On February 2, 2016 – Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2015 (Filing, 8-K, Gilead Sciences, FEB 2, 2016, View Source [SID:1234508942]). Total revenues for the fourth quarter of 2015 were $8.5 billion compared to $7.3 billion for the fourth quarter of 2014. Net income for the fourth quarter of 2015 was $4.7 billion, or $3.18 per diluted share compared to $3.5 billion, or $2.18 per diluted share for the fourth quarter of 2014. Non-GAAP net income for the fourth quarter of 2015, which excludes amounts related to acquisition, stock-based compensation and other, was $4.9 billion, or $3.32 per diluted share compared to $3.9 billion, or $2.43 per diluted share for the fourth quarter of 2014.

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Full year 2015 total revenues were $32.6 billion compared to $24.9 billion for 2014. Net income for 2015 was $18.1 billion, or $11.91 per diluted share compared to $12.1 billion, or $7.35 per diluted share for 2014. Non-GAAP net income for 2015, which excludes amounts related to acquisition, stock-based compensation and other, was $19.2 billion, or $12.61 per diluted share compared to $13.3 billion, or $8.09 per diluted share for 2014.

Product Sales
Total product sales for the fourth quarter of 2015 were $8.4 billion compared to $7.2 billion for the fourth quarter of 2014. In the fourth quarter of 2015, product sales in the U.S. were $4.8 billion compared to $5.5 billion in the fourth quarter of 2014. In Europe, product sales were $1.7 billion compared to $1.4 billion in the fourth quarter of 2014. Sales in other international locations increased to $1.9 billion compared to $373 million in the fourth quarter of 2014, primarily due to sales of Sovaldi (sofosbuvir 400 mg) and Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) in Japan.

Total product sales during 2015 were $32.2 billion compared to $24.5 billion in 2014, primarily due to sales of Harvoni which was launched in October 2014, partially offset by a decrease in sales of Sovaldi. For 2015, product sales in the U.S. were $21.2 billion compared to $18.1 billion in 2014. In Europe, product sales were $7.2 billion compared to $5.1 billion in 2014. Sales in other international locations increased to $3.8 billion in 2015 compared to $1.2 billion in 2014, primarily due to sales of Sovaldi and Harvoni in Japan.

Antiviral Product Sales
Antiviral product sales, which include products in our HIV and liver diseases areas, were $7.9 billion for the fourth quarter of 2015 compared to $6.7 billion for the fourth quarter of 2014 primarily as a result of the launch of our HCV products in Japan and continued launches of our HCV products across Europe, partially offset by lower sales of HCV products in the U.S. For 2015, antiviral product sales were $30.2 billion compared to $22.8 billion in 2014 primarily due to sales of Harvoni, partially offset by a decrease in sales of Sovaldi.

Other Product Sales
Other product sales, which include Letairis, Ranexa and AmBisome, were $523 million for the fourth quarter of 2015 compared to $496 million for the fourth quarter of 2014. For 2015, other product sales were $1.9 billion compared to $1.7 billion in 2014.

• During the fourth quarter of 2015, non-GAAP R&D expenses decreased, compared to same period in 2014, primarily due to the 2014 impact of up-front fees paid in connection with Gilead’s collaboration with ONO Pharmaceutical Co., Ltd. (ONO) and the purchase of a U.S. Food and Drug Administration (FDA) priority review voucher, partially offset by increased costs to support the continued progression of Gilead’s clinical studies in 2015.

• During 2015, non-GAAP R&D expenses increased, compared to 2014, primarily due to the progression of Gilead’s clinical studies, partially offset by the 2014 impact of up-front fees paid in connection with Gilead’s collaboration with ONO and the purchase of a FDA priority review voucher.

• During the fourth quarter and full year 2015, non-GAAP SG&A expenses increased, compared to same periods in 2014, primarily to support Gilead’s growth and the geographic expansion of its business.

