Sunesis Signs Deal, Improves Pipeline Prospects

South San Francisco based Sunesis announced a license agreement on April 5 with Millennium Pharmaceuticals to develop its pan-Raf kinase inhibitor. Under the terms of this deal, Sunesis received $4 million upfront and potentially $60 million in milestones as well as royalties. Millennium will pay for all costs of the Phase I trial, after which […]

Personalized Medicine Is Rapidly Progressing

An article cited by popular blogger Derek Lowe from Nature News, noted the genetic diversity of tumor cells. The scientists compared the genome sequences of tumors from 50 estrogen receptor positive patients from two clinical trials of aromatase inhibitors. Of these, 26 were estrogen-sensitive tumors while 24 were resistant. The data was crunched with supercomputers […]

Xenoport Drug Horizant approved

Today, the FDA approved Xenoport’s (NASDAQ:XNPT) and GlaxoSmithKline’s (NYSE:GSK) Horizant (gabapentin enacarbil) for the treatment of Restless Leg Syndrome (‘RLS’). EfficacyThe efficacy of Horizant in the treatment of patients with moderate-to-severe primary RLS was demonstrated in two 12-week clinical trials in adults. Recommended DoseThe recommended dosage of Horizant  is 600 mg once daily taken with food at about […]

Cubist and Optimer Holding Hands

After yesterday’s 13-0 FDA advisory committee vote of confidence in Optimer’s Clostridium difficile infection (CDI) drug, now known as Dificid (fidaxomicin), the company has moved quickly to secure a co-promotion agreement with antibiotics maker, Cubist. The agreement calls for joint sales of Dificid to physicians in hospitals, long-term care facilities and other healthcare institutions in […]

Be You Own VC

Venture capital investing has always belonged in the realm of an elite group of investors such as high net-worth individuals and large pension funds. VC is most commonly used to fund the development of early stage companies with novel technologies and require long holding periods. While the chance of failure for each individual project is […]

Optimer Receives Nod From FDA Panel

Today, the FDA’s independent expert panel voted unanimously 13-0 that Optimer’s drug, fidaxomicin, is safe and effective for the treatment of Clostridium difficile infection (CDI). The panel was split six for, six opposed, and one abstaining on the question of whether the drug was effective in lower the risk of recurrence. Given the strong backing […]

Cubist Settles Patent Lawsuit- Reader Questions

First off, Cubist has just settled with Teva over their patent litigation that will prevent Teva from entering the market until 2018. More details on that later. I got a some very good questions from a reader regarding Cubist and Cubicin so I thought I’d share them. There were quite a few, so I’m cherry […]

POZEN Gets Going With Licensing Deals, Positive Clinical Data

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 […]

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 […]