Ligand Licensee Onyx Pharmaceuticals Receives FDA Accelerated Approval of Kyprolis (carfilzomib) for Injection

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its licensee, Onyx Pharmaceuticals (Nasdaq: ONXX), received accelerated approval from the U.S. Food and Drug Administration (FDA) for Kyprolis™ (carfilzomib) for Injection, a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. The indication for Kyprolis is based on response rate. Currently, no data are available for Kyprolis that demonstrate an improvement in progression-free survival or overall survival. 

Kyprolis is formulated with Ligand’s Captisol®, which improves drug solubility and enables a reduced drug load. Ligand is entitled to receive a $600,000 milestone payment from Onyx Pharmaceuticals; Ligand also is required to make a payment of $3.5 million toward the former stockholders of CyDex Pharmaceuticals, which Ligand acquired in 2011. 

“We are very pleased with the FDA’s decision and congratulate Onyx on this significant achievement,” said John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. “Our Captisol license agreement with Onyx is a highly valuable asset for Ligand, and we look forward to the near-term launch of the product. The approval of Kyprolis further demonstrates the clinical advantages and commercial potential of Captisol.” 

The approval of Kyprolis was based on the results of the Phase 2b 003-A1 study, a single-arm, multicenter clinical trial that enrolled 266 patients with multiple myeloma, who had received a median of five prior anti-myeloma regimens. The primary efficacy endpoint was overall response (ORR) and determined by an Independent Review Committee using the International Myeloma Working Group (IMWG) criteria. ORR was 22.9% and median response duration was 7.8 months. 

Safety data were evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent carfilzomib. There were 37 deaths on study, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity. The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia, and congestive heart failure. The most common adverse reactions (incidence of 30% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.

Ligand Pharmaceuticals Announces Third Quarter Results

Ligand Pharmaceuticals IncorporatedLGND +2.08% (the "Company" or "Ligand") today announced financial results for the three and nine months ended September 30, 2011 and provided a business update."We are positioned for a strong close to what has been a very momentous year for our Company. GlaxoSmithKline has posted significant sales growth with Promacta(R) in recent quarters, and they just announced important Phase III data for the drug in patients with hepatitis C. In addition, Onyx Pharmaceuticals remains positive about the prospects for FDA approval of carfilzomib next year," said John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. "In addition to these programs, many others are advancing toward potential revenue generation for Ligand. In the past quarter, we announced new licensing transactions with Chiva Pharmaceuticals for Fablyn(R) and with Sage Pharmaceuticals for a platform Captisol(R) partnership for a broad range of central nervous system (CNS) conditions."

Ligand to Present at the BioCentury NewsMakers Conference on October 21

Ligand Pharmaceuticals Incorporated LGND -1.57% announced today that John Higgins, President and Chief Executive Officer of Ligand will present at the BioCentury NewsMakers Conference on Friday, October 21, 2011 at 10:30 a.m. Eastern time (7:30 a.m. Pacific). The conference takes place at the Millennium Broadway Hotel in New York City.A live webcast of the presentation will be available on the Company's website www.ligand.com . A replay of the presentation will be archived on the site for 30 days.

Ligand Pharmaceuticals Announces Third Quarter Results

Ligand Pharmaceuticals Incorporated (the "Company" or "Ligand") today announced financial results for the three and nine months ended September 30, 2010 and provided a business update.

"During the past few months we demonstrated the value and strength of Ligand's business model, and by managing a large portfolio of internal and partnered assets we have benefited recently from numerous important events," said John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals.

"Specifically, our royalty assets continue to grow from our partnership portfolio with the recent European and Japanese approvals of both Revolade(R) and Conbriza(R). We completed transactions in the third quarter that delivered cash and the potential for additional future payments to Ligand, including the CXCR4 agreement and divestiture of some discovery tools. Bristol-Myers Squibb recently announced data on its p38 Phase II rheumatoid arthritis program and we continue to advance our internal pipeline. In addition, shareholders supported the proposal to undertake a reverse stock split, which we believe will help attract even more interest in Ligand as we work towards becoming a financial growth company."

Third Quarter Results

On November 9, 2010, following approval from the Company's stockholders at a special meeting of stockholders on September 9, 2010, the Company announced a 1-for-6 reverse stock split of its common stock. Accordingly, all share and per share information for all periods presented has been restated to account for the effect of the reverse stock split.

Total revenues from continuing operations for the three months ended September 30, 2010 were $7.8 million, compared with $7.9 million for the same period in 2009.

Operating costs and expenses from continuing operations in the third quarter of 2010 were $23.9 million, including $15.9 million of lease exit and termination costs, compared with $27.6 million, including $15.2 million of lease exit and termination costs, in the third quarter of 2009. Research and development expenses decreased by $5.0 million for the third quarter of 2010 compared with the same period in 2009, primarily due to the elimination of costs associated with servicing collaboration agreements that have been terminated. General and administrative expenses increased by $0.7 million compared with the same period in 2009, primarily due to costs associated with our recent acquisitions of Neurogen Corporation and Metabasis Therapeutics, Inc.

The net loss for the third quarter of 2010 was $11.8 million, or $0.60 per share, compared with net income of $1.8 million, or $0.10 per share, in the third quarter of 2009. The loss from continuing operations in the third quarter of 2010 was $11.9 million, or $0.60 per share, compared with income from continuing operations of $1.1 million, or $0.06 per share, in the comparable 2009 quarter. Net income and income from continuing operations for the third quarter of 2009 include $20.4 million of accretion of deferred gain on sale leaseback related to the acceleration of deferred gain recognized during the period as a result of the Company's building lease termination. Income from discontinued operations in the third quarter of 2010 was $12,000, or $0.00 per share, compared with $0.7 million, or $0.04 per share, in the comparable 2009 quarter.

CORRECTING and REPLACING Ligand Pharmaceuticals Announces First Quarter Results

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported a correction to its earnings release issued on May 6, 2009 relating to a milestone earned from Pfizer, Inc. Under the terms of a 1991 research agreement with Pfizer and as a result of approval by the European Commission for Pfizer’s FABLYN® (lasofoxifene) Tablets, the Company earned a contractual milestone of $3.0 million. As previously disclosed on March 24, 2009 at the time of the European approval, under the terms of a 1996 settlement agreement, Pfizer had the right to pay for the milestone in cash or by returning shares of Ligand stock valued at a pre-determined price. Pfizer elected to pay for the milestone by returning 323,338 shares of stock it owned in Ligand valued as of the date of the 1996 settlement agreement (adjusted for Ligand’s 2007 return of capital), or $9.28 per share.

The Company reported the milestone in its May 6, 2009 earnings release as revenue at its contractual amount of $3.0 million. Subsequent to the Company's earnings release, as a result of continuing analysis of authoritative literature, the Company determined that the revenue associated with the milestone, previously reported as $3.0 million, should be recorded at the current fair value ($2.83 per share) of the 332,338 shares of stock on the date the milestone was earned, or $0.9 million, instead of at the stock valuation as defined in the 1996 settlement agreement

Accordingly, total revenues for the first quarter have been reduced to $9.5 million from $11.6 million, loss from continuing operations has increased to $7.5 million, or $0.07 per share, from $5.4 million, or $0.05 per share, and total net loss has increased to $5.1 million, or $0.05 per share, from $3.0 million, or $0.03 per share. Notwithstanding this change in valuation from a contractual basis to a GAAP accounting basis for how the milestone should be recorded, there is no impact on the Company’s cash balance, operating expenses or outstanding shares.