Parsippany, N.J-based Pacira Pharmaceuticals (NASDAQ: PCRX) announced today that the FDA approved its long-acting form of a pain drug called bupivacaine, which Pacira brands as Exparel. The approval marked a positive end to a bruising drug-development saga that began a dozen years ago. It also brightened up Pacira’s otherwise so-so third-quarter earnings, which the company also announced today. It said sales in the quarter dropped to $4 million from $4.5 million in the same quarter a year ago, and the quarterly loss widened to $9.5 million from $7.9 million.

Pacira—which maintains corporate offices in New Jersey and manufacturing and R&D operations in San Diego—expects to launch its new product in January to treat post-surgical pain. The company said in a statement today that the FDA approval was sufficiently broad to support an aggressive rollout to hospitals. The company also said that as part of a deal it formed in September, Durham, N.C.-based Quintiles will provide 63 salespeople to market the pain product.

Pacira started life as DepoTech, a San Diego company that developed a controlled-release drug-delivery technology called DepoFoam, which is part of the drug the FDA approved today. UK-based SkyePharma acquired DepoTech in 1998, but failed to manage it successfully, so a group of venture capitalists bought it in 2007 and reformed it as Pacira. Those VCs—MPM, HBM BioVentures, OrbiMed Advisors, and Sanderling Ventures—brought on board Dave Stack to run Pacira, primarily because of his success at The Medicines Company, where he helped turn the blood thinner bivalirudin (Angiomax) into a $400-million-a-year product.

When Xconomy met with Stack last May, he talked with us in a conference room bearing a sign that said “Exparel War Room,” which seemed fitting considering that he called the drug “the hardest thing I ever did in my life.” Indeed, getting to FDA approval wasn’t easy. In 2009, Pacira laid off a third of its workforce when the drug failed an early trial. Pacira pulled off an IPO in February of this year, raising $42 million, but the share price of $7 was about half of what Stack was expecting.

The company had expected to hear from the FDA on its bupivacaine product in July, but because the agency had requested additional information from Pacira, it extended the decision date by three months. Pacira’s shares dropped from $15 in late May to $9.56 as the FDA deadline approached. The stock went on a wild ride Friday as shareholders waited for the FDA news, zooming from a high of $11.10 to a low of $9.30 before settling to close at $10.18.

Pacira said today it expects revenues of $14 to $16 million for the year—about flat with last year’s results. Analysts on average expect the company to pull in revenues of $45 million next year.

Pacira’s shares were up 17 percent to $11.96 in pre-market trading today.

Comments (1) | Reprints | Share:          

Some powerful people in the pharmaceutical industry would like to see Brian Overstreet and his startup fall flat. Big pharma companies, on a few occasions, have told him to stop his spiel immediately, because they were afraid they could be put in a legally and ethically dubious position by hearing one more word.

When I told a Bay Area venture capitalist about Overstreet’s startup concept last week, it triggered a gut reaction. “I’d like to put that one out of business!” the VC said (I think half-jokingly. I think).

All the nervousness is coming from a new company called AdverseEvents.com, a Healdsburg, CA-based startup that seeks to bring order to the notoriously sloppy world of reporting on adverse events, the bad reactions people have to prescription drugs. The company, which emerged from stealth mode yesterday at the Health 2.0 conference in San Francisco, has devised a 17-step “data refinement process” to help doctors and health officials gather meaningful insights from the FDA’s adverse event records database known as Medwatch.

The current system—in which doctors voluntarily fax or e-mail forms about bad reactions they suspect are drug-related—has numerous well-documented flaws. Only about 500,000 reports are sent to the FDA each year, about one-tenth of the estimated number of actual bad reactions. And once reports get entered, they are littered with misspellings, misclassifications, incomplete entries, and incompatible file formats that make it extremely difficult to search the database. Those barriers have made it tough for the FDA, or anyone else, to spot the early warning signs of a dangerous drug until millions of people have been exposed, creating front-page scandals and highly litigious cases like the ones with the pain reliever rofecoxib (Vioxx) and the diabetes drug rosiglitazone (Avandia).

