On October 27, 2015 United Therapeutics Corporation (NASDAQ: UTHR) reported its financial results for the third quarter ended September 30, 2015 (Press release, United Therapeutics, OCT 27, 2015, View Source [SID:1234507917]).

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"We are pleased with our third quarter 2015 results as total revenues reached $386 million and each of our pulmonary arterial hypertension products realized their highest revenue levels ever," said Roger Jeffs, Ph.D., United Therapeutics’ President and Co-Chief Executive Officer. "We are also happy to report the first commercial sales of Unituxin for the treatment of high-risk neuroblastoma. These strong financial results will enable us to continue advancing our innovative product pipeline and returning value to our shareholders through our recently announced $500 million share repurchase program."

Financial Results for the Three Months Ended September 30, 2015

Revenues

Revenues for the three months ended September 30, 2015 increased by $56.3 million, compared to the three months ended September 30, 2014. The growth in revenues primarily resulted from: (1) a $22.6 million increase in Adcirca revenues, driven by price increases, which are determined by Eli Lilly and Company, and by an increase in the number of Adcirca bottles sold; and (2) a $19.9 million increase in Orenitram revenues due to an increase in the number of patients being treated. In addition, $4.7 million of the increase in revenue was due to our first commercial sales of Unituxin, which commenced during the three months ended September 30, 2015.

Expenses

Research and development expense.

Share-based compensation. The decrease in share-based compensation of $113.6 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, was primarily due to a 25 percent decrease in our stock price during the quarter ended September 30, 2015, compared to a 45 percent increase during the same quarter in 2014.

General and administrative. The decrease in general and administrative expense of $12.8 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, resulted from a $13.0 million decrease in grants to non-profit organizations that provide financial assistance to patients with pulmonary arterial hypertension.

Share-based compensation. The decrease in share-based compensation of $208.8 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, was primarily due to a 25 percent decrease in our stock price during the quarter ended September 30, 2015, as compared to a 45 percent increase during the same quarter in 2014.

Cost of product sales. The decrease in cost of product sales for the three months ended September 30, 2015, compared to the three months ended September 30, 2014, was due to the expiration of our royalty obligation to GlaxoSmithKline plc in October 2014. During the three months ended September 30, 2014, we incurred $24.9 million in royalty expense related to this royalty obligation.

Share-based compensation. The decrease in share-based compensation of $16.9 million for the three months ended September 30, 2015, compared to the same three-month period in 2014, was primarily due to a 25 percent decrease in our stock price during the quarter ended September 30, 2015, as compared to a 45 percent increase during the same quarter in 2014.

Gain on Sale of Intangible Asset

In September 2015, we sold the Rare Pediatric Priority Review Voucher (PPRV) we received from the FDA in connection with the approval of our Biologics License Application for Unituxin. In exchange for the voucher, we received $350.0 million from AbbVie Ireland Unlimited Company (AbbVie), a wholly-owned subsidiary of AbbVie Inc. The proceeds from the sale of the PPRV were recognized as a gain on the sale of an intangible asset, as the PPRV did not have a carrying value on our consolidated balance sheet at the time of sale.

Income Tax Expense

The provision for income tax expense is based on an estimated annual effective tax rate that is subject to adjustment in subsequent quarterly periods if components used to estimate the annual effective tax rate are updated or revised. Our estimated annual effective tax rates were approximately 38 percent and approximately 36 percent as of September 30, 2015 and September 30, 2014, respectively. Our 2015 estimated annual effective tax rate increased as of September 30, 2015 primarily due to a decrease in the estimated general business credits as compared to the prior year.

Non-GAAP Earnings

Non-GAAP earnings is defined as net income, adjusted for the following charges, which are presented net of our annual effective income tax rate, as applicable: (1) interest expense; (2) license fees; (3) depreciation and amortization; (4) impairment charges; and (5) share-based compensation expense (stock option, share tracking award and employee stock purchase plan). For 2015, we also adjusted non-GAAP earnings to eliminate the gain (net of our annual effective income tax rate) resulting from the sale of the PPRV in September 2015.

On October 27, 2015 Agenus Inc. (NASDAQ:AGEN), an immunology company discovering and developing innovative treatments for cancers and other diseases, reported its financial results for the third quarter ended September 30, 2015 (Press release, Agenus, OCT 27, 2015, View Source [SID:1234507795]).

