Tag Archives: BMS

Business, Finance, Occupation & Industry

Bristol-Myers Squibb to Present New Data on Hepatitis C and Hepatitis B Compounds at The Internation

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Bristol-Myers Squibb to Present New Data on Hepatitis C and Hepatitis B Compounds at The International Liver Congress TM (ILC) 2013

  • New data on an investigational, all-oral, triple DAA regimen of daclatasvir, asunaprevir and BMS-791325 to be included in official ILC Press Conference on April 24
  • New ALT flare data further characterize profile of peginterferon lambda-1a (Lambda) as investigational treatment for Chronic Hepatitis B (CHB)
  • Breadth of data underscores Company’s commitment to advancing the treatment of liver disease

PRINCETON, N.J.–(BUSINESS WIRE)– Bristol-Myers Squibb Company (NYS: BMY) announced today that 14 abstracts on the Company’s research in liver disease have been accepted for presentation at The International Liver CongressTM 2013, the 48th annual meeting of the European Association for the Study of the Liver (EASL), in Amsterdam, April 24 – 28.

Key presentations include:

  • New Phase 2 data on an investigational triple direct-acting antiviral (DAA) regimen of daclatasvir (NS5A replication complex inhibitor), asunaprevir (NS3 protease inhibitor) and BMS-791325 (NS5B non-nucleotide polymerase inhibitor) in patients with hepatitis C (HCV) genotypes 1a and 1b. The regimen is being studied as a potential interferon alfa-, ribavirin- and ritonavir-free treatment option to avoid the tolerability and drug-drug interaction profiles of these medicines. These triple DAA data will be highlighted in the official ILC Press Conference on April 24.
  • An analysis of all available safety data on 1,100 patients who received daclatasvir plus interferon alfa and ribavirin in Phase 2 studies. These data support the ongoing Phase 3 development program for daclatasvir and further studies of daclatasvir as a component of DAA-based HCV treatment regimens.
  • A characterization of ALT flares observed in hepatitis B (HBV) treatment with the investigational interferon Lambda vs. alfa interferon, reflecting differing profiles for the two compounds. Lambda is being developed as a potential alternative for alfa wherever interferon is used in the treatment of either HCV or HBV.
  • An analysis of sustained virologic response with daclatasvir plus sofosbuvir, with or without ribavirin, in patients with HCV genotype …read more

    Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Vertex Enters Agreement with Bristol-Myers Squibb for Phase 2 All-Oral Studies of VX-135 in Combinat

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Vertex Enters Agreement with Bristol-Myers Squibb for Phase 2 All-Oral Studies of VX-135 in Combination with Daclatasvir for the Treatment of Hepatitis C

-Two Phase 2 studies to evaluate once-daily combination of Vertex’s investigational nucleotide analogue VX-135 and BMS’ investigational NS5A replication complex inhibitor daclatasvir-

-Study in people with genotype 1 hepatitis C planned to begin in second quarter of 2013-

-Study in people with genotypes 1, 2 and 3 hepatitis C, including people with cirrhosis, planned for second half of 2013-

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (NAS: VRTX) today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb Company (NYS: BMY) to conduct Phase 2 studies of once-daily all-oral treatment regimens containing Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C. As part of the agreement, Vertex plans to conduct two Phase 2 studies of the combination, including an initial study in treatment-naïve people with genotype 1 HCV infection planned for the second quarter of 2013. Vertex plans to begin a subsequent study in treatment-naïve people infected with genotype 1, 2 or 3 HCV, including those with cirrhosis, in the second half of 2013, pending data from the initial study.

“With more than 170 million people infected worldwide, there is a critical need for new hepatitis C medicines that can offer people simpler and more tolerable treatment regimens that provide high cure rates,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “These studies with daclatasvir will provide the first opportunity to evaluate VX-135 as part of all-oral regimens in people with multiple hepatitis C genotypes and in people with cirrhosis.”

Clinical Development Plans for VX-135 with Daclatasvir

Under the terms of the agreement, Vertex will conduct two Phase 2 studies of VX-135 in combination with daclatasvir. The first study will enroll approximately 20 non-cirrhotic, treatment-naïve people with chronic genotype 1 HCV infection and is expected to begin in the second quarter of 2013. In the second half of 2013, …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Pharmaceuticals: Just What the Dow Ordered

Leave a comment

By Jessica Alling, The Motley Fool

Filed under:

With uncertainty over the fate of the Cypress economy still looming, it’s fascinating that investors in both Europe and the U.S. are flocking back to the markets — suggesting they are confident that the situation will be resolved. The Dow Jones Industrial Average doesn’t mind; it jumped 65 points higher this morning on investors’ return to the Street.

