On July 18, 2017 Johnson & Johnson (NYSE: JNJ) reported sales of $18.8 billion for the second quarter of 2017, an increase of 1.9% as compared to the second quarter of 2016 (Press release, Johnson & Johnson, JUL 18, 2017, View Source [SID1234519815]).

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Operational sales results increased 2.9% and the negative impact of currency was 1.0%. Domestic sales increased 1.6%. International sales increased 2.3%, reflecting operational growth of 4.4% and a negative currency impact of 2.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 0.5%, domestic sales decreased 1.0% and international sales increased 2.0%.*



Net earnings and diluted earnings per share for the second quarter of 2017 were $3.8 billion and $1.40, respectively. Second-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.8 billion. Second-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.7 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.0 billion and adjusted diluted earnings per share were $1.83, representing increases of 3.1% and 5.2%, respectively, as compared to the same period in 2016. * On an operational basis, adjusted diluted earnings per share also increased 6.9%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"Our second-quarter results reflect strong adjusted earnings growth and we are optimistic that the investments we are making will accelerate our sales growth in the second half of this year. Our pharmaceutical pipeline continued its strong momentum with the approval of TREMFYA as well as the submission and approval of several key line extensions," said Alex Gorsky, Chairman and Chief Executive Officer. "The Actelion acquisition establishes a new therapeutic area as well as another engine for growth and we are pleased to welcome the Actelion colleagues to the Johnson & Johnson Family of Companies. Together with all of our businesses, we will continue to transform the lives of patients around the world."

The Company increased its sales guidance for the full-year 2017 to $75.8 billion to $76.1 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2017 to $7.12 – $7.22 per share.*

Worldwide Consumer sales of $3.5 billion for the second quarter 2017 represented an increase of 1.7% versus the prior year, consisting of an operational increase of 2.3% and a negative impact from currency of 0.6%. Domestic sales increased 7.4%, international sales decreased 2.2%, which reflected an operational decrease of 1.1% and a negative currency impact of 1.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.8%, domestic sales increased 1.2% and international sales decreased 2.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by baby care products, partially offset by domestic over-the-counter products, including upper respiratory products and international anti-smoking aids, and NEUTROGENA beauty products.

Worldwide Pharmaceutical sales of $8.6 billion for the second quarter 2017 represented a decrease of 0.2% versus the prior year with an operational increase of 1.0% and a negative impact from currency of 1.2%. Domestic sales decreased 2.6%; international sales increased 3.3%, which reflected an operational increase of 6.1% and a negative currency impact of 2.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 0.5%, domestic sales decreased 2.6% and international sales increased 5.1%.* Worldwide operational sales growth was negatively impacted by approximately 4 points due to a positive adjustment of U.S. rebate accruals in the second quarter of 2016, which did not repeat in the second quarter of 2017.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma and IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer. Additional contributors to operational sales growth included STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, and INVEGA SUSTENNA/XEPLION/TRINZA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the Company announced the completion of the acquisition of Actelion Ltd., a leading biopharmaceutical company, for a total purchase price of approximately $30 billion in cash.

Also in the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for DARZALEX (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies. The European Commission (EC) granted approval for DARZALEX (daratumumab) for use in combination with lenalidomide and dexamethasone, or bortezomib (VELCADE) and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

In addition, a supplemental New Drug Application was submitted to the FDA to update the prescribing information for XARELTO (rivaroxaban) to add a 10mg dose to reduce patients’ risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy and regulatory submissions were made to both the European Medicines Agency and the FDA for a single-tablet, two-drug regimen of dolutegravir and rilpivirine for the maintenance treatment of HIV-1 infection.

In July, subsequent to the quarter, the FDA approved TREMFYA (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis.

Worldwide Medical Devices sales of $6.7 billion for the second quarter 2017 represented an increase of 4.9% versus the prior year consisting of an operational increase of 5.9% and a negative currency impact of 1.0%. Domestic sales increased 6.1%; international sales increased 3.9%, which reflected an operational increase of 5.8% and a negative currency impact of 1.9%. Sales included the impact of the first full quarter of the recently completed acquisition of Abbott Medical Optics which contributed 5.1%, to worldwide operational sales growth. Excluding the net impact of all acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales increased 0.8% and international sales increased 1.4%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business, ACUVUE contact lenses in the Vision Care business, and Advanced Surgery products, partially offset by declines in the Diabetes Care business.