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"We are rapidly advancing our broad pipeline of potentially best-in-class therapies and combination therapies for patients with cancer. We look forward to providing further details on this progress during our Analyst Day, scheduled for November 19 in New York City," said Dr. Garo H. Armen, Chairman and CEO of Agenus. "We have also strengthened our balance sheet by monetizing a portion of our QS-21 adjuvant royalty stream, which provided us with net proceeds of approximately $78 million. We also acquired the rights to antibodies targeting CEACAM1, expanding our portfolio to include powerful immune-modulators that may be complementary with other checkpoint modulators, including those in our pipeline."

Third Quarter 2015 Financial Results

For the third quarter ended September 30, 2015, Agenus reported a net loss attributable to common stockholders of $13.2 million, or $0.16 per share, basic and diluted, compared with a net loss attributable to common stockholders for the third quarter of 2014 of $8.2 million, or $0.13 per share, basic and diluted.

For the nine months ended September 30, 2015, the company reported a net loss attributable to common stockholders of $72.4 million, or $0.95 per share, basic and diluted, compared with a net loss attributable to common stockholders of $16.7 million, $0.28 per share, basic and diluted, for the nine months ended September 30, 2014.

The increase in net loss attributable to common stockholders for the nine-months ended September 30, 2015, compared to the net loss attributable to common stockholders for the same period in 2014, was primarily due to the advancement of our check point modulator programs including the $13.2 million charge for the acquisition of the SECANT yeast display platform in addition to other license and technology transfer arrangements. We also recorded a total of $14.2 million in non-cash expense for fair value adjustments to our contingent obligations. During the same period in 2014, the company recorded non-cash non-operating income of $10.7 million related to the fair value adjustment of our contingent obligations.

Cash, cash equivalents and short-term investments were $199.1 million as of September 30, 2015.

Third Quarter 2015 and Recent Corporate Highlights

In September, Agenus completed a $115 million non-dilutive royalty transaction pursuant to a Note Purchase Agreement with an investor group led by Oberland Capital Management, LLC for rights to a portion of the worldwide royalties on future sales of GlaxoSmithKline’s shingles (HZ/su) and malaria (RTS,S) prophylactic vaccine products that contain Agenus’ QS-21 adjuvant. The transaction resulted in net proceeds of approximately $78 million at closing.
Also in September, Agenus presented data at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) from an exploratory study showing the role of unique tumor neo-epitopes and immunological responses to Prophage in glioblastoma patients, highlighting the importance of patient-specific neo-epitopes in individualized immunotherapy for treating cancer.
In July, Agenus acquired rights to antibodies targeting Carcinoembryonic Antigen Cell Adhesion Molecule 1 (CEACAM1), a glycoprotein expressed on T cell and NK cell lymphocytes from Diatheva s.r.l., an Italian biotech company controlled by SOL S.p.A. CEACAM1 is overexpressed in melanoma, bladder, lung, colon, pancreas, and gastric cancers, and appears to mediate innate and adaptive immune suppression allowing tumors to escape immune destruction. Antibodies to CEAMCAM1 should be effective in treating patients with many forms of cancer.

On October 27, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported two poster presentations at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held November 5-9 in Boston, Massachusetts (Press release, Sunesis, OCT 27, 2015, View Source;p=RssLanding&cat=news&id=2103102 [SID:1234507820]).

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The details for the poster presentations are as follows:

Date and Time: Sunday, November 8, 2015 from 12:30 p.m. to 3:30 p.m. Eastern Time
Poster Title: PDK1 inhibitors SNS-229 and SNS-510 cause pathway modulation, apoptosis and tumor regression in hematologic cancer models in addition to solid tumors
Abstract/Poster Number: C198
Session Title: Therapeutic Agents: Small Molecule Kinase Inhibitors
Session ID: Poster Session C
Location: Exhibit Hall C-D

The full abstract can be viewed here.

