Technologies Limited. Any other trademarks in this press release are the property of their respective owners.