UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): December 1, 2009
ALEXION PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-27756 | 13-3648318 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
352 Knotter Drive, Cheshire, Connecticut 06410
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (203) 272-2596
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers |
(d) Election of Directors
On December 1, 2009, the Board of Directors of Alexion Pharmaceuticals, Inc. appointed William R. Keller as a director of Alexion, effective immediately. Mr. Keller is the founder and General Manager of Keller Pharma Consultancy, a pharmaceutical consulting firm in China. He is also a senior consultant to the Shanghai Foreign Investment Development Board and the Deputy General Manager of Zhangjiang Biotech & Pharmaceutical Base Development Co., Ltd. Mr. Keller will serve as a member of the Compensation Committee and the Nominating and Governance Committee.
There are no transactions and no proposed transactions between Mr. Keller (or any member of his immediate family) and Alexion (or any of its subsidiaries), and there is no arrangement or understanding between Mr. Keller and any other person or entity pursuant to which Mr. Keller was appointed as a director of Alexion.
As an Alexion director, Mr. Keller is entitled to receive an annual cash retainer of $57,000, which will be prorated for fiscal year 2009. Upon his election, Mr. Keller received a grant of stock options to purchase 5,620 shares of Alexion’s common stock, having an exercise price of $46.10, the closing price of Alexion’s common stock on the grant date of December 1, 2009. The inaugural options vest in three equal annual installments over three years. Further, in accordance with Alexion’s director compensation policy, Mr. Keller is entitled to receive a restricted stock award having a value of $183,000 based on the sixty day trailing average market price of Alexion’s common stock, awarded in January of each year and vesting on the first anniversary of the grant date; and a grant of stock options to purchase shares of common stock having a value equivalent to $122,000 calculated using the Black-Scholes model, typically granted upon re-election to the Board in May. Each such stock option has an exercise price equal to the closing price of the stock on the grant date and vests in four equal quarterly installments over one year.
A copy of the press release announcing Mr. Keller’s appointment is filed as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 8.01. | Other Items |
On December 2, 2009, Alexion announced the status of the regulatory review and approval of its Rhode Island manufacturing facility as a second source of supply for Soliris® (eculizumab). A copy of the press release announcing the update is filed as Exhibit 99.2 to this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits
| 99.1 | Press Release issued by Alexion Pharmaceuticals, Inc. on December 1, 2009 announcing the appointment of Mr. William R. Keller to the Board of Directors. |
| 99.2 | Press Release issued by Alexion Pharmaceuticals, Inc. on December 2, 2009 announcing the status of the review and approval of the Rhode Island manufacturing facility as a second source of supply. |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ALEXION PHARMACEUTICALS, INC. | ||||
| By: | /S/ THOMAS I.H. DUBIN | |||
| Date: December 2, 2009 | Name: | Thomas I. H. Dubin | ||
| Title: | Senior Vice President and General Counsel | |||
Exhibit 99.1
| Contact: | Alexion Pharmaceuticals, Inc. Irving Adler Sr. Director, Corporate Communications 203-271-8210 |
Makovsky & Company Kristie Kuhl (Media) 212-508-9642 |
Rx Communications Rhonda Chiger (Investors) 917-322-2569 |
Alexion Appoints
William R. Keller to its Board of Directors
Cheshire, CT, December 1, 2009 – Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Mr. William R. Keller has been appointed a Director of Alexion, effective immediately. With Mr. Keller’s appointment, there are now eight members of Alexion’s Board of Directors.
About William Keller
Mr. Keller brings more than 30 years of international business and management experience in the pharmaceutical industry to his position on Alexion’s Board of Directors. Currently, Mr. Keller is the General Manager of Keller Pharma Consultancy, a pharmaceutical consulting firm he founded in China. He is also a senior consultant to the Shanghai Foreign Investment Development Board, and serves as the Deputy General Manager of Zhangjiang Biotech & Pharmaceutical Base Development Co., Ltd.
From 1976 to 2003, Mr. Keller held various positions with Roche Group in Asia and South America. For the last ten of these years, he was the General Manager of Roche China Ltd. and Shanghai Roche Pharmaceutical Ltd., where he played a key role in the development of the overall Roche strategy and in the leadership of its business operations in China.
Mr. Keller is the Honorary President of the R&D-based Pharmaceutical Association, and the Vice Chairman of the Shanghai Association of Foreign Investment Enterprises. He is an Honorary Citizen of Shanghai.
Mr. Keller graduated from the School of Economics and Business Administration (Zurich). He will serve as a member of the Compensation Committee and the Nominating and Governance Committee of Alexion’s Board of Directors.
“William’s depth and breadth of experience in the pharmaceutical industry, particularly in Asia and the rapidly growing market of China, bring significant value to Alexion,” said Max Link, Ph.D., Chairman of the Board of Directors of Alexion. “His entrepreneurial and leadership experience will continue to strengthen our international presence and corporate governance.”
“The Board has made an excellent choice in selecting William to augment Alexion’s commercial expertise as the worldwide introduction of Soliris accelerates,” said Leonard Bell, M.D., Chief Executive Officer of Alexion. “The benefit of his guidance in new markets, especially in the developing world, will be greatly appreciated by our executive team.”
“With the global launch of Soliris, Alexion is in a unique position to serve patients with unmet medical needs in a growing number of countries,” said Mr. Keller. “I look forward to employing my experience in Asia and other very promising regions where Alexion is in the early stages of commercialization.”
About Alexion
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris® (eculizumab), Alexion’s first marketed product, is approved in the U.S., European Union, Australia and Canada as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
[ALXN-G]
This news release contains forward-looking statements, including statements related to the commercial prospects for Soliris in Asia and other regions. Forward-looking statements are subject to factors that may cause Alexion’s results and plans to differ from those expected, including, for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Soliris, delays in establishing commercial infrastructure, delays in developing or adverse changes in commercial relationships, the possibility that results of clinical trials are not predictive of safety and efficacy results of Soliris in broader patient populations, the possibility that initial results of commercialization are not predictive of future rates of adoption of Soliris, the risk that third party payors (including governmental agencies) will not reimburse for the use of Soliris at acceptable rates or at all, the possibility that Alexion will not be able to expand the use of Soliris into new markets, and a variety of other risks set forth from time to time in Alexion’s filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion’s Quarterly Report on Form 10-Q for the period ended September 30, 2009 and in our other filings with the Securities and Exchange Commission. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.
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Exhibit 99.2
| Contact: | Alexion Pharmaceuticals, Inc. Irving Adler, Sr. Director Corporate Communications 203-271-8210 |
Makovsky & Company Kristie Kuhl (Media) 212-508-9642 |
Rx Communications Rhonda Chiger (Investors) 917-322-2569 |
ALEXION REPORTS PROGRESS ON COMMISSIONING OF RHODE ISLAND
MANUFACTURING FACILITY AS SECOND SOURCE OF SUPPLY
CHMP Issues Positive Opinion for European Union; FDA Review Ongoing
CHESHIRE, Conn., December 2, 2009 – Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today provided updates on the regulatory review and approval, or commissioning, of Alexion’s Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of supply for Soliris® (eculizumab). The Company reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a “positive opinion” recommending final approval of the facility by the European Commission, which is expected in early 2010. Separately, the Company expects to meet with the U.S. Food and Drug Administration (FDA) to provide additional available information, and to discuss their request for a limited number of production runs in connection with their pre-approval inspection process.
Second Source of Supply
Since 2006, Alexion has been developing ARIMF to become a second source of supply of Soliris and to manufacture other antibody products. The facility does not yet provide Soliris for commercial use in any market. As a result of the Company’s previously described multi-source strategy, Alexion has existing supplies of Soliris sufficient to serve all anticipated clinical and commercial needs, while continuing to source product from its primary provider.
“We are pleased to receive the positive opinion from the CHMP, which would give us the option to use ARIMF as a second source to supply Soliris to European countries following final EU approval,” said Stephen P. Squinto, Executive Vice President and Head of Research and Development at Alexion. “We now look forward to progressing our discussions and satisfying the requirements of the FDA, which would give us the additional option of using our Rhode Island facility as a second source to serve the U.S. market as well.”
Separately, the Company provided an update on a previously described regulatory review of an external vialer previously used by Alexion. Alexion reported today that regulatory authorities have now permitted release to the marketplace of all batches of Soliris that were filled by this external vialer. The previously described contingent liability associated with these batches has now been completely resolved at no loss to the Company.
About Alexion
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions.
Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris® (eculizumab), Alexion’s first marketed product, is approved in the U.S., European Union, Australia and Canada as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
[ALXN-G]
Safe Harbor Statement
This news release contains forward-looking statements, including statements related to the commissioning of Alexion’s Rhode Island Manufacturing Facility and supplies of Soliris. Forward-looking statements are subject to factors that may cause Alexion’s results and plans to differ from those expected, including, for example, decisions of U.S. and European regulatory authorities regarding final approval for ARIMF as an alternate source of Soliris and other antibodies, regulatory compliance and production capabilities of third party suppliers, the accuracy of inventory forecasts, market conditions or clinical studies that could accelerate the use of Soliris, and a variety of other risks set forth from time to time in Alexion’s filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion’s Quarterly Report on Form 10-Q for the period ended September 30, 2009 and in our other filings with the Securities and Exchange Commission. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.
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