Date and Time: Sunday, November 8, 2015 from 12:30 p.m. to 3:30 p.m. Eastern Time
Poster Title: SNS-062 is a potent noncovalent BTK inhibitor with comparable activity against wild type BTK and BTK with an acquired resistance mutation
Abstract/Poster Number: C186
Session Title: Therapeutic Agents: Small Molecule Kinase Inhibitors
Session ID: Poster Session C
Location: Exhibit Hall C-D

On October 27, 2015 Mylan N.V. (Nasdaq: MYL) reported the U.S. launch of Levoleucovorin Calcium Injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single-use Vials, which is the generic version of Spectrum Pharmaceuticals’ Fusilev for Injection (Press release, Mylan, OCT 27, 2015, View Source [SID:1234507800]). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for rescue use after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

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Levoleucovorin Calcium Injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single-use Vials had U.S. sales of approximately $200 million for the 12 months ending June 30, 2015, according to IMS Health.

Currently, Mylan has 259 ANDAs pending FDA approval representing $98.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.

On October 27, 2015 Seattle Genetics, Inc. (Nasdaq: SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) reported that the companies have achieved completion of target patient enrollment in the phase 3 ECHELON-1 clinical trial (Press release, Takeda, OCT 27, 2015, View Source [SID:1234507821]). ECHELON-1 is a randomized trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced classical Hodgkin lymphoma (HL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for the frontline treatment of HL.

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Patients in ECHELON-1 were randomized to receive either ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), a recognized standard of care for frontline HL, or a novel combination consisting of ADCETRIS+AVD, which removes bleomycin from the regimen. The trial has enrolled approximately 1,300 patients, although it remains open at select sites to complete enrollment of approximately 20 patients in an additional cohort to fulfill an ex-U.S. regulatory commitment related to measurement of drug levels during treatment (pharmacokinetics). This continued enrollment will not affect the expected timing of data readout from the trial in the 2017 to 2018 timeframe, based on anticipated event rates. The ECHELON-1 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received European Medicines Agency (EMA) scientific advice.

"In the majority of the world, the standard of care for newly diagnosed Hodgkin lymphoma has not changed in more than three decades, and is based on the globally recognized ABVD regimen of four chemotherapy drugs. With the ECHELON-1 clinical trial, our goal is to redefine the standard of care with a novel ADCETRIS-based combination treatment regimen that improves patient outcomes with a manageable safety profile," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We look forward to reporting results from the ECHELON-1 trial to potentially support an ADCETRIS supplemental Biologics License Application seeking a label expansion for use in this setting."

"Approximately 25 percent of newly diagnosed Hodgkin lymphoma patients do not respond to initial therapy or relapse within the first two years. There is a significant need to identify additional potential therapies in this patient population that may provide a more durable response and fewer incidences of relapse," said Dirk Huebner, MD, Global Clinical Lead, Takeda Oncology.

Data previously presented at the ASH (Free ASH Whitepaper) Annual Meeting in 2012 and 2014 from a phase 1 trial evaluating ADCETRIS plus AVD demonstrated that 24 of 25 patients (96 percent) achieved a complete remission. Long-term follow-up data demonstrated three-year overall survival was 100 percent and three-year failure-free survival was 92 percent. The most common adverse events of any grade occurring in more than 30 percent of patients were neutropenia, nausea, peripheral sensory neuropathy, fatigue, vomiting, diarrhea, insomnia, bone pain, constipation and hair loss.

ECHELON-1 Trial design
The randomized, open-label, phase 3 trial is investigating ADCETRIS+AVD versus ABVD as frontline therapy in patients with advanced classical HL. The primary endpoint is modified progression free survival per independent review facility assessment using the Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Secondary endpoints include overall survival, complete remission and safety. The multi-center trial is being conducted in North America, Europe, South America, Australia, Asia and Africa. The study has enrolled approximately 1,300 patients who had histologically-confirmed diagnosis of Stage III or IV classical HL and had not been previously treated with systemic chemotherapy or radiotherapy. Data from the trial will be available when a pre-specified number of PFS events have occurred.

For more information about the trial, please visit www.clinicaltrials.gov.

About Classical Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system and is the most common type of blood cancer. There are two major categories of lymphoma: HL and non-Hodgkin lymphoma. Classical HL is distinguished from other lymphomas by the characteristic presence of CD30-positive Reed-Sternberg cells.

According to the American Cancer Society, approximately 9,050 cases of HL will be diagnosed in the United States during 2015 and more than 1,150 will die from the disease.

According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with HL each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS
ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials, including the phase 3 ALCANZA trial and two additional phase 3 studies, one in frontline classical HL and one in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory HL and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 55 countries. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.