Cash, Cash Equivalents and Marketable Securities
As of December 31, 2015, Gilead had $26.2 billion of cash, cash equivalents and marketable securities compared to $11.7 billion as of December 31, 2014. During 2015, Gilead generated $20.3 billion in operating cash flow, utilized $10.0 billion to repurchase 95 million shares of its stock and paid cash dividends of $1.9 billion, or $1.29 per share.

Corporate Highlights

• Gilead was the top corporate HIV/AIDS philanthropic funder and the No. 2 private HIV/AIDS philanthropic funder overall behind the Bill & Melinda Gates Foundation, according to the Funders Concerned About AIDS Report issued on December 8, 2015. Gilead gave $73.4 million in HIV/AIDS philanthropic support in 2014. The company’s corporate giving helps address the HIV epidemic on all fronts, including testing and linkage to care, enabling access to medicines, reducing disparities in the quality of healthcare and educating healthcare professionals on the latest advances in HIV therapies.

• Gilead is partnering with the U.S. government, the Bill & Melinda Gates Foundation and other corporate donors on the DREAMS initiative aimed at reducing HIV infections among adolescent girls and young women in sub-Saharan Africa. Gilead will provide funding to help the program purchase generic Truvada for use as pre-exposure prophylaxis (PrEP) among HIV-negative adolescent girls and young women in sub-Saharan Africa, as well as to support costs related to procurement, transportation and dissemination of PrEP.

Product & Pipeline Updates Announced by Gilead During the Fourth Quarter of 2015 Include:

Antiviral Program

• Announced that the European Commission granted marketing authorization for the once-daily single tablet regimen Genvoya for the treatment of HIV-1 infection. Genvoya is the first tenofovir alafenamide (TAF)-based regimen to receive marketing authorization in the European Union (EU). Genvoya is indicated in the EU for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

• Announced that FDA approved Genvoya for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive FDA approval. Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA levels less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.

• Announced positive 96-week results from two Phase 3 studies evaluating Genvoya for the treatment of HIV-1 infection in treatment-naïve adults. Genvoya was found to be statistically non-inferior to Stribild, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also had improved renal and bone laboratory parameters compared to those treated with Stribild. These data were presented at the 15th European AIDS Conference.

• Announced that the Marketing Authorization Application for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, was fully validated and under assessment by the European Medicines Agency (EMA). The data included in the application support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis. SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive accelerated review by the EMA.

• Announced that FDA approved Harvoni for expanded use in patients with genotype 4, 5 and 6 HCV infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.

• Announced that the company submitted a New Drug Application to FDA for an investigational, once-daily fixed-dose combination of SOF/VEL, for the treatment of chronic genotype 1-6 HCV infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with RBV for patients with decompensated cirrhosis. FDA assigned SOF/VEL with a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options.

• Announced that the company fulfilled a request for compassionate access to GS-5734, a novel nucleotide analogue in development for the potential treatment of Ebola Virus Disease. The compound was provided to two patients, one a female patient in the Royal Free Hospital in London in October and one in Guinea the following month, through a compassionate use request. Two Phase 1 human trials are now underway in healthy adult volunteers.

Oncology Program

• Announced positive results from a prespecified interim analysis of a Phase 3 study evaluating Zydelig in combination with bendamustine and rituximab (BR) for patients with previously treated chronic lymphocytic leukemia. The analysis found a 67 percent reduction in the risk of disease progression or death (progression-free survival) in patients receiving Zydelig plus BR compared to BR alone. Additionally, all secondary endpoints, including overall survival, achieved statistical significance in this interim analysis. These data were presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Cardiovascular Program
• Announced that FDA approved the use of Letairis in combination with tadalafil for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.

