On July 24, 2015 The U.S. Food and Drug Administration reported it approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy (Press release, , JUL 24, 2015, View Source [SID:1234506626]).

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Skin cancer is the most common cancer and basal cell carcinoma accounts for approximately 80 percent of non-melanoma skin cancers. Basal cell carcinoma starts in the top layer of the skin (called the epidermis) and usually develops in areas that have been regularly exposed to the sun and other forms of ultraviolet radiation. According to the National Cancer Institute, the number of new cases of non-melanoma skin cancer appears to be increasing every year. Locally advanced basal cell skin cancer refers to basal cancers that have not spread to other parts of the body, but cannot be curatively treated with local treatments, specifically surgery and radiation.

Odomzo is a pill taken once a day. It works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers. By suppressing this pathway, Odomzo may stop or reduce the growth of cancerous lesions.

"Our increasing understanding of molecular pathways involved in cancer has led to approvals of many oncology drugs in difficult-to-treat diseases for which few therapeutic options previously existed," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last three years." In 2012, Erivedge (vismodegib) was the first drug approved to treat locally advanced and metastatic basal cell carcinoma.

Odomzo carries a Boxed Warning alerting healthcare professionals that Odomzo may cause death or severe birth defects in a developing fetus when administered to a pregnant woman. Pregnancy status should be verified prior to the start of Odomzo treatment, and both male and female patients should be warned about these risks and advised to use effective contraception.

The efficacy of Odomzo was established in a multi-center, double-blind clinical trial, in which 66 patients with locally advanced basal cell carcinoma were randomly assigned to receive Odomzo 200 mg daily and 128 patients were assigned to receive Odomzo 800 mg daily. The study’s primary endpoint was objective response rate, which is the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s). Results showed that 58 percent of patients treated with Odomzo 200 mg had their tumors shrink or disappear. This effect lasted at least 1.9 to 18.6 months, and approximately half of the responding patients’ tumor shrinkage lasted six months or longer. Response rates were similar in patients who received Odomzo 800 mg daily, however side effects were more common at this dose.

At a dose of 200 mg daily, the most common side effects of Odomzo were muscle spasms, alopecia (hair loss), dysgeusia (distortion in the sense of taste), fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia (muscle pain), abdominal pain, headache, pain, vomiting and pruritus (itching). Odomzo also has the potential to cause serious musculoskeletal-related side effects, including increased serum creatine kinase levels [with rare reports of muscle tissue breakdown (rhabdomyolysis)], muscle spasms, and myalgia.

Odomzo is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation. Erivedge is marketed by Genentech in San Francisco, California.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On July 24, 2015 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the closing of its previously announced underwritten public offering (Press release, CytRx, JUL 24, 2015, View Source;p=RssLanding&cat=news&id=2070943 [SID:1234506623]). The gross proceeds from its sale of 10,465,000 shares of common stock at a public offering price of $2.75 per share, including 1,365,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, were approximately $28.8 million prior to deducting underwriting discounts and commissions and offering expenses payable by CytRx.

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CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and its drug discovery activities and for general corporate purposes, which may include pre-commercialization activities relating to aldoxorubicin, working capital, capital expenditures, research and development and other commercial expenditures.

Jefferies LLC acted as the sole book-running manager for the offering. Oppenheimer & Co. Inc., Aegis Capital Corp., FBR Capital Markets & Co., and H.C. Wainwright & Co. acted as co-lead managers for the offering.

The shares described above were sold pursuant to a shelf registration statement on Form S-3, including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC). The final prospectus supplement related to the offering also has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by email at [email protected] or by phone at 877-547-6340 or by accessing the SEC’s website at View Source

On July 24, 2015 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2015 (Press release, AbbVie, JUL 24, 2015, View Source;p=RssLanding&cat=news&id=2070868 [SID:1234506616]).

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"We are pleased with the high level of performance we’ve delivered through the first-half of 2015, consistent with our commitment to shareholders for top-tier growth this year and beyond," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "With the completion of the Pharmacyclics transaction, continued momentum from our on-market products and rapid evolution of our robust development pipeline, we are well positioned to deliver strong performance in the future."

