Thursday, August 7, 2014

Aspire Data A Big Plus For Amgen And Celgene

Amgen (NASDAQ:AMGN) released data from a planned interim analysis of the Aspire study that could lead to a significant sales boost. The late-stage multiple myeloma trial blew the doors off its primary endpoint of progression-free survival, or PFS. Patients receiving Kyprolis in combination with Celgene's (NASDAQ:CELG) Revlimid and low-dose dexamethasone -- abbreviated KRd -- reached a median 26.3 months without their disease worsening. That's 8.7 months longer than patients receiving Revlimid and dexamethasone without Kyprolis. Despite the fantastic results, the trial will continue as the positive trend toward overall survival hasn't reached statistical significance.
Fulfilling expectations
This is great news for Amgen as it jostles for a spot in the blossoming oncology space. It picked up the proteasome inhibitor just under a year ago, along with the rest of Onyx Pharmaceuticals, for about...
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Tuesday, August 5, 2014

SA: Momenta Pharmaceuticals Heading For A Repeat

While most promising young biotechs devote all resources to development of new drugs, Momenta Pharmaceuticals (NASDAQ:MNTA) is adopting a fairly unusual strategy of aiming for the middle. Its plan for developing biosimilars -- generic versions of complex biologics -- yielded short lived success in the past, and another winner is likely on the way.
Unlike small molecule generics, biosimilars have a much higher barrier to entry, offering jucier margins in return. Deep-pocketed partners Baxter (NYSE:BAX) and Novartis (NYSE:NVS) are eager to exploit Momenta's proprietary platform, as it may offer significant savings on development costs. If those savings don't materialize, Momenta could find itself in trouble.
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Sunday, February 2, 2014

Portola Pharmaceuticals Inc's Anticoagulant Gamechangers

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In a few years, Portola Pharmaceuticals (NASDAQ: PTLA  ) might be selling a leading thrombosis prophylactic, as well as a much needed antidote for the medication. In an effort to bring its antidote to the market quickly, the company may also benefit Bristol-Myers Squibb (NYSE: BMY  ) ,Pfizer (NYSE: PFE  ) , Bayer AG, and Johnson & Johnson. Lets take a look at the company's experimental drugs and see how this scenario could play out.
A simpler anticoagulant
Portola Pharmaceuticals may soon turn the world of blood thinners on its head. Less than a year after its IPO, the company has an oral once-daily inhibitor of Factor Xa, named betrixaban, in a pivotal Phase 3 trial for the prevention of blood clots known as venous thromboembolisms (VBTs).
After various types of surgery, patients are typically given enoxaparin as an injection in a hospital setting. The drug itself is safe, but keeping it at an effective level in the bloodstream is difficult. Due to this difficulty, the therapy is typically stopped when they're sent home. Far too often, patients then develop blood clots that pose serious health risks and require rehospitalization.
Betrixaban is a pill that can be taken once daily to continue prevention of VBTs without extensive monitoring. So far, it appears to maintain effective levels in the bloodstream without going overboard. Payers often penalize hospitals if patients are rehospitalized shortly after their discharge. If approved, betrixaban is likely to be very widely prescribed, saving health care providers a bundle.
Inhibition on... inhibition off
Trying to prevent blood clots can create as many problems as it solves. Patients are often treated with Factor Xa inhibitors, like betrixaban, suffer uncontrolled bleeding episodes or require emergency surgery. In either case, the ability to switch off the inhibition of clotting factors can save a life. Unfortunately, physicians do not have an effective switch, but Portola is developing the first.
Portola's most groundbreaking candidate is andexanet alfa, a recombinant protein designed to reverse the anticoagulant activity of Factor Xa inhibitors. Last May, this therapy became the first to...

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Saturday, February 1, 2014

How Sangamo BioSciences, Inc. Is Partnering to Success

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Several years ago, Sangamo BioSciences (NASDAQ:SGMO  ) made a big splash when it began clinical testing for its novel HIV therapy. Results so far have been promising, but this therapy is still in mid-stage development. Luckily, Sangamo's proprietary discovery platform has since attracted attention and licensing deals from the likes of Shire(NASDAQ: SHPG  ) and more recently Biogen Idec(NASDAQ: BIIB  ) . Lets take a closer look at these partnerships and see if they can eventually allow Sangamo to advance its own pipeline.
Curing chronic blood disorders
When it comes to outcome-based medicine, Sangamo has a platform that should have a large market opportunity. The company owns a gene-editing technology based on zinc-finger proteins (ZFPs.) The fingertips can be engineered to bind a specific sequence of DNA. The company insists that it can permanently switch the expression of any gene on or off.
The whole idea sounds a little too good to be true, but innovative powerhouse Biogen has been convinced to the tune of a $20 million upfront payment. The companies recently announced a partnership to develop beta-thalassemia and sickle cell therapies. The basic terms of the deal leave Sangamo responsible for research and development activities until it can be proved to work in humans. Biogen Idec would take the reigns at that point, providing Sangamo with milestone payments up to $300 million and...