During the quarter, FDA clearance was received for the 30-minute STERRAD VELOCITY Biological Indicator System for low temperature H202 sterilization as well as approval for the SURGICEL Powder Absorbable Hemostat for adjunctive hemostasis during surgery.

On July 17, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported it will receive a second undisclosed significant clinical milestone payment from Novartis, based on the collaboration and licensing agreement between the companies, relating to Prima’s IMP701 LAG-3 antibody (also referred to as LAG525) (Press release, Prima Biomed, JUL 17, 2017, View Source [SID1234519818]).

The LAG525 antibody is currently being evaluated in clinical trials together with Novartis’ PD1 inhibitor PDR001 for the treatment of cancer. Novartis has full responsibility for the continued development of the antibody program and Prima is eligible to receive further potential development-based milestone payments and royalties on sales following commercialisation of the products.

Mr. Marc Voigt, CEO of Prima, commented "We are very pleased by the progression of the LAG525 program. It is wonderful to see our commercial partners continuing to progress the development of LAG-3 products. This announcement, together with the other clinical and non-clinical data published regarding other LAG-3 directed drug development programs over the past twelve months is very encouraging."

About IMP701
IMP701 is a therapeutic antibody originally developed by Immutep S.A.S to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and don’t address the Treg pathway.

IMP701 was licensed to CoStim Pharmaceuticals in 2012 which was subsequently acquired by Novartis in 2014.

On July 17, 2017 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it has entered into a commercial license and supply agreement with Amgen, granting rights to use Ligand’s Captisol technology in the formulation of AMG 330 (Press release, Ligand, JUL 17, 2017, View Source [SID1234519812]). Captisol is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. AMG 330 is an anti-CD33 x anti-CD3 (BiTE) bispecific antibody construct. It is being investigated as a treatment for acute myeloid leukemia by Amgen.

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This license agreement replaces the prior research agreement which allowed Amgen to evaluate AMG 330 with Captisol in preclinical and early clinical studies. Under this new commercial license agreement, Amgen receives exclusive worldwide rights to combine Captisol with AMG 330 for use in humans for a wide variety of therapeutic indications. In addition to an upfront payment, Ligand is entitled to potential milestone payments, royalties and revenue from future sales of AMG 330 formulated using Captisol.

"This agreement expands our license relationship with Amgen on AMG 330," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "Ligand’s portfolio of fully-funded shots on goal continues to grow and contains a large number of Captisol-enabled drugs targeted to a number of serious diseases with unmet medical needs."

About AMG 330
AMG 330 is an anti-CD33 x anti-CD3 (BiTE) bispecific antibody construct. It is being investigated as a treatment for acute myeloid leukemia by Amgen.

On July 17, 2017 Cancer Prevention Pharmaceuticals, Inc. ("CPP") reported the launch of a Phase 2 clinical trial at Vanderbilt University Medical Center to evaluate CPP-1X in patients with precancerous gastric lesions who are at high risk for gastric cancer (Press release, Cancer Prevention Pharmaceuticals, JUL 17, 2017, http://canprevent.com/wp-content/uploads/2013/08/Gastric-Cancer-Trial-and-Orphan-Designation-2017-07-17.pdf [SID1234519811]).

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The trial is funded by the National Cancer Institute (NCI) and run in collaboration with Keith T. Wilson, M.D., and Douglas R. Morgan, M.D., MPH, of Vanderbilt University School of Medicine, Vanderbilt University Medical Center, and the Vanderbilt-Ingram Cancer Center. This randomized, double-blind, placebo-controlled pharmaco-prevention trial will enroll 300 patients. Each patient will receive daily treatment for 18 months to determine the drug’s effectiveness in ameliorating DNA damage in patients with premalignant atrophic gastritis or intestinal metaplasia. This trial is an initial step in a program to determine if CPP-1X can prevent gastric cancer.

In 2015, CPP received Orphan Drug Designation for CPP-1X for the treatment of gastric cancer including cancer of the gastro-esophageal junction from the U.S. Food and Drug Administration (FDA). CPP was also granted orphan designation in familial adenomatous polyposis and neuroblastoma in the United States and Europe Union.

