Daily Archives: March 8, 2017

- By Alberto Abaterusso

Janssen Research & Development LLC, part of Johnson & Johnson (JNJ) Pharmaceutical Research and Development reported last March 3 through the PRNewswire the results from two Phase 3 clinical trials, VOYAGE 2 and NAVIGATE.

During the studies the pharmaceutical company assessed its guselkumab for the treatment of adult patients affected by severe plaque psoriasis.

The patients treated with Janssen Research & Development's guselkumab achieved meaningful improvement in terms of skin clearance and other disease activity's measures versus the placebo and AbbVie's (ABBV) Humira (adalimumab).

At the end of the VOYAGE 2 clinical trial, in 84.1% of patients affected with severe plaque psoriasis and treated with Janssen Research & Development's guselkumab, a clear or minimal disease at week 16 was observed versus 8.5% of patients under placebo and versus 67.7% of patients taking Humira.

During the NAVIGATE clinical trial, the patients experienced a significantly greater improvement in skin clearance. These patients failed to respond adequately to an IL-12/23 monoclonal antibody (Stelara) and switched to guselkumab.

Results from VOYAGE 2 and NAVIGATE trials were presented at the 2017 American Academy of Dermatology Annual Meeting in Orlando, Florida, from March 3 to March 7.

The company says that "guselkumab is a human monoclonal antibody with a novel mechanism of action that specifically targets the protein interleukin (IL)-23 and is currently under review by health authorities in the U.S. and in Europe as a subcutaneously administered therapy for the treatment of adults living with moderate to severe plaque psoriasis."

Johnson & Johnson was trading at $123.61 per share Wednesday, down 22 cents or minus 0.19% from the previous trading day.

The 52-week range is between $106.07 and $126.07. The forward price-earnings (P/E) ratio is 16.79, and the stock is trading at 4.69 times its sales computed over the 12 trailing months period, at 4.64 times the book value and 13.01 times the EBITDA.

The stock is less volatile than the stock market with a beta of 0.68. It is uptrending and gained 7.48%.

As of Dec. 31, 2016, the company has $41.91 billion in cash on hand and securities and the total debt amounts to $27.13 billion, of which 82.6% is the portion of long-term debt.

The total debt to equity ratio is 38.52 versus an industry average of 11.52. The company is more indebted than its peers, however, the interest coverage ratio is 50.53. This means that the company can easily pay interest expenses on the outstanding debt.

Over the 12 trailing months time frame the company generated cash flow of $18.77 billion from its operations.

The free cash flow was $15.54 billion and part of this has been used to distribute dividends to the shareholders. Johnson & Johnson pays a quarterly dividend of 80 cents per share that leads to an annual dividend of $3.20 for a dividend yield of 2.59%.

The company has approximately 2.71 billion shares outstanding of which 0.02% is held by insiders and 67.30% by institutions.

Among the top institutional holders, the Vanguard Group Inc. stands out with 191,188,744 shares of Johnson & Johnson, or 7.03% of the company's total shares outstanding, valued $22.03 billion at Dec. 31, 2016.

AbbVie is trading at $64.12 per share, up 43 cents or plus 0.68% from the previous trading day.

Disclosure: I have no positions in any stock mentioned in this article.

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Results of Johnson & Johnson's Psoriasis Clinical Trials Impressive - Yahoo Finance

Psoriatic Arthritis Risk Increased by Depression Among Patients With Psoriasis Clinical Pain Advisor (registration) Researchers from Canada have demonstrated that depression is a significant risk factor for progression from psoriasis to psoriatic arthritis (PsA). Led by Ryan Lewinson, MD, PhD, from the Cumming School of Medicine at the University of Calgary, Alberta ...

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Psoriatic Arthritis Risk Increased by Depression Among Patients With Psoriasis - Clinical Pain Advisor (registration)

EAST HANOVER, N.J., March 6, 2017 /PRNewswire/ --Novartis announced today a new analysis (post hoc) of an uncontrolled extension study which shows moderate to severe plaque psoriasis patients treated with Cosentyx (secukinumab) rapidly regained clear or almost clear skin (Psoriasis Area Severity Index, PASI 100 or 90) following relapse during a treatment pause. The analysis also showed no anti-secukinumab antibodieswere observed during retreatment.1 PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in four regions of the body. Treatment efficacy is assessed by the reduction in the total score from baseline (i.e., a 75% reduction is known as PASI 75 and a 90% reduction is known as PASI 90). PASI 90 and 100 are higher standards of skin clearance compared to PASI 75. These findings were presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Fla., where Novartis presented over 35 scientific abstracts.

