Press Releases

SUNNYVALE, Calif., June 19, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today announced that The New England Journal of Medicine (NEJM) published results online of a Phase 1b/2 study evaluating the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Ibrutinib was shown to be safe and effective in patients with relapsed/refractory CLL or SLL, even in patients who were at high-risk due to factors such as deletion of part of chromosome 17 (del 17p).

Results of a separate study examining the safety and efficacy of ibrutinib monotherapy for the treatment of relapsed/refractory mantle cell lymphoma (MCL) has also been published online in NEJM today. Pharmacyclics sponsored both studies and is jointly developing ibrutinib with Janssen Research & Development, LLC.

The open-label study reported on 85 patients with relapsed/refractory CLL or SLL. The majority of patients had advanced disease and had previously undergone treatment with several rounds of therapies before enrollment in the study. Approximately one-third of patients enrolled in the study presented with a malignancy carrying del 17p. Patients with del17p typically respond poorly to chemoimmunotherapy, which is the current standard treatment for CLL.

"Patients with CLL and SLL have a great need for new, well tolerated and effective therapies," said lead author John C. Byrd, M.D., Director, Division of Hematology, D Warren Brown Professor of Leukemia Research, The Ohio State University Comprehensive Cancer Center. "These data are particularly exciting, as they demonstrate benefit for high risk CLL and SLL patients, with efficacy consistent across doses and continuing durable remissions lasting in excess of two years in the great majority of patients treated."  

Study participants were enrolled selected to receive either ibrutinib 420 mg (n=51) or 840 mg (n=34) as a once-daily, oral monotherapy. Both doses were associated with overall response rates of 71 percent. Del17p patients had an overall response rate of 68 percent. Two patients in the 420 mg dose arm had complete responses and 34 patients had partial responses. Across all relapsed or refractory patients, including the high risk patients, the estimated progression-free survival at 26 months was 75 percent. An additional 20 percent of patients treated with the 420 mg dose and 15 percent of patients taking the 840 mg dose achieved a partial response accompanied by lymphocytosis, an elevated blood lymphocyte count.

The majority of adverse events (AEs) observed in the study were considered to be Grade 1 or 2 in severity, including diarrhea, infections and fatigue. A total of six patients taking ibrutinib experienced an AE leading them to discontinue treatment with the drug. Severe AEs observed during the treatment period include pneumonia and dehydration (12 percent and six percent, respectively), as well anemia, neutropenia and thrombocytopenia (six percent, 15 percent and six percent, respectively). Grade 3-4 hematological toxicities were not common.

Data from this study were presented at the annual meeting of the American Society of Hematology in December 2012.

Study DesignThe Phase 1b/2, open-label, multicenter study was designed to determine the safety, efficacy, pharmacokinetics and pharmacodynamics of ibrutinib in patients with relapsed or refractory CLL. The primary objective of the study was to determine the safety of the two fixed-dose regimens of ibrutinib, assessed by evaluating the frequency and severity of AEs. Secondary efficacy endpoints included: overall response rate, progression-free survival and an exploratory endpoint of overall survival.

The study enrolled patients with a confirmed diagnosis of relapsed or refractory CLL or small lymphocytic lymphoma (a disease that mirrors the symptoms and progression of CLL) at eight sites in the U.S. Patients who participated in the study had a median of four prior therapies and 65 percent of the patients had advanced disease. Twenty-eight CLL patients had del17p, a genetic mutation associated with a poor prognosis.

About CLL CLL is a slow-growing blood cancer that starts in the white blood cells (lymphocytes), specifically the B-cells. CLL is the most common adult leukemia. Approximately 16,000 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the US. It is a chronic disease of the elderly with an average survival of about five years after diagnosis. Patients commonly receive multiple lines of treatment over the course of their disease.

In CLL the genetic mutation del17p occurs when the short arm of chromosome 17 is missing. Del17p is associated with abnormalities of a key tumor suppressor gene, TP53, which results in poor response to chemoimmunotherapy and worse treatment outcomes. It occurs in about seven percent of treatment naïve CLL patients, with approximately 20-40 percent of relapsed/refractory patients harboring the mutation.  

About ibrutinibIbrutinib was designed to specifically target and selectively inhibit an enzyme called BTK. BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and homing. Through these multiple actions, BTK helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a microenvironment necessary for survival.The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. The clinical development program currently includes 30 clinical trials, including six Phase 3 trials. Details about the complete ibrutinib clinical program is posted on clinicaltrials.gov. Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib.

About PharmacyclicsPharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify promising product candidates based on scientific development expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Presently, Pharmacyclics has two product candidates in clinical development and several preclinical molecules in lead optimization. The Company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.

The Company is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at http://www.pharmacyclics.com.  

NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words "anticipate", "believe", "estimate", "expect", "expectation", "should", "would", "project", "plan", "predict", "intend" and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our annual report on Form 10-K and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management's expectations or otherwise, except as may be required by law.

Contact:Ramses ErdtmannVice President of Investor Relations and Corporate Communications Phone: 408-215-3325

U.S. Medical Information, Pharmacyclics: 855-Ibrutinib [(855) 427-8846]

SOURCE Pharmacyclics, Inc.

JACKSONVILLE, Fla., June 19, 2013 /PRNewswire/ -- Fidelity National Financial, Inc. (NYSE: FNF), a leading provider of title insurance, mortgage services and diversified services, today announced that it was exercising its option to adjust the consideration mix in the previously announced acquisition of Lender Processing Services, Inc. ("LPS") by increasing the cash component of the total consideration by approximately $500 million and correspondingly decreasing the stock component of the total consideration by an equal amount.

FNF will directly provide $300 million of the $500 million increase, with funds affiliated with Thomas H. Lee Partners, L.P. ("THL") providing the remaining $200 million. The total consideration will be unchanged and the additional $500 million cash component will be offset by an equal reduction in the stock component of the total consideration.

On May 28, 2013, FNF signed a definitive agreement under which FNF will acquire all of the outstanding stock of LPS for $33.25 per common share, for a total equity value of approximately $2.9 billion.

Based on today's announcement, FNF will now pay approximately 67% of the total consideration for the LPS shares of common stock in cash and 33% in shares of FNF common stock, subject to adjustment as described in the definitive agreement and below.

As previously announced, at the closing of the LPS acquisition, FNF will combine its ServiceLink business with LPS in a new consolidated holding company. FNF will now sell approximately a 29% minority equity interest in the new consolidated holding company to THL for a total investment of approximately $581 million in cash. FNF will retain approximately a 71% ownership interest in the new consolidated holding company.

Under the definitive agreement, FNF's shares of common stock have been valued at $25.489 per share (the "Reference Price"). Based on the increased cash component of the total consideration, that now represents a fixed exchange ratio of 0.42948 shares of FNF common stock for each share of LPS common stock. Based on the Reference Price, FNF currently expects to issue approximately 37.8 million shares of FNF common stock to LPS common stockholders, representing approximately 14.2% of FNF's pro-forma, fully diluted outstanding shares.

Based on today's announcement, if FNF's average common stock price at closing is greater than $26.763, the exchange ratio will be adjusted to reflect the increased value that would have been received at closing without today's increase in the cash consideration. If FNF's average common stock price at closing is greater than $24.215 but less than $26.763, the exchange ratio remains fixed at 0.42948 per share of FNF common stock. If FNF's average common stock price at closing is between $20.00 and $24.215 per share, FNF will increase the number of shares of FNF common stock to be received by LPS stockholders such that LPS stockholders receive a minimum of $10.40 per share in value on the stock portion of the consideration, or $32.703 per share in total. If FNF's average common stock price at closing is less than $20.00, the exchange ratio will be fixed at 0.5200 per share of FNF common stock, in which event LPS will have a right to terminate the transaction. Additionally, on or before three trading days prior to the anticipated date of effectiveness of FNF's registration statement on Form S-4, FNF has the option to further increase the cash portion of the consideration from $22.303 per share of LPS common stock up to $33.25 per share of LPS common stock with a corresponding decrease in the stock portion of the merger consideration as provided for under the terms of the merger agreement, in which case the exchange ratio will be adjusted to reflect the new consideration mix. However, if FNF elects to further increase the cash portion of the consideration and FNF's average common stock price at closing is greater than $26.763, then the exchange ratio will be further adjusted to continue to reflect the increased value that would have been received at closing without any change in consideration mix.

The acquisition agreement includes a "go-shop" period effective through July 7, 2013, during which LPS is permitted to actively solicit alternative acquisition proposals from third parties. The acquisition agreement contains a break-up fee equal to approximately 1.25% of the total equity value of $2.9 billion payable to FNF if LPS terminates the acquisition agreement based on receiving a superior proposal during the "go-shop" period. The acquisition agreement also contains a break-up fee equal to approximately 2.5% of the total equity value if LPS fails to hold a shareholders meeting or terminates the agreement after the expiration of the "go-shop" period because it received a superior proposal after the expiration of the "go-shop" period. In addition, the acquisition agreement includes a break-up fee equal to approximately 2.5% of the total equity value if (i) a competing offer for LPS is made public by a third party, (ii) the acquisition agreement is terminated either as a result of the LPS shareholders voting against the transaction or the date of March 31, 2014 being reached and the LPS shareholders meeting not having been held or if LPS breaches its obligations which results in the failure of a closing condition and (iii) within twelve months after termination, LPS enters into or consummates any alternative transaction.