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Friday, January 31, 2014

What to Look for When Pfizer Inc. Reports Earnings

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Pfizer's  (NYSE: PFE  )  earnings call is coming up on Tuesday, January 28, just after the market opens. Losses from generic competition, an ongoing organizational overhaul, and string of recent downgrades will make this one of the most listened to calls of the season. With this much attention, there is likely to be a great deal of noise immediately following the call, but here are a a few critical points to help you focus on the essentials.
Unloading generics
Halfway through last year, Pfizer discussed the separation of its commercial operations into three distinct units. Two units for patent protected brands and one for generics. According to Reuters, Valeant Pharmaceuticals (NYSE: VRX  ) , Mylan Inc (NASDAQ: MYL  ) , andActavis (NYSE: ACT  ) , are all interested, but there's a small problem -- they probably can't afford it.
VRX Free Cash Flow (TTM) Chart
Pfizer's generics operations are contained within its Established Products and Emerging Markets reporting segment. It hauled in about $14.5 billion during the first nine months of 2013. The odds of any one of the above companies raising enough cash to make an outright purchase are slim. Also, the sale of smaller pieces to interested parties would probably incur enough taxes to erode the sales' profitability.
The company could avoid the tax charges if...

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Thursday, January 30, 2014

GlaxoSmithKline and Personalized Medicine Take Another Leap Forward

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Earlier this month, the FDA granted an accelerated approval to GlaxoSmithKline (NYSE: GSK  )  for Mekinist and Tafinlar as an oral combination therapy for treatment of patients with inoperable melanoma. Merck  (NYSE: MRK  ) has a promising new compound that may give it some competition going forward. For now, this relatively straight-forward label expansion holds important lessons for pharmaceutical companies, and investors.
The FDA had already approved Mekinist for patients with BRAF V600E or V600K mutations, and Tafinlar for patients with BRAF V600E only. Although the National Cancer Institute estimates over 920,000 Americans are living with melanoma, this is the first approved combination therapy.
Vertically integrated
Glaxo's recently approved combination therapy requires a positive result from BioMérieux's THxID BRAF Kit. As the number of new medicines with required companion diagnostics continues rising, few companies are better positioned to take advantage of this trend than Roche  (NASDAQOTH: RHHBY  ) . The Swiss giant is the world leader in in vitro diagnostics, and has its eye on personalized medicine. Early last year it won approval for Kadcyla, a late stage breast cancer therapy it developed in partnership with Immunogen(NASDAQ: IMGN  ) . Roche's subsidiary, Ventana, will be providing the companion diagnostic for Kadcyla.
Competition from Merck
Glaxo's melanoma combo-therapy is likely to face competition in the future from Merck's PD-1 immunotherapy lambrolizumab (MK-3475). In November 2013, the company released compelling data. At one year, the overall survival rate was 81%. With numbers like this, it's likely that this therapy will hit the market, and it may hit sooner rather than later. Merck has initiated a rolling submission for lambrolizumab's biologics license application. This means the FDA is reviewing data as it becomes available in an attempt to speed this promising therapy into physician's hands.
Why specific is good
Melanoma is one of the most commonly diagnosed cancers, and about half of all melanoma patients harbor a BRAF mutation. Glaxo's combo therapy was approved fairly quickly based on results from a 162 patient, open-label trial with an objective response endpoint, not years of overall survival data. The drug's genetic specificity played a role in this relatively speedy approval.
As an investor, the advantages of an accelerated review are that...

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Wednesday, January 29, 2014

Can Pfizer Inc. Recover From Its Latest Lung Cancer Setback?

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Over the past several years, Pfizer (NYSE: PFE  ) has taken bold steps to streamline its operations and improve profitability after a wave of patent expirations. Focusing on the company's emerging oncology segment seemed like a great plan, until the recent failures of a lung cancer candidate with high expectations.
Dacomitinib is an epidermal growth factor receptor tyrosine kinase inhibitor, one of many tumor fighting drugs more commonly referred to as EGFR inhibitors. This experimental drug was expected to eventually put its non-small cell lung cancer (NCLSC) competitors on the ropes. Unlike Tarceva from Roche (NASDAQOTH: RHHBY  ) and Iressa from partners AstraZeneca (NYSE: AZN  ) and Teva (NYSE: TEVA  ) , Pfizer's unique therapy is irreversible and acts on multiple receptor types. Let's take a look at just how far this will set back the restructured pharma giant.
The prize
Combined, Tarceva and and Iressa racked up about $2 billion worldwide in 2012. Dacomitinib wasn't expected to be a blockbuster on the scale of a drug like Lipitor, which was Pfizer's most successful drug and formerly the top-selling drug in the world. However, dacomitinib's failed trials would sting much less if they occurred during earlier stages of development.
What went wrong
Not long ago, dacomitinib had the competition shaking in their boots. Results from a 188 patient trial released at the end of 2012 showed significantly stronger responses when compared to Tarceva. The problem with the drug wasn't safety or response rates, but...

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