In the past week Bristol Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) have had two notably regulatory events for Apixiban, or ELIQUIS. On November 25th, the National Institute for Health and Clinical Excellence (NICE) made an unusually rapid decision to adopt and cover Apixaban for use by the state health service in the UK. This […]
ASH Stock Preview
2011 ASH Stock Preview It’s the end of the year, which can mean only one thing- the American Society of Hematology Convention is coming up! ASH is the year’s largest meeting for researchers and investors interested in hematology, or blood cancers. This year’s convention will be held from December 9th through 12th in sunny San […]
PFE & BMY – The anticoagulant market & the Apixaban Catalyst
Background: The market for anti-thrombosis agents is set for dramatic changes. A thrombus is an aggregation of platelets which plays a key part in several life-threatening diseases, such as myocardial infarction, stroke, deep-vein thrombosis, pulmonary embolism, stent thrombosis, as well as other medical conditions. The market for therapies against thrombosis can be broken down simply […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
DEPO – Buying Opportunity after Serada failure
Earlier in October, Depomed (DEPO), announced results from it’s Phase 3 trial, called BREEZE 3, testing Serada, an extended release gabapentin formulation for the use in post menopausal hot flashes. The trial failed to meet 1 of 4 primary endpoints, and failed to meet its key secondary endpoints. Below is an excerpt from Depomed’s press […]
INCY – Initiate Coverage on Incyte
Incyte Pharmaceuticals (INCY) Initiating Coverage: Incyte Pharmaceuticals is a small biotech company focused on developing treatments for cancer and inflammatory disorders. Lead compound Ruxolitinib (INCB18424) is awaiting FDA approval for the treatment of Myelofibrosis (MF) with an expected decision date on December 3rd. Ruxolitinib is also recruiting patients in a global Phase III study for […]
Run Biologics- The JAKs Are Coming
A new class of drugs targeting the JAK kinases is set to challenge today’s biggest selling biologics for the treatment of arthritis and other inflammatory diseases. Heading this class is Pfizer’s tofacitinib; this potent, but relatively un-selective JAK inhibitor demonstrated positive results in five pivotal trials earlier this year. Pfizer intends on filing for marketing […]
Opioid Pain Drug by Pfizer and Acura approved by FDA
The FDA has granted approval for an abuse-resistant opioid formulation made by Acura Pharmaceuticals (NASDAQ:ACUR) and Pfizer (NYSE:PFE). The drug is a reformulation of immediate release oxycodone. The trade name of the drug will be OXECTA, it was previously known as ACUROX. Pfizer’s media relations said that they can provide more information once the press […]
Good News For Pfizer Oral RA Drug
Pfizer announced results from two clinical trials of its JAK inhibitor, tofacitinib for rheumatoid arthritis at the European League Against Rheumatism (EULAR) in London on Wednesday. One study, a Phase III trial called ORAL Sync compared tofacitinib plus methotrexate to methotrexate alone in 792 patients with moderate to sever active RA who had an inadequate […]
Platform and Specialty Pharmaceutical Companies can bolster Big Pharma
The pharmaceutical industry is in a weak state, with an impending “patent cliff” that is forcing Big Pharma to reorganize and refocus. In 2011, roughly $20 billion in branded US sales dollars are “at risk” to patent expiry and generic competition. The pinnacle will be reached in 2013 and will subside after 2015. Fiscal Year […]
Pfizer moves forward with Pristiq for Hot Flashes
Last week, Pfizer (NYSE:PFE) announced that they had presented results from sub-study of Pristiq (desvenlafaxine) at the 59th annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG). The results were from a large, phase 3 trial, that sought to elaborate the safety and efficacy of Pristiq for the use in hot flashes […]
Pharma Companies Reformulate Pain Products: How Investors Can Benefit
In 2009, Purdue Pharma’s Oxycontin, an opioid pain reliever, reached annual sales that topped $3 billion. That represents a 300% increase over annual sales in 2001. Clearly, prescriptions for opioid drugs have increased without relent. But along with robust sales there has also been widespread and accelerating abuse. Tempering those abuses has been a focus […]
Depomed’s Stock Price Is a Gift Following FDA Approval of Pain Drug
Now that Depomed’s (DEPO) GRALISE has been approved by the FDA, making a bull case for Depomed becomes easy. GRALISE is an extended release gabapentin formulation, formerly DM-1796, that is prescribed once-daily for the treatment of post-herpetic-neuralgia (“PHN”), which is pain associated with shingles. Approval of GRALISE triggers a milestone payment of $48 million from […]
Investment Opportunities in Women’s Health
The next several months will be an exciting time for the women’s health space, with several important events that may represent an opportunity for investors. Most notably, Pfizer (PFE) has completed data collection for it’s 2186-patient study of Pristiq for the treatment of vasomotor symptoms, more commonly known as hot flashes. Wyeth, now part of […]
Serada Half Price Sale: DepoMed’s Stock Price Poised to Climb
Several weeks ago, DepoMed (NASDAQ:DEPO), a specialty pharmaceutical company, announced positive phase 3 trial results for the treatment of Post Herpetic Neuralgia (‘PHN’) with DM1796. But DepoMed’s news of success was soon eclipsed. Only one week later, the company announced that Serada didn’t meet its primary endpoints in two pivotal Phase 3 clinical trials for […]
Pharma companies looking to Women’s Health for growth
During menopause, women experience many symptoms associated with the natural change in hormone levels. Hot flashes and sexual dysfunction are the most prevalent symptoms, and if untreated can lead to sleep deprivation and even depression. Before the Women’s Health Initiative, women were effectively treating their menopausal symptoms with hormone replacement therapy. Since then, the medical […]
Wyeth drug shows promise in treating hot flashes
Today, Wyeth (NYSE:WYE) announced that their compound, bazedoxifene/conjugated-estrogens, significantly reduces the severity and frequency of menopausal hot flashes. Although the use of hormones has been associated with several potentially lethal side effects, Wyeth says that in this study, uterine bleeding was not statistically different from placebo and the rate of endometrial hyperplasia was less than […]
Pfizer expanding into emerging markets: Turkey
Rumors are buzzing in the pharma sector. Pfizer (NYSE:PFE) may be considering a takeover of Abdi Ibrahim, Turkey’s largest pharmaceutical company, demonstrating Pfizer’s shift from domestic markets to emerging markets. After it’s merger with Wyeth (NYSE:WYE), Pfizer’s executives organized at Castle Gray Skull and set it’s course to find it’s partners in the Middle East. […]
Women’s Health: Who can handle the heat for Hot Flashes?
After the Women’s Health Initiative there is an opportunity for new non-hormonal treatments for menopausal symptoms Some estimates believe this market may be up to $8 Billion USD Before the Women’s Health Initiative (‘WHI’), women were effectively treating their menopausal symptoms with hormone replacement therapy (‘HRT’), such as Premarin, Prempro and others. But since then, […]