"Our mission is to develop new therapeutics that focus on the prevention of cancer and its recurrence," said Jeffrey Jacob, CEO of CPP. "We are pleased to collaborate with the NCI and leaders in gastric cancer prevention at Vanderbilt University to evaluate the potential of CPP-1X in reducing the progression of precancerous lesions in high-risk patients, and thereby help prevent gastric cancer."

"Currently there are no agents for the prevention of gastric cancer in patients with precancerous conditions of the stomach," said Dr. Wilson. "Gastric cancer, which is also known as stomach cancer, is the third leading cause of cancer-related deaths in the world, and we need prevention options for these patients," added Dr. Morgan.

The American Cancer Society estimates the incidence of stomach cancer in the United States in 2015 to be about 24,590 cases, and about 10,720 people will die from this type of cancer this year.

CPP’s pharma partners have certain rights to CPP’s combination product CPP-1X/sulindac. CPP1X as a standalone therapy is owned exclusively by CPP.

On July 17, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that the U.S. Food and Drug Administration (FDA) has approved NERLYNX (neratinib), formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy (Press release, Puma Biotechnology, JUL 17, 2017, View Source [SID1234519809]). Puma expects neratinib to become commercially available in September 2017 and to be marketed as NERLYNX.

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FDA approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. Women (n=2,840) with early-stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.

The results of the ExteNET trial demonstrated that after two years of follow-up, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008).

The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.

"The fear of recurrence is ever present in the minds of most women with breast cancer, from the moment they are diagnosed to long after they finish adjuvant treatment," said Marisa C. Weiss, M.D., Chief Medical Officer and Founder of Breastcancer.org. "New and effective innovative therapeutic options provide huge hope to patients and their families, giving them a better chance of overcoming breast cancer with a chance for a full life."

"Despite advances in the treatment of early stage HER2-positive breast cancer, there remains a need for further therapeutic improvements in order to attempt to further reduce the risk of disease recurrence," said Puma Biotechnology CEO and President Alan H. Auerbach. "We are pleased to be able to bring this new medicine to patients with breast cancer. We would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial."

The full prescribing information for NERLYNX will be made available at WWW.NERLYNX.COM. The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first NERLYNX dose and continued during the first 2 cycles (56 days) of treatment and as needed thereafter. A Marketing Authorisation Application for neratinib is under review by the European Medicines Agency (EMA).

About HER2-Positive Breast Cancer
Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

Indication
NERLYNX is a tyrosine kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

Patient Support
Puma has developed the Puma Patient Lynx support program to provide patients and healthcare providers with assistance related to questions on accessing neratinib and referrals to resources that can help with reimbursement and financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or (1-855-816-5421).

Important Safety Information
There are possible side effects of NERLYNX. Patients must contact their doctor right away if they experience any of these symptoms. NERLYNX treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.

Diarrhea
Diarrhea is a common side effect of NERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 cycles (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:
· You should start taking loperamide with your first dose of NERLYNX.
· Keep taking loperamide during the first 2 cycles (56 days) of NERLYNX treatment and then as needed. Your healthcare provider will tell you exactly how much and how often to take loperamide.
· While taking loperamide, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.
· Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away.

Contact your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever.

Liver Problems
Changes in liver function tests are common with NERLYNX. The patient’s doctor will do tests before starting treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if your liver tests show severe problems. Symptoms of liver problems may include tiredness, nausea, vomiting, pain in the right upper stomach-area (abdomen), fever, rash, itching, yellowing of your skin or whites of your eyes.

Pregnancy
Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can harm your unborn baby. Birth control should be used while a patient is receiving NERLYNX and for at least 1 month after the last dose. If patients are exposed to NERLYNX during pregnancy, they must contact their healthcare provider right away.

Common side effects in patients treated with NERLYNX
In clinical studies, the most common side effects seen in patients taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased appetite, muscle spasms, dyspepsia, changes in liver blood tests results, nail problems, dry skin, abdominal distention, weight loss, and urinary tract infection.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or View Source . Patients and caregivers may also report side effects to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).
Please see Full Prescribing Information, available at www.NERLYNX.com .