Second-Quarter Results

Worldwide sales were $5.475 billion in the second quarter, up 11.1 percent year-over-year. On an operational basis, sales increased 19.4 percent, excluding an 8.3 percent unfavorable impact from foreign exchange rate fluctuations.

Second-quarter sales growth was driven by the continued strength of HUMIRA and other promoted products. Global HUMIRA sales increased 16.4 percent on an operational basis, or 7.6 percent including the impact of foreign exchange rate fluctuations. Strong U.S. HUMIRA growth continued, driven by double-digit growth across all three major market categories, rheumatology, dermatology and gastroenterology. Reported international HUMIRA sales growth in the quarter was reduced by nearly 18 percent due to unfavorable foreign exchange. First-half 2015 international HUMIRA sales grew nearly 9 percent on an operational basis, consistent with planning expectations and the full year forecast for international HUMIRA sales growth of 9 to 10 percent on an operational basis. As noted last quarter, the first-quarter international operational growth rate of nearly 15 percent was favorably impacted by the timing of shipments in select markets. Consequently, sales growth in the second quarter was negatively impacted by shipment timing.

Total company sales growth was also driven by $385 million in global VIEKIRA sales, now approved in 47 countries with additional approvals anticipated throughout the remainder of 2015, as well as strong operational growth from other key products including Creon, Synthroid and Duodopa.

Second-quarter U.S. IMBRUVICA sales were $234 million. AbbVie recorded a partial quarter of U.S. IMBRUVICA sales of $97 million and $10 million of international profit sharing based on the May 26 close date of the Pharmacyclics acquisition.

The adjusted gross margin ratio in the second quarter was 85.3 percent, excluding intangible asset amortization and other specified items. Gross margin expansion was driven by product mix, operating efficiencies and the impact of foreign exchange rates. The gross margin ratio under U.S. generally accepted accounting principles (GAAP) was 83.3 percent.

Adjusted selling, general and administrative (SG&A) expense was 25.1 percent of sales in the second quarter. On a GAAP basis, SG&A was 31.1 percent of sales.

Adjusted research and development (R&D) was 15.9 percent of sales in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline assets. On a GAAP basis, R&D was 17.9 percent of sales.

The adjusted operating margin in the second quarter was 44.2 percent, compared to 36.4 percent in second-quarter 2014. On a GAAP basis, the operating margin was 33.8 percent.

Adjusted net interest expense was $137 million, which reflects the impact of debt issued in conjunction with the Pharmacyclics acquisition. The adjusted tax rate was 21.9 percent in the quarter and 18.6 percent on a GAAP basis.

Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.08 in the second quarter, up 31.7 percent. Diluted earnings per share were $0.83 on a GAAP basis.

Key Events from the Second Quarter

On May 26, AbbVie successfully completed the acquisition of Pharmacyclics, accelerating AbbVie’s clinical and commercial presence in oncology. The acquisition aligns strategically to AbbVie’s business model, strengthening the company’s already robust oncology pipeline and further diversifying AbbVie’s revenue base.

AbbVie announced that the European Commission granted marketing authorization for IMBRUVICA (ibrutinib) as the first treatment option specifically approved for treatment of adult patients with Waldenstrom’s macroglobulinemia.

Results from the Phase 3 HELIOS study of IMBRUVICA were presented at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. The data demonstrated that patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) experienced an 80 percent reduction in the risk of disease progression or death when treated with ibrutinib in combination with bendamustine and rituximab, compared to patients receiving placebo in combination with bendamustine and rituximab.

AbbVie reported top-line results from the head-to-head Phase 3, RESONATE-2 study, which evaluated efficacy and safety of ibrutinib versus traditional chemotherapy, chlorambucil. Initial findings showed that treatment with ibrutinib improved progression-free survival rates, as well as met several secondary endpoints, including overall survival and overall response rates when used in treatment-naïve patients with CLL and SLL. Additional detailed data will be presented at an upcoming medical meeting. AbbVie anticipates submitting these data for regulatory review in the second-half of 2015.

