Healthcare Industry News: S.A.
News Release - February 23, 2012
Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. Enter a Collaboration Agreement for XIAFLEX(R) in Canada, Australia, Brazil and Mexico
Actelion Obtains Exclusive Rights for Two Potential IndicationsAuxilium to Receive up to $68.5 million in Aggregate Upfront, Regulatory, Pricing, Reimbursement and Sales Milestones
MALVERN, Pa., and ALLSCHWIL/BASEL, Switzerland, Feb. 23, 2012 -- (Healthcare Sales & Marketing Network) -- Auxilium Pharmaceuticals, Inc. (NAS.A.: AUXL ) and Actelion Pharmaceuticals Ltd. (SWX: ATLN.S) announced today that they have entered into a long-term partnership for the development, supply and commercialization of XIAFLEX® (collagenase clostridium histolyticum), a novel, first-in-class biologic for the potential treatment of Dupuytren's contracture and Peyronie's diS.A.e. Under the terms of the agreement, Actelion will receive exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's diS.A.e in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in these countries.
XIAFLEX has been approved by the U.S. Food and Drug Administration and the European MedicineS.A.ency aS.A.treatment for Dupuytren's contracture, and iS.A.so in development in Japan. In addition, XIAFLEX has been accepted for review by Health Canada for the treatment of Dupuytren's contracture in Canada and regulatory action is expected in the second half of 2012. Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico over the next 12 months. XIAFLEX iS.A.so being evaluated in a global phase III development program for Peyronie's diS.A.e with top-line data expected in late second quarter 2012.
"Today, Actelion and Auxilium have forged a partnership, which we believe has the opportunity to offer, subject to regulatory approval, the first, effective nonsurgical treatment for two diS.A.es in multiple new geographies," said Adrian Adams, Chief Executive Officer and President of Auxilium. "With the strength of Actelion's commercialization and development organization in these diverse and far-ranging markets, this relationship should further enhance our ability to bring this potentially groundbreaking product to a global audience."
Philippe de Lavenne, VP Actelion Pharmaceuticals, Head of Europe, Canada, Latin America, Middle East & Africa commented: "This tailored partnership has been designed to leverage Actelion's regulatory and marketing expertise, as well as our eS.A.lished local operating companies in these markets. Auxilium has done an outS.A.ding job in the development of this innovative product, and we look forward to contributing to making XIAFLEX a global success."
Under the terms of the agreement, Actelion will pay Auxilium $10 million upfront and will also make up to $16 million in potential regulatory, pricing, and reimbursement milestone paymentS.A.d $42.5 million in potential sales milestone payments. Auxilium will also receive increasing tiered double-digit royalties based on sales of XIAFLEX in Actelion's territorieS.A.d will supply product to Actelion at a predetermined cost.
Auxilium will remain primarily responsible for the global development of XIAFLEX in Peyronie's diS.A.e and will be responsible for all clinical and commercial drug manufacturing and supply. Actelion will be responsible for clinical development activitieS.A.d associated costs corresponding to any additional trials required for specific territories.
About Auxilium
Auxilium Pharmaceuticals, Inc. iS.A.specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in Europe; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's diS.A.e, in phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and is in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.
Auxilium SAFE HARBOR S.A.EMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This news release contains forward-looking S.A.ementS.A. defined by the Private Securities Litigation Reform Act of 1995, which discuss matters that are not facts, and may include words to indicate their uncertain nature such as "believe," "expect," anticipate," "intend," "plan," "should," "could," "estimate," "project," "will," and "target." Our forward-looking S.A.ements convey management's expectations, beliefs, planS.A.d objectives regarding future performance of the Company and are based upon preliminary information and management assumptions. No specific assurances can be given with respect to whether we will develop XIAFLEX for the treatment of multiple potential indications or achieve the results or indicated timing of clinical trials for XIAFLEX for the additional indications; regulatory approval will be obtained for XIAFLEX in any of Actelion's licensed territories within the anticipated timeframes, if at all; Actelion will be successful in developing and commercializing XIAFLEX in its licensed territories; or we will receive the indicated milestone or royalty payments from Actelion. While the Company may elect to update the forward-looking S.A.ements made in this news release in the future, the Company specifically disclaimS.A.y obligation to do so. Such forward-looking S.A.ementS.A.e subject to a wide range of riskS.A.d uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, resultS.A.d timing of clinical trials, success of marketing efforts, the need for additional reS.A.ch and testing, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration, and those risks discussed in our reports on file with the SecuritieS.A.d Exchange Commission (the "SEC"). Our SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "For Investors - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believeS.A.e immaterial which could also cause actual results to differ from those contained in the forward-looking S.A.ements.
About Actelion
Actelion Ltd iS.A.biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved aS.A.therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United S.A.es (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, iS.A.leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 2,500 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion S.A.eS.A.e traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).
Actelion SAFE HARBOR S.A.EMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
The above information contains certain "forward-looking S.A.ements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such S.A.ements include descriptions of the company's investment and reS.A.ch and development programS.A.d anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such productS.A.d products in the company's existing portfolio. Such S.A.ements reflect the current views of the company with respect to future eventS.A.d are subject to certain risks, uncertaintieS.A.d assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking S.A.ements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein aS.A.ticipated, believed, estimated or expected.
Source: Auxilium Pharmaceuticals
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
FindReps: Screen and connect with Medical Sales Rep candidates (Direct Reps and Independents) – anonymously, in real time.
RepJobs: Job Opportunities for Direct Sales Reps and New Product Lines for Independents!