If AdverseEvents.com can iron out the problems in the Medwatch database, and become an online repository for simpler side effect reporting, it’s conceivable this little startup could someday become an essential online resource for tracking side effects of $1 trillion worth of prescription meds sold around the world. It’s the kind of data source that could make or break multi-billion dollar products, and in some cases, entire companies.

Brian Overstreet

“The FDA is making labeling decisions, product withdrawal decisions, post-market safety decisions based on raw data and it’s very clear there’s no way they can accurately do that,” Overstreet says. “It was a very scary moment when we realized that, but from an entrepreneurial standpoint, it’s a great opportunity.”

AdverseEvents.com, like a lot of health startups, got its founding inspiration from a personal experience. Overstreet, previously the co-founder and CEO of Sagient Research, became interested in the issue in January 2010 when a partner’s wife got sick from a bad drug reaction and ended up hospitalized. He and his partner did some basic Internet searches to find out data on rates and severity of side effects linked to the drug in question, and came up empty-handed. The only useful information came from the drug’s FDA-approved prescribing information, which is based on results from small, controlled clinical trials—not from real-world experience with the tens of thousands or even millions of people who may have been prescribed the drug.

The partner’s wife ended up … Next Page »

Comments (4) | Reprints | Share:          

Menlo Park, CA-based Nevro, which is developing a neuromodulation device for the treatment of chronic back and leg pain, said yesterday that it has raised $58 million in a Series B financing round led by new investor Johnson & Johnson Development Corporation. Existing investors Aberdare Ventures, Accuitive Medical Ventures, Bay City Capital, Mayo Clinic, MPM Capital, and Three Arch Partners also participated in the round. The startup said the funds will go toward a pivotal clinical study of the device’s effects in the U.S. and help support international commercialization.

Comments | Reprints | Share:          

New York-based drug giant Pfizer (NYSE: PFE) is acquiring Icagen (NASDAQ: ICGN), a biotech company based in Research Triangle Park, NC, for $56 million, according to a press release. The two companies have been collaborating since 2007 to develop new pain drugs that manipulate sodium ion channels. Pfizer already owned 11 percent of Icagen’s stock. The acquisition is expected to close by the end of the year.

Comments | Reprints | Share:          

When the Institute of Medicine (IOM) released its report on chronic pain late last month, medical device makers cheered.

“A landmark report,” a Boston Scientific press release gushed.

“Chronic pain is a major public health issue, and we applaud Congress [and] the IOM…for their thoughtful recommendations,” Medtronic senior vice president Tom Tefft said in a statement.

Mandated by President Obama’s healthcare reform law, the IOM report laid out ways for the country to improve research and treatment of chronic pain, a condition that affects 116 million Americans.

So why such a big deal to medical device companies?

First, let’s start with the obvious. Pain management, through neuromodulation devices that shoot electricity into the nervous system, has become big business for medical device industry, especially its Big Three: Boston Scientific, Medtronic, and St. Jude Medical. Any high profile report that highlights a potential market of 100 million-plus patients is a good thing for those companies, especially as sales in core devices like pacemakers and implantable cardioverter defibrillators (ICDs) slows considerably.

Take Boston Scientific, based in Natick, MA. Neuromodulation was one of the few bright spots for the company in an otherwise dismal fiscal 2010. Sales of neuromodulation devices, including Precision Plus spinal cord stimulation (SCS) therapy, rose seven percent to $304 million from 2009 while cardiac rhythm management sales (pacemakers and ICDs) dropped 10 percent to $2.1 billion.

Medtronic, headquartered in Fridley, MN, has high hopes for its RestoreSensor SCS device, set to launch in the United States the first quarter of fiscal 2012. The company estimates a potential worldwide market of $1 billion for the device, which can adjust the amount of electricity it shoots into the spine depending on the patient’s position (walking, standing, lying down).

And earlier this week, St. Jude Medical, based in Little Canada, MN, said the Food and Drug Administration approved a limited release of its Epiducer lead (wire) system for SCS therapy. The system allows doctors to insert multiple leads into patient through one entry point.

But the IOM report is noteworthy for two other reasons.

First, the report declares chronic pain to be a “significant public health problem.” While this may seem fairly … Next Page »

Comments (2) | Reprints | Share:          

Shares of Durect (NASDAQ: DRRX), a Cupertino-based developer of drug-delivery technologies, fell 30 percent in morning trading to $2.21 after the FDA handed a complete-response letter to licensing partner Pfizer (NYSE: PFE) on an extended-release version of the pain drug oxycodone. The product, called Remoxy, is being developed by New York-based Pfizer and Pain Therapeutics (NASDAQ: PTIE) of Austin, and it includes anti-tampering technology licensed from Durect. The project has suffered some regulatory hurdles, including a previous complete-response letter issued in December 2008. Pfizer said in a statement that it would work with the FDA to address the issues raised in the current letter. Shares of the New York-based drug giant dipped about 1 percent to $20.28.

Comments | Reprints | Share:          

There seemed to be a spate of financings among San Diego’s life sciences companies in recent weeks, and some local CEOs are telling me more deals are in the works. Your briefing begins now.

—San Diego has added another startup to its growing cluster of companies developing next-generation genome sequencing and molecular diagnosis technologies. BioNanomatrix, which has raised nearly $29 million to develop its proprietary nano-scale DNA mapping technology, said it has moved its headquarters from Philadelphia to San Diego’s Torrey Pines mesa.

—Awarepoint‘s new CEO, Jay Deady talked with me about his strategy for expansion at the company, which specializes in proprietary wireless real-time location system for tracking equipment and supplies in hospitals and other health care facilities. Deady, who has been working to raise another round of venture capital, has moved to diversify Awarepoint’s products and has beefed up the company’s sales reps and account managers.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: [[VRTX]]), which has substantial operations in San Diego, agreed to pay $60 million upfront, and as much as $1.46 billion in follow-on payments to license new hepatitis C drug candidates from South San Francisco-based Alios Biopharma. I got a note from the Latham Watkins law firm, which was involved in the deal, that says: “This is the largest partnering deal Latham has ever done, the largest preclinical deal in history, the largest [hepatitis C] deal in history, and one of the 5 largest deals overall in biotech history. Had the full economics been announced, it would have been the largest biotech deal ever.”

—Luke’s BioBeat column argued that Twitter has become too useful for biotech executives to ignore anymore, and I think the same argument could be made for executives in other industries as well. As Luke put it: “I’ve been careful to follow people that have valuable and relevant information to report and share, while unfollowing everything else. I’ve expanded my professional network around the world by having conversations with readers I never would have met any other way. I’ve gotten story tips. And this is all happening even while … Next Page »

Comments | Reprints | Share:          

Redwood City, CA-based AcelRx Pharmaceuticals, which filed paperwork last November for an initial public offering on the Nasdaq exchange, set its IPO terms in an updated regulatory filing yesterday. The company, which is developing oral pain-control medications as a replacement for patient-controlled intravenous pain treatments in hospitals, said it hopes to sell 5.77 million shares of common stock for $12 and $14 per share, bringing in up to $81 million in working capital. Alta Partners, Kaiser Permanente Ventures, Pinnacle Ventures, Skyline Ventures, and Three Arch Partners have put more than $66 million into the five-year-old company.

Comments | Reprints | Share:          

Seattle-based Omeros has raked in $25 million for its drug discovery technology from a couple of unusual suspects—billionaire Paul Allen and Washington state’s Life Sciences Discovery Fund.

Omeros (NASDAQ: OMER) is collecting $20 million from Allen’s investment operation, Vulcan Capital, along with a $5 million grant from the state fund that aspires to spur more commercialization of biotech ideas in Washington. In an unusual deal structure, both Vulcan and the state agency will have skin in the game with Omeros. Vulcan and the Life Sciences Discovery Fund will be eligible for a percentage of the future profits from partnerships Omeros signs, and they will stand to collect royalties on product sales if the technology paves the way for new drugs against targets on cells known as G-protein coupled receptors (GPCRs).

