Successful commercialized products have become one of the hottest new survival strategies for biotech pipelines in the new and continuously cautious venture capital environment. Dara Biosciences Inc., of Raleigh, N.C., is securing its future with the acquisition of a solid commercial oncology product through a licensing agreement with Innocutis Holdings LLC.

The agreement will transfer U.S. commercial rights to Bionect (hyaluronic acid sodium salt, 0.2 percent) in oncology markets to Dara. Bionect is FDA-approved for skin irritation and burns, and Dara plans to offer it for treatment of skin conditions resulting from radiation and chemotherapy.

Dara said licensing Bionect is part of its strategy to build a focused portfolio of niche products for oncology and oncology supportive care. It plans to launch Bionect in the second quarter of 2012.

In addition to becoming an instant income stream for Dara, the product launch will demonstrate the company's ability to commercialize a drug in that market.

Bionect is a low-molecular-weight hyaluronic acid, a natural component of connective tissues. It is approved for the treatment of skin irritation.

Skin conditions that are caused by radiation include erythema, desquamation, rash, pain, itching and ulceration. Chemotherapy can cause radioepithelitis. Bionect is approved for skin irritation, and Dara contended it has significant potential in the mostly untapped oncology markets.

Bionect isn't the only commercial product in Dara's pipeline. The firm recently acquired Oncogenerix Inc., gaining exclusive U.S. rights to Soltamox (oral liquid tamoxifen citrate) for breast cancer. It also purchased U.S. commercial rights for gemcitabine.

Changes in capital markets and "longer-than-expected development timelines" were the motivation for implementing the new strategy, according to Dara. It expects to book its first commercial revenues with the launch of Soltamox in the third quarter.

It also expects to profit from gemcitabine, and will be filing a U.S. abbreviated new drug application in late 2012. Branded sales of gemcitabine, sold as Gemzar by Eli Lilly and Co., were $780 million in 2010.

Dara is seeking other products, particularly generic injectables, to include in its portfolio. Each new drug will support margin and profit growth, without appreciably adding to general and administrative expenses.

The organization created around those products will eventually provide a soft landing for Dara's internal pipeline products, including KRN5500 and DB959.

In 2010, Dara reported data showing that its drug candidate, KRN5500, reduced pain and was superior to placebo. In a Phase II trial, it significantly reduced neuropathic pain compared to placebo, and was well tolerated with limited adverse reactions. It also yielded positive results in a Phase IIa trial for neuropathic pain in cancer patients, showing a larger median decrease of pain with touch and cold compared to placebo.

There are no FDA-approved drugs for neuropathic pain. Current therapies include gabapentin, Lyrica (pregabalin, Pfizer Inc.), opioids, antidepressants and antiseizure drugs, but those tend to work poorly and can have serious side effects. Dara estimated the market at $2.5 billion annually.

KRN5500 is an FDA-designated fast-track candidate for neuropathic pain.

Its PPAR delta/gamma agonist for Type II diabetes, DB959, completed a Phase I trial in 2010. Its safety was comparable to placebo, with no moderate, severe or serious adverse events. That drug progressed to a Phase Ib study for pharmacokinetics of multiple ascending doses.

Dara, a public company, has executed a number of public and private offerings of stock in order to raise money for ongoing operations. It also has struggled to maintain minimum requirements for listing on Nasdaq.

In 2009, it received a notice of noncompliance from Nasdaq that it did not meet the requirement of $2.5 million stockholders' equity. Its stock price trended downward over time until licensing and acquisition of commercial assets in 2012 began to turn it around.

Dara's stock (NASDAQ:DARA), enjoyed a modest bump of 12 cents, to close at $1.56 Monday.

XOMA Corp. is another company that is feathering the nest for its embryonic products with profits from in-licensed approved products. It acquired U.S. rights to hypertension treatment Aceon (perindoperil erbumine) and fixed-dose combinations (FDC) of perindopril and other antihypertensives from French drugmaker Les Laboratoires Servier SA. (See BioWorld Today, Jan. 19, 2012.)

XOMA's previous relationship with Servier allowed the two companies to develop gevokizumab (XOMA 052) motivated the establishment of XOMA's commercial operations, and those commercial operations could also help XOMA quite a bit when it out-licenses the other drugs in its pipeline. (See BioWorld Insight, Jan. 23, 2012.)

The strategy is not new, although Dara and XOMA have implemented it much earlier in the development pipeline than usual.

In 1994, Cephalon Inc. signed up to co-promote Bristol-Myers Squibb Co.'s STadol NS (butorphanol tartrate) to establish a neurology sales force before approval of Provigil (modafinil).

More recently, Acorda Therapeutics Inc. acquired the U.S. rights to Zanaflex (tizanidine) from Elan Corp. plc ahead of its approval of Ampyra (dalfampridine), which Acorda had already licensed from Elan. (See BioWorld Today, Aug. 3, 1994, and July 30, 2004.)