AbbVie announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent. The median life expectancy for CLL patients with 17p deletion is less than 2-3 years. AbbVie expects to submit regulatory applications to U.S. and European agencies for this indication before the end of 2015.

Data from the Phase 3 ELOQUENT-2 study of elotuzumab were recently published in the New England Journal of Medicine. Elotuzumab is being developed in partnership with Bristol Myers Squibb, for front-line and relapsed/refractory multiple myeloma. Data showed that adding elotuzumab to standard of care in patients with relapsed/refractory multiple myeloma significantly reduced the risk of disease progression and demonstrated superior progression-free survival and overall response rates. The regulatory submissions are anticipated in the second-half of 2015.

The FDA granted priority review to AbbVie for its investigational, all-oral, interferon-free (IFN) therapy for the treatment of genotype 4 (GT4) chronic HCV in the United States. The New Drug Application (NDA) was accepted by the agency and is based on results from the PEARL-I study, which demonstrated 100 percent sustained virologic response rate at 12 weeks post-treatment (SVR12) when used with ribavirin (RBV), with no discontinuations due to adverse events. This investigational therapy also previously received Breakthrough Therapy Designation, and AbbVie anticipates regulatory action in the second-half of 2015.
New, pivotal data from the GIFT-I study of AbbVie’s all-oral, IFN- and RBV-free, two direct-acting antiviral (DAA) treatment with ombitasvir/paritaprevir/ritonavir in genotype 1b (GT1b) chronic HCV infected Japanese patients with and without cirrhosis were presented at the Annual Meeting of the Japan Society of Hepatology. Patients were both treatment-naïve and treatment-experienced. Primary endpoints were achieved, demonstrating 95 percent SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b chronic HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load. In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent SVR12. AbbVie’s two-DAA combination is currently under regulatory review in Japan and a decision is expected in the second-half of 2015.
AbbVie reported results from the TURQUOISE-III study in treatment-naïve and treatment-experienced patients with GT1b chronic HCV with compensated liver cirrhosis. These data demonstrated 100 percent SVR12 rates when treated with VIEKIRA without RBV. No patients discontinued treatment due to adverse events. Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.

AbbVie announced that the FDA granted VIEKIRA orphan drug designation for the investigational treatment of HCV infection in pediatric patients, 0 – 16 years of age. Orphan drug designations recognize the need for a treatment of a rare disease or condition. AbbVie will conduct an investigational clinical study to evaluate the efficacy and safety of VIEKIRA with or without RBV in pediatric patients with chronic HCV infection. VIEKIRA is currently not approved for this indication.

AbbVie announced that the FDA granted HUMIRA orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS), a painful, chronic inflammatory skin disease. AbbVie’s supplemental Biologic License Application (sBLA) is currently under review with the agency. The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently granted a positive opinion for this indication.

AbbVie recently received approval from the EMA for a new HUMIRA formulation, specifically designed to reduce injection pain and reduce injection volume.

AbbVie announced results from VISUAL‑I, a Phase 3 study investigating the efficacy and safety of HUMIRA in adult patients with uveitis. Results showed HUMIRA significantly lowered their risk of uncontrolled uveitis or vision loss. In May 2014, AbbVie received orphan drug designation from the FDA for the investigational treatment of certain forms of non‑infectious uveitis with HUMIRA. U.S. and EU regulatory submissions are expected in the second-half of 2015, following positive results from the second pivotal trial.
On June 18, the AbbVie board of directors declared a quarterly cash dividend of $0.51 per share, payable Aug. 14, 2015 to stockholders of record at the close of business on July 15, 2015. Since the company’s inception in 2013, AbbVie has increased its dividend by 28 percent.

Full-Year 2015 Outlook

AbbVie is confirming its adjusted diluted earnings-per-share guidance for the full-year 2015 of $4.10 to $4.30. The company’s 2015 adjusted diluted earnings-per-share guidance excludes $0.84 per share of intangible asset amortization expense, deal costs, integration, and other specified items, and includes $0.20 of dilution related to the Pharmacyclics acquisition. AbbVie’s diluted earnings-per-share guidance is $3.26 to $3.46 on a GAAP basis.