The deal provides an important new shot of cash for Omeros, which doesn’t have any moneymaking products on the market and didn’t raise as much capital for its drug development programs as it had hoped to in its IPO last year. The new financing will help Omeros push forward with its quest to identify ways to develop treatments that bind with more than 100 GPCR protein targets that have previously been considered “undruggable.”

An estimated 30 to 40 percent of all existing prescription drugs today are made to hit the more accessible forms of these targets, including big brand name therapies for allergies, pain, and mental illness. Merck’s loratadine (Claritin), Bristol-Myers Squibb’s aripiprazole (Abilify), and Purdue Pharma’s oxycodone (Oxycontin) are a few of the drugs that work this way. As anyone following the pharma business knows, companies are desperately looking for new blockbusters like that to replace the revenues they will lose in coming years as patents expire and cheap generic copies emerge.

By investing $25 million in the Omeros discovery technology, Vulcan and the Life Sciences Discovery Fund are essentially taking a piece of the action in a local company that thinks it has found a way to feed the pharma industry and satisfy its hunger for innovative new medicines.

“We see the Omeros GPCR technology as a major disruptive opportunity,” says Steve Hall, the managing director of Vulcan Capital. “Paul Allen is not a short term investor. We see potential to yield new innovation and returns over multiple decades.”

Steve Hall

Terms of the deal are unusual. Vulcan and the Life Sciences Discovery Fund will be eligible to get a “mid-teens” percentage of proceeds from any partnership income Omeros generates up to $1.5 billion. If Omeros generates $1.5 billion in cumulative proceeds from its GPCR program, Vulcan and the state agency will get a 1 percent slice of the subsequent revenue. Vulcan and the state agency will also get royalties on any products generated by the Omeros program. Vulcan is also getting warrants to buy shares in Omeros over the next five years at exercise prices of $20, $30, and $40 a share.

Investors may choke on their morning coffee today when they see those high warrant prices. Omeros, at Friday’s closing stock price, traded at just $7.30.

This is also clearly an unusual step for a state agency, but it’s not hard to see the underlying rationale. Washington state’s Life Sciences Discovery Fund has been whacked by 40 percent budget cuts by state lawmakers once before during the economic downturn. If Omeros can … Next Page »

Comments (1) | Reprints | Share:          

The big news: San Diego’s Orexigen inked a marketing deal around its obesity drug compound whose value could soar into the billions of dollars. We’ve got that and the rest of San Diego’s life science news for you here.

—Zogenix, the four-year-old San Diego startup that develops compounds for treating pain and central nervous system disorders, has filed for a $90 million IPO. The venture-backed biotech began marketing a treatment for migraines with its proprietary “DosePro” needle-free injector earlier this year.

—San Diego’s Orexigen Therapeutics (NASDAQ: OREX) awarded Japan’s Takeda Pharmaceutical an exclusive license to marketing Orexigen’s obesity drug combination of bupropion/naltrexone (Contrave) in the U.S., Canada, and Mexico. In return, Takeda agreed to pay Orexigen $50 million in upfront cash, as much as $1 billion in regulatory and sales milestone payments, and sales royalty payments of between 20 and 35 percent if the drug is ever brought to market in North America.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) said combining its drug candidate for hepatitis C with a standard treatment was able to cure 65 percent of patients who had not responded to a prior round of standard drugs alone. Vertex, which has substantial operations in San Diego, said more than 660 patients enrolled in its “Realize” study.

—San Diego Biopharmaceutical Halozyme Therapeutics (NASDAQ: [[ticker: HALO]]) today priced its offering of 8.3 million shares of its common stock at $7.50 a share, which would generate a total of almost $62.3 million to help fund further research and development of its product candidates. Halozyme has been developing products based on enzymes known as hyaluronidases that are a major component of both normal tissues, such as skin and cartilage, and tumors.

—Santarus (NASDAQ: SNTS), the San Diego specialty biopharmaceutical company, said it plans to launch a new Type 2 diabetes drug in the U.S. market this November. Santarus said bromocriptine mesylate (Cycloset) is the first FDA-approved drug for patients with type 2 diabetes to target the activity of dopamine, a chemical messenger between neurons within the central nervous system.

—San Diego’s ImThera Medical, which is developing an implantable device for treating sleep apnea, raised $1.3 million last month in a Series B round planned to total $3.5 million, according to a regulatory filing. ImThera CEO Marcelo Lima said in an e-mail that all funding in the round should be completed by next month, and came from high net-worth individuals. The startup, which I profiled in March, plans to use the funding to complete its European clinical trial studies.

Comments | Reprints | Share:          

San Diego-based Zogenix, which markets a needle-free injector for treating migraines, intends to raise $90 million through an initial public stock offering, according to a recent regulatory filing.

The biotech startup, which I profiled last month, has also been developing compounds for treating pain and central nervous system disorders, and plans to pair each new drug with its proprietary “DosePro” injector as a drug-and-device combination in seeking FDA approval. Zogenix CEO Roger Hawley told me the company has raised nearly $200 million ($164 million in venture funding and $35 million in debt financing) since it was founded in 2006.

Zogenix withdrew from a previous IPO filing that it submitted in 2008. Hawley told me last month the company required additional funding, and hinted that he wanted to get the Zogenix board to consider another IPO attempt.

Zogenix made the commercial launch of its migraine injector, which delivers the drug sumatriptan, in the United States nine months ago; it sells the drug-and-device combination as Sumavel DosePro, under a marketing agreement with Astellas Pharma. Zogenix says it also has entered into a partnership with Germany’s Desitin Arzneimittel GmbH to accelerate development and regulatory approvals in Europe.

The company also is in late-stage clinical trials for a formulation of hydrocodone, which Zogenix licensed from Elan, for treatment of severe, chronic pain in patients requiring around-the-clock opioid therapy.

In its filing with the SEC, Zogenix details its financial risks, saying the company is “largely dependent on the commercial success of Sumavel DosePro,” and has recognized just $6.1 million in net product revenue from January through the end of June. The company has incurred substantial losses since it was founded. It disclosed a net loss of $45.9 million in 2009 and $49.3 million for the first half of 2010, and shows accumulated debt of $173.8 million. The company also identifies extensive competition among large, well-capitalized companies offering treatments for migraines which, like Zogenix’s injection, are in the so-called triptan class. Zogenix says it expects its losses and negative cash flows to continue at least for several more years.

Comments (2) | Reprints | Share:          

It took centuries for the basic concept of a syringe—a plunger that fits tightly in a tube—to evolve into the medical hypodermic syringe, which uses a hollow needle to inject medication beneath the skin.

The founders of San Diego’s Zogenix say they have developed a faster and simpler method for subcutaneous injections—and on a much faster track.

The specialty pharmaceutical company was founded just four years ago, and won FDA approval for its combined migraine drug and needle-free delivery system in mid-2009. It began selling its sumatriptan delivery device in January, under a marketing agreement with Illinois-based Astellas Pharma that was announced last August.

Zogenix also found time since 2006 to raise a total of $199 million in capital ($164 million in venture funding and $35 million in debt financing) and to initiate a pivotal, late-stage trial of a controlled-release formulation of a second drug candidate, a novel tablet form of hydrocodone for long-term, chronic pain.

Suffice it to say, the company has accomplished a lot in a short time.

Roger Hawley

But Zogenix CEO Roger Hawley says it wasn’t exactly clear what technologies Zogenix would develop when he founded the startup with seed funding from some of San Diego’s most-prominent life science investors, including Cam Garner, the former chairman and CEO of Dura Pharmaceuticals. Hawley, who had previously worked at Brisbane, CA-based InterMune and Glaxo, says he met Garner after Elan had acquired San Diego-based Dura for $1.8 billion in 2000.