With the Federal Open Market Committee scheduled to make its new policy announcements this afternoon, the market may get a little bit messy before the close of trading, but for now things are looking up. Since investors may be approaching banks with caution before the FOMC info is released later today, one sector has stood out as the early winner: pharmaceuticals.

Pfizer is the big winner this morning, up by 1.04% as of this writing. The pharma giant is being applauded for the recent approval of Uplyso, a plant-cell-expressed treatment for Gaucher disease, with Israeli-based partner Protalix Biotherapeutics. The drug, which was approved for use in Brazil, is the first of its kind for the treatment of Gaucher’s — it’s produced by Protalix’s plant-cell-based protein manufacturing system, which uses genetically engineered carrot cells. The U.S.-based Pfizer is coming under some scrutiny at home, however, as at least one U.S. sentator is questioning the price tag of the company’s oral rheumatoid arthritis medication, Xeljanz. The drug was approved by the FDA in November and is slated to hit the market soon, but its $25,000 annual cost seems a bit extreme to some.

Merck is also up this morning by 1%. Despite last week’s news about more delays for the company’s post-anesthesia drug, investors are happy about some more recent developments. Merck has entered into a collaboration with Bristol-Meyers Squibb for the promotion of Glucophage in China, as well as a deal with Nordic Bioscience to develop sprifermin for osteoarthritis of the knee. BMS and Merck will promote in China the diabetes drug discovered by Merck in order to gain a larger share of the growing diabetes-patient market in that country. For its collaboration with Nordic, Merck will develop and commercialize the new treatment, while Nordic Biosicences will provide clinical development services.

Outside of the Dow, beleaguered Affymax is up 4.76% this morning after shedding more than 60% yesterday. The company continues to struggle following the recall of its only drug, Omontys, a treatment for dialysis patients with anemia. The drug was recalled after it was linked to three fatalities during its use. The company has slashed its workforce by 76% and is weighing a decision to declare bankruptcy since the recall — and the investigation into the adverse reactions to the drug is only getting started.

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 …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

3 Big Concerns for the Pharmaceutical Industry

Leave a comment

By Sean Williams, The Motley Fool

Filed under:

It’s not uncommon for me to applaud the pharmaceutical industry as a solid long-term investment. Pharmaceutical companies offer relatively stable (but often impressive) margins; they cater to an aging population in need of treatment that is only growing; and many offer hearty dividends, which is perfect for those investors who are less risk-averse and looking to diversify their investment portfolio.

But, it’s not all cookies-n’-cream either. In fact, there are quite a few serious concerns that could threaten to sap pharmaceutical earnings and growth despite the positives which I’ve listed above. Today I’ll outline three scenarios that should be cause for concern among the pharmaceutical industry and discuss what’s being done by the sector to combat these threats.

1. Generic competition
The biggest concern on the mind of every pharmaceutical company shareholder is whether your company has the pipeline to survive “going over the patent cliff.” In 2012, an estimated $38.3 billion worth of drugs fell prey to the patent cliff and generic competition, with a minimal amount of branded medication replacing those now expired drugs, according to a research report put out by Accenture. The good news for pharmaceutical companies is that this trend in patent expirations versus replacement sales is expected to tighten by 2016, with just $17.8 billion in sales expirations projected. While promising, that still doesn’t solve the question of what pharmaceutical companies are to do now if their pipelines are in peril.

Generic drug producers bring a double-edged sword to the table. Not only do they get the privilege of receiving a shorter drug review process because they only need to prove bioequivalence to the branded drug, but generics are also ridiculously cheaper to produce than branded drugs since there’s no need for clinical trials — quickly wiping out 90%, or more, of a branded drug’s revenue stream within a year. Now I’m not saying generics don’t have their place, because I’ve had this discussion already and determined that low-cost generics are a smart addition to your portfolio, but it depends on how smart your pharmaceutical company is handling the oncoming cliff.

So far, Bristol-Myers Squibb and Eli Lilly have shown investors how not to handle the patent cliff.

Bristol-Myers has been intent on enhancing its “string-of-pearls” strategy, which involves purchasing new drugs into its pipeline. That strategy got the company a $1.8 billion writedown last year after its $2.5 billion purchase of Inhibitex in January 2012 turned out to be a dud. Inhibitex’s primary drug, later to be known as BMS-986094, for hepatitis-C was found to have caused a death in a patient and hospitalizations of numerous other patients. With the drug scrapped, Bristol-Myers has been left with egg all over its face. Perhaps the recent FDA approval of blood-thinner Eliquis will help change that, but I’m not holding my breath.

Eli Lilly, my selection for pharma’s most perilous pipeline, is in even a more precarious position. This year alone, Eli Lilly …read more
Source: FULL ARTICLE at DailyFinance