Inflammation Program
• Announced that Gilead and Galapagos NV entered into a collaboration for the development and commercialization of the JAK1-selective inhibitor filgotinib for inflammatory disease indications. This collaboration represents an opportunity to add complementary clinical programs to our growing inflammation research and development efforts. Phase 2 trial data show that filgotinib has the potential to be an effective and well-tolerated oral therapy for patients with rheumatoid arthritis (RA) and Crohn’s disease. Phase 3 trials in RA and Crohn’s are expected to start in mid-2016 pending the successful outcome of discussions with regulatory authorities.

On February 2, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a worldwide license agreement with Tizona Therapeutics, Inc., an immunology company developing next generation therapies for cancer and autoimmune disease(Press release, Ligand, FEB 2, 2016, View Source [SID:1234508944]). Under the license, Tizona will use the OmniRat, OmniMouse and OmniFlic platforms to generate fully human mono- and bispecific antibodies. Ligand will be eligible to receive annual platform access payments as well as patent filing fees, clinical milestone payments and royalties for each successful OmniAb antibody. Tizona will be responsible for all costs related to the program.

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"We have now added Tizona as a new partner as they expand their immuno-oncology and inflammation drug discovery efforts," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "This is the second licensing deal struck by Ligand on OmniAb and the 18th commercial partner overall, which represents a strong continued momentum for the technology. We believe the OmniAb platform has great potential to enable the discovery and development of novel medicines to meet major medical needs."

About OmniAb

OmniAb includes three transgenic animal platforms for producing mono- and bispecific human therapeutic antibodies. OmniRat is the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and generates antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. The three platforms use patented technology, have broad freedom to operate and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability.

On February 02, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal second-quarter 2016, provided an update on recent business highlights, maintained its fiscal year 2016 revenue guidance, raised its fiscal year 2016 earnings guidance and provided fiscal third-quarter 2016 financial guidance (Press release, Myriad Genetics, FEB 2, 2016, View Source [SID:1234508950]).

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"We are pleased with the first half of fiscal year 2016 which has positioned us to deliver upon our financial guidance for the full year," said Mark C. Capone, president and chief executive officer of Myriad. "Our new products are making significant strides towards broader market adoption and reimbursement on a worldwide basis. Additionally, we are excited to announce that our companion diagnostic portfolio has expanded to five tests with the addition of two new tests that have been incorporated into additional pharmaceutical company collaborations. We remain on track to achieve our five-year strategic goals and build Myriad into a diversified, global, leader in personalized medicine."

Business Highlights

myRisk Hereditary Cancer
Myriad presented an interim analysis of a large clinical utility study comparing myRisk Hereditary Cancer to BRACAnalysis at the San Antonio Breast Cancer Symposium (SABCS). In the interim analysis, myRisk Hereditary Cancer increased the number of patients receiving clinically appropriate risk reduction measures by 61 percent.
The Company announced today that 61 percent of its hereditary cancer revenue is now under three-year, non-cancellable, payer contracts.

Vectra DA
Vectra DA volumes were up 13 percent year-over-year in the fiscal second-quarter with more than 38,000 tests performed.
At the American College of Rheumatology Annual Meeting, Myriad presented multiple studies on the potential ability of Vectra DA to predict therapy response. One study demonstrated that Vectra DA predicts response for methotrexate incomplete responders to DMARDs or biologics. In another study, Vectra DA predicted which patients could taper their therapy without experiencing flares.
During the second quarter, Myriad announced the issuance of the first patent pertaining to the Vectra DA testing process by the U.S. Patent and Trademark Office.

Prolaris/Urology
Prolaris sample volume was up 104 percent year-over-year and 26 percent sequentially with over 3,500 tests ordered.
At the 2016 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), Myriad presented data on more than 11,000 men with prostate cancer to evaluate their ability to pursue active surveillance based upon the Prolaris Combined Score (PCS); 63 percent of the men qualified for active surveillance based on their PCS, almost doubling the number of eligible patients when compared to traditional pathology.
Myriad also presented its first validation study on the myPlan Renal Cancer prognostic test at ASCO (Free ASCO Whitepaper) GU. When the myPlan score was combined with pathological stage to provide a combined prognostic score (CPS), patients with a high CPS had a three-fold increased risk of recurrence compared to patients with a low score.

