This excerpt taken from the SVNT 8-K filed Apr 3, 2009.
EAST BRUNSWICK, N.J., April 3, 2009 Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that it has entered into definitive agreements with select existing and new institutional investors to sell 5.93 million units consisting of (i) one share of its common stock, $0.01 par value per share, and (ii) one warrant to purchase 0.85 shares of its common stock in a registered direct offering for gross proceeds of approximately $31.0 million, before deducting placement agents fees and estimated offering expenses. The investors have agreed to purchase the units for a negotiated price of $5.23 per unit.
The initial per share exercise price of the warrants is $10.46. In the event that the company publicly announces that the U.S. Food and Drug Administration has issued a complete response letter with respect to the companys Biologics License Application for its KRYSTEXXA (pegloticase) product candidate (the BLA), then the exercise price shall, from and after the eleventh trading day following the first such public announcement by the company, be changed to be the weighted average price for the common stock for the five trading days immediately preceding the tenth trading day following the date that the company publicly announced that the FDA issued its complete response letter. In no event may the exercise price exceed $10.46 or be less than $1.57.
The warrants are exercisable at any time on or after the date of issuance and expire on a date that varies based on the FDAs response to the BLA. If the FDA responds to the BLA with a complete response letter constituting approval or rejection of the BLA, then the warrants expire nine months after the date the company publicly announces that the FDA issued its complete response letter. If the FDA responds to the BLA with a complete response letter that does not constitute an approval or rejection, then the warrants expire on the earlier of the date that is 15 months after the date that the company publicly announces that the FDA issued its complete response letter and the date that is nine months after the date on which the company publicly announces that it has addressed all items required by the FDA before the BLA can be approved.
The closing of the offering is expected to take place on or about April 8, 2009, subject to customary closing conditions. Lazard Capital Markets LLC served as the sole placement agent in connection with the offering. Copies of the final prospectus relating to this offering may be obtained at the Securities and Exchange Commission web site at http://www.sec.gov, or from Savient Pharmaceuticals, Inc. at One Tower Center, 14th Floor, East Brunswick, NJ 08816 Attention: Investor Relations.
The common stock and warrants described above are being offered by Savient pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the company, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
This excerpt taken from the SVNT 8-K filed Feb 19, 2009.
EAST BRUNSWICK, N.J. (February 12, 2009) Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that the Company filed amendments to strengthen and clarify the data included in the previously submitted pegloticase Biologics License Application (BLA), which was granted priority review. The amendments focus on topics identified by the BLA Oversight Committee (the Committee) of the Board of Directors as a result of its review of the BLA filing and also address review-related questions from the Food and Drug Administration (FDA).
Since its formation on November 19, 2008, the Committee, Chaired by Board Member Dr. Lee S. Simon, M.D., a former Director of the Analgesic, Anti-Inflammatory, Ophthalmologic Drug Products Division of the FDA and a Board Certified Rheumatologist with 25 years of clinical practice experience, has assumed oversight of all Company activities related to the FDAs BLA review process. The Committee has conducted a comprehensive review of the BLA filing with the assistance of external experts. In late January 2009, the Board of Directors also formally retained Dr. Simon as a consultant to assume day-to-day supervision of the BLA and Advisory Panel preparation.
We believe the steps we have taken further clarify the favorable risk to benefit profile of pegloticase. Securing FDA approval remains our number one priority and we believe making these amendments is an important step toward achieving that goal. We look forward to continuing to work with the FDA as we move through the regulatory process. The Committee, our retained external experts, along with the management team, continue to believe in the relative benefit to risk profile of the safety and efficacy of this exciting product candidate when used in treating patients who suffer from treatment failure gout, said Paul Hamelin, President.
Key Amendments to the BLA
I believe the recent amendments significantly enhance the overall application and better position the BLA to undergo a satisfactory FDA review. This is an exciting new therapy that, if approved, has the potential to have a meaningful impact on the patients who need it, said Dr. Simon. Through our multi-faceted review, which included new analyses and further interpretation of data from a number of external experts, we have gained a greater understanding of the relative safety and efficacy of pegloticase and further clarification on the most appropriate uses for this product. Significantly, the data also confirms that a death imbalance of pegloticase does not exist.
Improved Understanding of Cardiovascular Risk
In late November 2008, the Company engaged an experienced independent panel of clinical experts, headed by Dr. William B. White, Professor of Medicine, Calhoun Cardiology Center, University of Connecticut School of Medicine, to perform a formal blinded and unblinded post-hoc adjudication of all cardiovascular events included in reports of Serious Adverse Events, Infusion Reactions and Severe Infusion Reactions from the Phase 3 pegloticase trials. The primary event evaluation was predicated on the Anti-Platelet Trialist Collaborative (APTC) assessment criteria. This is a standardized approach that the FDA has widely accepted as a method of evaluating cardiovascular risk. APTC cardiovascular events include deaths, nonfatal myocardial infarction or nonfatal stroke. Dr. White and his panel concluded that:
In addition to the work of Dr. White and his team, a
This excerpt taken from the SVNT 8-K filed Feb 19, 2009.
EAST BRUNSWICK, N.J. (February 12, 2009) Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced the appointment of David G. Gionco to the position of Vice President, Chief Financial Officer & Treasurer. Mr. Gionco replaces Brian Hayden, who has been terminated as Savients Chief Financial Officer, effective immediately.
We are pleased to announce Davids appointment. As our current Vice President of Corporate Finance and Controller, David will be able to seamlessly step in as Chief Financial Officer. Since joining Savient in 2006, David has distinguished himself as a true leader in the financial and operational areas. Davids experience and dedication makes him well-suited to lead our finance and accounting departments. I look forward to working with David in the months ahead as we continue to move through the FDA regulatory process and towards what we hope will be a successful approval of KRYSTEXXA (pegloticase), said Paul Hamelin, President, Savient Pharmaceuticals.
Mr. Gionco has spent more than 18 years in the pharmaceutical industry, including the past three years with Savient where he most recently served as Vice President of Corporate Finance and Controller. Through his career, Mr. Gionco has held various audit, corporate accounting, financial planning, finance and controller roles of increasing responsibility at companies including Medco, Merck & Co., Progenics Pharmaceuticals and Odyssey Pharmaceuticals, where he served as Acting Chief Financial Officer/Director of Finance and Controller before joining Savient. In addition, Mr. Gionco has 7 years of financial auditing experience with a major public accounting firm. Mr. Gionco holds a B.S in Accounting from Fairleigh Dickinson University and an MBA from Rutgers University.