Previous data has shown favorable results for continuous over intermittent treatment, however sometimes patients have treatment pauses.3 This new analysis shows that if psoriasis patients relapse during treatment pauses, the majority can achieve previous high levels of efficacy after only 16 weeks of retreatment with Cosentyx.1

"It is very clear that patients get the best results from continuous treatment," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "However, if for some reason treatment has been interrupted, this analysis gives patients and clinicians the peace of mind that Cosentyx is likely to help people quickly achieve clear skin once again."

The data show the majority of patients with the highest response levels to Cosentyx (PASI 90, PASI 100) after one year of treatment on the 300 mg dose regained a high response level (PASI 75 or higher) 12-16 weeks after treatment re-initiation. For patients who previously achieved PASI 75 and relapsed after treatment discontinuation (n=136), this analysis shows that by Week 16 of retreatment with Cosentyx, 94% of patients regained a PASI 75 response, 79% of prior PASI 90 responders (n=117) regained a PASI 90 response and 67% of prior PASI 100 responders (n=67) regained a PASI 100 response. The median time to relapse was 28 weeks.1

In addition, the safety profile was consistent with that observed in previous studies. No patients in this analysis tested positive for anti-secukinumab antibodies. The most common adverse events (AEs) in the Cosentyx-treatment arm were nasopharyngitis (20.7 exposure adjusted Incidence Rate [IR] per 100 patient years), arthralgia (12.6 IR) and upper respiratory tract infections (12.4 IR).1

"This study addresses a common issue in clinical practice that happens when plaque psoriasis patients are on biologic therapy and have to stop for any number of reasons, and then re-start the biologic," said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center and lead study investigator. "Importantly, we found that stopping and re-starting Cosentyx led to good re-capture of clinical responses. Low immunogenicity associated with Cosentyx may offer a partial explanation of these results and warrants further analysis."

Cosentyx is the only IL-17A inhibitor approved in plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS), and more than 30,000 U.S. patients have been prescribed Cosentyx in the post-marketing setting across all indications.2

About Cosentyx (secukinumab) and interleukin-17A (IL-17A)

Launched in January 2015, Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.

Cosentyx is approved in more than 75 countries for the treatment of moderate to severe plaque psoriasis which includes the U.S., European Union countries, Japan, Switzerland, Australia and Canada. In the U.S., Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

In addition, Cosentyx is the first IL-17A inhibitor approved in more than 65 countries for the treatment of active AS and PsA, which includes the U.S. and European Union countries.

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Novartis is committed to ensuring patients and prescribers have access to Cosentyx. Cosentyx currently is covered on over 95% of U.S. commercial formularies across its three approved indications for plaque psoriasis, PsA and AS.4

About the Cosentyx retreatment study

An uncontrolled, extension study of ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), which compared Cosentyx with placebo, and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), which compared Cosentyx with placebo and etanercept. A total of 181 patients treated with Cosentyx 300 mg who achieved a PASI 75 response at the end of the core studies (Week 52) were re-randomized to receive placebo every four weeks until relapse. Upon relapse, patients were retreated with Cosentyx 300 mg.1

About psoriasis

Affecting about 7.5 million Americans, psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions (plaques), which can cause itching, scaling, and pain.5Patients reported these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult.6-8 Additionally, patients with psoriasis are at increased risk for other chronic illnesses.9

INDICATIONS

COSENTYX (secukinumab)is a prescription medicine used to treatadults:

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections

COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections.

Before starting COSENTYX, tell your doctor if you:

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel Disease

New cases of inflammatory bowel disease or "flare-ups"can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious Allergic Reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?

See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information, including Medication Guide.

DisclaimerThe foregoing release contains forward-looking statements that can be identified by words such as "launch," "can," "may," "launched," "committed," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Cosentyx, or regarding potential future revenues from Cosentyx. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Cosentyx will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Cosentyx will be commercially successful in the future. In particular, management's expectations regarding Cosentyx could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisLocated in East Hanover, NJ, Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis For Novartis multimedia content, please visit http://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com

References

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff

Julie Keenan

Novartis Global Media Relations

Novartis Pharmaceuticals Corporation

+41 61 324 7999 (direct)

+1 862 778 6367 (direct)

+41 79 593 4202 (mobile)

+1 862 926 9532 (mobile)

eric.althoff@novartis.com

julie.keenan@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central

North America

Samir Shah

+41 61 324 7944

Richard Pulik

+1 212 830 2448

Pierre-Michel Bringer

+41 61 324 1065

Thomas Hungerbuehler

+41 61 324 8425

Isabella Zinck

+41 61 324 7188

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novartis-cosentyx-shows-almost-all-psoriasis-patients-rapidly-regain-skin-clearance-following-a-treatment-pause-300418218.html

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Novartis' Cosentyx shows almost all psoriasis patients rapidly regain skin clearance following a treatment pause - Yahoo Finance