Companion Diagnostics
At SABCS, Myriad presented multiple studies demonstrating the ability of the myChoice HRD test to predict response to DNA damaging agents. In a pooled analysis of five statistically significant studies, patients with a positive myChoice HRD score had a three-fold increase in pathological complete response when compared to those patients with a negative score.
Today, Myriad is announcing the addition of two new companion diagnostics. The first is a tumor sequencing panel that contains the full sequencing of 80 clinically actionable genes and is customizable for our pharmaceutical partners to support clinical trials. The second new companion diagnostic is a proprietary assay that evaluates the functionality of the immune pathway and predicts response to immunotherapy. The Company already has signed undisclosed research collaborations with major pharmaceutical partners on each of these new products to be evaluated in combination with myChoice HRD.

International
International revenues were up 29 percent sequentially in the second quarter and accounted for four and a half percent of total revenue in the quarter.
At SABCS, Myriad presented a study that evaluated 928 patients in the TransATAC cohort that compared the performance of EndoPredict to the widely-used first generation breast cancer prognostic test. In this study, EndoPredict more accurately predicted 10-year distant metastases when compared to the first-generation prognostic test.
During the fiscal second-quarter, Myriad won a competitive tender for EndoPredict in France that is expected to generate revenue during calendar year 2016. Additionally, Helsana, the largest insurance provider in Switzerland, announced a favorable coverage decision for Prolaris.

Share Repurchase
During the quarter, the Company repurchased approximately 0.6 million shares, or $25 million, of common stock under our share repurchase program and ended the quarter with approximately $92 million remaining on our current share repurchase authorization.

Fiscal Third-Quarter and Fiscal Full-Year 2016 Financial Guidance

The Company is maintaining its fiscal full-year revenue guidance of $750 to $770 million and raising its adjusted earnings per share guidance from the previous range of $1.60 to $1.65 to $1.63 to $1.68. Additionally, Myriad is issuing fiscal third-quarter 2016 financial guidance with revenues of $183 to $185 million and adjusted earnings per share of $0.37 to $0.39.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal second-quarter financial results and fiscal third-quarter and fiscal full-year 2016 financial guidance.

ImmuNext reported that the first patient has been dosed in a Phase 1 clinical trial of the anti-VISTA antibody, JNJ-61610588 (Press release, ImmuNext, FEB 2, 2016, http://immunext.com/news.php [SID:1234511069]). JNJ-61610588 is the first anti-VISTA antibody to enter the clinic.
The compound is a monoclonal antibody designed for the treatment of cancer, and was developed as part of the license and collaboration agreement with Janssen Biotech, Inc. Janssen Research & Development is running the study.
The Phase I trial will enroll patients with advanced solid tumors. The initial portion of the study is designed to evaluate safety, pharmacokinetics, and pharmacodynamics of ascending doses of JNJ-61610588.
Additional information may be found at clinicaltrials.gov, using identifier NCT02671955.

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On February 2, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported an update on its commercial and clinical development efforts with respect to its Lymphoseek (technetium Tc 99m tilmanocept) injection, the first and only FDA-approved receptor-targeted lymphatic mapping agent, and the Manocept immunodiagnostic development pipeline (Press release, Navidea Biopharmaceuticals, FEB 2, 2016, View Source;p=RssLanding&cat=news&id=2135015 [SID:1234508951]).

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2015 Commercial Highlights

In 2015, the Company created and executed a new commercialization strategy for Lymphoseek to better leverage the label expansion approved by the FDA in October 2014 and, over time, accelerate its market penetration. This included a complete refresh of the brand, moving away from a feature-based selling approach to a customer-centric one focused on the benefits to the surgeon and patient.

