POZEN recently announced it had struck a licensing deal with Cilag GmbH, a division of Johnson & Johnson to develop and commercialize its migraine treatment, MT-400 in Brazil, Colombia, Ecuador and Peru. The company also reported positive data in a Phase I study titled Co-Rx of its combination aspirin/ immediate-release omeprazole tablet, PA32540 in conjunction […]
Cubist Has A Date With Teva
The date is fast approaching for Cubist’s face-off with Teva in its court battle over Teva’s Paragraph IV filing against Cubicin patents. A judge is set to hear their case in less than a month on April 25 unless the two parties settle beforehand. I’ve opined on multiple occasions that I do not believe Teva […]
Strategies and Outlook for Xenoport’s Upcoming FDA PDUFA Date
Within a week, Xenoport (NASDAQ:XNPT) and partner GlaxoSmithKline (NYSE:GSK) should receive feedback from the FDA regarding the NDA for Horizant, a gabapentin pro-drug for the treatment of Restless Leg Syndrome (‘RLS’). With several recent clinical trial failures, approval is paramount for Xenoport. Earlier this month, Xenoport announced that its ‘GERD’ product candidate, arbaclofen placarbil, was […]
Gilead Is On A Roll
It appears the tide is finally turning for Gilead Pharmaceuticals. After hitting a 52-week low of $31.76 in late August 2010, it has since rallied 30% to reach $41.30 on news of successful Phase III trials of its integrase inhibitor, though that is still well below the stock’s $48.44 high from March last year. Gilead […]
Despite Abbott Parting With Gralise, Depomed’s Future Looks Bright
During the past week, Depomed (DEPO) announced two significant business development updates. On March 15th, Depomed granted non-exclusive rights for its proprietary extended-release metformin patents, this time, to Boehringer Ingelheim. On March 16th, Depomed announced that they and Abbott (ABT) have reached an agreement over Gralise. Moving Forward From Abbott The details of the agreement […]
Seattle Genetics Consolidating Its Strong ADC Position
Today, Seattle Genetics announced a partnership with Abbott to develop a drug against a single target using their antibody-drug-conjugate (ADC) technology. Abbott will pay $8 million upfront and up to $200 million in milestones as well as royalties on worldwide sales, if any. This deal comes quickly after news of the expansion of an ADC […]
Idenix Not Worth The Wait
HCV is a highly lucrative space to be in right now- witness the huge spike in Pharmasset’s share price merely on the presentation of tantalizing Phase 1 data. An entirely new class of treatments are emerging, reshaping the HCV landscape and creating multi-billion dollar opportunities. The rush is on to create a better- no, the […]
Pozen Gets Social To Sell Drugs
Pozen is a small, unconventional drug developer with two approved drugs and another expected to soon follow. The company specializes in devising novel formulations of existing drugs, allowing for an easier path to regulatory approval and lower cost of development. Its migraine drug, Treximet, is a combination of sumatriptan (Imitrex) and naproxen, and arthritis drug […]
Why is Exelixis Shrinking?
Exelixis has skyrocked over 300% from its August lows to its current price of about $12 on positive news for its lead compound, cabozantinib in prostate cancer, giving it a market cap of about $1.3 billioin. It is now positioned to file an NDA for its initial indication of medullary thyroid cancer (MTC) in the […]
Calistoga and Plexxikon: Gone in The Blink Of An Eye
I discussed the merits of these company’s in a short post back in June last year (Calistoga Pharmaceuticals and Plexxikon- Two Biotechs to Keep an Eye On). I had hoped to see them become public companies because I saw promise in their technologies and wanted to participate in their upside. Too late. Both have recently […]
Cubist Pharmaceuticals: Lots of Cash and Low Valuation
This is the kind of company I like- cash rich and undervalued. Cubist Pharmaceuticals had $910 million in cash at the end of 2010 and a current market cap of approximately $1.3 billion. It had 2010 revenue of $636.4 million and anticipates full year 2011 revenue in the range of $680 to $700 million, about […]
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 […]
Bionovo Completes Financing, Announces Plan of Action: Is the Worst Over?
Earlier this month, Bionovo (NASDAQ:BNVI), a development-stage pharmaceutical company, announced a plan of action for its lead product candidate, Menerba, an oral, botanical, drug candidate for the treatment of menopausal hot flashes. In the press release, the company clearly communicated its goal with regards to Menerba’s development timeline (click to enlarge images): This new timeline is […]
FDA Setbacks Make Vivus a Buying Opportunity
Vivus (NASDAQ:VVUS), a specialty pharmaceutical company, has faced some setbacks with its drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA, outlining a path to approval, which left investors who expected approval dissappointed. In January 2011, the company met […]
Depomed: Attractive and Under-Appreciated Potential
It almost seems counterintuitive that majority shareholders of Depomed (DEPO) have been adding shares after the FDA approval of Gralise, a once-daily treatment for post-herpetic neuralgia. One might expect that large funds would look to the high volume created with an FDA decision as an opportune exit strategy. Yet that hasn’t happened, several funds have […]
Gilead Continues Move Into Oncology With Calistoga Acquisition
What a change a decade makes. Back in 2001, Gilead was a high-flying biotech, in the early legs of its growth projectory. Management at the time was laser focused on the company’s HIV franchise, deciding to sell its oncology assets to a little company called OSI Pharmaceuticals for $200 million. Since then, Gilead has grown […]
Genzyme Sold, Who’s Next?
Now that Genzyme has been acquired by Sanofi-Aventis, money managers have begun asking- where did all that money go? A Dow Jones Newswire article by Steven Russolillo reasoned that arbitrage players who held much of Genzyme shares have been quickly dividing that money between big and small name players for months now. Still, $20 billion […]
GSK Pursues Fabry Disease Drug as Orphan Indications Are All The Rage
Amicus has just signed a deal with GSK giving the large pharma worldwide rights to their Fabry disease drug, Amigal, in return for $60 million in upfront payments and $170 million in milestones. Patients are currently enrolling in a Phase III trial of Amigal, with preliminary results expected by the end of this year. This is fantastic […]
Eli Lilly: Plenty Of Talk, Now Time For Results
Eli Lilly CEO, John Lechleiter, Ph.D., has been making the rounds lately promoting innovation in pharmaceutical research. Most recently, he delivered the keynote speech at The Economist’s 2011 Pharma Summit: Reinventing Pharma for a New Generation this past February 10, in London. In his remarks, Lechleiter highlighted some of the problems facing the innovative drug […]
Alexion Goes From Acquisition Target To Acquirer
Alexion Pharmaceuticals reported revenues and major developments in its 2010 4th quarter report yesterday. Revenue continued climbing at a rapid clip, 2010 net product sales increased 40 percent to $541.0 million, compared to $386.8 million in 2009 and is projected to grow to between $715-$735 million in 2011. 2010 non-GAAP net income increased 54 percent […]