"The increase in the cash component of the total consideration for LPS brings more stability and less potential volatility to the total consideration that LPS stockholders will receive," said FNF Chairman William P. Foley, II. "It reduces their exposure to movements in FNF's common stock price over the next several months until the closing of the acquisition, which is expected to occur in the fourth quarter of 2013. LPS stockholders also retain the ability to participate in the future performance of FNF's common stock and the anticipated benefits of the transaction in a gradually improving residential real estate market by receiving approximately 33% of the total consideration in shares of FNF common stock. We continue to believe that the acquisition of LPS will create significant value for all FNF stockholders."

The transaction is subject to approval by LPS and FNF stockholders, approvals from applicable federal and state regulators and satisfaction of other customary closing conditions. Closing of the transaction is currently expected to occur in the fourth quarter of 2013.

About FNF

Fidelity National Financial, Inc. (NYSE: FNF), is a leading provider of title insurance, mortgage services and diversified services. FNF is the nation's largest title insurance company through its title insurance underwriters - Fidelity National Title, Chicago Title, Commonwealth Land Title and Alamo Title - that collectively issue more title insurance policies than any other title company in the United States. FNF owns a 55% stake in American Blue Ribbon Holdings, LLC, a family and casual dining restaurant owner and operator of the O'Charley's, Ninety Nine Restaurant, Max & Erma's, Village Inn, and Bakers Square concepts. FNF also owns an 87% stake in J. Alexander's, LLC, an upscale dining restaurant owner and operator of the J. Alexander's and Stoney River Legendary Steaks concepts. In addition, FNF also owns a 51% stake in Remy International, Inc., a leading designer, manufacturer, remanufacturer, marketer and distributor of aftermarket and original equipment electrical components for automobiles, light trucks, heavy-duty trucks and other vehicles. FNF also owns a minority interest in Ceridian Corporation, a leading provider of global human capital management and payment solutions. More information about FNF can be found at www.fnf.com.

Important Information Will be Filed with the SEC

FNF plans to file with the SEC a Registration Statement on Form S‑4 in connection with the transaction. FNF and LPS plan to file with the SEC and mail to their respective stockholders a Joint Proxy Statement/Prospectus in connection with the transaction. The Registration Statement and the Joint Proxy Statement/Prospectus will contain important information about FNF, LPS, the transaction and related matters. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT AND THE JOINT PROXY STATEMENT/PROSPECTUS CAREFULLY WHEN THEY ARE AVAILABLE.

Investors and security holders will be able to obtain free copies of the Registration Statement and the Joint Proxy Statement/Prospectus and other documents filed with the SEC by FNF and LPS through the web site maintained by the SEC at www.sec.gov or by phone, email or written request by contacting the investor relations department of FNF or LPS at the following:

FNF and LPS, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the merger agreement. Information regarding the directors and executive officers of FNF is contained in FNF's Form 10-K for the year ended December 31, 2012 and its proxy statement filed on April 12, 2013, which are filed with the SEC. Information regarding LPS's directors and executive officers is contained in LPS's Form 10-K for the year ended December 31, 2012 and its proxy statement filed on April 9, 2013, which are filed with the SEC. A more complete description will be available in the Registration Statement and the Joint Proxy Statement/Prospectus.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Forward Looking Statements

This press release contains forward-looking statements that involve a number of risks and uncertainties. Statements that are not historical facts, including statements regarding expectations, hopes, intentions or strategies regarding the future are forward-looking statements. Forward-looking statements are based on FNF or LPS management's beliefs, as well as assumptions made by, and information currently available to, them. Because such statements are based on expectations as to future financial and operating results and are not statements of fact, actual results may differ materially from those projected. FNF and LPS undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The risks and uncertainties which forward-looking statements are subject to include, but are not limited to: the ability to consummate the proposed transaction; the ability to obtain requisite regulatory and stockholder approval and the satisfaction of other conditions to the consummation of the proposed transaction; the ability of FNF to successfully integrate LPS's operations and employees and realize anticipated synergies and cost savings; the potential impact of the announcement or consummation of the proposed transaction on relationships, including with employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; weakness or adverse changes in the level of real estate activity, which may be caused by, among other things, high or increasing interest rates, a limited supply of mortgage funding or a weak U.S. economy; FNF's dependence on distributions from its title insurance underwriters as a main source of cash flow; significant competition that FNF and LPS face; compliance with extensive government regulation; and other risks detailed in the "Statement Regarding Forward-Looking Information," "Risk Factors" and other sections of FNF's and LPS' Form 10-K and other filings with the Securities and Exchange Commission.

SOURCE Fidelity National Financial, Inc.