Impax licenses U.S. rights to AstraZeneca migraine drug, variations likely

Mark Hollmer — Wed, 01 Feb 2012 09:32:57 -0500

Impax Pharmaceuticals is paying AstraZeneca ($AZN) $130 million so it can license U.S. commercial rights for three versions of the migraine drug Zomig. Their agreement also allows for new variations of the treatment. The Hayward, CA-based outfit is a division of Impax Laboratories ($IPXL), which has a proprietary controlled-release drug delivery technology it uses to develop specialty generics and branded products. We can surmise that a controlled-release version of Zomig (or versions) is likely to come out of the deal, longer-term.

Impax announced the licensing deal on Feb. 1. and will pay the initial cash in quarterly payments throughout the year. In return, the company gains exclusive U.S commercialization rights to Zomig's tablet, orally disintegrating tablet and nasal spray drug delivery formulations. As part of the agreement, Impax also gains non-exclusive rights to develop new products containing zolmitriptan and market them using the Zomig brand name.

AstraZeneca stands to make even more money in the long run. Impax said it will fork over tiered royalty payments to AstraZeneca based on future sales of zolmitriptan-related products. So where does Impax stand to gain here? The company can count the gross profit of Zomig sales in the U.S. retroactively as of Jan. 1. Executives also plan to use the drug to help grow Impax's sales force as it develops its IPX066 Parkinson's drug.

Zomig, by the way, generated $163 million in net U.S. sales during the 12 months ending Sept. 30, 2011, according to Impax.

- here's the announcement

Engineers develop concentrated proteins to simplify, transform drug delivery

Mark Hollmer — Tue, 31 Jan 2012 17:49:47 -0500

Right now, protein biopharmaceuticals are fairly diluted and administered intravenously at a hospital. A group of researchers from The University of Texas at Austin promise to transform the nature of those drugs, with a densely packed group of proteins they've developed that could allow formulations for safer and more effective use at home.

The finding, detailed in the ASC Nano journal, is a long way from changing how drugs are formulated and delivered. More research will be necessary in animals and humans to prove the concepts true. But if subsequent research succeeds, it could transform how treatments are delivered for ailments from infectious disease to cancer and arthritis, the researchers argue. Rather than force a patient to sit at a hospital as cancer drugs or other protein biopharmaceutical treatments are administered intravenously, the new group of proteins is designed to allow for drug delivery formulations that patients could inject at home. The researchers believe that the new group of densely packed proteins could also allow for more precisely targeted and safer treatments.

Lead researcher Keith Johnston was bold enough to refer to the finding as "a disruptive innovation that could transform how we fight diseases." Johnston is a chemical engineering professor at UTA's Cockrell School of Engineering.

Basically, as researchers explain, they've developed a new physical form of proteins, packed into high concentrations but in nanometer-sized clusters. At that size, they could pass through a needle into a patient, the researchers believe. Further, unlike those in previous attempts, the new proteins are dense enough not to unfold or form aggregates that could harm patients, they note.

- here's the release
- read the journal abstract

AMT's Glybera, delivered through virus, faces Euro reg delay

Mark Hollmer — Tue, 31 Jan 2012 16:42:46 -0500

European regulators have slammed on the breaks and delayed an approval decision for Amsterdam Molecular Therapeutics' Glybera, a gene therapy delivered by an altered virus for patients with a rare condition that leads to recurrent pancreatitis.

This is where things get dicey. In delaying its decision, the European Commission wants more information first from the European Medicines Agency's Committee for Human Medicinal Products, which recommended against approving the drug in June, in part due to risk-related concerns. In an official statement, the Dutch company said it was "encouraged" that regulators want more data before making a decision, though regulators haven't set a final timeline for ruling on the matter.

"The ongoing debate shows that the authorities are determined to find the best process of dealing with such innovative treatments and technologies," AMT CEO Jörn Aldag said in a statement. In the meantime, the company said it is pursuing partnerships for its other treatments and slashing jobs by about half, based on the CHMP recommendation to decline Glybera's approval.

Glybera is designed to treat patients who face lipoprotein lipase deficiency, a rare inherited condition that can lead to dramatically higher levels of fat in the blood and repeated pancreatic inflammation. Those suffering from the condition have no other treatment option. Glybera is delivered through a single series of "small intramuscular injections" in the legs, according to the company's website. The drug carries a healthy LPL gene into the body in an altered adeno-associated virus that is drawn to muscle cells, the company explains. Muscle cells help build healthy LPL production.

- here's the release

Amylin gets FDA OK for weekly diabetes drug Bydureon

Mark Hollmer — Tue, 31 Jan 2012 12:11:59 -0500

Say hello to Bydureon, a once-weekly injectable treatment for Type 2 diabetes finally approved by the FDA on Jan. 27. Amylin Pharmaceuticals ($AMLN) developed the drug using controlled release drug delivery technology supplied by Alkermes ($ALKS). Amylin is billing the drug as the "first and only" weekly Type 2 diabetes treatment approved to date by the FDA, versus the standard twice-daily injections. Bydureon consists of biodegradable microspheres, which release a controlled amount of the drug over 7 days. Regulators previously rejected Bydureon twice before. Release | Story

Takeda abandons Euro rights to Durect's controlled-release pain drug

Mark Hollmer — Tue, 31 Jan 2012 11:09:50 -0500

For the second time this year, Durect ($DRRX) faces a setback over its controlled-release anti-pain drug Posidur.

The Cupertino, CA-based company disclosed that its European development and marketing partner for the drug is backing out. Takeda Pharmaceutical ($TKPHF) is giving back European product rights to the drug, which it had owned since its September acquisition of Nycomed. Just a few weeks ago, Durect endured a 30% drop in its share price, after announcing disappointing Phase III data from a 305-patient trial showing Posidur failed to provide a statistically significant improvement in pain levels. (Patients with abdominal surgeries took part.)

Posidur blends bupivacaine with Durect's Saber controlled-release drug delivery technology, which uses a high-viscosity base to enable controlled release. The treatment is delivered directly into a surgical wound, where it proceeds with a controlled release of bupivacaine for up to three days, according to the company.

CEO James Brown put an optimistic spin on the company's latest news. In a statement, he said he was "disappointed" that Nycomed/Takeda ended its partnership, but Durect will seek a replacement partner for the European and other markets. And as Brown told us at the J.P. Morgan Healthcare Conference, the company will analyze data from its Phase III trial, evaluate positive, additional trial data regarding hernia and shoulder pain and submit everything to the FDA by midyear as part of a pre-NDA meeting to discuss how to proceed.

Durect inked a $212.5 million U.S. licensing deal with Hospira ($HSP) in 2010, which Brown added he expects will continue.

- here's the Durect release

New drug delivery system slows water filtration, displaces air

Mark Hollmer — Fri, 27 Jan 2012 19:40:01 -0500

Scientists at Brigham and Women's Hospital in Boston and Boston University have concocted a new drug delivery mechanism that could work over a period of months, carrying a pain or cancer treatment. The system relies on extremely water-repellent materials and air, of all things.

For more details, read the Journal of the American Chemical Society. To get the short version, read on.

To start, the researchers built their system with superhydrophobic (water resistant) meshes derived from biocompatible polymers, created with electrospinning fabrication. They loaded an anti-cancer drug into the meshes, and then tracked its release in a liquid solution, as well as how the mesh performed.

Their in vitro study found that they affected the rate the drug releases by removing an air pocket inside the material. By releasing or keeping the air pocket they could control how fast or slow the compound discharged. What's more, the scientists also figured out that the process prevents immediate release of the drug and can maintain a steady discharge for some time, perhaps over a few months.

A drug delivery mechanism with that much staying power would come in handy for thoracic surgery or could help deliver drugs to prevent tumors from growing back after surgery, Yolonda Colson, director of the Dana-Farber Cancer Institute/Brigham and Women's Hospital Cancer Center, said in a statement. She and BU biomedical engineering and chemistry professor Mark Grinstaff mentored the study's main author, Boston University graduate student Stefan Yohe.

Much more research will be needed both in the lab and in subsequent trials, and scientists will also have to prove the delivery method is safe for use in people.

- here's the release
- read the journal abstract

Nanotech transforms cyclosporine into safer transplant drug

Mark Hollmer — Fri, 27 Jan 2012 14:23:55 -0500

Scientists are eyeing nanotech drug delivery as a way to help reduce organ transplant failures.

The Times of India reports that researchers at the University of Strathclyde in Scotland are working on a nano-sized drug particle version of cyclosporine, which is used already to help prevent organ rejection. Doctors would encapsulate the drug inside the nanoparticles to make sure it stays at its maximum concentration, and then trigger the compound to release slowly in order to avoid side effects the conventional dose can trigger, such as kidney and liver damage.

The drug is typically given orally or intravenously, and works by preventing the body's white blood cells from rejecting the transplanted organ, according to the Mayo Clinic.

Lead researcher Ravi Kumar explained that the experiment increased the level of the drug that becomes active in the system, but its slow release via the nanoparticles helped reduce any toxic effect on the kidneys.

Researchers will have to study this further, replicate the findings in people and ensure that the nanoparticles are safe and are not themselves toxic for long-term human use. But if successful, anything that can boost cyclosporine's safety profile will ultimately help ensure the success of organ transplants. The drug is also used to treat other conditions such as arthritis and lupus, Kumar told the newspaper, and so those patients could potentially benefit from a safer cyclosporine experience.

Details of Kumar's research are published in the Journal of Biomedical Nanotechnology.

- here's The Times of India story

Report: Roche transferring Israeli diabetes operations to Europe

Mark Hollmer — Tue, 24 Jan 2012 16:47:18 -0500

Less than two years after paying $200 million for diabetes pump developer Medingo, Roche's diagnostic division ($RHHBY) is shutting down the company and transferring its operations from Israel to Europe.

The Israeli newspaper Globes reported the news Jan. 22.

Roche's acquisition of the Israeli company gave it some nifty technology--a semi-disposable insulin-dispensing patch and a remote control to adjust insulin delivery. FierceMedicalDevices reported back in 2010 that Roche had hoped to launch the tech globally by 2012, assuming it received necessary approvals. Globes said that Medingo's tech, after a delay, is still slated to reach various markets within a few months.

As far as what will happen to Medingo and its 100 employees, Globes quotes "sources" as saying that Roche is consolidating insulin pump research and development activity in Europe as part of a substantial restructuring effort. Most of Medingo's employees have been offered new jobs in Europe.

Globes speculated that Israel's development capabilities were likely outweighed by Roche's need to cut costs.

- here's the Globes story

Related Article:
Roche pays $160M up front for diabetes tech

This could be the year of nanotech-enabled medicines

Mark Hollmer — Tue, 24 Jan 2012 16:09:16 -0500

Nanotech-enabled medicines are coming of age.

That's the big message I came away with after a recent telephone chat with Kevin Bitterman, a life sciences investor with Polaris Venture Partners in Waltham, MA.

He couched that statement with some history. Nanotechnology as it relates to life sciences generated buzz as early as 2000, Bitterman explained. But Polaris didn't make its first initial investments in the space until 2006-2008. And he sees some of those investments bearing fruit today, in a way that they may not have when the technology first gained attention.

Bind Biosciences is one Polaris portfolio company. It uses nano-engineering behind its targeted cancer therapeutics dubbed Accurins, which are designed to "selectively accumulate at the site of the disease." Another, Selecta Biosciences, a 2011 Fierce 15 company, is developing nanoparticle vaccines and was founded in part by the famed MIT researcher Robert Langer. It's focused on making targeted vaccines more effective by nanoparticle tech. A third--Cerulean Pharma--is developing nanotech for making market- and development-stage drugs safer and more effective.

Late 2011 saw each of those companies gain significant investor attention in a startup market that continues to otherwise struggle. Bind and Selecta each raised about $47 million from a Russian fund led by Rusnano and others to accelerate their various pipeline developments. Cerulean closed a $15 million Series D financing round in December to fuel a Phase II study of a nanotechnology-enabled oncology drug for non-small cell lung cancer.

Bitterman spoke subjectively, of course. But he said he believes that the new rounds of financings are "an indicator of the excitement in this space" after mixed results from drug-related nanotech in years past.

Nanotechnology-driven drugs haven't worked for a variety of reasons, such as use of the wrong polymer, toxicity, or problems with manufacturing and scaling up.

"It's no small feat to bring all of these pieces together," he said.

But Bitterman said Bind, Selecta and Cerulean, and other companies in Polaris' portfolio--and others in the space today--likely have learned from these challenges and engineered their products with these development issues in mind.

"You will finally be hearing about patient's lives being impacted by this technology," he told me. "That is going to be, at least for us, the story. Nantech is no longer the future. It is really the present."

We'll be watching closely to see how these companies' stories bear out. - Mark Hollmer (twitter | email)

University of Arkansas heightens nanomedicine research efforts

Mark Hollmer — Tue, 24 Jan 2012 11:44:12 -0500

Another player is joining the field of nanomedicine-related research and development: The Arkansas Nanomedicine Center. To be housed at The University of Arkansas' College of Medicine, the new institution will gather the university's 35-plus faculty members from various departments who are pursuing or thinking of pursuing nanomedicine-related research under one umbrella, according to Arkansas News. The goal is to encourage researchers from different disciplines with the same interests to work together toward figuring out innovative nanomedicine-related treatments that could cure disease or repair tissue damage. Story