Overview: Pharmacyclics is a mid-stage drug discovery company with several compounds in clinical development. The company’s major focus is a Bruton’s Tyrosine Kinase (Btk) inhibitor for non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma, PCI-32765, now in Phase II trials. It is in a broad program in testing against the major NHL subtypes both as monotherapy and […]
EXEL – Initiating Coverage on Exelixis
(Updated October 25th- MTC trial meets primary endpoint) Overview: Exelixis is a developmental stage oncology company with a single wholly owned compound XL184, or “cabozantinib” in Phase III trials for medullary thyroid carcinoma (MTC). This is a double blind placebo controlled trial with a final endpoint of progression free survival (PFS) initiated in 2008 after […]
INCY – Incyte: Q3 2011 Update
Incyte Corporation: October 27, 2011 Q3 Report Highlights: Incyte provided updates on its third quarter finances and key clinical programs this morning. The company is anticipating approval of ruxolitinib by the PDUFA date of December 3. Launch preparations are advancing; 60 reps have been hired. A request for modification of the Phase III RESPONSE trial […]
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 […]
Is Pharmasset The Next Gilead?
The HCV landscape is looking eerily similar to that of HIV treatments at its infancy, with a few differences. While the development of drugs for HIV took off quickly after identification of the disease, only now are truly effective therapies coming to market for HCV, led by pioneering work from Vertex. HIV drug development was […]
Niche Drugs Won’t Save Big Pharma
It seems many in the science community think niche drugs are the salvation for Big Pharma’s woes. With Pfizer’s crizotinib and Roche’s Zelboraf each expected to reach blockbuster status while targeting narrow populations, many are of the belief that future drugs should be aimed toward similarly small populations. This strategy is unlikely to generate consistent […]
Where Is Lilly In The PI3K Race?
Some 15 years ago, scientists at Eli Lilly discovered the first PI3kinase inhibitor, code name LY294002. Although only of modest potency and selectivity, it became widely used by the research community as a tool compound to elucidate the PI3K pathway. In recent years, the field has taken off with compounds in development for oncology and […]
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 […]
Antibody Engineering Wars
Therapeutic antibodies have been in use for decades now, becoming a mainstay for the treatment of cancer and inflammatory diseases. The molecules have evolved quickly through scientific advancements from simple mouse antibodies to complex humanized antibody-drug conjugates. Rapid growth in this category has grabbed Big Pharma’s attention, shifting its focus away from traditional small molecule […]
Borrowing Ideas In Drug Development
In the world of small molecule drug development, companies often talk about their large compound screening libraries or special chemistry platforms. You know the story: large numbers of compounds are tested against a target to generate hits, subsequent testing and manipulation narrow down the hits to a small number of leads. Finally, after passing many […]
Celsion- Approval Seems Likely
Celsion is working on a cancer therapy called ThermoDox, a heat sensitive liposomal doxorubicin formulation. The technology was developed as a way to target drug delivery to the tumor. Liposomes were designed to be stable at normal body temperatures but mild hyperthermia (increasing body temperature) in the range of 41 to 42°C would trigger the […]
YMI- Is It Investment Grade?
After taking a post-ASCO fall and sinking below $2.50, YM Biosciences is back near $3.00 with a couple assists from biotech columnist Adam Feuerstein, first naming it a top 10 pick for stocks under $300 million then in a separate article called it the best of the ten. Like many biotechs, YMI’s fortunes are tied […]
Exelixis- Why The Holdup?
Why so long to file an SPA (Special Protocol Assessment), investors wonder. An SPA in itself is not necessary, but sets up agreed upon protocols and endpoints of a pivotal trial that will be used to file for a new drug application (NDA). Having one in place may give the trial sponsor more confidence while […]
Cubist Unlikely To Acquire An Antibiotics Company
Now that Cubist has Teva off its back, its stock has risen from the low 20s to the mid 30s. It is often suggested as a takeover candidate, but with a large cash horde and a history of M&A activity, Cubist is just as likely to be the acquiring company. With a market cap of […]
On Eli Lilly And Innovation
Eli Lilly CEO John Lechleiter is calling for U.S. immigration officials to issue more green cards, saying a shortage of highly skilled immigrants is stifling innovation in the pharmaceutical industry. (Bloomberg) Really? Last I heard the industry has been on a firing binge, cutting back on R&D while outsourcing a multitude of functions to CROs. […]
AstraZeneca- How Much Longer Can It Go On?
A great article in the Wall Street Journal by Hester Plumridge AstraZeneca’s Too-Concentrated Solution talks about the company’s sale today of its medical devices unit AstraTech to Dentsply International. With the sale, AstraZeneca is focusing its resources the core prescription drugs business. This doesn’t sound like a good plan considering AstraZeneca doesn’t exactly have the […]
Dual-Targeted Kinase Inhibitors: The Next Wave In Cancer Treatments
Cancer drug developers have long waffled between the virtues of potent, highly specific inhibitors versus messier ones like Sutent; but there may be a middle ground. Today, multiple small molecules targeting receptor tyrosine kinases VEGF, EGFR, and HER2 have been approved along with a bunch of non-selective kinase inhibitors. The only successfully targeted non-receptor kinase […]
Exelixis May Have Competition For Its Prostate Cancer Drug
Bone metastases is a painful condition that occurs in about 90% of advanced prostate cancer patients and is associated with shorter overall survival. In the last few years, many advances have been made in the treatment of prostate cancer, with several new drugs approved and more on the horizon. Approved drugs include Provenge, Jevtana, Zytiga, […]
YM Biosciences Continues Post-ASCO Fall
YM Biosciences has taken it on the chin after its ASCO presentation failed to impress investors. Its stock is now down about 21% from a high of $3.78. The company has several projects but practically all its value is placed on lead JAK inhibitor CYT387, in development for the treatment of the blood cancer Myelofibrosis. […]
Pharmasset’s Backdoor Entrance Into The HCV Market
Another day, another upgrade. Today, it’s Citi increasing its target from $71 to $200. It would seem all the analyst must rely on the same numbers. The thesis here is Pharmasset’s lead wholly owned compound, PSI-7977, could get on the market as early as 2014 and the company could become profitable by 2016. Those are […]