In concert with the rebranding efforts, the Company also recruited, hired and trained a new salesforce in the latter part of the second quarter of 2015. The new direct sales team focused on targeting the highest priority territories. The Company anticipated the sales team’s contributions would be most significant starting the fourth quarter of 2015 and onward based on the four- to six-month sales cycle of Lymphoseek.

The initial launch of the new commercialization strategy resulted in the following during 2015:

Grew sales by 141% year over year, based on preliminary unaudited Lymphoseek sales to Navidea of $10.2 million for 2015 representing total brand revenue of approximately $20 million;

Ended the year at an annualized sales run rate for Lymphoseek of over $15 million in revenue to Navidea, which does not reflect the opportunity for additional growth in existing and expansion sales territories throughout 2016;

Achieved an increase of 55% in "average daily doses sold" from the end of 2014 through the end of 2015;

Increased penetration into large accounts – nearly tripling the number of accounts that averaged more than 20 doses per month in 2015 versus 2014; and,

Expanded the network of cancer centers and hospitals that use or plan to use Lymphoseek which now includes 17 of the top 20 US Best Hospitals for Adult Cancer as reported by the most recent U.S. News and World Report.

Rick Gonzalez, President and Chief Executive Officer, said, "We enter 2016 with positive momentum behind our new commercialization strategy. We expect our sales team’s strong contributions to continue to accelerate product revenues throughout the year. In addition, European sales revenues are expected to be generated from commercialization efforts to begin in the fourth quarter. In parallel, our R&D team is aggressively advancing our immunodiagnostics pipeline focused on significantly larger market opportunities including Rheumatoid Arthritis (RA), which has a prevalence of approximately 3.8 million patients in the U.S. and Europe. We will share additional details on our plans for 2016, including an update on Macrophage Therapeutics and the sale of NAV4694, during our upcoming year-end earnings conference call."

Clinical Development Update

The Company continues to work toward a more focused development program using its Manocept platform in immunodiagnostics, including the FDA label expansion for Lymphoseek (Tc99m tilmanocept) into RA and Kaposi’s sarcoma (KS). Importantly, the costs of these development programs will be defrayed by NIH grants awarded to the Company in 2015 totaling over $3.8 million.

In the next 90 days, the Company intends to:

Advance Lymphoseek Label Expansion into RA:

Meet with the FDA before the end of March 2016 to share preclinical results on the intravenous route of administration (IVROA) and discuss and agree on the Phase 1 and 2 clinical plan for our Rheumatoid Arthritis (RA) immunodiagnostic program. This is a follow-up meeting to the one that took place in May 2015, where the Company and the FDA confirmed requirements for a preclinical submission package for the use of Lymphoseek in IVROA; and,

Finalize preparations to initiate a Phase 1 pilot trial evaluating subcutaneous injection of Tc99m tilmanocept in active RA subjects in the first half of 2016. During the second half of 2016, the Company intends on initiating a subsequent Phase 1/2 registrational trial of IV-administered Tc99m tilmanocept for the RA immunodiagnostic application.

Support the existing Lymphoseek label in Lymphatic Mapping:
Expand patient enrollment in the FDA/EMA mandated pediatric trial for children with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping and who meet special criteria for pediatric sentinel node biopsy. Since the first patient was dosed in December 2015, two new sites have been added including Cincinnati Children’s Hospital Medical Center;

Enroll first patient at the MD Anderson Cancer Center in the Company’s multi–center cervical cancer study;

Initiate patient enrollment in the Investigator Initiated Study (IIS) endometrial cancer study directed by Dr. Michael McHale at UC San Diego Health System; and,

Expand patient enrollment in the cardiovascular immunodiagnostic study, an IIS study in collaboration with Massachusetts General Hospital. Based on encouraging findings in the first patients dosed, we are very excited by the potential and are seeking to accelerate and expand this funded program using a protocol for IVROA.

About Lymphoseek
Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.

Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM