Written by LaVoie Group | 03 June 2013
Posted in Featured Coverage

CAPTURE: Compliance and Preference for Tamoxifen Registry Focuses on Gaining Insights Into Aspects of Tamoxifen Therapy in Breast Cancer Patients

June 3, 2013

RALEIGH, NC and CHICAGO, IL--(Marketwired - June 03, 2013) - DARA BioSciences, Inc. (DARA), a specialty pharmaceutical company focused on oncology supportive care products, announced today that the Company has enrolled eight U.S. oncology centers in its IRB-approved breast cancer patient registry study, CAPTURE (Compliance and Preference for Tamoxifen Registry). The registry is designed to gain valuable insight into adherence to prescribed tamoxifen treatment; patient preference for a liquid formulation of tamoxifen; and prevalence of difficulties in swallowing among breast cancer patients taking tamoxifen tablets.

DARA announced the study today at the American Society of Clinical Oncology (ASCO) annual meeting. DARA and its distribution partner, ONCO360, a leader in oncology pharmacy services, are located at Booth #12121.

Patient enrollment and recruitment for CAPTURE is underway. Up to 20 cancer centers in the United States and 620 patients are targeted for participation in this study. CAPTURE was initiated to support the recent launch of Soltamox® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen available for patients who prefer or need a liquid formulation of tamoxifen. Participating patients currently on tamoxifen therapy for breast cancer are asked to complete an online questionnaire.

The CAPTURE registry questionnaire asks patients about their adherence to prescribed tamoxifen therapy, whether they have a preference for a liquid form of the medication (Soltamox, tamoxifen citrate oral solution) or tamoxifen tablets and if they have any swallowing difficulties.

CAPTURE was developed in conjunction with DARA's Scientific Steering Committee, including two recognized leaders in the fields of oncology and breast cancer, Stefan Glück, M.D., Ph.D., Sylvester Distinguished Professor of Medicine, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, FL; and Jivesh Sharma, M.D., Presbyterian Hospital of Dallas, TX, and CEO of NEXGEN Oncology, Dallas.

"Soltamox is a new option for breast cancer patients requiring tamoxifen, and CAPTURE is an important initiative that will provide a compendium of data from a large cohort of patients to support physicians who prescribe tamoxifen. I believe key findings from this study will enable health care providers to better understand the complexities of patient adherence and the patient's preference or need for a liquid form of tamoxifen to potentially assist in long term tamoxifen compliance," Dr. Stefan Glück, Professor of Medicine said.

CAPTURE's key objectives are to:

• Understand patient preference for tamoxifen tablets or an oral tamoxifen liquid solution: Some patients may prefer one dosage form over another for ease of use or for other reasons;
• Ascertain whether patient participation in choosing their preferred dosage form may lead to better adherence;
• Correlate adherence to tamoxifen therapy with factors such as, age, ethnicity, history of smoking, alcohol intake, surgery, and radiation therapy;
• Understand patient adherence to long-term tamoxifen therapy and how it may be affected by swallowing difficulties; and
• Identify factors that might drive patient preference for the oral liquid form of tamoxifen therapy.

The Company expects to publish the CAPTURE data and to present it at scientific meetings. DARA also plans to share the results with clinicians in order to help them understand challenges facing patients with breast cancer, with the ultimate goal of treatment optimization and improved adherence.

Soltamox (tamoxifen citrate, oral solution) is bioequivalent to, and has the exact same label indications as, the tablet form of tamoxifen. Tamoxifen is indicated for the treatment of ductal carcinoma in situ (DCIS); as adjuvant treatment of node-positive breast cancer; in the treatment of metastatic breast cancer; and for breast cancer risk reduction in high risk women. Currently, there are more than 1.8 million prescriptions of tamoxifen written on an annual basis in the United States. Existing FDA-approved tamoxifen product labeling supports up to five years of treatment.

About DARA BioSciences, Inc .

DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products.

DARA increased its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, which is widely used in the treatment and prevention of breast cancer. Soltamox is the only FDA-approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who prefer a liquid formulation or cannot tolerate existing solid tablet formulations of this drug. DARA has exclusive U.S. rights to Soltamox through a license from Rosemont Pharmaceuticals, Ltd.

In June 2012, DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy. DARA has rights to market Bionect in the US oncology/radiology markets under license from Innocutis. Soltamox was launched formally as DARA's second commercial product in December 2012, coincident in timing with the 35th Annual San Antonio Breast Cancer Symposium. In late April, 2013, DARA launched its third product,Gelclair®, an FDA-cleared product for the treatment of oral mucositis for which DARA also has exclusive U.S. commercial rights through a license from Helsinn Group in Switzerland.

DARA is also developing a cancer-support therapeutic compound, KRN5500, for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN) in patients with cancer. This product is an excellent fit with DARA's strategic oncology focus, has successfully completed a Phase 2a clinical trial, and has been designated a Fast Track Drug by the FDA. DARA has created an improved, potentially commercializable formulation of this drug and is in active partnering discussions regarding further clinical development. DARA has also submitted an Orphan Drug Application to the FDA for the use of this drug in painful CCIPN.

For more information please visit our web site at www.darabio.com.

Safe Harbor Statement

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in DARA's most recent Annual Report on Form 10-K, filed with the SEC on March 28, 2013. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox®, Gelclair® or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect, Soltamox, Gelclair or other products in the U.S. or elsewhere, DARA's ability to develop and bring new products to market as anticipated, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the current regulatory environment in which DARA develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to successfully integrate Oncogenerix and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.

Written by LaVoie Group | 15 May 2013
Posted in Featured Coverage

Radius Health CEO: Skin Patch Data is the Value Driver

By Ben Fidler

May 13, 2013

 For Radius Health, it’s all about September.“[We] would have ended up inevitably giving away a lot of value if [we] tried to do this in one fell swoop and the one fell swoop would’ve been done in the IPO,” he says. “Once you’re a public entity, you could have spectacular results, and then something untowardly happens in Spain, and all of a sudden you’re kind of in the same mix [as everyone else].”

That’s when the Cambridge, MA-based biotech will unveil the mid-stage data on a version of its experimental osteoporosis drug, BAO58, which is administered through a patch affixed to the skin.

CEO Michael Wyzga makes no bones about it: the moment is huge for Radius, despite the fact that the patch isn’t the company’s most advanced drug program (an injectable version is currently in late-stage clinical trials). The way Wyzga sees it, good news could swing Radius’ value high enough to make its big move.

“It’ll be a killer drug when we get it out there,” says Wyzga, who was Genzyme’s CFO before joining Radius in December 2011. “As we go past that, we’ll see. But we’ll do it on the back of a good valuation and good results.”

Radius has raised $240 million in total funding through four separate financing rounds from investors such as MPM Capital, Brookside Capital, BB Biotech Ventures, and F2 Biociences III. F2 led its latest round last month, a $43 million haul just five months after Radius yanked a potential IPO.

Radius believes it can change the market for osteoporosis treatments by adding a skin patch armed with an effective anabolic drug to the mix.

Osteoperosis, a degenerative bone condition that the International Osteoperosis Foundation says affects roughly 200 million women worldwide, is typically treated with bisphosphonates such as risedronate (Actonel, Warner Chilcott) and ibandronate (Boniva, GlaxoSmithKline) that work by preventing the bones from decaying. Some patients who take bisphosphonates still suffer from bone fractures—about 2 million osteoporosis-related bone breaks occur in the U.S. alone every year, according to Radius.

This has left an opening for a new crop of drugs, such as Eli Lilly’s (NYSE: LLY)  teriparatide (Forteo) and Amgen’s (NASDAQ: AMGN) AMG-785 (still in clinical trials), that work by building up the bones rather than preventing them from weakening. Teriparatide posted $1.2 billion in sales in 2012.

Both of those drugs are administered through injections, however. While Radius has developed an injectable version of BA058 that is currently undergoing a 2,400-patient, 18-month late-stage clinical trial that will wrap up in late 2014, Wyzga believes Radius can unlock its real value after the data on the patch comes out later this year.

Truth be told, Wyzga would have no problem keeping Radius private. Private companies are familiar with their shareholders and have more decision-making flexibility regarding potential licensing deals or capital raising moves, he says. Wzyga, for example, recalls living through the messy Genzyme-Carl Icahn proxy battle, which ultimately led to the billionaire activist investor winning a few seats on the biotech giant’s board roughly a year before it was sold to Sanofi.

“Maybe I’ve been a little marked by that,” he says. “I think it’s always functionally easier to be a private company than a public company.”

Wyzga says Radius has been approached by strategic partners hoping to “get in front of the patch data.” But the company hasn’t budged or reached out on its own, and won’t anytime soon.

“I’m not an optimistic guy—as a matter of fact, most stuff doesn’t work,” he says. “[But] we are dangerously close on this patch data. We’ve made it so far.”

The $43 million Radius raised in April will get the company through the data release with another six or seven months to spare, which Wyzga believes will be ample time for Radius to make its move, assuming the data are good.

Wyzga concedes that, should the drug make it through clinical trials and win approval from regulators, Radius likely can’t—and doesn’t necessarily want to—build the necessary infrastructure to sell it on its own. That would appear to set Radius up for a buyout or partnership when the timing is right.

“I think it’d be a blast to build it out in the U.S., but I’m not sure we’ll get that far. And value maximization, I think, is the key to our current shareholders,” he says.

“If we could find a way to keep it private at least until that point and maybe until a little time after that, we surmise that we’re going to have pretty good results,” he says. “[And] we surmise that can be a pretty good value driver.”

Radius is a little fortunate that it will even be able to consider such a thing, because it would’ve been a publicly traded company by now if Mother Nature hadn’t stepped in.

Radius, which already reports its results publicly after merging with an unlisted shell company in early 2011, has toyed with the idea of an IPO for almost two years now without pulling the trigger. Radius announced plans to go public and raise $86 million in February 2012, and it set a range of $8.50 to $10.50 apiece for 6.5 million shares in October.

Wyzga says the company was all set to price at the end of October, but Hurricane Sandy barreled through New York City and shut down the financial markets for days. Radius thought of pushing the offering back a week, but that would’ve put its IPO right in the middle of the pre- and post-election market turmoil. So Radius passed, and ultimately yanked the IPO altogether in November.

Instead, the company raised $43 million privately in April, and now hopes that bit of luck will help it create more value in September.

Written by LaVoie Group | 09 May 2013
Posted in Featured Coverage

Rockwell Medical Set to Disrupt Dialysis Treatment with New Drugs, DaVita Deal

By Sarah Schmid

May 9, 2013

In the late 1990s, Wixom, MI-based Rockwell Medical revolutionized the dialysis industry by being the first to develop, patent, and bring to market a dry acid mixing system for hemodialysis concentrate. It eliminated the need for the bulky 55-gallon drums that were the industry standard at the time. Now, CEO Rob Chioini believes the company is prepared to disrupt the market again with a product that will significantly decrease the need for expensive erythropoietin stimulating agents (ESAs), drugs that treat anemia in kidney dialysis patients.

Currently in Phase 3 trials nearing completion, Rockwell's drug Soluble Ferric Pyrophosphate (SFP) is an iron salt adminstered to dialysis patients through dialysate to replace the iron lost during dialysis. Chioini says once in the dialysate, SFP enters the bloodstream and binds to apo-transferrin before being taken to the bone marrow, mimicking the way dietary iron is processed in the human body. Compare that to the current method, where the iron is injected into dialysis lines encased in a carbohydrate shell. That iron must go through the liver, causing a potentially adverse effect if too many carbohydrates build up in the liver.

In February, Rockwell released data from a nine-month study in the United States that randomized 108 patients equally to dialysate containing SFP-iron versus conventional dialysate.  The study found that SFP reduced the need for ESAs like Amgen's epoetin alfa (Epogen) during hemodialysis by 37.1 percent. On May 19, Rockwell will present the results of the study at the prestigious European Renal Association - European Dialysis and Transplant Association Congress in Istanbul.

Rockwell is also preparing to launch Calcitriol, an FDA-approved generic drug to treat secondary hyperparathyroidism in dialysis patients. Calcitriol's active ingredient is vitamin D, which Chioini says is one of the three main drugs used in dialysis along with epoetin alfa and intravenous iron.

Representing a combined $950 million market, Chioini believes SFP and Calcitriol will be game changers for Rockwell Medical. In 2011, the government changed its reimbursement rules. Before 2011, dialysis centers would receive a payment for the dialysis treatment and then an additional payment reimbursing the clinic for the drugs used. As a result, Chioini says, providers used the ost expensive drugs possible to bump up the reimbursement amount. Now, the government gives one lump payment to cover everything. "That's very beneficial for Rockwell because both of our drugs lower costs," he adds. "We expect to do really well."

Chioini is also feeling confident because of a national product supply deal Rockwell announced this week with DaVita, one of the nation's largest dialysis providers. Covering a five-year period, it will significantly increase the number of DaVita dialysis centers using Rockwell products.

As Rockwell waits for the Phase 3 clinical trials to be completed--one finishes this month, while the other one wraps in August--Chioini says the company is ready for all it has invested in bringing thees products to market to pay off. "We're moving along, ready for the next big event to occur," he says.