“Cam was sort of exiting Elan at the time when I was recruited,” Hawley says. They were both founding investors in the startup, along with Jim Blair of Domain Associates, Hybritech founder David Hale, and Scott Glenn, a former Quidel CEO who was then with San Diego-based Windamere Ventures. “We all put a little seed money into the company, and I started looking for a product,” Hawley says.

As it turned out, Hawley says the first product they looked at was a … Next Page »

Comments | Reprints | Share:          

Ascent Therapeutics, a Cambridge, MA-based pre-clinical stage drug development company, announced today that it has changed its name to Anchor Therapeutics to better reflect its technology. The company is developing drugs based on “pepducins,” which anchor in cell membranes to target molecules called G protein coupled receptors that are involved in ailments such as cancers, heart disease, inflammation, pain, and metabolic disorders. Anchor’s backers include HealthCare Ventures, Novartis Option Fund, and TVM Capital.

Comments | Reprints | Share:          

Cadence Pharmaceuticals’ plans to market an intravenous form of acetaminophen received another regulatory setback today. The FDA told the San Diego-based company that it could not approve the drug because of manufacturing problems at a plant where the drug is made.

The company’s shares dove nearly nine percent to close at $9.46.

Cadence (NASDAQ: CADX) said that the FDA discovered the problems during an inspection of the facility on February 5. The factory is operated by a third party manufacturer, which intends to respond promptly to the FDA, Cadence said.

In a press release, Cadence said it plans to request a meeting with the FDA to make sure the manufacturing deficiencies are addressed. The FDA did not request additional studies of the drug or raise any safety or efficacy issues, Cadence said. That’s a sign the setback could be temporary.

In November, the FDA extended by three months its deadline for completing its review of Cadence’s application to market the intravenous pain reliever. The deadline was extended to give the agency time to review additional clinical pharmacology data Cadence submitted at the request of the FDA.

Cadence developed the drug for use in hospitals as an alternative to opioid-based pain relievers, which can be habit-forming and can cause other side effects, such as constipation. Patients recovering from abdominal surgery can’t swallow the acetaminophen pills or capsules that are currently available.

Cadence plans to position its drug as a safer option to opioid drugs. However, acetaminophen also carries side effects, including … Next Page »

Comments | Reprints | Share:          

Cambridge, MA-based Javelin Pharmaceuticals (AMEX:JAV) has agreed to be acquired by Myriad Pharmaceuticals (NASDAQ:MYRX) of Salt Lake City in an all-stock merger, the companies reported last week. The merger agreement would initially give Javelin shareholders control of 41 percent of the stock in the combined company and up to 45 percent ownership of the merged firm depending on the timing of the potential FDA approval of Javelin’s lead anti-pain drug, an injected formulation of diclofenac (Dyloject). The merger, which is expected to close in the first quarter of 2010, has been approved by the boards of both companies but must also be approved by the shareholders of each firm.

Comments | Reprints | Share:          

Cambridge, MA-based Hydra Biosciences said today it has formed a partnership with Lexington, MA-based Cubist Pharmaceuticals (NASDAQ: CBST) to develop new pain medications. Hydra will receive $5 million upfront, plus another $5 million annually for two years to support Hydra’s R&D, with an option to renew the partnership. The deal focuses on Hydra’s work on ion channel compounds, specifically drugs that interact with the TRPA1 receptor that’s thought be related to pain.

Comments | Reprints | Share:          

One of the most common drugs in the world, acetaminophen pain reliever that’s found in Tylenol and Excedrin, got some bad press last week. An FDA advisory panel recommended new restrictions be placed on the drug because it can cause liver failure at high doses. So if you’re San Diego-based Cadence Pharmaceuticals, and the future of your business depends on marketing a new version of acetaminophen to hospitals, it wouldn’t be surprising if you were a little nervous.

But Cadence CEO Ted Schroeder didn’t sound the least bit rattled last week about the dynamics of the pain reliever market when I interviewed him and his newly hired commercial lieutenant, Scott Byrd.

