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Amarantus Outlines LymPro Alzheimer's Diagnostic Development Strategy

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By Business Wirevia The Motley Fool

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Amarantus Outlines LymPro Alzheimer’s Diagnostic Development Strategy

SUNNYVALE, Calif.–(BUSINESS WIRE)– Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced a development timeline for its LymPro Blood Test for Alzheimer’s disease (“LymPro”). LymPro is designed to diagnose Alzheimer’s disease by identifying immune-based biomarkers in the blood of Alzheimer’s patients, allowing physicians to definitively differentiate Alzheimer’s disease from other forms of dementia, a key unmet medical need in the management of Alzheimer’s patients. Human clinical studies for LymPro with over 160 patients have been completed to date, showing high sensitivity and specificity for Alzheimer’s disease diagnosis.

“The LymPro assay represents a blood-based peripheral means to assess the integrity of the regulatory function of the cellular machinery within the Central Nervous System,” said Amarantus corporate advisor Adam J. Simon, Ph.D. “Although we all experience various triggers and assaults on our brain as we age, why do some people succumb to Alzheimer’s while others show cognitive resilience? The LymPro test can potentially tell us who is susceptible to abnormal cell-cycle re-entry and who has sufficiently strong regulatory function in their neurons to arrest cell-cycle re-entry due to triggers such as age, diet, viral infection, stress, or brain injury that could eventually lead to Alzheimer’s disease.”

After establishing the analytical performance of the assay in an outsourced GLP laboratory, Amarantus plans to conduct a small clinical performance study at an independent laboratory in the second quarter of 2013 to verify the previously published findings. During the third quarter of 2013, the Company expects to initiate a pivotal diagnostic accuracy study (Phase 2) at the same independent laboratory to generate sufficient data to validate the clinical performance (sensitivity / specificity) that would support a CLIA launch, with data available in the first half of 2014. As part of that pivotal study, LymPro will be evaluated as an “aid to the diagnosis of Alzheimer’s disease.” The Company intends to initiate commercial worldwide sales following assessment of the validation study data. Thereafter, the Company intends to gain U.S. clearance or approval for the test through the Food and Drug Administration‘s de-novo Pre-market notification 510(k) or Premarket Approval (PMA) process, which would represent a 3-month to 2-year process. Ultimately, the Company believes LymPro could be approved by the FDA as a companion diagnostic product in combination with one or more therapeutic products.

“We are excited with the progress and upcoming activities related to our LymPro Alzheimer’s test, which addresses a market opportunity in excess of $500 million annually,” said Gerald E. Commissiong, President and Chief …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Is Merck's Type 2 Diabetes Blockbuster in Trouble?

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By Maxxwell A.R. Chatsko, The Motley Fool

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For the last several years, Merck has been able to ride the success of its leading type 2 diabetes franchise Januvia/Janumet, which generated $5.75 billion in sales last year and represented more than 14% of total pharmaceutical revenue. The successful franchise has taken the top spot from Singulair in the titan’s product lineup and will continue to anchor the company for the foreseeable future. In fact, after Januvia and Janumet, only three products have shots at eclipsing $2 billion in sales in 2013.

This will be a tough year for Merck as Singulair experiences its first full year of generic competition in the United States and loses exclusivity in major European markets. The company is relying heavily on its type 2 diabetes drug franchise to offset as much stagnation as possible. While growth is expected, there is a wave of next generation competition that is about to hit the diabetes market. Couple that with new safety concerns for patients taking DPP-4 inhibitors and GLP-1 agonists and things could get messy. Are Merck and Januvia in trouble?  

A big-picture view
Understanding the big picture is important to understanding how Januvia’s vulnerability affects Merck. The company has taken a lot of heat in recent years for its expensive R&D program, which has swallowed almost $28 billion total and represents 19.6% of total revenue over the last three years alone. That means little without comparing it to competitors’ ratios, but investors and analysts can agree that returns have been lacking for such a massive budget.  

Merck does have bright spots in its product lineup such as Januvia, Gardasil, Zetia, and Isentress. Unfortunately, it also has a series of delays and gaffes in its pipeline. The company had a Food and Drug Administration, or FDA, decision on its next generation anesthesia reversal agent Suggamadex delayed until the second half of 2013. Some analysts expect an eventual U.S. launch to double annual sales to $575 million by 2016, but with several regulatory delays since 2008 some question if it will ever get the nod.  

Internal delays have also hit osteoporosis drug odanacatib, which analysts penciled in for $2 billion in peak annual sales. The series of hiccups forced Merck to can R&D chief Peter Kim for former Amgen chief Roger Perlmutter. It will take time to cut the fat off the company’s R&D program, but hopefully Perlmutter can revitalize and refocus the pipeline.

Hearing footsteps
As you can see, Merck has a lot riding on Januvia’s continued success. The drug has yet to falter in any major way and is generally accepted as one of the safest therapies for patients with type 2 diabetes. That could change with a recently concluded study — the first of its kind — linking the drug and Bristol Meyers Squibb‘s Byetta to a doubling in pancreatitis cases. The FDA has had past concerns with the two drugs, which increase levels of the hormone (GLP-1) responsible for insulin production.

It’s …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Pick Your Poison: Diabetes or Pancreatic Cancer

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By Brian Orelli, The Motley Fool

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The Food and Drug Administration warned Thursday that diabetes drugs might be elevating the rate of pancreatic cancer.

Investors shouldn’t be surprised. Nor particularly worried.

We’ve known for years that GLP-1 drugs increase the likelihood of pancreatitis. I wrote about an FDA warning about Byetta nearly five years ago.

Last month, a study in JAMA Internal Medicine showed that Byetta — which is now owned by AstraZeneca and Bristol-Myers Squibb after they bought Amylin Pharmaceuticals — and Merck‘s Januvia double the rate of pancreatitis.

Januvia is a DPP-4 inhibitor, but GLP-1 drugs and DPP-4 inhibitors work on the same pathway to lower glucose — DPP-4 inhibits GLP-1 activity — so it’s not surprising that they would have the same effect on the pancreas.

The latest warning comes from unpublished data shared with the FDA that showed inflammation and pre-cancerous cellular changes in pancreas biopsies from patients taking DPP-4 inhibitors and GLP-1 drugs.

Since it’s believed to be a class effect, the FDA warning extends beyond Januvia and Byetta to all the DPP-4 inhibitors and GLP-1 drugs: Novo Nordisk‘s Victoza, Bristol and Astra’s Onglyza, Takeda’s Nesina, Eli Lilly and Boehringer Ingelheim’s Tradjenta, and their combination products.

If the drugs were pulled from the market, it would be devastating to the companies, especially Merck since Jaunvia is a multibillion-dollar blockbuster. But investors shouldn’t worry quite yet. This is very preliminary data and “pre-cancerous cellular changes” doesn’t necessarily lead to a large increase in the rate of cancer.

It seems possible — dare I say likely — that the FDA will find that the drugs cause a small increase in the rate of pancreatic cancer, but that the benefits outweigh the increased risk. The agency will slap a warning on the drugs, and we’ll be back to business as usual.

Can Merck beat the patent cliff?
This titan of the pharmaceutical industry stumbled into 2013 and continues to battle patent expirations and pipeline problems. Is Merck still a solid dividend play, or should investors be looking elsewhere? In a new premium research report on Merck, The Fool tackles all of the company’s moving parts, its major market opportunities, and reasons to both buy and sell. To find out more click here to claim your copy today.

var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, …read more
Source: FULL ARTICLE at DailyFinance