Cadence is sharpening up its marketing game plan this year, as it spends the next few months vying for FDA approval of the first intravenous form of acetaminophen, called Acetavance. This drug will be pitched to hospitals as a safer alternative to narcotic pain relievers like Vicodin and Percocet, which can be addictive and cause constipation and other side effects. Lots of patients recovering from surgery can’t swallow the standard oral form of acetaminophen, and at $8 a dose, Wall Street analysts are expecting this could make Acetavance into a $500 million-a-year product. Cadence’s market research suggests that as many as 70 percent of patients undergoing surgery complain that drugs didn’t control their pain well enough afterwards, and the company is hoping to position its drug as a safer first option.

“Hospitals are under pressure to improve their pain management, but they’re also under pressure to reduce narcotic pain reliever use,” Schroeder says. “You can’t accomplish both … Next Page »

Comments | Reprints | Share:          

Cadence Pharmaceuticals (NASDAQ: CADX), the San Diego-based developer of a new pain medication, said today it has filed an application to seek FDA approval to start selling it in the U.S. The drug, an intravenous form of acetaminophen with the trade name of Acetavance, reached its goal of providing pain relief in a clinical trial. If approved, it would be the first new IV pain reliever approved in the U.S. in more than 20 years, the company said.

Comments | Reprints | Share:          

Alkermes is in the midst of a makeover. The Cambridge, MA-based company (NASDAQ: ALKS) is morphing from a steady-as-she-goes developer of technology that improves drugs for partners into a more classic biotech that swings for the fence. This means Alkermes is now getting in the high-risk and high-reward game that goes with developing new drugs on its own.

Today, the company is inviting analysts and investors to its headquarters for its first annual R&D day to give them a detailed rundown of what to watch for in the company’s pipeline. Late last week, I got a preview from CEO David Broecker, who wanted to talk about a couple of new drugs for alcohol addiction and pain.

Alkermes (ALK-er-meez) has been around since 1987, and has became known in the biotech industry for its expertise in making existing drugs more stable and longer-lasting in the bloodstream, which allows less frequent dosing. It licensed that technology to partners to help improve their products, and it scored a hit with a long-acting version of the schizophrenia drug risperidone, marketed by Johnson & Johnson as Risperdal Consta. That drug has become a $1.3 billion-a-year hit, has helped mentally ill patients stay on their meds better than older oral pills, and it has turned Alkermes into a consistently profitable company.

The company is trying to take advantage of that financial stability, by building up an internal R&D staff of 80 to 90 people with the capability to develop drugs from start to finish. Those people have been working on two specific drug candidates in very early stages of development that Broecker says he likes for alcohol addiction and pain.

“This is a coming out party for us,” Broecker says. “We’re not your father’s drug delivery company anymore.”

The story of Alkermes’ bid to develop its own drug actually traces its roots back to October 2006, when the company bought a library of experimental compounds from Rensselaer Polytechnic Institute in Troy, NY. These drug candidates were designed to block or stimulate opioid receptors on cells. That means they might have the potential to block pain in the same way that morphine does, and also treat addictive disorders.

The first drug that’s beginning to emerge from this library is called ALKS 33. This drug is designed to be a once-daily pill for people trying to kick an addiction to alcohol. What’s intriguing is that this drug isn’t broken down by the liver, like most other drugs. That can be a problem for people with alcohol addiction, who tend to already have damaged livers, Broecker says. Instead, this drug is filtered out via the kidneys, and excreted via the urine. The drug has the potential to be more potent, or effective in lower doses, than naltrexone (Vivitrol), the product Alkermes currently markets for treating alcohol addiction.

ALKS 33 has already passed through a preliminary clinical trial of 16 healthy volunteers, which shows … Next Page »

Comments | Reprints | Share:          

TorreyPines Therapeutics (Nasdaq: TPTX) says it has reduced its workforce to just three employees—the CEO, CFO, and Vice President/General Counsel. In September 2008 the company said it had 13 employees, which was down from more than 40 at the beginning of last year. The company, which was known as Neurogenetics until 2005, is focused on developing treatments for migraines. TorreyPines sold its Alzheimer’s research program to partner Eisai Co. four months ago.

Comments | Reprints | Share: